Speakers

Distinguished speakers from health authorities, from the University of Freiburg, from the University of Strasbourg, from the European Directorate for the Quality of Medicines (EDQM) and from global and local pharmaceutical and biotechnology companies support the course by their contribution. They are internationally renowned experts providing distinctive expertise to the course participants.

The presentations impart relevant basic and specific knowledge, case studies are presented and discussed and interactive presentations allow the attendees to comment and discuss. By this the course is very lively, the participants benefit from the exchange between the group and the speakers. Presentation techniques are also trained among the participants as the results of the group work on case studies or home work are presented as part of the course.

In the following overview the speakers of the course are presented with their specific background and the topics they present in the course.

A | B | C | D | E | F | G | H | I | J | K | L | M | N | P | R | S | T | V | W

A

Eric Abadie

Euremed Consulting

Eric

Dr E. ABADIE is a physician. He has qualified in internal medicine, cardiology and endocrinology-diabetology in Paris university in 1981.

After having been resident and consultant in several Parisian hospitals, he joined the pharmaceutical industry, being international project manager at Roussel Uclaf, Director of development at Wellcome, and Director of Medical Affairs at SNIP. In this latter position, he represented the pharmaceutical industry in the main official committees at the Ministry of Health such as the Marketing Authorization, Transparency, Pharmacovigilance Committees.

In 1994, he joined the French Medicine Agency as Director of Therapeutic Evaluation Department. In 1995, he was appointed French member of the Efficacy Working Party, satellite of the CPMP. In this position he has been Rapporteur (and author) of several CPMP clinical guidelines in the field of diabetology, cardiology, osteoporosis, and central nervous system. In 1997, he became CPMP member. From 2001 until 2007, he has been vice chairman of the CHMP, and from June 2007 until April 2012 CHMP chairman. He has been also chairman of the Pharmacogenetics Working Party from 2001 until 2012. In the ICH process he has been the EU topic leader for the Common Technical Document, and ICH Steering Committee member until October 2007.

Since October 2012, he is consultant for the pharmaceutical and diagnostic industries.

He is the author of approximately 100 publications in clinical and medical science, member of the Editorial board of Cardiology (2005), and Associate Professor at the Tor Vergata University, Roma , in the Department of Epidemiology and Public Health, Liege University. He holds also a Master of Business Administration at the Centre de Perfectionnement des Affaires in Paris (1992). He has been nominated in 2003 Chevalier de la Légion d’Honneur.

Topic lectured:

Seminar 2

Stephane Andre

F. Hoffmann - La Roche

Stephane

Dr. Stephane Andre is Head of EU/International Regulatory Affairs of the Hoffmann - La Roche and Genentech integrated company in Basel as well as core member of the Drug Safety Committee. He has been working in the field of regulatory affairs since 17 years up to now. From 1995 to 1999 he was Associate Director in International Regulatory Affairs Liaison, Oncology, Anti-infectives, anti HIV drugs and Director and Head of the Corporate Regulatory Affairs Oncology Liaison Europe at Rhone-Poulenc Rorer. He was Vice President of WYETH Pharmaceuticals in USA from 2000 to 2007 and responsible for different fields, including Womens` Health and Clinical Trial Application. Since 2007 he worked as Site Head of Pharma Drug Regulatory at Hoffmann - La Roche and since 2009 he has been working as Head of the EU/ROW Regulatory Affairs for that company. He is responsible for the Basel regulatory teams, the collaboration with Chugai as well as the Welwyn site Regulatory teams to the EU team of Regularity professionals reporting to Basel team.

Topic lectured:

Seminar 8: Interactions of companies and agencies in the development of biopharmaceuticals

Michael Ausborn

F. Hoffmann – La Roche

Michael

Dr. Michael Ausborn is currently working for the Global Head Formulation Research pRED at F. Hoffmann – La Roche Ltd. Once absolved his PhD in Pharmacy he worked as PostDoc at the University of Florida. After several positions in the field of Drug Delivery in Germany and Switzerland he moved again to the USA and worked for the Novartis Center for Cell and Gene Therapy. From the year 2000 to 2004 Dr. Ausborn worked as Group Head Pharmaceutical Development Parenteral & Topical Dosage Forms, TR&D at Novartis Pharma AG in Basel. 2005 he became Head of the Pharmaceutical & Analytical Research & Development at F.Hoffmann-La Roche Ltd, Basel where he is still working in another position.

Topic lectured:

Seminar 4.1: Formulation and drug product manufacturing of biopharmaceuticals

B

Violetta B. Kyburz

Fishawack Archimed AG, Basel/Zofingen

Violetta

Violetta B. Kyburz has more than 30 years of experience in the pharmaceutical and biotech industry. She is a seasoned senior executive with in-depth knowledge in the areas of strategy, leadership, transformation, and project management. She is also experienced in due diligence processes, in the evaluation of innovative product ideas and business models.

Violetta holds a bachelor degree in business administration and a MAS diploma in Business Psychology. In addition, she has been trained at the Ashridge Business School and London Business School.

Topic lectured:

Seminar 9

  • Psyhological aspects of project management

Matthew Baker

Antitope Ltd.

Matthew

Dr. Baker is a founder and the Chief Scientific Officer of Antitope Ltd, a Cambridge (UK) based company which specializes in assessing and reducing the immunogenic potential of biologics. He has held senior management positions at a number of companies including Biovation (subsidiary of Merck KGaA), CTL Ltd and Whatman BioSciences. As an academic researcher Dr. Baker has a background in B and T cell immunology and completed post-doctoral positions in Cambridge, UK after obtaining his PhD in cellular immunology at University of Birmingham, UK.

Topic lectured:

Immunogenicity Integrated - Interactive Workshop: Understanding the mechanisms involved in immune responses to therapeutic proteins

Raffaella Balocco

WHO

Raffaella

Dr. Raffaella Balocco is a pharmacist Doctor and has a PhD in Pharmacology.

She worked at the "Mario Negri Institute for Pharmacological Researches in Milan before joining WHO in 1992.

From 1992 to 2001 she worked in the regulatory support Unit within WHO and travelled all around the world in particular in EMRO (Eastern Mediterranean Region) and AFRO (Africa) Countries. Since 2001 she is the Manager of the International Nonproprietary Names Programme in the Department of Essential Medicines and Pharmaceutical Policies.

Topic lectured:

Seminar 4.1: International Nonpropriatory Name (INN) of biopharmaceuticals

Andreas Bechthold

University of Freiburg

Andreas

Prof. Dr. Andreas Bechthold has been working in the field of pharmaceutical biotechnology since more than 20 years. As postdoc he worked in Seattle, USA and in Kyoto, Japan. After his habilitation in 2000 he moved to Kiel and in 2001 he became Head of Pharmaceutical Biology and Biotechnology in Freiburg. He is cofounder of Combinature-Biopharm AG, a biotech company located in Berlin. The last three years he was Dean of the Faculty for Chemistry, Pharmacy and Earth Science. Andreas Bechthold is pharmacist with a Ph.D. in pharmaceutical biology from the Bonn University.

Topic lectured:

Glyn Belcher

PV Consultancy UG

Glyn

Dr. Glyn Belcher has over 30 years experience in clinical development and drug safety in the pharmaceutical industry. Dr. Belcher qualified in medicine from Oxford and Cambridge and received his PhD in neuropharmacology from the latter university. After a number of years in hospital internal medicine he joined Schering and worked in clinical research in the UK affiliate before moving to headquarters in Berlin, first as Head of Cardiovascular Clinical Research and later as Head of a New Safety Department covering clinical development activities. Dr. Belcher then became Director of Clinical Drug Safety for Takeda Europe. His most recent full-time position in the industry was as Vice President of Drug Safety and Risk Management for all ex-USA territories of Biogen Idec. Dr. Belcher currently continues to work part-time as consultant safety physician to Biogen Idec and other companies as well undertaking an increasing commitment to teaching and training in the areas of clinical development and pharmacovigilance.

Topic lectured:

Seminar 6

  • Pharmacovigilance core processes III
  • Implications of the EU PV legislation - Questions & Answers
  • Benefit Risk Management in Practice
  • Case Studies

Ilham Benassou

Novartis Pharma AG

Ilham

Ilham Benassou is Sub-Region Head in Drug Regulatory Affairs within the Region Europe & Greater China at Novartis in Basel, Switzerland.

She joined Novartis in 2006 and worked as EU RA manager and then as Global RA Director in several therapeutic areas including anti-infective, transplantation and Women & Health products. She has track record of successful submissions and regulatory experience on products spanning from phase I to Phase IV. In her current role, she is providing regulatory leadership for more than 20 countries across the European continent including a role as Regulatory Lead for the IMI SAFE-T consortium for the qualification of clinical safety biomarkers.

Prior to joining Novartis, Ilham Benassou was intern research scientist at the PASTEUR Institute in Paris where she graduated with a Bachelor Degree in biochemistry. She then trained as biotechnology engineer from University of Sciences in Rouen. She completed her education at the University of Pharmacy in Paris XI with a Master Degree in biotechnology and international regulatory affairs.

Topic lectured:

Seminar 1:

  • Regulatory institutions and other stakeholders of the European system of pharmaceuticals, their functions and role

Christine Bendall

Pharview Ltd.

Christine

Christine Bendall qualified as a solicitor in England and Wales in 1985 and subsequently worked in private legal practice and (on secondment) for the Medicines Control Agency in the UK (now MHRA) specialising in the regulation of pharmaceuticals in the EU. She has a particular interest in clinical research and drug safety. She now works as a consultant to the pharma industry and also lectures regularly on university courses and at industry conferences on regulatory and legal matters. She has written for numerous publications, including contributing a chapter on the legal aspects of pharmacovigilance in “Detection of New Adverse Drug Reactions” (now in its 5th Edition; edited by, Talbot and Waller).

Topic lectured:

Seminar 6

  • EU PV regulatory requirements at time of authorisation
  • Case Study
  • EU PV regulatory requirements post-authorisation
  • Differences between EU and non-EU requirements with respect to PSMF, ICSR, periodic reports, RMP, product information
  • Implications of the EU PV legislation - Questions & Answers

Denis Bourgarel

European Patent Attorney & French Patent Counsel

Denis

Dr Denis Bourgarel is a European patent attorney and French patent counsel. He has been working in the patent field for 13 years. He was trained in a patent law firm based in Paris, where he qualified as a European Patent attorney to represent clients before the European Patent Office. He then worked as in-house patent attorney at the patent department of an international pharmaceutical company based in Basel where he handled due diligence, freedom-to-operate and patent portfolio management related to biologics, biomarkers and research tools. Since 2010, he has joined Cabinet Plasseraud as patent counsel, and is specialized for advising in the biotech, pharmaceutical and biochemistry fields. Denis Bourgarel supports clients (universities, start-ups, industry) for patent drafting and global prosecution, and also represents them in opposition and appeal proceedings before the European Patent Office.

Topic lectured:

Seminar 8:

  • An introduction about patenting biopharmaceuticals and freedom-to-operate studies

Meriem Bouslouk

G-BA / Federal Joint Committee

Meriem

As a desk officer in the pharmaceuticals department of the G-BA, Dr. Bouslouk’s field of expertise focuses on the early benefit assessment of pharmaceuticals under AMNOG, the new German Act on the Reform of the Market for Medicinal Products. Her main tasks include preparing and presenting documents for the pharmaceuticals subcommittee with an emphasis on orphan drugs, liaising with the pharmaceutical industry, and representing the G-BA at international events.

Topic lectured:

3rd Annual Biopharmaceuticals Meeting

  • The German AMNOG

Daniel Brasseur

former PDCO Chair- CHMP member

Daniel

Daniel Brasseur (born 07.06.51) is bachelor of the European School in Brussels and was graduated as a licensed paediatrician (1981) after studying medicines at the Free University Brussels (ULB). After a 3 years stay in Central Africa and 2 years as a Medical Director in Industry, he moved to the University Children’s Hospital Queen Fabiola (Belgium) and specialised in nutrition.
At the laboratory of Paediatrics and Metabolic Diseases, he built up a unit for Nutrition and Pharmacology. He studied the impact of diet and nutrition on several enzymatic systems and immune reactions. His interest in infantile research led him to chair since 1994 the Ethical Committee of his Institution (up to 2001) and to participate to the evaluation of new and innovative drugs. This naturally brought him to take part in his National Drug Commission as an evaluator and further (1997) as a co-ordinator of the team of medical assessors at the Federal Ministry of Public Health. He continued his activities and moved to the Federal Agency for Medicines and health products ( FAMHP) when this body was created (January 2007).
He joined CPMP in 1997 at the European Medicines Agency (EMA, London) and was elected chair in 2001 up to 2007. He was also the Chair of the CHMP-Paediatric Expert Group and a member of the CHMP-Vaccine Expert Group at the same Agency. Later in 2007 he became chair of the Paediatric Committee (PDCO) at the EMA and was re-elected in 2010. In his academic activities he is an Associate Professor of Paediatrics and a Professor of Nutrition at the Faculty of Medicine (Free University Brussels-ULB) and still works as a part time consultant at the University Children’s Hospital (Brussels).
He is a member of the National Council for Hygiene and of the National Nutrition Council. He was a member of the Scientific Subcommittee on Diet and Allergy of the European Food Safety Agency (EFSA) since 2002-2005. He is a member of several international societies in nutrition and pharmacology.
He is the author or co-author of more than 100 publications and communications in paediatrics, nutrition and infantile pharmacology.

Topic lectured:

Seminar 5

  • EMA and the Paediatric Committee (PDCO)
  • The scope of the Paediatric Investigation Plan (PIP)
  • List of paediatric needs and priority list of off-patent medicines
  • Publication of clinical trial results
  • Development of regulatory guidelines on considerations of drug development in children

Andrea Braun-Scherhag

F. Hoffmann-La Roche Ltd

Andrea

Dr. Andrea Braun-Scherhag has been Head of EU Regulatory Affairs at Hoffmann-La Roche, Basel since February 2013. She is responsible for collaboration with affiliates, product teams and EU Regulatory Intelligence.

Beforehand she was Head of Regulatory Affairs at Roche Pharma AG, Grenzach since August 2007. As graduated plan officer she was responsible for pharmaceutical quality as well as she had strategic and functional regulatory responsibility for the German market incl. development products.

From October 2002 till July 2007 she was Head of Global Regulatory Affairs, DSM Nutritional Products in Kaiseraugst, Switzerland.

Between September 1994 – September 2002 she had various roles (from trainee to Global Regulatory Leader) in Regulatory Affairs at Hoffmann-La Roche, Basel, Switzerland.

Between July 1991 - August 1994 she prepared her PhD Thesis in immunology at the Pharmaceutical Institute at the University of Basel and at Hoffmann-La Roche, Basel, Switzerland

She studied pharmacy at the University of Heidelberg, Germany.

Topic lectured:

2nd Annual Biopharmaceuticals Meeting

4th Annual Biopharmaceuticals Meeting

  • Optimization of Regulatory Pathways for innovative products

Jörg Breitkreutz

Heinrich-Heine-University Düsseldorf

Jörg

Jörg Breitkreutz studied Pharmacy from 1987 to 1991 at the Westphalian Wilhelms-University of Münster, Germany. He finished his PhD in 1996 at the Institute for Pharmaceutical Technology and Biopharmaceutics in Münster under the supervision of Prof. Rüdiger Gröning. From 1996 to 1997 he joined Thiemann Arzneimittel GmbH in Waltrop, Germany, as the Head of Product Coordination. In 1997 he went back to the university in Münster to work on his habilitation thesis (2004) on pediatric drug formulations. In 2004 he became professor for pharmaceutical technology at the Institute of Pharmaceutics and Biopharmaceutics at the Heinrich-Heine-University in Düsseldorf, Germany and today is the director of this institute. Joerg Breitkreutz is member of the European Paediatric Formulation Initiative (EuPFI) and serves as external expert for various regulatory bodies and companies. In 2010 the non-for-profit International Association of Pharmaceutical Technology (APV) elected him for the president. His research focuses on pediatric and geriatric drug formulations, development of orphan drugs and process analytical technologies.

Topic lectured:

Seminar 5

  • Requirements on paediatric drug formulations

Karl-Heinz Buchheit

EDQM

Karl-Heinz

Dr. Karl-Heinz Buchheit obtained his degree in pharmacy from the Johann-Wolfgang-Goethe University in Frankfurt/M. (Germany) and his Ph.D. in pharmacology in 1984 from the same university. From 1984 until 1999 he worked as research scientist and group leader in preclinical pharmacology for Novartis/Sandoz in Basel (Switzerland). From December 1999 to August 2013, he was Deputy Head of the Department Biological Standardisation, OMCL Network & HealthCare at the EDQM (Council of Europe, Strasbourg, France) and secretary of the Steering Committee of the Biological Standardisation Programme. Since August 2013 he is Head of the same department which is responsible for the activities of the EDQM in the fields of biological standardisation, the OMCL network, blood transfusion, organ-, tissue and cell transplantation, pharmaceutical care, anti-counterfeit measures and consumer health protection.

Topic lectured:

Seminar 7

  • Surveillance of medicines through testing in the EU/Europe

- OMCL Network
- CAP testing program and Market Surveillance
- Official Control Authority Batch Release (OCABR)

Zaklina Buljovcic

PharmaLex GmbH

Zaklina

Zaklina Buljovcic, Pharmalex GmbH, Director Scientific Services, Principal Consultant Innovative Therapies. 

She is a biologist by training and holds a PhD in Natural Sciences. She started her professional career in F&E at a small Biotech Company in Heidelberg, Germany in 2000 and joined PharmaLex in 2004. At PharmaLex she held various positions and established different kind of product groups focusing e.g. on tissue preperations, herbal or veterinary products. Since 2008 she is working at PharmaLex as project manager on various ATMP products supporting mainly SME Biotech Companies. This is including strategic regulatory support, preperation of national and EU Scientific Advices, preperation of IMPDs, as well as dossieres for hospital exemption in Germany and EU Centralized Procedures. She is also one of the leading regulatory experts in Germany for ATMPs, giving regularly lectures on various ATMP-topics and engaging in joint industry / health authority working groups.

Topic lectured:

Seminar 3

  • Overview on ATMPs
  • Case studies to illustrate the challenges in the development of ATMPs

Josefine Buth

Biotest Pharma GmbH

Josefine

Josefine Buth is heading the Global Regulatory Organisation as VP Corporate Regulatory Affairs at Biotest AG. She holds a diploma in nutritional sciences and a Master Degree in Drug Regulatory Affairs (MDRA) . Her more than 10 years experience in Regulatory Affairs in the fields of Immunoglobulins, plasma proteins and monoclonal antibodies covers all development stages and the lifecycle management of biologics in Europe, US and approx. 80 countries world-wide.

Topic lectured:

Seminar 8

  • Regulatory strategy for the introduction of changes in the manufacturing process

C

Lidia Cánovas

Asphalion, S.L.

Lidia

Lidia Cánovas has a degree in Pharmacy from the University of Barcelona and is currently the General Manager - Commercial of Asphalion, S.L., consultancy company to which she associated in 2003.

Her main activities focus on consulting and strategic direction of projects in the area of Regulatory Affairs and Development for Europe and USA, actively participating in scientific advice, Paediatric Plans, Orphan Drug Designations, Development Plans, Centralized procedures, decentralized and mutual recognition in permanent contact with the regulatory authorities. She also has extensive regulatory experience in innovative, biological, biotech and advanced therapy.

She previously held positions in the pharmaceutical industry as Director of Regulatory Affairs, Vice-Director of R&D and Technical Director (Qualified Person).

Topic lectured:

Seminar 1:

  • Format and content of the marketing authorisation application: The Common Technical Dossier (CTD)
  • Module 1 of the CTD: General information
  • Labeling, Package Leaflet and Summary of Product Characteristics (SmPC)

Laura Gomes Castanheira

ANVISA

Laura Gomes

Laura Gomes Castanheira is a pharmacist (graduated in 2002). She has a master degree in immunology (since 2004). She has been with ANVISA since 2005. Ms Gomes Castanheira is the Head of Safety and Efficacy Evaluation office in ANVISA since 2009. This office is responsible for biological and new drugs licensing and clinical trials. From 2007 to 2009 she was the coordinator of biological products coordination at ANVISA. From 2005 to 2007 she was a specialist responsible of biological marketing authorization dossiers analysis at ANVISA. From 2004 to 2005 she was a teacher and researcher  at a private university in Brazil (Faminas). She worked at the Immunology department at this university.

Topic lectured:

3rd Annual Biopharmaceuticals Meeting:

  • Authorising biopharmaceuticals in Brazil - pathways for biotech products, biologicals, vaccines, biosimilars and ATMPs

Monika Chabicovsky

MC Toxicology Consulting

Monika

Dr. Monika Chabicovsky is an independent consultant for drug development and regulatory affairs. She trained in experimental cancer research and toxicology at the Medical University of Vienna, the University of Cardiff and the University of Innsbruck. She holds a PhD in cancer research, a master in toxicology and a diploma in regulatory affairs. She is a EUROTOX registered toxicologist, author of several scientific publications in peer-reviewed journals and holds international patents. Previously she was with Austrian and US biotech companies, where she was responsible for regulatory affairs and toxicology. Since 2005 she works with Granzer Regulatory Consulting & Services as a Senior Consultant in Munich. In 2006 she founded MC Toxicology Consulting, with its core business focused on the nonclinical development of biologics, small molecules, vaccines and advanced therapy medicinal products. Dr. Chabicovsky has signed responsible or contributed significantly to drug development programs and Marketing Authorisation Applications of numerous drugs in Europe, USA & Canada.

Topic lectured:

Seminar 4.2:
  • The non-clinical CTD of biopharmaceuticals

Paul Chamberlain

Biopharma Excellence / bioLOGICA Consulting

Paul

He has accumulated substantial industrial experience in the development of biopharmaceutical products. This experience includes a broad scientific background, incorporating the application of analytical and bioanalytical technologies to the quality control of therapeutic proteins. At MDS Pharma Services Paul was responsible for providing expert consulting on strategies for biopharmaceutical development programs as well as leading development teams responsible for the execution of contracted analytical, bioanalytical, non-clinical, clinical and regulatory services. In this role Paul prepared briefing packages to support Pre-IND and other regulatory agency discussions and defined activities associated with pertinent stagegates in the product development cycle – including lead candidate selection, manufacturability assessment and IND-enabling studies. He also served as a member of the Scientific and Regulatory Advisory Boards of different companies and was involved in due diligence assessments of various in/out-licensing opportunities. In order to focus on strategic planning and the preparation of responses to regulatory agency questions Paul formed his own consulting practice, bioLOGICA Consulting, in July 2007. In addition, in October 2007, Paul was appointed to the Advisory Board of NDA Regulatory Science, where he collaborates with former senior European regulators. FDA-facing experience includes involvement in the preparation of IND’s and BLA’s for recombinant proteins, as well as direct interactions up to the level of FDA Advisory Committee meetings to support product registration decisions.

Topic lectured:

Seminar 4.2:

  • Immunogenicity
  • Erythropoeitin

Immunogenicity Integrated - Interactive Workshop:

  • The current regulatory environment for new therapeutic proteins and biosimilars exemplified by cases following a risk-based strategy

3rd Annual Biopharmaceuticals Meeting:

  • Essentials to know in 2013 on immunogenicity of therapeutic proteins. An update on most recent occurrences, regulatory activities and scientific progress

Coaching: Applying risk assessment to the design of an effective comparability protocol

Workshop: Immunogenicity - Understanding the Regulatory Philosophy:

  • How is immunogenicity assessed for different product types, from biosimilars to enzyme/factor replacement therapies?
  • What are the implications of this philosophy for data presentation? Intrinsic immunogenicity & systems biology
  • Product quality
  • Case examples illustrating impact of product type on nature of bioanalytical data package
  • The “Integrated Summary of Immunogenicity” model

Dagmar Chase

Clinrex GmbH

Dagmar

Dr. Dagmar Chase graduated in Computer Science with a secondary focus on Theoretical Medicine at the Technical University in Munich and has a PhD in Human Biology from the Medical Faculty of the University in Ulm, Germany.
Dr. Chase co-founded the company GMI, a full service CRO for clinical trials phase II – IV, in 1983. Besides developing GMI into one of the largest CROs in Germany, Dr. Chase concentrated on Quality Management as well as the development of training programs for the pharmaceutical industry.
In order to be able to offer international services to GMI’s clients she was instrumental in the merger of GMI with the US-based CRO Kendle International Inc in 1997, holding the position of Vice President until the beginning of 2004.
In March 2004 Dr. Chase started up Clinrex, a consultancy firm for clinical research. In addition to providing training and consulting for all aspects of GCP and Quality Management, she focuses on GCP gap analyses and inspection readiness programs, management of DSMBs/DMCs  and project coordination  e.g. helping sponsors to identify and manage the right partners in the EU (legal representation, CROs, etc.). Dr. Chase is President of the German CRO Association BVMA e.V. (Bundesverband Medizinischer Auftragsinstitute) and Vice President of the EU CRO Federation (EUCROF).

Topic lectured:

Seminar 7:

  • The principles of GCP

Anne Cook

MHRA

Anne is a Senior Quality Assessor in the Biologicals and Biotechnology Unit at MHRA (Medicines and Healthcare products Regulatory Agency) in the UK, where she has worked for 9 years. She has assessed new Marketing Authorisation Applications and variations for a number of biotechnology products, from enzyme replacement therapies to biosimilar products. Her work also involves evaluation of blood products, vaccines and allergy products within the Biologicals Unit. She is a member of the Biosimilar Quality Guideline revision working party at the European Medicines Agency.

Anne previously worked in the pharmaceutical industry and did academic research for several years, where she gained relevant experience. She spent 15 years at British Biotechology in Oxford, where her career took her from research in protein biotherapeutics into product development and finally manufacturing of a recombinant glycoprotein product for Phase II clinical trials.

Topic lectured:

4th Annual Biopharmaceuticals Meeting:

  • News and Trends in Europe: update of EMA activities including the Biosimilar Medicinal Product Working Party (BMWP) and Committee of Advanced Therapies (CAT) activities

Judith Creba

Novartis Pharma AG

Judith

Judith Creba has a PhD in Biochemistry from Birmingham University in the UK and spent 5 years working in Research in the Pharma Industry in the areas of Neuroscience, Pain, Cardiovascular and Metabolism. Judith has many years of experience in Regulatory Affairs and drug development in Novartis - working in different areas such as Oncology and Infectious Diseases, where she was involved in the development and approval of an antimalarial drug, and as the EU Regulatory Head of the Cardiovascular and Metabolism Group where she was involved in the successful development, approval and life cycle management of some key products of Novartis. Judith is now Head of EU Liaison and Policy in Drug Regulatory Affairs at Novartis where she is involved in Health Authority Liaison and also represents Novartis in various working groups in Industry Trade Associations such as EFPIA.

Topic lectured:

Seminar 1:

  • Regulatory Institutions and other Stakeholders of the European System of Pharmaceuticals, their functions and role

4th Annual Biopharmaceuticals Meeting:

  • Experience with the pilot EMA-HTA joint scientific advice

Koen Crombez

Merck Sharp & Dohme (Europe), Inc.

Koen

Koen Crombez holds a Master degree in Science (Biology) and a PhD degree in Medical Sciences, both obtained at the University of Leuven (Belgium).
Koen started his career in Regulatory Affairs in 2005 within the European Regulatory Affairs department at Bristol-Myers Squibb, where he coordinated regulatory activities within the Infectious Diseases and Oncology therapeutic areas. Since 2009, Koen is working within the Regulatory Affairs Europe team at Merck Sharp & Dohme as a regulatory liaison, first within the Ophthalmology franchise. Currently, he is mainly responsible for providing regulatory strategic input into programs in the Infectious Diseases franchise (both licensed products and development programs).
Koen has a profound interest in paediatric development and advises the European and Global Regulatory Affairs team at Merck on strategic and procedural issues around EU paediatric development, in the framework of his assignment as EU paediatric subject matter expert.

Topic lectured:

Seminar 5:

  • The EU Regulation No 1901/2006 on medicinal products for paediatric use – the Paediatric Regulation
  • Regulation for medicines in children in other regions with focus on the US
  • Implications of the EU legislation for the pharmaceutical industry: Perspectives, challenges and opportunities
  • Case illustrating PIP practice with discussion

David M. Cross

Cross Pharma Consulting Limited

David M.

David is Founder and Managing Director of Cross Pharma Consulting Ltd which specialises in providing non-clinical scientific and regulatory support to the Biotech and Pharma industry. Formerly, David was a Regulatory Strategy Lead for non-clinical drug safety at Pfizer UK Ltd where he worked on projects at all stages of development and was responsible for crafting the company position on non-clinical data for review by regulatory agencies. David was previously Director of DMPK and Drug Safety at Astex Therapeutics, a Drug Discovery Project Leader and Project Manager at GSK, and a Section Manager in DMPK at Rhône-Poulenc Rorer. His work involves integration of pharmacology, drug metabolism, pharmacokinetics and toxicology into an integrated package. He has a PhD in Biochemistry and a BSc in Cell Biology and Immunology from universities in the UK.

Topic lectured:

Seminar 5:

  • Juvenile animal studies

D

Gabriele Dallmann

EUCRAF and Biopharma Excellence

Gabriele

Dr. Gabriele Dallmann is an internationally renowned biopharmaceutical expert with more than 25 years of experience in drug development and regulatory affairs of biopharmaceuticals. At the Paul-Ehrlich-Institut where she was Head of the Section "Mono- and polyclonal antibodies" she has been involved in the European process of authorisation of biopharmaceuticals and represented the PEI in committees and working parties of the EMA in London. Stimulated by discussions on the lack of an adequate training platform providing young professionals with the distinctive knowledge on biopharmaceutical-related regulatory affairs she initiated in 2006 an intensive dialogue with distinguished experts from authorities, universities and companies to develop EUCRAF. Dr. Dallmann works as a biopharmaceutical consultant and is involved in development, strategic and market access projects, regulatory submissions, scientific advice and due diligence procedures.

She is biologist with a PhD in immunology from Berlin University and visiting lecturer on biopharmaceuticals at Freiburg University.

Topic lectured:

Chairperson of the 1st, 4th and 5th Annual Biopharmaceuticals Meeting

Seminar 1: Legal particulars for biopharmaceuticals

Seminar 2: Strategic considerations on selecting the authorisation procedure

Seminar 3: The product class of blood products, Certification scheme on plasma Master File (PMF), Plasma derived products as a component of a medical device

Seminar 4.2: Introduction to Group work: Benefit-risk assessment for monoclonal antibodies (Herceptin, Remicade, Tysabri, Raptiva)

Seminar 7: The Regulatory Affairs department at the interphase to Quality Management and GxP

Seminar 8: Strategic considerations on interactions with regulatory agencies

Seminar 9: Conducting effective agency meetings, Agency Code of Conduct

Coaching Event Agency meetings: The discussion meeting - the special hearing of the EU scientific advice and during the MAA procedure

Simon Day

Clinical Trials Consulting & Training Limited

Simon

Simon has spent 30 years working in clinical trials, mostly in the pharmaceutical industry but also including five years at the UK and European regulatory agencies. He now works as a statistical and regulatory consultant to pharmaceutical and biotechnology companies around the world. He specialises in training and consulting on drug development programmes, scientific advice / end of Phase II meetings and preparations for oral explanations and advisory committees.
He is a former president of the International Society for Clinical Biostatistics; he is joint editor of Statistics in Medicine and previously joint editor of the Journal of the Royal Statistical Society. He is an associate editor of Pharmaceutical Statistics and British Journal of Clinical Pharmacology. In 2012 he was elected a Fellow of the Society for Clinical Trials.
He has published widely in statistical and medical journals, is author of one book “Dictionary for Clinical Trials” and is joint editor of the “Textbook of Clinical Trials”, both published by Wiley.
He has served on a variety of data monitoring committees both for industry- and government-sponsored trials. He is chairman of the External Advisory Panel for the Department of Statistics at Oxford University and an Associate on the faculty at Johns Hopkins University in Baltimore. He is also vice-Chairman of the West London Research Ethics Committee. He has given numerous lectures and courses on statistics and clinical trials all around the world, including courses at the FDA on development and regulatory assessment of orphan drugs.

Topic lectured:

Seminar 4.2:

  • The principle of clinical development of biopharmaceuticals
  • Group work: Benefit-risk assessment for monoclonal antibodies

Seminar 8:

  • Strategic considerations on interactions with regulatory agencies

Seminar 9:

  • Agency meetings exam

Coaching Event: Agency meetings

  • Opportunities of agency meetings in the EU and US
  • Scientific Advice Meetings during development

Jacques Descotes

ImmunoSafe, University of Lyon

Jacques

Dr. Descotes, MD, PharmD, PhD, is professor of medical pharmacology at Lyon University and Head of the Poison Center and Pharmacovigilance Department at Lyon University Hospitals.
For the past 30 years he has been involved in the non-clinical and clinical safety evaluation of pharmaceuticals in particular from an immunotoxicological perspective.
He is a fellow of the US Academy of Toxicological Sciences and a Eurotox Registered toxicologist. Dr. Descotes is the author of 14 books devoted to immunotoxicology, human toxicology and drug safety, and over 300 original and review articles.

Topic lectured:

Immunogenicity Integrated - Interactive Workshop:

  • Recognising and interpreting clinical signals

Kora Doorduyn - van der Stoep

MEB

Kora

She works at the Medicines Evaluation Board (MEB) in The Netherlands. She held several positions within the MEB, regulatory, management. Her current position (since 2009) is CMDh member (EU-representative)/Policy adviser of the department Policy, Governance and Regulatory Affairs. Since May 2009 she is acting as Member and official representative in the CMDh (Co-ordination Group Mutual Recognition and Decentralised Procedures – Human) on behalf of the MEB. She is member of several working parties of CMDh with issues related to (the new) Pharmacovigilance legislation (like RMPs/PSURs) as an area for special attention. She has a very broad experience in coordinating/assessing national and European (MRP/DCP/Centralised procedures) application procedures related to marketing authorisations, variations, renewals, worksharing procedures, CHMP and CMD referrals. She has coordinated/assessed a large number of procedures in the role as CMS/RMS and/or rapporteur. From 2002 -2007 she has been managing both regulatory project leaders and clinical assessors in a Pharmacotherapeutic group. In this position she was also responsible for processing/scheduling all registration procedures within this Pharmaco-therapeutic group. She was also a regular visitor of the MRFG (since the establishment of this group) and she represented The Netherlands in the MRFG from 1 January 1997 until 1 October 1997 during the first Dutch presidency of this group. She graduated MSc Pharmacy (in 1983) and as a pharmacist (in 1985).

Topic lectured:

Seminar 2:

  • Variations-Europe Regulations and national legal provisions for changes to the CTD

Mairéad Duke

Épée Services Ltd.

Mairéad

Dr. Mairéad Duke is a dedicated chemistry, manufacturing and quality control (CMC) regulatory affairs professional with 19 years experience in the biopharmaceutical industry. She is founder and Director of Épée Services Ltd through which she offers consultancy services in biopharmaceutical CMC regulatory affairs specializing in biopharmaceutical products covering all stages of development and lifecycle management. Dr. Duke graduated with a degree in Biochemistry from National University of Ireland, Galway and subsequently obtained her PhD in Cell and Molecular Biology.

Topic lectured:

Seminar 4.1:

  • Quality Module 3 of the CTD for biopharmaceuticals
  • Characterisation, quality control and analytical techniques
  • Changes in process and their implications on the molecule, the comparability exercise
  • Submissions of comparability packages - experience with the Change Management Protocol

E

Rembert Elbers

Federal Institute for Drugs and Medical Devices

Rembert

Prof. Dr. Rembert Elbers is currently Head of BfArM Unit "Orphan Drugs and Rare Diseases."

He studied chemistry and medicine in Hannover and Munich and gains over 41 years of experience. Initially, he worked at the Institute for Physical Biochemistry, LMU Munich, investigating the intracellular compartimentation of energy metabolism. Later, he moved to the Walther Straub Institute for Pharmacology of the LMU Munich investigating molecular mechanisms for the toxicity of amino- and amidophenol derivatives. After joining the BfArM, he worked 1987 - 2000 as a head of unit in charge of scientific co-ordination of NCE drug assessment and European and International matters relating to drug regulatory affairs. From 2000 - 2012 he headed the BfArM Oncology, Haematology und Immunology unit. Since 2000 he is also the German member of the European Committee on Orphan Medicinal Products (COMP) and tasks related to this position are now his main duties at the BfArM.

Topic lectured:

Topics lectured

Seminar 1:

  • Orphan Medicinal Products in the EU/EEA

Jörg Engelbergs

Paul-Ehrlich-Institut

Jörg

Dr. Jörg Engelbergs is currently working for the Paul-Ehrlich-Institut in Langen as regulatory-scientific expert for polyclonal and monoclonal antibody (mab) based therapeutics, including mab-biosimilars and fusion proteins (pharmaceutical quality / CMC and non-clinic) and further as expert for biomarkers / personalized medicines. He is involved in the European process of authorization of biopharmaceuticals, comprising scientific assessments and advices. Further activities are assessments of GCP conformity of clinical phase I-III trials, national and third-country (USA/Asia) GMP inspections, and basic research on biomarkers. For EDQM he is acting as expert in the Host-Cell Protein (HCP) Working Party and in the P4Bio Working Party and for EMA he is acting as member in the Pharmacogenomics Working Party (PGWP). He has been also co-author of the EMA guideline on production and quality control of monoclonal antibodies and related substances.

Dr. Engelbergs holds a Diploma in biology and a Ph. D. in cell biology and biotechnology. Before he joined the PEI, he has gained large experience in experimental cancer and neuropharmacology research with focus on targeted monoclonal antibody and biomarker based personalized biomedicines. In this time he was head of "Neuropharmacology laboratory" and in parallel head of clinical core “Genotyping service center" at Department of Neurology at University of Essen Medical School. Before, he has been scientific project leader in various cancer research projects and in parallel head of the "Monoclonal antibody research and production unit" at the Institute of Cell Biology (Cancer Research) at the West German Cancer Center.

Topic lectured:

Seminar 4.1:

  • Stability of biopharmaceuticals
  • Regulatory CMC concerns and issues

F

Bruno Flamion

NDA Regulatory Advisory Board

Bruno

Bruno Flamion is a Belgian national, MD/PhD from the University of Brussles, specialist in internal medicine and nephrology and full Professor of physiology and pharmacology at the University of Namur, Belgium (since 1998). He has been a medical and pharmacological expert for the Belgian Federal Agency for Medicines and Health Products (FAMHP) for 12 years and has worked for the European Medicines Agency (EMA) in London for 10 years, acting as CHMP member, vice-chair of the Pharmacogenomics Working Party, chair of the Pharmacokinetics group, and chair of the Scientific Advice Working Party for 6 years (2005 - 2010).

Bruno Flamion has also chaired the Committee for Reimbursement of Medicines in Belgium (2010 - 2012). This Committee is part of the National Insitute for Health and Disability Insurance. Bruno is a member of Regulatory Advisory Boards of CIRS (Center for Innovation in Regulatory Science) and NDA. Bruno's interests lie in clinical pharmacology, drug development (both regulatory and health technology assessment/reimbursement aspects), patient care and basic research.

Topic lectured:

Seminar 8:

  • HTA as a new element of ther regulatory strategy - national requirements and European initiatives
  • Reimbursement in Europe
  • Consideration on how tzo design clinical development programmes to be used for approval and HTA

Marielle Fournier

Voisin Consulting

Marielle

As Director, Marielle has several responsibilities within the management of projects involving the design and implementation of global regulatory strategies for the development, evaluation and marketing of medical devices & medicinal products, and especially combination products (i.e. drug/device) and borderline products. She closely follows the evolution of new regulations in Europe.

Marielle also specializes in Quality regulations, such as ISO 9001 / ISO 13485 and EU GMP regulations, and has good knowledge on QSR (21 CFR part 820). She assists in the identification, development and implementation of Quality Systems appropriate to the need, complexity and size of an organization.

Marielle has also important knowledge in European medical devices vigilance (including FSCA and FSN), as well as pharmacovigilance management.

Prior to joining Voisin Consulting, Marielle was Regulatory Affairs Director and Responsible Pharmacist for the La Rochelle site of Carl Zeiss Meditec - Surgical Ophthalmic Business Unit, manufacturing and marketing ophthalmic devices, including implantable, and sterile medicinal products worldwide. She also supervised the Quality Assurance department of this company for several years. Marielle previously worked for Columbia Laboratories, American development company as Regulatory Affairs Officer for hormonal medicinal products and was fully involved in development, sub-contract manufacture and controls of products.

Marielle earned her Pharm.D. degree from the Universities of Pharmacy of Paris XI (Chatenay Malabry) and Clermont Ferrand, France, followed by a post-graduate diploma in Health Care Laws at the Law University of Paris XI (Sceaux).

Topic lectured:

Seminar 1:

  • The regulatory framework for drug/device combination products

Georges France

Novartis Consumer Health Services SA

Georges

With an experience of 25 years in Quality and Regulatory in the pharmaceutical industry, Georges joins Novartis from Pfizer where he was Vice President of Global Quality Strategy & Affiliate Quality and Compliance. Before that he progressed through various positions at Wyeth, the latest as Vice President of Quality & Compliance in Europe Africa and the Middle-East. Georges holds a Doctor of Pharmacy degree and a post-graduate degree in Pharmacology and INSEAD and start his career as a biologist in a hospital
Georges’ main external activities include:
Member of the Efpia TDOC where he represents Efpia as the topic leader in ICH for ICH Q10 (Pharmaceutical Quality System) and Efpia topic leader for the ICH Quality IWG (implementation working group) for Q8 (Quality by Design), Q9 (Quality Risk Management) and Q10 respectively. In addition Georges is Vice Chair for Quality in IFPMA and a member of the French Academy of Pharmacy.

Topic lectured:

Seminar 7:

  • Compliance and steady optimisation of production and processes

Michelle Frazier-Jessen

Amgen, USA

Michelle

Dr. Frazier-Jessen has over 12 years of experience in the biotechnology regulatory affairs field and is currently employed at Amgen as a Director, CMC Regulatory Affairs. Prior to this, she was employed at Micromet, Inc. as Senior Director, Regulatory Affairs, at Macrogenics, Inc. and MedImmune, where she held positions with increasing levels of responsibility. Prior to her employment in the biopharmaceutical industry, Dr. Frazier-Jessen was a Review Biologist and Acting Team Leader in the Division of Monoclonal Antibodies, Office of Biotechnology Products at CDER, FDA. Her responsibilities at FDA included research into the role of cytokine signaling in monocytes and macrophages as well as review of Chemistry, Manufacturing and Controls sections of investigation New Drug (IND) applications, biologics license applications (BLAs) and supplements. Dr. Frazier-Jessen also participated in Pre-Approval Inspections (PAIs) and Biennial inspections as a Product Specialist. She is active in numerous professional societies and is an Associate Director for CASSS (California Separation Science Society). Dr. Frazier-Jessen earned her bachelor’s degree in Microbiology from Washington State University and her Ph.D. in Cell Biology, Neurobiology & Anatomy from Loyola University Chicago. She has over six years of post-doctoral research training experience in cell biology/immunology/inflammation.

Topic lectured:

Seminar 8:

  • Interactions with FDA in the pre-IND process

Cornelius Fritsch

Novartis Pharma AG

Cornelius Fritsch has been with Novartis since 2006. He specializes on in vitro assays to quantify the activity of biomolecules. He has been involved in the development of both, innovator biologics and biosimilars.

Topic lectured:

3rd Annual Biopharmaceuticals Meeting:

  • Determining the indication for a biosimilar monoclonal antibody – when is extrapolation an option for obtaining all of the indications of the reference product? How is the selection of the reference product justified?
    - The analytical experience for functional characterisation.

G

Tatiana Gaban

Roche Pharma Brazil

Tatiana

Tatiana Gaban has a Pharmacy & Biochemistry degree by Unversidade de Sao Paolo in Brazil. She is post-graduated in Business Administration specialized in Management Practices by New York University. Tatiana has been working with Regulatory Affairs since 1998 in pharmaceutical industries such as Janssen-Cilag, Novartis, Pfizer and currently at Roche. In 2008 she performed a role as Regional Regulatory Affairs in Pfizer Headquarters to support Latin AMerica activities. Currently she is working as Regulatory Affairs Head at Roche Brazil., being responsible for New Licenses and Post-Approval applications, Labeling Updates, GMP Certification Management, Regulatory Compliance and other regulatory related activities.

Topic lectured:

3rd Annual Biopharmaceuticals Meeting:

  • Looking at other regions: Brazil - Industry experience with authorisations of biopharmaceuticals in Brazil

Surendra Gokhale

Roche

Surendra

Dr. Surendra Gokhale is currently Senior Group Manager in the Global Regulatory Affairs in Roche Basel, having joined Roche Basel in research in 1990. He moved to regulatory affairs in 1995 and has worked as Global Regulatory Leader on several projects in different therapeutic areas.

He is currently heading the EU/International Clinical Trials regulatory management group at Roche head office in Basel. Global approach for the clinical development keeping in mind the GCP concept and the patient in focus is the main goal of his work. Working for the innovative Industry, finding the alignment between different regional regulatory aspects in the EU, US, Asia and Latin American countries and Global development plans is the main focus of his work.

As part of Roche Global Regulatory affairs, since 2008 Dr. Gokhale is Roche representative on the Regulatory Affairs group [ERLC], EU Clinical Trials subgroup, of the European Pharmaceutical association [EFPIA]. He was member of the EFPIA in the ICH M5 subgroup. Since mid-2014 he is the EFPIA Topic leader on the ICH E6 [R2] group dealing with the GCP guideline update. He also represents Roche in the IFPMA Regulatory group [RPTS].

After basic education in organic medicinal Chemistry at Pune, India; he has worked as research scientist with Ciba-Geigy in the area of tropical diseases, and spent 15 months at University of Konstanz, Germany where he worked in the area of Oligonucleotide Synthesis and model studies towards the automated synthesis of tRNAs. At Roche Basel he had spent further 5 years in basic Research and has worked in the several disease areas including development and successful launch of the first HIV protease Inhibitor.

Topic lectured:

5th Annual Biopharmaceuticals Meeting:
  • Preparedness for the Clinical Trial Regulation in the EU - A company Perspective

Fiona Greer

SGS M-Scan

Fiona

Following a PhD in Protein Biochemistry from Aberdeen University, she joined M-Scan Ltd. in 1984 to found the Biochemical Services Department. Here she pioneered and applied developments in Mass Spectometry for structural characterisation. She was appointed Director of Biochemical Services in 1988. At the same time she was instrumental in establishing a facility in the United States where she was appointed Vice President. Dr. Greer was responsible for establishing the Quality Management Systems and for directing Quality Assurance across the four M-Scan laboratories. With over 30 years of experience in the structural analysis of glycoproteins using instrumental techniques she has published many articles on the use of mass spectrometry to fulfil regulatory characterisation requirements. She is regularly invited to give presentations at international meetings and has designed and presented various training cources. She is now Global Director for Biopharma Services Development, SGS M-Scan.

Topic lectured:

Seminar 4.1:

  • Isoform, molecular subspecies characterisation and glycosylation

Ronald Grobe-Einsler

Consultant, formerly Bayer

Ronald

Dr. Ronald Grobe-Einsler has a PhD in Chemistry and Medicine.

Postdoctoral he worked for several years as Deputy Medical Director at Beecham Wülfing in Neuss.

After three years working for Bayer AG as international Clinical Project Manager for antidementia drugs he became in 1993 Medical Director Germany at Bayer AG, Leverkusen. In 1998 he moved to London where he worked as Medical Director Europe and Overseas. From the year 2000 to 2007 he was Head of the Global Clinical Pharmacology at Bayer AG. Since his retirement in 2007 he is working as Consultant for the pharmaceutical industry.

Topic lectured:

Seminar 4.2:

  • Research to early development: a clinical pharmacology perspective

Steffen Gross

Paul-Ehrlich-Institut

Steffen

Dr. Steffen Gross is Head of the Section Monoclonal and Polyclonal Antibodies, Laboratory Head as well as Scientific Assessor at the Paul-Ehrlich-Institut in Langen. After his Ph.D. degree in 1998 he had a postdoctoral position at the Institute of Cellular Signaling in the Netherlands. In 2001 he moved to Frankfurt and worked for several years at the University of Frankfurt as research group leader. Since 2005 he is working for the Paul-Ehrlich-Institut where he is responsible for assessments, batch control, inspections, research, scientific advice and regulatory. He is an expert in the field of cell biology , molecular biology and quality and preclinic of monoclonal antibodies, immunoglobulin and also has experience in the field of Batch release/CAP.

Topic lectured:

Seminar 2:
  • European Regulations and national legal provisions for changes to the CTD
  • Variations to the Biotech CTD
2nd Annual Biopharmaceuticals Meeting:
  • Introducing changes in the manufacture – nowadays common but also easy? The current practice for an assessor
3rd Annual Biopharmaceuticals Meeting:
  • Trends, decisions and new guidelines in the past year – CMC requirements for antibody-drug conjugates, QbD experience, substantial amendments and variations, clonality requirements, batch release and more
4th Annual Biopharmaceuticals Meeting:
  • Does innovation reach authorities: trends in scientific advice and review procedures
5th Annual Biopharmaceuticals Meeting:
  • Current topics discussed related to CMC of biopharmaceuticals
    -QbD – is this reality for Biopharma?
    -Critical findings in variations
    -Requirements for CMC changes of biosimilars

H

Kathy Hartmann-Campbell

Communication Coach

Kathy

Kathy Hartmann-Campbell was born and raised in the US and has lived in Basel for nearly 30 years. She graduated from Yale University with honors in philosophy and pursued a career in sales management and marketing before moving to Switzerland. After completing further training in applied psychology, and serving two and a half years as head of language training at Hoffmann-LaRoche, she started her own company in 1990 as a communication trainer and coach. She has worked locally and abroad with corporate clients such as Novartis, Syngenta, Roche, Ciba, IBM and the Bank for International Settlements, leading courses in all areas of communication skills and facilitating workshops and teambuilding sessions. As a public service to the expatriate community of Basel, she regularly offers workshops on understanding cultural differences. She has worked closely with regulatory affairs professionals to develop their communication effectiveness, conducting training programs in meeting management, presenting, negotiating, interpersonal and intercultural communication. In addition, she has prepared teams and conducted rehearsals for meetings with and presentations to regulatory authorities.

Topic lectured:

Seminar 9:

  • Effective interpersonal communication
  • Good practices for virtual communication
  • Content and delivery of presentation

Susanne Heiland-Kunath

Takeda Pharmaceuticals International GmbH

Susanne

From June 2014 Susanne Heiland-Kunath is Head of Regulatory Affairs Europe, Vaccines Business Unit. She transitioned from heading Global Development Regulatory Therapeutic Area Immunology and Respiratory in Takeda. She has a working experience of more than 14 years in the field of international regulatory affairs for development products at Takeda. She has been involved in the development, approval and lifecycle management of products in different areas such as Gastroenterology, Respiratory and Immunology diseases, including the development of monoclonal antibodies in Rheumatoid Arthritis. She has gained substantial experience in European Scientific Advice procedures and FDA meetings for several development products, as well as in MAA submissions and approvals under the Centralised Procedure, Decentralised Procedure and Mutual Recognition Procedure. This includes the successful Rx-to-OTC switch of a gastroenterology product via the Centralised Procedure. She also has been involved in the MAA submissions and registration procedures in more than 70 countries for a key respiratory product at Takeda. She holds a PhD in Biology from the University of Konstanz, Germany. After her PhD thesis in Molecular Genetics she went to Beijing, China, with a scholarship by the DAAD for 1 year, which included working at Bayer Healthcare Beijing.

Topic lectured:

Seminar 8:

  • A cross-functional strategic forum to support decision-making for regulatory processes

Ralf Hess

PAREXEL

Ralf

Dr. Ralf Hess holds a PhD degree in virology and immunology together with a Masters degree in biology (genetics, microbiology, cell biology and organic chemistry) from the University of Freiburg, Department of Virology, Germany and subsequently held an academic position in the Department of Virology between 1987 and 1996 during which time he focused on medical virology, diagnostics and epidemiology. Ralf has extensive experience in academia, industry and the regulatory environment and is a Principal Consultant at PAREXEL and is affiliated with ASM (American Society for Microbiology) since 1996, ESCV (European Society for Clinical Virology) since 2004, GfV (Gesellschaft für Virologie = Society for Virology, DE, AUT, CH) since 1990, DGHM (Deutsche Gesellschaft für Mikrobiologie und Hygiene, German Society For Microbiology and Hygiene) since 1999, BioValley Deutschland e.V. (Freiburg, Germany) since 1996, a member of European QP (Qualified Person) Association since 2007, a member of European Society of Virology (new organization (04/09) since June 2009, an ECA (European Compliance Academy) and PDA (Parenteral Drug Association) member. Prior to his position at PAREXEL, Ralf was the Chief Scientific Officer at HISS Diagnostics (1996 to 2007), an in-vitro diagnostic medical device manufacturer where he was responsible for R&D, manufacturing as well as being Head of Regulatory Affairs. Ralf has extensive knowledge of medical device regulations (ISO, certification and accreditation), GLP, GCLP and GMP and was registered as a Qualified Person with Swiss Medic (2007-2012). In the time that Ralf has been at PAREXEL (more than 7 years) his expertise in virus safety and manufacturing has meant he has been actively involved in identifying and resolving competitive GMP compliance issues, advising on biological assay selection and validation as well as assessing biosafety concerns for various biotechnology products including biosimilars, and vaccines. Ralf is also a recognized expert in immunogenicity and has extensive knowledge of biological assay platforms and their application to immunogenicity testing and assessments. Ralf understands EU GMP and regulatory affairs legislation for drug and devices and provides strategic compliance services for drug, device and drug-device combination product manufacturer. He recently became an APIC certified Auditor (eff. from June 5, 2014) for ICHQ7 Biologics.

Topic lectured:

Seminar 7:

  • The principles of GLP

Graham Higson

Gch Pharma Consulting

Graham

Graham Higson has spent over 35 years in the pharmaceutical industry and, since January 2014 is Managing Director and owner of GCH Pharma Consulting Ltd, specialising in the provision of strategic regulatory advice, drug development, regulatory outsourcing and organizational development. He is currently a partner of, and responsible for Regulatory Affairs at, Avillion LLP, a drug development company with an innovative business model for the clinical development and approval of late stage pharmaceutical products. He is also a member of the NDA Regulatory Advisory Board, comprising former senior European regulators and industry experts.

Prior to establishing his own consulting company, he was Managing Director of NDA Advisory Services where he was accountable for the organization’s Regulatory and HTA Advisory Boards. Earlier in his career he was Global Head of Regulatory Affairs for the Medical Diagnostics division of GE Healthcare and previously he spent five years at AstraZeneca as Vice President and Global Head of Global Regulatory Affairs leading the regulatory organisations across six R&D sites in the UK, Sweden, US and Japan. This followed a number of senior regulatory positions both in the UK and USA during his 11 year tenure at Pfizer. Prior to that he worked at Gensia, Sandoz, Ciba-Geigy, Synthѐlabo and Baxter Healthcare.

He has also been a member of both the EFPIA and PhRMA regulatory affairs committees, the CMR Regulations Advisory Board and the TOPRA Regulatory Advisory Council.

Topic lectured:

Seminar 2:

  • European Centralised procedure at the EMA

Lois Hinman

Novartis Pharmaceuticals Corporation, USA

Lois

Lois Hinman is Global Head of Early Development Regulatory Affairs, at Novartis Pharmaceuticals.  She is based in East Hanover, New Jersey and leads a global team of regulatory professionals who provide strategic regulatory input into programs in the Novartis portfolio from the time of candidate selection to proof-of-concept.  Lois has significant experience in biologics development over many years initially leading the research efforts to develop the first approved drug/antibody conjugate, Mylotarg, in the early 1990’s.  She is an internal expert in regulatory strategies for biologics at Novartis and is an active member of industry policy groups supporting initiatives on both personalized medicines and implementation of biosimilar pathways.  She was the PhRMA lead on the ICH E15 and E16 guidances on Pharmacogenomics and is a member of the BIO Biosimilars Implementation Team, the PhRMA Biosimilars Key Issue Team and the EBE Expert Group on Biosimilars.  Lois has over 20 years of experience in pharmaceutical R&D, with a focus on biologics programs and her career has included Discovery Research, Project Management, Business Development/Licensing as well as Regulatory Affairs.  Lois received her Ph.D. in biochemistry from Cornell University, with a minor in neuroscience, and is the author of numerous publications and abstracts.

Topic lectured:

2nd Annual Biopharmaceuticals Meeting:

  • Experience with the regulatory landscape in the EU and U.S. for the introduction of new formulations and new dosage forms

Philipp Hoffmann

Daiichi Sankyo Europe

Philipp

Dr. Philipp Hoffmann is currently Senior Director Business Development & Licensing and leads a small BD team at Daiichi Sankyo Europe. His focus is the global search and evaluation of biologicals for the EU market, mostly in the field on oncology. Dr. Hoffmann received a degree in biology from the University of Göttingen. A scholarship from the University of California San Diego enabled him to work at the Scripps Research Institute. At Scripps he laid the technical foundation in the field of recombinant antibodies for his following PhD work performed at the University of Hamburg, which was supported by a grant from the Deutsche Krebshilfe. He entered the biotech industry in 2000 by joining the start-up Xerion Pharmaceuticals as a Staff Scientist. The subsequent engagement with MorphoSys, firstly as a Team Leader later as an Alliance Manager, led to his transition from Research to the commercial aspects of Product Development. Several partnerships with Big Pharma from EU, US and Japan were managed by Dr. Hoffmann. At Daiichi Sankyo he has been involved in several licensing agreements with biotech companies and the evaluation which led to the acquisition of Plexxikon. One of his priorities are commercial evaluations of biosimilars for the EU market.

Topic lectured:

Be successful in biopharmaceutical partnering: Due diligence as the essential element

Josefin-Beate (Josi) Holz

LEO Pharma / Bioneer-Consulting

Josefin-Beate (Josi)

Josi is a serial entrepreneur and experienced executive leader with a broad background in drug development in oncology, haematology, inflammation and immunology. She has generated a track record in successful execution of translational medicine and acceleration of drug development from research stage into clinical proof of concept and towards product registration for a significant number of small molecule drug candidates and biologics, including mAbs and novel protein drug formats. In her role as executive management member, Josi has built development functions “from scratch” and successfully combined project and portfolio management with corporate objectives - e.g. financing, partnering and licensing to maximise the value of projects towards commercialisation. As MD with training in oncology, Josi started her career with BMS in 1995 and has since then worked internationally with prestigious large and mid size Pharma companies (Gilead, OSI, LEO Pharma) and SMEs in the Biotechnology sector (U3 Pharma, GPC Biotech, Ablynx NV).

Topic lectured:

Seminar 3

  • The product class of monoclonal antibodies (mAb)

Alicia Hong

WilmerHale

Alicia

Alicia Hong is the China Liaison Officer and Head of China Practice in the German Corporate and International Arbitration Practice Groups. She joined the firm in January 2009.
Ms. Hong’s practice focuses on China-related work in life science, automobile and renewable energy industries. During her career in China from 1997 to 2003, she was involved in some key joint venture projects in transportation and machinery industries. Since 2007, she has been a member of the firm’s life sciences practice group and has developed deep knowledge about China life sciences landscape and related deal making process. She has built contacts in both China and Europe, including international companies, state-owned enterprises, and domestic private companies in such sectors. In addition to assisting US and European companies in its partnering process and contract drafting and negotiations, she is helping Chinese companies’ overseas mergers and acquisitions, strategic alliances and public listing. She has facilitated relationships between European and Chinese companies and advised clients on their joint venture contracts, technology transfer and licensing agreements as well as other collaboration agreements. She played critical role in discussions and negotiations between European companies and its Chinese partners. Prior to joining the firm, Ms. Hong was China Officer with Mayer Brown LLP in Frankfurt. During her time in China, she was Contract Manager with ThyssenKrupp in Shanghai for its maglev transrapid project and was a Chinese attorney for an international law firm in Shanghai. She also has experience working for the Shanghai Municipal Foreign Economic Commission.

Topic lectured:

Coaching: China strategy - the essentials to register pharmaceuticals up to market entry in China

  • What you should know about China
  • Patent situation / Compulsory license

Thomas Hünig

University of Würzburg

Thomas

Prof. Dr. Thomas Hünig has been Head of Institute and Chariman of the Department of Immunology at the Institute for Virology and Immunobiology, University of Würzburg since 1990.

Since 2009 he has been speaker at the Interdisciplinary Center for Clinical Research (IZKF) in Würzburg, Vice Dean for Research at the Medical Faculty and Member of the University Senate. Since 2003 he has been speaker at GSLS class "Infection and Immunity". Between 2000 - 2009 he was speaker at the Graduate College 520 "Immunomodulation", between 2002 - 2009 at the SFB 479. Between 1999 - 2006 he was Coordinator of the VW-Junior Research Group. His previous positions included: Group Leader, Gene Center/MPI Munich; Head of a Research Group of the SFB 105, Würzburg; Postdoc with Dr. M. Bevan, Massachusetts Institute of Technology.

He has been a member in several advisory boards: Biomedical Commission of the Fritz Thyssen Foundation (since 2/2008); Scientific Advisory Board, Wilhelm-Sander-Stiftung (since 2007); IZKF Erlangen (since 2002); Scientific Advisory Board of the Research Center Borstel (2001 - 2010) DFG panel microbiology, virology and immunology (2000 - 2008); Scientific Advisory Board of the BNI for Tropical Medicine, Hamburg (2001 - 2007); Scientific Advisory Board of the Institute for Immunology, Heidelberg (1992 - 2002). He received the following awards: Humboldt/South African Research Award (1997), Aronson-Preis (1994), Award of the German Society for Hygiene und Microbiology (1985), Heisenberg fellowship (1985).

He holds degrees in Biology from Universities of Würzburg and Heidelberg; PhD: Immunology, University of Würzburg (1978), Habilitation: Immunology, University of Würzburg (1984).

Thomas Hünig discovered a class of CD28-specific monoclonal antibodies which were termed "superagonists" for their stimulatory potential. He was main founder of TeGenero AG which developed the humanized CD28 superagonist TGN1412.

Topic lectured:

3rd Annual Biopharmaceuticals Meeting:

  • The storm has cleared: RESTORE as a new in vitro system for understanding the TeGenero trial

I

Esther Imboden

Regulix Ltd.

Esther

Dr. Esther Imboden is Director of REGULIX LTD, Regulatory Affairs Consultancy in Switzerland. She has a technical background with more than 17 years regulatory affairs experience in the pharmaceutical industry and an extensive understanding of all aspects of the European and Swiss Licensing Procedures and the FDA (CBER) regulatory processes specifically in the product registration of sterile biological preparations as well as production plant submissions. Before the foundation of her own company in 2001, where she offers national and international regulatory affairs consultancy, specifically in the field of product registration of sterile preparations, biological products as well as registration of production plants, she has been working for ten years as Director, respectively as Senior Manager of Drug Registration and Regulatory Affairs at ZLB Zentrallaboratorium BSD SRK and ZLB Bioplasma AG in Switzerland.

Topic lectured:

Seminar 2:

  • Marketing Authorisation and Clinical Trial Authorisations Applications in Switzerland

J

Angelika Joos

Merck Sharp & Dohme (Europe), Inc.

Angelika

Angelika Joos is a licensed pharmacist. Since 2001 she is responsible for regulatory policy issues at Merck Sharp & Dohme's Regulatory Affairs department in Brussels. Before focusing on policy she was working at the European and German Regulatory Affairs departments of MSD as well as for Nycomed Arzneimittel GmbH. Over the past 15 years, Angelika has gained strategic as well as operational experience with all regulatory procedures and various products in different therapeutic areas. In her current position as Head Regulatory Policy EU & Most of World she is responsible for monitoring and implementing regulatory policies & procedures and advising the company on regulatory strategies. One of her current priorities includes the implementation of the Paediatric Regulation into the EU regulatory framework. Since 2004 she is a member of the EFPIA Regulatory Liaison Committee and specifically involved in activities related to paediatric policies. She is also a company delegate to the IFPMA Pediatric Task Force established in 2008. In addition she is co-chairing the global Merck Pediatric Development Committee since 2011.

Topic lectured:

Seminar 5:

  • The EU Regulation No 1901/2006 on medicinal products for paediatric use – the Paediatric Regulation
  • Regulation for medicines in children in other regions with focus on US
  • Implications of the EU legislation for the pharmaceutical industry: perspectives, challenges and opportunities
  • Case illustrating PIP practice

K

Sibylle Kaiser

Biotest Pharma GmbH

Sibylle

Dr. Sibylle Kaiser is heading the Group Corporate Regulatory Affairs Development at Biotest AG. She is a Regulatory Affairs professional with more than 12 years of pharmaceutical industry experience. In her current position she is involved in planning and implementation of regulatory strategies for drug development programs and product enhancement plans. She has expert knowledge of regulatory requirements (CMC, preclinical, clinical) for development and life cycle management of antibodies, antibody-drug-conjugates, and plasma-derived products. Therapeutic area experience includes immunodeficiency and haematologic diseases, oncology and prevention of virologic infection. Prior to joining Biotest she was working for Abbott GmbH and Aventis Pharma. She holds a PhD in cancer research, a diploma in Molecular Biology and a Master Degree in Drug Regulatory Affairs (MDRA).

Topic lectured:

Seminar 8

  • Regulatory strategy for the introduction of changes in the manufacturing process

Susanne Keitel

EDQM

Susanne

Susanne Keitel is a licensed pharmacist with a Ph.D. in pharmaceutical technology. Her work experience includes 10 years in pharmaceutical development in industry, with five years as Department Head of ”Pharmaceutical Development/Oral Dosage Forms“ at the former Schering AG, Berlin. From 1997 to 2005, she held the position of Division Head Pharmaceutical Quality at the Federal Institute for Drugs and Medical Devices (BfArM), Germany. She additionally served as Acting Head of the Division European Procedures from November 2003.

From July 2005 to October 2007, Susanne Keitel was Head of EU, International Affairs at BfArM. During her time with BfArM, she represented the agency in a number of EU committees, including the Joint CHMP/CVMP Quality Working Party (QWP), the EMEA Paediatric Working Party and the European Commission’s Notice to Applicants Group. She was actively involved in the International Conference on Harmonization (ICH), where she acted as the EU topic leader and rapporteur for the ICH guidelines on stability testing and pharmaceutical development. On a national level, she was from 2001 to 2007, Chair of the German Pharmacopoeia and the German Homeopathic Pharmacopoeia. Since October 2007, Susanne Keitel is Director of the European Directorate for the Quality of Medicine & HealthCare (EDQM) of the Council of Europe in Strasbourg.

She also lectures in the postgraduate course “Master of Drug Regulatory Affairs” at Bonn University, where she is responsible for the module on the quality dossier. In 2009, Dr. Keitel was elected as corresponding Foreign Member at the French Académie Nationale de Pharmacie.

Topic lectured:

Seminar 7:

  • European Directorate for the Quality of Medicines and Healthcare (EDQM)
  • Agency´s batch release
  • OMCL network
  • Official Control Authority Batch Release (OCABR)
  • CAP testing
  • PICS and WHO

Niamh Kinsella

NDA Regulatory Science Ltd.

Niamh

Niamh Kinsella is a biotechnological product development specialist, with particular interest in development of biosimilar medicinal products and Advanced Therapy Medicinal Products.
She has experience in pharmaceutical quality (chemistry, manufacturing and control, CMC), strategic development and regulatory processes and requirements accumulated through years within industry and regulatory consulting. During this time, she has worked in the development of biotechnological products, biosimilar products and Advanced Therapy Medicinal Products and this experience includes manufacturing process and formulation development, comparability strategies during process development, stability assessments and overall strategic development from a CMC perspective. She has been involved in the development of regulatory and product development strategies for a wide range of biotechnological products, including originator and biosimilar recombinant proteins, monoclonal antibodies and related substances, prophylactic and therapeutic vaccines, cell therapy products and gene therapy products. She has also been involved in the development of comparability programmes for products during development and following approval.
Niamh joined NDA Regulatory Science Ltd as a Senior Regulatory Consultant and biotechnological product expert in 2010 where she has supported companies throughout all stages of the product lifecycle.

Topic lectured:

Coaching: Applying risk assessment to the design of an effective comparability protocol

Elisabeth Kirchisner

Roche

Elisabeth

Dr. Elisabeth Kirchisner, Director Technical Regulatory Affairs, Roche

Dr. Elisabeth Kirchisner is a pharmacist by training and holds a PhD in Pharmaceutical Chemistry from the Ludwig-Maximilians University in Munich.

She started her professional career in 2003 at Roche Diagnostics GmbH in Penzberg. Since then she has been working for Technical Regulatory Affairs for biotech products with increasing responsibilities. She has worked on INDs/ IMPDs for several early development projects before leading all technical regulatory activities for the global marketing application of a new monoclonal antibody in 2011-2014.

Elisabeth is now heading a department within the Technical Regulatory Development/ New Products organization of Roche in Penzberg.

Topic lectured:

Thomas Kirchlechner

Sandoz GmbH

Thomas

Thomas Kirchlechner holds a Master's degree in chemistry from the University of Munich and a PhD from Otago University in Dunedin, New Zealand. He has over 14 years experience in the pharmaceutical industry, including finished dosage form production, active ingredient strategic sourcing, and, for the last 11 years, in regulatory affairs specializing in biopharmaceutical and biosimilar products at Sandoz GmbH Kundl, Austria.

Topic lectured:

Seminar 4.2:

  • Regulatory principles of development of biosimilar medicinal products in the various regions 
    - EU
    - FDA
    - WHO
  • Global development, experience with submissions in different regions
  • Experience with Sandoz biosimilars
  • Current considerations on regulatory requirements for monoclonal antibodies developed as biosimilars
  • Biosimilar Case Study

3rd Annual Biopharmaceuticals Meeting:

  • Industry experience with authorisations of biopharmaceuticals in Brazil

Matthew Klimek

F. Hoffmann-La Roche Ltd.

Matthew

Matthew Klimek, PharmD is a Regulatory Program Manager currently working in Product Development Oncology at F. Hoffmann-La Roche Ltd. in BAsel, Switzerland. He completed his Pharm.D. at St. John's University in New Yorl, USA followed by a 2-year fellowship program in regulatory affairs at Schering-Plough/Merck through Rutgers University in Brunswick, NJ, USA. After completing his fellowship, Matt joined Product Developmgent Regulatory Affairs at Roche in Nutley, NJ, USA. Matt has experience working across several therapeutic areas (cardiovascular, metabolic, neurology and oncology) in North America and Asia in both early and late-stage product development. As of September1, 2012, Matt has transitioned from Roche's site in Basel, Switzerland. Matt is currently an EU/ROW regulatory program manager on a late-stage product and a regulatory lead on an early-stage product in Oncology.

Topic lectured:

Seminar 2:

  • Japanese Regulatory Affairs
  • Regulatory Affairs in the USA

Steven Kozlowski

FDA

Steven

Steven Kozlowski is the Director of the Office of Biotechnology Products, Office of Pharmaceutical Science, at the Center for Drugs Evaluation and Research (CDER), FDA. OBP is responsible for the quality review of monoclonal antibodies and most therapeutic proteins at CDER. OBP also provides expertise on immunologic responses to therapeutic proteins and performs mission related research. Dr. Kozlowski received his medical degree from Northwestern University and trained in Pediatrics at the University of Illinois. Prior to joining the FDA, Dr. Kozlowski worked as a staff fellow in the Molecular Biology Section of the Laboratory of Immunology, NIAID, NIH. He studied the immune responses to proteins and peptides during his fellowship. Dr. Kozlowski joined the Division of Monoclonal Antibodies in 1993 and was tenured as a Senior Investigator in 2000. He has been involved in all phases of the regulatory process as a reviewer, from pre-IND product development through inspections, licensing and post approval supplements. Dr. Kozlowski served as the acting Director of the Division of Monoclonal Antibodies from 2004-2005. He has also served as an instructor and as an adjunct clinical reviewer at FDA. Dr. Kozlowski’s research interests include the effects of drugs on the immune system. He is involved in ongoing policy development for biosimilars and Quality-by-Design approaches for the manufacture of biopharmaceutical products.

Topic lectured:

3rd Annual Biopharmaceuticals Meeting:

  • The FDA draft guidance on biosimilar product development

4th Annual Biopharmaceuticals Meeting:

  • News and Trends in the US: update of FDA activities including the status of the FDA draft guidance on biosimilar product development
  • The EMA-FDA biosimilar cluster

Hartmut Krafft

Paul-Ehrlich-Institut

Hartmut

Dr. Hartmut Krafft gained his master degree and PhD at the German Cancer Research Centre Heidelberg, Department of Cell Biology and Immunology. As Post-Doc he worked at the German Cancer Research Centre and the European Molecular Biology Laboratory in Heidelberg as well as for the Institute of Pathology at the University Hospital in Regensburg. At the Paul-Ehrlich-Institut he was responsible for marketing authorization, batch release and regulatory affairs of immunoglobulins, sera and monoclonal antibodies.

Currently he is working as Head of the section Clinical Trials at the PEI. He is Chair of the Heads of Medicines Agencies (MA) Clinical Trials Facilitation Group (CTFG) and Coordinator of the Voluntary Harmonisation Procedure (VHP).

Topic lectured:

Seminar 2:

  • Clinical Trial Application (CTA) in Europe: legal basis and relevant procedure

4th Annual Biopharmaceuticals Meeting:

  • Clinical trials in the EU: where do we stand with the update of the clinical trial regulations

Arno Kromminga

IPM Biotech

Arno

PD Dr. Arno Kromminga is founder and CEO/CSO of GLP-certified IPM BIOTECH, is heading the Immunology at the Clinical Laboratory Lademannbogen in Hamburg, Germany, and has a position at the University of Kiel, Germany. He studied biochemistry and immunology and has 15+ year experience in assay development and is author of multiple publications in peer-reviewed journals and books. He is cofounder of the European Immunogenicity Platform (EIP). He gained substantial industrial experience in various biotech companies. He has been involved in the development and establishment of novel immunological and cellular assays for immunogenicity testing and PK/PD analysis for pre-clinical and clinical studies in compliance with GLP regulation. Most importantly he aims to interpret ADA, PK/PD data in the context of clinical consequences and manifestations.

Topic lectured:

Immunogenicity Integrated - Interactive Workshop

  • Bioanalytical method selection

Harald Kropshofer

F. Hoffmann - La Roche

Harald

Dr. H. Kropshofer is Senior Personalized Healthcare Leader in the Pharmaceutical Division of F. Hoffmann-La Roche. He is located in the head quarter in Basel, Switzerland. He is a corporate expert in clinical immunology and immunosafety in late stage clinical drug development – with a particular focus on risk assessment and mitigation related to immunogenicity, hypersensitivity and infusion related side-effects of therapeutic proteins in the therapeutic areas oncology, hematology, inflammation, autoimmunity and neurological diseases.

Dr. Kropshofer is biochemist and immunologist by training. Prior to joining Roche in 2001, he was Research Group Leader at the German Cancer Research Center in Heidelberg, Germany and at the Basel Institute for Immunology, Switzerland. He is Associate Professor in cell biology & immunology at the University of Heidelberg since 2000.

Dr. Kropshofer has more than sixty publications to his credit in peer-reviewed journals, and is a regularly featured speaker at international conferences in Europe and USA.

Topic lectured:

Immunogenicity, Part III: Monitoring and Assessment of Clinical Immunogenicity

Pekka Kurki

Finnish Medicines Agency

Pekka

Dr. Pekka Kurki, M.D, Ph.D, acts as a research professor at the Finnish Medicines Agency (Fimea).

Before joining the Finnish regulatory agency in 1997, he worked in the pharmaceutical industry (clinical research), both in Europe and in the U.S.A. Dr. Kurki's clinical speciality is internal medicine with sub-speciality in rheumatology. He has a teaching affiliation to the University of Helsinki (clinical immunology). His scientific interest also includes cell biology, rheumatology and regulatory science.

He has had several scientific positions at the European Medicines Agency (EMA), including the membership the Committee of Human Medicinal Products (CHMP, 2000-7), chairmanships of the working parties for comparability (2002-3), biosimilars (BMWP, 2004-7), cell therapy (2002-4), and cell-based medicinal products (CPWP 2005-7). In addition, he acted as the chair of the ad hoc group for xenogeneic cell therapy (2001-3), a member of the biologicals working party (BWP, 1998-9) and a member of the ad hoc innovation Think Tank group of EMA (2005-7).

Currently, he is an alternate member of the EMA management board and an expert in the BMWP.

Topic lectured:

Immunogenicity: Understanding the regulatory philosophy (2)
  • Evolution of the regulatory approach related to the immunogenicity requirements
  • What is meant by a “risk-based approach” to immunogenicity assessment from the regulator’s perspective?
  • What are the implications of this philosophy for data presentation?
  • Conditions of use & patient-related factors
  • Clinical evaluation of immunogenicity and how does it contribute to the benefit-risk assessment
  • Role of the Risk Management Plan
  • How to tell a good story

L

Anja Lageneckert

F. Hoffmann-La Roche Ltd.

Anja

Anja Langeneckert, PhD has been working as Group Leader of Early and Late Development at the International Regulatory Affairs department at F. Hoffmann-La Roche Ltd, Basel since November 2007. Before this appointment she was Global Regulatory Leader between April 2001 and October 2007 at Roche. From 1999 till 2001 she worked at the Roche Consumer Health, Vernier (Geneva) and Kaiseraugst at the Medical Information and Regulatory Affairs Unit.

Her education is the following: Certification as a German Pharmacist (1996), PhD in Pharmacy, Pharmacokinetics, Johann-Wolfgang Goethe University, Frankfurt, Germany (1999) and TOPRA Diploma Regulatory Affairs (2007).

Topic lectured:

2nd Annual Biopharmaceuticals Meeting:

  • Personalised medicine to deliver innovations of the future – what is the focus in development and what are the scientific and regulatory challenges?

Sylvie Le Glédic

Voisin Consulting Life Sciences

Sylvie

Sylvie Le Glédic is in charge of the design and implementation of global regulatory strategies for the development of medical devices and in vitro diagnostics (IVDs). Furthermore, she is actively involved in the evolution and the re-writing of the EU IVD Directive, and closely follows the new regulations for registration of Companion Diagnostics. Sylvie is based in Voisin Consulting Life Sciences’ Paris office.


Sylvie brings over two decades of experience in the regulatory field of IVD medical devices, achieving the implementation of the IVD Directive at Bayer Diagnostics in the EU, as well as the registration of the CE marked Company’s IVDs with the applicable European Competent Authorities. Sylvie has significant experience in the preparation and submission of regulatory filings according to the EU Conformity Assessment procedures to achieve CE marking for placing IVD products on the market in Europe. She managed numerous contacts with regulatory bodies (Notified Bodies and EU Competent Authorities) and supported the Pre- and Post-market IVD vigilance activities and reporting in Europe.
Sylvie is a graduate of the University of Paris VI with a degree in biochemistry. Her work experience grew from marketing responsibilities and registration of diagnostics products with the French Competent Authority to extended National and European regulatory responsibilities at Bayer Diagnostics then Siemens HealthCare Diagnostics, for all Central Laboratory and Diabetes Care devices. The Central Laboratory devices included biochemistry, haematology, immunology, blood gas and molecular biology products, under Annex II List A and List B. She closely collaborated with the US manufacturer for the reporting of adverse events to the EU Regulatory Agencies, including the MDRs reported to the FDA. She achieved the CE marking of the reagents and software for the risk assessment of Trisomy 21, obtained with the French Notified Body, LNE.


Recently at BioSystems International, she was in charge of the development of a diagnostic test for lung cancer detection. She managed the clinical trials performed for the validation of the test and the creation of the 510(k) and CE technical files, and prepared the pre-IDE meeting with the FDA.

Topic lectured:

3rd Annual Biopharmaceuticals Meeting:

  • Where do we stand with EU and US requirements for drug-diagnostic companion developments?

Geneviève Le Visage

Novartis Pharma AG

Dr Geneviève Le Visage is currently heading the EU Regulatory Intelligence & Policy group at Novartis Pharma AG in Basel. Prior to this, she worked for ten years at the European Medicines Agency in London, mainly in the Medical Information sector, where she set up the processes for the publication of public-friendly documents, such as question-and-answer documents designed to explain the rationale for the Agency’s decision on new medicines approvals or on safety reviews. This included defining the standards for the documents, as well as training and managing the medical writing team. She also coordinated all EMA’s activities regarding European Public Assessment Reports (standard operating procedures, monitoring activities, support to internal and external users of EPARs, development of the product and EPAR pages of the EMA website). Prior to joining the EMA, she worked for GlaxoSmithKline in West London in the field of prescribing information.

Dr Le Visage is a pharmacist, having graduated from Nantes University (France) and also holds a masters in Science Communication from Imperial College, London (UK).

Topic lectured:

Seminar 1:

  • Regulatory institutions and other stakeholders of the European system of pharmaceuticals, their functions and role

Florian Lengyel

Boehringer Ingelheim Pharma GmbH & Co. KG

Florian

Florian Lengyel is a Global DRA CMC Manager Biopharmaceuticals and topic leader for drug/device combination products at Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany. He graduated with degrees in Environmental Biology (B.Sc.) and Applied Environmental Sciences (M.Sc.) from the Queen’s University of Belfast, Northern Ireland and holds a PhD in Animal Physiology from the University of Bayreuth, Germany.
After a short stint as a post-doc he worked at Vetter Pharma-Fertigung GmbH & Co. KG, Ravensburg, Germany as a Regulatory Affairs Associate and later as Deputy Team Leader Reg. Affairs / Compliance for over 5 1/2 years. He joined Boehringer Ingelheim in April 2012. He has more than 8 1/2 years’ experience in CMC Regulatory Affairs specializing on drug product and delivery devices for bio-pharmaceuticals and small molecules. Florian Lengyel also lecturs at Medicademy, Copenhagen, Denmark.

Topic lectured:

Seminar 4.1:

  • Consideration for the CMC development and submission requirements for a drug-device combination product

Johannes Löwer

Past President Paul Ehrlich Institute, Past President BfArM

Johannes

Johannes Löwer was born on 20 November 1944 in Vienna. He studied medicine at the Universities of Würzburg and Tübingen from 1963-1969 and qualified as a physician in 1972 while pursuing studies in physiological chemistry and biochemistry from 1970-1974 at University of Tübingen.

Dr. Löwer received a postdoctoral fellowship from Friedrich Miescher Laboratory at the Max Planck Society, Tübingen to pursue research in the field of RNA tumor viruses from 1976-1980.

In 1981 Dr. Löwer joined the Paul-Ehrlich-Institut, Federal Agency for Sera and Vaccines, Langen and headed the Cytology Section from 1982-1991 and the Division of Human Virology from 1987-2002. Dr. Löwer was appointed President of the Paul-Ehrlich-Institut on 7 June 2001. He retired from this position 30 November 2009.

Dr. Löwer holds the following degrees: Dr. med. [M.D.], the University of Tübingen, 1972; Qualification as physician, Stuttgart, 1974; Diplom-Biochemiker [M.Sc. in Biochemistry], the University of Tübingen, 1975; Venia legendi in Medical Virology, Faculty of Human Medicine, the University of Frankfurt, 1990: Professor of Medical Virology, Faculty of Human Medicine, the University of Frankfurt, 1999

Dr. Löwer’s former positions: President of the Federal Institute for Drugs and Medical Devices (BfArM), Bonn, 2009-2010; Acting Director of the Federal Institute for Drugs and Medical Devices (BfArM), Bonn, 2007-2009; President of the Paul-Ehrlich-Institut, Langen, 2001-2009; Acting Director of the Paul-Ehrlich-Institut, Langen, 1999-2001; Deputy Director of the Paul-Ehrlich-Institut, Langen, 1991-1999; Head of Human Virology Division, Paul-Ehrlich-Institut, Langen, 1987-2002; Head of Cytology Section, Human Virology Division, Paul-Ehrlich-Institut, Langen, 1982-1991; Scientist at the Paul-Ehrlich-Institut, Langen, 1981-1982; Postdoctoral fellowship at the Friedrich Miescher Laboratory of the Max Planck Society, Tübingen, 1976-1980

Topic lectured:

2nd Annual Biopharmaceuticals Meeting:
  • Don’t forget them! Risks associated with virus contaminations

Chairman of the 1st, 2nd, 3rd, 5th Annual Biopharmaceuticals Meeting

Paul Lucas

Amgen Ltd.

Paul Lucas is currently Senior Manager in the Global Regulatory CMC function of Amgen Ltd, based in Cambridge U.K. In this role Dr Lucas is a team leader responsible for regulatory strategy for European and Emerging Market filings for development and commercial products in Amgen’s portfolio. Prior to Amgen, Dr Lucas was Research Fellow in the New Products CMC function of the Regulatory CMC group of Pfizer Global Research and Development with global responsibility for regulatory aspects of medical devices and combination products. At Pfizer Dr Lucas was also involved in the late stage development and registration of products both the Pharmaceutical R&D and Regulatory Groups.

Dr Lucas holds a Bachelors degree in Pharmacy form the University of Wales and has been a registered Pharmacist since 1992. He received his PhD on the subject of Gene Transfer to Eukaryotic Cells Using Cationic Polypeptides from the University of Bath, School of Pharmacy and Pharmacology in 1995. Dr Lucas subsequently worked in as a Post-doctoral Research Fellow in the Pharmaceutical Technology group of the same department, where he researched powder technology relating to delivery of inhaled proteins.

Topic lectured:

Seminar 4.1

M

Avril Mankel

Santen GmbH

Avril

Dr. Avril Mankel has a PhD in Cell and Developmental Biology and is currently working at Santen GmbH. She was Senior Manager Regulatory Affairs at NDA Regulatory Service GmbH in Munich, Germany. After having worked for several years as post-doc at the University of Würzburg, the University Hospital and the Max-Planck-Institute for Molecular Genetics in Berlin she has been working for 14-years in the pharmaceutical industry now. She is an expert in the area of regulatory strategic advice for the development of medicinal products in Europe, submission and follow-up of MAA, full management for Scientific Advice and Protocol Assistance procedures, preparation of and advice on Briefing Books including questions and company positions for Scientific Advice and Protocol Assistance procedures, full management of Paediatric Investigation Plans (PIP) / Waiver / Deferral applications at EMA, preparation of documents required for the application of Paediatric Investigation Plans (PIP) / Waivers / Deferrals, preparation of documents for the application for Orphan Designations, preparation of documents for re-examination procedures after negative CHMP opinions, maintenance of approved licenses (follow-up measures, renewals, variations, implementation of regulations as required by EMA and national Agencies), preparation of IMPDs and IBs for Clinical Trial Applications. She acted as representative for companies at meetings with EMA and national agencies.

Topic lectured:

Seminar 5:

  • The Paediatric Investigation Plan (PIP)

Seminar1:

  • Format and content of the marketing authorisation application: The Common Technical Dossier (CTD)
  • Module 1 of the CTD
  • Module 2 of the CTD
  • Labeling, Package Leaflet and Summary of Product Characterisitcs (SmPC)
  • Risk Management Plan (RMP)

Jacques Mascaro

Merck Serono

Jacques

Dr. Jacques Mascaro holds a PhD in Biology from University of Pharmacy in Aix-Marseille II. He started to work in Regulatory Affairs in 1989 as Manager of Regulatory Compliance Europe at Du Pont Pharma S.A. in Geneva. From 1994 to 1996 he worked as Chief Technical Officer International at Collagen International Inc.. Afterwards he became Senior Vice President for Pharmaceutical Affairs at H. Lundbeck AS. 1999 he changed to the Drug Information Association in Switzerland where he was European Managing Director. From 2001 to 2004 he was Director of European Regulatory Affairs at Johnson & Johnson. After 3 years with F. Hoffmann-La Roche as Head of European Regulatory Affairs Jacques Mascaro was Senior Vice President of Global Regulatory Affairs, Pharmacovigilance and Quality Assurance at Elan Pharma International. He is currently Senior Vice President, Global Regulatory & Quality Assurance at Merck Serono.

Topic lectured:

Seminar 8:

  • Regulatory strategy

Nils Matzen

NiSiPharm GmbH

Nils

Following his university studies of microbiology/biochemistry (Dipl.-Biol., Kiel) and PhD thesis (laboratory work in Coventy/UK; Dr. rer. nat., Kiel), Nils started his professional career 1982 at SmithKline, later GSK. After several management functions in regulatory affairs, clinical research, medical information, product management, and sales management, he became vice president commercial operations and managing director marketing. During this time, and under his responsibility, the GSK vaccines business in Germany was established, and reached sales of >250 mio € in 2003.

In 2004 Nils changed to Chiron/Novartis Vaccines and Diagnostics, where he was Vice President Commercial Operations for Central Europe, and where he grew the business from 98 mio € to 320 mio € by the end of 2007.

2008 he founded, together with Dr. Silke Sittner, his own company, NiSiPharm GmbH, offering his know-how in the commercialization of pharmaceutical/biotech products as a consultant, or as an interim manager, respectively, to the pharmaceutical and biotech industry.

His operational, executive experience includes general management, local, European and global marketing and sales management, merger/acquisition and business development, global launch projects, and health policy/market access in EU. Examples of NiSiPharm service assignments are, e.g., management functions in commercial operations (respiratory, HIV, oncology, vaccines, generics), market evaluation and recommendations to establish German businesses of foreign pharma, diagnostic, and medical devices companies, pharmapolitical projects, or the commercial evaluation and business planning of a new biological compound after phase 2 of the clinical development for a venture capital fund. During his professional life, Nils has initiated, and was involved in, numerous due diligence processes, he is experienced in vendor, as well as buyside due diligence, and is going to contribute insights and learnings from his real cases.

Topic lectured:

Be successful in biopharmaceutical partnering: Due diligence as the essential element

Dirk Mentzer

Paul-Ehrlich-Institut

Dirk

Medical education was performed at University hospital in Frankfurt am Main, Germany. Paediatric specialist training commenced 1992 at University Children hospital in Frankfurt am Main and at Royal Belfast Hospital for Sick Children. The special interest during Paediatric education included Neonatology, paediatric Haematology and infectious disease.

Medical dissertation was finalised in 1995. Appointment as a Consultant in General Paediatric in 2001 at University Children hospital in Frankfurt am Main and the last appointment in Paediatric was at Princess Royal University Hospital in Bromley, London.

Dr. Dirk Mentzer, MD has been Head of Pharmacovigilance at Paul-Ehrlich-Institut in Langen, Germany since 1 September 2004

Memberships:

  • Member of Paediatric Working Party of the CHMP since 01/ 2005
  • Member of the EV Telematic Implementation Group at the EMA (2004-2007)
  • Member of Eudravigilance Expert Working Party of the CHMP (2005-2007)
  • Co-opted Member for Paediatric Pharmacovigilance in the CHMP-
  • Pharmacovigilance Working Party at the EMA since 2/ 2006
  • Member of the Drug Safety Commission of the German Society of Paediatrics since 3/2006
  • Member of the Paediatric Committee at the EMA since 07/ 2007
  • PDCO vice-chair since 9/2010
  • PDCO chair since 9/ 2013

Topic lectured:

5th Annual Biopharmauticals Meeting:
  • Where to go in the EU with the Paediatric Investigational Plan (PIP)? An update on the most recent PDCO work

Beatrix Metzner

Boehringer Ingelheim

Beatrix

Dr. Beatrix Metzner studied chemistry at the University of Regensburg and the Albert-Ludwigs-University of Freiburg where she was specialized in biochemistry. Furthermore she was PhD student at the Department of Experimental Dermatology at the University of Freiburg and Post Doctoral research Fellow at the Memorial Sloan-Kettering Cancer Center (Immunology Program) in New York (Research fellowship of the German Research Society).From 2000 she worked at MediGene AG as Senior Scientist, later Manager Operations and Senior CMC Project Manager. In 2005 she started to work at Merck KGaA as Project Manager (CMC - Bio-manufacturing/Protein Supply).In 2007 she moved to Global Regulatory Oncology where she has been working as Director Global Regulatory Oncology since November 2008. Since November 2013 she took over the position as Head of Global Regulatory CMC Strategy Biosimilars at Boehringer Ingelheim.

Topic lectured:

Seminar 4.1:

  • Quality Module 3 of the CTD for recombinant and classical biopharmaceuticals
  • Characterisation, quality control and analytical techniques
  • Essential differences in Module 3 considerations USA
  • Essentials for Module 3 in Japan
  • Changes in process and their implications on the molecule, the comparability exercise

Geneviève Michaux

Hunton & Williams

Geneviève

Geneviève is a Belgian and French qualified attorney who focuses on issues surrounding the regulation of drugs, biologicals, medical devices, cosmetics and food in Europe, both at the Union and national level.
Geneviève specialises in European, French, and Belgian food and drug law, with particular emphasis on pharmaceuticals and medical devices. Her work covers a wide range of issues, including regulatory status of borderline products, clinical trials, life cycle management, labelling and promotions, and issues raised by specific categories of medicinal products, such as orphan or advance therapy medicinal products. Geneviève provides assistance to pharmaceutical companies on important new legislative projects and policy developments in the EU and has, among other matters, helped shape the new EC Paediatrics Regulation. She regularly instructs and supervises local counsels for pan-European or worldwide projects. She also has broad litigation experience in life science matters, including product liability, advertising and promotional activities, and generic approvals.
Geneviève is recognized as a leading regulatory lawyer in legal directories and by many organizations. She has published many articles on food and drug law and regularly speaks at legal and regulatory conferences on pharmaceuticals and medical devices.

Topic lectured:

Seminar 5:

  • PIP-related legal aspects

Seminar 1:

  • Introduction into the European regulatory system
  • The European Pharmaceutical Legislation

3rd Annual Biopharmaceuticals Meeting:

  • Session 2: Biosimilar monoclonal antibodies in the EU and the US and Session 3: Drug-diagnostic companion development panel discussion

4th Annual Biopharmaceuticals Meeting:

  • Is the legal pathway ready to regulate drug-diagnostic companion developments?

5th Annual Biopharmaceuticals Meeting:

  • Protection of Biological Medicinal Products – Latest Developments

Catherine Milne

EDQM

Catherine

Catherine Milne received her doctoral degree from the University of Toronto, Department of Molecular and Medical Genetics in 1994 and subsequently conducted independent research as a post-doctoral fellow at the Medical Research Council, Laboratory of Molecular Biology in Cambridge, England in the field of molecular genetics and developmental biology. Since 1999 she has been at the Council of Europe, European Directorate for the Quality of Medicines & HealthCare (EDQM) where she is the scientific officer responsible for the Networks of Official Medicines Control Laboratories (OMCLs) involved in Official Control Authority Batch Release (OCABR) of human vaccines, medicinal products derived from human blood and plasma, and veterinary vaccines respectively. She is also involved in the EDQM Biological Standardisation Programme (BSP) and has coordinated a number of projects for the standardisation of methods and reference materials for the evaluation of human and veterinary vaccines and medicinal products derived from human blood and plasma with a focus on the 3Rs (reduction, refinement and replacement of animal use).

Topic lectured:

Seminar 7

  • Surveillance of medicines through testing in the EU/Europe

- OMCL Network
- CAP testing program and Market Surveillance
- Official Control Authority Batch Release (OCABR)

Dominique Monferrer

Asphalion S.L.

Dominique

Dr. Dominique Monferrer holds a degree in Human Biology and a PhD in X-ray Macromolecular Crystallography. She worked for several years as a researcher at molecular laboratory institutions and synchrotrons in Spain and Germany before joining Asphalion as regulatory affairs consultant.

As regulatory affairs manager, her main areas of expertise include providing scientific assessment in development of chemical drugs and biologics (including biosimilars and cell-therapy medicinal products), carrying out and overseeing CMC and medical writing of regulatory documentation (e.g. IMPDs, scientific advice briefing packages, registration dossiers, etc.), as well as conducting viability analyses and designing tailored roadpmaps for innovative medical devices and in-vitro diagnostics.

Topic lectured:

Seminar 1:

  • Format and Content of the MAA Dossier: CTD and eCTD
  • Module 2 of the CTD

Bernd Müller-Beckmann

Bernd

Bernd Müller-Beckmann has more than 30 years experience in pharmaceutical industry where he held various scientific and managerial positions in the field of preclinical drug research & development and clinical development. Until recently he was the coordinator for preclinical safety at Roche’s Pharmaceutical Research and Development Center in Penzberg, Germany. Prior to this assignment he served as Global Coordinator for Biopharmaceuticals Safety at F. Hoffmann-La Roche Ltd., Basel, Switzerland. Under his leadership a company guideline for the non-clinical safety evaluation of biopharmaceuticals was developed, now a globally harmonized internal standard reference. In earlier roles as scientist and Head of Pharmacology & Toxicology he was involved and contributed to the discovery, preclinical and clinical development of a number of novel small molecules and biologics for various therapeutic areas, i.e. oncology, bone metabolism, diabetes, lipid metabolism and cardiovascular diseases. Bernd Müller Beckmann studied veterinary medicine at the universities of Berlin and Giessen. He holds a Ph.D. from the university of Giessen and is a board certified specialist for pharmacology and toxicology.

Topic lectured:

Seminar 4.2:

  • Principals of non-clinical development of biopharmaceuticals
  • The non-clinical CTD
  • What is special in the non-clinical development of biopharmaceuticals

Jan Müller-Berghaus

Paul-Ehrlich-Institut

Jan

Dr. Jan Müller-Berghaus is co-opted CHMP member and clinical assessor at the Paul-Ehrlich-Institut. He was Head of Section Monoclonal and Polyclonal Antibodies at the Paul-Ehrlich-Institut, Germany. He started his career in 1990 as Intern in Pediatrics at the Universtity of Cologne. From 1992 to 1996 he worked there as Resident in Pediatrics. In 1996 he became Fellow in Pediatric Oncology. Two years later he moved to the USA, where he worked as Research Associate at the Department of Surgery at the University of Pittsburgh. In 2002 he became Senior Research Associate at the German Cancer Research Center at the University of Heidelberg. In 2005 he changed to the Paul-Ehrlich-Institut, where he is still working.

Topic lectured:

Seminar 8:

  • Interactions with regulatory agencies in the EU to receive scientific advice
  • Scientific Advice from National Competent Authorities
  • Interactions of companies and agencies in the development of biopharmaceuticals

2nd Annual Biopharmaceuticals Meeting:

  • Potential future regulatory pathways taking into account the European HTA requirements

3rd Annual Biopharmaceuticals Meeting:

  • How to incorporate HTA considerations into clinical development – strategy, company structure, stakeholders involved, scientific considerations for future clinical developments of incorporating criteria to determine additional benefit

4th Annual Biopharmaceuticals Meeting:

  • EMA contributions to facilitate innovation: current state of the benefit-risk projectand the pilot project on adaptive licensing
  • Case study: the approval of the first biosimilar monoclonal antibody
  • Thoughts on the value of clinical trials to demonstrate similarity: what is their role in the overall similarity package and what do they show us

5th Annual Biopharmaceuticals Meeting:

  • How is the approved SmPC understood by the HTA Bodies and why does it matter

Silvia Muñoz Botella

EDQM

Silvia

Silvia Muñoz Botella received her doctoral degree in Pharmacy in 1994 from the University Complutense of Madrid. In 1996, she joined the EDQM, where she works as scientific officer in the Department of Biological Standardisation, OMCL Network and HealthCare (DBO). She is responsible for the physico-chemical Proficiency Testing Scheme (PTS) programme and the Market Surveillance Studies (MSS) programme.

Topic lectured:

Seminar 7

  • Surveillance of medicines through testing in the EU/Europe

- OMCL Network
- CAP testing program and Market Surveillance
- Official Control Authority Batch Release (OCABR)

N

Tilo Netzer

PharmaLex GmbH

Tilo

Tilo Netzer is a pharmacist by training and holds a PhD in Pharmacology. He started his career with Merck KGaA in Germany in 1992 and held at Merck various positions in Clinical Development and Regulatory Affairs where he significantly contributed to the successful developmentas well as marketing authorization of Erbitux. In the context of the integration of Merck and Serono in 2007 he became Head of Global Regulatory Oncology and in January 2009 he was appointed Head of Global Regulatory Affairs at Merck and Serono. In June 2012 Tilo joined PharmaLex as Partner, Business Development and Regulatory Strategy.

Topic lectured:

Seminar 2:

  • The PDUFA process at FDA

P

Jean-Yves Pabst

University of Strasbourg

Jean-Yves

Jean-Yves Pabst is a pharmacist and professor in pharmaceutical law and economics. He is Professor at the Faculty of Pharmacy & Vice-President Finance at the Universtity Strasbourg. Since then, he has been committed in the organization of partnerships with other Universities of the region in order to ensure the complementarity of both initial training and life-long learning.

In 2005 he established the major subject “European law and regulatory affairs” for the Masters degree in Drug Science with the active support of the Strasbourg Law Faculty and the European Directorate for the Quality of Medicines.

Jean-Yves Pabst has over 18 years experience as a pharmacist in regulatory affairs in the pharmaceutical industry.

Topic lectured:

Maria Pascual

Cellerix SA

Maria

Dr Maria Pascual holds a degree in Pharmacy from the University of Granada, obtained her PhD in Immunology from the Spanish National Research Council (CSIC), and her Master’s degree in Regulatory Affairs from Autonoma University in Barcelona. She is specialised in regulatory affairs for advanced therapies, is an external adviser to the European Medicines Agency (EMA), and is Chair of the Regulatory Committee of the European Alliance for Advanced Therapies. Dr Pascual has more than 10 years’ experience in cell therapy companies.

Topic lectured:

Gesa Pellier

Novartis Pharma AG

Gesa

Senior Regulatory Affairs Professional with 20 years regulatory experience across a broad variety of therapy areas. 7 Years at Local level (Germany). 13 Years at Region / Global level (8.5 years in regional role, 4.5 years in therapeutic area roles

Current Appointment (since 07/08): DRA Head Europe Lead of all regulatory aspects of development and marketed products in Drug Regulatory Affairs in Europe. Responsible for resource planning and utilization of Basel-based DRA group, including DRA associates in all European Country Pharma Organisations

Previous Novartis appointments

01/08 – 06/08: Global DRA Head, Immunology and Infectious Diseases. Global Leadership of a team of regulatory professionals, providing regulatory support for a broad portfolio of programs, projects and brands in the Immunology and Infectious Diseases Business Franchise in various stages of development and Health Authority review.

08/07 - 12/07: Global DRA Head, Ophthalmology, Dermatology, Gastroenterology, Urology

01/07 - 07/07: Global DRA Head, Dermatology, Gastroenterology, Urology

04/06 - 12/06: EU DRA Head, Arthritis, Bone, Gastroenterology, Urology

04/05-03/06: Senior Regulatory Manager with global responsibility for a GI drug (Zelmac/Zelnorm)

Topic lectured:

Seminar 1:

  • Regulatory Institutions and other Stakeholders of the European System of Pharmaceuticals, their functions and role

Silvia Pfaff

Novartis Pharma AG

Silvia

Dr. Silvia Pfaff is Global Head Regulatory Excellence in Drug Regulatory Affairs at Novartis in Basle, Switzerland.

She joined Novartis in July 2007 as EU Regional Head for the Business Franchise Immunology and Infectious Diseases and then took on global responsibility as Global Therapeutic Area Lead for Immunology and Bone.

Prior to joining Novartis she was Director, Therapeutic Area Immunology, at Abbott Laboratories and Knoll AG in Ludwigshafen, Germany.

She has got more than 20 years of regulatory experience in positions with increasing responsibility at Sanofi, Boehringer Mannheim, Knoll, Abbott and Novartis with a focus on biologics over the past 15 years.

She has a proven track record of successful submissions of global products in Europe, the US and Japan and achieving approvals with highly competitive labels.

Dr. Pfaff trained as pharmacist at the University of Heidelberg and earned her Ph.D from the Technical University in Munich.

Topic lectured:

Seminar 1:

  • Regulatory Institutions and other Stakeholders of the European System of Pharmaceuticals, their functions and role

Seminar 9:

  • The regulatory affairs´professional

Coaching Event: Agency meetings

  • Pre-submission meetings

Michael Pfleiderer

Paul-Ehrlich-Institut

Michael

Michael Pfleiderer, Biopharma Excellence, Principal Consultant
Dr. Michael Pfleiderer joined Biopharma Excellence as of March 1st, 2016. In his role as Principal Consultant he will deal with all scientific, regulatory and strategic aspects related to vaccines. Before joining the Biopharma Excellence team he was working at the Paul-Ehrlich-Institut, German Federal Institute for Sera and Vaccines in Langen as Head of "Section Viral Vaccines" and later on as Head of Section "International Cooperation and Regulatory Services". Furthermore he was the Head of the WHO Collaborative Center for the Evaluation and Standardization of Vaccines established at PEI in August 2014. For EMA he was acting as the Chairman of the Vaccine Working Party, Chairman of the Pandemic Task Force as well as Chairman of the CHMP/BWP Influenza ad hoc Working Group. Before his carreer at PEI, Dr. Pfleiderer was working at Baxter AG in Vienna as Head of Laboratory of recombinant Proteins and afterwards Head of Department of Recombinant Vaccines.

Topic lectured:

Seminar 3:
  • Development and regulation of vaccines
  • Use of Antigen Master File
  • Future regulation of seasonal and pandemic influenza vaccines
  • Cervarix as an example for successful authorisation of a HPV vaccine (tandem talk)
5th Annual Biopharmaceuticals Meeting:
  • New treatments for Ebola or other emerging diseases outbreaks – how does the expedited pathway work to make them available to patients?

Monika Pietrek

Pietrek Associates GmbH

Monika

Dr. Monika M. Pietrek is a medical doctor and epidemiologist with more than 25 years of experience in international drug development and post-authorization safety monitoring/risk management. She has worked in clinical care, pharmaceutical and CRO industries as well as at the German regulatory agency responsible for vaccines and biologics.

Dr. Pietrek is the founder of Pietrek Associates GmbH, an independent consultancy firm to the pharmaceutical and biotechnology industry. Her team has contributed to several marketing authorisation applications, risk management and pharmacovigilance projects as well as more than 300 GCP/GVP audits and mock inspections.

For more than 10 years she has been co-chairing the EU Pharmacovigilance (PV) Working Group of industry experts. In this capacity Dr. Pietrek has been involved in the development and review of the EU PV legislation since the public consultation in 2006. She has published about Good Pharmacovigilance Practices, the PV terminology and the new EU PV legislation and PV quality management.

Dr. Pietrek has served as DIA volunteer for more than 20 years, as a speaker, session chair, theme leader and as a member of various programme committees for the annual conferences and workshops in North America and Europe, the Continuous Medical Education Committee and the Advisory Council Europe. She is a member of the Editorial Board of the Therapeutic Innovation and Regulatory Science (TIRS) Journal.

Since 2010 Dr. Pietrek has been coordinating and teaching the PV Module of the MSc in Regulatory Affairs for Biopharmaceuticals (www.eucraf.eu) in collaboration with the University of Strasbourg.

Her interests are benefit/ risk assessments of medicinal products and process optimisation in clinical research and pharmacovigilance, balancing solutions to meet patient needs and public health decisions as well as to support innovative drug development. More details are available on www.pietrekassociates.com.

Topic lectured:

Seminar 6:

  • Introduction to the Pharmacovigilance
  • Pharmacovigilance System and core PV processes I
  • Pharmacovigilance concepts and core processes II
  • Implications of the EU PV legislation - Questions & Answers
  • Safety Communication and Transparency
  • PV Quality Management
  • Case Studies

2nd Annual Biopharmaceuticals Meeting:

  • Impact of the new Pharmacovigilance Legislation on Biopharmaceuticals – procedures, processes, impact

3rd Annual Biopharmaceuticals Meeting

John Purves

formerly EMA

John

Dr. John Purves is a life science consultant having recently retired from the European Medicines Agency where he worked for 14 years, first as Head of the Biotechnology and Biological Products Sector and most recently, as Head of the Sector for the quality of medicines. He was involved in many areas dealing with biological medicinal products, including biosimilar, influenza and advanced therapy products. Prior to joining the EMA, Dr. Purves was Manager of the Biotechnology and Biological Unit at the UK Medicines Control Agency, now the Medicines and Healthcare Products Regulatory Agency. At the UK agency, he was involved in the drafting of a number of European Union guidelines including those on the manufacture and control of recombinant-DNA products and products derived from human blood and plasma. Dr. Purves also oversaw efforts to minimise the risk of the transmission of spongiform encephalopathies to humans through medicinal products. Dr. Purves graduated in pharmacy from the Heriot Watt University in Edinburgh in 1968 and received his doctorate in pharmaceutical microbiology from the University of Strathclyde in 1973. Following university, he worked in research and development at Smith and Nephew Ltd in the UK.

Topic lectured:

Chairman of the 3rd and 4th Annual Biopharmaceuticals Meeting

Seminar 1:

  • Development of biologic legislation and control biologics in Europe and future pathways
  • Legal particulars for biopharmaceuticals
  • International collaboration of agencies
  • Small and Medium Size Enterprises (SME)

R

Bernd Raffelsberger

Formerly Pfizer

Bernd

Dr. Raffelsberger holds a diploma in Chemistry from the Albert-Ludwig University of Freiburg, Germany and a Ph.D. in Organic Chemistry and Mass Spectocrospy. He joined Pfizer in 1979 as a Lab Manager for Instrumental Analytics. Over the years responsibilities increased in the area of Method Validation, Stability Management and Quality Control. In 1994 Bernd became Head of the Quality Design group of Warner- Lambert Freiburg and in 1998 Head of Quality Design Europe. Between 2000 and 2004 main responsibilities were Head of Quality Assurance and Head of Analytical Research in Product and Process Development for new pharmaceutical products. From 2004 until 2013 he was Head of the Quality organization of Pfizer Freiburg. Since 2013 he worked for Pfizer Freiburg in a new function as advisor for Quality- and GMP-projects.

Topic lectured:

Seminar 7:

  • Experience with inspections conducted by the different inspectorates from Europe, U.S. and Japan
  • How an inspection is performed

Jens Reinhardt

Paul-Ehrlich-Institut

Jens

Dr. Jens Reinhardt is assessor for quality and non-clinic in the Division of Medical Biotechnology at the Paul-Ehrlich-Institut.

Before joining the PEI in 2008, he worked as postdoctoral fellow at the Stanford University, at the Station Biologique de Roscoff (France), and at a biotech company in Munich.

At the PEI he is assessing clinical trial applications and marketing authorisation applications for advanced therapy medicinal products. He is part of the team that provides national scientific advice at PEI. He was also involved in the assessment of marketing authorisation applications for vaccines against pandemic influenza. Since 2011 Dr Reinhardt is Alternate Member of the Scientific Advice Working Party at the European Medicines Agency in London.

Topic lectured:

4th Annual Biopharmaceuticals Meeting

  • Does innovation reach authorities: trends in scientific advice and review procedures: trends towards more Phase II studies, dose finding for biopharmaceuticals - novel Modelling and Simulation Group, devices in ATMP

Birgit Reipert

Baxter BioScience

Birgit

Birgit Reipert, PhD, is Director of the Department of Immunology within the Franchise Hemophilia/Hematology at Baxter BioScience. In addition she has got a lectureship at the Medical University of Vienna (Austria). She received her PhD from the Ernst-Moritz Arndt University, Greifswald (Germany), and postdoctoral training at the Institute for Medical Immunology at the Charitè, Berlin (Germany), at the Department of Immunology of the Institute for Cancer Research, Berlin and at the Paterson Institute for Cancer Research, Manchester (UK). Birgit Reipert joined Immuno AG in 1994 and Baxter AG in 1997. Birgit Reipert has a long standing interest in the immunogenicity of therapeutic proteins and in the search for new approaches to prevent unwanted immune responses to these proteins.

Topic lectured:

Immunogenicity Integrated - Interactive Workshop:

  • Non-clinical modelling of identified risks

Ilona Reischl

AGES - Austrian Medicines and Medical Devices Agency

Ilona

Ilona Reischl joined the Austrian Medicines and Medical Devices Agency AGES/MEA in March 2006 and currently holds the position of a Senior Expert in the Institute for Assessment and Analysis with a focus on the quality assessment of biological medicinal products including Advanced Therapy Medicinal products. She is the Austrian member of the European Medicines Agency Biologics Working Party and the Committee for Advanced Therapies. Her regulatory expertise includes Clinical Trials and Non-interventional trials, scientific advice procedures and compassionate use.

Starting in academic research in immunology she transitioned to the regulation of medicines at the US Food and Drug Administration (FDA) assessing the quality of biotech investigational new drug applications (INDs) and working on a research project on T cell signalling.

Her initial training comprised a degree in pharmacy, a PhD in immunology/allergology and postdoctoral experience at an industrial research institute, the University of Southampton (UK) and the National Institutes of Health (USA).

Topic lectured:

2nd Annual Biopharmaceuticals Meeting:
  • Clinical trials for biopharmaceuticals in the EU – experience with the VHP, numbers, challenges and changes and overview on the review of the legislation
3rd Annual Biopharmaceuticals Meeting:
  • Regulatory activities relevant to biopharmaceuticals in Europe – from updates on clinical trial regulations to recent regulatory decisions to new guideline initiatives
  • News and trends: Session 1 panel discussion Chaired by workshop co-chairs
4th Annual Biopharmaceuticals Meeting:
  • Practical implications including transparency initiative
5th Annual Biopharmaceuticals Meeting:
  • The trend in Marketing Authorisation Applications for biologicals covering drug-device combinations – how do we deal with them?

Ruth Rettenmeier

PAREXEL International GmbH

Ruth

Ruth Rettenmeier, PhD, Senior Consultant, PAREXEL Consulting is Biologist with more than 19 year experience in in late stage product development, regulatory affairs and project management.

She is offering regulatory consulting, providing strategic support and doing project management in complex regulatory applications projects, incl. scientific and regulatory experience in preparation, compilation of documents / CTD sections and submission to authorities.

Her focus is on consulting and preparation of Module 1 and Labelling documents for all kinds of MAAs (authority approval and post approval processes) in all EU countries. She is managing complex Language Service projects (25 EU/EEA languages) within the Linguistic Review Process (EU Centralised Procedure), also consulting on Mock-up and Readability.

Topic lectured:

Seminar 2:

  • Changes to the SmPC

Sol Ruiz

Spanish Medicines Agency (AEMPS), Parque Empresarial "Las Mercedes"

Sol

Sol Ruiz is Head of Sector of Biotechnology and Advanced Therapies at the Spanish Medicines Agency. She has a PhD in Biology (Immunology) after completing her PhD research project in the Dept. of Biochemistry and Molecular Biology at the University of California Irvine (CA, USA). She is the chair of the BWP (Biologics Working Party) at the EMA (European Medicines Agency) and the Spanish representative in the group since 1997. She is also a member of the CAT (Committee for Advanced Therapies) and a co-opted member of the CHMP (Committee for Human Medicinal Products) since 2007. She also participates in several working groups related to biotechnological/biological products and advanced therapies both at the EMA and at the European Pharmacopoeia. She has been an invited speaker at numerous national and international meetings.

Topic lectured:

5th Annual Biopharmaceuticals Meeting:
  • An update on the activities of the CAT

S

Frank A. Scappaticci

Genentech Inc. / Roche

Frank A.

Frank A. Scappaticci, MD, PhD is a clinical oncologist and hematologist working at Genentech / Roche. Dr. Scappaticci obtained his undergraduate degree at Yale University in biochemistry. Subsequently, he trained at the University at Buffalo / Roswell Park where he obtained his medical and graduate degrees. He completed his internship and residency in Internal Medicine at the University of Pennsylvania. Following this, he obtained his Medical Center. After a short period on faculty at Stanford and the University of California / Davis he joined Genentech approximately 9 years ago and has been working on late stage clinical trial development for Avastin. He had led numerous filings for Avastin that eventually led to approval for Avastin in colorectal, non-small cell lung, and renal cancers. Recently, Dr. Scappaticci was appointed as the clinical science leader on the Roche Biologics Task force.

Topic lectured:

3rd Annual Biopharmaceuticals Meeting:

  • Panel discussion - Biosimilar monoclonal antibodies in the EU and the US

Beate Schäfer

Bristol-Myers Squibb

Beate

Beate Schäfer studied pharmacy at the University of Tübingen and graduated in 1987.

She has been working for more than 20 years in different areas of Regulatory Affairs and pharmaceutical Quality Assurance in national and European positions.

More than 10 years she worked for SmithKline Beecham/Glaxo SmithKline, finally as Associate Director Regulatory Affairs and Quality Assurance, Germany. Thereafter she had several European positions as:

  • Head of Regulatory Affairs EMAI at Wrigley (1 year),
  • Head of Regulatory Affairs Europe at Santen (6 years)
  • European Head Regulatory Affairs Cardiovascular & Metabolism at Novartis (2,5 years)

In 2011 she joint Bristol-Myers Squibb Germany as Head of Regulatory Sciences and pharmaceutical Quality Assurance. Since 2014 she is in addition representing Regulatory in a global brand teams of BMS .

Topic lectured:

Seminar 8:

  • The regulatory affairs department at the interphase – cooperation with the market access department and its role in HTA

5th Annual Biopharmaceuticals Meeting:

  • How is the approved SmPC understood by the HTA Bodies and why does it matter

Michael Schaub

Asphalion, S.L.

Michael

Michael holds a degree in biology from the University of Konstanz, Germany. He started his scientific career participating in several research projects at the Oregon State University and the Florida Atlantic University. In 2006, he returned to Europe and continued his work as a research scientist at the Centre for Genomic Regulation in Barcelona.

He began his career as a regulatory affairs consultant when he joined ASPHALION, S.L. in 2007. Nowadays, his responsibilities include the strategy and management of international drug registration procedures, the preparation and evaluation of the respective dossiers, as well as the conduct of scientific advice procedures and pre-submission meetings with international regulatory authorities. He acquired specific knowledge in several projects for innovative products, such as Biologicals and Advanced Therapy Medicinal Products. Other areas of his expertise include the strategic preparation of paediatric investigation plans as well as the implementation of electronic submission standards.

In 2013, Michael moved to Munich, thus returning to his home country Germany, where he established ASPHALION’s first branch office.

Topic lectured:

Seminar 1:

  • Format and content of the marketing authorisation application: The Common Technical Dossier (CTD)
  • Module 1 of the CTD: General information
  • Labeling, Package Leaflet and Summary of Product Characteristics (SmPC)

Florian Scheich

Roche Diagnostics GmbH

Florian

Dr. Florian Scheich holds a Diploma in Biology from the University of Würzburg. His PhD studies in the field of Immunology he did at the Technical University of Munich. Since 2007 he is working at Roche Diagnostics GmbH, Penzberg, as Manager Technical Regulatory Affairs.

Topic lectured:

Seminar 4.1:

  • Essentials for CTD Module 3 in Japan

Christian Schneider

Danish Health and Medicines Authority

Christian

Christian K. Schneider, MD, is Medical Head of Division Medicines Licensing and Availability at the Danish Medicines Authority. Between 2009 and 2013 he was chairman of the European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT). Between 2007 and 2011 he was co-opted member of the CHMP, the Committee for Medicinal Products for Human Use, for the area of "Quality and safety (biological), with expertise in Advanced Therapies - Gene, Cell and Tissue Therapies". He is chairman of the CHMP Working Party on Similar Biological Medicinal Products (BMWP) and was previously member of the CHMP Scientific Advice Working Party (SAWP). He has been actively involved in the drafting of several multidisciplinary CHMP guidelines. Before joining the Danish Health and Medicines Authority as a Senior Medical Officer in 2011, he was Director and Professor and Head of Division "EU Co-operation/Microbiology" at the Paul-Ehrlich-Institut, the German Federal Agency for Sera and Vaccines. Before, Christian K. Schneider was working for more than two years as a postdoctoral researcher at the Max-Planck-Institute for Neurobiology, Neuroimmunology (Martinsried, Germany), where he worked in experimental immunology in the field of T cell immunology of inflammatory myopathies and multiple sclerosis. During his clinical career, Christian K. Schneider worked in clinical immunology and hemato-oncology (Department of Internal Medicine III, University Erlangen-Nuremberg, Germany).

Topic lectured:

Seminar 1:
  • Legal particulars for biopharmaceuticals
2nd Annual Biopharmaceuticals Meeting:
  • Follow up on activities related to the guideline on biosimilar monoclonal antibodies
3rd Annual Biopharmaceuticals Meeting:
  • An update on CAT activities during the last year and what to expect in the future
  • News and trends: Session 1 panel discussion Chaired by workshop co-chairs
  • The EU framework on biosimilar monoclonal antibodies: Where have we come from? Where are we going
4th Annual Biopharmaceuticals Meeting:
  • News and Trends in Europe: update of EMA activities including the Biosimilar Medicinal Product Working Party (BMWP) and Committee of Advanced Therapies (CAT) activities
  • The EMA-FDA biosimilar cluster
5th Annual Biopharmaceuticals Meeting:
  • News and trends in Europe: Update on the last year. Marketing Authorisation and guideline activities

Thomas Schreitmüller

Roche

Thomas

Thomas Schreitmüller holds a Diploma and PhD in Biochemistry from the University of Munich (Max Planck Institute for Biochemistry, Munich, Martinsried and Institute for Clinical Chemistry and Clinical Biochemistry University of Munich). In 1989 he joined Roche holding various positions in the biotech area (e.g. Analytical R&D, technical project management). Since 2003 Thomas was heading the department "Analytical R&D and Quality Control Biotech Products" at Roche Pharma Technical Operations in Basel, Switzerland. The department assumed responsibility for basic analytical research in the context of biotech products, was doing the analytical development and quality control of biotech development products and clinical supplies respectively, and was responsible for the quality control of Roche marketed biotech products (e.g. Roferon-A, Neupogen, Zenapax, Herceptin, Mabthera, Pegasys, Avastin) manufactured at Roche Basel. Since 2010 Thomas is the Global Lead for Regulatory Policy and Strategy for Biologics within Roche.Health-/Industry-Organisation Activities - 1989-present: Roche representation in various WHO-, ICH-, IFPMA-, EFPIA-, EBE-biotech working groups. Currently member of: EBE Regulatory & Technical Affairs Committee,IFPMA Biotherapeutic Working Group.Member of the Organizing Committee of the “CMC Strategy Forum Europe” http://www.casss.org, Member of the Scientific Planning Committee of the “PDA Workshop on Monoclonal Antibodies” http://www.pda.org/europe. Conferences, Lectures-Lectures on Analytical Biotechnology, Characterization of Biotech Products, Biotech Products Manufacturing, Biosimilars as well as Regulatory Issues associated with Biotech Products in conferences all over the world e.g. Argentina, Austria, Belgium, Brasil, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dubai, Ecuador, France, Germany, Guatemala, India, Indonesia, Japan, Jordan, Malaysia, Mexico, Nigeria, Peru, Philippines, Poland, Portugal, Russia, South Africa, Spain, Switzerland, Thailand, UK, USA, Uruguay, Venezuela, Vietnam.

Topic lectured:

3rd Annual Biopharmaceuticals Meeting:

  • Determining the indication for a biosimilar monoclonal antibody – when is extrapolation an option for obtaining all of the indications of the reference product? How is the selection of the reference product justified?
    - How much can we extrapolate immunogenicity data?

Gabriele Schricker

Morphosys AG, Munich

Gabriele

Dr. Gabriele Schricker is Director, Program Leader for proprietary drug development (biologics) in oncology and inflammatory diseases at Morphosys AG. She holds a PhD in Biology from the University of Cologne, Germany. After her PhD thesis in Zoology, she gained a second qualification in Scientific Information Management. Gabriele has a broad background of more than 16 years hands-on experience in international project management, information management and quality assurance in electronic document management. She started her career at a clinical CRO for 3 years and worked during the last 14 years for 6 biopharmaceutical companies in Germany, Switzerland and Italy. Furthermore, she is engaged in team development and personality coaching since more than 10 years and co-founder of “Kompetenz-Netzwerk für Coaching und Psychotherapie”.

Topic lectured:

Seminar 9:

  • Interaction of central project management with Regulatory Affairs

Robert Schultz-Heienbrok

Xendo Deutchland GmbH

Robert

Robert Schultz-Heienbrok has been educated in medical biology, followed by a PhD in protein biochemistry. He has completed a post-graduate program in Regulatory Affairs and has over 10 years of practical experience in the field. Working both with multinational pharmaceutical companies and small start-ups, Robert has gained broad experience with international submission procedures and dossier requirements for regulatory compliance as well as new market approvals. In 2009 he has been appointed Managing Director of Xendo Deutschland GmbH, a German subsidiary of the Dutch pharmaceutical service company Xendo B.V. His group focuses on regulatory affairs of marketed products, regulatory consultancy for biopharmaceutical developments and regulatory data management.

Topic lectured:

Seminar 9:

  • Regulatory intelligence and document management

Martina Schwinger

Novartis Pharma AG

Martina

Martina Schwinger is a biologist with in-depth knowledge of regulatory requirements and environment in China in theory and practice with focus on new project development and a good understanding of regulatory requirements in other regional countries, also with regards to biologics. She has been working at Novartis in different roles in the agrochemical industry in the field Human Resources. Since 2003 she is Regional Regulatory Manager in Regional DRA at Novartis Pharma. She is responsible for Lucentis, the top bio-product of Novartis Pharma in regional countries as well as for regulatory intelligence on China, Australia and South Korea.

Topic lectured:

2nd Annual Biopharmaceuticals Meeting

  • Requirements of authorization of biopharmaceuticals in China

Seminar 2:

  • Regulatory System for 
    - Clinical Trial Applications
    - Marketing Authorisation
    - The life cycle of authorizations in China

Coaching: China Strategy - The essentials to register pharmaceuticals up to market entry in China:

  • What is the Today’s Regulatory Environment
  • Case Study: Filing a CTA in China for a biological
  • Data protection / Market exclusivity
  • IDL vs Manufacturing license
  • CMC – specific challenges
  • Biosimilars – current situation & outlook

Diane Seimetz

Biopharma Excellence

Diane

Dr. Seimetz has over 16 years of global drug development, regulatory affairs and partnering experience in the biopharmaceutical industry.

She is co-founder of Biopharma Excellence, a consulting company specialized in drug development, regulatory affairs and partnering strategies.

She is the former Executive Vice President and Chief Scientific Officer of Fresenius Biotech. In this function she was responsible for Regulatory Affairs, Medical Affairs, Preclinical and Clinical Development as well as Program Management. Together with her team she developed on an international level the first bispecific, trifunctional antibody catumaxomab. After successful approval in the EU, this antibody was awarded the “Prix Galien” which honors outstanding research and innovative drug development.

She was involved in numerous due diligence projects for both, in-licensing and out-licensing strategies.

Dr. Seimetz looks back on a large number of meetings with EMA, national European agencies, FDA, Health Canada, and TGA as well as other jurisdictions. She has dealt with these regulators during (parallel) scientific advice, pre-submission, submission and post-authorization phases of projects as well as GMP and GCP inspections.

She planned and implemented product life cycle strategies including post marketing studies and publications to increase product value.

Her product portfolio knowledge covers mono- and polyclonal antibodies, antibody-drug conjugates, recombinant proteins, complex peptides, advanced therapy medicinal products as well as medical devices. She has in-depth experience with the development and approval of new products and biosimilars.

Dr. Seimetz received her degree in pharmaceutical science from the University of the Saarland and completed her PhD at the University of Heidelberg. Her research work related to glycotargeting in oncology was conducted at the German Cancer Research Center and the Johns Hopkins University in Baltimore, USA. Dr. Seimetz has a Master’s Degree in Drug Regulatory Affairs. In her thesis she assessed the EU and US environment for early market access and the essential requirements within a pharmaceutical company.

Topic lectured:

Seminar 4.2:

  • From scientific advice to successful marketing authorization – experience with the European authorization of the bispecific monoclonal antibody Removab

Be successful in biopharmaceutical partnering: Due diligence as the essential element

Wiebke Siegel

former inspector at RP Darmstadt

Wiebke

Wiebke Siegel is a pharmacist. After experience for near twenty years in clinical pharmacy and later one pharmaceutical supply of hospitals she changed to the Paul-Ehrlich-Institut. There she was in the section hematology and transfusion medicine involved in regulatory affairs including inspections for blood products. 2002 she moved to the pharmaceutical department of the Regierungspräsidium Darmstadt. Here she was responsible for the manufacturing authorization of blood products and biological medicinal products like stem cells, tissues, reproduction medicine and plasma derived products as well as other pharmaceutical products and also for the inspection of pharmaceutical manufactures. She got experience in European pharmaceutical legislation, was some years Head of the German Expert Group Blood and was member of the national working group blood. She has also experience in international GMP-inspections worldwide for pharmaceutical products. She retired in 2010.

Topic lectured:

Seminar 7:

  • Special GMP considerations for biopharmaceuticals including advanced therapies

Jennifer Sims

Integrated Biologix GmbH

Jennifer

Jenny has a Bachelor of Science degree and a PhD in Pharmacokinetics and Toxicology. Jenny has 25 years experience in preclinical drug development from both the regulatory (UK MHRA, UK delegate to CHMP Safety Working Party) and industry perspectives, with an emphasis on biotechnology products (monoclonal antibodies, therapeutic proteins, vaccines, gene and cell therapies and xenotransplantation). In addition to experience of preclinical drug development in a large pharma environment (Global Head Biologics Safety and Disposition, Novartis Institutes of BioMedical Research and Director of Safety Assessment for Biopharmaceuticals, AstraZeneca), Jenny also has experience as both Preclinical Director and Head Safety Assessment with several start-up and small biotech companies (Syngenta Biopharma, Cambridge Antibody Technology, MedImmune) and developing relationships with CROs and external partners. Jenny is Past vice Chair of the BioSafe leadership group and was EFPIA topic leader and Rapporteur for ICH S6 revision.

Topic lectured:

Seminar 4.2:
  • The Tegenero case and its implications for the development of new biopharmaceuticals
2nd Annual Biopharmaceuticals Meeting:
  • Current scientific considerations in the preclinical development of biopharmaceuticals in 2012 following the news from the ICH S6 guideline revision process
5th Annual Biopharmaceuticals Meeting:
  • Summary of the NC3R workshop held in June 2014: a future vision for non-clinical protein-based biotherapeutic development

Michael Soldan

Merck Serono

Michael

Dr. Michael Soldan holds a PhD in Human Biology/Pharmacology from University Marburg. After one year as postdoctoral research fellow at University Marburg he worked for three years as Regulatory Affairs Manager at Centeon GmbH (now Aventis Behring GmbH). In 2001 he became Head of Regulatory Affairs Group at Hemophilia Europe. From 2003 to 2005 he was Head of Regulatory Affairs at Chiron Behring GmbH (now Novartis Behring). In 2005 he changed to Gruenenthal GmbH where he was Head of Corporate Regulatory Affairs. He held the same position at Biotest AG from 2006-2008 until he became Senior Vice President of the Medical/Regulatory Affairs Business Unit. As of July 2012 Dr. Soldan became Head Regulatory Global Department Biosimilars at Boehringer Ingelheim. He works now at Merck Serono.

Topic lectured:

Seminar 8:

  • Regulatory strategy for the introduction of changes in the manufacturing process

Doris Irene Stenver

Danish Health and Medicines Authority

Doris Irene

Doris Irene Stenver, MD, MPA
Chief Medical Officer, Danish Health and Medicines Authority

Education
1986 Medical Degree from Copenhagen University, the Faculty of Medicine
2007 Master Degree in Public Administration, Copenhagen Business School

Clinical Experience
During 12 years (1986-1998) she worked at university hospitals in the Copenhagen area, and in 1995 she became specialist in internal medicine. Her clinical experience covers a wide range of medical specialties, e.g. nephrology, endocrinology, haematology, cardiology and infectious diseases. Her research activities were primarily within the areas of haematology, immunology, nephrology and endocrinology.

Regulatory Experience
She joined the Danish regulatory authorities and the EU Pharmacovigilance Working Party in 1998. In 2002 she became member of the European Risk Management Strategy Facilitation Group. As of July 2012 she is member of the Pharmacovigilance Risk Assessment Committee. Her regulatory experience comprises all aspects of pharmacovigilance, including scientific evaluation of drug safety issues, development of risk management strategies, policies and guidelines, provision of scientific advice to the pharmaceutical industry, cooperation with academia and communication to health care professionals and the public on drug safety concerns. She is strongly engaged in the establishment of an international Pharmacovigilance Diploma education, in cooperation with the Danish Association of Pharmaceutical Industry / Medicademy, both as member of the education steering committee, as course leader and speaker. In 2004 – 2008 she was a member of DIA Advisory Council for Europe.

Topic lectured:

5th Annual Biopharmaceuticals Meeting:
  • Pharmacovigilance in the EU with emphasis on biopharmaceuticals – PRAC activities update
  • Post-approval efficacy studies

Sabine Straus

CBG - MEB

Sabine

Dr. Sabine Straus has been with the Medicines Evaluation Board (MEB) in The Netherlands since 1997, where she started as an assessor Pharmacovigilance. Prior to working at MEB she held different positions in the pharmaceutical industry for 12 years, her last job was Medical Director at Searle Monsanto in The Netherlands. In the period 2001 - 2004  she combined her work at the MEB with a research position at the Erasmus Medical Center in Rotterdam on the topic "drugs, Qtc prolongation and sudden cardiac death". In addition she started her training as clinical epidemiologist at the same university and completed her Master of Science in Clinical Epidemiology in 2002. Her research resulted in a PhD degree in 2005.

From December 2005 until July 2012 she was Head of the Department of Pharmacovigilence. As of July 2012 she is a staff member at the MEB and the Dutch representative in the Pharmacovigilance Risk Assessment Committee (PRAC). In addition to her work at the MEB she holds a position as associate professor at the Erasmus Medical Center, department of Medical Informatics in Rotterdam. Her main research focus is on additional risk minimisation, pregnancy prevention programs, signal detection and signal management.

Topic lectured:

3rd Annual Biopharmaceuticals Meeting:

  • The new PRAC: six months after inauguration

4th Annual Biopharmaceuticals Meeting:

  • Pharmacovigilance in the EU with emphasis on biopharmaceuticals – PRAC activities update

Ashley Strougo

Astellas Pharma Global Development Europe

Ashley

Dr. Ashley Strougo is a scientist in pharmacokinetics modelling & simulation (M&S) at Astellas where she has been involved in different paediatric projects for a variety of indications. Ashley was born in Rio de Janeiro where she graduated as a pharmacist in 2001. In 2005 after research projects involving the use of PK-PD modelling in the field of pharmacology, clinical pharmacology and pediatrics she obtained her M.Sc. degree in Bio-Pharmaceutical Sciences at Leiden University in The Netherlands. Prior to joining Astellas in 2007 Ashley worked as a pharmacometrician to a consultancy company using M&S to identify and address key drug development issues. Since 2008 she is also a visiting scientist at Leiden University where she investigates different M&S techniques for bridging clinical data from adults to children as part of her PhD project.

Topic lectured:

Seminar 5:

  • Considerations for developing and executing the PIP
  • Paediatric Networks

Susanne Szabo

Novartis Oncology

VP & Head DRA EGM & LATAM

Basel SWITZERLAND

Topic lectured:

Seminar 2:

  • The regulatory system in China

T

Joyce Tait

Innogen Institute

Joyce

Joyce Tait has an interdisciplinary background covering both natural and social sciences and has worked on the agrochemical, pharmaceutical and life science industries, specifically strategic planning for innovation, governance and regulation, and stakeholder attitudes and influences. Relevant life science areas include synthetic biology, genetic databases, GM crops, biofuels, pharmaceuticals, stem cell therapies and translational medicine. Current and recent appointments: John Innes Centre Science and Impact Advisory board; UK Department for Business Innovation and Skills (BIS) Synthetic Biology Leadership Council (Chair of Governance Subgroup); UK Department of Health Emerging Science and Bioethics Advisory Committee (ESBAC); Board of Directors, Roslin Foundation; Scottish Science Advisory Council. She also chaired the Working Party of the Nuffield Council on Bioethics on ‘Biofuels: Ethical Issues’.

Topic lectured:

5th Annual Biopharmaceuticals Meeting:
  • Regulation and other factors influencing the development of biopharmaceuticals. The innovator´s perspective

Tetsuya Tanimoto

Cancer Institute, Japanese Foundation for Cancer Research, Tokyo, Japan

Tetsuya

Tetsuya Tanimoto, M.D. has a broad experience in internal medicine with specific expertise in hematology/oncology, clinical drug development and evaluation with a current position as a medical reviewer for new drug application at the administrative office in Tokyo.  His brief medical experiences are as follows: he started his medical career in a general internal medicine at Kyushu University in Fukuoka in 1997. Due to his interest in clinical trial design and hematology/oncology, he joined the 3-year residency program at National Cancer Center Hospital in Tokyo.  Afterwards, he was employed as a staff physician of Hematology Division at Kyushu University Hospital and Matsuyama Red Cross Hospital in Shikoku, where he was involved in the wide range of patient care including hematopoietic stem cell transplantation.  During his subsequent academic career in Tottori University Hospital in Tottori, he assumed responsibilities as a ward chief as well as an assistant professor.  Since 2007 he has been assigned as a medical reviewer at Pharmaceutical and Medical Devices Agency (http://www.pmda.go.jp/english/index.html) in Tokyo and experienced a wide range of clinical trial protocols, drug and device development strategies and review of marketing authorization applications for various cancer drugs, antibiotics, vaccines, monoclonal antibodies, blood products and diagnostic tests as well as in regulatory actions due to efficacy/safety issues.  After 5-year experience at PMDA, he starts a new career at Japanese Foundation for Cancer Research, Navitas Clinic in Tokyo and works as a visiting physician in Fukushima. In addition he is looking for opportunities to launch a collaborative project between Japan and Shanghai, China.

Topic lectured:

2nd Annual Biopharmaceuticals Meeting:

  • Recent trends in the regulatory practice of authorizing biopharmaceuticals in Japan

Gertrud Thormann

The HST Consulting Network GmbH.

Gertrud

Dr. Gertrud Thormann-Huber is Partner and Principle Consultant of The HST Consulting Network GmbH. As an independent consultant she advises and assists many biopharmaceutical companies in the global development and regulatory strategies for successful approval of their recombinant proteins and/or monoclonal antibodies while often acting as a member of their global development teams or in the position of the Director Clinical & Regulatory Affairs. She has over 30 years experience with several pharmaceutical companies in all fields of drug development with a special emphasis on the development and regulatory issues of biotechnology-derived compounds and the interactions with the EMEA and FDA. Before setting-up her own consultancy firm in 1995 she has been 10 years with F. Hoffmann-La Roche in Basle where she has a track record of successful approvals of several submitted MAAs for recombinant proteins and in her last position she was a senior member of the global regulatory management team. Gertrud Thormann-Huber has a Degree in Pharmacy and PhD in Natural Sciences with specialization in pharmaceutical biology from University Munich.

Topic lectured:

Seminar 9:

  • Conducting effective meetings

Markku Toivonen

NDA Advisory Services Ltd.

Markku

Dr. Toivonen qualified as a physician and specialist in internal medicine from Helsinki University. A regulatory professional with over 25 years of experience from positions in pharmaceutical industry (Orion Pharma), regulatory authorities and consultancy. As of April 2005, Dr. Toivonen is Scientific Director of NDA Advisory Services Ltd. and member of NDA Advisory Board. Prior to this he was Head of Section, Marketing Authorisation Department (2003 - 2005) and Senior Medical Officer (1997 - 2002) both at the National Agency for Medicine. He was a member of the CPMP/CHMP 1997 - 2004.

Dr. Toivonen chaired the EMEA Scientific Advice Working Party (2003-2004); the CPMP Scientific Advice Review Group (SciARG) (2000-2003); and the CPMP Ad hoc group on (pre-) clinical comparability of biotech products (2001-2002).

Topic lectured:

3rd Annual Biopharmaceuticals Meeting:

  • A case study for the indication multiple sclerosis

Ralf Tönjes

Paul-Ehrlich-Institut

Ralf

Dr. Ralf Reinhard Tönjes (RRT; German) is research scientist and group leader at Paul- Ehrlich-Institute (PEI), Federal Institute for Vaccines and Biomedicines, Division of Medical Biotechnology, Langen, Germany. RRT is at PEI since 1991. At current, he is head of section “Non-vital tissue preparations, Xenogeneic cell therapeutics”. As such he is concerned with the fields of human tissue preparations and xenotransplantation. He founded the German working group for xenotransplantation (DAX) in 1998. He teaches as an associate professor (Außerplanmäßiger Professor) for biochemistry at Goethe University, Frankfurt/Main, Germany. RRT’s area of research is focused on endogenous retroviruses and retroelements of men and animals.

Topic lectured:

Seminar 4.2:

  • European and national regulation, procedures and practical experience with Tissues
  • Current status of products for xenotransplantation

V

Connie van Oers

Xendo

Connie

Dr. Connie van Oers  has been educated in Molecular Sciences followed by a PhD in Molecular Biology. She has over 20 years experience in Life Science industry of which about 15 years in Regulatory Affairs. She has a broad experience in management of regulatory submissions of both marketed and innovative medicinal products. She was manager Regulatory Affairs, Quality Assurance and Pharmacovigilance for the Dutch affiliate of a multinational pharmaceutical company. Currently, she is managing consultant of an experienced team of consultant dealing with various aspects of regulatory affairs, including Program Management and ATMPs.

Topic lectured:

Seminar 2:

  • European National Mutual recognition (MRP) and Decentralised procedure (DCP)
  • European Centralised Procedure at the EMA

Alex Veldman

CSL Behring

Alex

Alex is a board certified pediatrician, neonatologist and pediatric cardiologist with more than 10 years of experience in managing critically ill newborns and children in large university hospitals and 3 years of experince in the role as Director in Global Clinical R&D at CSL Behring. His clinical expertise in the area of pediatric and neonatal critical care medicine becomes evident in > 50 pubmed listed research papers that received > 700 citations.

In the last three years, Alex focused on the transition of programs form pre-clinical Proof of Concept into first–in-human Phase 1 studies. Alex is familiar with the scientific and regulatory requirements for pre-clinical toxicology, immunogenicity and dose finding. In his current role as leader of a multifunctional clinical development team in a highly matrixed environment he has successfully designed the key strategy of several clinical development plans for new bio-pharmaceuticals from Phase I to Phase III and negotiated a pathway to registration with the major global regulatory bodies (EMA, TGA, MFDS, PMDA and FDA). Alex is familiar with the process of orphan drug registration in various legislations and has experience in developing pediatric investigational plans (PIP) as required for the market authorization for new medicines in the EU.

Alex has successfully partnered an academic drug development program with a US pharmaceutical company (Alexion Pharmaceuticals, Connecticut, USA) and had the lead responsibility for the clinical part of the due diligence in that process. In addition to his role in industry, he is still holding an academic position as Associate Professor in the Faculty of Medicine, Dept. of Pediatrics at Monash University in Melbourne, Australia.

Topic lectured:

Seminar 4.2:

  • Case study: Molybdenum Cofactor deficiency: Bench to bedside and Beyond

Heike Volkmer

Volkmer & Burt Consulting Team

Heike

Heike has almost 30 years of experience in national and international regulatory affairs, with specialist expertise in the European centralised procedure for biotechnologically-derived medicinal products. During this time, Heike has contributed to the successful approval of several biological and biotechnological products, including one of the first biosimilar medicines. Over the years, Heike has established a large number of personal contacts with representatives of the national EU authorities, the EMEA, CDER, CBER, TGA, and various other international agencies. She is a recognised expert for regulatory strategy and has authored or co-authored a number of CMC Expert Reports (Quality Overall Summaries). Since October 2000, Heike is Managing Partner of the VBC Team, a position she shares with her long-standing colleague, Tony Burt.

Topic lectured:

Seminar 4.1:

  • Characterisation of biopharmaceuticals (3.2.S.3)

Jens Vollmar

GSK

Jens

Jens Vollmar studied medicine at the university Erlangen-Nuremberg where he acquired his doctor title at the institute for virology working on herpes viruses. Since 1995 he held positions in clinical research at SmithKline Beecham, GlaxoSmithKline and Amgen with focus on biopharmaceutical products and vaccines.

From 2002 he was medical director of Bavarian Nordic where he set up a clinical development, safety and regulatory affairs department. Amongst others he collaborated closely with US government and US FDA regarding the development of new smallpox and HIV vaccines.

Since 2007 he is head of the medical therapeutic area vaccines, tropical and travel medicine at GSK in Munich Germany. In this position he is in charge of medical affairs and clinical development of the entire GSK vaccine portfolio in Germany.

Topic lectured:

Seminar 3:

  • The industry perspective and experience with the recent pandemic influenza
  • Cervarix as an example for successful authorisation of a HPV vaccine (tandem talk)

Benita von Glahn

Boehringer Ingelheim Pharma GmbH & Co. KG Regulatory Affairs Biosimilars

Benita

Pharmacist by training with PhD in pharmaceutical chemistry from University of Heidelberg, Germany. Started in pharmaceutical industry in 1998, in German Drug Regulatory Affairs at Mundipharma, Limburg (Lahn), Germany. In 2002 took a position in Regulatory Affairs Immunology at Abbott. From July 2007 lead the International Regulatory Affairs Team Immunology and was appointed in Jan 2011 as TA Head for Humira within Global Regulatory Strategy. Joined Boehringer Ingelheim in February 2013 as Head of Development Regulatory Affairs, Biosimilars. Master’s degree of Drug Regulatory Affairs from University of Bonn in 2008 and a Special Pharmacist degree for Drug Information in 2007.

Topic lectured:

Seminar 8:

  • Interactions with FDA in the pre-IND process

Seminar 2:

  • Regulatory Affairs in Japan

Karen von Graevenitz Buser

F. Hoffmann-La Roche Ltd.

Karen

Karen v. Graevenitz is currently working at Novartis. She was previously Senior Regulatory Program Manager for Key Emerging Markets on metabolic compounds currently in clinical development at F. Hoffmann-La Roche Ltd. After finishing the Pharmacy School at the University of Basel (Switzerland), she worked for nearly 2 years in a Pharmacy before joining F. Hoffmann - La Roche Ltd. in Basel in 1989 as a Medical Manager in the Medical Marketing Department. She worked in several disease areas. She moved to regulatory affairs in 1999 as European partner on several projects in different therapeutic areas. She has extensive experience of the EU procedures and had several interactions with the CHMP members, EMA and its different working parties. Then, she took over an E7 Lead Role in 2009 and played a key role in developing regulatory strategies for metabolic compounds for Key Emerging Markets. Over the last 3 years, she was involved in several CDE Hearing Meetings in China.

Topic lectured:

Seminar 2:

  • The regulatory system in China

Coaching: China strategy - the essentials to register pharmaceuticals up to market entry in China

  • What is the Today’s Regulatory Environment
  • Case Study: Filing a CTA in China for a biological
  • Ethnicity
  • Potential factors delaying filing/approval in China

Sandra von Meier

Merck Serono

Sandra

Sandra von Meier started her career as a scientist working on tumor vaccines at Medigene AG, a biotech company south of Munich. Beginning of 2001 she was promoted into business development and was responsible for partnering of Medigene projects as well as in-licensing of new projects. She was part of the team closing the marketing partnership with Astellas for Medigene's prostate cancer product Eligard.

In 2008 Sandra was promoted to Senior Manager Business Development having the main responsibility for Medigene's lead oncology project. From 2011 she took on the additional responsibility of project coordination for this Phase II oncology project leading the respective scientific team and also supervising an additional Phase II study (IIT) conducted in HER negative breast cancer.

In 2012 she closed the first partnering deal for Medigene's lead oncology project and was promoted in 2013 to Head of Business Development of Medigene. In this function she reported directly to the board and closed the worldwide partnership for Medigene's oncology project. In 2013 she also took on partnering responsibility for Medigene's autoimmune development candidate which was licensed to Falk Pharma in spring 2014. The same year still Sandra joined Merck’s Global Business Development Team with responsibility for Oncology and more recently Immuno Oncology transactions. In this function she was part of the Merck Pfizer deal team which closed as one of the largest transactions for a preclinical candidate in autumn last year. She is currently the Director Business Development Oncology in Merck Serono.

Sandra studied Biochemistry at the FU Berlin and then moved to London in 1995 for her Diploma at the Institute of Cancer Research. In 1996 she was awarded a joint PhD scholarship from the Ludwig Institute for Cancer Research in London in collaboration with GlaxoSmithKline in Stevenage. Sandra received her PhD from University College London in 1999.

Topic lectured:

Be successful in biopharmaceutical partnering: Due diligence as the essential element

W

Heike Wachenhausen

Wachenhausen Rechtsanwälte

Heike

Heike provides advice across the full range of regulatory matters relating to medicinal products and medical devices on German and European level with particular focus on development, marketing authorization and product safety (vigilance).

Heike has been working as a regulatory lawyer for fourteen years. She started her career in the practice group “Healthcare, Life Sciences and Chemicals” in the Düsseldorf office of Clifford Chance and for six years she worked with law firm Sträter in Bonn before she became Head Legal Regulatory & Development in the legal department of Novartis AG based in Basel, Switzerland, in 2009. In 2011, Dr Wachenhausen decided to return to Germany in order to set up her own law firm, which would specialize in pharmaceutical law and medical devices law and to use her many years of experience advising industrial companies as an in-house specialist or as an external legal adviser.

Heike holds a PhD in law. Her doctoral thesis deals with clinical trials with persons incapable of giving informed con sent.

Heike is the author of various publications and a speaker at specialist conferences. She annotates, for example, Sections 40 ff. of the German Drug Act (AMG) on clinical trials of medicinal products on human beings in the AMG commentary (eds. Kügel/Müller/Hofmann) and is editor of the Wiesbaden commentary on medical devices law (eds. Hill/Schmitt).

Languages: German, English

Topic lectured:

Seminar 8:

  • Regulatory protection of medicinal products

Hans Joachim Wallny

Novartis Pharma AG

Hans Joachim

Dr. Hans-Joachim Wallny is a Technical project leader at the departement „Process Sciences and Production“, Novartis Pharma AG Switzerland. He was leading the technical team who recently achieved the approval of a monoclonal antibody (ILARIS) for the treatment of a rare autoinflammatory disease (CAPS) in US, EU and Switzerland.

Before this assignment he was head of a bioanalytics group, responsible for the development and validation of biological potency assays and high molecular impurity assays for bio¬pharmaceuticals during early development. Before he was head of the bioassay group, which included the responsibility for routine performance of bioassays for marketed products.

One of his main scientific ambitions was to develop and implement modern, fast and reliable bioassays using early cellular events as read-outs (e.g. reporter gene assays, KIRA assays, etc.). For this he was honored with the title “Novartis Leading Scientist” in 2003.

Prior to joining Novartis in 1997, he was a Lab head in the Biotechnology departement, Research and Development of Biotest Pharma GmbH, Germany, responsible for the development of bioanalytical methods and analytics for preclinical/clinical trials (1995-1997).

Dr. Wallny was previously a Scientist at the Basel Institute for Immunology, Switzerland (1992-1995) after receiving his Ph.D. degree in Biochemistry/Immunology from the University of Tübingen, Germany. Dr. Wallny received a diploma in biochemistry from the University of Tübingen, Germany in 1989.

Topic lectured:

Seminar 4.1:

  • Bioassay

Jian Wang

Health Canada

Jian

Chief, Clinical Review Division in Centre for Evaluation of Radiopharmaceuticals & Biotherapeutics, Biologics and Genetic Therapies Directorate, Health Canada

Dr. Wang manages a team of clinical and medical reviewers. His division conducts non-clinical, PK/PD and clinical evaluations, and has regulatory responsibility over the biological drugs for haematological, oncological, infectious, cardiovascular and renal diseases.  Radiopharmaceuticals, gene therapies, Subsequent Entry Biologics/ biosimilars and therapeutic vaccines are also regulated by his division.  He provides pre-submission consultations to drug manufacturers, and makes pre-market regulatory recommendations to the senior management.  He actively participates in various Health Canada, ICH, WHO, PAHO and DIA working groups and expert committees.  He is also a regularly-invited speaker for biologics and biosimilars at local and international meetings and workshops.

Dr. Wang received his MD from Harbin Medical University, China in 1982, and was awarded PhD in Physiology from the University of British Columbia, Canada in 1989.  He joined Health Canada in 1996 with many years of scientific and clinical research experience in both academic and clinical settings. 

Topic lectured:

5th Annual Biopharmaceuticals Meeting:
  • Case study: Approval of biosimilar infliximab in Canada
  • Authorising biopharmaceuticals in Canada – pathways for biotech products, biologicals, vaccines, biosimilars and ATMPs

Andrew Warren

Novartis Pharma AG

Andrew

Andrew is a Director of Bioanalysis at Novartis, where he is responsible for the development, validation and implementation of preclinical and clinical PK, PD and immunogenicity assays. Prior to joining Novartis, Andrew was head of Clinical Immunology in the GlaxoSmithKline Biopharmaceuticals Unit, where he was responsible for clinical biomarker and clinical immunogenicity assays to support the biopharmaceuticals portfolio. Prior to this Andrew headed a clinical biomarker lab at GSK within the Translational Science and Genetics department. 
Earlier in his career Andrew worked in a number of academic institutes, at the University of London where he was a Wellcome Trust fellow working on lymphocyte activation, as a post-doctoral fellow at University of Texas working on lymphocyte development, as a lecturer at University of Wales, working on viral immunology and as a postdoctoral fellow at the UK National Institute for Medical Research, studying dynamic interactions between host immune response and virus infections. Andrew has a PhD in Biochemistry from the University of London.

Topic lectured:

Immunogenicity Integrated - Interactive Workshop:

  • Integrated data analysis

John Warren

Former MHRA

John

John Warren is a clinical scientist who established Medicines Assessment Ltd as a pharmaceutical consultancy in 2011 (see medicinesassessment.com). Previously he worked for the UK Medicines Healthcare products Regulatory Agency (MHRA) as an Expert Medical Assessor from 1995-2010 evaluating new drug applications for the UK and Europe across the therapeutic spectrum. He was a member of the European Scientific Advice Working Party 2003-2010 and the European Pharmacokinetic Subgroup of the Efficacy Working Party 2007-2008. He contributed to the EU Notes for Guidance on Asthma, COPD, ARDS and Bioequivalence. When appointed to the MHRA in 1995 he took a concomitant five year Honorary Senior Lecturer post in Clinical Pharmacology at St Thomas' Hospital.

Previous appointments include Senior Lecturer at the National Heart and Lung Institute, with Honorary Consultant status at the Brompton, Charing Cross and Chelsea & Westminster Hospitals, 1990-1994. This followed a Senior Registrar post in Clinical Pharmacology at the Royal Postgraduate Medical School 1986-1990.

He holds triple specialist accreditation in the UK in General Medicine, Clinical Pharmacology and Cardiology. He is the author of over 100 publications in international journals on the physiology and pharmacology of the autonomic system and a book on the Endothelium.

Topic lectured:

Seminar 4.2:

  • The clinical CTD of of biopharmaceuticals
  • Principles of the clinical review and decision on the benefit-risk conclusion

Harald A. Weber

F. Hoffmann La - Roche Ltd, Basel (Switzerland)

Harald A.

Dr. Harald Weber received his medical degree from the Humboldt-University/School of Medicine (Charité) in Berlin and is trained in Internal Medicine and Oncology at hospitals in Germany and at UWCCC in Madison, Wisconsin. He was also a research fellow at the Institute of Immunology and Department of Dermatology at the Humboldt-University (Charité). Main subjects of his research were the immune-modulating effects of synthetic peptides on bone-marrow cells and the immune system in murine models and immune-compromised patients. After practicing medicine in several hospitals in Germany Dr. Weber worked at Boehringer Ingelheim in Germany as medical team leader for several early and late stage development projects. He joined Hoffmann La-Roche in Basel in 2000 and was tenured as a Clinical Scientist and Clinical Science Leader in 2003. He has been involved in the development program of Herceptin in HER2 positive early breast cancer and was the clinical lead for the development of Avastin and its approval in metastatic colorectal cancer in Europe and other countries. Until the end of 2013 he led the global development of a subcutaneous formulation of Herceptin resulting in its approval in EU in 2013. His research interests include the effects of drugs on the immune system, new targeted therapy approaches, especially for patients with breast cancer, and the clinical development of biopharmaceutical products. He is currently the strategic and medical lead for all scientific aspects related to biopharmaceuticals/biosimilars and provides medical, scientific and regulatory expertise in this field to Global Medical Affairs teams, especially in the oncology/hematology diease area.

Topic lectured:

Immunogenicity, Part III: Monitoring and Assessment of Clinical Immunogenicity

Martina Weise

BfArM, Federal Institute for Drugs and Medical Devices

Martina

Martina Weise, MD, works at the Federal Institute for Drugs and Medical Devices (BfArM), Germany, since 2001, where she is currently Head of the Unit on Diabetes/Cardiovascular System. She is also the alternate German member of the European Committee for Medicinal products for Human Use (CHMP) and Vice Chair of the Biosimilar Medicinal Working Party (BMWP). She has extensive experience in drafting biosimilarity guidelines for the EMA and the WHO and, with her team, reviews biosimilar applications in the EU.

Dr. Weise is board-certified pediatrician, has over 10 years of professional experience in pediatrics including pediatric endocrinology and clinical and laboratory research in Germany and the USA. She has also published various scientific articles in international peer-reviewed journals focused on growth and adrenal disorders and, more recently, on biosimilars.

Topic lectured:

5th Annual Biopharmaceuticals Meeting:
  • News and trends in Europe: An update on the EMA Biosimilar Medicinal Products Working Party (BMWP)

Susanne Wiegel

MorphoSys AG

Susanne

Dr. Susanne Wiegel is Director Business Development at MorphoSys AG, a world leading biotechnology company located close to Munich, Germany. For the past seven years at MorphoSys, she was responsible for compound in- and out-licensing - as well as a variety of other BD activities - including in-licensing “MOR208” for MorphoSys’ own clinical pipeline, and out-licensing the clinical stage asset “MOR103” to Glaxo-Smith-Kline, two compound deals that were highly relevant in MorphoSys’ maturation from a pure antibody platform enterprise into a biopharmaceutical company. From 1996 to 2001, Susanne studied Biochemistry at the University of Hannover, Germany, and afterwards prepared her Ph.D. in structural biology at the Helmholtz Centre for Infection Research in Braunschweig. In 2004, Susanne joined the consulting firm McKinsey&Co where she consulted pharma and chemical companies, as well as health care providers. Afterwards, she worked in business development at MediGene AG on various portfolio management and business development topics, among those out-licensing of an anti-inflammatory drug, prior to joining MorphoSys in 2008.

Topic lectured:

Be successful in biopharmaceutical partnering: Due diligence as the essential element

Hannelore Willkommen

Regulatory Affairs & Biological Safety Consulting

Hannelore

Dr. Hannelore Willkommen works as Consultant for Regulatory Affairs and Biological Safety of biopharmaceuticals. She is active in international organisations like PDA (Parenteral Drug Association) and she leads at present PDA’s Biotech Interest Group in Europe.

Hannelore Willkommen worked for more than 25 years at the German regulatory agency, the Paul-Ehrlich Institute. In this capacity, she was responsible for the marketing authorisation and supervision of biological medicinal products and, as her special field, for the viral and TSE safety assessment of biopharmaceuticals in national and European license procedures. Dr. Willkommen played a leading role in drafting national and European guidelines on viral and TSE safety of biotech and blood products.

Topic lectured:

Seminar 4.1:

  • Safety of starting material and auxiliary material of animal and/or human origin used in the process or formulation of the medicinal product
  • Adventitious Agents Safety Evaluation and EDQM TSE related certification