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Speakers

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

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

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

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

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?

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

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

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

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?

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

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

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

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

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