Prof. Dr. Edward Geissler, Director of Experinmental Surgery, Department of Surgery, Regensburg University Medical Centre University

Professor Geissler is a basic scientist with a primary interest in organ transplation research. He received his PhD (1991) and postoctoral training in Transplantation Immunology at the University of Wisconsin, Madison, Department of Surgery. Currently he is the Director of Experinmental Surgery at the University of Regensburg, Department of Surgery, where he has developed a range of interests.

Professor Geissler remains engaged in Transplantation Immunology reserach, with the aim of contributing to the development of novel tolerance induction strategies. He is presently leading a recently established EU-FP7 international consortium aimed at applying cellular therapy to renal transplant recipients as a means of reducing allograft rejection. In addition, he has developed a strong focus in his research laboratories on the study of cancer in organ transplant recipients. In particular, he has studied mechanisms by which specific immunosuppressants may be used to diminish the increasingly recognised problem of cancer in transplant recipients. Here too he is bridging the gap between his research laboratories and the clinic by conducting an ongoing multinational clinical trial aimed at reducing hepatocellular carcinoma recurrence in liver transplant recipients. In 2008, he received "The Deutscher Krebspreis" for translational research in cancer from the German Cancer Society.

Dr. Steffen Gross, Scientific Assessor and Laboratory Head, Section Monoclonal and Polyclonal Antibodies, Paul-Ehrlich-Institut

Dr. Steffen Gross is Deputy Head of the Section Monoclonal and Polyclonal Antibodies, Laboratory Head as well as Scientific Assessor at the Paul-Ehrlich Institute 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-Institute 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.

Dr. Lois Hinmann, Drug Regulatory Affairs: Global Head, Early Development & Licensing, Novartis Pharmaceuticals Corporation

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.

Dr. Anja Lageneckert, F. Hoffmann-La Roche

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).

Prof. Dr. Johannes Löwer, President IABS

Johannes Löwer was born on November 20, 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 June 7, 2001. He retired from this position November 30. 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 Tübin-gen, 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

Dr. Jan Müller-Berghaus, Clinical, Assessor, Paul-Ehrlich-Institut

Dr. Jan Müller-Berghaus is currently working as clinical assessor of the 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.

Dr. Gopalan Narayan, MHRA

Dr. Silvia Pfaff, Drug Regulatory Affairs Head, Novartis Pharma AG

Dr. Silvia Pfaff is Drug Regulatory Affairs Head for the Business Franchise Immunology and Infectious Diseases at Novartis in Basle, Switzerland.
Prior to joining Novartis in July 2007 she was Director, Therapeutic Area Immunology, at Abbott Laboratories and Knoll AG in Ludwigshafen, Germany. She has got almost 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.

Dr. Monika Pietrek, Pietrek Associates

Dr. Monika M. Pietrek is a medical doctor and epidemiologist. Having worked in clinical care, pharmaceutical and CRO industries and at a regulatory agency, she has a broad based experience in international health care with specific expertise in clinical development, drug safety and risk management. In addition, Dr. Pietrek has gained substantial knowledge in process design/analysis and quality management.
During the past 20 years she has held senior positions at Behringwerke, the Paul-Ehrlich-Institute, Hoffmann-La Roche and PRA International, managing staff and projects across continents. Since 2009 Dr. Pietrek and colleagues provide their services to the pharmaceutical, biotechnology and medical device industry through Pietrek Associates GmbH, an independent consultancy firm.
Dr. Pietrek has served as DIA volunteer for more than 17 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. At present she is a member of the Professional Education, Training and Development SIAC and the Editorial Board of the DIA Journal as well as of the programme committee of the Clinical Forum 2011.
For more than 12 years Dr. Pietrek has been co-chairing a European PV expert group who focuses on operational aspects of drug safety and risk management. She has also been contributing to various initiatives led by ISPE, EFGCP, 7th MISG New Technology Forum and has been a regular speaker at international conferences.

Dr. Ilona Reischl, AGES – Austrian Medicines and Medical Devices Agency AGES/PharmMed

Ilona Reischl joined the Austrian Medicines and Medical Devices Agency AGES/PharmMed
in March 2006, as Head of the Division in charge of Clinical Trial Assessment, now the Department for Clinical Trials, Preclinical and Statistical Evaluation in the Institute for Marketing Authorisation of Medicinal Products & Lifecycle Management.
She transitioned from practical research 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).
She is the Austrian member of the European Medicines Agency Biologics Working Party and the Committee for Advanced Therapies.

Dr. Gabriele Schäffner-Dallmann, Study Director EUCRAF, Biopharmaceuticals Expert, Formerly PEI

Dr. Gabriele Schäffner-Dallmann is an internationally renowned 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. Currently, Dr. Dallmann works as a consultant and is involved in development, strategic and market access projects. She is the founder of Pharmatching.com, an internet platform supporting outsourcing.
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 an intensive dialogue with distinguished experts from authorities, universities and companies to develop EUCRAF.
As biologist with a PhD in immunology from Berlin University, she is also visiting lecturer on biopharmaceuticals at Freiburg University..

Dr. Christian Schneider, Senior Medical Officer, Danish Medicines Agency, formerly Paul-Ehrlich-Instiut

Christian K Schneider, MD, is Senior Medical Officer at the Danish Medicines Agency. He is currently on a leave from the Paul-Ehrlich-Institute, the German Federal Agency for Sera and Vaccines, where he has been working as Director and Professor and Head of Division “EU Co-operation/Microbiology”. He is the chairman of the EMEA’s Committee for Advanced Therapies (CAT), which started its work in January 2009. Between 2007 and 2011 he was co-opted member of the CHMP, the Committee for Medicinal Products for Human Use at the European Medicines Agency EMEA, 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 guidelines, including the CHMP Guideline on Strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products (the former “high-risk products guideline”), the CHMP Guideline on Comparability of Biotechnology-Derived Medicinal Products after a change in the Manufacturing Process – Non-Clinical and Clinical Issues, and CHMP Guideline on Immunogenicity Assessment of Biotechnology-derived Therapeutic Proteins for which he acts as Rapporteur.
Before he joined the Paul-Ehrlich Institut, Christian K Schneider was working for more than two years as a postdoctoral researcher at the Max-Planck-Institute for Neurobiology, Department of Neuroimmunology (Martinsried, Germany), where he worked in experimental immunology in the field of T cell immunology of inflammatory myopathies and multiplesclerosis. During his clinical career, Christian K Schneider worked in clinical immunology and hemato-oncology (Department of Internal Medicine III, University Erlangen-Nuremberg, Germany.

Dr. Marta Scwinger, Senior Regulatory Expert, Novartis Pharma AG

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.

Dr. Jennifer Sims, Head Biologics Safety & Dispostion, Novartis Pharma AG

Dr. Jennifer Sims is currently Head Biologics Safety & Dispostion, Translational Sciences, NIBR based in Basel, Switzerland.
Dr. Sims has a Bachelor of Science degree, a PhD in Pharmacokinetics and Toxicology, and a Masters Certificate in Project Management. She has over 20 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 (Novartis and AstraZeneca), Dr. Sims 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. She is Vice Chair of the BioSafe leadership group and the EFPIA topic leader and Rapporteur for ICH S6 revision.

Dr. Tetsuya Tanimoto, Cancer Institute,  Japanese Foundation for Cancer Research, Tokyo, Japan

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.

Dr. Gertrud Thormann,  The HST Consulting Network GmbH

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.

Dr. Karen von Graevenitz Buser,  Senior Regulatory Program Manager, F. Hoffmann-La Roche Ltd.

Karen v. Graevenitz is currently working as a Senior Regulatory Program Manager for Key Emerging Markets on metabolic compounds currently in clinical development. 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.