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Speakers

The keynote lecture was given by Prof. Joyce Tait, Innogen Institute, UK. We had representatives from several European Agencies, as well as from the Health Canada and the FDA.

The speakers’ panel included:

  • Joyce Tait, Innogen Institute, UK
  • Surendra Gokhale, Roche
  • Steffen Gross, Paul-Ehrlich Institut
  • Steven Kozlowski, FDA
  • Dirk Mentzer, Paul-Ehrlich Institut, PDCO Chairman
  • Genevieve Michaux, Hunton & Williams
  • Jan Müller-Berghaus, Paul-Ehrlich-Institut, CHMP Member
  • Michael Pfleiderer, Paul-Ehrlich-Institut, BWP Chairman
  • Ilona Reischl, Austrian Medicines and Medical Devices Agency, CAT Member
  • Sol Ruiz, Spanish Medicines Agency, CAT Member
  • Christian Schneider, Danish Health and Medicines Authority, CHMP Member
  • Beate Schäfer, BMS
  • Jennifer Sims, Integrated Biologix GmbH
  • Doris Irene Stenver, Danish Health and Medicines Authority, PRAC Member
  • Jian Wang, Health Canada
  • Martina Weise, BfArM, Vice Chair BMWP

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

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

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

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

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

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

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

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

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?

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?

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

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

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

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

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

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

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

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)