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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

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

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

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

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

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)

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

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

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