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Speakers

Meriem Bouslouk

G-BA / Federal Joint Committee

Meriem

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

Topic lectured:

3rd Annual Biopharmaceuticals Meeting

  • The German AMNOG

Laura Gomes Castanheira

ANVISA

Laura Gomes

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

Topic lectured:

3rd Annual Biopharmaceuticals Meeting:

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

Paul Chamberlain

Biopharma Excellence / bioLOGICA Consulting

Paul

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

Topic lectured:

Seminar 4.2:

  • Immunogenicity
  • Erythropoeitin

Immunogenicity Integrated - Interactive Workshop:

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

3rd Annual Biopharmaceuticals Meeting:

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

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

Workshop: Immunogenicity - Understanding the Regulatory Philosophy:

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

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

Cornelius Fritsch

Novartis Pharma AG

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

Topic lectured:

3rd Annual Biopharmaceuticals Meeting:

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

Tatiana Gaban

Roche Pharma Brazil

Tatiana

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

Topic lectured:

3rd Annual Biopharmaceuticals Meeting:

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

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

Thomas Hünig

University of Würzburg

Thomas

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

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

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

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

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

Topic lectured:

3rd Annual Biopharmaceuticals Meeting:

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

Thomas Kirchlechner

Sandoz GmbH

Thomas

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

Topic lectured:

Seminar 4.2:

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

3rd Annual Biopharmaceuticals Meeting:

  • Industry experience with authorisations of biopharmaceuticals in Brazil

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

Sylvie Le Glédic

Voisin Consulting Life Sciences

Sylvie

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


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


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

Topic lectured:

3rd Annual Biopharmaceuticals Meeting:

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

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

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

Monika Pietrek

Pietrek Associates GmbH

Monika

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

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

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

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

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

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

Topic lectured:

Seminar 6:

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

2nd Annual Biopharmaceuticals Meeting:

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

3rd Annual Biopharmaceuticals Meeting

John Purves

formerly EMA

John

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

Topic lectured:

Chairman of the 3rd and 4th Annual Biopharmaceuticals Meeting

Seminar 1:

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

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?

Frank A. Scappaticci

Genentech Inc. / Roche

Frank A.

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

Topic lectured:

3rd Annual Biopharmaceuticals Meeting:

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

Christian Schneider

Danish Health and Medicines Authority

Christian

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

Topic lectured:

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

Thomas Schreitmüller

Roche

Thomas

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

Topic lectured:

3rd Annual Biopharmaceuticals Meeting:

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

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