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Speakers

Pekka Kurki

Finnish Medicines Agency

Pekka

Dr. Pekka Kurki, M.D, Ph.D, acts as a research professor at the Finnish Medicines Agency (Fimea).

Before joining the Finnish regulatory agency in 1997, he worked in the pharmaceutical industry (clinical research), both in Europe and in the U.S.A. Dr. Kurki's clinical speciality is internal medicine with sub-speciality in rheumatology. He has a teaching affiliation to the University of Helsinki (clinical immunology). His scientific interest also includes cell biology, rheumatology and regulatory science.

He has had several scientific positions at the European Medicines Agency (EMA), including the membership the Committee of Human Medicinal Products (CHMP, 2000-7), chairmanships of the working parties for comparability (2002-3), biosimilars (BMWP, 2004-7), cell therapy (2002-4), and cell-based medicinal products (CPWP 2005-7). In addition, he acted as the chair of the ad hoc group for xenogeneic cell therapy (2001-3), a member of the biologicals working party (BWP, 1998-9) and a member of the ad hoc innovation Think Tank group of EMA (2005-7).

Currently, he is an alternate member of the EMA management board and an expert in the BMWP.

Topic lectured:

Immunogenicity: Understanding the regulatory philosophy (2)
  • Evolution of the regulatory approach related to the immunogenicity requirements
  • What is meant by a “risk-based approach” to immunogenicity assessment from the regulator’s perspective?
  • What are the implications of this philosophy for data presentation?
  • Conditions of use & patient-related factors
  • Clinical evaluation of immunogenicity and how does it contribute to the benefit-risk assessment
  • Role of the Risk Management Plan
  • How to tell a good story

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

Markku Toivonen

NDA Advisory Services Ltd.

Markku

Dr. Toivonen qualified as a physician and specialist in internal medicine from Helsinki University. A regulatory professional with over 25 years of experience from positions in pharmaceutical industry (Orion Pharma), regulatory authorities and consultancy. As of April 2005, Dr. Toivonen is Scientific Director of NDA Advisory Services Ltd. and member of NDA Advisory Board. Prior to this he was Head of Section, Marketing Authorisation Department (2003 - 2005) and Senior Medical Officer (1997 - 2002) both at the National Agency for Medicine. He was a member of the CPMP/CHMP 1997 - 2004.

Dr. Toivonen chaired the EMEA Scientific Advice Working Party (2003-2004); the CPMP Scientific Advice Review Group (SciARG) (2000-2003); and the CPMP Ad hoc group on (pre-) clinical comparability of biotech products (2001-2002).

Topic lectured:

3rd Annual Biopharmaceuticals Meeting:

  • A case study for the indication multiple sclerosis

Moderator

Gabriele Schäffner-Dallmann

Study Director EUCRAF/ Biopharmaceuticals Expert

Dr. Gabriele Schäffner-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 and 4th 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