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Immunogenicity Part 1 » Speakers
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Speakers

Matthew Baker

Antitope Ltd.

Matthew

Dr. Baker is a founder and the Chief Scientific Officer of Antitope Ltd, a Cambridge (UK) based company which specializes in assessing and reducing the immunogenic potential of biologics. He has held senior management positions at a number of companies including Biovation (subsidiary of Merck KGaA), CTL Ltd and Whatman BioSciences. As an academic researcher Dr. Baker has a background in B and T cell immunology and completed post-doctoral positions in Cambridge, UK after obtaining his PhD in cellular immunology at University of Birmingham, UK.

Topic lectured:

Immunogenicity Integrated - Interactive Workshop: Understanding the mechanisms involved in immune responses to therapeutic proteins

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

Jacques Descotes

ImmunoSafe, University of Lyon

Jacques

Dr. Descotes, MD, PharmD, PhD, is professor of medical pharmacology at Lyon University and Head of the Poison Center and Pharmacovigilance Department at Lyon University Hospitals.
For the past 30 years he has been involved in the non-clinical and clinical safety evaluation of pharmaceuticals in particular from an immunotoxicological perspective.
He is a fellow of the US Academy of Toxicological Sciences and a Eurotox Registered toxicologist. Dr. Descotes is the author of 14 books devoted to immunotoxicology, human toxicology and drug safety, and over 300 original and review articles.

Topic lectured:

Immunogenicity Integrated - Interactive Workshop:

  • Recognising and interpreting clinical signals

Arno Kromminga

IPM Biotech

Arno

PD Dr. Arno Kromminga is founder and CEO/CSO of GLP-certified IPM BIOTECH, is heading the Immunology at the Clinical Laboratory Lademannbogen in Hamburg, Germany, and has a position at the University of Kiel, Germany. He studied biochemistry and immunology and has 15+ year experience in assay development and is author of multiple publications in peer-reviewed journals and books. He is cofounder of the European Immunogenicity Platform (EIP). He gained substantial industrial experience in various biotech companies. He has been involved in the development and establishment of novel immunological and cellular assays for immunogenicity testing and PK/PD analysis for pre-clinical and clinical studies in compliance with GLP regulation. Most importantly he aims to interpret ADA, PK/PD data in the context of clinical consequences and manifestations.

Topic lectured:

Immunogenicity Integrated - Interactive Workshop

  • Bioanalytical method selection

Birgit Reipert

Baxter BioScience

Birgit

Birgit Reipert, PhD, is Director of the Department of Immunology within the Franchise Hemophilia/Hematology at Baxter BioScience. In addition she has got a lectureship at the Medical University of Vienna (Austria). She received her PhD from the Ernst-Moritz Arndt University, Greifswald (Germany), and postdoctoral training at the Institute for Medical Immunology at the Charitè, Berlin (Germany), at the Department of Immunology of the Institute for Cancer Research, Berlin and at the Paterson Institute for Cancer Research, Manchester (UK). Birgit Reipert joined Immuno AG in 1994 and Baxter AG in 1997. Birgit Reipert has a long standing interest in the immunogenicity of therapeutic proteins and in the search for new approaches to prevent unwanted immune responses to these proteins.

Topic lectured:

Immunogenicity Integrated - Interactive Workshop:

  • Non-clinical modelling of identified risks

Andrew Warren

Novartis Pharma AG

Andrew

Andrew is a Director of Bioanalysis at Novartis, where he is responsible for the development, validation and implementation of preclinical and clinical PK, PD and immunogenicity assays. Prior to joining Novartis, Andrew was head of Clinical Immunology in the GlaxoSmithKline Biopharmaceuticals Unit, where he was responsible for clinical biomarker and clinical immunogenicity assays to support the biopharmaceuticals portfolio. Prior to this Andrew headed a clinical biomarker lab at GSK within the Translational Science and Genetics department. 
Earlier in his career Andrew worked in a number of academic institutes, at the University of London where he was a Wellcome Trust fellow working on lymphocyte activation, as a post-doctoral fellow at University of Texas working on lymphocyte development, as a lecturer at University of Wales, working on viral immunology and as a postdoctoral fellow at the UK National Institute for Medical Research, studying dynamic interactions between host immune response and virus infections. Andrew has a PhD in Biochemistry from the University of London.

Topic lectured:

Immunogenicity Integrated - Interactive Workshop:

  • Integrated data analysis