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Biosimilar Workshop 2015

Speakers
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Speakers

Beatrix Metzner

Boehringer Ingelheim

Beatrix

Dr. Beatrix Metzner studied chemistry at the University of Regensburg and the Albert-Ludwigs-University of Freiburg where she was specialized in biochemistry. Furthermore she was PhD student at the Department of Experimental Dermatology at the University of Freiburg and Post Doctoral research Fellow at the Memorial Sloan-Kettering Cancer Center (Immunology Program) in New York (Research fellowship of the German Research Society).From 2000 she worked at MediGene AG as Senior Scientist, later Manager Operations and Senior CMC Project Manager. In 2005 she started to work at Merck KGaA as Project Manager (CMC - Bio-manufacturing/Protein Supply).In 2007 she moved to Global Regulatory Oncology where she has been working as Director Global Regulatory Oncology since November 2008. Since November 2013 she took over the position as Head of Global Regulatory CMC Strategy Biosimilars at Boehringer Ingelheim.

Topic lectured:

Seminar 4.1:

  • Quality Module 3 of the CTD for recombinant and classical biopharmaceuticals
  • Characterisation, quality control and analytical techniques
  • Essential differences in Module 3 considerations USA
  • Essentials for Module 3 in Japan
  • Changes in process and their implications on the molecule, the comparability exercise

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
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Moderator

Diane Seimetz

Biopharma Excellence

Diane

Dr. Seimetz has over 16 years of global drug development, regulatory affairs and partnering experience in the biopharmaceutical industry.

She is co-founder of Biopharma Excellence, a consulting company specialized in drug development, regulatory affairs and partnering strategies.

She is the former Executive Vice President and Chief Scientific Officer of Fresenius Biotech. In this function she was responsible for Regulatory Affairs, Medical Affairs, Preclinical and Clinical Development as well as Program Management. Together with her team she developed on an international level the first bispecific, trifunctional antibody catumaxomab. After successful approval in the EU, this antibody was awarded the “Prix Galien” which honors outstanding research and innovative drug development.

She was involved in numerous due diligence projects for both, in-licensing and out-licensing strategies.

Dr. Seimetz looks back on a large number of meetings with EMA, national European agencies, FDA, Health Canada, and TGA as well as other jurisdictions. She has dealt with these regulators during (parallel) scientific advice, pre-submission, submission and post-authorization phases of projects as well as GMP and GCP inspections.

She planned and implemented product life cycle strategies including post marketing studies and publications to increase product value.

Her product portfolio knowledge covers mono- and polyclonal antibodies, antibody-drug conjugates, recombinant proteins, complex peptides, advanced therapy medicinal products as well as medical devices. She has in-depth experience with the development and approval of new products and biosimilars.

Dr. Seimetz received her degree in pharmaceutical science from the University of the Saarland and completed her PhD at the University of Heidelberg. Her research work related to glycotargeting in oncology was conducted at the German Cancer Research Center and the Johns Hopkins University in Baltimore, USA. Dr. Seimetz has a Master’s Degree in Drug Regulatory Affairs. In her thesis she assessed the EU and US environment for early market access and the essential requirements within a pharmaceutical company.

Topic lectured:

Seminar 4.2:

  • From scientific advice to successful marketing authorization – experience with the European authorization of the bispecific monoclonal antibody Removab

Be successful in biopharmaceutical partnering: Due diligence as the essential element

Tilo Netzer

PharmaLex GmbH

Tilo

Tilo Netzer is a pharmacist by training and holds a PhD in Pharmacology. He started his career with Merck KGaA in Germany in 1992 and held at Merck various positions in Clinical Development and Regulatory Affairs where he significantly contributed to the successful developmentas well as marketing authorization of Erbitux. In the context of the integration of Merck and Serono in 2007 he became Head of Global Regulatory Oncology and in January 2009 he was appointed Head of Global Regulatory Affairs at Merck and Serono. In June 2012 Tilo joined PharmaLex as Partner, Business Development and Regulatory Strategy.

Topic lectured:

Seminar 2:

  • The PDUFA process at FDA