Webinar: Biosimilar Development - From Science to Market
Sponsored by: SGS M-Scan Group
Focused on:
Date: 22rd March
Days old: 5069
Time: 15:00 GMT
Biosimilar Development - From Science to Market
Biosimilar products are fact! Various countries throughout the world have established legal and regulatory pathways to allow “copies†of an off-patent biotherapeutic product to be brought to market. However, these are not simple generics as in the case of small molecules. The fundamental difference with these large, complex protein molecules is that they cannot be absolutely identical to the original. Instead it must be demonstrated that they are similar by performing a side-by-side comparison with a reference sample of the originator molecule.
During this webinar, an overview of Biosimilar Development strategies will be discussed. Hear how you can rise above the many challenges- legal, regulatory, non-clinical and clinical to develop biosimilar products for global markets.
Presented by
Dr Alex Kudrin, MB BS Hon, MSc, PhD,
Medical Director - Takeda UK (Global R&D)
Dr Alex Kudrin graduated from Orenburg Medical Academy in Russia in 1997 and received his PhD and MD in Respiratory Medicine and Immunology from Moscow Medical University in 2001. He completed SHO clinical rotation at Cambridge University Hospital and following award of Membership in Royal College of Physicians (UK) in 2007 he joined GlaxoSmithKline Biologicals (Brussels, Belgium) as a Senior Clinical Development Manager in Worldwide Influenza Vaccines Clinical Development. He was appointed as a Medical Assessor in Biological Unit of Licensing Division at MHRA (London, UK) in 2007. Dr Kudrin has joined Takeda Global R&D in January 2011 as a Medical Director in Gastroenterology, Urology and Musculoskeletal Medicine.
Dr Kudrin has specific interests in business models of small biotechnology and pharmaceutical companies, mergers & acquisitions, risk mitigating strategies in managing clinical development portfolios. His clinical interests include research in oncology, immunology, vaccines; clinical development, medical affairs and licensing of biological products; emerging markets in South East Asia and Eastern Europe.
Dr Fiona M Greer BSc, MSc, PhD,
Global Director, BioPharma Services Development, SGS M-Scan
Dr Fiona Greer Phd, Global Director, BioPharma Services Development, SGS M-Scan Group, received a B.Sc. Food Science and an M.Sc. Forensic Science from Strathclyde University, and a Ph.D. in Protein Biochemistry from Aberdeen University, Scotland, UK. Joined M-Scan in 1984 to found the Biochemical Services Department and develop and exploit the new and emerging mass spectrometry techniques for protein and carbohydrate analysis. Over 25 years experience in the structural analysis of proteins and glycoproteins using instrumental techniques, and many publications in this area. Involved in the analysis of a diverse range of biotech products
Key Learning Objectives
- What is a biosimilar product and how are they defined?
- Legal and regulatory issues
- Analytical methods most suited to characterizing biosimilars for chemical structure, biological activity, and safety factors and comparing these to the originator product. - What Clinical studies must be performed?
- MAB Biosimilars-increasing complexity?
Audience
- Actavis Group - Global Director Clinical Quality Assurance
- Apotex Inc. - Patent Attorney Bio-Pharmaceuticals
- Biogen Idec - Associate Director Bio-Pharmaceuticals Development
- Bristol-Myers Squibb - Director (Regulatory and Compliance CMC Biologics)
- Pfizer - Associate Director Preclinical