Development of Orphan Biologics: Challenges and Opportunities

On April, 18^th, a webinar will cover the topic "Development of Orphan Biologics: Challenges and Opportunities". The speakers cover aspects of clinical trial design for orphan biologics products, key strategies for ensuring clinical trial supply throughout clinical development and the regulatory and legislative framework for delivery to patients.

Prof. Matthias P. Schönermark M.D., Ph.D., founder and managing director of SKC, is one of the speakers. He provides an overview of the current status of orphan drug development in the European Union (EU), discusses the main challenges for market entry of new orphan drugs into the EU market and highlights key recommendations to drug developers to address these challenges.

Find the complete agenda here:

• 15:00: Welcome and introduction. Claire Skentelbery, Director General EuropaBio
• 15:05: Current Development of Orphan Drugs in Europe. Matthias Schoenermark, Professor, President and CEO, SKC Beratungsgesellschaft mbH
• 15:15: Orphan Biologics and CGT Development - CMC and Clinical Trial Supply Considerations. Wai Lam Ling, Ph.D., Vice President, Science and Technology, Catalent
• 15:45 - Successful Strategies and Business Model For Companies Bringing Their Orphan Drug To Market. Thomas Bols, Head of Government Affairs and Patient Advocacy, EMEA & APAC, PTC Therapeutics

Please register at EuropaBio.