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Advanced Therapy Medicinal Products (ATMPs) are becoming game-changers by demonstrating sustainable improvement or even cure for various chronic diseases where previously no therapeutic options were available. This has been demonstrated by recently approved gene therapies for rare diseases and CAR T cell therapies for leukaemia and lymphoma. Despite the enormous potential and the increasing number of therapies in the pipeline, only a limited number of therapies have made it to market.

While regulations have since matured, some specific challenges remain concerning manufacturing, quality, safety and efficacy of such therapies. To the developer, the road to market is marked by both promise as well as road bumps that are unique to this new class of therapeutics. This seminar seeks to highlight the challenges and opportunities for ATMPs from both regulator and industry viewpoints.

PDA Chapter Presidents

PDA Singapore Chapter

A registered pharmacist, Dr. Emily Cheah is currently the Managing Director of Charles River Laboratories Singapore (Microbial Solutions). Emily oversees strategic technical operations and market development in Singapore, Malaysia, and Indonesia; and is involved in the implementation of new technology/services at the Singapore site. She also conducts numerous training for the Industry. She received her Ph.D. (Pharm. Technology) from the National University of Singapore and EMBA from INSEAD.

Emily is President of the PDA Singapore Chapter and is an active volunteer with the Chapter since its inception in 2014.

PDA Australia Chapter

Micheal Schafferius currently holds the position of Application Specialist for Separation Technologies and quality at Sartorius Australia, working for Sartorius for the past 10 years. Micheal has worked in the pharmaceutical and biopharmaceutical industries for more than 20 years. His experience includes roles focused on Filtration, Single Use Technologies, Quality Assurance, Validation and Sterile Manufacturing with local and international companies. Micheal is the current PDA Australia chapter President.