Taking place virtually this June, the 10th Annual HPAPI Summit will unite a global community of experts who are involved in the safe, quality and cost-effective development and commercialization of highly potent compounds.
In a previously slow-moving field, recent months have seen huge advances in regulatory guidance, technology, and potent pipelines. Changes to EU Annex 1, much anticipated revision from Health Canada, and the FDA's tightened regulations on mutagenic impurities, have left drug developers and CDMOs are facing more pressure to ensure cGMP compliance for HPAPI. This is heightened by the accelerated commercialization of ADCs and anticipated growth of highly potent compounds in emerging pipelines for innovative treatments.
Covering the latest in containment, industrial hygiene, EHS and Outsourcing, the HPAPI summit will provide you with a comprehensive guide to ensure safety and compliance in your HPAPI processes. However, it has never been more vital to look beyond purely containment, to explore the whole story of HPAPI development and manufacturing. Hence across 2 steams and 3 workshops, the 2021 meeting will introduce themes such as:
Safe handling in Research and Development and scale up to clinical with case studies from Novartis, Tarveda Therapeutics and Vertex
Green chemistry and environmental impact, lifecycle management and outsourcing with sessions championed by Ipsen, Takeda and Clovis Oncology
Uniting innovative containment with first-class facility design shown by Merck, Novo Nordisk and ILC Dover case studies
Continuous manufacturing, automation and emerging technologies to ensure your HPAPI development and manufacturing is onboard with industry 4.0
Speakers: Sayantan Chattoraj, GSK Fellow, Scientific Leader, GSK, Reinhold Maeck, Associate Director Tech Transfers, Boehringer Ingelheim, Katarzyna Wegner, Acting Chemical Process Development Manager, Ipsen, Mike Whaley, Global VP EHS, Ipsen, Gowri Sukumar, Director CMC and Regulatory Affairs, Iterion Therapeutics, Jay Brown, Director Environmental, Health and Safety, Mayne Pharma, Angela Wagner, Associate Principal Scientist, Merck, Emily Gullotti, Associate Principal Scientist, Merck, Damien Boyd, Regional Industrial Hygiene (EMEA region), MSD, Senior Representative, Novo Nordisk, Craig Williams, Process Hazards Specialist, Syngenta, Ester Lovsin Barle, Head of Product Stewardship and Health, Takeda, Chris Sears, Senior Director CMC, Tarveda Therapeutics, Mark Witcher, Senior Consultant, Excyte, Bob Sussman, Managing Director, SafeBridge Consultants, Scott Patterson, Vice President Pharma/Bio Technical Support, ILC Dover, Dean Calhoun, President/CEO, Affygility Solutions, Maurits Janssen, Senior Director Strategic Business Development, Small molecules, Lonza, Reinaldo Marin, Senior EHS Manager, Pacira Pharmaceutics , Milica Glogovac, Senior Manager Health Hazard Assessment, Novartis, Ijaz Ahmed, Scientist II Process Chemistry ImmunoGen, Brain Haney, Director, Global Technical, AMRI, Jason Korbel, Technical Services Manager, Cambrex Charles City, Duane Smith, Associate Director of Environmental, Health and Safety, Hikma Pharmaceuticals
Schedule:
10:00 to 17:00