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2nd Operationalize: Expanded Access Programs Summit, 15 - 17 February 2022, Boston USA

2nd Operationalize: Expanded Access Programs Summit, 15 - 17 February 2022, Boston USA


Date of beginning

Tuesday, 15 February 2022


3 days




United States


Elena Berrinio


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This 2nd Operationalize: Expanded Access Programs summit is here to bring you solutions.By bringing together the world's leading Expanded Access Programs thinkers, this exclusive platform will clarify the complex issues through end-to-end Managed Access/Compassionate Use program operationalization. Through open discussion, sharing best-practice case studies, and removing hypotheticals: this event provides an unrivaled opportunity to solve your challenges across the entire timeline.Whether it's program set-up, US and EU regulatory pathways, product supply, data collection, logistics, ethical considerations, or internal collaborating - ensure you aren't repeating past mistakes by hearing global leaders recall their experiences with a shared goal of providing you with pragmatic solutions to solve these complex hurdles.URLs:Tickets: Developer conference + workshop day: USD 3997.0,Drug Developer conference only: USD 2999.0,Drug Developer workshop only: USD 1928.0,Solution provider conference + workshop day: USD 4797.0,Solution provider conference only: USD 3599.0,Academic/start-up conference + workshop day: USD 3397.0,Academic/start-up conference only: USD 2599.0,Academic/start-up workshop only: USD 1098.0Speakers: Cath Lawrence, Rare Disease Franchise Lead - Bionical Emas, Tom Watson, COO - Bionical Emas, Gwen Stiewing, Patient Advocate - I AM ALS, Sandrine Fontaine, Head of CMO office Management and Oversight Office of the Chief Medical Officer - GSK, Sarah Misenko, Senior Manager, Office of CMO, Oncology - GSK, Donna Cowan, Associate Director Expanded Access Programs and Registry - Stealth BioTherapeutics, Kevin Weatherwax, Managing Director - Michigan Institute for Clinical and Health Research, Karen Frascello, Director, Global Medical Affairs, Early Access - Alnylam Pharmaceuticals, Ramona Reichenbach, Head of Managed Access Center of Excellence - Novartis, Marjorie Zettler, Director of Clinical Science - Regor Pharmaceuticals, Kathleen Long, Director, Medical Affairs Operations - Alkermes, inc., Christian Valencia, Medical Director, Global Medical Affairs Oncology - EMD Serono, Helen Kellar-Wood, Head, Pre-Approval Access Operations, Global Development Operations - Bristol Myers Squibb, Jean Godin, Global Head of Humanitarian and Managed Access Programs and Medical Governance - Sanofi Genzyme, Mari Mitrani, Chief Science Officer - Organicell, Daniel O'Connor, Medical Assessor - MHRA, Alaa Hamed, Global Head of Medical Affairs Rare Diseases - Sanofi Genzyme, Richard Klein, Director, Expanded Access Programs and Policy - GE2P2 Global Foundation, Magali Taiel, Chief Medical Officer - Gensight-Biologics, Paula Singer, Senior Manager, Global Medical Affairs, Early Access - Alnylam Pharmaceuticals, Stephanie Petrone, Consultant - Navigate Clinical, Gretchen Randlett, Advisor, Expanded and Continued Access - Eli Lilly, Rachel Harrison, Senior Manager Early Access Program - Apellis Pharmaceuticals, Jeffrey Waldron, Managing Director - Sherborn Consulting Group, Sara Radenovic, Expanded Access Manager - GSK, Annmarie Galli, Head, Global Medical Affairs Research and Compassionate Use/ Managed Access Programs - GSK, Lisa Kearns, Researcher, Division of Medical Ethics - NYU Grossman School of Medicine, Toni Williams, Global Business Development Director - Clinigen Group, Tobias Polak, Director Real-World Data - myTomorrowsDate and Time: On Tuesday February 15, 2022 at 9:00 am (ends Thursday February 17, 2022 at 5:00 pm)Venue Details: Aloft Seaport District, 401-403 D Street, Boston, Massachusetts, 02210, United States