The 5th Operationalize: Expanded Access Programs Summit

Expanded Access Programs (EAPs) are increasingly recognized as an ethical imperative in modern healthcare. More companies are opening EAPs to provide critical therapies to patients who would otherwise lack access. However, challenges persist, especially when navigating the complex regulatory landscape of global programs. From country-specific regulations to post-trial access, managing global supply chains, importation, licensing, and labeling standards remains a critical focus for ensuring patients worldwide receive the treatments they need.

Join over 120 thought leaders from Access, Medical Affairs, Clinical Operations, and Clinical Supply for an unparalleled opportunity to network, exchange insights, and explore innovative strategies for overcoming the regulatory and operational hurdles that complicate global access to life-saving therapies.

At this year's summit, you'll gain actionable insights on successfully planning and executing Post-Trial Access Programs, navigating the regulatory landscapes of the US, LATAM, Europe, and South and East Asia, and developing compliant, effective global access strategies. You'll also explore best practices for creating exit plans and transition strategies that address hurdles in reimbursement, off-request processes, and country-specific regulations-plus so much more!

URLs:
Website: https://go.evvnt.com/2716597-0?pid=176
Tickets: https://go.evvnt.com/2716597-1?pid=176
Brochure: https://go.evvnt.com/2716597-3?pid=176

Prices:
Conference Only - Industry Pricing - On the Door Price: USD 3099.00,
Conference + Workshop Day - Industry Pricing - On the Door Price: USD 4397.00,
Conference Only - Academic Pricing - On the Door Price: USD 2699.00,
Conference + Workshop Day - Academic Pricing - On the Door Price: USD 3797.00,
Conference Only - Vendor Pricing - On the Door Price: USD 3799.00,
Conference + Workshop Day - Vendor Pricing - On the Door Price: USD 5297.00

Speakers: Allison Webb Senior Project Manager Blueprint Medicines, Amber Fisher Senior Clinical Research Manager: Expanded Access and Investigator Initiated Study Programs Kura Oncology, Anh Tran Clinical Operations TA Head Alexion Pharmaceuticals, Annie Drelles Senior Director - Office of Medical Access, Global Oncology Medical Affairs Daiichi Sankyo, Becket Feierbach Managed Access Programs Lead Gilead Sciences, Bethany Bearden Assoc. Director EAP Blueprint Medicines, Brent Kreider President Biomed Valley Discoveries, Deborah Nicodemos Managed Access and Programs Lead Novartis, Debra Litwak Senior Director, Global Medical Affairs, Investigator Initiated Trials and Compassionate Use Programs BeiGene, Dennis Akkaya Chief Commercial Officer myTomorrows, Dennis Akkaya Chief Commercial Officer myTomorrows, Jasmina Ahrens Global Lead, Rare Humanitarian Operations Sanofi Genzyme, Jennifer Abovich Senior Manager, Global Oncology Expanded Access Takeda, Joseph Muenzer Professor of Pediatrics University of North Carolina, Kirsten Hoyer Associate Director Ascendis Pharma, Laura Carr Executive Director and Head of Global Medical Affairs, Oncology Trial Management, Resources and Operations Daiichi Sankyo, Laura Gagnon Director, Global Oncology Expanded Access Takeda, Lea Ann McNee Director of Communication and Stakeholder Engagement Reagan-Udall Foundation for the FDA, Leigh-Ann Durant Head of North America Medical Governance, Chief Medical Officer Governance and Operations Merck KGaA, Michael Bethel Global Head of Access Mechanisms Biogen, Michelle Clausen Senior Director, Expanded Access Enterprise Medical Community Pfizer, Nicole Garmon Director, Clinical Supply Strategy and Management Pfizer, Safwan Kezbor Senior Medical Director, Clinical Development Shionogi, Sarah Gilmore Director Managed Access Programs, Global Medical Affairs Gilead Sciences, Simon Morgan Team Lead, Qualified Person Pfizer

Time: 9:00 am to 5:00 pm