More companies than ever are launching managed access programs, trying to disentangle a matrix of country-specific regulations, and navigating complicated operational challenges in conducting pre-approval and posttrial access programs. Due to this, it has never been more critical to unite the community of large pharma, leading biotech, regulators, and patient advocates operationalizing compassionate use studies to bring life-changing treatment options to patients in need.
Returning to Boston for the 4th year, the 2024 Operationalize Expanded Access Programs Summit is uniting stakeholders executing managed access programs to bridge the gap between clinical research and commercial supply, generate insight from pre-approval use in clinical practice, and bring meaningful therapies to patients faster.
Uniquely positioned to elucidate country-specific regulatory pathways, optimize labelling and packaging requirements, and understand how to better support patients and physicians, join the community of 120+ experts in managed access, clinical operations, and supply leads to share the latest case studies in operationalizing expanded access programs and streamline access to life-changing therapies.
This is your one-stop shop to capturing industry’s latest case studies in This is your one-stop shop to capturing industry’s latest case studies in setting up a program globally, reaching physicians and patients, collecting real-world data, and maximizing vendor selection to improve the operationalization of EAP and streamline access to life-changing therapies.
Key agenda highlights include:
- Navigate global regulatory policies with Novartis and GSK to understand how to mitigate timelines in LATAM regions and how to successfully deliver a project in the Middle East
- Grasp the experiences of patients and physicians with the University of Michigan and Riboscience to discover unique strategies to better engage them and overcome the huge unmet need globally
- Determine the role of real-world evidence with AstraZeneca through leveraging AI tools and a digital patient community to advance EAPs by incorporating a centralized way to identify way patients with the highest need
- Optimize vendor selection and qualification with BeiGene by assessing the choice between using external vendors or leveraging internal resources
- Deliberate practical clinical supply strategies with Alexion Pharmaceuticals to successfully deliver a global project by ensuring labelling consistency across the supply chain and its accordance with GNP
At the summit you’ll get the chance to listen to the experiences of patients and physicians to truly understand their pain points and deliberate ways to overcome them. Directly ask physicians from the University of Michigan and University of Pennsylvania and patients from Her ALS Story your burning questions on ease of access, education on EAP, regulatory hurdles, and RWE generation.
New to 2024, a focussed and interactive Pre-Conference Workshop Day will cover everything you need to know to either set up or advance your programs, this is your opportunity to immerse yourself with industry leaders from Novartis, Daiichi Sankyo, UCB, Alexion, argenx, Eli Lilly, The PBC Foundation and Her ALS Story to:
- Navigate local and global regulations to understand country-level challenges and how to mitigate them
- Construct a reliable system to optimize the management of requests
- Understand the approach towards post-trial access to maintain ethical responsibility to patients that’d benefited from the program
- Operationalize working with patients and patient advocates to better support them and enhance program efficiency
With 16 new speakers and 10 new companies sharing their latest case studies in operationalizing expanded access programs and streamlining access to life-changing therapies, don’t miss content not presented before from: Benjamin Rotz, Associate Vice President, Global Medical Policy and Strategy Eli Lilly, Deborah Nicodemos Managed Access Programs Lead Novartis, David Stein Senior Director, Medical Study Operations Regeneron, Akash Srivastava Senior Manager, Medical Affairs Operations Biogen, Jasmina Ahrens Global Lead, Rare Humanitarian Operations Sanofi and more!
Don’t miss out on your opportunity to be amongst physicians, patients and passionate EAP and clinical supply experts from Novartis, GSK, Biogen, Sanofi, Eli Lilly, Regeneron, and many more to discover novel strategies in overcoming operational hurdles and deliver life-saving treatments to patients more efficiently.
But don’t just take our word for it: “Excellent agenda and speakers!” – Novartis, “Very interactive summit, I learned a lot” – Ascendis Pharma, “Great to be able to have best practices shared across companies” – Alexion Pharmaceuticals, “It was great to hear everyone sharing experience, knowledge, and challenges” – GSK
Download the full Event Guide here https://operationalize-eap.com/whats-on/full-event-guide/ to discover:
- 25+ speakers’ case studies to improve your EAP
- Your opportunities to engage directly with EAP experts during panel and roundtable discussions
- Full workshops summaries to deep dive with leading minds in the field
- Registration information, discounts and more!
