2021 Workshop Day
Workshop A: Research, Plan & Operationalize Your Program: Assess the Full Value Chain Before the Rubber Hits the Road
Monday, February 22 | 9:00-11:00 EST
New to the Expanded Access scene? Unsure of the value of EAPs in your company? Wide-eyed at the thought of knowing where to start?
Walk through the initial considerations, steps required and mistakes to avoid when setting up these altruistic programs. Ensure you have a clear understanding of what to expect, and what will be expected from you, as you enter an EAP. Understand how to move programs between countries depending on approval and gain contrasts between the US and EU reimbursement system.
Through a mixture of presentations, intimate project group activities and open Q&A opportunities, leave the workshop with a fundamental and complete understanding of how to set up and operationalize an Expanded Access Program.
Attend this workshop to:
- Learn how data collection, correct intradepartmental structure, research into the disease prevalence and dispersion among regions should be done to ensure program success
- Gain a broader understanding of the investment, both budget and resources, required to operate such a program
- Understand the value in using an EAP for gaining further market share, collecting real-life data and building greater relationships with patients and HCPs
Georges van Baelen
Founder & CEO
Operationalizing IND Treatment Protocol for Rare & Expensive Therapies.
Monday, February 22 | 11:30-13:30 EST
The rare and ultra-rare disease space is desperate for more information in EAP set up and operationalization. With a limited, varied and distant patient body, running a clinical trial is often out the question. But what are the considerations needed for a single-patient access program?
After building a solid understanding of the EAP space, take those key considerations and consider the IND route of setting up a program. Learn from Carrie’s experience in the operationalization of single patient expanded access work in building and releasing expensive biologic treatments through the IND process and Australian Special Access Scheme.
Following a presentation by Carrie on the key lessons learned in building an expanded access program, there will be focused workgroups enabling collaboration with fellow industry peers to consider specially concocted situations to work through.
Return to share and build upon decisions made with time for an intimate Q&A opportunity after to have your questions heard and answered.
You should attend this workshop if you:
- Work in the rare/ultra rare disease space.
- Are considering or are already involved in single patient access programs.
- Are looking for answer on: where to collect and manage funding; How to collaborate with HCPs; and how to build internal infrastructurefor harmonized care.
Carrie-Lynn Langlais Furr
Founder & CEO
Bacteriophage & Drug Development Consultants
Carrie’s regulatory and scientific accomplishments include 7 FDA market approvals, 8 INDs and 2 International Expanded Access Programs. Working with over 30 pharma companies and in operational, regulatory and program management capacities, her knowledge and deep understanding of this topic makes this workshop a must-have for personal and practical education.