Addressing Unmet Medical Needs: Implementing a Successful Early Access Program
Sponsored by: Idis Managed Access, part of the Clinigen Group
- Early Access
- Clinical Development
Date: 14 July
Time: 3PM London/10AM New York
Join us for the latest thinking on Managed Access Programs (MAPs)
All over the world, many patients with serious illnesses can't get access to the medicines they need. The available therapies haven't worked and there are no available clinical trials, or a new drug isn't accessible where they live. For these patients, access to a drug outside of the traditional channels can represent a life-saving opportunity.
So how can industry respond to this demand?
Since 1987, regulations have evolved worldwide to enable physicians and pharmacists to gain access to investigational therapies on a ‘named’ patient basis. The access enabled by these programs can offer significant benefits to patients and their healthcare providers, and are often the only option remaining to patients.
Idis Managed Access is the market leader in the development, implementation, and management of such Managed Access Programs (MAPs), and is trusted by pharmaceutical and biotechnology companies worldwide due to our delivery of robust solutions that address the unmet medical needs of patients around the world.
Idis MA will be hosting a complimentary webinar on Thursday, 14th of July, at 3pm UK time, to discuss the current global early access environment, and to highlight ways to better plan and manage early access requests for your products.
Furthermore, we will cover such relevant topics as;
• Key trends driving demand for early access
• Key considerations for success at each stage of the product lifecycle
• Evolving regulatory requirements for early access in emerging and mature global markets
• Developing a robust internal and external early access policy
• Compliantly raising awareness of your early access program
• Utilizing early access data to support your clinical development plan
So please join us in order to better understand how implementing an early access program could be of benefit to your development program!
Business Development Director, IDIS Managed Access part of the Clinigen Group
Kieron joined the Clinigen Group in 2014 and is responsible for consulting with Biotech and Pharmaceutical companies on Managed Access Programs. Kieron specializes in advising companies on strategy development, Program set up and the implementation of specialist access programs for unlicensed medicines. Prior to joining Clinigen, Kieron has spent 15+ years within the Pharmaceutical industry fulfilling a range of roles including Head of Cardiovascular Division at Servier Laboratories Ltd contributing to European and Global development plans. Within this time, Kieron has led a number of global pre-launch and launch activities for treatments addressing areas of high unmet medical need. Kieron now focusses his energies on working alongside Pharma and Biotech Companies to consider their strategy for Early Access, developing Global Programs and allowing patients to gain access to treatments that would otherwise be unavailable within their respective countries.
Strategic Services Consultant and Patient Advocacy Manger, IDIS Managed Access part of the Clinigen Group
Rob has a strong career history in the pharmaceutical environment beginning in sales and progressing to medical communications in both the domestic and international arena. He has a good depth and breadth of experience across the core marketing disciplines over a product's life cycle from discovery to decline management. Rob's experience covers many aspects - from brand development and commercialisation, KOL advocacy and scientific platform development through to educational solutions for patients and physicians. He has worked on orphan products in the rare disease marketplace and supported the GSK medical/marketing team on the communication programmes for a number of Managed Access Programs for their HIV portfolio including the development of the HIV Positive Program. Rob has worked across therapeutic fields partnering with patient groups to provide better access to therapies and improve outcomes
Strategic Services Consultant, IDIS Managed Access part of the Clinigen Group
With a PhD in Analytical Chemistry, Nicola has a background that includes managing pharmaceutical development projects. Nicola has also delivered a number of Managed Access Programs for a variety of Pharmaceutical and Biotech Companies and understands the key requirements and regulations surrounding the process. She also has extensive experience in the set-up and delivery of EDC systems in all phases of clinical development and across several therapeutic areas.
As part of the Strategic Services Department Nicola helps Idis' MA clients gain the maximum benefit from their MAPs.
Key Learning Objectives
- Gain a sound understanding of the early access environment
- Determine if an early access programme is suitable for your assets
- Understand what additional value these programmes can add to your product development plan
- Medical Affairs
- Clinical Operations
- Clinical Development
- Market Access Managers
- Supply Chain/Logistics Managers
- Product Managers