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!
Kieron Lewis
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.
- 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
