Clinigen Global Access Programs (GAP):
On behalf of pharmaceutical and biotech companies, we manage essential programs that provide access to critical medicines for physicians and their patients all over the world. But what is a Global Access Program? Known by many terms from ‘expanded access’ and ‘named patient’ to ‘compassionate use’ and ‘early access’, a global access program enables physicians to access treatments that are not available in their own country for patients with an unmet medical need. Wherever they are, we can deliver treatments quickly, efficiently and, most importantly, ethically.
Clinigen GAP provides a complete solution for our clients, from small niche biotech companies to top 10 pharmaceutical organizations. All of our programs are tailored specifically to meet the needs of patients, our clients and the therapy area involved. Our GAP team has experience of delivering over 100 programs across a wide range of therapy areas and many of our clients would be willing testify to our exceptional levels of service as well as our ability to implement tailored programs. Our GAP team delivers on all necessary aspects of a program, including regulatory, quality, logistics, legal, financial and customer services, all of which are utilized through a dedicated Project Manager, who provides clients with a single point of contact throughout the whole GAP process.
Many companies with development products in speciality areas of high unmet need such as cancer or rare disease choose to consider an Early Access/Named Patient/Compassionate Use Program to run alongside late stage clinical development, enabling patients to access products outside of clinical trials prior to commercial availability. Considering Early Access whilst a product is in development can serve to enhance an asset’s value as you are assessing the options available for commercialisation globally.
If the decision has already been taken internally to run an access program or if early access has not even been considered and advice on the environment is needed, Clinigen are willing to work with members either F2F or over a TC to provide guidance on the options available and share our experience of running access programs.