Journal of Genetic Syndromes & Gene Therapy
Open Access
ISSN: ISSN: 2157-7412
ISSN: ISSN: 2157-7412
Stuart Bell
VP Consulting, UK
Scientific Tracks Abstracts: J Genet Syndr Gene Ther
This presentation will cover the evolution over the last 10 years of pre-approval access (expanded access/early access/compassionate use/named patient supply) to drugs, with an emphasis on orphan drugs and rare diseases. â?¢ The presentation will include; â?¢ How has the landscape changed over the last 10 years? â?¢ What are the driving forces behind these changes? â?¢ How have the regulations changed in recent years, and what has the impact been? â?¢ What are the commercial opportunities provided by pre-approval access to orphan drugs? â?¢ What do the next 5-10 years hold for pre-approval access to orphan drugs?
Stuart has more than 20 years of healthcare and pharma consulting experience, with a particular focus in unlicensed medicines and pre-approval access. He is one of the senior management team responsible for establishing Inceptua Medicines Access and is responsible for Inceptua’s consulting engagements, covering strategy and policy, real-world evidence, communications and market access. Prior to Inceptua, Stuart set up the Consulting Dept. at Idis/Clinigen, pioneering the development of global corporate strategies on preapproval access and developing the first pre-approval-specific EDC for real-world data collection. He has formerly held roles as: Principal, Real-World Evidence at IQVIA, Director, Informatics Initiative, UK Dept. of Health, Consultant to the European Association of Neuro-Oncology and Director of Communications for the European Cancer Organization.
Email id: stuart.bell@inceptua.com