July 11, 2012
Lynn Fallon will present at the CBI’s 5th Annual Congress on Access Programs for Investigational and Pre-Launch Drugs, taking place July 19-20, 2012 in Philadelphia, Pennsylvania. Ms. Fallon will present a case study, “Overcome Hurdles to Execute a Successful Expanded Access Program (EAP) – Voraxaze” on Friday, July 20th at 2:15p ET.
An EAP provided access of the product Voraxaze® (glucarpidase) to treat patients — half of whom were children — with toxic levels of methotrexate (a commonly used cancer chemotherapy drug) in their blood that could potentially lead to kidney failure. A number of factors could have made this program fail: It involved a relatively high-cost biologic product, it needed rapid IRB approval, and the drug shipment was needed within 24 hours. In the case study, see an example of one program that dispels many common fears and challenges of executing a successful EAP, including how logistics of the program can impact strategy, cost, outcomes and risks, as well as how companies can use data in the future.
Clients of CTI will be provided with a $300 voucher to be applied to the registration fee if they are interested in attending.
Ms. Fallon is co-founder of CTI and has over 19 years of clinical, academic and industry experience. Ms. Fallon has lead the development and expansion of CTI since its inception and is responsible for all aspects of the Consulting Division, including drug development, educational programs, scientific writing, strategic planning, and licensing and acquisition programs.
CBI’s 5th Annual Congress on Access Programs for Investigational and Pre-Launch Drugs is a tailored two-day meeting for those considering or currently working on the design and execution of a variety of access management programs, all aiming to achieve the same goal – provide investigational, pre-launch or end-of-lifecycle drugs to patients for treatment purposes.