The upcoming FDA Workshop on Drug Development is a historic opportunity for the ME/CFS* community to establish ME/CFS as a priority for drug development. To inform, educate and engage with the community so that our individual contributions have amplified impact, we are pleased to announce a spring webinar series and a special patient-focused survey.
Title: Overview of the Drug Development Landscape
Date/Time (live event): March 28, 2013 at 1:00 p.m. EDT
Speaker: Kristin Schneeman, Program Director, FasterCures
Host: Kim McCleary, CEO, The Solve ME/CFS Initiative
In the first program of our Spring 2013 Webinar Series, we welcome Kristin Schneeman, program director for FasterCures, as our guest speaker. Kristin will outline the process to translate scientific discoveries into accessible medical solutions. She will define the major components of the research and development (R&D) cycle as a basis for helping community members understand the landscape for drug development. She will contrast it with the landscape for basic research, an area that is more familiar to most patient advocates and community members.
FasterCures is an “action tank” that works to improve the medical research system — to speed the time it takes to get important new medicines from discovery to patients. It is described as “a nimble and independent organization, a ‘safe place’ for key stakeholders of the medical research enterprise to come together and get things done.”
Kristin Schneeman joined FasterCures in April 2005 as program director, with primary responsibility for its innovation portfolio of projects and activities, focused on best practices in the funding and conduct of medical research and innovative collaborations among players in the research enterprise. She brings to FasterCures 20 years’ experience in public policy, politics, academia and the media.
The Solve ME/CFS Initiative is proud to be a member of FasterCures’ TRAIN network, one of 55 organizations recognized by FasterCures as “fast becoming the engine behind innovation in disease research – collaborative, mission-driven, strategic in their allocation of resources, and results-oriented.” TRAIN organizations have “a singular focus on, and a significant stake in, getting promising therapies from the laboratory bench to the patient’s bedside as rapidly as possible.”
President & CEO Kim McCleary will host the webinar and provide additional information about how the Solve ME/CFS Initiative is fostering the development of safe and effective treatments for ME/CFS. Applying a venture philanthropy model, the Association serves as convener, connector and collaborator to move promising discoveries through the drug development process, keeping the patient as our central focus every step of the way. Kim also serves as a member of FasterCures’ TRAIN Advisory Board.
Here are some resources about this topic; you might find them interesting to review in advance, or helpful after the webinar.
- “Getting Started” and “Crossing Over the Valley of Death” (FasterCures publications)
- “The FDA: Past, Present & Future” (video from FasterCures’ Celebration of Science)
- Drug Development and Approval Process (FDA materials)
- FDA Drug Approval Process (FDA infographic)
The webinar recording has been posted at http://bit.ly/mar-28-webinar.
We make every effort to record our webinar programs and post the recordings on our YouTube channel for those unable to attend the live event and for later reference.
*We use the term ME/CFS to refer to conditions also known as chronic fatigue syndrome, CFS, myalgic encephalomyelitis, myalgic encephalopathy, ME and by other names.March 18, 2013