Upcoming Webinar: Finding Your Strongest Voice for Public Testimony

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. Learn more about the FDA workshop here: http://bit.ly/fda-mtg-agenda To inform, educate and engage with the community so that our individual contributions have amplified impact, we are hosting a six-program spring webinar series and a special patient-focused survey.

Program-2-Theme-rev-300x182Topic: Finding your strongest voice for public testimony
April 4, 2013 at 1 p.m. EDT
Speakers: Leigh Reynolds and Kim McCleary
Recording Link: http://www.youtube.com/watch?v=-zLyJlx3Jmw&feature=youtu.be

The upcoming FDA workshop and spring meeting of the federal CFS Advisory Committee offer opportunities for advocates to shape policy decisions by sharing their experiences and expressing their views. Communicating effectively about the tremendous burden of illness ME/CFS places on the individual, the family, the community and country will be crucial to bringing about more responsive policy and stronger federal programs for research, education and services.

In this program, CFIDS Association CEO Kim McCleary will describe the FDA’s Patient-Focused Drug Development Program, a series of 20 federally mandated disease-specific meetings FDA will conduct over the next five years. CFS and ME have been selected by FDA as the first topic of this meeting series. A March 11, 2013 article in the Pink Sheet Daily, a leading pharma publication, describes the importance of this designation:

“CFS and ME will be the focus of the first meeting convened under FDA’s Patient-Focused Drug Development initiative, and the inaugural session may serve as a model for future workshops under the program… The decision to make CFS/ME the focus of one of the highly coveted ‘disease of the quarter’ meetings under the reauthorized Prescription Drug User Fee Act cements these conditions as a test case for incorporating patient input into the drug development process for conditions with a high unmet need.” Speakers-277x300

Kim will describe how this aspect of the April 25-26 workshop ties into broader drug development issues.

The Solve ME/CFS Initiative’s Engagement Manager, Leigh Reynolds, will share ways to make patient testimony as effective as possible and ways to participate in the drug development process leading up to and beyond the FDA meeting.

Both speakers are informed by more than two decades of experience working with patient communities, health agencies and policymakers. The FDA has set April 8, 2013 as the deadline for workshop registration (in person or by web cast), requests to participate on the panel, requests to provide public testimony and submission of written testimony. Written comments after the April 25-26 workshop will be accepted until August 2, 2013. We’ll address these opportunities (and others!) during this webinar to help advocates make the most of them.

Here are some resources about this topic; you might find them interesting to review in advance, or helpful after the webinar:

Learn more about other webinars in the series (http://bit.ly/spring-series). The recording for our first program of the series, “Overview of the Drug Development Landscape,” is now available for on-demand viewing at http://bit.ly/mar-28-webinar.

We look forward to your participation!

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 27, 2013