FDA Meeting with Prader-Willi Syndrome Representatives

(Left to Right) Jim Kane, PWSA (USA) Research Advocacy Chair; Janalee Heinemann, PWSA (USA) Director Of Research & Medical Affairs;  Rob Lutz, PWS (USA) board member and coordinator of the PWS Collaborative Therapeutic Development Team; Theresa Strong, FPWR Scientific Advisory Board Chair and board member

(Left to Right) Jim Kane, PWSA (USA) Research Advocacy Chair; Janalee Heinemann, PWSA (USA) Director Of Research & Medical Affairs; Rob Lutz, PWS (USA) board member and coordinator of the PWS Collaborative Therapeutic Development Team; Theresa Strong, FPWR Scientific Advisory Board Chair and board member

We have just come back from a meeting we had in DC representing Prader-Willi syndrome as patient advocates with the FDA. With several drugs in the pipeline that could potentially be significantly helpful to PWS, we want to make sure that the FDA has all of the information they need on the syndrome, and to know the potential need for accelerating these drug studies. This has been a collaborative effort between PWSA USA and FPWR. We were excited to find out that several divisions of FDA were eager to learn more about PWS, and 15 key people from 7-8 divisions within the FDA attended the meeting. Representing Prader-Willi syndrome at the meeting was our dynamic foursome (see picture). Special thanks goes to Jim Kane who put together the extensive leave behind packet of materials and information to which we all contributed, and to Kerry Headley who helped design the packet. We were told by one person that it was the most comprehensive and professional looking packet they have ever seen from advocacy group.  Also, we want to thank the National Organization for Rare Disorders (NORD) for advising us and financially supporting our travel. The long term goal is to establish an ongoing relationship with the FDA, and we are well on our way due to this groundbreaking meeting.

This is exciting times – never before in my 30+ years with the Association have I seen this much interest by pharmaceutical companies in developing drugs that will benefit our children!

Janalee Heinemann

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About pwsatoday

PWSA (USA) is an organization of families and professionals working together to raise awareness, offer support, provide education and advocacy, and promote and fund research to enhance the quality of life of those affected by Prader-Willi syndrome.
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