We have BIG news……we have representation on the FDA Advisory Committee.
Our Percy has qualified and has been accepted to function as Patient Representatives to the FDA Advisory Committees. Congratulations Percy and Congratulations Cholangiocarcinoma Foundation patients, families and friends.
The process of application and acceptance is lengthy, challenging and very time consuming. Our Percy weathered the storm (so to say) and is now officially representing our patient community and that of other diseases.
A quick overview of the position:
The Patient Representative is responsible for providing the Food and Drug Administration (FDA) and the advisory committee the unique perspective of patients and family members directly affected by a serious or life-threatening disease. The Patient Representative should have:
• Personal experience with and/or be knowledgeable about the specific illness or condition under discussion by the committee;
• The ability to articulate the perspective of patients;
• Experience as a patient advocate
• Formal affiliation with a patient advocacy organization;
• The ability to identify issues through communication with patient constituencies.
The Patient Representative’s role is to provide the advisory committee and FDA insight on issues, problems, and/or questions pertinent to the viewpoint of patients and family members living with a specific serious or life-threatening disease. S/he serves as either a voting or non-voting member of the advisory committee.
At the conclusion of each meeting, the Patient Representative will be encouraged to provide OSHI with a brief summary of his/her experience on the advisory committee and suggestions for enhancing patient representation, if any.
The Patient Representative must be well-informed about patient concerns and have the ability to understand and actively participate in advisory committee discussions. The Patient Representative serves on advisory committees when a product or therapy (drug, biologic or medical device) related to a serious or life-threatening disease is under reviewRead More
Attendance at ASCO is kind of a marathon event. It provides the opportunity to share resources, interact with physicians, researchers and other advocates while attending planery session, symposiums, and sessions focusing on improving the treatment and care of people living with cancer. It reflects the Cholangiocarcinoma Foundation’s commitment to educational research, and public policy goals and to provide our patient community with the most up to date information available.
While Percy and Karen attended sessions on common concepts in oncology which include cancer pathways, genomics, biomarkers, statistics, and patient protections, Barbara and Stella interacted with the numerous physicians, researchers and others visiting our busy booth. As for Marion, most of her time was taken up by attending various, closed session meetings pertaining to the disease of Cholangiocarcinoma and the process and development of clinical trials.
Traffic at our booth has increased dramatically over the last few years and we are happy to report that ASCO 2012 has been a successful event. We are witnessing an increased effort by the scientific and medical and community in furthering research and improving treatment options for our community. As we continue to strive to support the efforts of finding a cure for this cancer, we are encouraged and hopeful that our goal can be achieved.
A big thank you to Percy, Barbara, Karen, Stella and Marion for donating their voluntary and non-compensated time and efforts to this annual event. Given the current economic situation volunteering for our non-profit organization truly has become a gift of love.
Save the date for the 5th annual Tee Off For Hope Golf Outing Saturday September 8th at Reeves Golf Course followed by a cookout/after party at 3727 Drakewood Drive, Cincinnati, OH. If you have not attended this event you will be amazing by the support and generosity. Registration and additional information to follow in the coming weeks. Mark your calendars and spread the word, we can do this one fundraiser at a time.Read More