By: Kelli Collins, VP Patient Engagement and Tonya Saffer, VP Health Policy
On September 27th and 28th the National Kidney Foundation Kidney Advocacy Committee Members participated in the Food and Drug Administration (FDA) meeting, “Evidence-Based Treatment Decisions in Transplantation: The Right Dose & Regimen for the Right Patient/Individualized Treatment”.
Left to right: Shanon Woodward, Kelli Collins, Haley Newkirk, Brandy Webster, Alex Barrios
Kidney Advocacy Committee members Alex Berrios, Brandy Webster, and Haley Newkirk provided the patient perspective presenting as part of a panel entitled: The Patient Perspective on their Organ, Treatment and Hopes for Future Management (changes, improvements).
The National Kidney Foundation has collaborated with the FDA to bring the patient voice to the table for the past several years and is encouraged to see FDA continue to prioritize patient engagement in the process of drug development.
This year, NKF’s kidney transplant recipient advocates, along with two lung recipients, shared their individual experiences and challenges with transplant, side effects, and immunosuppressant medication. “I enjoyed being able to be a voice at the table, speaking on behalf of my fellow kidney transplant recipients, so that those in charge of drug development hear directly from the people the drug is intended to help. I also enjoyed learning about the upcoming adherence tools that are being discussed,” Alex Berrios.
After presenting their individual experiences, patients engaged in an open panel and Q&A session. Each recipient’s story was unique but also shared many common threads. All were incredibly grateful for how a kidney transplant changed their life for the better. Each patient struggled with side effects and complications to varying degrees. Some common side effects of the immunosuppressant medication were insomnia, skin cancer, cognitive or memory changes, and weight gain. They also shared challenges with adherence and high cost of medications.
“As a patient, I learned a lot more about how the drug development process works and how the research and development challenges in the organ transplantation field may affect my care,“ Haley Newkirk says, “I hope that the conversations among patients, regulators, physicians, and researchers will lead to better and more individualized treatments in the future.”
Left to right: Alex Barrios, Brandy Webster, Haley Newkirk, Shanon Woodward
Also, in attendance was National Kidney Foundation board member and transplant surgeon Matthew Cooper, MD. The meeting was the result of a Public-Private Partnership created in April 2017 and founded by the American Society of Transplantation, the American Society of Transplant Surgeons, the Critical Path Institute and the FDA.
“The Transplant Therapeutics Consortium and the meeting today are shining examples of how the FDA and stakeholders in transplant, especially our patients, are coming together and appreciating we all have a common goal in developing safe and innovative medications and interventions to expand opportunities for transplantation as well as increase the life years gained for those fortunate to receive the Gift of Life,” said Dr. Cooper.
Longtime National Kidney Foundation volunteer and prominent epidemiologist Josef Coresh, MD shared research and findings from a multi-year meta-analysis that examined the largest compilation of data ever collected on chronic kidney disease (CKD), first presented at a workshop hosted by the National Kidney Foundation in March 2018. The joint workshop held with the FDA, European Medicines Agency (EMA) and NKF examined how measuring biomarkers could expedite clinical trials and spur innovation in delaying or preventing progression. Dr. Coresh shared this data and discussion at the FDA meeting as it may also have applications to developing drugs targeted at preventing transplant rejection.
This FDA meeting highlighted the importance and critical need for innovation in transplant and brought together clinical, research, and patient expertise to help achieve the goal of better treatments for those living with kidney disease. The National Kidney Foundation is grateful for the work that AST, ASTS, C-Path and the FDA are doing to spur new drug development in transplantation. The input and perspective of transplant recipients was central to the discussion and will be used to further efforts to align drug development with goals that are most important to patients.
Share your experience as a transplant recipient with the FDA. Send comments via this link: https://www.regulations.gov/document?D=FDA-2018-N-3010-0001 and click Comment Now! Comment period will be open until November 19th.
Learn more about the conference and watch a recording of the webinar here: https://www.fda.gov/Drugs/NewsEvents/ucm605761.htm
Related information:
Advocacy in Action 
Good work!
My daughter had a kidney transplant when she was 13. It lasted 30 yrs. In the last years she developed skin cancer. She is now 45 and today went to Johns Hopkins for an evaluation. She has been told that cancer will be a big problem if she has another transplant. I had hoped that there would be new drugs which would not produce the cancer. Very sad for her.