The backstory on why we need your story
by Lung Transplant Foundation Executive Director, Amy Skiba
Eighteen months, 3 weeks and two days. That is exactly how long our organization had been urging the FDA to let us hold an Externally-Led Patient-Focused Drug Development (or EL-PFDD) meeting. And finally, on June 22, 2022, it happened and the FDA is all ears!
Many of you knew and were inspired by our organization’s founder, Jeff Goldstein. I was lucky enough to work with Jeff, if only for a short time. In 2009, he founded The Lung Transplant Foundation (LTF) for one reason—to help others who had undergone a lung transplant as he had—improve their chances of surviving.
When people asked why he founded the Lung Transplant Foundation, I can remember Jeff explaining,
“Since my transplant, I have lost several friends to rejection…I couldn’t wrap my brain around this rejection issue that took my friends so quickly and suddenly…and was quite likely to take me as well.”
His words were prophetic. Chronic rejection issues known as a condition called Bronchiolitis Obliterans Syndrome, or BOS (pronounced boss) ultimately took Jeff’s life in June of 2021.
In September of 2020, when the FDA first announced it would be holding Patient-Focused Drug Development Meetings, Jeff said,
“This is it! This is our chance to make our case!!”
Jeff knew that by putting names, faces and stories to BOS, we could really start gaining ground on effective therapies to treat it. He also knew that an externally-led PFDD meeting would be our only chance to get in front of the FDA and tell the stories surrounding BOS. He immediately went to work gathering the materials we’d need for our Letter of Intent.
Even toward the end of his life, when he was ailing, Jeff was laser-focused on persuading the FDA to agree to hold this meeting about BOS. Jeff and I finished up our Letter of Intent to the FDA on June 20, 2021. He passed away two weeks later. In July, we got the green light to have the June 2022 PFDD meeting.
You can imagine how bittersweet this happy news was for everyone who had known Jeff and worked with The Lung Transplant Foundation. The first step toward his primary goal had been accomplished but he lost his battle with chronic rejection before seeing it happen. Please help us carry on Jeff’s legacy by ensuring this pivotal meeting is well-attended.
I’m so happy that Jeff’s wife Martha will be speaking at the June 22 meeting to remind us about Jeff’s life, his wishes, and his goal for BOS to be vanquished.
So you see, not only is this June 22 meeting a dream realized, it is also a tribute to Jeff’s life. Participating in the meeting in any way you can is an action we can take to honor all those who have been sidelined or lost to this poorly understood condition.
If you have been touched by BOS, we want to hear from you. We want the FDA staff in attendance to hear directly from patients, their families, caregivers and patient advocates.
By doing so you will help us achieve Jeff’s vision, to help create a world where all lung transplant patients can live long, healthy lives.
Thank you in advance for anything you can do to help us make the most of this meeting.