The Lung Transplant Foundation to Host Externally-Led Patient-Focused Drug Development Meeting to Help Educate FDA on Living with Bronchiolitis Obliterans Syndrome (BOS)
Meeting to be Held Wed., June 22, 2022 from 10:00 a.m. – 3:00 p.m. ET in Washington DC.; Event will be Livestreamed for Virtual Attendees
Bronchiolitis Obliterans Syndrome (BOS) is One of the Most Severe Complications After Lung Transplantation; Currently, There are No Approved Treatment Options
An Estimated 50% of Lung Transplant Patients Develop BOS within Five Years Post-Transplant
The Lung Transplant Foundation (LTF), a non-profit organization dedicated to creating a world where all lung transplant patients live long, healthy lives, announced today it will host an externally-led patient-focused drug development meeting with the U.S. Food and Drug Administration (FDA) on Wednesday, June 22, 2022, from 10:00 a.m. – 3:00 p.m. ET in Washington DC. This historic event is intended to help educate the Agency and the public about the challenges of living with Bronchiolitis Obliterans Syndrome (BOS).
BOS, also referred to as chronic rejection, is one of the most severe complications after lung transplantation. Approximately 50 percent of lung transplant patients develop BOS within five years post-transplant, the highest rejection rate of any transplanted organ. BOS usually leads to respiratory failure and death within 2 to 4 years after diagnosis ii, underscoring the immense need for effective treatment options.
“This is the first time that regulators and policymakers on the Hill will hear directly from patients and caregivers about what it is like to live with BOS, a disease that represents an incredibly high physical, the emotional and economic burden on patients, their caregivers, and the healthcare system,” said Amy Skiba, executive director of The Lung Transplant Foundation. “We believe that understanding the patient journey can help the FDA make more informed decisions as they review potential therapies for BOS and will assist pharmaceutical companies in the design of clinical trials for BOS patients.”
The June 22 Meeting will be a Livestream and will include patient testimonials, as well as remote audience participation (register here). The meeting agenda will focus on two patient panels and audience discussion sessions on living with BOS, treatments for the disease, and potential clinical trials for BOS. LTF encourages patients and caregivers impacted by or at risk of developing BOS to take a brief survey here. The anonymous information gathered will be used to help guide and inform content for this meeting as well as future LTF activities.
“While lung transplants give recipients a second chance of life, unfortunately, an estimated 50 percent of recipients will develop BOS five years post-transplant and be faced with no approved treatment options,”
said John Michael Reynolds, M.D., associate professor of pulmonary, allergy and critical care medicine at Duke University School Medicine.
“As clinicians, we applaud the LTF for leading the way for transplant patients who have already faced an incredibly long and arduous journey with lung disease and eagerly welcome new therapeutic options to help change a patient’s prognosis, should BOS occur.”
The burden of BOS on the healthcare system is significant. Double lung transplantation costs in the U.S. are estimated to be over $1 million.iii Meanwhile, the per-patient mean direct costs in the U.S. for treating lung transplant recipients with BOS exceed $150,000 in the year following diagnosis compared to transplant recipients without BOS.iv
LTF would like to thank our participating sponsors, Altavant Sciences, patientMpower, Zambon USA Ltd., and Mallinckrodt Pharmaceuticals for helping to make this event possible.
About The Lung Transplant Foundation:
The Lung Transplant Foundation (LTF) was founded as a non-profit organization by a group of lung transplant recipients from Durham and Chapel Hill, NC. Since 2009, we have raised funds and have been an advocate for lung transplant research. We also provide education and emotional support for transplant recipients and their caregivers through our Mentorship.
We can’t do it alone. We invite you to help us breathe life into lung transplant research by making a donation or learning more about how you can be involved.
Amy Skiba, Executive Director, LTF
M: +1 570-815-4243
Media Relations Contacts:
Elixir Health Public Relations
M: +1 862-596-1304
M: +1 917-567-7136
i Weigt, et al. Semin Respir Crit Care Med. 2013;34(3):336–351.
ii Chambers DC, et al. J Heart Lung Transplant. 2018;37(10):1169–1183.
iii Milliman Research Report. 2017.
iv Sacks, NC., et al. J Heart Lung Transplant; 2020;39(4):S364-365. doi.org/10.1016/j.healun.2020.01.446.
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.