3Daughters to Lead Panel at BIO International Convention on Patient Reported Outcomes that Includes FDA Division Director
Dr. Christina Chang, FDA Director of the Division of Urology, Obstetrics and Gynecology to Join Panel Discussing Patient Reported Outcomes through the Lens of IUD Insertion Pain
BOSTON, June 16, 2025 (GLOBE NEWSWIRE) -- 3Daughters, Inc., a clinical development company fueling revolutionary healthcare for women, is proud to announce its founder and CEO, Mary Beth Cicero, will moderate a breakout session at this week’s annual BIO International Convention in Boston entitled: “Patient-Reported Outcomes are Front and Center for Drug Development and with the FDA and the CDC.” Dr. Christina Chang, FDA Director of the Division of Urology, Obstetrics and Gynecology will join the panel, which is scheduled for Tuesday, June 17th at 11:00 AM Room 254B at the Boston Convention Center.
The session, selected by BIO out of 250 applications, will focus on the questions of how to identify and address patient concerns, how they can change medical practice, and how to build patient-reported outcomes into a clinical development program. 3Daughters is addressing IUD insertion pain with a novel nonhormonal frameless intrauterine delivery platform (IUD) that conforms to a women’s body and is combined with a Slider™ (inserter/retriever) to eliminate steps, pain and strings. The panel will elaborate on the case study of IUD insertion pain from a patient and physician perspective as well as comments from the FDA and a leading CRO, Parexel.
Women on social media have been speaking out about IUD insertion pain, describing the procedure as “the worst pain imaginable” or saying they “almost passed out.” Duke University researchers reviewed the top 100 TikTok videos and found that almost all (96.8%) highlighted pain and some (27.6%) mentioned distrust of health care professionals. These videos have received over 1.4 billion views. This public outcry from women has led to updated practice guidelines on IUD insertion pain from the CDC and most recently, the American College of Obstetricians and Gynecologists (ACOG). 3Daughters is building patient-reported outcomes into their development program and is intent on delivering ‘the best IUD experience’ for women.
Joining Mary Beth will be four distinguished speakers, including:
- Christina Chang, MD, MPH - Director, Division of Urology, Obstetrics and Gynecology, U.S. Food and Drug Administration;
- Nancy Kivel, MD - Senior Vice President, Global Health General Medicine and Section Head Women's Health for Parexel International;
- Aaron Lazorwitz, MD, PhD - Assistant Professor, Div. of Complex Family Planning & Reproductive Sciences, Yale University School of Medicine; and
- Kelsey Craig – A patient advocate and recent graduate of Bridgewater State University with a B.S. in health studies who experienced significant IUD pain and passed out.
In addition, 3Daughters has been selected by BIO as an emerging company finalist to present at its annual Start-Up Stadium on Wednesday June 18th 2:00 to 2:10 pm in the North Lobby as part of the reproductive/sexual health therapeutic focus area. Start-Up Stadium is designed to provide companies with the opportunity to engage key members of the investment community, venture philanthropy groups, strategic partners, and non-dilutive capital at the world’s largest biotechnology partnering event.
3Daughters expects to disrupt the $1.5 billion U.S. IUD market with a truly innovative integrated IUD system to meet women’s needs and address pain and everything women dislike about the outdated plastic-T-shaped IUDs. The company’s frameless nonhormonal IUD is designed to conform to a woman’s body and is combined with a Slider™ (inserter/retriever) as part of an integrated system that is completing preclinical development with an IND filing expected this year. 3Daughters is raising a Series A of $15M to fund the clinical trials, scheduled to start next year.
About 3Daughters™
3Daughters is a clinical development company focused on revolutionary healthcare for women where cutting-edge research and innovation is desperately needed. The Company’s technology platform is based on physics and geometry to deliver targeted drug therapy to the uterus. The first product, 3D-001, is a frameless, magnetic, nonhormonal IUD for long-acting contraception that conforms to a woman’s body and is combined with our unique, patented Slider™ system (inserter/retriever) designed to eliminate steps and pain points as well as the nuisance factor of strings needed for removal of current IUDs. 3Daughters’ vision is to solve health issues for women, particularly significant and neglected problems, like IUD pain. 3Daughters plans to radically disrupt the IUD market by addressing the major adoption barrier — insertion (and retrieval) pain. This pain is associated with all outdated rigid, plastic T-shaped framed IUDs on the market and prevents women from selecting one of the most effective forms of birth control.
Visit 3daughtershealth.com for more information.
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