- 3Daughters aims to uniquely address and fill major gaps in Women’s Health
- Assembles experienced Women’s Health team and World Class SAB to advance development of novel long-acting reversible contraception technology
Mansfield, MA., July 13, 2023 — 3Daughters, an emerging clinical development company fueling evolutionary healthcare for women, announces key senior leadership appointments and the formation of a Scientific Advisory Board (SAB) to support the development of its lead asset (3D-001), a highly innovative and frameless intrauterine device (IUD) for contraception.
Women’s Health and associated research remains highly underserved but represents a significant market opportunity for improved treatment options for women around the globe. 3Daughters’ mission is to usher in a new era of refined and innovative Women’s Health products starting with an elegantly designed self-assembling IUD technology. With a unique frameless uterine delivery platform, 3Daughters expects to transform the rapidly growing IUD market in the US and address the need for improved contraceptive options and potentially lower the number of unintended pregnancies.
Research shows that IUDs are one of the most effective forms of contraception and tend to be women’s preferred choice. However, IUD insertion pain is common, and many women describe it as ‘severe to excruciating’. The current T-shaped framed IUDs (five approved in the US) have arms and dangling strings needed for removal and this outdated design has not changed significantly since first entering the US market in 1988.
3Daughters has addressed IUD insertion pain with a frameless self-assembling technology that is expected to be easily inserted into the uterus with a uniquely designed i-Glider™ for insertion and a simple magnetic retriever (r-Glider™) completes the process for removal. Both the IUD technology and Glider (inserter/retriever) system are patented. This sophisticated solution will overcome the major barrier to IUD adoption and take away the ‘fear factor’ for practitioners and patients relating to IUD insertion pain.
3Daughters has assembled a highly experienced Women’s Health team to drive the development plan forward for its lead product candidate, 3D-001, to enter the clinic next year. These key leadership roles and appointments are:
Dr. Gary Shangold named Chief Medical Officer (CMO) – Brings over three decades of medical, scientific and executive experience as a reproductive endocrinologist. He has held roles as CMO of Enteris BioPharma and Xanodyne Pharmaceuticals, and CEO of NovaDel Pharma. Dr. Shangold previously held senior roles in clinical research and regulatory affairs at RW Johnson Pharmaceutical R&D (J&J) and as Medical Director for Ob/Gyn/Infertility at Serono Labs.
Dr. Mary Mahony named Chief Scientific Advisor (CSA) – Seasoned medical affairs veteran with almost four decades of experience in reproductive medicine and endocrinology. Most recently, she was EMD Serono’s Vice President of Fertility and Endocrinology leading the medical team for pharmaceutical products and IVF laboratory medical devices. Her research focus includes human sperm pre-fertilization capacitation events on the cellular level, and she has extensive publication and journal credits in this field.
Dr. William Bracken named Head of Toxicology – Brings extensive toxicology and preclinical experience regarding drug safety having held senior roles at AbbVie as Director of Global Preclinical Safety and Chair of the Drug Safety Committee. Dr. Bracken also conducted expansive research at Oak Ridge National Labs, Fred Hutchinson Cancer Research Center and the Midwest Research Institute focused on mechanisms of carcinogenicity.
In addition, the Company has engaged a group of eight Key Opinion Leaders (KOLs) in Women’s Health as members of its Scientific Advisory Board:
David F. Archer, MD, Chair, 3Daughters, Scientific Advisory Board Professor of Obstetrics and Gynecology & Director of the Clinical Research Center, Eastern Virginia Medical School
Chanelle Coble-Sadaphal, MD Chief, Division of Adolescent Medicine, NYU Grossman School of Medicine
Tara Kumaraswami, MD, MPH Associate Professor of Obstetrics and Gynecology, Associate Director, Ob/Gyn Residency Program, UMASS Chan Medical School
Siripanth Nippita, MD, MS Chief, Division of Family Planning and Clinical Associate Professor, NYU Grossman School of Medicine
Mary Lake Polan, MD, PhD, MPH Professor of Clinical Obstetrics, Gynecology, Reproductive Sciences, Yale University School of Medicine
David Turok, MD, MPH, FACOG Chief, Division of Family Planning & Associate Professor, Department of Obstetrics and Gynecology, University of Utah
James A. Simon, MD, CCD, NCMP, IF, FACOG Past President, The International Society for the Study of Women’s Sexual Health (ISSWSH) Clinical Professor of Obstetrics and Gynecology, George Washington University
Carolyn Westhoff, MD Professor of Obstetrics and Gynecology, Reproductive Health, Population, Family Health, and Epidemiology, Columbia University Editor, Contraception
Mary Beth Cicero, Co-Founder and CEO of 3Daughters, commented, “The 3Daughters story is rapidly progressing with our new highly-experienced Senior Leadership team. It is my privilege to work alongside Drs. Shangold, Mahony and Bracken who will bring their collective Women’s Health expertise to every aspect of our clinical development program and rapidly advance our product candidate through regulatory approval. Like me and my Co-Founder, Shelley Amster, they are determined to bring more innovation to Women’s Health and address problems like IUD insertion pain that has been difficult to solve and neglected.
“Also, we are extremely pleased to have the support and advice of a World-Class group of scientific thought leaders and clinicians as members of our Scientific Advisory Board who will help to provide the advice and guidance for our research and development efforts.”
Ms. Cicero added, “As we prepare to file our IND and complete our Phase 1 study next year, I am looking forward to the 3Daughters team delivering on our planned milestones. We are dedicated to Women’s Health and doing everything we can to bring innovation to this field, starting with our proprietary frameless IUD and Glider delivery system.”
Shelley Amster, Co-Founder and Chief Strategy and Growth Officer of 3Daughters stated “Women make up more than 50% of the global population, which means the target market for products focusing on their health is massive. Supporting innovation in female health doesn’t just benefit women, it helps everyone. Our primary mission at 3Daughters is to champion women and drive innovation and superior products that promote their health.”
Background on the 3DaughtersUterine Delivery Platform and IUD Solution
Invented at University of Massachusetts, Amherst by Dr. Carlos Gradil, a world renowned veterinary reproductive specialist, the 3Daughters frameless IUD is ‘simple, smart, and sophisticated’ based on physics and geometry. The patented magnetic technology self – assembles in the uterus into a stable triangular ‘ring’ conformation that adapts to the uterine environment. Dr. Gradil demonstrated the safety and contraceptive effectiveness of the selfassembling IUD technology in performance horses and this data has been published in peerreviewed journals. For more information on this trailblazing technology, visit the 3Daughters website: 3daughtershealth.com.
3Daughters is an emerging company focused on evolutionary healthcare for women where attention is desperately needed with cutting-edge research and innovation. The Company isdeveloping its lead product (3D-001), a frameless, magnetic, nonhormonal intrauterine device (IUD) for long-acting contraception, with a goal of radically transforming the IUD market byeliminating the major adoption barrier — insertion pain. This pain is associated with all current T-shape 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.
Mary Beth Cicero