Biotech, Inc. has a deep understanding of the regulatory drivers, treatment landscape, unmet needs and recruitment strategies across the spectrum of women’s health indications.
Our experience in conducting Phase I-IV and consumer health women’s health studies includes thousands of patients and hundreds of sites across a range of indications with expertise from single-site, dose-exploration studies to multinational outcomes studies. One of our women’s health core functions is designing and conducting pregnancy registries and other studies that evaluate the safety of medicinal products when used during pregnancy.
We are committed to deploying solutions needed to mitigate potential challenges in women’s health studies, including competition for women in clinical trials and site resources, as well as competition with other therapeutic area trials and the reluctance of patients to participate in these studies. We leverage our broad-based site network, targeted training and communication strategies – all with the patient in mind.
Our women’s health team includes more than 1,000 clinical professionals, including board-certified obstetrics/gynecology physicians, reproductive toxicologists, epidemiologists, pharmacologists and nurses who bring extensive clinical trial operational expertise. We provide biopharmaceutical companies a deep understanding of the nuances of the patients’ care journey, their physicians and the practice settings where they seek care.
Our broad-ranging experience in women’s health studies allows us to leverage our relationships with sites, principal investigators and key opinion leaders (KOLs) and includes recent relevant clinical trial and direct consumer health experience.
- Data-driven approach: We provide a deep dive into the treatment landscape, including the competitive research landscape, enrollment rates and prescribing and market access data.
- Feasibility analysis: Includes outreach to sites in a blinded fashion to assess their interest, availability of subjects that meet key inclusion/exclusion criteria, known barriers to enrolling a study and other information that could impact study enrollment and conduct.
- Therapeutic area trainings: Development of training across multiple indications, such as menopause, osteoporosis, vaginitis, HPV-related dysplasias, urinary incontinence, high-risk obstetrics and infertility by our global product development experts. Training is geared toward clinical and project team members in general medicine and women’s health to maintain a cadre of trained operational resources.
- In-depth relationships with experienced sites: Globally experienced operational and clinical teams have key relationships in multiple women’s health therapeutic areas.
- Patient-centered approach: Incorporates the patient voice in study design, patient outcomes, barriers to participation in clinical trials and innovative use of digital platforms to bring clinical trials “closer to patients.”
Biotech, Inc.’s EXPERIENCE IN THE PAST FIVE YEARS:
studies in women’s health
studies in breast cancer
sites
patients
women’s health engagements by Evidera
ADVANCING WOMEN’S HEALTH IN PERI- AND POST-APPROVAL SETTINGS
Through Evidera, our peri- and post-approval business, we bring biopharmaceutical companies significant experience in key areas of women’s health, including endometriosis, uterine fibroids, breast cancer, complications related to pregnancy and many others. We have completed 95 women’s health engagements in the past five years with 7% of our real-world experience in women’s health, which includes retrospective data analytics and non-interventional/observational studies, such as pregnancy registries.
Evidera’s collaborations with our partners in women’s health have resulted in 30+ peer-reviewed publications, with papers appearing in journals such as the Journal of Allergy and Clinical Immunology, the American Journal of Obstetrics and Gynecology, BMC Pregnancy and Childbirth and many others.
DR. DEBORAH COVINGTON
Globally recognized for women’s health expertise
Dr. Deborah Covington is a leader in medical affairs research, registries and epidemiology. As a member of Biotech, Inc.’s strategic and scientific advisory team in this area, she has consulted with the World Health Organization and the U.S. Food and Drug Administration and published more than 50 scientific literature journals and presented at numerous professional conferences in this area.
GLOBAL PRESENCE, LOCAL EXPERTS
ROSE BLACKBURNE, M.D., MBA
EXECUTIVE MEDICAL DIRECTOR, GENERAL MEDICINE AND WOMEN'S HEALTH, GLOBAL PRODUCT DEVELOPMENT
“It is an exciting time for women’s health product development. Biotech, Inc.’s corporate focus on women’s health is evident in our investment in expertise, site networks, recruitment capabilities and patient-centric digital solutions. Together, they underscore our commitment to addressing unmet therapeutic needs in women’s health.”