Early last month, Integrium launched its expansion into the dermatology therapeutic area. Dr. Mary Spellman, dermatology drug development expert, will lead Integrium’s Dermatology Clinical Research Group.
The company’s new Dermatology Clinical Research Group will help its clients design studies, leverage its relationships with investigators to help identify and recruit study patients, and effectively manage their studies.
“Selecting the right CRO partner is critical to our success,” said Dr. Sharon Levy, Senior Vice President of Product Development for Graceway Pharmaceuticals, a firm focused on developing branded prescription products for the dermatology and women’s health therapeutic areas. “We selected Integrium not only for their scientific and clinical trial expertise, but for their experience in studies of topical therapies. They have helped us complete enrollment and lock the study database ahead of schedule for a multi-center Phase 2 trial.”
Dr. Spellman is a board-certified dermatologist with 20 years of experience in clinical research and drug and medical device development. Dr. Spellman has helped to achieve US FDA and ex-US approvals for multiple topical, systemic, and biological drugs, as well as dermatological devices and vaccines, and has served as a medical and safety officer, and nonclinical and clinical development and regulatory strategist to biopharmaceutical and device companies. In addition to working with Integrium, Dr. Spellman maintains a pharmaceutical and medical device consulting practice.
Before Integrium, Dr. Spellman served as Chief Medical Officer at Revance Therapeutics, where she was responsible for the development of novel topical therapies for aesthetic and medical dermatology indications. Before that she held senior roles at Biogen Idec, Inc., Connetics Corporation (now Stiefel Laboratories, Inc., a GlaxoSmithKline company) and Novartis Pharmaceuticals. Before entering the biopharmaceutical industry, Dr. Spellman was an Assistant Professor of Medicine (Dermatology) and Director of Dermatology Clinical Research at the University of California, San Diego School of Medicine and Medical Center, and an attending physician at the Veterans Affairs Medical Center in San Diego. After earning her medical degree from the Medical College of Wisconsin, she completed an internship in Internal Medicine Residency at Northwestern University McGaw Medical Center and a Dermatology Residency at the Medical College of Wisconsin Affiliated Hospitals. She is a member of the Board of Directors of the Women’s Dermatologic Society and the Editorial Board of the Journal of the American Academy of Dermatology.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.