Five adjunct faculty members have joined the Regulatory Affairs Program at the George Washington University (GW) School of Medicine and Health Sciences (SMHS).
In announcing the new faculty members, Melissa Tice, PhD, director of the program and assistant professor at SMHS, said their addition is part of a plan to strengthen the program. That plan includes revising course materials to reflect evolving regulatory affairs procedures and taking advantage of GW's location to provide student internships and fellowships at government agencies and pharmaceutical companies in the area.
GW Health Sciences' Department of Clinical Research and Leadership (CRL) offers two degrees in regulatory affairs: a master's degree and a graduate certificate, both of which are available online. The GW programs have been developed through collaborations with regulatory affairs professionals from the health care industry and governmental agencies.
"As regulatory science and regulations evolve in support of the development of next-generation innovative therapies and devices for patients, there is an increasing need for well-trained regulatory affairs professionals to guide teams on the correct path for drug and device approvals," Tice said. "We are excited to welcome five new faculty members who bring considerable knowledge and industry experience to our program. This is an exciting time to work in regulatory affairs." Tice says that the increase in communication and coordination of regulations across the global community will lead to growth of regulatory affairs career paths and increase opportunities.
The five new adjunct faculty members are:
--Robin McGarry, MD
Dr. McGarry joins GW Health Sciences as an adjunct associate professor in CRL. She is a board-certified internist and nephrologist with more than 30 years of experience in the pharmaceutical industry. Currently, she is an independent clinical and regulatory consultant. Dr. McGarry has held positions in both large and small pharmaceutical companies including Immunomedics, Inc., Astellas Pharma, Inc., Pfizer, Inc., Zambon Corp., Ciba-Geigy Corp. (now Novartis), and ICI Pharmaceuticals (now Astra-Zeneca). These positions included senior leadership/functional and line management of global pharmacovigilance organizations, medical affairs and clinical development groups, and matrix management of multidisciplinary groups for product development teams and special projects. As vice president of worldwide safety at Pfizer, she led and managed extensive restructuring, process reengineering, and rapid expansion of a large pharmacovigilance organization. As head of global medical safety at Astellas, she designed and implemented a new global medical safety organization. Most recently, she built a new drug safety and pharmacovigilance department for Immunomedics. Throughout her career, she has collaborated closely with regulatory affairs groups, contributing to regulatory strategic approaches, based on her experience across various pharmaceutical functions and in-depth knowledge of global health authority regulations and requirements. Dr. McGarry has experience teaching in the pharmaceutical industry, including developing and conducting workshops and lectures for various clinical development, medical, pharmacovigilance, and regulatory topics. She earned her MD from the University of Medicine and Dentistry of New Jersey-New Jersey Medical School.
--Victoria Demby, PhD
Demby joins GW Health Sciences as an adjunct assistant professor in CRL. She is an executive director and team lead in the Global Regulatory Affairs, Oncology Department at GlaxoSmithKline (GSK) in Collegeville, Pennsylvania. She is an experienced regulatory affairs professional who has held roles of increasing responsibility in various therapeutic areas. Before joining GSK, she was a global regulatory lead at Merck & Co., Inc., responsible for several Keytruda® indications; obtaining approvals for unresectable malignant melanoma in Japan; the first approval in China, and the first adjuvant indication in the United States, European Union, Australia, and Japan; and accelerated approval of Merkel cell carcinoma in the United States. Demby brings a unique perspective to the program, sharing her experiences and knowledge of the global regulatory community and steps taken in various countries to ensure access to safe and effective drugs. She leads the newly launched regulatory sciences community with the American Association of Pharmaceutical Sciences. She has previously taught at the University of Maryland, Baltimore. She has a PhD from the University of Kansas.
--Lou Ann Eader, PhD
Eader joins GW Health Sciences as an adjunct assistant professor in CRL. She has been working in the pharmaceutical industry since 1991 and has been with Merck & Co., Inc. since 1997. At Merck, Eader has worked on early and late development programs in a variety of therapeutic areas --immunology/anti-inflammatory, central nervous system, oncology, diabetes, and metabolic disorders. She has lead teams in health authority engagement and obtained global marketing licenses for a variety of products. Before joining Merck, she worked in regulatory affairs with Proctor and Gamble, Inc. Other experience includes working in both research and regulatory affairs with Sigma Tau Pharmaceuticals and with the Frederick Cancer Research Center in Experimental Immunology. She has held adjunct faculty appointments at Hood College and Marymount University. Eader has a PhD from Johns Hopkins University.
--Iris Gibbs, JD
Gibbs, president and founder of Gibbs Pharma Solutions, a pharmaceutical advertising and promotion training company, joins GW Health Sciences as an adjunct assistant professor in CRL. She is partner, general counsel, and chief regulatory officer for NG Medical Solutions, a personal protective equipment delivery firm, and oversees regulatory affairs, advertising and promotion, labeling, regulatory intelligence and government affairs at Karyopharm Therapeutics in Newton, Massachusetts. Gibbs has more than 20 years of experience advising executive leadership across multiple regulatory functions with global pharmaceutical and medical device organizations. She has trained third parties and employees on federal regulations for pharmaceutical drug and medical device advertising and promotion. She earned her JD from Atlanta's John Marshall Law School.
--Joseph Lamendola, PhD
Lamendola joins GW Health Sciences as an adjunct assistant professor in CRL. He is a senior strategic advisor in drug development to the pharmaceutical Industry. He is senior vice president and principal of the Regulatory Center of Excellence for Your Encore and president of JF Lamendola Consulting, LLC., where he advises pharmaceutical companies. Lamendola has held key executive positions, including vice president of U.S. regulatory affairs at Schering Plough and vice president of U.S. regulatory science and regulatory intelligence/policy at Bristol Myers Squibb (BMS). He was responsible for developing BMS's U.S. regulatory organization which provided strategic direction for drug development in the United States. In addition, he has led efforts that have resulted in the approval of more than 30 non-disclosure agreements in more than 10 different therapeutic areas. His experiences span new chemical entities, 505B2 applications, and Orphan Drugs. Lamendola has a PhD from Drexel University.