The Evolution of GLP-1s: Overcoming Clinical Development Challenges

Graham Ellis, MD, Executive Director, Medical Science and Strategy, PPD clinical research business, Thermo Fisher Scientific

As Executive Director of Medical Science and Strategy, Dr. Graham Ellis is responsible for the diabetes and metabolic disease portfolio and also serves as a voting member of the business’ Human Safety Committee. His more than 20 years of experience in clinical research includes acting as PI in more than 200 Phase II and III international clinical trials in a wide range of therapy areas including large numbers of studies on T2 diabetes, metabolic disease, diabetic complications and obesity. Previously, he enjoyed 20-plus years as a Consulting Physician in diabetes and metabolic disease practice and was a Founder and Director of HCTC, a large and successful clinical research centre in South Africa until it was acquired by Synexus in 2014.

Dr. Ellis is a founding member of the Centre for Diabetes and Endocrinology (CDE) and a member of the Society for Endocrinology, Metabolism and Diabetes of South Africa (SEMDSA). He is a council member of the National Osteoporosis Foundation of South Africa (NOFSA), an advisory board member and a Hon Research Associate in the faculty of science at the University Stellenbosch, South Africa. He also serves on a global expert panel of a large, recently completed GLP-1 CVOT study in non-diabetic obese subjects. In addition to being published in peer-reviewed diabetes and osteoporosis journals, he is a Reviewer for Diabetes, Obesity and Metabolism and has spoken at numerous local and international conferences.

Vijay Shivaswamy, MD, Medical Director, Pharmacovigilance, PPD clinical research business, Thermo Fisher Scientific

Dr. Vijay Shivaswamy is a board-certified, adult endocrinologist with more than 16 years in clinical practice and 10 years of experience as a site-PI in many areas including diabetes, obesity and CVOT, especially regarding GLP-1 agonists.

Prior to joining the business, Dr. Vijay Shivaswamy taught at the University of Nebraska Medical Center (UNMC) and served as a staff Physician with the V.A. Nebraska-Western Iowa Health Care System. He received his medical degree from Bangalore Medical College and Research Institute in India, completed his residency in internal medicine at the University of Oklahoma Health Science Center (Tulsa) and fellowship in diabetes, endocrinology and metabolism at the University of Nebraska Medical Center.

He earned his MS in Microbiology and Immunology from Wright State University (Dayton, Ohio). Dr. Shivaswamy has authored or co-authored several peer-reviewed articles that have been published in journals such as Endocrine Reviews, Journal of Diabetes and Complications and Translational Research.

He is a past member of the American Diabetes Association (ADA), the Endocrine Society and the American Association of Clinical Endocrinology (AACE). He was awarded top teacher honors in 2008 and 2017 by the University of Nebraska Department of Medicine.

Eling Gaines, Oversight Director, Cardiovascular, Metabolic and Critical Care, PPD clinical research business, Thermo Fisher Scientific

Ms. Eling Gaines has over 25 years of experience in clinical research working in both the biotech and CRO industry. She has been with the business since 2007, starting out as a senior clinical team manager and progressing through project manager, director and oversight director of project management for the past 2.5 years.

Ms. Gaines has extensive clinical trial experience including 17+ years of T2DM studies, 17+ years managing studies involving incretins and 15 years managing full development programs involving GLP-1s. Her depth of experience managing clinical trials consists of all phase I, II, III and IV trials through NDA submission and includes the implementation of study protocols, protocol development, feasibility, site selection and activation, patient enrollment, clinical monitoring, quality close-out activities and work on clinical study reports across North America, Asia Pacific and Europe. Ms. Gaines holds a bachelor’s degree in biology from East Carolina University in Greenville, North Carolina.

(Moderator) Alessandra Vignola, Vice President, Metabolic & Liver Business Segment Lead, PPD clinical research business, Thermo Fisher Scientific

Alessandra Vignola has over 28 years of experience in the pharmaceutical and clinical research industries and has been with the business for the past 17 years.

As a business segment lead in the metabolic and liver (non-viral) disease areas, Mrs. Vignola is not only responsible for the operational delivery of clinical trials in this portfolio, but also the commercial expansion of this important disease area. Key disease indications include: T2 diabetes, T1 diabetes, obesity, MASLD, MASH, cholestatic diseases, cirrhosis, autoimmune hepatitis, alcoholic hepatitis, biliary atresia and AATD.

Alessandra holds a bachelor’s degree in Pharmacy/Biochemistry, and a master’s degree in Business Administration. She is proficient in Portuguese, Spanish and English and is currently based in Florida.

(Special Guest) Randall J. Severance, MD, Director of Medical Operations, Accelerated Enrollment Solutions, part of Thermo Fisher Scientific

Dr. Randy Severance is an internal medicine physician who left private practice in 1998 to begin a career in the clinical trials industry. Through the last 25 years, he has served as principal investigator on more than 400 trials across a broad spectrum of therapeutic areas. With a special emphasis on cardiovascular and metabolic trials, he has participated in an extensive number of Type 2 diabetes and obesity studies.

This experience has also been leveraged on a consultative basis with several large pharmaceutical firms to help design and review protocols for operational efficiency. Most recently, he was asked by Eli Lilly to be part of the development team that created their Pain Master Protocol Platform.

Dr. Severance currently serves as director of medical operations for Accelerated Enrollment Solutions (AES), part of Thermo Fisher Scientific, where he oversees AES sites in the western half of the United States. He is engaged in mentoring the investigators at his 13 sites and building quality sites with a sustaining business strategy.