Neurodegenerative Disease Research: Steps to a Successful Clinical Trial

Anne-Marie Nagy, Ph.D., Executive Director, Strategic Development, Neuroscience, Premier Research

Dr. Anne-Marie Nagy is an Executive Director in Strategic Development Department with Neuroscience focus. Previously, she has worked in Academia, Pharmaceutical and CRO sectors in various Clinical Development and Project Management positions at SMB Laboratories, Lilly, PPD and most recently as Therapeutic Strategy Lead in Psychiatry at Quintiles.

Dr. Nagy has more than 20 years’ experience in preclinical and clinical research, managing clinical trials /program deliveries across NA, EMEA, ASIAPAC and LA and all phases (I, IIa/b, III, IIIb, and IV) as well as providing operational and therapeutic strategies to proposals in Neurosciences including schizophrenia, MDD, BPD, adult and pediatric ADHD, Anxiety, Substance Dependency, Binge Eating Disorders, Multiple Sclerosis, Epilepsy, Cervical Dystonia.

Dr. Nagy received her doctorate degree in Biomedical Sciences with the highest mention from the Faculty of Medicine of the Free University of Brussels, Belgium. She is certified by Barnett Good Clinical Practice and received from the Belgian Government the “Research Associate Status.” During her academic path, Dr. Nagy received awards from Jean de Meyer Foundation from the Royal Academy of Sciences, Letters and Arts of Belgium and the Vesale Foundation from the Saint-Pierre Hospital University of Brussels.

Carol M. Gaines, M.D., Senior Medical Director, Premier Research

Dr. Carol M. Gaines has worked in clinical research for more than 15 years, more than 15 years of experience in a clinical practice setting focused on general neurology, five peer-reviewed publications, more than 300 protocols reviewed for study proposal and design, and executed clinical trials in phases 1-4. She has developed drugs, biologics and devices across general medicine and neuroscience indications including, multiple sclerosis, Alzheimer’s disease Parkinson’s disease, amyotrophic lateral sclerosis, epilepsy, acute and neuropathic pain. Her experience includes translating compounds to the clinic and Pre-IND discussions with FDA, clinical development planning and strategy, lifecycle management, medical monitoring, safety data review, report writing and publication.

Dr. Gaines began her career developing products for the Pharmaceutical industry as a staff physician at another CRO with a focus on phase 1-2 central nervous system (CNS) studies, adding shortly after to her responsibilities as a medical director overseeing clinical trials at Abbott Labs and EMD Serono (Merck KgA), and more recently phase 1- 3b/4 trials, post hoc exploratory analysis, and life cycle management.

Dr. Gaines has designed phase 1-4 interventional and non-interventional studies. She has supported the Health Economics and Outcome Research team, marketing and commercial teams. She was lead for US medical information, MSL and field strategy and payer strategy. She has held positions in drug and device development in Medical Affairs, focusing on neurodegenerative diseases and CNS broadly, but also supported rheumatology and oncology in the US. In her role in various drug development and medical affairs teams, she focused on early to late stage life-cycle management strategies within US clinical development programs. She was responsible for key areas such as launch and post-launch activities, expert development, advisory boards, medical/scientific education, medical communication strategy, and US business development strategy.

Dr. Gaines is seasoned in GCP, regulatory and compliance in the design, execution and delivery of quality data for early clinical drug development, proof of concept, registration trials and post market strategy. She practiced neurology, having completed her training at the Medical College of Wisconsin from 1978-1986 and began work in the Pharmaceutical industry in 2000.

Todd Leathers, MBA, Executive Director, Strategic Development, Neuroscience, Premier Research

Todd Leathers’ clinical research experience spans more than 20 years in the Pharmaceutical industry in positions of increasing responsibility and leadership capabilities. As Executive Director, Strategic Development, CNS, Mr. Leathers is responsible for providing the strategic planning, coordination, knowledge and expertise within the CNS therapeutic area for projects and standalone consultative services. His role supports the operational execution teams and Business Development with regard to designing effective and efficient clinical trials/programs bringing specific regulatory, medical/scientific and operational knowledge in the CNS space.

Prior to joining Premier, Mr. Leathers served as the Senior Director, Strategic Solutions at Acurian, a global patient enrollment and retention provider. He provided leadership and tactical guidance to a team of Business Development Directors and led discussions and interactions with Pharmaceutical sponsors related to strategic utilization of patient recruitment and retention services. Prior to Acurian, He spent more than 12 years at AstraZeneca in various roles of increasing responsibility, most recently as Senior Director, Clinical Development. In this role, he had overall accountability for the delivery of clinical development opportunities. He led global, cross-functional teams responsible for delivering the clinical components of a development compound from Phase I through submission activities and lifecycle management.

Mr. Leathers has worked across all phases of clinical development, from Phase I through Phase IV, and in many therapeutic areas with special focus in CNS, GI, pediatrics, infection, and respiratory. He worked extensively on megabrands such as Nexium®, Sustiva®, Seroquel® and Seroquel XR®, delivering on the pediatric indications for Nexium® and the sNDA for adjunct depression with Seroquel XR®. Mr. Leathers earned an MBA with emphasis in Management and Leadership from the Lebow College of Business, Drexel University. He also holds a BA in Chemistry, from Lycoming College.