Navigating Multi-Sponsor Registries: The Journey to Success

Bill Row, MBA, MS, Vice President, Late Phase, INC Research

Bill Row interacts with senior management, customers, business development, and project teams to coordinate Late Phase Operations providing strategic direction, scientific consulting, and executive oversight. Mr. Row is a recognized leader in the design, operational strategy, and commercial applications of late phase studies with nearly two decades experience at both Pharma and CRO. He has held leadership roles in Clinical Operations, Project Management, and Strategy/Innovation spanning all phases of clinical development. Over the last 10 years, Mr. Row has held Executive Management roles exclusively in the Late Phase, real-world research environment with expertise in strategy and implementation of non-interventional, epidemiological, outcomes, HEOR, peri-approval, and market access programs.

According to Bill, “Late Phase and real-world research is extremely complex and requires a great deal of experience to get it right. We’re working with sponsors, regulatory authorities, health care providers, and patients to provide insight into key drivers of disease, treatment and safety measures that exist in the general population. Application of real world evidence has applications across all phases of development, and the stakeholders are demanding more of this insight at every stage of development. I am passionate about collaborating with our customers to provide the most cutting edge, efficient, fit-for-purpose approach to real world data generation.”

Mr. Row holds a BA in Experimental Psychology from Purdue University, a MBA from Xavier University, and a MS in Pharmaceutical Science from the University of Cincinnati. He is located at INC Corporate Headquarters in Raleigh, North Carolina, USA.

Dr. Jessica Albano, PhD, MPH, Senior Director, Epidemiology, INC Research

Dr. Albano has more than eight years experience in a clinical research organization (CRO) as an epidemiologist with Phase IV and observational/non-interventional studies. Jessica Albano also has 5 years experience as an epidemiologist with the American Cancer Society and conducting research in an academic setting. Her areas of expertise include design and implementation of observational epidemiologic studies, statistical analysis and results interpretation, conducting literature reviews, and authoring publications. Additional skills include the application of surveillance data from public use data bases including census and vital statistics data and medical claims data to study design, feasibility, and aggregate safety reports.

She has served as Principle Investigator providing scientific oversight for a number of longitudinal observational studies and has been an invited speaker at the NIH on global patient registries and the FDA on pregnancy exposure registries. She actively participates with the International Society of Pharmacoepidemiology (ISPE) and the International Society of Pharmacoeconomics and Outcomes Research (ISPOR).

Dr. Susan Sinclair, PhD, MPH, Associate Professor, UNCW College of Health and Human Services, and Sr. Advisor, INC Research

Dr. Sinclair is an epidemiologist with 25 years of experience in public health epidemiology and pharmacoepidemiology with a primary focus on medication safety during pregnancy and birth defects. Dr. Sinclair has participated in numerous observational studies and clinical trials over the past 17 years and is currently an associate professor at the University of North Carolina Wilmington. She worked in several roles in the clinical research industry at another CRO (1998-2004) and INC Research (2004-2006); and has served as a Senior Advisor to INC Research for 10 years (2006-present). Dr. Sinclair is a consultant to the Food and Drug Administration’s (FDA) Drug Safety and Risk Management Advisory Committee and has authored over 60 peer-reviewed published articles and abstracts. Dr. Sinclair was an Epidemic Intelligence Officer for the Centers for Disease Control and Prevention (CDC) from 1996 through 1998 and earned the rank of Lieutenant Commander in the US Public Health Service. Prior to completing her master’s and doctoral degrees in public health, she worked as a critical care nurse at Duke University Medical Center (Durham, NC) and Memorial Sloan Kettering Cancer Center (New York, NY).