Now Available On Demand 

Robin Bliss, PhD

Vice President, Strategic Consulting, Veristat

Robin Bliss, PhD joined Veristat in 2011, and is currently Vice President, Strategic Consulting. In her role, Robin oversees and executes Strategic Clinical Development Consulting, collaborating with Regulatory Consulting, Clinical and Medical Consulting and Statistical Consulting. A statistician with 15+ years’ experience, Robin is skilled in planning and implementing complex study protocols, planning and executing study analysis, marketing applications, and providing statistical and strategy representation at regulatory agency meetings. Prior to joining Veristat, Robin worked with Brigham and Women’s Hospital Orthopedic and Arthritis Center for Outcomes Research and with Boston University School of Public Health Environmental Health Department. Robin earned her PhD and MA in Biostatistics from Boston University, US.

Debora Manning, MPH

Strategic Consulting Fellow, Biostatistician, Veristat

Debora Manning, Strategic Consulting Fellow and Biostatistician at Veristat, is a strategic contributor, providing consulting services on study-specific and global programs, including input towards clinical development plans, protocols, study design, biostatistical plans and analysis, and regulatory submissions, and offering expert guidance and support throughout a product’s lifecycle. Her wide-ranging therapeutic expertise includes oncology, neurological disorders, immunodeficiency disorders, and rare diseases. Debora has played pivotal roles in leading interactions with regulators and developing successful marketing applications (NDA, BLA, MAA). Debora received her BA in mathematics from Wheaton College (MA), her MPH in biostatistics from Boston University School of Public Health, and her graduate certificate in regulatory affairs and health policy from the Massachusetts College of Pharmacy and Health Sciences.

Toni Marie Nearing, BS

Principal Regulatory Strategist, Veristat

Ms. Nearing’s career spans over 30 years of regulatory experience: sixteen and a half (16.5) years as Senior Director in Global Regulatory Affairs within global CROs, 13 years at the FDA in regulatory affairs and legislative policy, primarily with the Center for Drug Evaluation and Research, and five (5) years of Industry experience as Director of Regulatory Affairs in mid-size and large pharma. A key focus of her efforts has been the development of regulatory strategy from proof of concept through successful product registration, launch, and lifecycle management. This has resulted in a successful registration track record, including 505(b)(1) and 505(b)(2) applications and a biologics marketing application. 
Toni Marie has been involved in pre-and post-marketing global strategies across numerous therapeutic areas such as (but not limited to):  Oncology, Dermatology, Antivirals, Antidepressants and Antipsychotics.  She holds a Bachelor of Sciences degree from the University of Maryland, College Park, and has received numerous awards at FDA and in the Industry.