Speakers:
Nicolle Gatto, PhD, MPH
Chief Science Officer, Aetion
Nicolle is an epidemiologist with more than 20 years of industry experience. She serves as a senior scientific voice ensuring appropriate and principled use of real-world data and real-world evidence, designing and communicating scientific frameworks, standards, and methodologies, and collaborating with stakeholders globally.
Before Aetion, Nicolle was the Group Head for Vaccines and Oncology with the Epidemiology Group at Pfizer, providing strategic leadership, oversight of comprehensive epidemiology strategies to examine the safety of medicines, consultation on design of pragmatic trials and hybrid studies, and expertise on methods-related epidemiologic issues. She has designed and implemented primary and secondary data collection observational studies and pragmatic trials and has presented to and negotiated these studies with FDA and EMA. Nicolle is Fellow of the International Society for Pharmacoepidemiology and an Adjunct Assistant Professor of Epidemiology at Columbia University and Tulane, teaching pharmacoepidemiology, causal inference, and confounding control methods courses.
Ulka Campbell, PhD, MPH
Head of Scientific Strategy, Aetion
Ulka Campbell is the Head of Scientific Strategy at Aetion. In this role, she provides methodological and regulatory expertise on studies across therapeutic areas and leads research to inform regulatory real-world evidence best practices. Previously, she was at Pfizer for 14 years working in the regulatory epidemiology group and later as the Head of Safety Surveillance Research at Pfizer.
Nicholaas (Nick) Honig, JD
Senior Regulatory Counsel, Aetion
Nicholaas Honig is a Senior Regulatory Counsel at Aetion. In this role he advises clients on regulatory approaches involving real-world evidence and analyzes FDA approval decisions to understand real-world evidence precedent. Prior to joining Aetion, Nicholaas worked at Pfizer in the company's Chief Business Office. He also has practical experience with FDA's Office of Chief Counsel and the Massachusetts General Assembly's Joint Committee on Healthcare Financing.
Moderator:
Laura Dormer
Editor, The Evidence Base
Editor in Chief, Journal of Comparative Effectiveness Research
Editorial Director, Becaris Publishing