Fit-for-purpose matchmaking: A data selection and RWE approach for both regulatory and HTA audiences

This webinar will review considerations for the design and data selection for RWE studies, including external control arm studies, to meet regulatory and HTA needs.

Regulators and agencies responsible for market authorization and health technology assessment (HTA) are increasingly using real-world evidence (RWE) to enhance their decision-making. Life sciences companies must ensure that data utilized for RWE generation is considered fit-for-purpose.

Focusing on an external control arm (ECA) use case, we will share lessons learned highlighting the advantages of a data-agnostic approach to data selection, understanding regulatory and HTA expectations, and obtaining diverse stakeholder insights. The audience will gain appreciation for considering multiple perspectives, including regulators, HTAs and payers, when evaluating data and planning for RWE submissions.

Of interest to all those interested in: pharmacoepidemiology, RWE, market access, manufacturers, biotech, data vendors.

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What you will learn:

Appreciate challenges and opportunities related to meeting diverse regulatory and HTA RWE needs and expectations.
Understand how to systematically evaluate RWD sources to meet different regulatory, HTA and payer expectations for various uses, including external control arms.
Learn how to design RWE studies to meet regulatory and HTA needs with relevant evidence synthesis, stakeholder insights, and other means.

Speakers:

Allie Sosinsky
Director, Pharmacoepidemiology and Safety, Genesis Research Group

Alexandra (Allie) Sosinsky designs and implements observational research studies using secondary databases to support regulatory evidence generation needs. She is a trained pharmacoepidemiologist with over 12 years of experience leading label expansion, external comparator arm, natural history, and post-authorization studies. Allie received her ScM in Epidemiology and Maternal Child Health from the Harvard T.H. Chan School of Public Health, and previously held positions at the Brigham and Women's Hospital Division of Pharmacoepidemiology and the Massachusetts General Hospital Center for Women's Mental Health.

Carole Longson
Professor and Independent Senior Advisor

Carole is a respected leader in health technology assessment with considerable achievements in research, public and private sectors. She has unparalleled insight into the health technology innovation pipeline having pioneered the development of NICE’s health technology evaluation programs. After a career in drug discovery at GSK, Carole was an Executive Director at NICE from 2000 to 2018 and Chief Scientific Officer at the Association of the British Pharmaceutical Industry from 2018 to 2020. She was formerly President of Health Technology Assessment International and now is an independent advisor including Life Science Advisor at NICE.

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