Our REMS experts
Given the inevitability of more frequent FDA requirement of risk evaluation and mitigation strategies prior to drug marketing approval, we checked in with REMS experts about the early stages of risk strategy development. We asked, what are the top three things that a risk strategist should do before starting to prepare a REMS program as part of an FDA submission?
Our experts come from two consultancies and a contract research organization. They were chosen based on the depth of REMS experience at their companies, and because of their outspokenness on REMS topics.
Annette Horner is senior director for clinical compliance at Compliance Implementation Services in Media, PA. CIS is a strategy consultancy with expertise spanning global clinical R&D through U.S. commercial compliance and government programs.
Jeffrey Fetterman is president and CEO at ParagonRx, a Wilmington, DE, consultancy for pharmaceutical product risk assessment and REMS design and implementation.
Frank Gallo is executive director for risk management at Pharmaceutical Product Development (PPD), a large contract research organization in Wilmington, NC.
There are, of course, many other well qualified REMS experts, from consultancies, regulatory bodies, contract service providers and drugmakers. Our choice of consultancies and a CRO as the voice in this report stems from our desire to provide a REMS perspective that is informed by both the regulatory and manufacturing sides.
Following are what Horner, Fetterman and Gallo advise risk strategists at the outset of a REMS project. We present their answers in the order (first, second, third) they submitted them.
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