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Vice President, Worldwide Policy and Public Affairs
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At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care produc... more.
PR Summit - The Organization for Public Relations Leaders
Pfizer, David Verbraska, VP of Worldwide Policy & Public Affair
PR Best Practices Roundtable
Pfizer, David Verbraska, VP Worldwide Public Affair
Pharma Exec Blog » Meetings
Panel moderator David Verbraska, Vice President for Regulatory Policy and Intelligence at Pfizer, noted the FDA stood at an â€œinflection pointâ€� in transitioning from simply engaging with patient groups to demonstrating how patient needs and outcomes rest at the center of drug review, based on clear metrics understood by all.
As FDA tries to work out the finer points of the law, Pfizer relies on a simple metric in advancing the patient perspective. â€œOur goal is to innovate in bringing new therapies to patients that significantly improve their lives. We leave it to each patient to define what â€˜significantlyâ€™ means, based on their own unique experience â€" it could be in helping to establish the right endpoints in a trial or shaping a post-marketing approval study that tracks safety and side-effect profiles.â€� Panel moderator David Verbraska, Vice President for Regulatory Policy and Intelligence at Pfizer. Panel moderator David Verbraska, Vice President for Regulatory Policy and Intelligence at Pfizer. At the FDA, however, engagement with the patient is still more of an experiment, with highly variable expectations coming from each side â€" and industry is often caught in the middle. â€œPatient groups will say they desire more contact, or that things are not moving fast enough at the FDA for them. We then have to ask what level of involvement do you want, and to what end?â€� No one yet has a definitive response to these questions.â€� Instead of having to constantly reframe the discussion, Verbraska says what the industry needs is a clearly articulated pathway to collaborate with patient groups in informing and shaping decisions on market authorizations from the FDA. The panel â€" which included, in addition to Verbraska, Andrew Emmett, Managing Director for Scientific and Regulatory Affairs at BIO; Marc Boutin, Chief Operating Officer of the National Health Council, and Kimberly McCleary, Director of Strategic Initiatives at Faster Cures â€" suggested a number of improvements to the â€œVoice of the Patientâ€� process, as follows:
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Representing the other side of the coin, David Verbraska, Pfizer's vp, regulatory policy, said, "Should FDA choose to mandate public disclosure of investigator financial information, Pfizer recommends that the agency not require listing of specific payments or dollar amounts.
David Verbraska, IFPMA Regulatory Policy and Technical Standards Committee member Vice President, Worldwide Regulatory Policy and Intelligence, Pfizer