Скачать или смотреть Tips for Submitting Drug Proposals to the FDA | Ashley Preston

In this episode of @darshantalks, we discuss Global Regulatory Leadership with guest Ashley Preston. #AshleyPreston, SVP of Regulatory Affairs, Quality and Operational Excellence at Syros Pharmaceuticals (https://www.syros.com/), explains how to engage with the FDA if a pharma company needs to get a particular #drug approved. It is essential to plan out what you're going to say to the #FDA well in advance. Engaging early, frequently, and reasonably helps you stand out among the other requests the FDA has. The meetings with FDA are not to tick off something in your to-do list. Instead of having the forum for namesake, use the time you're given to achieve a specific outcome and have the data available to justify your position. Gain the maximum benefit from engagement by asking whether they agree with your proposals and align meeting around the time all the relevant data is collected, not the other way around. A pre-"ind" meeting to clear doubts with FDA about expected results can be conducted after drug candidate and their activities in non-clinical studies are identified. Enabling "Ind" GOP talk studies can be used to file this practice meeting; otherwise, the FDA will ask these questions in the end meeting, which causes more lag time. It is required for drug development companies to remember that they are the ones who need to complete their targets of releasing the drug onto the market, so they need to act efficiently and not wait for the FDA. When it comes to the protocol for these kinds of conferences, his company first looks at the preliminary responses from FDA and hone in on the questions they want to address using experts in those areas of core content. They look at available data to provide inputs as the topic comes up for discussion, suggest options and look for alternatives. The role of regulatory affairs is to facilitate and manage conversations from a regulatory perspective. They need to get what they need to move and execute the desired strategy. Drug development relies on SMEs to provide content, drafts for submissions or proposals for meetings, synthesise data and craft a persuasive narrative for drugs. He concludes by highlighting key leadership facets such as communication and listening. There needs to be a mentality that the FDA is not the enemy but trying to make sure people get access to quality and safe medicines that even the employees of these companies would use if they were sick.

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1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact.
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