Atul MahableshwarkarDr. Atul Mahableshwarkar is the Senior Vice President of Drug Development at Emalex Biosciences. He is a trained psychiatrist who began his career in clinical practice and academia. Since joining the pharmaceutical industry, he has had the opportunity to learn from both successes and failures in his clinical trial work at companies of all sizes.Atul shares that early in his career, he was more interested in research than methodology. He credits his colleagues at the time with opening his eyes to the fact that incorrect operations can sink an otherwise viable product. The interest in methodology that that understanding sparked has shaped his career over the last 15-20 years.Episode HighlightsThe pivotal role of strong methodology in allowing good products to succeedAtul’s advice for others beginning to design clinical trialsWhat he sees as the greatest challenges clinical trials have in commonHow teams can help motivate clinical trial participationWhere standard concepts of patient-centricity may be lackingHow collaboration can help minimize mistakesThe Orphan Drug and Fast Track designations Emalex has earned from the FDA, and how other organizations can pursue Orphan Drug statusHow the pandemic nearly tripled Emalex’s enrollmentThe importance of supporting sites that may feel threatened by decentralized clinical trialsThe pandemic-enforced recruitment practices he plans to continueKey considerations in choosing a preferred ratings scale, and what his isRater training as a misnomer that needs revisingHow to assess and manage raters appropriatelyThe value of monitoring data and communicating insights to stakeholders in real timeLinkshttps://www.linkedin.com/in/atul-mahableshwarkar-07772338/https://emalexbiosciences.com/https://isctm.orghttps://cnssummit.org