Dr. 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 Highlights
The pivotal role of strong methodology in allowing good products to succeed
Atul’s advice for others beginning to design clinical trials
What he sees as the greatest challenges clinical trials have in common
How teams can help motivate clinical trial participation
Where standard concepts of patient-centricity may be lacking
How collaboration can help minimize mistakes
The Orphan Drug and Fast Track designations Emalex has earned from the FDA, and how other organizations can pursue Orphan Drug status
How the pandemic nearly tripled Emalex’s enrollment
The importance of supporting sites that may feel threatened by decentralized clinical trials
The pandemic-enforced recruitment practices he plans to continue
Key considerations in choosing a preferred ratings scale, and what his is
Rater training as a misnomer that needs revising
How to assess and manage raters appropriately
The value of monitoring data and communicating insights to stakeholders in real time
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