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The Startup's Guide to Setting Up Cell Therapy Manufacturing: Navigating Regulations, Resources and Timelines

A conversation with Dr. Mukesh Kumar, CEO and Founder of FDAMap.

In the most recent episode of our podcast, The Life Science Rundown, The FDA Group's Nick Capman sat down with Mukesh Kumar, PhD, RAC, for a deep dive into the challenges of setting up GMP facilities for cell therapy startups.

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Dr. Kumar is CEO and Founder of FDAMap, a Washington DC-based firm helping manufacturers and developers of FDA-regulated products in regulatory affairs, quality assurance, clinical trials, and smart development strategies.

His key expertise is in global regulatory project management, regulatory submissions, compliance inspections, operational management, supply management, clinical operations, and multi-national project management for medicinal and diagnostic products. He has led the clinical development of over 100 products over the last 20 years.

Discussion points include:

  • Common questions startups have around engaging with the FDA and determining costs and timelines for GMP facility setup and clinical trials.

  • Recommendations for engaging regulatory experts early and doing first-in-human manufacturing in-house rather than through a CMO to reduce costs and time.

  • The importance of educating oneself on regulations before meetings with experts or the FDA to get the most benefit from those interactions.

  • Best practices for GMP facility setup and clinical trials in a cost-effective manner to advance cell therapies to patients.

Dr. Kumar has been a leader in more than 150 clinical trials in about 34 countries, including countries in the EU, Taiwan, Korea, Japan, China, Canada, countries in South America, Australia, and India.  He has led over 100 GCP, GLP, GMP, and GACP audits in the US and several countries in Europe, North and South America, and Asia in the last 15 years. He has conducted numerous training workshops on FDA compliance-related issues and authored numerous peer-reviewed articles.

His weekly blog, FDA Puran, is subscribed by over 80,000 readers globally. He is also the Professor (Adjunct), Regulatory Sciences, at the School of Medicine, George Washington University, Washington DC. Dr. Kumar has a PhD in biochemistry and is a certified regulatory professional by the Regulatory Affairs Professionals Society, USA.

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