The FDA Group's CEO Nick Capman sits down with Mukesh Kumar, PhD, RAC, for a deep dive into the challenges of setting up GMP facilities for cell therapy startups.
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. Mukesh 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.
He 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 more than 100 GCP, GLP, GMP, and GACP audits in the US and several countries in Europe, North and South Americas, and Asia in the last 15 years. He has conducted numerous training workshops on FDA compliance-related issues and has authored numerous articles in peer-reviewed journals.
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 is a PhD in Biochemistry and a certified regulatory professional by the Regulatory Affairs Professionals Society, USA.
Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/