ARTICLES BY BIKASH CHATTERJEE
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![Navigating Rocky Seas]( "Navigating The FDA's Emergency Use Authorization Process")
Navigating The FDA's Emergency Use Authorization Process5/14/2020The FDA has been authorized to grant Emergency Use Authorizations for SARS-CoV-2. This will impact both internal manufacturing and the CDMOs that drug sponsors employ.
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![Business Continuity & The Coronavirus]( "Business Continuity & The Coronavirus: Are Your Pharma Operations At Risk?")
Business Continuity & The Coronavirus: Are Your Pharma Operations At Risk?3/4/2020In the face of a pandemic, the value of a robust business continuity plan cannot be overstated. Organizations should actively evaluate those plans, focusing on service providers and partners.
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![Biotech scientist looking at test tube]( "New FDA Draft Guidance: Qualification Process For Drug Development Tools")
New FDA Draft Guidance: Qualification Process For Drug Development Tools2/3/2020The FDA recently issued its draft guidance on the qualification process for drug development tools (DDTs), as part of the commitment mandated by the 21st Century Cures Act. The draft guidance provides a high-level description of the intent and content of the DDT program, but it does not address evidentiary standards or performance criteria for purposes of DDT qualification, leaving it to industry to propose the scientific argument and data package.
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![FDA-KASA-feature]( "Understanding The FDA's KASA Framework")
Understanding The FDA's KASA Framework10/30/2019The FDA's Knowledge-Aided Assessment & Structured Application Framework marks an ambitious step forward in standardizing and increasing the efficiency of the drug review process. Here's what it will take for the framework to succeed.
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Opportunities And Risks In The Global Regulatory Environment2/13/2014
Todd and Todd interview Bikash Chatterjee, the President and Chief Technology Officer at Pharmatech Associates. Bikash provides an excellent overview of the global regulatory environment, along with both the opportunities and risks for the pharmaceutical industry. Additionally, he offers expert insights into effective cross-cultural business collaborations and highlights science and technology innovations that will be game-changing in the next five to ten years.
Bikash Chatterjee
Bikash Chatterjee is CEO of Pharmatech Associates. He has over 30 years’ experience in the design and development of pharmaceutical, biotech, medical device, and IVD products. His work has guided the successful approval and commercialization of over a dozen new products in the U.S. and Europe. Chatterjee is a member of the USP National Advisory Board and is the past chairman of the Golden Gate Chapter of the American Society of Quality. He is the author of Applying Lean Six Sigma in the Pharmaceutical Industry and is a keynote speaker at international conferences. Chatterjee holds a B.A. in biochemistry and a B.S. in chemical engineering from the University of California at San Diego.