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Posted On: 08/26/2021 5:07:11 PM
Post# of 148902
CytoDyn Appoints Seenu Srinivasan, Ph.D. as Executive Director of CMC Regulatory Affairs
Download as PDFAugust 26, 2021 5:02pm EDT
Dr. Srinivasan provides 30 years of broad regulatory and drug development experience including a career serving as Director of CMC Regulatory Affairs for Regeneron Pharmaceuticals, Inc. where he led the CMC strategy and successfully submitted a monoclonal antibody based BLA (Dupixent approved in 2017)
VANCOUVER, Washington, Aug. 26, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"
, a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the appointment of Seenu Srinivasan, Ph.D., as Executive Director-CMC Regulatory Affairs.
Dr. Srinivasan provides CytoDyn with 30 years of experience in pharmaceutical drug development, including extensive CMC development experience in developing APIs (small and large molecules) and drug products (biological and small molecules) from early phase to commercialization, strategy development and execution. He has led the CMC portions of development (process development/engineering, analytical development, formulation development, stability testing under cGMP conditions, and preparation of all technical documents for regulatory filing).
Dr. Srinivasan’s career included serving as Director of CMC Regulatory Affairs for Regeneron Pharmaceuticals, Inc. where he led the CMC strategy and successfully submitted a monoclonal antibody based BLA (Dupixent approved in 2017). Prior to Regeneron, Dr. Srinivasan served as Global Vice President/Chief Scientific Officer, CMC Pharmaceutical Development Services for Covance Laboratories Inc. (a Laboratory Corporation of America Holdings company) where his primary responsibilities included strategy development, P&L responsibility for the business unit, all CMC activities and API development under cGMP for Phase 1 and 2 and cGMP stability, and CMC project/program management. Dr. Srinivasan earned B.Sc. Ed. (Chemistry and Physics, First Class), Regional College of Education, Mysore, India, M.Sc. (Chemistry, First Class), Indian Institute of Technology, Madras, India, M.S. (Education) and Ph.D. (Chemistry), Purdue University, and was a Postdoctoral Research Fellow (Electrochemistry), at Michigan State University.
Dr. Srinivasan, commented, “I am very excited about the opportunity to join CytoDyn at such an important time when our management team can define and shape the Company’s future by advancing our multi-pathway approach to evaluating leronlimab for so many potential indications.”
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, stated, “We are very fortunate to add Dr. Srinivasan to our CMC regulatory management team. His deep experience and proven leadership qualities will clearly enable him to be a strong contributor in setting the strategic course for our long-term future.”
Download as PDFAugust 26, 2021 5:02pm EDT
Dr. Srinivasan provides 30 years of broad regulatory and drug development experience including a career serving as Director of CMC Regulatory Affairs for Regeneron Pharmaceuticals, Inc. where he led the CMC strategy and successfully submitted a monoclonal antibody based BLA (Dupixent approved in 2017)
VANCOUVER, Washington, Aug. 26, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"
, a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the appointment of Seenu Srinivasan, Ph.D., as Executive Director-CMC Regulatory Affairs. Dr. Srinivasan provides CytoDyn with 30 years of experience in pharmaceutical drug development, including extensive CMC development experience in developing APIs (small and large molecules) and drug products (biological and small molecules) from early phase to commercialization, strategy development and execution. He has led the CMC portions of development (process development/engineering, analytical development, formulation development, stability testing under cGMP conditions, and preparation of all technical documents for regulatory filing).
Dr. Srinivasan’s career included serving as Director of CMC Regulatory Affairs for Regeneron Pharmaceuticals, Inc. where he led the CMC strategy and successfully submitted a monoclonal antibody based BLA (Dupixent approved in 2017). Prior to Regeneron, Dr. Srinivasan served as Global Vice President/Chief Scientific Officer, CMC Pharmaceutical Development Services for Covance Laboratories Inc. (a Laboratory Corporation of America Holdings company) where his primary responsibilities included strategy development, P&L responsibility for the business unit, all CMC activities and API development under cGMP for Phase 1 and 2 and cGMP stability, and CMC project/program management. Dr. Srinivasan earned B.Sc. Ed. (Chemistry and Physics, First Class), Regional College of Education, Mysore, India, M.Sc. (Chemistry, First Class), Indian Institute of Technology, Madras, India, M.S. (Education) and Ph.D. (Chemistry), Purdue University, and was a Postdoctoral Research Fellow (Electrochemistry), at Michigan State University.
Dr. Srinivasan, commented, “I am very excited about the opportunity to join CytoDyn at such an important time when our management team can define and shape the Company’s future by advancing our multi-pathway approach to evaluating leronlimab for so many potential indications.”
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, stated, “We are very fortunate to add Dr. Srinivasan to our CMC regulatory management team. His deep experience and proven leadership qualities will clearly enable him to be a strong contributor in setting the strategic course for our long-term future.”
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