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 Unive
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Dr. Srinivasan is yet another of those pieces that our current team is putting together. The "heft" I was referring to in a prior post is exemplified in this Dr.'s credentials. He has that "been there and done that" pedigree we need so badly.
From Linkedin page:
Seenu Srinivasan
Pharmaceutical Executive
Senior pharmaceutical executive with 20+ years in development, primarily CMC. Experienced in leading/supervising multi functional groups globally with P&L responsibilities. Several NDAs and ANDAs submitted/approved. CMC strategy including regulatory.
Specific experience includes:
- Small molecule development (all CMC aspects) from concept to commercialization; strategy development and execution, regulatory, and project management
- M&A
-Proteins and peptides (process development, scale up (QbD-based), analytical dev, and regulatory)
- API development (from mg to kg quantities), DMF and CMC regulatory
- Analytical chemistry development including QC release testing, compendial testing and stability testing under GMP, and CMC regulatory
- Preformualtion and formulation development, scale up, process development, tech transfer to manufacturing, process validation, trouble shooting manufacturing processes
- Dosage forms expertise: solid, liquid, sterile liquid, controlled delivery, specialized dosage forms including liposomal and dermal
- Clinical Trial Materials manufacturing for Phase 1, 2, and 3 under GMP, and CMC regulatory
- CRO and CMO outsourcing
- GMP expertise, QA support, and CMC regulatory
- Statistically designed experiments (DOE), and QbD
- Supervised over 185 professionals
- Technical sales/marketing support, effective client interactions
- Dossier preparation (CMC only), CMC regulatory strategy
