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Balaji V. Kadri
Senior Director of Pharmaceutics & Clinical Supplies @Lexicon Pharmaceuticals, Inc.
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WORK HISTORY
Senior Director of Pharmaceutics & Clinical Supplies @Lexicon Pharmaceuticals, Inc.
Houston, TX, US
CMC lead for formulation development, cGMP manufacturing & clinical supplies of NCE drug products from phase 1 through phase 3 (US & worldwide studies up to patients/800 clinical sites).• Working with various CDMOs for formulation development, Clinical Manufacturing and distribution/returns/destruction of clinical supplies (US/World-wide clinical sites).• Review clinical protocols for SAD/MAD/ Phase 2b/Phase 3 efficacy studies (open and blinded studies with booklet labels).• Review/author CMC sections for IND/NDA filings.• Routine communication with Clinical Operations, Regulatory, cGMP/Clinical Quality, Drug Safety, Preclinical, Finance, Legal, Patent Attorney, and clinical CRO vendors.
EDUCATION
University of Toronto
M.Sc., Pharmacy (Pharmaceutics)
University of Texas
MBA, Business Administration and Management, General
Dr. MGR Medical University
M.Pharm, Pharmaceutics
SKILLS
ABOUT BALAJI V. KADRI
Expertise encompasses various CMC functions including formulation development, clinical manufacturing, commercial manufacturing, clinical supplies, analytical development/validation, quality control, regulatory submission, and warehouse. More than two decades of experience working in mid-size brand & contract manufacturing/CDMO organizations,
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