Shanthakumar Shantha Tyavanagimatt

About Shanthakumar Shantha Tyavanagimatt

I love making a difference in people’s lives through innovative medicines. As a dynamic and forward-thinking pharmaceutical executive, I bring a patient-centric emphasis and an enterprise-wide perspective to drive development, approvals, and launch of life-changing products. With extensive expertise in transitioning development-stage organizations into commercial success, I have played a pivotal role in achieving corporate growth. Proven leadership in early and late-stage CMC development, technical & QA operations, process development, manufacturing, supply chain, drug development, clinical pharmacology, Phase-1 clinical design & Operations, regulatory affairs, and commercialization. Achieved 4 NDA/MAA approvals, spearheaded several 505(b)2 products & ANDAs, and managed over 30 IND/IMPDs (phase 1-3 CT). Some of my key skills and accomplishments include:• Providing strategic leadership, implementing CMC and drug development solutions to ensure “right the first time” approvals and global expansion• Building and managing global CMC Tech Ops, clinical Pharmacology, preclinical, program management, and high performance teams• Played pivotal role in CTI’s growth from $100M in 2016 to $1.7Bn acquisition in 2023 • Generated over $500M in revenue from successful product launches for SIGA Technologies• Reduced costs by 25% through efficient supply chain management and contract negotiations• Leading technical due diligence for new drugs in-licensing, M&A activities, and portfolio development• Developing and managing budgets, P&L, corporate value creation, risk management, life cycle management, change management, competitive intelligence, organizational development, and transformationMy leadership style emphasizes initiative, innovation, communication, collaboration, influence, honesty, and a focus on operational excellence, consistently delivering results.My mission is to ensure the safety, efficacy, and compliance of the new medicines we develop so patients can look forward to stronger and longer lives.Feel free to reach out if you’re interested in collaborating on cutting-edge pharmaceutical projects. I’d love to hear from you.

Experience

1. Chief Technical Officer, SVP

   Geron Corporation

   Oct 2025 — Present · San Francisco, CA, US

   Executive leadership across end-to-end CMC product development from preclinical through NDA and commercialization. Accountable for global CMC strategy, CMC regulatory submissions, and GxP regulatory inspection readiness. Oversight of Drug Substance and Drug Product development, clinical and commercial supply chain, external manufacturing, and Quality Assurance functions.* Responsible for enterprise-level GxP quality systems (GMP, GLP, GCP), compliance, and risk management across global operations. Drive alignment of IP strategy with technical development to support innovation, lifecycle planning, and long-term value creation.* Partner to executive leadership and cross-functional teams, ensuring products are developed and delivered with quality, speed, and regulatory integrity.

Education

• Manipal Academy of Higher Education

  M.S Pharm (Pharmaceutics)

• Bangalore University

  Bachelor of Pharmacy - BPharm

• University of Utah

  Post-Doc

• The Maharaja Sayajirao University of Baroda (MSUB), Vadodara

  PH.D