Shantha Tyavanagimatt Email & Phone Number

South San Francisco, Ca, Us

Maryland, United States

Directs strategic vision, leadership, and operational management across CMC development, manufacturing, supply chain, and preclinical operations from early development to late-stage clinical and commercialization. Steers long-range strategic plans and operational priorities for regulated programs, advancing drug development pipelines with robust manufacturing processes, and ensuring regulatory compliance. Engages with the executive team and the Board of Directors, influencing decision-making and driving initiatives that align with corporate goals. Upholds regulatory compliance and advances readiness for NDA/MAA approvals, ensuring a smooth transition to commercialization.

Greater Seattle Area

I lead the global CMC Technical Operations, Intellectual Property, Clinical Pharmacology, and Research Operations teams at CTI Biopharma, a commercial-stage company focused on novel therapies for blood-related cancers with high unmet needs.Key Accomplishments and Responsibilities: •Spearheaded development and filing of CMC, nonclinical, and Clin Pharm sections of NDA/MAAs and achieved approval of VONJO (oral) and Pixuvri (injectable) oncology products• Implemented manufacturing and supply chain strategies, ensuring uninterrupted product availability for clinical studies and commercialization• Directed pre-NDA, EOP2, and post-NDA regulatory negotiations, cementing critical CMC and clinical pharmacology strategies• Pivotal role defending technical due diligence during CTI's $1.7 billion acquisition by SOBI • Achieved > 30% reduction in manufacturing and operations cost• Successfully designed and executed post-marketing DDI and special population clinical studies• Led Pre-approval Inspection readiness, leading to successful NDA and MAA approvalsCMC Technical Leadership: • Managed API and drug product development, manufacturing, supply chains, and CMC regulatory• Directed CMOs, CROs, and CLOs partnerships and contracts• Budgeting & cost analysisDrug Development and Clinical Stewardship:• Led clinical pharmacology, phase-1/post-marketing CT operations, PK/PD, and nonclinical development• Identified new MOAs leading to label changes and a significant increase in revenueStrategic Oversight and Governance:• Strategised regulatory, drug development, and corporate strategies• Championed portfolio developments, lifecycle management, technical due diligence, and M&A governance• Developed IP strategies and product life extension• Implemented innovative Quality policies and procedures

Greater Seattle Area

Provided visionary and strategic leadership for global API, drug product and analytical development, CMC regulatory, QC & stability, quality operations, supply chain, drug development, manufacturing, portfolio, and project management for oncology products. Advised on development and regulatory strategies and ensured tactical execution on time and within budget. Nurtured strategic external partnerships with over several global CMOs/CROs/CLOs and pharmaceutical business partners. Managed all the operations related to product development, manufacturing (QbD/validation), CMO selection, and audits. Skillfully negotiated contracts and adeptly managed CMC and manufacturing budgets to optimize resource allocation. Actively participated in leadership governance committees, proactively identified new projects, and led due diligence to identify new growth opportunities. Guided and executed transformative business enhancements, fortifying global operations and streamlining processes for greater efficiency and success. Spearheaded CMC regulatory submission for IMPD/MAA/NDA/IND. Led continuous process improvements and operational excellence program.

Corvallis, Oregon Area

API,drug product development, scale-up and commercialization, CMC regulatory strategy and writing IND/NDA, analytical development/validation, stability studies and shelf-life determination, CMO/CRO selection & quality audits, supply chain/distribution, liaison with Government partners such as BARDA.CDC, DMPK and Tox. Review clinical trial design, animal and human PK studies, non-clinical studies protocol, bioanalytial validation. Identified new products for acquisition or collaboration and participated in due diligence of external partners' technology. Directed discovery and development of novel candidates for in-house discovery projects including dengue, broad spectrum anti-viral, Ebola and Lassa fever. Identified appropriate delivery technologies for insoluble and low permeable drug candidates.

API, DP development, scale-up and commercialization, CMC regulatory filings, analytical development, DMPK and Tox.

Drug substance and Drug product development, process and technology transfer, stability studies, Analytical method development and validation, Pharmacokinetics/toxicology, bioanlaytical development, quality and technical audit of GXP facilities, CMO/CRO selection, budget and contract negotiation, regulatory submission of IND/NDA filing.

Drug delivery of insoluble drug products, strategies for improvement of oral bioavailability, life cycle management strategies, 505(b)2 product development, novel controlled release technologies, clinical supplies manufacturing, clinical design, CMC regulatory and analytical development.

Oral drug delivery systems and absorption mechanism. Lipid delivery system for immediate and controlled release application.

Preformulation, formulation development of ANDA/NCEs and new products, improvement of oral bioavailability, absorption studies, regulatory CMC IND/NDA writing and filing, CMC project coordination, and clinical trial material manufacturing. Built a formulation, process development, and biopharmaceutics facility. Hired and trained a team of 9 scientists.

Pre-formulation, drug product development, CMC IND filing, discovery support, manufacturing clinical supplies, IND/ANDA writing. Generic product and process development. Set up insoluble drug delivery platforms and labs. Build and train a new CMC team to support NCEs and differentiated product development.

Setting up preformulation and formulation lab, developing clinical trial products and ANDA/NDA pipeline products.

Post-Doc, Pharmaceutics - Drug Delivery

Worked with Prof. Higuchi on improvement of oral absorption of challenging molecules. New delivery strategies of existing molecules

Ph.D, Pharmaceutical Technology

Activities and Societies: Supported Human Bioequivalence studies, assisted in organizing international conferences and seminars. Also.

M.S Pharm (Pharmaceutics), Pharmaceutical Sciences

Bachelor Of Pharmacy - Bpharm, Pharmacy