Shantha Tyavanagimatt

Shantha Tyavanagimatt, Ph.D., has an extensive work experience in the pharmaceutical industry. Shantha began their career at Ranbaxy as a Scientist, where they were involved in pre-formulation, drug product development, and CMC IND filing. Shantha later became a Senior Scientist and set up insoluble drug delivery platforms and labs.

After Ranbaxy, Shantha joined Dr. Reddy's Laboratories as an Associate Director, leading formulation research and development. Shantha contributed to preformulation, formulation development, and regulatory CMC IND/NDA writing and filing. Shantha also built a formulation and process development facility and trained a team of scientists.

Following their time at Dr. Reddy's Laboratories, Shantha worked at the University of Utah as a Post-doctoral Research Assistant, studying oral drug delivery systems and absorption mechanisms.

Shantha then joined Lipocine, Inc as a Lipid Formulation Specialist, focusing on lipid delivery systems for immediate and controlled release applications.

Next, Shantha served at SIGA Technologies, first as Director of CMC and Formulations, and later as Vice President of Drug Development and Manufacturing. In these roles, they were responsible for API and drug product development, CMC regulatory strategy, analytical development, and supply chain management.

Most recently, Shantha held leadership positions at CTI BioPharma and SIGA Technologies. At CTI BioPharma, they served as Senior Vice President, leading global pharmaceutical operations and early development. Their accomplishments include overseeing the development and filing of CMC, nonclinical, and Clin Pharm sections of NDA/MAAs and achieving product approvals. Shantha also implemented manufacturing and supply chain strategies, achieved cost reduction, and conducted post-marketing clinical studies. During their tenure, CTI BioPharma was successfully acquired by SOBI.

At SIGA Technologies, Shantha served as a Senior Vice President and was responsible for drug development, manufacturing, and CMC regulatory strategy. Shantha led API and drug product development, scale-up, and commercialization, as well as quality audits and supply chain management. Shantha also worked closely with Government partners and played a key role in IND/NDA writing.

Throughout their career, Shantha has demonstrated strong leadership, strategic oversight, and technical expertise in various roles within the pharmaceutical industry.

Dr. Shantha Tyavanagimatt has a Ph.D. in Pharmaceutical Technology from Maharaja Sayajirao University of Baroda, Vadodara. Shantha also holds an M.S. Pharm (Pharmaceutics) degree from Manipal Academy of Higher Education. Additionally, they completed a post-doctoral program in Pharmaceutics - drug delivery at the University of Utah. In terms of additional certifications, Dr. Tyavanagimatt obtained a PMP certification from the Project Management Institute in December 2014. Shantha also holds a Regulatory Affairs Certificate in Pharmaceuticals from the Regulatory Affairs Professionals Society (RAPS), which they obtained in February 2014.