Gautam Ghatnekar, DVM, PhD – An Entrepreneur’s Story: Case Study of Translation of a Drug through Clinical Trials- April 19th, 2016

April 19, 2016

TBMH Suite 201

1 Riverside Circle

Roanoke, Virginia 24016

Dr. Ghatnekar is the President & CEO of FirstString Research, Inc., a clinical-stage biotechnology company located in Charleston, South Carolina.  Dr. Ghatnekar studied veterinary medicine and developed his own veterinary practice specializing in small animal medicine and surgery. In 2000, he enrolled in a graduate program at North Carolina State University and in 2004 graduated with a PhD in Comparative Biomedical Science . During his doctoral studies, he was President of the Graduate Student Association and won various awards, including the Teratology Society Marie W. Taubeneck award for excellence in research and leadership and an American Heart Association Pre-Doctoral Fellowship. Following his PhD, Dr Ghatnekar did a post-doc with Dr Gourdie at the Medical University of South Carolina (MUSC). During these studies, Dr. Ghatnekar established ACT1 as a technology platform, with applications in regenerative medicine and he and Gourdie formed FirstString Research, Inc. in 2005. Under his leadership, FirstString Research has advanced the clinical development of its lead product Granexin Gel – a topical formulation containing the ACT1 peptide – through human clinical trials. The gel was tested on 48 subjects in a Phase 1 study and has been evaluated in three Phase 2 human clinical trials for acute surgical wounds and chronic wounds, such as diabetic foot ulcers and venous leg ulcers. The results from clinical trials were published in 2015 in the Journal of Investigative Dermatology (Nature) and Wound Repair and Regeneration. Phase III clinical trials on diabetic foot ulcers are now underway. Dr. Ghatnekar’s experience and expertise in preparing regulatory documentation, developing both GLP preclinical studies and clinical trial protocols; and working knowledge of both the device (CDRH) and drug (CDER) regulatory routes and requirements, has led FirstString Research to successfully navigate the FDA and obtain IND approvals. Dr. Ghatnekar is a member of various prestigious national and international scientific societies including the Wound Healing Society and the Association for Advancement of Wound Care. He has been awarded multiple Phase I and Phase SBIR/STTR small business grants by the NIH, is PI on a prestigious NIH BRiDG award and serves on NIH study sections as a reviewer. In 2006, he accepted the ‘Innovators 2006’ award, sponsored by the Charleston Regional Business Journal.  Dr. Ghatnekar was also recognized recently by the Charleston Regional Business Journal as one of Charleston’s ‘Forty Under 40’.