Dennis M. Hester, Ph.D., an accomplished biotech professional with over 30 years of experience in regulatory affairs, quality assurance and product development, appointed as Senior Vice President, Chemistry, Manufacturing and Controls
Sumitra M. Ghate, a proven regulatory affairs leader with over 25 years of pharmaceutical and biotech product development experience, appointed as Vice President, Regulatory Affairs
MIAMI, FL / October 25, 2021 / iTolerance, Inc. (“iTolerance” or the “Company”), a biotechnology company focused on the development of innovative regenerative medicines, today announced the appointments of and Dennis M. Hester, Ph.D., Senior Vice President of Chemistry, Manufacturing and Controls, effective July 2021, and Sumitra M. Ghate, Vice President, Regulatory Affairs, effective October 2021, to the Company’s executive leadership team.
“We are pleased to welcome Dennis and Sumitra to the iTolerance leadership team. The ability to attract two industry-leading executives with such accomplished backgrounds represents a noteworthy achievement for the Company and speaks volumes to the potential of our regenerative medicine technology platform, iTOL-100,” stated Dr. Anthony Japour, Chief Executive Officer of iTolerance. “With this leadership team in place, I believe we are now well positioned to execute on our development strategy as we work to advance our lead program, iTOL-101, toward a first-in-human study as quickly as possible.”
Dennis M. Hester, Ph.D.
Senior Vice President, Chemistry, Manufacturing and Controls
Dr. Hester commented, “Regenerative medicine has the potential to be an important tool in the way physicians treat diseases. However, one significant drawback to cell/organioid implantation today is the need for patients to be on life-long immunosuppression due to the risk or rejection. I believe that iTolerance’s technology may have the ability to solve that problem by creating localized immune tolerance. I am excited to be joining the team to drive iTOL-100 forward, opening up the possibilities of regenerative medicine.”
Dr. Hester has been involved with product development for over 30 years and has spent the last 20 years working with a broad range of therapeutic agents, formulation technologies and routes of administration. His experience spans small molecule solid oral therapeutics, a broad range of inhalation formulations, and peptide, protein and cell based sterile injectable products, for use in a number of indications including diabetes, infectious diseases and oncology. Dr. Hester has an impressive track record of successfully leading programs into, and through, clinical development resulting in launch readiness and/or commercial sales. He has contributed to over two dozen INDs and the approval of six commercial products with a number of compounds presently in late-stage clinical development.
Prior to joining iTolerance, Dr. Hester served as Senior Vice President, Technical Operations, with responsibilities for Regulatory Affairs, Quality Assurance, and Technical Operations including Chemistry, Manufacturing and Controls (CMC) at Calidi Biotherapeutics. Prior to joining Calidi, Dr. Hester held leadership roles at a number of companies including Vice President, Product Development and Head of CMC at Mirati Therapeutics, Senior Director, Pharmaceutical Sciences and Head of CMC at Aragon Pharmaceuticals and Director, Pharmaceutical Development and Head of CMC at Intellikine, Inc. Additionally, Dennis obtained extensive biologics experience while working at Nektar Therapeutics, Amylin Pharmaceuticals and other companies as a full time employee or as a consultant.
Dr. Hester holds a Ph.D. in Physical Chemistry from the University of Southern California, an American Chemical Society Accredited Bachelor of Science degree in Chemistry from the United States Air Force Academy and is an inventor on seven issued patents.
Sumitra M. Ghate
Vice President, Regulatory Affairs
“Type 1 Diabetes is a significant unmet medical need and even with advances in insulin therapy, patients struggle to maintain glycemic targets and disease management can be a significant burden to these patients and their families. Regenerative medicine offers a potential solution, but chronic immunosuppression remains a challenge. I believe iTOL-101 can overcome this issue and has the potential to be a curative therapy for Type 1 Diabetes. I am thrilled to be joining the team as we work to advance iTOL-101 in a first-in-human clinical study in the near-term,” added Ms. Ghate.
Ms. Ghate is an accomplished regulatory affairs leader with over twenty-five years of drug, biologic, and device development experience in the pharmaceutical and biotech industry. She has extensive expertise in developing and executing strong global regulatory strategies to minimize regulatory risk and accelerate development timelines. Over the course of her career, she has led the development of over twenty INDs and CTAs and three initial marketing applications, along with multiple marketing supplements.
Prior to joining iTolerance, Ms. Ghate’s roles included Head of Regulatory Affairs at Histogenics Corporation, a regenerative medicine company developing a late phase tissue-engineered combination product. She also worked at Eli Lilly and Company across a nearly 20-year tenure in areas of CMC and regulatory with over ten years focused on diabetes. Most recently, she served as President of Artimus Regulatory Consulting, LLC providing strategic regulatory guidance for drugs and biologics, including regenerative medicine products. Additionally, she partnered with Bruder Consulting and Venture Group in the areas of regulatory strategy, FDA interactions, and regulatory submissions for cell therapy and tissue repair products.
Ms. Ghate received her BS in Organismal Biology and her BA in Chemistry from the University of Kansas. Additionally, she earned her US and EU Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.
About iTolerance, Inc.
iTolerance isa privately held biotechnology company focused on the development of innovative regenerative medicines. The Company’s lead program, iTOL-101, is an adjunct therapy with pancreatic islet cell implant currently in development for the treatment of or as a potential breakthrough cure for Type 1 Diabetes. iTOL-101 has demonstrated compelling efficacy in non-human primate studies. The Company plans to advance iTOL-101 towards an IND and first-in-man study. Additionally, the Company is advancing its regenerative cell therapy platform to fuel a robust pipeline addressing high-value indications. For more information, please visit itolerance.com.
Chief Executive Officer
JTC Team, LLC
SOURCE: iTolerance, Inc.
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