Company Management

Carmell Therapeutics is led by an experienced management team with a proven track record of success – from research and development through commercialization. Our organization is a great supporter of women in leadership, with over 50% of our senior management team being female.

Randy Hubbell Randy Hubbell, President & CEO

Prior to Carmell Therapeutics, Randy was the Chief Commercial Officer for Cardiva Medical, a start-up medical device company focused on delivering technology to reduce the complications associated with vascular access. In this role, Randy successfully designed and implemented the commercial strategy and execution to drive the sales of Cardiva’s vascular closure device product line. Before Cardiva, Randy was with Johnson & Johnson for 13 years in various sales and marketing roles, his last role as a Worldwide Vice President at Ethicon Biosurgery. Before moving to Ethicon, Randy worked in the J&J pharmaceutical sector as the WWVP for Global Strategic Marketing (PGSM) for the pain and cardiovascular therapeutic areas. Prior to J&J PGSM, Randy was Executive Director of Strategic Alliances at Cordis Cardiology. Randy started at Cordis in 2001 as Director of Stent Marketing and had responsibility for the launch of CYPHER®, the first drug-eluting stent, in the US market in 2003. In 2000, Randy had responsibility for sales and marketing at Enmed, an Internet start-up with web-based technology for conducting clinical trials. From 1998 to 2000, Randy was Executive Director of Sales and Marketing for Vasca, a start-up medical device company. Prior to Vasca, Randy was in sales and marketing for Boston Scientific from 1993 to 1998 and prior to BSC, Randy was in sales for IBM from 1985 to 1993. Randy received his Masters in Business Administration from Loyola University and his Bachelors of Science from Tulane University.

James Hart James Hart, M.D., FACS, FACC, FACCP – Chief Medical Officer

An experienced cardiovascular and thoracic surgeon for 20 years, Dr. Hart recently retired after serving 12 years at Johnson & Johnson with multiple roles of increasing responsibility, being named VP Medical Operations in 2006, Worldwide VP, Evidence Based Medicine and Chief Medical Officer for Ethicon in 2011 and, finally, Chief Medical Officer and VP Medical Affairs for J&J’s Global Surgery Group in 2012. Dr. Hart was very active with the regulatory, clinical and evidence-based medicine strategy and execution for Ethicon Biosurgery, including new and novel BLA (Biologic License Application) technologies approved by CBER (Center for Biologics Evaluation & Research). He received the prestigious Johnson Award in 2012 for his pioneering work in biologics.

Donna Godward Donna Godward, Chief Quality Officer

Donna Godward retired from Johnson & Johnson in 2016 where she served as Chief Quality Officer, Medical Devices & Diagnostics (MD&D) from 2010-2016. As Chief Quality Officer, Ms. Godward provided strategic direction and oversight for all areas of quality and regulatory compliance across the global MD&D business sector. She partnered with senior business leaders to assure end-to-end quality and regulatory compliance, from development through manufacturing, distribution and end-customer use. As a member of the Quality & Compliance Leadership Team, she was responsible for recommending policy and developing standards across Johnson & Johnson. Prior to this role, Ms. Godward served as Worldwide Vice President of Regulatory, Quality & Compliance for the Cordis franchise, with responsibility for quality assurance, regulatory affairs, regulatory compliance and healthcare compliance. During her tenure, Ms. Godward built strong partnerships with operations and R&D to improve effectiveness in new product development and launches, and strengthened the global capability of the function. A leader in quality leadership development, Ms. Godward also was instrumental in helping to create the Johnson & Johnson Executive Quality Leadership Development Program. She also served as co-chair of the Johnson & Johnson Global Quality Council and as a member of the Johnson & Johnson Supply Chain Council. Ms. Godward joined Johnson & Johnson in 2000 as Executive Director, Quality, Regulatory & Compliance, for Ortho-Clinical Diagnostics, Inc. (OCD). She later assumed the role of Worldwide Vice President of Quality, Regulatory & Compliance for OCD, with responsibility for quality systems, regulatory affairs and compliance for all manufacturing sites and products worldwide. Prior to joining Johnson & Johnson, Ms. Godward held positions in quality, regulatory and operations with Merck, Bristol Myers Squibb and Steris Corporation. She earned a B.A. in Biological Sciences from Indiana University and an MBA from Washington University.

Stephanie Kladakis Stephanie Kladakis, Ph.D., Chief Scientific Officer

Dr. Stephanie Kladakis has over 14 years of experience in medical device and materials product development across three different organizations, J&J (Depuy Biologics), NMT Medical and Cohera Medical. In her most recent role at Cohera, a company which develops novel, internal synthetic adhesives and sealants, Dr. Kladakis was the VP of R&D and responsible for leading the team to develop Sylys® Surgical Sealant which gained EU (CE Mark) and US IDE (Investigational Device Exemption) approval. Prior to Cohera, Dr. Kladakis was a program manager at NMT Medical directing the bioabsorbable septal repair implant program - (BioTREK™). Dr. Kladakis started her medtech development career at J&J (DePuy Biologics) as a senior engineer responsible for leading cross-functional and cross-company teams through various stages of feasibility teting and product development for new products in orthopedic tissue engineering, specializing in meniscus and soft tissues. Dr. Kladakis received her PhD from Georgia Tech with a major in Bioengineering and Materials (Minor: Management of Biotechnology) and her Bachelor of Science from Harvard University with a major in Engineering Sciences (Biomedical), Cum Laude.

Janet Vargo Janet M. Vargo, Ph.D., Vice President, Clinical Sciences

Throughout her 17-year career in the medical products industry, Dr. Vargo has advised companies and negotiated with regulatory bodies on clinical trial designs and regulatory strategies for innovative, state-of-the-art devices, diagnostics, biomarkers, biologics, and combination products. She has managed global clinical and regulatory operations both through internal teams and outsourced models. Dr. Vargo has planned and executed major organizational changes resulting from mergers, acquisitions, or outsourcing. In addition to designing and executing pivotal clinical studies, she evaluates early phase clinical and non-clinical data to help inform pivotal study designs, and evaluates new business opportunities from clinical, regulatory, and key stakeholder adoption perspectives. In addition to her role at Carmell Therapeutics, Dr. Vargo serves as a Strategic Advisor of Clinical Development & Regulatory Affairs in the Medical Device Practice of YourEncore™, a leading provider of resource and consulting services in the Life Sciences space. From 2012 to 2015 Dr. Vargo was Board Member and Head of Clinical and Regulatory Affairs for Mentor, LLC, a Johnson & Johnson Company. Prior to her work at Mentor she advised on clinical trial design, device and biologics safety analyses, due diligence efforts, and regulatory strategy for new-to-the-world products for the entire Johnson & Johnson Medical Device and Diagnostic sector from 2011 to 2015. In her corporate Johnson & Johnson position, Janet originated and led a Johnson & Johnson enterprise-wide program to leverage the company’s vast internal expertise to benefit higher-risk, novel product development efforts. This Independent Review Program helped to develop Johnson & Johnson’s talent and improved the probability of success for business-critical development programs. Janet obtained her doctorate in Behavioral Neuroscience at Miami University of Ohio, with emphases in mechanisms of recovery of function after brain injury, statistics, and experimental design.

Toby Silverman, M.D., Regulatory Affairs (consultant)

Dr. Toby Silverman is a trained M.D. with a strong background in management, clinical and anatomic pathology, molecular biology, clinical trial design and analysis, emergency preparedness, and FDA regulation of biologics, drugs, and devices. Dr. Silverman served for 19 years at the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) and was most recently Senior Advisor in the Office of Blood Research and Review. Dr. Silverman was responsible for key CBER initiatives related to biologic development, pharmacovigilance and hemovigilance, which involved safety monitoring of blood and related components. Dr. Silverman was also formerly Branch Chief of the Clinical Review Branch in the Division of Hematology at FDA.