Meet the Team
ProKidney team averages more than twenty years of experience, with over 150 years cumulative experience in the discovery, development, manufacturing and commercialization of biotechnology, pharmaceutical, and device products. They are guided by a vision to bring transformational medical technology to patients and are advancing multiple products through clinical development toward commercialization.
Tim Bertram has over 30 years of medicine development expertise and led innovations in cellular therapeutics for over 14 years. He previously served as CEO of RegenMed Therapeutics, after serving as President of Research and Development to bring four cell-based therapeutic products from discovery through Phase II clinical development.
Tim has also served as a senior scientific executive at Pfizer, SmithKline Beecham Pharmaceuticals, and Procter & Gamble Co; as a faculty member at the University of Illinois; and as a visiting scientist to the National Institutes of Health. Tim has been a leadership mentor to scientists in government, academics, and industry. His experience includes worldwide leadership of multidisciplinary scientific teams for the pharmaceutical industry, government and private foundations focusing on the resolution of challenges in pharmaceutical productivity and defining industrial applications of advanced molecular, cellular and whole organism technologies for selecting optimal therapeutic candidates with experience in discovery, development and registration of small molecules and cell-based therapy products.
Deepak. Jain, PhD has over 40 years of experience in the development of tissue engineered and cell therapy products. Previously, Dr. Jain was the COO at Twin City Bio before co-founding and running RegenMed Therapeutics as COO. Earlier, Dr. Jain was Senior Vice President of Bioprocess R&D and Technical Operations at Tengion responsible for bioprocess research, process development and clinical manufacturing of advanced regenerative medicine and cell therapy products including urinary bladder replacement and kidney regeneration. Prior to Tengion, Dr. Jain was the Executive Director of Process Development and Manufacturing Technical Support at Advanced Tissue Sciences responsible for development of two tissue engineered marketed products for therapeutic applications in the skin, cartilage and cardiovascular areas. Dr. Jain has held several positions at Merck and Johnson & Johnson, leading the development of biotechnology products with a focus on recombinant proteins. Dr. Jain was instrumental in the development and manufacturing support of J&J’s multi-billion dollar product for the treatment of anemia. More recently, Dr. Jain was as a full-time consultant for Baxter Corporation responsible for establishing a commercial manufacturing facility overseas for a marketed recombinant protein. Dr. Jain is also highly experienced in regulatory CMC submissions for biologics, devices and combination products. Dr. Jain served as the Chairman of Cell Therapy Ad hoc Advisory Panel for United States Pharmacopoeia and served as a member of USP’s Biologics & Biotechnology Expert Committee and as Chairman of the American Society for Testing and Materials Task Group on Preservation of Cells and Tissue Engineered Medical Product’s with Cells.
Senior Vice President of Clinical Development
Dr. Stavas leads the strategic advancement of clinical trials and scientific discovery and development at ProKidney. He has over 30 years of experience in medical practice, academics and research endeavors and been affiliated with ProKidney since 2012. He serves as liaison between consultants, clinical investigators and scientists, and actively involved in trial implementation and medical oversight. He has been the President of Medical Groups and State Radiology Societies, Radiology Department Chair and attained the rank of Professor at multiple academic institutions. Joe holds an MD degree from Creighton University School of Medicine and specialty training at the University of Minnesota. He attended the University of California-San Diego for subspecialty training and earned a Master of Public Health degree from the University of North Carolina-Chapel Hill. He has been awarded fellowship recognition from the American College of Radiology and Society of Interventional Radiology along with membership in AOA and The Gold Foundation Humanism Society.
Head of Quality
With over 30 years experience within the pharma/biologics field with advancing roles in Quality, Gail has provided quality leadership and guidance in the start-up of several large-scale facilities both domestically and internationally. She has been pivotal in the licensing of first multi-valent vaccine (HibTiter®) and for successful licensing for world’s first Mab biosimilar in South Korea, EU and several Eastern European and South American countries (Remsima®). She has extensive experience with quality systems, auditing, CROs, CMOs, fill/finish operations, supply chain, computer systems, validation, regulatory submissions and inspections, pharmacovigilance, and licensed and developmental (phase I-IV) products. Ward is a graduate of School of Computer Technology with a degree in Computer Programming and holds an AS in Education from Campbell University. She is a CQA and CQIA through ASQ and holds memberships to ACRP, RAPS, ASQ, and ASCM.
SVP Regulatory Development
Darin J. Weber, PhD joined the Company as Senior Vice President of Regulatory Development in September 2020. He is responsible leading development and implementation of the Company’s regulatory strategy in all markets, worldwide. Weber has been working in the field of cell and gene advanced therapies for more than 20 years having previously served in senior leadership roles at Medeor Therapeutics and Mesoblast. Weber previously was a Senior Consultant for cellular and gene therapies at Biologics Consulting Group, LLC. Prior to joining industry, Weber held positions of increasing responsibility at the FDA’s Center for Biologics Evaluation and Research, including as Chief of Cellular Therapies Branch in the Office of Cellular, Tissues and Gene Therapies, (now known as the Office of Tissues and Advanced Therapies). He is a long serving member on United States Pharmacopeia (USP) expert committees for human tissues and advanced therapies. Weber received his BS from The Evergreen State College and a PhD in Biochemistry and Biophysics from Oregon State University.
James Coulston joined ProKidney in February 2019 as Vice President, Finance. Since 2007, Mr. Coulston has held positions of increasing responsibility in finance at private equity backed and publicly traded life science companies. From 1999 to 2006, Mr. Coulston held positions of increasing responsibility in assurance and advisory services at Ernst & Young. Throughout Mr. Coulston’s career he has transitioned companies through multiple transactions including initial-public offerings, follow-on public offerings, spin-outs, mergers and acquisitions. Mr. Coulston holds an undergraduate degree in accounting and a Master of Accounting degree from North Carolina State University and is a Certified Public Accountant in the state of North Carolina.
VP Clinical Operations
Ashley Johns has been with ProKidney for several years and has managed multiple cell therapy programs during her time with ProKidney. She has extensive knowledge in the neurological and regenerative medicine therapeutic areas, having managed over 20 clinical trials from Phase I through Phase IV. Prior to joining the ProKidney team she owned and operated Johns Clinical Consulting in Raleigh, NC. Throughout her career she has worked at the site level and served as a Clinical Project Manager at two cell therapy companies, managing an inter-disciplinary product development team with domestic and international trial sites. Mrs. Johns received her B.S. in Clinical Research from the University of North Carolina at Wilmington and her Masters of Health Science from George Washington University.