The 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.
Dr. Bertram has served as Chief Executive Officer of ProKidney since January 2019. Since February 2017, Dr. Bertram has served on the board of directors of NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells. Dr. Bertram served as Chief Scientific Officer of Tengion Inc. from 2004 to 2014 after serving as President of Research and Development, where he brought four cell-based therapeutic products from discovery through Phase 2 clinical development. Dr. Bertram was also involved in the development and registration of eight medical products while serving as a senior executive at Pfizer Inc. (NYSE: PFE), SmithKline Beecham Pharmaceuticals, and The Procter & Gamble Company (NYSE: PG) from 1985 to 2004. He was a faculty member at the University of Illinois, and a visiting scientist at the National Institutes of Health. Dr. Bertram received his D.V.M. in Biology and Veterinary Medicine and his Ph.D. in Cellular Pathology from Iowa State University and was board certified in Veterinary Pathology in 1984.
Mr. Coulston has served as ProKidney’s Chief Financial Officer since January 2022. Prior to that, Mr. Coulston served as ProKidney’s Senior Vice President, Finance from January 2021 to December 2021 and ProKidney’s Vice President, Finance from February 2019 to December 2020. Before joining ProKidney, from August 2015 to January 2019, Mr. Coulston served as the Executive Director, Finance of Banner Life Sciences LLC, a privately held clinical-stage pharmaceutical company combining a proven history of formulation expertise with proprietary technologies to create specialty pharmaceuticals that solve real unmet clinical needs, where Mr. Coulston oversaw the financial, human resources, and IT activities. From 2007 to 2015, Mr. Coulston held finance roles of increasing responsibility at Targacept Inc. (Nasdaq: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™ before it merged with and into Catalyst Biosciences, Inc. (Nasdaq: CBIO), a clinical-stage biopharmaceutical company focused on creating and developing novel medicines to address serious medical conditions, including Senior Director, Finance and Controller. Mr. Coulston earned his B.S. and master’s degree in accounting from North Carolina State University and is a Certified Public Accountant in the state of North Carolina.
Mr. Girolamo joined ProKidney as Chief Legal Officer in March 2022. Prior to that, he spent 11 years at Caladrius Biosciences, Inc. (Nasdaq: CLBS), where he served as Chief Legal Officer, Senior Vice President of Corporate Development and Corporate Secretary. He began his legal career at Cahill Gordon & Reindel in 1990 and later at Reid & Priest, practicing in the areas of securities law, intellectual property, employment law and general commercial litigation. After private practice, Mr. Girolamo spent 12 years on Wall Street in institutional equities as a series 24, 7 and 63 licensed principal at Oppenheimer & Co., CIBC World Markets, Leerink Swann (now SVB Securities LLC) and Summer Street Research Partners where he specialized in equity research, sales, and trading of biotechnology, pharmaceuticals and medical technology market sectors. Mr. Girolamo then served as an analyst and portfolio manager at Lion’s Path Capital managing a long-short portfolio of biopharma and med-tech equities. Mr. Girolamo received an A.B. with honors from Harvard College, a J.D. from the University of Pennsylvania Law School and an MBA from Columbia Business School.
Dr. Jain has served as ProKidney’s Chief Operating Officer since March 2016. Dr. Jain brings over 36 years of experience in the development of tissue-engineered and cell therapy products. Previously, Dr. Jain held management roles of increasing responsibility at Johnson & Johnson (NYSE: JNJ) and Merck (NYSE: MRK) and was involved in the development of four marketed products including Johnson & Johnson’s erythropoietin-based drug Eprex (epoetin alfa). Dr. Jain has served as Chairman of the American Society for Testing and Materials Task Group on Preservation of Cells and Tissue Engineered Medical Product’s with Cells and has served as Chairman of the USP Tissue and Tissue-based Products Ad hoc Advisory Panel and was member of the USP Biologics and Biotechnology Cell, Gene and Tissue Therapy Expert Committee. Dr. Jain received his B. Tech and M. Tech in Chemical Engineering and his Ph.D. in Biochemical Engineering from the Indian Institute of Technology in Delhi, India.
Dr. McKenzie has served as ProKidney’s Chief Medical Officer since April 2022. Prior to that, she held roles of increasing responsibility at IQVIA / Quintiles since June 2007. Most recently, Dr. McKenzie served as Vice President, Medical, Global Head of Lifecycle Safety Project Leadership and Strategic Solutions from November 2019 to March 2022, and as Vice President, Medical, Global Head of Marketed Product Safety and Medical Information from March 2015 to November 2018, and as Executive Director, Medical, Global Head of Safety Aggregate Reporting and Analytics from January 2013 to March 2015, and as Executive Director, Medical, Global Head of Medical Safety from January 2009 to January 2013, and as Associate Medical Director from June 2007 to January 2009. Prior to joining IQVIA / Quintiles, Dr. McKenzie was Medical Director and Medical Safety Officer at Ashfield / Drug Safety Alliance from October 2005 to May 2007. Dr. McKenzie has expertise in clinical, pharmacovigilance and regulatory affairs, with over fifteen years of industry experience. In addition to her corporate roles, Dr. McKenzie was Dialysis Unit Medical Director at NaphCare in Raleigh, NC, from 2006 to 2020, making her intimately familiar with the challenges faced by patients undergoing dialysis. She holds a B.S. in Biology and Psychology from Duke University and an M.D. from Duke University School of Medicine. She completed a residency in internal medicine and a fellowship in nephrology at Duke University Medical Center. Dr. McKenzie is a Fellow of the American Society of Nephrology and an Associate of the American College of Physicians.
Ms. Johns has served as ProKidney’s Senior Vice President of Clinical Operations since January 2022. Prior to that, Ms. Johns served as Vice President of Clinical Operations from March 2019 to January 2022, where she managed multiple cell therapy programs for ProKidney. She has extensive knowledge in the neurological and regenerative medicine therapeutic areas, having managed over 20 clinical trials from Phase 1 through Phase 4. From March 2016 to March 2019, Ms. Johns established and operated Johns Clinical Consulting as its President to provide clinical operation consulting services to ProKidney, its sole client. Ms. Johns was responsible for overseeing the clinical development of and the regulatory requirements for the REACT program of ProKidney when working at Johns Clinical Consulting. From June 2010 to March 2016, Ms. Johns worked on multiple cellular therapy programs at ProKidney and Tengion, a regenerative medicine company, and site levels, including, PMG Research, Inc., Advance Neurology and Southeast Area Health Education Center, prior to joining ProKidney. Ms. Johns received her B.S. in clinical research from the University of North Carolina at Wilmington and her Master’s of Science in Health Science degree in Clinical Operations and Healthcare Management from George Washington University.
Tim has over 30 years of experience in the biological and pharmaceutical manufacturing industry with over 25 years working in the biologics arena in both commercial and clinical operations. Additionally, Tim has more than 20 years in contract manufacturing. His primary focus has been in aseptic parenteral manufacturing.
Tim is the Senior Vice President, Manufacturing with ProKidney, LLC. Prior to joining ProKidney LLC, Tim was Chief Manufacturing Officer for Matica Biotechnology, a start-up CDMO providing Cell and Gene manufacturing Services to clients developing vaccines and virus-based cell and gene therapy products. Tim has worked for protein and virus CDMO’s including Lonza, helping clients to bring their novel products to market. He was also involved in the launch of Dendreon’s Provenge, a cell therapy treatment for prostate cancer, the 1st commercially approved immunotherapy in the United States. Tim has also extensively worked with large and small molecule products in vaccines manufacturing. Tim earned his BS from Kent State University.
Dr. Stavas has served as ProKidney’s Senior Vice President of Clinical Development since October 2019 and leads the strategic advancement of clinical trials and scientific discovery and development. He brings over 30 years of experience in medical practice, academics and research endeavors and has been affiliated with ProKidney since 2012. He also serves as liaison between consultants, clinical investigators and scientists, and is actively involved in trial implementation and medical oversight. From May 2016 to October 2019, Dr. Stavas served as the Chairman of the Department of Radiology and was responsible for clinical and academic operations, research, and healthcare system strategy at Creighton University School of Medicine, an academic university and a healthcare system provider. From October 2005 to December 2008, Dr. Stavas served as the Division Chief for Clinical Interventional Radiology Procedures and was responsible for research trials and division operations at the University of North Carolina at Chapel Hill Hospital. Dr. Stavas holds a M.D. degree from Creighton University School of Medicine and completed his Radiology Residency at the University of Minnesota—Minneapolis. He attended the University of California San Diego for subspecialty training in Interventional Radiology at UCSD Hospital. Dr. Stavas also earned a Master of Public Health degree in Health Policy and Management from the University of North Carolina at Chapel Hill.
Dr. Weber has served as ProKidney’s Senior Vice President of Regulatory Development since September 2020 where he is responsible for leading the development and implementation of ProKidney’s regulatory strategy in all markets, worldwide, and interfacing with regulatory authorities. Dr. Weber has over 25 years of experience in cellular and tissue-based regenerative medicine products, with previous roles as Senior Vice President of Regulatory and Quality at Medeor Therapeutics, from February 2016 to December 2019; Executive Vice President of Global Regulatory Affairs and Quality Management at Mesoblast, from June 2011 to February 2016; Senior Consultant for Cell and Gene Therapies at Biologics Consulting Group from February 2004 to May 2011, and 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) from September 1996 to January 2004. He is a long-serving member of United States Pharmacopeia (USP) expert committees for human tissues and advanced therapies. Dr. Weber received his B.S. in Molecular Biology from The Evergreen State College and a Ph.D. in Biochemistry and Biophysics from Oregon State University.