We’ve been around for a while and we’re proud of the company we’ve built which is why we want you to know we are here for you today and we’ll be here for you tomorrow too. That’s the Twin City Bio way.
There are lots of CDMOs in the world. But none quite like Twin City Bio. Despite the scale and size of our company, we conduct our business in the right way, by respecting all stakeholders at all times and delivering value for money to our clients.
We develop cell therapy strategies that are more efficient, safer and have fewer side effects then current standards of care. With manufacturing teams at the ready, we are able to fulfill the needs of all our clients’ developmental processes and clinical trials.
Meet the Team
Twin City Bio averages more than twenty years of experience, with over 150 years cumulative, 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.
Bertram 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.
Bertram 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.
Dr. Jain co-founded and joined RegenMedTX in 2015 as Chief Operating Officer and has over 33 years of experience in biotechnology, tissue engineering, cell therapy and regenerative medicine bioprocess research & development and GMP manufacturing. Before joining RegenMedTX, 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 human-based tissue engineered products for therapeutic applications in the skin, cartilage and cardiovascular areas. Dr. Jain has held several positions of increasing technical and management responsibility 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 accomplished at directing product development from research to the clinic, process scale-up, technology transfers, GMP facility design, process validation and manufacturing of biotechnology-derived recombinant proteins and tissue engineered cell therapy and regenerative medicine products. He is highly experienced in regulatory CMC submissions for biologics, devices and combination products. Dr. Jain serves 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. Dr. Jain has also 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.
Dr. Jain has over 70 publications, presentations and abstracts, two book chapters and many patents in the field biologics, tissue engineering, cell therapy and regenerative medicine. Dr. Jain received a PhD from the Indian Institute of Technology, Delhi in Biochemical Engineering.
Senior Vice President of Clinical Development
Dr. Stavas leads the strategic advancement of clinical trials and scientific discovery and development at inRegen. He has over 30 years of experience in medical practice, academics and research endeavors and been affiliated with inRegen 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.
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.
James Coulston joined Twin City Bio 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 over seven years of experience in the clinical research field, having worked as a research coordinator and project manager at the site and sponsor levels. Prior to opening Johns Clinical Consulting in 2015, Ashley worked 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 has managed multiple programs for inRegen over the past few years and has done extensive work with FDA and MPA regulatory authorities to gain approvals for clinical trials across multiple therapeutic areas. She has extensive knowledge in the neurological and regenerative medicine therapeutic areas, having managed over 20 clinical trials from Phase I through Phase IV.
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.
Connect with our team and we will get back to you quickly.