Consultants

Andreas (Andy) Bader, PhD

Dr. Andreas Bader joined Triumvira in January 2018. Dr. Bader is a seasoned biotech executive with more than 20 years’ experience in oncology drug-discovery and development, and business and research strategies. Dr. Bader is Co-founder and CEO of Orros Biotherapeutics LLC, and previously acted as a scientific Co-Founder of Mirna Therapeutics, Inc., where he held multiple leading positions in R&D and led research programs from discovery to the completion of a Phase 1 clinical trial. During his 10-year tenure at Mirna, he participated in various business development activities, including fund-raising efforts via government grants, VC investments and the company’s IPO in 2015. Prior to Mirna, Dr. Bader functioned as the Scientific Lead of the microRNA therapeutics program at Asuragen, Inc. Dr. Bader completed his post-doctoral training at The Scripps Research Institute, La Jolla, California, received his PhD in Biochemistry in 2000 and his MSc degree in Biology in 1997 from the University of Innsbruck, Austria. Dr. Bader is co-inventor of 15+ patents and patent application families, co-author on 40+ peer-reviewed scientific articles, and has a Google Scholar h-index of 31.

Michael (Mike) Mendicino, PhD

Dr. Michael Mendicino began working with Triumvira in February 2018, where he consults on CMC, regulatory affairs, and translational R&D. Dr. Mendicino established Hybrid Concepts International (HCI) in 2016 as a consultancy and advisory firm in the fields of cell therapy, ex vivo modified cell therapies (gene or non-gene modified), in vivo gene therapy, regenerative medicine, tissue engineering, and cell-based drug discovery. Dr. Mendicino previously worked at four biotech companies, leading or supporting areas such as CMC and strategic regulatory affairs, R&D, commercial, manufacturing process development, product & technology due diligence activities, and regulatory and competitive intelligence. Prior to that, Dr. Mendicino held an appointment at the FDA in the Office of the Commissioner with the regulatory science and innovation team, where he supported IP protection and emerging technology policy. He also worked in FDA’s Center of Biologics Evaluation and Research, now Office of Tissues and Advanced Therapies, where he was a product reviewer for submission and pre-submission review for innovative biologic products, devices and combination products. He also performed pan-IND trend assessments published in Nature Biotechnology and Cell Stem Cell. Dr. Mendicino is a member and representative for the Alliance for Regenerative Medicine (ARM; Co-Chair of the Science & Technology Committee) and the International Society for Cellular Therapy (ISCT), and is also currently a Board Member and Co-Founder for the non-profit Standards Coordinating Body for Gene, Cell and Other Regenerative Therapies, and Cell-based Drug Discovery corporation. Dr. Mendicino received his PhD in Immunology and his HBSc in Molecular Biology/Genetics from the University of Toronto.

Michael (Mike) Mendicino, PhD

Dr. Michael Mendicino began working with Triumvira in February 2018, where he consults on CMC, regulatory affairs, and translational R&D. Dr. Mendicino established Hybrid Concepts International (HCI) in 2016 as a consultancy and advisory firm in the fields of cell therapy, ex vivo modified cell therapies (gene or non-gene modified), in vivo gene therapy, regenerative medicine, tissue engineering, and cell-based drug discovery. Dr. Mendicino previously worked at four biotech companies, leading or supporting areas such as CMC and strategic regulatory affairs, R&D, commercial, manufacturing process development, product & technology due diligence activities, and regulatory and competitive intelligence. Prior to that, Dr. Mendicino held an appointment at the FDA in the Office of the Commissioner with the regulatory science and innovation team, where he supported IP protection and emerging technology policy. He also worked in FDA’s Center of Biologics Evaluation and Research, now Office of Tissues and Advanced Therapies, where he was a product reviewer for submission and pre-submission review for innovative biologic products, devices and combination products. He also performed pan-IND trend assessments published in Nature Biotechnology and Cell Stem Cell. Dr. Mendicino is a member and representative for the Alliance for Regenerative Medicine (ARM; Co-Chair of the Science & Technology Committee) and the International Society for Cellular Therapy (ISCT), and is also currently a Board Member and Co-Founder for the non-profit Standards Coordinating Body for Gene, Cell and Other Regenerative Therapies, and Cell-based Drug Discovery corporation. Dr. Mendicino received his PhD in Immunology and his HBSc in Molecular Biology/Genetics from the University of Toronto.

Jay Stoudemire, PhD

Jay began to consult for Triumvira in 2018 to contribute to the execution and oversight of preclinical study protocols. Dr. Stoudemire has 25+ years industry experience in both biotech and well-established pharmaceutical environments with a record of developing and leading the strategy and execution of programs to support the preclinical evaluation of biologic and small molecule drug candidates from lead optimization to product approval across diverse therapeutic areas. He received his PhD in Microbiology from the University of Miami and completed a postdoctoral fellowship at the Cardiovascular Research Institute at the University of San Francisco. He established a consulting group, Nonclinical Development Consultants, LLC in 2018.