Team
Isosceles has assembled a team with decades of experience in successfully developing FDA-approved parenteral pain products from intravenous and surgical site injectables to transdermal patches and sublingual tablets. Our team has a singular focus: to create a rapid onset non-opioid/non-NSAID product with fast onset and long acting analgesia.
CEO and Chief Medical Officer
Mike Royal is a senior pharmaceutical executive with 30+ years of clinical research and development and medical and regulatory affairs experience, particularly in 505(b)(2) NDAs across several indications, but also with NCEs and ANDAs. He has been responsible for clinical trial oversight from phase 1 through phase 4, including multi-site/multi-country trials and has an established track record for innovative solutions to development obstacles. He has been instrumental in setting product launch and lifecycle management strategies. He is board-certified in internal medicine, anesthesiology, pain management and addiction medicine and has over 190 peer-reviewed publications, book chapters and abstracts/posters.
Executive Chairman of the Board
Timothy R. Wright is a highly accomplished executive with a 30 year track record of building, transforming and positioning pharmaceutical organizations for continued growth across highly competitive markets. A visionary, focused leader recognized for creating value and improving quality of life leveraging his extensive experience in pain management and inflammatory diseases. Wright has achievements leading full lifecycle development of novel therapeutic modalities, from conception through commercialization and growth across North America, Europe and Asia.
President
Brett Lanier is a medicinal chemist with over a decade of experience in the pharmaceutical industry and founding member of Isosceles Pharmaceuticals. His background includes extensive knowledge around the chemical synthesis and pharmaceutical scale GMP manufacturing of synthetic Cannabinoids, and controlled substances. He has worked within the medical device, clinical research and pharmaceutical contract manufacturing industry with branded and 505(b)(2) branded generic customers at all levels of drug development from pre-formulation, early and late phase trials and commercial launch post FDA approval.
Chief Commercial Strategy and Marketing
Art Morelli is a successful pharmaceutical industry professional with a 30+ year track record of building brands, launching new products and accelerating the growth and development of companies worldwide. Art is a recognized leader in strategic planning and in formulating and executing solutions to complex problems. Art has extensive experience in pain management, cancer and in opioid risk management.
Regulatory Affairs Strategy
Mark Mannebach has 30 + years of experience in the Pharmaceutical Industry in the area of Regulator Affairs with experience in Quality Assurance, Program Management and Pharmaceutical Science. Mannebach has experience in the development of branded and speciality pharmaceuticals, and biologics in many therapeutic areas including extensive experience in ophthalmology and pain management, neurology/CNS, and anti-inflammation. Mannebach has experience filing NDA’s, BLA’s, PME’s, ANDA’s and 505(b)(2) submissions.
Senior Medical Advisor & Member Board of Directors
Robert Stein, a Duke University Graduate School alumni, has a strong background in a wide ranging expertise from drug discovery, clinical research, development and trials in biopharmaceuticals and oncology. Robert served as Executive Director and Head of Pharmacology at Merck Sharp & Dohm, SVP of R&D and CSO for Ligand Pharmaceuticals, and EVP of Research & Pre-Clinical Development Dupont-Merck Pharmaceuticals. He also served as President of Incyte, Roche and CEO of KineMed, Inc. as well as a Senior Advisor of R&D at Agenus, Inc. and is an Operating Partner at Samsara BioCapital.