Dr. Jeff Benner is an entrepreneurial physician and biotech innovator who transitioned from a distinguished 38-year career in retina surgery to focus full-time on addressing the opioid crisis. Since retiring from ophthalmology, he dedicated his career to addiction medicine and therapeutic innovation. He serves as Co-CEO of Akyso Therapeutics, where he leads the development of iSTEP-N™, a long-acting, bioabsorbable naltrexone implant designed to improve treatment outcomes in opioid use disorder (OUD).

Dr. Benner was Co-Principal Investigator on a multi-year, $15M NIH/NIDA grant that funded the development and early clinical testing of iSTEP-N™, which demonstrated safety, tolerability, and sustained therapeutic levels in first-in-human studies. His leadership helped secure FDA clearance of the company’s IND and progression of the program into Phase 1b trials.

In addition to his work at Akyso, Dr. Benner has founded multiple biotech startups, holds more than 10 issued U.S. patents, and has published extensively in both ophthalmology and addiction medicine. His entrepreneurial vision is grounded in a commitment to improving patient adherence and access to effective, long-acting therapies that can transform the trajectory of recovery for people with OUD.

Dr. Steven Cohen is a surgeon, inventor, and entrepreneur with over 30 years of clinical and research experience. He co-founded Akyso Therapeutics and serves as Co-CEO, where he directs strategy, regulatory development, and translational research for the company’s pipeline of long-acting, bioabsorbable drug-delivery implants for substance use disorders.

As Co-Principal Investigator on NIH-funded grants, Dr. Cohen has led the iSTEP-N™ implant program through preclinical development, FDA IND clearance, and successful first-in-human trials. He brings unique perspective as both a physician and an inventor, having served as investigator in more than 100 clinical trials and holding multiple patents, including innovations in drug delivery systems and surgical devices.

Dr. Cohen is also Clinical Professor of Ophthalmology at the University of South Florida, where he has trained generations of ophthalmologists. Earlier in his career, he co-developed a surgical device that was commercialized and is now marketed by Bausch + Lomb.

Dr. Pravin Soni is a pharmaceutical scientist with over 30 years of experience in drug delivery, formulation development, and CMC strategy. He has held senior leadership positions at both Fortune 500 pharmaceutical companies and cutting-edge biotech firms, where he successfully advanced multiple products from early concept through late-stage clinical development and global regulatory approval. At Akyso Therapeutics, Dr. Soni leads the chemistry, manufacturing, and controls (CMC) strategy for the iSTEP-N™ implant, overseeing polymer selection, process scale-up, analytical validation, and regulatory compliance. His deep expertise in polymer-based systems, long-acting injectables, and combination product development has been critical in creating robust, patient-friendly therapies. Beyond technical leadership, Dr. Soni brings decades of experience in regulatory interactions with the FDA and EMA, ensuring Akyso’s development programs meet the highest standards of quality and rigor. His work provides the foundation for advancing Akyso’s pipeline of innovative long-acting treatments for opioid use disorder and related conditions.

Dr. Josh Berman is a physician-scientist with deep expertise in clinical trial strategy and execution across industry, government, and academia. He previously served as Chief Medical Officer of Columbia Care, where he led medical oversight for one of the nation’s largest medical cannabis providers. Earlier in his career, he was a Medical Officer at the FDA, contributing to regulatory policy and review in the Division of Anesthesia, Analgesia, and Addiction Products. Dr. Berman also held leadership roles at the National Institute on Drug Abuse (NIDA), where he advanced public–private partnerships and supported translational research in addiction therapeutics.

At Akyso Therapeutics, Dr. Berman provides strategic guidance on clinical trial design, regulatory interactions, and translational development for the iSTEP platform. He brings a unique perspective at the intersection of regulatory science, public health, and industry innovation, helping to advance long-acting treatments for substance use disorders.

Chris Lumpkin is a seasoned product developer with over 20 years of experience in the surgical field, specializing in ophthalmology and neurosurgery. His expertise spans the full product development lifecycle — from market research and prototype design to manufacturing processes and marketing strategy.

Chris has held senior roles in both corporate and startup environments, including Director of R&D at Peregrine Surgical, where he led the development of several patented ophthalmic devices such as sapphire ocular scrapers, microsurgical forceps, and fiber optic probes. His leadership extended to overseeing project planning, budgeting, and quality control systems to ensure product reliability and regulatory compliance.

Earlier in his career, Chris served as Production Manager and Director of R&D at Synergetics, Inc., where he helped build operational frameworks for quality assurance and coordinated engineering teams to develop instruments used in neurosurgery and microsurgery. As a consultant with Protomedics, LLC, he advised on market-driven product strategies and design improvements.

Adrienne O’Reilly is a senior quality assurance leader with broad experience in biopharmaceuticals, drug–device combinations, and gene therapies. She has held quality leadership roles at companies including Immunovant, Savara, and Xeris, where she oversaw global GxP quality systems, inspection readiness, and compliance with FDA and EMA regulations. At Akyso Therapeutics, Ms. O’Reilly leads quality strategy for the iSTEP-N™ implant, ensuring rigorous standards across development, manufacturing, and clinical operations. Her expertise strengthens Akyso’s ability to deliver safe, reliable, and innovative long-acting therapies for patients with opioid use disorder.

Dr. Mary Ellen Cosenza is an accomplished regulatory affairs executive with more than 25 years of experience in global drug development. She served as Executive Director of U.S. Regulatory Affairs at Amgen, where she led regulatory strategy for multiple successful product approvals across therapeutic areas. At Akyso Therapeutics, Dr. Cosenza advises on regulatory pathways, IND strategy, and global compliance for the iSTEP-N™ implant. Her proven record of guiding novel therapies through FDA and EMA approval provides Akyso with unmatched regulatory expertise in advancing first-in-class drug–device combinations.

Martha Riddle is a senior regulatory affairs executive with over 30 years of experience in the development and implementation of global CMC regulatory strategies for small and large molecule products and for successful interactions with FDA and other global regulatory agencies. She has been responsible for successfully developing the CMC sections for numerous investigational drug applications, as well as multiple new drug marketing applications receiving approval in the United States, Canada, European Union, Australia, and Japan. Ms. Riddle was formerly Senior Director of CMC Regulatory Affairs at NantWorks; Director of CMC Regulatory Affairs at Abraxis BioScience; and Associate Director of CMC Proprietary Regulatory Affairs at Watson Pharmaceuticals. In her early career, she was the Manager of Regulatory Affairs at Marsam Pharmaceuticals and USL Pharma (formerly Rosemont Pharmaceutical Corporation); Manager of Regulatory Affairs/Regulatory Compliance at Granutec, Inc.; and Regulatory Affairs Coordinator at Sovereign Pharmaceuticals, Inc.