Optimizing the Value Proposition in Small Companies with Limited Budgets

TBA

John Goldberg is the Chief Medical Officer for Rafael Holdings, Inc., a biotechnology company focused on investing in and developing life-changing medicines for patients and families living with challenging diseases. Prior to this role, John was the Chief Medical Officer at Oncorus, an oncolytic virus and RNA medicine oncology drug developer. In collaboration with the scientific and manufacturing teams, he was responsible for driving the clinical studies of Oncorus’ viral immunotherapies, and for ongoing development and regulatory strategies. He is a seasoned biotech executive and drug developer with 19 years of clinical trials experience across academia and industry. Other prior roles include Senior Medical Director at H3 Biomedicine, where he led the clinical trial of H3B-8800 (first spliceosome modulator in clinic), clinical development at Agenus, and the leadership of the pediatric oncology Phase 1 program at the University of Miami. John’s immunotherapy experience includes first-in-human neo-antigen vaccines, dendritic cell vaccine and GVAX trials, as well as checkpoint inhibitors and costimulatory agonists. He is a  pediatric oncologist with 18 years of experience treating children with cancer and enrolling patients in clinical trials. John received his pediatric hematology oncology training at the Dana-Farber Cancer Institute and Children’s Hospital Boston, and his general pediatrics training at the University of Rochester. John is a graduate of the University of Massachusetts Medical School and the college of the University of Chicago where he concentrated in the biological sciences.

Scott Harris has served as Chief Medical Officer of Altimmune (NASDAQ: ALT), a publicly traded company developing next generation peptide therapeutics for obesity and liver disease, since 2019. He has 20 years of experience of development in gastroenterology, hepatology and metabolism therapeutics. He co-founded Lyric Pharmaceuticals in 2015, where he raised a $20.8 M Series A financing round and served as its Chief Medical Officer. Dr Harris also served as Chief Medical Officer of Avaxia Biologics and Ocera Therapeutics, and he headed clinical development at Napo Pharmaceuticals, where he authored the ADVENT study, the first Phase 2/3 adaptive trial to result in a drug approval (Mytesi®, 2012). He has collaborated with the FDA Division of Gastroenterology and the American Gastroenterological Association on sponsored forums on drug development and clinical trial design. Dr Harris has an MD from Harvard Medical School. He completed medical residencies at John Hopkins Hospital and the University of Pennsylvania and a Gastroenterology and Hepatology Fellowship at Yale University School of Medicine. He serves on the scientific advisory board of Protagonist Therapeutics and RedHill Biopharmaceuticals and holds a seat on the faculty of Georgetown University School of Medicine, where he teaches a graduate course in drug development.

Dr Jen Seda is a seasoned medical executive with over 20 years of experience specializing in rare diseases, medical devices, and innovative therapeutics, always prioritizing patient well-being. She excels in developing corporate portfolio strategies and guiding teams through medical and clinical execution. At SSI Strategy, Dr Seda offers interim leadership from VP to CMO levels, advising medical executives and leading teams to develop solutions for clients at various developmental stages. With 5 years in gene therapy, 15 years in rare disease, and 2 years in digital diagnostics and therapeutics. Prior to joining SSI, Dr Seda served as interim CMO/VP at biologics, gene therapy, and digital diagnostic firms, successfully navigating pivotal moments such as Series B rounds, IPOs, and acquisitions, ensuring milestone achievement and facilitating clinical trials and medical affairs activities. She also held the role of VP of Market Access, Government, and Medical Affairs at TerumoBCT, a global device company, overseeing various Therapeutic areas. She also led the Global Medical Affairs team at Baxter Healthcare’s Biologics division, overseeing launches in rare disease within pulmonology and neurology. She has helped build robust medical affairs and medical information teams, at Coviden’s Respiratory and Monitoring division, and led both medical affairs and marketing teams at Talecris Biotherapeutics to market leadership in rare disease. Dr Seda holds a medical degree from the Mayo Clinic, with neuroimmunology training, and completed her undergraduate studies at U.C. Irvine. Her extensive experience, ranging from preclinical work at Amgen to strategic planning from bench to bedside, underscores her comprehensive expertise in the medical field.