Edward Schnipper, MD
Clinical Development
Ed is an oncology clinical-development leader with decades of experience advancing cancer therapies from clinical strategy through regulatory approval. Ed held senior clinical-development roles at Hoffmann-La Roche, SEQUUS, and ALZA, where he led the clinical development work behind Doxil's FDA approvals, the first liposomal doxorubicin-derivative approved to treat a solid tumor.
Adam George, PharmD
Regulatory
Adam is a regulatory affairs leader with deep FDA and industry experience across oncology drug development. A former FDA clinical reviewer in the Office of Hematology and Oncology Products and senior reviewer in the Office of Prescription Drug Promotion, Adam brings first-hand experience reviewing INDs and NDAs including 505(b)(2) submissions. He previously held senior regulatory roles at Teva Pharmaceuticals and PureTech Health.
Philip Sager, MD
Cardiovascular Safety
Philip is a cardiologist and electrophysiologist with deep expertise in cardiovascular safety assessment for drug development. He has held senior industry and academic roles, served in leadership roles related to ICH E14 and the Cardiac Safety Research Consortium, and is a past chair of the FDA Cardio-Renal Advisory Committee. He has advised industry and regulatory agencies on cardiovascular risk assessment across development-stage and approved products.
William Mikrut, MSc
Biometrics
Bill is a biometrics and biostatistics leader with over 30 years of experience supporting late-stage clinical development, including FDA interactions, Phase 3 trial design, integrated efficacy and safety analyses, and NDA submissions.
Joyce James, PhD
Clinical Pharmacology
Joyce is a clinical pharmacology leader with deep experience spanning PK/PD, ADME, bioanalytical strategy, and drug metabolism. She has led early-development and clinical-pharmacology functions at Odonate Therapeutics and Lyric Pharmaceuticals, held senior clinical pharmacology and DMPK roles at Ambit Biosciences and Cytokinetics, and previously served as a Research Fellow at Merck Research Laboratories.
Scott Rudge, PhD
CMC
Scott is a CMC and pharmaceutical operations leader with more than three decades of experience directing process engineering, process development, product development, technology transfer, validation, and manufacturing strategy for biopharmaceutical products. He co-founded RMC Pharmaceutical Solutions, later acquired by Syner-G BioPharma Group, and has built and led technical teams across the biopharmaceutical industry.
Michael Shuster, PhD, JD
Intellectual Property
Michael is a life sciences intellectual property attorney with deep experience advising pharmaceutical companies on patent strategy, portfolio analysis, diligence, prosecution, litigation, and transactional IP matters. Michael is a partner in Goodwin's Life Sciences group. Prior to joining Goodwin, Michael co-headed the Life Sciences group at Fenwick & West LLP. Michael supports Gemini Therapeutics' intellectual property strategy, including portfolio positioning, diligence, partnering, and transaction-related IP issues for aldoxorubicin.
Asher is a life sciences corporate and transactions attorney with extensive experience advising public and private biotechnology and pharmaceutical companies across financing, licensing, collaboration, joint venture, M&A, governance, and outside general counsel matters. A partner at Sidley Austin and co-leader of its global Technology and Life Sciences Transactions practice, Asher supports Gemini Therapeutics' corporate strategy, governance, partnering, and transaction execution for aldoxorubicin.