30-year biopharmaceutical industry veteran with senior leadership across operations, strategy, M&A, and therapeutic licensing. Proven clinical development leader who has advanced 20+ regulated medical technologies to market under FDA standards, including programs addressing patients with significant unmet medical needs. Broad therapeutic depth spanning cardiology, neurology, oncology, and gene therapy. Recognized dealmaker with a strong record of forging strategic partnerships that accelerate innovation and commercialize breakthrough treatments. Led multiple successful divestitures and product sales to top-tier industry players, including SmithKline, Sanofi, Merck, and Pasteur Merieux.

30-year industry career including large pharma and small biotech leading the development of new medicines in cancer, inflammation, fibrosis, osteoporosis, respiratory and lymphatic disorders. Advanced dozens of therapeutic drug programs from discovery and preclinical development through Phase 1 and beyond. Authored more than 30 scientific publications and 12 therapeutic drug patents. PhD in molecular biophysics. Postdoctoral training in clinical pharmacology and immunology at Vanderbilt University.

Allan and Tina Neill Professor of Lymphatic Research and Medicine at Stanford University School of Medicine. A fellow of the American College of Cardiology, American College of Angiology, and American College of Physicians, as well as a member of the International Society of Lymphology, American Society of Internal Medicine, the Society of Vascular Medicine and Biology, and the Paul Dudley White Society. As a principal investigator or co-investigator, he has led numerous clinical trials researching various aspects of lymphatic disease, vascular biology and cardiovascular medicine. Editor-in-Chief of Lymphatic Research and Biology. Co-founder of LE&RN. Medical degree from Duke University School of Medicine, internship and residency training in internal medicine at the Peter Bent Brigham Hospital of Harvard Medical School, and fellowship training in the cardiac unit of Massachusetts General Hospital, Harvard Medical School.

25 years of branded and generic pharma experience covering a full spectrum of dosage forms. Expertise working from discovery to post-marketing phases, with extensive experience managing US and International CRO/CMOs for the manufacturing of cGMP APIs and DP with thorough knowledge of relevant FDA and EMA regulations. Authored 15 FDA, EMA and Health Canada regulatory submissions and was the leader of CMC program for major orphan NDA nasal spray. PhD in Food science with an emphasis on analytical chemistry and toxicology from Rutgers University.

Manages preclinical drug development teams, advises on strategy, and acts as a logistical conduit between client leadership, scientists, SMEs, vendors, and other program stakeholders. Led dozens of therapeutic programs in a wide range of modalities, indications, and stages of development. Ph.D. in molecular biology and biochemistry from Loyola University Chicago.

More than 20 years of experience in regulatory and strategic consulting, providing regulatory guidance to Sponsors throughout all stages of their development programs across various therapeutic areas. Expertise developing and reviewing major global submissions, including investigational applications (INDs/CTAs) and marketing applications (NDAs/MAAs), and guiding Sponsors through milestone interactions with regulatory authorities in the US, Canada, EU, and UK. Collaborates with cross-functional teams to deliver high-quality regulatory advice supporting a range of products and programs, from small molecules to live biotherapeutic products. Experienced in leading product development plans, regulatory roadmaps, gap analyses, and due-diligence activities.

Supports the strategic planning and execution of Celltaxis's clinical development programs, working closely with the leadership team to evaluate development pathways, shape regulatory strategy and clinical trial design, and guide site engagement, CRO selection, and operational delivery. More than 25 years of experience in clinical research, with senior leadership positions across pharmaceutical companies, CROs, Phase 1 clinical units, and clinical research sites. Expertise spanning clinical development strategy, early-phase research, site networks, operational execution, quality systems, regulatory inspection readiness, and sponsor oversight, including establishing MHRA-accredited Phase 1 units and leading global clinical programs. Her approach combines scientific rigor, operational practicality, and a focus on development pathways that are attractive to regulators, investigators, patients, and potential partners.

Passionate drug hunter with expertise in Discovery and Translational R&D spanning oncology, inflammation, autoimmune disorders, and reproductive biology. Over 12 years of experience advancing small molecule programs from target selection through preclinical proof-of-concept and de-risking. Proven leader of cross-functional teams and global CRO networks. Co-founder of a discovery-stage startup in the reproductive health space. PhD in Chemistry from the University of Wisconsin–Madison and postdoctoral training in Chemical Biology and Developmental Biology from Stanford University.

Well-known biostatistician with a long history supporting clinical trials. A senior member of the Biostatistics faculty at the Harvard School of Public Health and the Department of Surgery at Harvard Medical School, where he was affiliated for over 25 years. Co-founded Boston Biostatistics Inc, which became Averion International and then Aptiv Solutions before its acquisition by ICON plc in 2014, and founded the Boston Biostatistics Research Foundation, Lavin Consulting, and Melior Capital Management. Author or co-author of more than 200 peer-reviewed publications and the first to propose that Phase 2 oncology studies use tumor measurements rather than binary response outcomes. Has served as Lead Biostatistician for 90 FDA approvals and clearances to date—including PMAs, NDAs, BLAs, 510(k)s, de novos, and an HDE—on the basis of which over 250 million people have been treated, diagnosed, or monitored. PhD in Applied Mathematics from Brown University. The first and only person elected a Fellow of both the American Statistical Association and the Regulatory Affairs Professional Society, and an FDA Special Government Employee for 33 years.