Executive Summary
Dr. James “Jim” Gilligan is a seasoned executive, scientist, and entrepreneur with more than 40 years in bio-pharmaceutical drug development. He has co-founded and helped lead multiple bio-pharma companies, including Tarsa Therapeutics, Unigene Labs, Herborium, Inc., and a biotech joint venture based in China, with particular depth in peptide-based therapeutics, from discovery and pharmacology through CMC, Phase I–III clinical development, and regulatory approval.
Over his career Jim served as Chief Scientific Officer and Co-Founder of Tarsa Therapeutics and as Vice President of Product Development at Unigene Laboratories, where he led major peptide programs partnered with GSK, Parke-Davis, and other industry collaborators focused on oral calcitonin and PTH therapeutics for musculoskeletal disease. He is inventor or co-inventor on more than 20 patents, several still pending, and co-author on manufacturing and formulation patents as well as peer-reviewed journal articles on novel therapeutic peptides and their clinical utility.
As a Managing Partner at The Bracken Group, Jim advises biotech and pharma clients on drug development and strategic planning, pharmacology and preclinical activities, CMC, due diligence, feasibility and licensing deals, and U.S. and international regulatory strategy, across musculoskeletal and cardiovascular disease and, more recently, psychedelic-assisted psychotherapy. Clients engage Jim when a program needs a scientist-executive who can connect bench science to development strategy and investor-ready decisions.
Areas of Expertise
Drug Development & Strategic Planning
End-to-end development strategy and roadmapping, from target and molecule selection through preclinical, clinical, and regulatory milestones.
Peptide-Based Therapeutics
Discovery, formulation, and clinical development of novel therapeutic peptides, including oral calcitonin and PTH programs for musculoskeletal disease.
Pharmacology, Preclinical & Toxicology
Pharmacology, toxicology, and preclinical activities that translate mechanism into a defensible, clinic-ready development package.
CMC & rDNA Product Development
Chemistry, manufacturing, and controls plus recombinant DNA product development, including manufacturing and formulation strategy for biologics and peptides.
Phase I–III Clinical & Regulatory Strategy
Design and execution of early and late phase clinical programs, with U.S. and international regulatory planning across the development lifecycle.
Due Diligence, Licensing & Partnerships
Scientific and commercial due diligence, feasibility assessment, and licensing deals, plus partnerships with investment bankers, venture capitalists, and brokers.
