Preclinical Development Discussion: The "Black Box" between Med Chem and Clinical
Dave Garman
Independent Consultant, Consultant
A discussion with pharma leaders on the roadmap for early development with Tox, ADME, CMC and Phase 1 clinical design. Topics include Toxicity program for peptides, how to pick clinical dose, and preclinical to clinical translation. Panelists brought their experiences and discussed lessons learned in short presentations and a moderated roundtable.
Until recently, Dave Garman was the Chief Technology Officer for NoNO Inc, a biotechnology company directed at the development of novel peptide therapeutics to treat neurological disorders with unmet medical needs. His roles encompassed most aspects of the development of a peptide therapeutic for the treatment of stroke from initial animal studies in the laboratory through global Phase 3 clinical trials. Dr. Garman’s primary responsibilities include all aspects of manufacturing and regulatory interactions related to CMC, preclinical safety pharmacology and toxicity assessment of peptide therapeutics, intellectual property and the development of both next generation and novel peptide therapeutics for the company pipeline.