Expertise spans basic research through Phase I and includes IND-enabling pharmacology, efficacy and mechanistic studies using a variety of therapeutic strategies. Experience in multiple clinical areas including cancer, autoimmunity, inflammation, metabolics, hematology and pain.
Identifying client needs, developing and implementing preclinical/translational R & D strategy, compiling and adhering to project plans and budgets.
Performing literature-based project assessments, designing and implementing study protocols and integrating study results into ongoing development plans.
Evaluating, selecting and managing appropriate contract research organizations (CROs) and academic collaborators.
Performing scientific and intellectual property due-diligence on new corporate ventures and product in-licensing opportunities.
Writing relevant sections of INDs, business plans, reports, manuscripts, grants and other scientific and corporate documents.
Designed and implemented IND-enabling preclinical strategy for oncology therapeutic now in Phase II. Evaluated and directed CROs to perform a series of in vitro/in vivo studies including mechanism of action, efficacy in orthotopic and metastatic xenograft models, pharmacokinetic and biodistribution studies.
Developed and implemented preclinical strategy for a series of biologics, one of which is now in Phase I. Performed literature-based assessments of novel therapeutic agents for autoimmune disease and transplantation, followed by immunoassay development, in vitro mechanism of action studies and in vivo efficacy and biomarker experiments performed by CROs.
Designed and implemented preclinical pharmacokinetic and pharmacodynamic studies in rodents and non human primates. Data were used to determine optimal dosage for each therapeutic in in vivo efficacy studies in autoimmune/inflammatory, metabolic/endocrinology and xenograft models.
Implemented studies to document the in vitro activity and in vivo efficacy and toxicity of a targeted oncology therapeutic both as a single agent and in combination with standard cytotoxic drugs. Compound is now in Phase I.
Provided scientific evaluation of new corporate ventures. Assessed scientific and clinical data and evaluated input from thought leaders in the field. Proposed internal preclinical development strategy for chosen corporate ventures.
Evaluated intellectual property position of a variety of therapeutic and diagnostic approaches for potential new partnership opportunities.
Worked with team to write and submit INDs including obtaining, analyzing and graphing data from IND enabling studies and writing a series of study reports.
Wrote business plans, Investigator Brochures, INDs, grants and manuscripts.
Represented company at scientific meetings, presented findings and initiated collaborations with industrial, academic and government institutions.
Ph.D. Cancer Biology, Stanford University, Stanford, CA.
B.S. Molecular Genetics, University of Rochester, NY.