I bring the following to consultations:

• Two decades as an academic surgical oncologist, followed by two decades in cancer drug development, with advanced qualifications in AI/ML, digital technology, regulatory affairs and public health from Harvard, MIT, Johns Hopkins, and UC Berkeley (MD, MPH, MS, FACS, FSSO).

• A record of successfully developed medicinal drugs at Pfizer and AstraZeneca, focused on small-molecule signal transduction inhibitors (most recently RAS and adjacent pathways), immunotherapy and other biologics, bifunctional antibodies, ADCs, and cancer vaccines.

• Experience across Phase 1 to Phase 3 trials, including IND and NDA filings, FDA interactions, which included the prevention of clinical holds.

• Medical safety and pharmacovigilance judgment, including expedited FDA safety reporting and the assessment of serious and unexpected adverse reactions.

• Command of complex regulatory filings, grounded in both clinical development from the oncology and medical perspective and regulatory requirements under the CFR and EU Regulations and Directives.

• Agentic AI for clinical trial operations, including developing TrialTriage, a semi-autonomous prescreening workflow, alongside AI and machine-learning methods for trial data analysis.