Phase 1 Strategy, Simplified
We’re your strategic partner from first idea to regulatory approval
About Stone Lake Consulting
What We Do
Led by a recent FDA medical review officer, Stone Lake Consulting provides strategic guidance for complex early-phase clinical trials. We help biotech teams navigate regulatory expectations, optimize trial design, and make confident decisions. Our approach reduces waste, manages risk, and accelerates progress toward meaningful clinical outcomes.
Who We Are
Jason Steinberg is a double board-certified oncologist and seasoned clinical development expert with experience as an FDA reviewer, medical monitor, and trial principal investigator. At Stone Lake Consulting, he provides strategic guidance across therapeutic areas, with a focus on early-phase trial design and regulatory insight.
Stacy Siegel brings a unique blend of legal expertise and business acumen to Stone Lake Consulting, where she leads strategic planning, operational execution, and the firm's growth initiatives. Her background in biotech and health law, with an expertise in clinical trials, informs the firm’s mission to deliver high-impact consulting solutions.