Turning an academic discovery into a viable biotech company requires not just scientific promise but also strategic planning, development foresight, and early operational clarity. We support academic founders and early-stage biotech teams, whether launching companies around licensed technologies or spinning out from university labs, by turning scientific concepts into development-ready programs.

Representative work includes partnering with a founder-led startup to assess technology potential, map the competitive landscape, and plan for preclinical package readiness. Engagements like these help teams build credible, investable strategies aligned with early development milestones.

Evaluating therapeutic assets and platform technologies requires not just scientific insight but also a clear understanding of feasibility, differentiation, and executional risk. We help development teams and investors navigate licensing and investment decisions with confidence by combining technical analysis with strategic perspective.

Our engagements have included supporting diligence on a licensed clinical asset to uncover root causes of manufacturing challenges and inform executive decision-making during a pivotal-stage program. Work like this helps teams de-risk development paths, align strategy with operational realities, and make confident, data-informed decisions at critical inflection points.

Bringing in external assets means more than securing a license; it involves aligning development strategy, organizational capabilities, and technical expectations. We guide biotech teams in evaluating the feasibility and operational fit of in-licensed programs, including comparability planning, product characterization, and integration with existing infrastructure.

Our experience includes facilitating the integration of in-licensed clinical assets, with a focus on comparability strategy, product characterization, and transfer readiness planning. Work like this helps teams integrate external programs more effectively, reduce risk across CMC functions, and advance development with greater speed and alignment.

Achieving regulatory milestones depends on the execution of a development strategy that aligns technical rigor, organizational readiness, and program milestones. We work with organizations to design or evolve phase-appropriate CMC roadmaps that integrate process, analytical, and quality strategies from the outset.

We’ve led efforts to guide a preclinical asset to IND clearance within 12 months, supporting CMC readiness through development strategy, external partner coordination, and clinical manufacturing preparation. This support enables teams to anticipate regulatory expectations, align technical and operational execution with development timelines, and minimize downstream program issues.