The technology transfer function of a leading cancer research institute needed a development plan for a promising small molecule lead series against a novel anti-invasion/anti-metastasis target for solid tumors. The plan was required to support fundraising from venture capital investors with the complication of demonstrating the prospective differentiation of inhibitors for this proprietary target versus recent new entrants.
Our consultants reviewed the scientific literature and the lead academic’s proprietary results to determine therapeutic areas where the known activity provided the most compelling rationale. We then assessed the competitive landscape, both for marketed drugs and for those in clinical development, to determine the most likely options for positioning. Next we created a credible target therapeutic profile and positioning for a successful agent, developing an outline screening cascade, combining the academic’s proprietary in vitro and in vivo assays with others relevant to the mechanism of action and a cascade of standard ADME, PK and toxicology screens. This was to create an optimization and a preclinical development plan for the lead product. Indicative costs for process development and primary and secondary production of clinical trial materials were then produced. We assessed strategic options for early-stage clinical development and produced an integrated project plan and timetable. Finally, we costed the overall plan, with a range of contingencies, to provide a funding requirement for the project. The client then successfully used the plan to obtain a term sheet from a venture capital investor.