Alacrita was requested by the technology transfer function of a leading cancer research institute to produce a development plan for a very promising small molecule lead series against a novel anti-invasion/anti-metastasis target for solid tumours. The plan was required to support fund raising from venture capital investors. The complication was to demonstrate the prospective differentiation of inhibitors of this proprietary target versus recent new entrants in one of the targeted tumour types.

Alacrita consultants initially reviewed the published background 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 those in clinical development, in those areas to determine the most likely options for positioning.

Alacrita consultants then created a credible target therapeutic profile and positioning for a successful agent, and developed an outline screening cascade, combining the academic’s proprietary in vitro and in vivo activity assays with other assays relevant to the mechanism of action and an appropriate cascade of standard ADME, PK and toxicology screens, for lead optimization and a preclinical development plan. Indicative costs for process development and primary and secondary production of clinical trial materials were then produced. Lastly, strategic options for early stage clinical development were assessed and an integrated project plan and timetable produced. Finally, the overall plan, with a range of contingencies, was costed 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.

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