Pharmaceutical product development

Our expert teams are ready to support you through every step of the pharmaceutical product development process, leveraging our scientific, clinical and commercial expertise to help you maximize value at each stage.

Our expert consultants provide expert advice in all areas of the product development process, drawing upon in-industry experience to develop preclinical strategies, direct or execute development plans and provide many other aspects of pharmaceutical product development.


Case study: pharmaceutical development plan to support fundraising

Challenge

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 pharmaceutical product development 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.

Solution

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. We then generated indicative costs for process development and primary and secondary production of clinical trial materials. We assessed strategic options for early-stage clinical development and produced an integrated project plan and timetable.

Finally, we costed the overall pharmaceutical product development 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.

Learn more about how Alacrita’s experts provide drug development consultancy by reading our other case studies on pharmaceutical product development here.

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