Challenge

A company had developed a technology for overcoming solubility issues in drug formulations and was planning to develop a small number of 505 (b)(2) candidate molecules. The client had already conducted an in-house assessment of opportunities, but requested Alacrita's support to provide an external expert assessment and to check if there were candidate molecules that had been overlooked by the internal team.

Solution

Working with one of Alacrita's formulations technology specialists, we screened FDA-approved molecules that were no longer covered by valid patents or that would lose patent protection in the coming three years. We identified molecules where hydrophobicity presents issues. We assessed these molecules for:

• Unmet needs inherent in currently marketed products (clinical, safety, patient convenience, HCP convenience);
• Value proposition of meeting identified needs;
• Bearable market price for improved product.

The final deliverable was a shortlist of potential candidate projects from which the client selected a subset for technical development.

Our Strategy & Commercialization Support

Whether you need guidance charting your optimal path to market, technical or market insight to prioritize your R&D portfolio, or strategic support to help you best position your biotech or program for a fundraising round, we can assist.

Our consultants average 20-30 years of industry experience and bring significant first-hand knowledge to every project. Our core team leverages our Expert Network, which contains over 90 expert strategy and commercialization consultants who specialize in specific technologies and disease areas, allowing us to provide precisely relevant expertise across the below functional disciplines: