PharmaDirections

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Case Studies Since our founding, we have served pharmaceutical and biotechnology companies of all sizes, providing experienced scientific leadership and serving as integral parts of in-house teams to help advance preclinical and pharmaceutical development programs. To learn more, please review these examples of our results-driven implementation process, or contact us directly. Scientific Due Diligence for Technology Investment A company was in the late stages of due diligence on a licensing/investment for a ‘novel’ gastroretentive dosage form technology which claimed to increase bioavailability and reduce side effects of its molecule. PharmaDirections was tasked with review of the CMC data package to determine appropriate scientific justification for the drug claims... (click for more)> Strategic Development Plan for Lead Selection Through Proof of Concept Clinical Trial A venture firm considering an investment in a new discovery asset sought assistance from PharmaDirections to understand the costs required to reach major drug development milestones which triggered significant increases in asset valuation... (click for more)> Preclinical Assessment of Metabolite Contribution to Drug’s Mode of Action The Client wished to reformulate a reference-listed drug and use in a new indication. However, the drug’s primary pharmacologic effects were highly species specific and failed to correlate with drug plasma levels... (click for more)> Candidate Selection and Lead Optimization A company was in the early stages of constructing a pipeline of proprietary leads using a novel chemistry platform with the ability to transform the absorption and tissue uptake of known drugs. PharmaDirections was tasked with designing a preclinical research strategy that could demonstrate the full potential of the platform... (click for more)> Formulation Development of a Patent Protected Once Daily Controlled Release Oral Product The Client's proprietary scientific hypothesis suggested that a once daily controlled release oral formulation might convey better tolerability resulting in a competitive advantage. The Client sought PharmaDirections to perform the development of a proprietary controlled release formulation to lead their portfolio... (click for more)> In silico Pharmacokinetic Modeling to Reformulate Product for Lifecycle Extension The Client was exploring avenues for lifecycle extension by reformulating a twice-a-day marketed product into a once-a-day product. The Client approached PharmaDirections, to determine the feasibility and development path for reformulation... (click for more)> Reformulation to Achieve Acceptable Stability Profile for NDA Submission and Commercialization The Client had progressed into a Phase 3 clinical program with a controlled release combination drug formulation in which one of the drug substances exhibited an unacceptable long term stability profile. An alternate formulation had to be rapidly developed...

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