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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...
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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...
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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...
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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...
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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...
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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...
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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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Risk Mitigation and Formulation Development of a Once Daily Controlled Release Oral Product
The Client identified a medical and market advantage to introducing a once-daily dose form (with improved tolerability) to compete with commercially available immediate release product marketed by another pharmaceutical firm...
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Technical Transfer of Manufacturing Methods and Processes
The Client obtained rights to develop an investigational drug for a series of new indications. The Client required rapid turnaround on transfer of manufacturing and analytical methods, along with exploratory formulation research on different excipients and dose strengths...
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NDA Regulatory Support and Strategy for Manufacturing Technology Transfer and Commercialization
The Client required a technical transfer of partially developed manufacturing process from an overseas CRO/CMO to the US for commercialization...
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Locate Customized Manufacturing Capability
Without success, the Client searched for nearly a year to find a CMO that would accommodate a manufacturing process requiring a large piece of customized processing equipment to be placed under Class 100 laminar air flow conditions between the aseptic filling and capping processes...
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Drug Development and CMC Budget, Planning and Schedule Process
The Client was a development-stage company which had just completed series B financing and had achieved favorable results from the proof of concept clinical trials on its drug candidates. The Client was actively pursuing several goals: 1) additional financing, 2) joint development partnership with a ‘big pharma’ company and 3) entering the public market...
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Project Management for Just-in-Time (JIT) Manufacturing
Five stakeholders on 2 continents and 3 countries needed an International vendor process that was consistently repeatable in multiple campaigns to meet clinical window and optimize use of CTM...
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Phase 1 Clinical Bioequivalence Study for Accelerated FDA Submission
PharmaDirections’ Client was aggressively placing and supplying Phase 3 clinical trials. Due to the volume demands of the large scale Phase 2 work, the Client decided to move manufacturing locations...
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CMC Regulatory Strategy to Accelerate Entry into Phase 3
The Client was a Phase 2 company having just completed and achieved
favorable results from the proof of concept clinical trials on its drug candidate. They were actively pursuing several options for starting Phase 3...
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