Case Studies
Strategic Planning
Scientific Due Diligence for Technology Investment
Benefits of Case:
• Prevented company from making a poor investment: saving cost associated with technology investment along with down-stream reformulation and manufacturing efforts
Background and Challenge:
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 along with any relevant reformulation strategies.
PharmaDirections Strategy:
• Assemble an expert, cross-disciplinary team to evaluate the dosage form technology and existing scientific data for the selected drug
• Analyze technology mechanism and effect to determine the scientific rationale for the proposed product by combining in silico modeling, formulation, and manufacturing expertise
The Objectives:
PharmaDirections assembled a cross-disciplinary team of formulation development, PK/PD and preclinical development experts to review the technology data package. Per the primary objective requested by the client, the expert team concluded the formulation approach to a gastroretentive dose form was acceptable and would have a high probability of success in delivering drug to the upper portion of the small intestine. While the expert team concluded that the data package looked good and would be sufficient for regulatory submission (the primary objective as requested by the client), it had concerns about the technology, itself. Utilizing in silico modeling to examine the gastro-effect, the team determined it could quickly create a cheaper competitive drug with the same or better bioavailability and side effect characteristics.
Value for the Client:
• The Client saved cost associated with investing/licensing specific technology as well as downstream cost associated with potential development and manufacturing efforts
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Strategic Development Plan for Lead Selection Through Proof of Concept Clinical Trial
Benefits of Case:
• Reduced Development Risk
• Detailed task, timeline and cost roadmap to critical development milestones
• Selected the lead program from over 200 candidates
• Raised a syndicated Series A round of $15 million
• Increased asset valuation and validate investment
Background and Challenge:
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.
PharmaDirections Strategy:
• Assemble an expert, cross-disciplinary team to evaluate the asset
• Start with the clinical endpoint (the client’s milestone) that would drive asset valuation
• Perform a gap analysis of the existing data package to determine the missing elements required for clinical success
• Develop a comprehensive strategic preclinical development plan with detailed timeline and price table
The Objectives:
PharmaDirections assembled a cross-disciplinary team of experts to design the most efficient strategic plan to navigate the path from lead selection through proof of concept. The strategic plan addressed preclinical safety and toxicology, the CMC strategy and program, and the regulatory steps which balanced the development risk with optimal use of financial resources. The final strategic plan included a detailed narrative with respective Gantt chart indicating specific timelines and cost for each task including key assumptions and risk assessment.
Value for the Client:
• Armed with a detailed plan to achieve valuation milestones, our venture client validated their investment in the asset and became the lead investor in a $15million Series A round
• The Board of Directors utilized the comprehensive strategic development plan to manage the new company
• Clear lead program with focused direction
• Virtual project with no investment in fixed assets (salaries)
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