Our approach in assessing pharmaceutical and biotechnology opportunities is a sophisticated technical due diligence process where we:
- address regulatory gaps and technical issues, using a Pharma-GPS devised tool to identify, prioritize, and manage technical risk; and
- evaluate the target product profile for alignment with preclinical and clinical study aims to assure adequate claims support and product differentiation from competitors.
Our team of Ph.D., MD, and MBA scientists are experts in their fields, while possessing broad-based knowledge in all functional areas and years of experience as part of team-based projects. This unique combination of skills permits rapid assessment of the technology and better focus on value-impacting areas.
Our clients for this service represent smaller companies and start-ups seeking to improve success in out-licensing their products, multinational companies/investors seeking a thorough technical evaluation of their in-licensing opportunities, and companies pursuing market entry into China. A similar approach can be used to conduct a mock due diligence prior to an actual technical due diligence by a potential licensee.
Our team will evaluate all available data on the product, to include regulatory, agency communications, CMC, pharmacology, preclinical safety and PK, clinical, and clinical protocols. A summary report will:
- identify and assess program-impacting risks, along with detailed risk mitigation options and probabilities of successful mitigation using an assessment tool that simplifies the analysis;
- recommend strategic options to build additional value for the licensing opportunity (e.g., phase 4 claims, life cycle management, IP strategy)
The assessment process typically is accomplished in 1-2 days in an on-site visit or online via a secure dataroom, with a final report available by 3 weeks.
Applying Our Product
The technology evaluation is organized and presented in a style and format that are familiar and persuasive to a multinational company or investor. It is easily adaptable to a nonconfidential presentation that can be used for partnering meetings and initial interactions with potential partners. We keep the focus on showcasing project strengths and mitigating liabilities, thereby maximizing the value of the opportunity and improving negotiating power.
Clients seeking assistance in evaluating their in-licensing prospects can
expect a report that analyzes the upside potential of the opportunity balanced against the probabilities of significant project risks remaining at any key investor milestones or the time of product registration. While identifying and managing risk is important, we also seek to uncover any hidden value that which may not have been apparent to the licensor.
When requested, Pharma-GPS can conduct a comprehensive market analysis/forecasting for target geographies, including dimensioning of issues involving formulary access and reimbursement potential.
Market-Entry into China
In collaboration with our partners in China, we:
- conduct technical due diligence of the opportunity, including an evaluation of intellectual property
- conduct market research on the commercial potential in China using proprietary databases
- work with the Chinese SFDA to clarify and negotiate favorable outcomes pre- and post-CTA