Reviving Shelved Assets
Unlocking Clinical Potential through Innovation
Client Overview: A large pharmaceutical company approached GOTBio to review multiple drug assets that had been shelved due to a range of issues, including scientific concerns, management conflicts, and regulatory challenges. Over hundreds of millions of dollars had been invested in these assets, and the company sought an external, unbiased perspective to assess their science and clinical value and potential for repurposing.
GOTBio’s Objectives:
- Provide a comprehensive analysis of each asset’s history, including development milestones, manufacturing issues, and patent constraints.
- Investigate the underlying reasons for shelving the assets, whether scientific, managerial or related to regulatory and patent hurdles.
- Evaluate the feasibility of repurposing these assets for new therapeutic applications, identifying any concerns related to safety, efficacy, and investment.
- Use GOTBio’s innovative approaches, leveraging bioinformatics tools and expert networks, to find solutions and potential new uses for these assets.
Assessment Approach: GOTBio adopted a multi-disciplinary innovation process, integrating bioinformatics tools, literature reviews, and a network of experts in pharmacology, regulatory affairs, science, and clinical development. The team focused on analyzing the assets’ chemical profiles, known safety data, preclinical/clinical data, and potential biomarkers and off-target effects that could provide insight into alternative therapeutic areas.
- Development History Review:
- Each drug asset’s development timeline was mapped, identifying critical points where challenges arose, whether scientific, managerial, or regulatory. This included identifying potential manufacturing bottlenecks and patent expiration or protection issues.
- Regulatory Analysis:
- A detailed evaluation of regulatory challenges faced by each asset was conducted. GOTBio’s regulatory experts outlined strategies for overcoming previously identified hurdles and mitigating future issues.
- Investment and Cost-Benefit Analysis:
- GOTBio examined previous and ongoing costs associated with the assets and provided an updated financial analysis of what it would cost to repurpose these drugs. This included conducting a cost-benefit analysis of potential new indications compared to the original targets.
- In-depth Drug Target and Clinical Indication Analysis:
- GOTBio performed an in-depth analysis of the proposed drug targets and their originally intended clinical indications. This analysis included evaluating the latest scientific literature, clinical trial outcomes, and any emerging data on similar targets or indications. The team assessed the biological relevance of the drug target, its mechanism of action, and whether it remained a viable therapeutic option based on current medical knowledge using deep literature interrogations, bioinformatics, biomarker analyses, and clinical trial knowledge. This step also helped identify potential alternative clinical indications that the drug might better serve.
Proposed Solutions: Through rigorous analysis and expert consultation, GOTBio identified several key solutions to address the previous concerns, including:
- Innovative Repurposing:
- GOTBio identified potential new applications for several assets based on emerging clinical needs, such as targeting secondary therapeutic areas with unmet medical needs. For example, an asset initially developed for cardiovascular diseases showed potential as a treatment for rare metabolic disorders based on bioinformatics predictions, biomarker changes, and off-target effects data.
- Manufacturing Optimization:
- GOTBio’s manufacturing consultants identified opportunities to streamline production, addressing previously flagged and antiquated inefficiencies, which significantly reduced production costs and timelines for repurposing.
- Regulatory Strategy:
- A strategy for navigating regulatory challenges was provided, including suggestions for new indications that might fall under more favorable regulatory pathways, such as orphan drug status or fast-track designations. This approach reduced the time and cost burden for clinical re-entry.
- Patent & Intellectual Property Review:
- GOTBio worked with intellectual property (IP) experts to extend or revise the patent strategy for assets nearing expiration, ensuring that any newly repurposed drugs would have adequate IP protection to maximize their commercial potential.
- Cross-disciplinary Solutions:
- Leveraging GOTBio’s cross-disciplinary network, the team addressed managerial concerns by facilitating new collaborations between the client’s internal teams and external innovation experts. This included fostering a culture of innovation to overcome organizational stagnation.
Outcomes: Several assets were found to have real value in today’s clinical space and are currently undergoing further development for new therapeutic areas. GOTBio’s innovative process led to the identification of cost-effective solutions and strategies to move these assets forward, bringing them back into clinical pipelines with strong commercial potential. These efforts provided the company with several new candidates to reintroduce into their product pipeline, giving new life to previously shelved drugs and expanding their portfolio.
Additionally, one asset, after being identified as highly suitable for development in a different therapeutic area, was sold to another company. This sale allowed the client to recover a significant portion of their initial investment in the asset, turning a previously stagnant resource into a profitable venture.
By addressing past challenges and leveraging cutting-edge bioinformatics and regulatory expertise, GOTBio helped unlock hidden value, ultimately contributing to both immediate financial returns and long-term pipeline growth.
Conclusion: GOTBio’s expert-driven, cross-disciplinary approach provided the client with a comprehensive solution to repurpose their shelved assets, delivering new opportunities for clinical and commercial success. By addressing previous scientific concerns, regulatory hurdles, and management issues, GOTBio transformed inactive drug assets into viable candidates for new therapeutic indications, including one asset being sold to recover investments.
