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Preclinical Trial Design: Advancing Research in Neuropathic and Cancer Pain
Challenge:
A small pharmaceutical company, in collaboration with an investigator from a major academic research center, sought to test the efficacy of a drug in murine models for neuropathic and cancer pain. The partners required a robust preclinical trial design to demonstrate proof of concept and facilitate progression toward commercialization, while aligning experimental approaches with industry standards.
Solution:
To address these needs, we reviewed the current dataset from recently completed trials, complemented by an extensive literature review to inform the trial design. Our team provided expert guidance on in vitro cell requirements, co-culture experimental design, and the scientific assays necessary to establish proof of concept and progress to in vivo trials. Additionally, we facilitated strategic partnerships between the collaborators and leading research centers to drive the project’s advancement toward commercialization.
Outcomes
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Strategic Data Integration: Established a clear understanding of internal data and defined success metrics to guide the trial’s progression.
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Holistic Research Evolution: Supported a seamless transition from in vitro to in vivo and ex vivo studies, ensuring a cohesive narrative for the research.
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Collaborative Ecosystem: Facilitated connections with research scientists, pathologists, electrophysiologists, and funding entities to strengthen the project's foundation.
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Scientific Impact: Contributed to multiple publications in top-tier pain research journals, enhancing the project’s visibility and credibility.
Key Takeaway
By providing scientific expertise and fostering strategic collaborations, this project advanced from early in vitro studies to comprehensive preclinical models, setting a strong foundation for breakthrough treatments in neuropathic and cancer pain.