Addressing Preclinical Gaps in Biotech Trials
To prevent delays in biotech trials, it is crucial to address preclinical gaps and ensure early toxicology readiness, as well as strong scientific collaboration with CRO partners.
Ben Edwards, chief operating officer at Avance Clinical, emphasized the importance of addressing preclinical package gaps to avoid delays and creating a sound scientific argument for new drugs.
Key factors to accelerate trial startup and regulatory approval include:
- Obtaining patient data early to inform decision-making
- Utilizing CROs with deep scientific capabilities
- Adopting adaptive trial designs
- Maintaining continuity with the same CRO
- Effective coordination across functions through integrated teams and data visualization
Author's summary: Addressing preclinical gaps is crucial for biotech trial success.
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