Enabling Adaptive Clinical Trials through Integrated Development and Manufacturing Solutions
The adoption of adaptive designs in clinical trials represents a paradigm shift towards a more efficient and flexible approach, overcoming the limitations of traditional fixed designs. Adaptive designs expedite and refine various aspects of the trial design, ultimately safeguarding patients from ineffective treatments. One of the operational challenges limiting the adoption of adaptive designs in clinical development programs is the time it takes to manufacture GMP clinical supplies at trial sites. A viable solution to this challenge is the manufacturing of formulations and dosage forms "on-demand," which not only enhances dosing flexibility but also considerably reduces development timelines and costs. It optimizes the use of active pharmaceutical ingredients (API) and supports decision-making in dose selection with real-time clinical data. In this webinar, industry experts will discuss how a manufacturing on-demand strategy can enhance your clinical development and improve drug supply utilization. Additionally, the experts will share how to ensure that your adaptive trial is appropriate for regulatory submission.
Key learning objectives:
- Gain insight into how an adaptive dosing protocol can be accommodated by a GMP-compliant manufacturing on demand approach, resulting in cost reduction, optimized resource utilization, and reduced API requirements and development time.
- Discuss the strategic use of extemporaneous approaches such as API or blend in bottle for reconstitution as a solution or suspension, or liquid or lipid formulations that allow for rapid formula adjustments and accurate dosing in early-stage development.
- Learn what regulators look for when evaluating an adaptive trial.
