Planning for Phase 1 Success: Key Takeaways, Deb Kientop, Deka Biosciences

Deb Kientop, VP of Clinical Operations at Deka Biosciences, delivered an informative presentation on how to plan for success in Phase 1 clinical trials at COG New England 2024. The session covered a range of topics, from clinical development and protocol considerations to outsourcing strategies and site selection.

One of the key takeaways from Deb's presentation was the importance of creating a Target Product Profile (TPP) and a Clinical Development Plan (CDP) early in the process. These documents serve as a blueprint for the entire clinical research strategy, helping to define the critical path for the program and estimate resource requirements.

Deb also discussed the crucial questions that need to be answered by the clinical trial protocol, such as determining the optimal dose, toxicity, and safety profile of the drug in humans. She emphasised the importance of considering operational aspects, such as evaluating standard of care versus study requirements and their impact on site selection.

When deciding between outsourcing and conducting the trial in-house, Deb advised assessing available resources, expertise, and preparedness. If outsourcing is the chosen path, she recommended carefully evaluating CROs based on their experience in the relevant therapeutic area and the specific services required.

Deb also stressed the significance of building and maintaining relationships with sites and investigators, as these connections can greatly impact the success of the study. She suggested adopting strategies similar to the Medical Science Liaison (MSL) model to foster effective communication and engagement with sites.

Throughout the presentation, Deb highlighted the need to align clinical and corporate goals, ensuring that the Phase 1 study fits within the overall objectives of the company. She also shared a case study of Deka Biosciences' own experience in planning a Phase 1 trial, demonstrating how the company navigated challenges such as compressed timelines and complex protocol requirements by establishing strong partnerships and mitigating potential risks.