Strategies to Mitigate Vendor-Related Risks in Your First-in-Human Clinical Trials—Real Cases with Vendors Contracting

About this session

JJP Biologics is a small biopharma company that is focused on monoclonal antibodies research. In general, proteins are challenging entities in development. Thus, mitigating vendor-related risks in first-in-human clinical trials is crucial for safe and efficient drug development. Through real-world cases, we would like to show best practices in vendor qualification selection through due diligence. We will present our approach to proposing clear and comprehensive contracts/agreements that define roles, responsibilities, deliverables, timelines, and quality expectations. Methods to ensure vendors have robust quality management systems and Standard Operating Procedures (SOPs) in place are also within the presentation scope. We will discuss how to adopt a risk-based approach to vendor oversight, focusing resources on higher-risk activities. Last, we will also advise on how to prepare a valid Request for Proposal and how to compare proposals in order to, on the one hand, ensure coverage of the entire scope of work and, on the other hand, be able to effectively compare bids from different suppliers.

Speaker

• DL

  Dawid Lyzwa

  Head of Clinical Development · JJP Biologics

  Speaker