Stakeholder Engagement CROs, Vendors, and Sites. Driving the Business of Science. S1E5

In this episode of Driving the Business of Science, Stakeholder Engagement: CROs, Vendors, and Sites, Keith Parent, CEO of Court Square Group, discusses the complexities of stakeholder engagement in the life science industry with Kimberly Guedes, VP of Clinical Operations at Intensity Pharmaceuticals. Keith and Kim explore the challenges facing small biotechs when partnering with large CROs, emphasizing the need for fit for purpose, cost-effective solutions like RegDocs365™. Kim discusses the importance of selecting the right CROs and vendors, especially for niche therapeutic areas like CNS. Keith and Kim also discuss the high costs of clinical trials, the necessity of careful planning, and the impact of global regulatory differences. Additionally, Kim shares her involvement with the Alzheimer's Association and the importance of support for caregivers and patients.

Kim Guedes Background and Her Role at Intensity Pharmaceuticals
• Keith introduces Kim Guedes, VP of Clinical Operations at Intensity Pharmaceuticals, and asks her to provide background information.
• Kim shares her 30-year experience in the industry, including roles in academia, large pharma, smaller pharma, CROs, and start-up biotech.
• Keith highlights Kim's understanding of working with both CROs and sites from a clinical operations perspective.
• Kim discusses the differences between working in large pharma and start-up biotechs, emphasizing the hands-on approach in smaller companies.
Challenges of Working with CROs and Vendors
• Kim explains the importance of partnering with smaller to mid-size CROs for start-up biotechs due to resource limitations.
• She emphasizes the need for open conversations and input from CROs to gain insights into what works and what doesn't.
• Kim discusses the challenges of working with larger CROs who may not have adapted their SOPs for smaller biotechs and may require more hand-holding.
• Keith and Kim discuss the high costs of phase three studies and the need for cost-effective solutions.
Fit for Purpose and Cost Management
• Keith and Kim discuss the concept of "fit for purpose" and the importance of finding vendors that meet specific needs without excessive costs.
• Kim shares her experience with Court Square Group's RegDocs365 system, which provided a cost-effective solution for managing clinical and regulatory content.
• They discuss the importance of managing budgets and the challenges of dealing with high fees from CROs and vendors.
• Keith highlights the need for small companies to focus on spending money on science rather than IT systems.
Dealing with Startup Sites and Contract Negotiations
• Kim talks about the challenges of working with startup sites that use their fees as a revenue stream, sometimes without bringing in patients.
• She shares her approach to negotiating contracts with sites, including incentives for bringing in more patients.
• Kim emphasizes the importance of doing homework on sites to ensure they provide good data and are willing to work collaboratively.
• Keith and Kim discuss the importance of working with sites that are willing to be flexible and collaborative.
Kim's Involvement with the Alzheimer's Association
• Keith shifts the conversation to Kim's involvement with the Alzheimer's Association, where she is on the executive committee for the Ride to End Alzheimer's.
• Kim explains the importance of the Alzheimer's Association in supporting caregivers and patients, especially with the lack of federal funding.
• She shares her personal experience with the ride and the support it provides for research and patient care.
• Keith and Kim discuss the upcoming ride in Hampton Beach, New Hampshire, and the importance of raising awareness and funds for Alzheimer's research.
Global Expansion and Clinical Supply Chain Challenges
• Kim discusses Intensity Pharmaceuticals' global expansion and the challenges of working in different countries, including regulatory requirements and logistics.
• Keith shares his experience with a company working on the clinical supply chain of drugs, highlighting the complexities of transporting temperature-sensitive drugs.
• They discuss the importance of safeguarding drugs during transport and ensuring they arrive at their destination in good condition.
• Kim emphasizes the need for careful planning and collaboration with logistics providers to ensure the success of clinical trials in different countries.
Final Thoughts and Advice for Small Biotechs
• Kim provides final advice for small biotechs, emphasizing the importance of careful planning and methodical execution to save costs and meet timelines.
• She highlights the need for deep discussions with teams to ensure everyone is on the same page and working towards the same goals.
• They conclude the podcast with a focus on the importance of collaboration, careful planning, and effective vendor management in the life science industry