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Clinical Outsourcing Topics: COG West Coast 2023


Clinical outsourcing allows pharmaceutical and biotech companies to access specialized expertise, innovative technologies, and global patient populations. By partnering with contract research organizations, sponsors can optimize clinical trial operations, accelerate enrolment, enhance data quality, and reduce costs.


Amongst a diverse range of topics, COG West Coast taking place this November in San Francisco, features a rich program of outsourcing specific presentations. I’ve featured 4 below delivered by representative of Terns Pharmaceuticals, August Research, Pfizer, and Alladapt Immunotherapeutics.


Attendance at COG West Coast is complimentary for those representing a Pharmaceutical, Biotech, Medical Device or Academic institution. Registration can be found here.



Phase I Outsourcing: Small Biotech Perspective


Nonnie Licona, Senior Director R&D Outsourcing, Contracts & Vendor Management at Terns Pharmaceuticals. Phase I trials require a significant investment for small biotech companies, with average costs estimated at $4 million. For a small biotech, selecting the right CRO and vendor partners is crucial to ensure optimal spending and maximize the likelihood of success.


In this case study Nonnie will share insights from past planning of a Phase I trial in non-alcoholic steatohepatitis (NASH). Nonnie will share the methods Terns utilized to engage potential CRO/vendor partners for this study. This will include details on their approach to identifying, assessing, and selecting partners best suited for a small biotech conducting an early phase trial. Attendees will gain an inside perspective on strategies for small biotechs to leverage when outsourcing phase I trials in order to align partners well to their needs and set their clinical program up for success.



Clinical Outsourcing Trends in 2023


Dana Leff Niedzielska, CEO at August Research will share a presentation focusing on outsourcing strategies for small biotech sponsors of clinical trials. Choosing the right CRO partner is critical for study success. The outsourcing market is constantly changing due to economic factors, regulations, and staffing issues.


Dana will share case studies from her experience at small and large CROs over 20 years. These case studies will illustrate effective and ineffective outsourcing models for small biotechs. Dana will also discuss recent outsourcing trends that are impacting 2023 models, providing insights into current best practices for small sponsors. The presentation will provide small biotechs with an understanding of key factors for successful CRO selection and partnership.



How to Leverage Vendors/ CROs


Todd Reul, Director – Clinical Outsourcing at Pfizer will draw from his experience working with small, medium, and large biotech companies to share methods for sponsors to gain leverage over CROs and vendors when conducting clinical trials.


Todd will provide insights and strategies for sponsors to optimize their partnerships with CROs/vendors, maximizing efficiency and outcomes when outsourcing clinical trial activities. The goal from this session is to equip sponsors, no matter their size, with effective tactics to drive optimal sponsor-CRO/vendor relationships and contractual terms, for successful trial execution.



Top 10 Tips for CRO Selection


Christopher Saunders, Executive Director Development Outsourcing at Alladapt Immunotherapeutics brings over 20 years of experience sourcing CROs for biotech and pharma companies across Europe and the US. He has recently been through the CRO selection process for a Phase III program. Based on his expertise, he will share his top 10 tips for effectively selecting a CRO partner.


Discussing best practice for engaging internal stakeholders when evaluating potential CRO partners. Securing alignment on CRO requirements and assessment criteria across internal teams. Chris will cover tactics for negotiating contract terms with shortlisted CROs to ensure optimal terms for the sponsor. Sharing the key criteria sponsors should utilize when assessing CROs during the partner selection process.



Further Reading:



Any questions? Reach out to me directly at djo@thepbcgroup.com

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