Archives: Agenda

• Working closely with FSP vendors: how much oversight do you need?
• Benefits and challenges of moving to an FSP outsourcing model
• Comparing vendor management strategies between pharma and biotechs: do you need a different
approach?
• Why is FSP becoming a popular outsourcing model: what benefits can this offer sponsors?

MODERATOR:
Rich Polgar, Managing Director, Danforth Advisors

PANELLISTS:
Melanie Goodwin, Director, Clinical Outsourcing,
Immunocore
Russell Bland, Director, Clinical Outsourcing and
Innovation, Jazz Pharmaceuticals
Terry Katz, Senior Director, Biostatistics and Data
Management Planning and Functional Excellence, Daiichi
Sankyo, Inc

Clinical R&D outsourcing needs and models have evolved over the last few years. Many biopharma companies are transitioning to a function-driven sourcing model where we can have a set of fit-for-purpose preferred suppliers to bring in flexibility and agility. Challenges in sourcing needs, pros and cons of different sourcing models will be discussed.

• Addressing historical issues with trial recruitment in certain populations in order to ensure diversity
• Community outreach as a method to reduce distrust around clinical trial participation
• Sourcing new sites in communities with high numbers of under-represented populations
• Language and translation: how to ensure your trial materials are accessible to non English speaking participants

• How Generative AI can streamline clinical data review, enhance efficiency, and reduce operational burden
• Agentic AI’s potential to elevate data management from task-based automation to intelligent, autonomous systems
• Real-world applications demonstrating the impact of AI-powered agents in clinical trial oversight
• What’s next in AI evolution and how to prepare your data management processes for scalable change

• KPIs in clinical research: what should you be measuring to determine your performance?
• Working collaboratively with your CROs and vendors throughout your clinical trial: where are you falling short?
• Tools and technology available to facilitate processes around performance measurement

• Priorities and considerations when working with vendors and external suppliers
• Cultivating collaborative relationships with vendors and CROs
• Managing procurement and outsourcing during an integration of two companies
• Developing a plan for effective supplier relationship management to ensure your trial runs smoothly

MODERATOR:
John Seman, Chief Executive Officer, Revitale Pharma

PANELLISTS:
Albert A Siha, Group Lead Director, Oncology, Internal Medicine, and Inflammation & Immunology, Pfizer Nupur Modi Murali, Director, Clinical Operations, Bausch Health Kathleen Cohen, Senior Vice President, Clinical Development Operations, Avalo Therapeutics Susan Neal, Senior Director, Clinical Operations, Novavax

• Healthcare themes in a Trump Administration
• Update on key priorities and opportunities
• Short and long term effects of staffing and budget cuts