Trends to Watch in the Externally Sponsored Research (ESR) Space

Looking to successfully navigate Externally Sponsored Research (ESR)? We’ve gathered timely insights from a recent conversation with senior scientific and operational leaders from six biopharma companies - a part of our ongoing ESR Forum, which brings together a community of ESR experts to discuss trends and topics, share and learn via real life experiences and develop and share industry guidance. 

Companies are moving away from potential use of co-sponsored studies to maintain clear legal and compliance guardrails across ESR programs. 

Complexities associated with assuming some Sponsor regulatory responsibility in a co-sponsorship model is leading to a shift in focus towards refining and expanding Collaborative Research (CR) frameworks.  

Tiered CR frameworks are common based on the level of biopharma activities and input: 

• Minimal input such as protocol design. 

• Interest in providing additional support, such as data analysis or access to samples. 

• High-level support requiring engagement with a Contract or Academic Research Organization, often for CR with registrational intent. 

Evolving ESR portfolio metrics are a major industry focus, with increased emphasis on research impact. 

Companies are refining cycle-time and budget metrics, such as fair market value effectiveness, while acknowledging the nuanced nature of ESR, including clinical versus observational studies. 

Impact KPIs have become critical, including: 

• Percentage of ESR study approvals aligned with strategy. 

• Publication and conference impact, including social media reach, time to publication and impact of journals and congresses. 

• Effectiveness in filling Evidence Generation (EvGen) gaps. 

Resource and budget forecasting remains a challenge due to limited visibility and ad-hoc ESR proposal submissions. 

While ESR planning is inherently reactive, improvements have been achieved through: 

• Strengthening connection to EvGen planning cycles. 

• Optimizing use of open submission, submission windows and call-for-proposal cycles. 

• Ensuring regular touchpoints with medical field teams to understand the latest KOL interactions. 

• Conducting robust trial feasibility and risk assessments upfront. 

• Increasing engagement with Investigators to set realistic study timelines. 

ESR drug supply continues to be unnecessarily burdensome due to inaccurate forecasts and prioritization challenges. 

Clinical drug supply is the most common source for ESR programs due to the lack of prioritization by commercial drug supply functions. 

Improvements include: 

• Direct site shipments. 

• Enhanced operational support for forecasting. 

• Development of drug ordering tools for Sponsors. 

• Building effective forecasting algorithms leveraging company-sponsored study tools with ESR risk adjustments. 

AI-enabled tools and automation are beginning to streamline ESR operations. 

Emerging technologies are enhancing processes, such as: 

• Collaborative protocol review. 

• Portal automation for study status tracking and communication. 

• AI-assisted publication review. 

Study performance management and terminations remain a delicate balance for ESR operational teams. 

Industry perception suggests Sponsors are often too lenient on ESR delivery milestones. Study termination rates remain low, ranging from two to five percent annually, though broader portfolio reviews lead to significant rightsizing. 

Key challenges: 

• Managing expectations across ESR Operations, Medical Affairs, Clinical and Legal. 

• Setting clear termination rights in contracts, such as discontinuation if contracting takes over six months. 

• Strengthening soft-skills training for MSLs and Study Operations Leads handling sensitive discussions. 

Interested in Attending the Next Forum? 

Our next forum will be held in Q3 2025. Email [email protected] and [email protected] if you are interested in attending.

Contributors 

Kelli Walker, Pharm.D., M.S. | Director, Medical Affairs Consulting 

Dom Faulkner | Engagement Manager, R&D Consulting