Building a Competitive IIT Program: Best Practices to Support Better Funding, Resourcing, and Approval Policies

Industries Profiled:
Biopharmaceutical; Pharmaceutical; Medical Device; Manufacturing; Biotech; Consumer Products; Diagnostic; Health Care; Laboratories


Companies Profiled:
Alnylam Pharmaceuticals; Arrowhead Pharmaceuticals; AstraZeneca; Baxter International; Bayer; Biotest AG; Eli Lilly and Company; Eisai; Incyte; Intellia Therapeutics; Ionis Pharmaceuticals; Jazz Pharmaceuticals; PDS Biotechnology; Pierre Fabre; Regeneron; Rigel Pharmaceuticals; Santen; Sobi; Stemline Therapeutics; Summit Therapeutics; Veloxis Pharmaceuticals

Study Snapshot

Best Practices, LLC conducted a benchmark survey with 22 Medical Affairs and IIT leaders from 21 biopharma organizations. The research segments insights by geography (US, EU, Global) and company size (Large vs. Mid/Small Pharma), allowing you to compare your scope and performance against industry peers. To enhance benchmarking, Best Practices, LLC also incorporates proprietary data on IIT program FTEs, phase intervals, streamlining strategies, and submission review approaches.

Key topics covered in this report include:

• Optimizing IIT Budgets and Funding Strategies
• Key Policies and Compliance Guidelines for IIT Programs
• Streamlining IIT Management and Approval Processes
• Best Practices for Enhancing IIT Review Efficiency
• Geographic and Company Size Trends in IIT Program Execution

• Study Mix: Across the total benchmark class, 57% of approved studies are Interventional, 21% are Retrospective, and 9% are Preclinical on average.

• EU vs. US Differences in MSL Involvement: EU MSLs tend to be slightly more involved in IIT programs overall than US counterparts, especially in proposal review and the publications process.

• Benchmark study objective and methodology
• Benchmark study partners
• Geographic responsibilities
• Key takeaways and data summary
• Average program size and support – Summary
• IIT budget comparison – Large pharma vs. mid-small pharma averages
• Cost breakout overview
• IIT program policy and rate cap sharing
• Overhead limits and rejections
• Role of MSLs in the IIT process

• Types of IITs supported – Total benchmark class
• Types of IITs supported – Geographic comparison
• IIT program scope: Approved products, ongoing studies, and annual initiations
• Average duration of IIT studies from initiation to close-out
• IIT program scope and duration – Geographic comparison
• IIT program budgets: Reported totals (large pharma vs. mid-small pharma) and budget range
• IIT spend per product: Reported totals (large pharma vs. mid-small pharma) and spend range
• IIT spend per study: Reported totals (large pharma vs. mid-small pharma) and spend range
• IIT studies supported per product: Reported totals (large pharma vs. mid-small pharma) and support range
• IIT study spend in the US: Average, minimum, and maximum per study type
• IIT study spend in regions excluding the US: Average, minimum, and maximum per study type
• Breakdown of activities and costs in IIT proposals: Personnel, study, and other related costs
• Geographic comparison of IIT proposals: Breakdown of personnel and related costs
• Geographic comparison of IIT proposals: Breakdown of study costs

• Disclosure of IIT program policies and publicization of maximum allowable indirect rate caps to investigators
• IIT program policy sharing and indirect rate caps publication – Geographic comparison
• Maximum allowable indirect rates (overhead costs) per study and percentage of IIT submissions rejected due to exceeding limits
• Deliverables required before final payment to investigators
• Deliverables required before final payment to investigators – Geographic comparison
• Access to IP rights included in IIT agreements

• Functions involved in IIT approvals at your organization
• Functions involved in IIT approvals at your organization: US focus
• Functions involved in IIT approvals at your organization: EU focus
• Functions involved in IIT approvals at your organization: Global function
• MSL involvement in IIT process phases
• MSL involvement in IIT process phases: US vs. EU differences
• Percentage of IIT proposals submitted through different channels and portals used for managing proposals
• Channels and management portals used for IIT proposals – Geographic Comparison
• Online portal management: Flow of information/data and KOL/investigator engagement

• Number of FTEs dedicated to IIT management and their responsibilities across the process
• Time spent on IIT contracting management (in days)
• Top approaches to increase efficiency in IIT review
• Review process for concept proposals: Rolling basis vs. submission window