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CLINICAL RESEARCH STEERING COMMITTEE

Meeting Minutes

Key Considerations for Supporting IITs in EU/US

Meeting Date:

19 November 2025

Meeting Type:

CRSC Meeting

Prepared By:

Lisa Mulder (CHAIR)

ATTENDEES

Sylvain Bedard

CRSC Chair

Suzanne (Suus) Plezier - Jonkheer

CRSC Chair

Leticia Tarilonte

CRSC member

Alyssa Marino

CRSC member

Dan Larson

CRSC member

Doris Sanchez

CRSC member

Nathalie Riebel

CRSC member

Carol Lewis Cullinan

CRSC member

Kerry Eischen

Guest

Lisa Mulder

Admin

AGENDA / KEY QUESTIONS

01

Industry Rationale for IITs

02

IIT Models and Strategic Timing

03

Data, Safety, and Regulatory Requirements

04

Sponsor Responsibilities and Required Documentation

05

Relationship Building and Site Oversight

06

Risk Management and Safety Signal Oversight

07

Strategic Timing and Funding

08

Internal Oversight Structures

09

Additional Notes

KEY TAKEAWAYS

Industry Rationale for
IITs

IITs are increasingly used by early-stage companies to generate early / proof-of-concept data in a faster and more cost-effective way.

Industry Rationale for IITs

  • IITs are increasingly used by early-stage companies to generate early / proof-of-concept data in a faster and more cost-effective way.
  • IIT data can support fundraising but carry risks: poor data quality, inconsistent safety reporting, and unexpected findings.
  • The approach also depends on whether the IIT is the primary source of data or an add-on to a more advanced and larger program.
Read MOre

IIT Models and Strategic Timing

Full IIT: Investigator holds IND in the US / clinical trial application in the EU, while the sponsor provides drug and/or funding. This provides the least sponsor control and carries the highest risk.

IIT Models and Strategic Timing

  • Full IIT: Investigator holds IND in the US / clinical trial application in the EU, while the sponsor provides drug and/or funding. This provides the least sponsor control and carries the highest risk.
  • EU clinical trial application seems always owned by the Investigator for an IIT.
  • US IIT can operate under its own IND or under the Company IND; the latter seems preferred from a safety-reporting perspective.
  • NIH does not seem to be very flexible with IITs. NIH contracting through a CRADA was mentioned as particularly challenging.
  • Hybrid IIT: Sponsor retains the IND in the US or provides structured support in the EU, while the investigator leads scientifically. Sponsor involvement may include protocol development, database build, safety reporting, and data outputs.
  • Timing is critical: IITs should align with development plans and financing events and should not be initiated too early.
Read MOre

Data, Safety, and Regulatory Requirements

Data quality is the biggest challenge. It is recommended that sponsors be involved in:
Database build (e.g., REDCap can be compliant).
Monthly data reviews / check-ins ….

Data, Safety, and Regulatory Requirements

  • Data quality is the biggest challenge. It is recommended that sponsors be involved in:
    • Database build (e.g., REDCap can be compliant).
    • Monthly data reviews / check-ins.
    • Funding for resources, such as staff for data entry.
  • All safety events must flow into the Company’s safety database and DSUR.
  • Pharmacovigilance outsourcing is feasible and relatively low cost.
  • GDPR and data transfer agreements must be planned early.
Read MOre

Sponsor Responsibilities and Required Documentation

An internal IIT steering committee was proposed to consolidate input across Clinical
Operations, Quality, Safety, Regulatory, Biostatistics, and Clinical Supplies

Sponsor Responsibilities and Required Documentation

Prioritize solid documentation and engagement through:

  • Contract / Clinical Trial Agreement (CTA): Define roles and responsibilities, involvement in study design, data collection, access to and review of data, safety reporting, publication rights, IP protection, confidentiality, drug storage and accountability, monitoring, biomarker testing, and the role during audit / inspection.
  • It was suggested to introduce milestone payments if the Company is considering an independent grant payment.
  • Charter: An internal IIT steering committee was proposed to consolidate input across Clinical Operations, Quality, Safety, Regulatory, Biostatistics, and Clinical Supplies.
  • SOPs: Establish a governance process for IIT evaluation, approval, oversight, safety reporting, and inspection readiness.
  • Data Transfer Agreements: Required in the EU and at some US institutions.
  • Real-time check-ins: Proactive collaboration and real-time check-ins were flagged as very important.
Read MOre

Relationship Building and Site Oversight

Monthly calls, on-site visits, and trackers for performance.
Providing sites with manuals, templates, and CRFs reduces deviations.

Relationship Building and Site Oversight

  • Strong site relationships are essential: monthly calls, on-site visits, and trackers for performance.
  • Providing sites with manuals, templates, and CRFs reduces deviations.
  • Milestone-based payments can encourage timely enrollment and data entry.
Read MOre

Risk Management and Safety Signal Oversight

Risks include poor data quality and missed safety signals.
Recommended: proactive sponsor visits and contingency planning for inspections.

Risk Management and Safety Signal Oversight

  • Risks include poor data quality and missed safety signals.
  • Recommended: proactive sponsor visits and contingency planning for inspections.
  • Predetermined milestones and oversight measures help manage liabilities.
Read MOre

Strategic Timing and Funding

IITs are increasingly used for proof-of-concept in tight funding environments.

Strategic Timing and Funding

  • IITs are increasingly used for proof-of-concept in tight funding environments.
  • Trade-offs were discussed regarding IITs as side projects versus being central to the development strategy.
Read MOre

Internal Oversight Structures

Clinical Operations should have a significant role in IITs, and this may impact workload depending on the project and collaboration with the Investigator.

Internal Oversight Structures

  • Clinical Operations should have a significant role in IITs, and this may impact workload depending on the project and collaboration with the Investigator.
  • Proposal to form an internal IIT steering committee for cross-functional review and oversight.
  • This structure helps ensure decisions align with company development strategy and regulatory expectations
Read MOre

Additional Notes

Publication rights must be carefully managed in agreements to avoid premature disclosure of material information.

Additional Notes

  • Publication rights must be carefully managed in agreements to avoid premature disclosure of material information. Clear delineation of sponsor versus investigator responsibilities is critical to avoid regulatory or reputational issues.
  • Hybrid IITs can balance independence with sponsor oversight but require strong governance and documentation.
  • Label should include “for investigational use only” or language as required per local regulation.
  • Navigate information related to Investigational Product and/or intellectual property as documented in the agreement.
Read MOre
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