Breakout 3: Building Risk Management into the Core of Your Trial Design
Small but Mighty – Using Proportional Risk to remain “Small but Mighty”Smaller sponsors and biotech teams often lack the luxury of large QA or oversight departments. This session reframes R3’s risk management requirements as an opportunity rather than a burden.
Facilitator: Jennifer Bentsen Gordon
Bio
Jenny currently holds the position of VP, Clinical Operations at City Therapeutics. She has worked in academic and industry settings for 23 years, in large pharma, mid-sized and small biotech, including Abbott, Vertex, Biogen, Bioverativ and Sanofi, Freeline and most recently as the VP of Clin Ops at Editas Medicine. Her experience has encompassed all phases of clinical development, from concept/ strategy to leading teams and contributing to hands on clinical trial execution, predominantly in rare disease patients with biologics, gene and cell therapy and siRNA.
Discussion Subtopics
- Building a culture of proactive risk thinking with limited resources.
- Embedding risk assessment into daily decisions (protocol design, monitoring, vendor management).
- Leveraging external partners smartly without losing accountability.
- Turning risk management into a value story for investors and partners.
Did You Miss a Conversation? Catch Up On Session All Breakouts Here
Breakout 1
Different Maps, Same Destination: Interpreting Oversight Under R3
Breakout 2
Data Under Pressure – Integrity and Systems in the R3 Era
Breakout 3
Using Proportional Risk to remain “Small but Mighty”
Breakout 4
Ready or Not – Inspection Readiness under R3
Seuss+ Supports Sponsors Where Strategy and Oversight Meet
At Seuss+, through our Vendor Relationship Maximization Method (VRMM) and fit-for-purpose Quality Management Systems (QMS), we bring structure that flexes with your trial, not against it.
Our clients have:
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Developed lean SOPs tailored to critical-to-quality factors, reducing noise and maximizing impact
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Embedded risk registers, governance templates, and audit-ready logs from startup through inspection
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Navigated CRO and vendor oversight with strategic clarity and scalable processes
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Shifted internal team culture from “reactive firefighting” to confident, structured decision-making
ICH E6(R3) isn’t about doing less, it’s about doing what matters most, with clarity.