【活動訊息】12/9_SPARK GLOBAL Webinar Series - 4
Protocol Development for Investigator-Sponsored Studies
SPARK GLOBAL is pleased to announce the launch of the new SPARK GLOBAL Webinar Series, a monthly forum that brings together experts and participants from all SPARK GLOBAL affiliates. With invited speakers and rotating time zones, the series ensures broad participation and accessibility across the global community. Each month, an exciting new webinar will follow, offering valuable insights and perspectives from leaders in the field.
Event Details:
Date: 9 December 2025 (Tuesday)
Time: 5 PM PT | Dec 10 9:00AM CST ( Taiwan Time )
Location: Online via Zoom
Speaker:
Lyn Frumkin
Scientific Advisory Board Member | ADRx, Inc.
Lyn Frumkin is a biotechnology consultant with expertise in life sciences investment and early-stage company development. He has held leadership roles at Amgen and ICOS, guiding global clinical programs and regulatory strategies. Currently, he serves on the scientific advisory board of ADRx, Inc., and advises several biotech firms. Lyn has also contributed to Stanford’s SPARK programs and volunteered in medical relief efforts in Haiti. He holds an MD-PhD from the University of Washington and specialized training in neurology and infectious diseases.
Online via Zoom | Please register
Click here to register
Key Takeaways
1. Investigator-Sponsored Trials Can Advance Drug Development
- Academic, investigator-led studies play an important role in accelerating early-stage clinical insights.
- These trials often generate novel findings that help direct larger, well-controlled studies.
- They can address clinically relevant questions not always prioritized in industry-sponsored programs.
2. Resource Limitations Affect Study Scale and Operations
- Compared with industry or government trials, investigator-sponsored research frequently faces operational and financial constraints.
- Smaller participant numbers and limited infrastructure may affect study feasibility and statistical power.
- Strategic planning is essential to maximize value despite limited resources.
3. More Likely to Involve Drug Repurposing and High-Risk Populations
- Investigator-led trials commonly explore new therapeutic uses for existing drugs.
- These studies often begin directly in patient populations rather than healthy volunteers.
- They may enroll individuals with severe illness, multiple comorbidities, or higher mortality risk, offering unique clinical insights.
4. Strong Protocol Design Is Critical to Maintain Rigor
- Thoughtful protocol development is essential to ensure scientific and ethical quality despite limited resources.
- Well-designed protocols help generate credible, interpretable outcomes.
- High-quality results can lay the groundwork for future large-scale, well-controlled clinical trials.
5. These Studies Provide Foundational Evidence for Larger Trials
- Despite challenges, investigator-sponsored trials often produce early signals that inform subsequent research directions.
- Their findings can identify promising interventions worthy of expanded clinical investment.
- They serve as a crucial bridge between initial clinical hypotheses and full-scale drug development programs.