Archives: Agenda

In 2026, clinical research is characterized by a “flight to quality,” with biopharma investment consolidating into high-competition therapeutic areas that offer the greatest scientific and commercial potential.  In addition, the industry is moving from a phase of pilot testing into a “year of implementation”, where advanced technologies likeArtificial Intelligence (AI) take shape.  In this session an overview will be presented around both the funding environment and what is the indication focus today and also shifts in implementation of new and innovative ways to implement clinical research.

• Discussing how digital workflows impact inspections
• Preparing AI-related documentation and audit trails
• Strengthening quality systems for evolving expectations

Moderator: John Seman, CEO, Revitale Pharma

• Exploring automated data cleaning and reconciliation
• Supporting near real‑time decision‑making
• Strengthening interoperability across clinical systems

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• Exploring the meaning of risk sharing across roles
• Supporting balance between procurement and R&D priorities
• Strengthening partnership models through transparency

Moderator: Carrie Lewis, Executive Director, Clinical Program Optimization, Keenova Therapeutics

• How CRO incentive plans are typically structured and where misalignment starts
• Why they often fail: volume-driven KPIs over quality and outcomes
• The impact on timelines, data quality, and sponsor–CRO relationships
• Moving towards outcome-based, shared risk/reward models
• Practical examples of more effective incentive frameworks

• Interpreting what has materially changed under ICH E6(R3), including governance, risk-based quality management, and sponsor oversight expectations
• Sharing how companies are operationalizing the updated guidance six months in—what has actually changed in trial design, conduct, and oversight
• Identifying common implementation challenges, grey areas, and lessons learned when aligning internal processes, CRO partnerships, and inspection readiness

Moderator: Carrie Lewis, Executive Director, Clinical Program Optimization, Keenova Therapeutics

• How historical male-centric assumptions shaped clinical research — and how this affected evidence generation, safety signals, and patient outcomes
• What has changed in prioritizing sex and gender today — including regulatory focus, better data capture, and new enabling tools
• How sex differences appear across the research lifecycle — using real-world case studies to show impacts on trial interpretation and success
• Why this is a pivotal moment for clinical research — with sex-aware data driving better insights, outcomes, and more representative evidence