Date: September 24, 2024 Location: Amgen, 9605 Medical Center Drive, Rockville, MD 20850 Format: In-person conference

Welcome and Opening Remarks

Host: Kevin Bugin, AVP, Head of Global Regulatory Policy and Intelligence, Amgen

Session Summary

Roundtable Session #1: Good Practices Leading to Success

Moderators: Chenguang Wang, May Mo

Key Insights for Maximizing Impact

To maximize the impact and value of a statistical innovation group within a business:

  1. Understand the business model
  2. Deliver value to the business
  3. Be recognized by the business, statistical field, and regulatory agencies

Building Trust and Recognition

  • Trust is essential for success and collaboration
  • While trust grows organically, a top-down approach can be more efficient
  • Establishing formal processes to embed statistical innovation into drug development is crucial

Strategic Questions for Innovation Groups

Every statistical innovation group should consider:

  • Who are your stakeholders? (R&D heads, cross-functional heads, Regulatory, etc.)
  • Who are your partners? How do you collaborate with each other?
  • Who are your advocates?

Opportunities for Differential Value

Innovation statisticians can offer unique value by:

  • Serving as a central hub for internal projects across therapeutic areas
  • Acting as point of contact for external consultants
  • Becoming subject matter experts in decision-making and statistical topics
  • Leading strategic projects like developing guidance documents

Roundtable Session #2: Challenges

Moderators: Haoda Fu, Jennifer Schumi

Key Challenges Identified

Early Involvement

  • Many missed opportunities due to lack of involvement from the beginning
  • Need for matrix team concept or “checkbox” step in protocol development

Resource Management

  • Heavy workloads and limited resources stretch groups thin
  • Innovation statisticians often treated as “fire fighters” with little recognition
  • Challenging to establish resource models compared to trial statisticians

Career Development

  • Career paths require clear definition to attract and retain talent
  • Need for mobility between product and innovation roles
  • Should not view product and innovation statisticians as separate career paths

Organizational Positioning

  • Groups must decide their position: consulting team (reactive) vs. lighthouse (proactive)
  • Data science integration: statisticians should participate in hiring processes

Roundtable Session #3: Future of the Statistical Innovation Community

Moderators: Satrajit Roychoudhury, Kentaro Takeda

Future Focus Areas

Priority topics for statistical innovation groups:

  • Estimands
  • Dose optimization
  • Combination trials
  • External controls
  • Non-proportional hazards and crossing survival curves
  • Accelerating R&D cycles
  • Scientific vs. operational elements of clinical trials
  • Portfolio decision-making
  • In silico/simulated trials

Looking Forward

2025 Summit: Pfizer has graciously offered to host the Statistical Innovation Community Summit in 2025.

Key Takeaways

The 2024 summit reinforced the critical importance of:

  1. Strategic positioning of innovation groups within organizations
  2. Early engagement in drug development processes
  3. Clear career development paths for innovation statisticians
  4. Cross-functional collaboration and stakeholder engagement
  5. Formal processes for embedding innovation in business operations

The 2024 summit continued to build momentum for the statistical innovation community, addressing both strategic and operational challenges while identifying key areas for future development.