Theme: “From Applying Innovation to Building an Innovative Culture”

Date: November 9, 2023 Time: 8:00 AM - 5:00 PM Location: Regeneron Pharmaceuticals, 777 Old Saw Mill River Rd, Tarrytown, NY 10591 Format: Hybrid (In-person: ~100 attendees, Virtual participation available)

Event Overview

The inaugural Statistical Innovation Community Summit marked a historic milestone in bringing together statisticians from the FDA, academia, and over 20 pharmaceutical companies to discuss how statistical innovation can optimally enhance medical product development.

Program Agenda

7:30 AM - 8:00 AM: Registration and Breakfast

8:00 AM - 8:30 AM: Opening Remarks

Chair: Chenguang Wang

9:00 AM - 11:30 AM: Keynote Session

Title: “Maximizing the Impact of Innovative Statistical Methods in Partnership with Health Agencies”

Organizers: Satrajit Roychoudhury, Chenguang Wang

Distinguished Keynote Speakers

  • John Scott (FDA): “FDA Complex Innovative Trial Design (CID) Program”
  • Ying Yuan: “BOIN: How it was Developed in Collaboration with the FDA”
  • Neal Thomas: “Dose-finding with Emax Modeling: Experience with FDA Methodology Qualification”
  • Jose Pinheiro (Johnson & Johnson)

11:30 AM - 1:00 PM: Lunch and Networking Mixer

1:00 PM - 2:15 PM: Session I - Statistical Innovation in Action

Organizers: Kentaro Takeda, Chenguang Wang, May Mo

Case studies demonstrating the potential of innovative approaches:

  • Haoda Fu (Eli Lilly)
  • Binbing Yu (AstraZeneca)
  • Li Wang (AbbVie)
  • Inna Perevozskaya (GSK)
  • Jiawen Zhu (Genentech)
  • Jian Zhu (Servier)
  • Ron Yu’s team member (Gilead) - Open-source software

2:15 PM - 3:30 PM: Session II - Maximizing Impact as Core Organization

Organizers: Elena Polverejan, Satrajit Roychoudhury, Ron Yu

Chair: Philip He (Daiichi Sankyo) Moderator: Elena Polverejan

Business models, roles, and responsibilities within organizations:

Organizational Representatives

  • Ron Yu (Gilead)
  • Kentaro Takeda (Astellas)
  • Jose Pinheiro (Johnson & Johnson)
  • May Mo (Amgen)
  • Demissie Alemayehu (Pfizer)
  • David Ohlssen (Novartis)
  • Yongming Qu (Eli Lilly)

3:30 PM - 3:45 PM: Coffee Break

3:45 PM - 4:45 PM: Panel Discussion Session III

Organizers: Jose Alvir, Jinglin Zhong, Marcia Levenstein

Moderator: Jinglin Zhong

Topic: “How can we more effectively organize the statistical innovation community and empower all members within it?”

Panelists

  • Lei Nie (FDA)
  • Keaven Anderson (Merck)
  • Ram Tiwari (Bristol Myers Squibb)
  • Vlad Dragalin (Johnson & Johnson)
  • Olga Marchenko (Bayer)
  • Sammi Tang (Servier)
  • Minghui Chen (University of Connecticut)
  • Claude Petit (Astellas)
  • Scott Berry (Berry Consultants)

4:45 PM - 5:00 PM: Closing Remarks

Chair: Satrajit Roychoudhury

Summit Impact and Recognition

Community Response

The summit’s success demonstrated the statistical innovation community’s:

  • Enthusiasm and energy throughout the organization process
  • Sophistication in addressing complex methodological and operational challenges
  • Dedication to advancing pharmaceutical statistics

Key Outcomes

The summit established important principles for the statistical innovation community:

  1. Business Integration: Innovation groups must understand business needs and deliver measurable value
  2. Partnership Focus: Must collaborate with all functional teams in pharmaceutical organizations
  3. Recognition Imperative: Community requires acknowledgment from both statistical field and pharmaceutical organizations
  4. Training and Development: Need for appropriate training programs and career paths

Future Vision

The summit positioned statistical innovation as the fourth cornerstone of pharmaceutical statistics organizations, alongside:

  • Data Management
  • Programming
  • Biostatistics

Organizing Committee

Leadership Team

  • Co-Chairs: Chenguang Wang (Regeneron), Satrajit Roychoudhury (Pfizer)
  • Committee Members: May Mo, Elena Polverejan, Kentaro Takeda, Xiaolong (Ron) Yu, Jinglin Zhong, Jose Ma. Alvir, Marcia Levenstein

Institutional Support

  • Regeneron Leadership: Jeen Liu, Bret Musser, Ned Braunstein
  • Sponsor: ASA New York Metro Area Chapter

Legacy and Continuation

The inaugural summit established the foundation for:

  • Annual summit series
  • Community hub for statistical innovation
  • Recognition pathway for innovation statisticians
  • Collaborative framework between industry, academia, and regulatory agencies

The 2023 Inaugural Summit was a pivotal moment in establishing the Statistical Innovation Community as a recognized and vital part of pharmaceutical research and development.