Program

Accelerating Drug Development Through Responsible AI

Day 1 (June 9, 2025)

Location: Ocean Gateway, 14 Ocean Gateway Pier, Portland, Maine 04101

All times are in Eastern Time.

11:00 AM – 12:00 PM

Registration
12:00 PM – 5:00 PM

Tutorials (Coordinators, Nareen Katta, AbbVie; Margaret Gamalo, Pfizer Inc.)
12:00 PM – 2:00 PM Tutorial 1: Large Scale Processing and Analysis of Wearable Device Data, Yiorgos Christakis, Pfizer Inc and Lukas Adamowicz, Pfizer Inc.

2:00 PM – 2:15 PM

Break
2:15 PM – 5:00 PM Tutorial 2: TMLE in Drug Development. Susan Gruber, TL Revolution, Hana Lee, U.S. Food and Drug Administration, and Mark van der Laan, UC Berkeley

 

Day 2 (June 10, 2025)

Location: Ocean Gateway, 14 Ocean Gateway Pier, Portland, Maine 04101

All times are in Eastern Time.

7:00 AM – 8:00 AM

Registration and Breakfast

8:00 AM – 8:05 AM

 Welcome: David Madigan, Northeastern University; Kannan Natarajan, Pfizer, Inc; and Ron Wasserstein, American Statistical Association.
8:05 AM – 9:00 AM Keynote Address, Jeremy Forman, Pfizer Inc., Moderator, Demissie Alemayehu, Pfizer Inc.
9:00 AM – 10:40 AM

Plenary Session 1, Chair, Bingzhi Zhang, Sanofi

  • “AI and digital health for drug discovery and development”. Tommaso Mansi, Johnson and Johnson.
  • “Targeted Learning, HAL, and Causal Inference for Generating Real-World Evidence in Drug Development”. Mark van der Laan, UC Berkeley
  • “Using Statistical Foundations to Demonstrate Effectiveness of AI/ML Algorithms for Clinical Utility”. Charmaine Demanuele, Pfizer Inc.

10:40 AM – 10:50 AM

Break/Posters

10:50 AM – 12:30 PM

 

Plenary Session 2, Chair, Javier Cabrera, Rutgers University

  • “Safety First: Systematic Approaches to Hallucination Mitigation in Clinical AI”. Malaikannan Sankarasubbu, Saama Technologies
  • “Stage-Aware Learning for Dynamic Treatments”. Annie Qu, UC Irvine
  • “Leveraging the power of AI/ML to enhance statistical inference in clinical trials: opportunities and learnings”. Scott McClain, SAS
  • “Sequential testing and meta-analysis with e-values”. Aaditya Ramdas, Carnegie Mellon

12:30 PM – 2:00 PM

Lunch
2:00 PM – 3:00 PM

Fireside Chat with Robert M. Califf, Former U.S. Commissioner, Food and Drug Administration; Duke University School of Medicine

Moderator, David Madigan, Provost, Northeastern University
3:00 PM – 4:00 PM

Panel Discussion on “Statistics/Data Science Leadership in the Era of AI /ML in Pharma”. Biopharma Statistics Leadership Consortium. Moderator, Kannan Natarajan, Pfizer Inc.

Panelists:

  • Matt Austin, Amgen
  • Pandurang Kulkarni, Eli Lilly and Company; Aparito LLC
  • Surya Mohanty,  Johnson and Johnson
  • Maoxia Zheng, Genentech/Roche

 

4:00 PM – 4:15 PM

Break
4:15 PM – 5:25 PM

Keynote Panel: “Responsible AI in Medical Research”, Moderator, Subha Madhavan, Pfizer Inc.

Panelists:

  • Tala Fakhouri, Food and Drug Administration
  • Usama Fayyad, Northeastern University
  • Andy Houseman, Sanofi
  • Suchi Saria, Johns Hopkins University
  • Ajay Yekkirala, Superluminal Medicines Inc.

5:25 PM – 5:30 PM

 

 Closing Remarks and Acknowledgments, Demissie Alemayehu, Pfizer Inc.

5:30 PM – 7:30 PM

Networking Reception
Roux Institute, Northeastern University,
100 Fore Street, Portland, ME 04101