BBSW 2025
“Driving Smarter Decisions: Data, AI, and Statistics”
Nov 6-7, 2025
Crowne Plaza Hotel, Foster City, CA
[Draft] Full Program book
Draft Agenda (PDF Version)
Day 1 (Part 1): November 6, 2025 (Thursday) [Magellan Main Room Unless Otherwise Specified]
Time | Speaker | Topic | Speaker | Topic |
7:45-8:45 AM | Registration, Breakfast and Networking | |||
8:45-9:00 AM | Welcome and Opening Remarks | |||
9:00-10:00 AM | Keynote Speech: Venkat Sethuraman (Roche) Topic: Electrifying R&D: The Data, Design, and Digital Revolution in Pharma Chair: Ron Yu (Gilead) | |||
10:00-10:30 AM | Break | |||
10:30 AM-12:30 PM | Statistical Session #1 (Parallel Track): Smarter Acceleration: AI in Clinical Development Chair: Tara Maddala (TigerTeam Bio) | Data Science Session #1 (Parallel Track): Data Science Solutions [Room Syracuse] Chair: Jenny Yuan (Scorpion Therapeutics) | ||
10:30-11:00 AM | Brendan O’Leary (Consultant) | AI-Enabled Medical Devices – Engaging Effectively with Regulators | Chendi Liao (Recursion Pharma) | The Climb and the View: How Open-Source Technologies Empower Small Pharma |
11:00-11:30 AM | Will Ma (HopeAI) | AI Teammates in Clinical Development: Integrating Clinical Insights with Statistical Innovations | Daniel Sjoberg (Genentech) Workshop: ARDs + AI: Building the Future of Clinical Reporting with {gtsummary} and {cards} | |
11:30 AM-12:00 PM | Xin Zhao (Day One Biopharmaceuticals) | AI Empowered Clinical Trial Ecosystem | ||
12:00-12:30 PM | Babak Alipanahi (Exal Bio) | AI Meets RNA for Early Lung Cancer Detection | ||
12:30-1:30 PM | Lunch and Networking | |||
1:00 -1:30 PM | Poster Viewing | |||
Day 1 (Part 2): November 6, 2025 (Thursday) [Magellan Main Room Unless Otherwise Specified]
Time | Session |
1:30-3:00 PM | Non-technical Session: Influence and Negotiation Speaker: Charlotte Freeman (Gilead) Title: Insight to Influence: Strategic Communication to Get More of What You Want Chairs: Merrill Birkner (Gilead) and George Wu (Gilead) |
3:00-3:10 PM | Chito Hernandez (Stillwave & UCSD) The Art of Getting Unstuck: What Comes Next? |
3:10-3:40 PM | Poster Lightning Intro Chairs: Nalin Tikoo (TrapezoidX) and Haijun Ma (Exelixis) |
3:40-3:50 PM | Break |
3:50-4:00PM | Ted Lystig (BridgeBio) Recent (Statistical) Developments in DC and Potential Implications |
4:00-4:10 PM | Judy Li (AstraZeneca) From Data to Decisions: The Multi-Disciplinary Edge for Modern Statistician |
4:10 -5:10 PM | Special Feature: Fireside Chat with May Wang (Palo Alto Networks) Topic: Exploring Uncharted Territory – the Role of AI in Modern Healthcare Host: Jing Huang (CareDx) |
5:10-5:40 PM | Raffle |
5:40-6:40 PM | Speed Networking [Room Syracuse] Chairs: Nalin Tikoo (TrapezoidX) and Haijun Ma (Exelixis) |
5:40-7:00 PM | Mixer and Happy Hour |
Day 2 (Part 1): November 7, 2025 (Friday) [Magellan Main Room Unless Otherwise Specified]
Time | Speaker | Topic | Speaker | Topic |
8:00-8:45 AM | Registration, Breakfast and Networking | |||
8:45-9:00 AM | Day 2 Opening Remarks | |||
9:00-10:00 AM | Keynote Speech: Sylvia Plevritis (Stanford) Topic: Multimodal AI in Biomedical Research and Clinical Care Chair: Ray Lin (Genentech) | |||
10:00-10:30 AM | Break | |||
10:30 AM-12:30 PM | Statistical Session #2 (Parallel Track): Frameworks and Strategies for Driving Smarter Decisions Chair: Godwin Yung (Genentech) | Data Science Session #2 (Parallel Track): Data Standards and Beyond [Room Drake] Chair: Zijie Yuan (Encoded Therapeutics) | ||
10:30-10:45 AM | Mark van der Laan (UC Berkeley) | Targeted Learning as a Principled Statistical Approach for Decision Making | Jingyuan Chen (Genentech) Coen Bernaard (Genentech) | PRO Outputs in Oncology and the FDA Technical Specifications Guidance |
10:45-11:00 AM | Dominique Kagele (Roche) | Powering Trials, Empowering Decisions: The Biostatistician’s Dual Role in Governance | ||
11:00-11:15 AM | Trina Weller (Ulu Ventures) | Beyond Data: The Role of Decision Science | Navdeep Pal (Genentech) | Real-World Data – Analysis-Ready Datasets: A Standardised, Specialised and Innovative Data Solution for Efficient Real-World Data Analysis |
11:15-11:30 AM | Jing Huang (CareDx) | Making the Hard Calls: Executive Strategies and How You Can Shape Decisions from Any Seat | ||
11:30 AM-12:00 PM | Panel Discussion | Wei Cui (Cytokinetics) | Strategic Programming Leadership in Small Biotech: Building Submission & Inspection-Ready Deliverables from the Ground Up | |
12:00-12:30 PM | Yingying Wei (Genentech) | Using Large Language Models for Consistency Checking Tables, Listings, and Graphs | ||
12:30-2:00 PM | Lunch and Networking | |||
1:00-2:00 PM | R Meetup [Room Drake] Moderators: Peilin Zhou (CIMS) and Yinqi Zhao (Genentech) Sara Altman (Posit) - Getting Started with LLMs in R: Tools and Best Practices Nalin Tikoo (TrapezoidX) - Leveraging AI and R for Efficient Clinical Trial Reporting: A Phase I Case Study Q&A with Sara and Nalin | |||
Day 2 (Part 2): November 7, 2025 (Friday) [Magellan Main Room Unless Otherwise Specified]
Time | Speaker | Topic | Speaker | Topic |
1:00-1:30 PM | Poster Viewing (voting due by 1:45pm via BBSW App) | |||
2:00-2:20 PM | Poster Awards With Remarks by Haoda Fu (Amgen) | |||
2:20-4:20 PM | Statistical Session #3 (Parallel Track): Smarter Trial Designs and Analyses Chair: Mengjia Yu (AbbVie) | Data Science Session #3 (Parallel Track): Data Analytics and AI [Room Drake] Chair: Gianna Huang (Gilead) | ||
2:20-2:50 PM | Jitendra (Jeetu) Ganju (Ganju Clinical Trials) | Designing Better Clinical Trial Endpoints and Analysis Methods | Jing Dai (Jazz) | Streamlining Machine Learning Modeling in Neuroscience Clinical Trials through Cross-Functional Collaboration |
2:50-3:20 PM | Susan Halabi (Duke University) | Predictive Modeling with Artificial Intelligence for Stratification and Enriched Biomarker-Driven Trial | Yi Hong (Gilead) | Agentic Solution for Clinical Trial Enrollment Forecasting |
3:20-3:50 PM | Yang Song (Neurocrine) | Dose Switching after Interim Dose Selection in Seamless Two-Stage Adaptive Designs | Chaithanya Bandi (Genentech) | Agentic AI in Pharma: Multi-Agent Architecture for Accelerating Operational Workflows |
3:50-4:20 PM | Daniel Gillen (UC Irvine) | Are Futility Bounds Futile? | Kevin Lee (Clinvia) | Leveraging Gen AI (ChatGPT, Gemini) API for Advanced Biometric Analysis in SAS, Python and R |
4:20-4:40 PM | Break | |||
4:40-5:30 PM | Sponsor Talks, Raffle, and Closing Remarks | |||
5:30-6:30 PM | Mixer and Happy Hour | |||
Vendor Exhibits all day for both days.