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Tuesday, June 17
 

4:00pm EDT

#261: Advancing Premarketing Safety Analytics through FDA and Industry Partnerships
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
207A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-593-L04-P; CME 1.00; RN 1.00

We will leverage the PHUSE Safety Analytics Education library and the recent AE Groupings in Safety (AEGiS) white paper to operationalize the FDA Medical Queries and Standard Safety Tables and Figures (ST&Fs).

Learning Objectives

Discuss how to operationalize FDA Medical Queries (FMQs) and Standard Safety Tables and Figures (ST&Fs) in safety reporting; Identify ways to use the PHUSE Safety Analytics Education Library to enhance safety analytics; Describe ways to leverage the PHUSE AE Groupings in Safety (AEGiS) white paper to improve adverse event groupings in safety analysis.

Chair

Greg Ball, PhD

Speaker

PHUSE AE Groupings in Safety (AEGiS) White Paper
Robert (Mac) Gordon, MS

PHUSE Safety Analytics Education Library
William Palo, MS

FDA Medical Queries (FMQs)
Linda Jeng, MD, PhD

Standard Safety Tables and Figures (ST&Fs)
Y. Veronica Pei, MD, MEd, MPH


Speakers
avatar for Greg Ball

Greg Ball

Safety Data Scientist, ASAPprocess, United States
Greg served in the Navy before earning his MS in statistics from Purdue University and his PhD in biostatistics from the University of Texas. He co-led a company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded... Read More →
avatar for Robert (Mac) Gordon

Robert (Mac) Gordon

Director, Biostatistics, Johnson & Johnosn Innovative Medicines, United States
Mac received a Masters in Statistics and graduate certificates in Public Health, Pharmacovigilance and Pharmacoepidemiology. He has been involved in pharmacovigilance, signal detection and data visualization for most of his career, including membership in several multi-disciplinary... Read More →
avatar for Linda Jeng

Linda Jeng

Associate Director for Biomedical Informatics, FDA, United States
Dr. Linda Jeng holds an MD and PhD in Cell and Molecular Biology from the University of Pennsylvania. She completed a residency in Pediatrics and Medical Genetics at Rainbow Babies and Children's Hospital and the University Hospitals of Cleveland, followed by a fellowship in Clinical... Read More →
avatar for William Palo

William Palo

Director, Safety Statistics, AbbVie, United States
Bill has an MS in Applied Statistics from the University of Iowa and has been an industry statistician for over 30 years with over half that time dedicated to product safety. He is currently the therapeutic head of safety statistics for the late-stage oncology portfolio at AbbVie... Read More →
avatar for Y. Veronica Pei

Y. Veronica Pei

Acting Associate Director, Biomedical Informatics and Regulatory Review Science, FDA, United States
Dr. Veronica Pei is a board-certified emergency physician and a commissioned officer in the U.S. Public Health Service currently serving as Associate Director (Acting) of Biomedical Informatics and Regulatory Review Science team in the Office of New Drugs (OND), FDA. In this role... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session
 
Wednesday, June 18
 

1:45pm EDT

#341: Techquity in Digital Trials: Tech, Data, and Operationalizing Equity in Clinical Research
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
207B
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-641-L04-P; CME 1.00; RN 1.00

Industry leaders explore how biopharma is leveraging data foundations and technological advancements, including AI/ML, to improve access and representation in clinical trials, moving from DEI planning to tangible progress in clinical research.

Learning Objectives

Identify key areas where tech and analytics facilitate health equity advancement, focusing on achievable, tech-enabled outcomes; Illustrate concrete use cases where tech and data can support equitable clinical research, such as community outreach, recruitment, and measurement against diversity action plans; Discuss non-technical success factors needed to wholly support data-driven tech

Chair

Katrina Rice, MS

Speaker

From Data to Action: Driving Inclusive Clinical Trials
Del Smith, PhD, MS

Placing Patients First in the Era of Advanced Tech and AI
Patrick Gee, SR, PhD, MS

Responsible AI and Diversity in Clinical Trials
Nicole Ward, MBA, MS, PMP


Speakers
avatar for Patrick Gee

Patrick Gee

Chief Executive Hope Dealer & Founder, iAdvocate, United States
As a Healthcare Consultant and Professional Global Patient Activist, Patrick has received numerous accolades, such as the American Society of Nephrology President’s Medal and Celeste Castillo Lee Lectureship in 2022, and the National Kidney Foundation’s Celeste Castillo Lee Patient... Read More →
avatar for Katrina Rice

Katrina Rice

Chief Delivery Officer, Biometrics Services, eClinical Solutions, United States
Katrina Rice is an accomplished Chief Delivery Officer with an impressive career that spans over 25 years and includes advancement into increasingly demanding leadership roles. With a solid history of leading business transformations and managing global portfolios, she is as much... Read More →
avatar for Del Smith

Del Smith

Co-Founder and Chief Executive Officer, Acclinate Inc., United States
Del is the co-founder and CEO of Acclinate, a trusted digital health company focused on greater health equity through inclusive research. He has built a diverse team and AI/ML platform to help the pharmaceutical and healthcare industry access and engage communities of color so that... Read More →
avatar for Nicole Ward

Nicole Ward

Senior Product Manager, Business Insights & Technology, Bristol Myers Squibb, United States
Nicole G. Ward is a customer-centric servant leader with 15+ years of project / program management expertise and solid track record of translating complex business requirements into simple technology solutions spanning across multiple industries (Healthcare, IT, Consumer, Pharmaceutical... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session |   02: ClinTrials-Ops, Session

4:00pm EDT

#359: Cutting Through the Hype: How are AI and Emerging Technologies Accelerating Progress Now?
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
209ABC
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-655-L04-P; CME 1.00; RN 1.00

We’ve all heard the hype around emerging technologies and what it means for our industry, but when it comes down to adding value on the ground today, what advancements are actually making a difference in drug discovery, development, and distribution?

Learning Objectives

Describe and explain the advancements in data analytics and emerging technologies that are adding value to biopharma companies today.

Chair

Jessica Federer, MPH

Speaker

Panelist
Leo Barella

Panelist
Diogo Rao


Speakers
LB

Leo Barella

Chief Technology Officer, Takeda, United States
avatar for Jessica Federer

Jessica Federer

Board Member, Angelini Ventures, United States
Ms.Federer is an independent board member for public and private companies, and is a globally recognized leader in digital transformation and health technologies. Previously, she was the Chief Digital Officer for one of the world’s largest life sciences companies, leading the enterprise-wide... Read More →
DR

Diogo Rao

Chief Information Officer, Eli Lilly, United States
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Forum
 
Thursday, June 19
 

9:00am EDT

#406: Beyond the Frequentist Approach in Hard to Recruit Populations: Acceptance of Bayesian Methods for Registration/Pivotal Trial
Thursday June 19, 2025 9:00am - 10:00am EDT
144ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-673-L04-P; CME 1.00; RN 1.00

Alternative methods to a frequentist approach, such as Bayesian, may be superior in certain situations; particularly, when analyzing trial data to support approvals in small populations. Regulators are increasingly considering novel methods.

Learning Objectives

Examine global considerations for leveraging Bayesian approaches in pivotal trials to support marketing authorization; State and debate the situations and circumstances where the Bayesian approach may be the most appropriate method of analysis; Discuss health authority considerations that could facilitate the use of alternative analytical methods beyond the frequentist approach; Identify ways to bridge existing gaps in applying Bayesian methods in clinical research.

Chair

Philip Hougaard, DrSc, PhD

Speaker

FDA perspective
Yun Wang, PhD

EMA Perspective
Andrew Thomson, PhD, MA, MS

Industry Perspective
Scott Berry, PhD


Speakers
avatar for Scott Berry

Scott Berry

President and Senior Statistical Scientist, Berry Consultants LLC, United States
Scott Berry is President and a Senior Statistical Scientist at Berry Consultants, LLC. He earned his MS and PhD in statistics from Carnegie Mellon University and was an Assistant Professor at Texas A&M University before co-founding Berry Consultants in 2000. His primary interests... Read More →
PH

Philip Hougaard

Vice President, Biostatistics and Data Science, Lundbeck A/S, Denmark
Vice President in biostatistics at H. Lundbeck A/S, Denmark. He has worked 40 years in the industry. He is Doctor of Science based on frailty models. He is the author of “Analysis of multivariate survival data”. He is external professor at University of Southern Denmark.
avatar for Andrew Thomson

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
Andrew Thomson is a statistician with over 18 years in the European regulatory system. He is currently in the taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and... Read More →
avatar for Yun Wang

Yun Wang

Deputy Division Director, CDER/OTS/OB, FDA, United States
Dr. Yun Wang is the Deputy Division Director for Division of Biometrics II in the Office of Biostatistics at CDER/FDA since March 2021. Before taking her current role, Dr. Wang was a statistical team leader and reviewer supporting anti-diabetic and hematologic products development... Read More →
Thursday June 19, 2025 9:00am - 10:00am EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Session |   02: ClinTrials-Ops, Session
 
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202A
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Ballroom
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TBD
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  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD-Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
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  • 12: ProfDevelopment
  • 13: Spotlight
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  • 18: InnovationTheaters
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  • Biomarkers
  • Cell and Gene Therapy
  • Clinical Trial Design
  • Diagnostics
  • Digital Technology
  • Global Perspectives
  • Non-CE
  • Patient Experience
  • Payers
  • Pediatrics
  • Rare Disease
  • Real-World Data (RWD) / Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Convergence and Harmonization
  • Regulatory Reliance
  • Student Programming