Full Schedule

10:00 AM – 2:00 PM East Coast USA Time

Cell and Gene Therapy: Transforming Treatment Paradigms for Patient-Centric Care

This session requires an additional registration fee.

Chair: – US Food and Drug Administration

Chair: – Genentech

Chair: – US Food and Drug Administration

Speaker: – US Food and Drug Administration

Speaker: – Takeda

Speaker: – Genentech

Cell, Gene, Regenerative & Nuclei Acid (CGRN)Early Development & Drug Safety (EDDS)

8:00 AM – 6:30 PM East Coast USA Time

Speaker Ready Room

11:00 AM – 6:30 PM East Coast USA Time

Registration and ASCPT Info Desk

3:00 PM – 4:45 PM East Coast USA Time

Opening Session

Chair: – Merck & Co.

Award Recipient: – Tenacia CP BIO Consulting, LLC

Award Recipient: – University of Pennsylvania

Award Recipient: – Koneksa Health

Award Recipient: – University of Florida

Award Recipient: – University of California, San Francisco

Award Recipient: – Duke University

4:00 PM – 5:00 PM East Coast USA Time

State of the Art Lecture - Anthony S. Fauci, MD

State of the Art Speaker: – Georgetown University

Moderator: – Merck & Co.

5:00 PM – 6:30 PM East Coast USA Time

Opening Reception

5:00 PM – 6:30 PM East Coast USA Time

Poster Session I

5:15 PM – 5:45 PM East Coast USA Time

Presidential Trainee Showcase

7:00 AM – 8:00 AM East Coast USA Time

Network/Community Networking Breakfast

7:00 AM – 6:30 PM East Coast USA Time

Registration and ASCPT Info Desk

7:00 AM – 6:30 PM East Coast USA Time

Speaker Ready Room

8:30 AM – 9:15 AM East Coast USA Time

Dolores Shockley Diversity and Inclusion in Clinical Research Award Lecture

Award Lecturer: – University of Alabama at Birmingham

Pharmacogenomics (PGx)Specific Populations (SPO)

9:30 AM – 10:15 AM East Coast USA Time

Leon I. Goldberg Early Investigator Award Lecture

Award Lecturer: – University of Southern Denmark

Award Presenter: – Ohio State University

Biomarkers & Translational Tools (BTT)Membrane Transporter (MT)

9:30 AM – 10:30 AM East Coast USA Time

Challenges and Opportunities of RNA Therapeutics, A Roller Coaster from Discovery to Recovery I: Pioneering Patient-Centric RNA Therapeutics for Rare Diseases

Chair: – Regeneron

Chair: – Merck & Co.

Speaker: – Alnylam

Speaker: – Sanofi

Speaker: – US Food and Drug Administration

Rare Diseases (RD)Cell, Gene, Regenerative & Nuclei Acid (CGRN)

9:30 AM – 10:30 AM East Coast USA Time

Exploring Expanded Access: Balancing Patient Needs and Regulatory Considerations

Chair: – Takeda

Chair: – DS Clinical Pharmacology Consulting

Speaker: – Takeda

Speaker: – US Food and Drug Administration

Speaker: – Voices for ALS

Rare Diseases (RD)Oncology (ONC)

9:30 AM – 10:30 AM East Coast USA Time

Transformative Advancements in the Treatment of Immune-Mediated Diseases: Integrating Patient-Centric Clinical Pharmacology with Translational MID3 for Biologics

Chair: – Merck & Co.

Chair: – Daiichi Sankyo

Speaker: – Daiichi Sankyo

Speaker: – US Food and Drug Administration

Speaker: – Merck & Co.

Moderator: – University of Florida

Biologics (BIO)Translational Informatics (TI)

10:30 AM – 11:00 AM East Coast USA Time

Networking Break

11:00 AM – 11:45 AM East Coast USA Time

Sheiner-Beal Pharmacometrics Award Lecture

Award Lecturer: – Anoixis Corporation

Award Presenter: – Department of Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo

Pharmacometrics & Pharmacokinetics (PMK)

11:00 AM – 12:00 PM East Coast USA Time

Challenges and Opportunities of RNA Therapeutics, A Roller Coaster from Discovery to Recovery II: Translational Science with an Emphasis on Special Populations

Chair: – Roche

Chair: – GlaxoSmithKline

Speaker: – Roche

Speaker: – University of Washington

Speaker: – GlaxoSmithKline

Specific Populations (SPO)Physiological Based Pharmacokinetic Modeling and Simulation (PBPK)

11:00 AM – 12:00 PM East Coast USA Time

From Data to Recovery: Integrating EHR, Omics, and Pragmatic Clinical Trials for Faster Drug Development

Chair: – University of Cincinnati/St Elizabeth Healthcare

Chair: – US Food and Drug Administration (Midnight Sun Technologies)

Speaker: – The Ohio State University

Speaker: – Regeneron Genetics Center

Speaker: – US Food and Drug Administration

Pharmacogenomics (PGx)Biomarkers & Translational Tools (BTT)

12:00 PM – 1:30 PM East Coast USA Time

Networking Lunch

2:30 PM – 3:00 PM East Coast USA Time

Networking Break

Location: Broadmoor Hall Foyer and International Hall Foyer

3:30 PM – 4:15 PM East Coast USA Time

2024 Darrell Abernethy Early Stage Investigator Award Lecture

Award Lecturer: – University of California, San Francisco

Infectious Diseases (INF)

3:30 PM – 4:30 PM East Coast USA Time

Balancing Patient-Centric and Model-Informed Drug Development (MIDD) Approaches to Optimize Dose Selection in Rare Diseases: Are We There Yet?

Chair: – Merck KGaA

Chair: – Alexion, AstraZeneca Rare Disease

Speaker: – Certara

Speaker: – Alagille Syndrome Alliance

Speaker: – US Food and Drug Administration

Rare Diseases (RD)Pharmacometrics & Pharmacokinetics (PMK)

5:00 PM – 6:30 PM East Coast USA Time

Poster Session II

5:00 PM – 6:30 PM East Coast USA Time

President’s Networking Reception

5:20 PM – 5:50 PM East Coast USA Time

Poster Walk I

5:55 PM – 6:25 PM East Coast USA Time

Poster Walk II

7:00 AM – 8:00 AM East Coast USA Time

Network/Community Networking Breakfast

7:00 AM – 12:00 PM East Coast USA Time

Registration and ASCPT Info Desk

7:00 AM – 2:30 PM East Coast USA Time

Speaker Ready Room

8:15 AM – 9:15 AM East Coast USA Time

ASCPT Community Face-Off: Perspectives on Patient Centricity Across the ASCPT Community Spectrum

Chair: – GlaxoSmithKline

Chair: – Pfizer

Speaker: – Merck & Co.

Speaker: – Abbvie

Speaker: – University of Florida

Speaker: – Certara USA

Speaker: – Mayo Clinic

Speaker: – AstraZeneca

Speaker: – Pfizer, Inc.

Speaker: – EMD Serono

Speaker: – University of California, San Francisco

Speaker: – EMD Serono

Speaker: – Cincinnati Children's Hospital

Speaker: – Merck & Co.

Speaker: – Mayo Clinic Graduate School of Biomedical Sciences

Speaker: – Pfizer

Early Career (EC)

8:15 AM – 9:15 AM East Coast USA Time

Global Strategies for Clinical Pharmacology and Labelling in the Treatment of Mental Disorders in Pregnant and Lactating People

Chair: – BullFrog AI

Chair: – GlaxoSmithKline

Speaker: – Johns Hopkins

Speaker: – Certara

Speaker: – US Food and Drug Administration

Specific Populations (SPO)Mental Health & Addiction (MHA)

9:30 AM – 10:30 AM East Coast USA Time

State of the Art Lecture

11:00 AM – 11:45 AM East Coast USA Time

Oscar B. Hunter Career Award in Therapeutics Lecture

Award Lecturer: – The Ohio State University

Award Presenter: – University of Florida

Pharmacogenomics (PGx)Biomarkers & Translational Tools (BTT)

11:00 AM – 12:00 PM East Coast USA Time

GLP-1 Agonists for Addiction: A Novel Therapeutic Approach toward Recovery for an Undertreated Disorder

Chair: – National Institute on Alcohol Abuse and Alcoholism

Chair: – Learned Consulting Group

Speaker: – National Institute on Drug Abuse

Speaker: – University of Southern California

Speaker: – Penn State University

Mental Health & Addiction (MHA)Special Populations (SPO)

11:00 AM – 12:00 PM East Coast USA Time

Informed Treatment Decisions; Model-Based Meta-Analysis + Machine Learning = Accurately Ranking Treatment Effectiveness + Predicting New Trials

Chair: – Human Predictions

Chair: – UCB

Speaker: – Equation AB

Speaker: – UCB

Speaker: – Human Predictions

Speaker: – UCB Pharma

Speaker: – UCB

Drug Utilization & Outcomes (DUO)

11:00 AM – 12:00 PM East Coast USA Time

Optimizing Dose Selection For Bispecifics: Lessons Learned

Chair: – Exelixis, Inc.

Chair: – AbbVie

Speaker: – Gilead Sciences

Speaker: – US Food and Drug Administration

Speaker: – Genmab

Oncology (ONC)Biologics (BIO)

12:00 PM – 1:30 PM East Coast USA Time

Networking Lunch

1:30 PM – 2:15 PM East Coast USA Time

Rawls-Palmer Progress in Medicine Award Lecture

Award Lecturer: – University of California, San Francisco

Award Presenter: – University of California, San Francisco

Specific Populations (SPO)Physiological Based Pharmacokinetic Modeling and Simulation (PBPK)

1:30 PM – 2:30 PM East Coast USA Time

Dose-optimization in Oncology: Identifying Gaps and Opportunities

Chair: – Gilead Sciences

Speaker:

Speaker: – EMD Serono

Speaker: – US Food and Drug Administration

Speaker: – National Cancer Institute

Oncology (ONC)

1:30 PM – 2:30 PM East Coast USA Time

Pediatric Extrapolation: Unlocking the Clinical Pharmacology Toolbox to Accelerate Drug Access for Our Little Patients

Chair: – AbbVie Inc

Chair: – Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences AstraZeneca

Speaker: – US Food and Drug Administration

Speaker: – AbbVie

Speaker: – AstraZeneca

Drug Utilization & Outcomes (DUO)

1:30 PM – 2:30 PM East Coast USA Time

Unleashing the Power of Large Language Models in Drug Development: Transformative Insights and Innovative Applications

Chair: – Critical Path Institute

Chair: – Amgen

Speaker: – University of Maryland

Speaker: – Massachusetts Institute of Technology

Speaker: – University at Buffalo

Translational Informatics (TI)Pharmacometrics & Pharmacokinetics (PMK)

2:30 PM – 3:00 PM East Coast USA Time

Networking Break

3:00 PM – 4:00 PM East Coast USA Time

Advancing Decentralized Clinical Trials for Rare Diseases and Special Populations: Perspectives and Opportunities

Chair: – Biogen

Chair: – Pfizer

Speaker: – Voices for ALS

Speaker: – UCB Biosciences, Inc

Speaker: – US Food and Drug Administration

Specific Populations (SPO)Rare Diseases (RD)

3:00 PM – 4:00 PM East Coast USA Time

How Can Clinician Researchers Leverage Their Clinical Service to Contribute Real-World Patient Outcomes to Advance Precision Medicine Utilization and Generate Discovery?

Chair: – University of Florida

Speaker: – Hospital of the University of Pennsylvania

Speaker: – Sanford Imagenetics

Speaker: – National Institute on Alcohol Abuse and Alcoholism

Pharmacogenomics (PGx)Mental Health & Addiction (MHA)

3:00 PM – 4:00 PM East Coast USA Time

IGNITE Pragmatic Clinical Trials Network Trial Results

Chair: – University of Florida

Chair: – University of Alabama at Birmingham

Speaker: – Mount Sinai

Speaker: – The Ohio State University

Speaker: – University of Florida

Speaker: – Indiana University

Speaker: – Vanderbilt University

8:30 AM – 3:00 PM East Coast USA Time

Revolutionizing End-to-End Drug Discovery, Development, and Clinical Utilization Through Quantitative Medicine

Chair: – Genentech

Chair: – US Food and Drug Administration

Chair: – Pfizer

Speaker: – US Food and Drug Administration

Speaker: – CLL Society

Pharmacometrics & Pharmacokinetics (PMK)Regulatory Science (RS)