Full Schedule

7:00 AM – 5:00 PM EDT

Speaker Ready Room Open

Location: Regency V

8:00 AM – 5:00 PM EDT

Pre-Conference Registration and CrowdPass Open

Location: Regency Foyer

9:00 AM – 9:10 AM EDT

Opening and Welcome

Speaker: – Certara

Translational & Precision Medicine (TPM)

9:10 AM – 9:35 AM EDT

Introduction of RWD and RWE and Advancing Utilization of RWD and RWE in Clinical Pharmacology and Translational Research – Academia Perspective

Speaker: – University of Florida

9:35 AM – 10:00 AM EDT

Advancing Utilization of RWD and RWE in Clinical Pharmacology and Model-Informed Drug Development – Industry Perspectives

Speaker: – Pfizer

Translational & Precision Medicine (TPM)

10:00 AM – 10:25 AM EDT

Advancing Their Utilization in Clinical Pharmacology– Regulatory Perspectives

Speaker: – US Food and Drug Administration

Translational & Precision Medicine (TPM)

10:25 AM – 10:50 AM EDT

Real World Data Sources, Quality, and Analytics Considerations for Generating RWE

Speaker: – Aridhia Bioinformatics

Translational & Precision Medicine (TPM)

11:00 AM – 12:30 PM EDT

Case Studies Demonstrating the Application of RWD/RWE In Drug Development For Various Scenarios

Speaker: – Genentech

Speaker: – Eli Lilly and Company

Speaker: – Genentech

Speaker: – Pfizer

1:30 PM – 1:40 PM EDT

Hands-On Workshop - Drug X Introduction

Speaker: – Certara

Translational & Precision Medicine (TPM)

3:45 PM – 4:30 PM EDT

Panel Discussion with Presenters and Panelists from Academia, Industry, EMA, FDA, WHO on the Vision/Future of RWE/RWD in Clinical Pharmacology, Translational Research and Drug Development and Approval; Data Quality & Data Standards

Speaker: – Pfizer

Translational & Precision Medicine (TPM)

4:30 PM – 4:35 PM EDT

Wrap Up

Speaker: – Pfizer

Translational & Precision Medicine (TPM)

4:35 PM – 5:30 PM EDT

Posters and Refreshments brought to you by ICON

Location: Regency VII

8:00 AM – 11:30 AM EDT

Board of Directors Meeting (by invitation only)

Location: Spring

8:00 AM – 6:30 PM EDT

Speaker Ready Room Open

Location: Regency V

11:00 AM – 6:30 PM EDT

ASCPT Info Desk, CrowdPass, and Registration Open

Location: Centennial Ballroom Foyer

2:00 PM – 2:45 PM EDT

Awards Reception (by invitation only)

Location: Spring

3:00 PM – 4:00 PM EDT

Opening Session brought to you by Genentech

Location: Centennial III

Moderator: – Gilead Sciences

Award Recipient: – University of Florida

Award Recipient: – York College/Graduate Center, City University of New York

Award Recipient: – US Food and Drug Administration

Award Recipient: – Schmith PK/PD Consulting LLC

Award Recipient: – US Food and Drug Administration

Award Recipient: – University of Washington

Award Recipient: – University of Utah

Award Recipient: – University of Florida

Award Recipient: – Morna Conway, Inc., Scholarly Publishing Consulting

4:00 PM – 5:00 PM EDT

Dolores Shockley Diversity and Inclusion in Clinical Research Award Lecture

Location: Centennial III

Award Lecturer: – Scripps Research Translational Institute

Award Presenter: – Gilead Sciences

5:00 PM – 6:30 PM EDT

Opening Reception brought to you by Gilead

Location: Grand Hall

5:00 PM – 6:30 PM EDT

Poster Session I

Location: Grand Hall

5:15 PM – 5:45 PM EDT

Presidential Trainee Showcase

Location: Learning Center

5:20 PM – 5:50 PM EDT

Poster Walk I: Leveraging PBPK Modeling to Support Drug Utilization

Location: Grand Hall Foyer

Chair: – Certara

Chair: – University of North Carolina at Chapel Hill

5:55 PM – 6:25 PM EDT

Poster Walk II: Translational Approaches for Optimal Dosing In Patients brought to you by Janssen

Location: Grand Hall Foyer

Chair: – Merck & Co.

Chair: – University of Montana

6:30 AM – 6:30 PM EDT

ASCPT Info Desk, CrowdPass, and Registration Open

Location: Centennial Ballroom Foyer

7:00 AM – 8:00 AM EDT

Network/Community Networking Breakfast coffee brought to you by Pfizer

Location: Grand Hall

7:00 AM – 8:00 AM EDT

Unattended Posters Available for Viewing

Location: Grand Hall

7:00 AM – 6:30 PM EDT

Speaker Ready Room Open

Location: Regency V

8:15 AM – 9:15 AM EDT

State of the Art Lecture - Cynthia Whitney

Location: Centennial III

State of the Art Speaker: – Emory University

Chair: – Gilead Sciences

Infectious Diseases (INF)Global Health (GH)

9:30 AM – 10:30 AM EDT

Diversity and Inclusion in Clinical Trials for Rare Diseases: Together We Can Achieve the Unachievable

Location: Regency VI

Chair: – Takeda

Chair: – Parexel International

Speaker: – Voices for ALS

Speaker: – Parexel

Speaker: – US Food and Drug Administration

Rare Diseases (RD)Special Populations (SPO)

9:30 AM – 10:30 AM EDT

Hi Cancer, We Come Bearing Gifts, Antibody-Drug Conjugate

Location: Centennial IV

Chair: – York College/Graduate Center, City University of New York

Chair: – Genentech

Speaker: – Lymphoma Coalition

Speaker: – Genentech

Speaker: – US Food and Drug Administration

Early Development & Drug Safety (EDDS)Regulatory Science (RS)

9:30 AM – 10:30 AM EDT

How Could Debunking Biases in R&D Decisions Lead to More Equitable Healthcare?

Location: Centennial III

Chair: – GlaxoSmithKline

Chair: – Novo Nordisk

Speaker: – University of Florida

Speaker: – McKinsey & Company

Speaker: – US Food and Drug Administration

Pharmacometrics & Pharmacokinetics (PMK)Drug Utilization & Outcomes (DUO)

10:30 AM – 10:45 AM EDT

Micro-Learning Lounge brought to you by ICON: Oral Tyramine Challenge Testing of MAO Inhibitors – Replace, Reduce, Refine the Vintage Design

Location: Regency Foyer

Partner Presenter: – ICON

10:30 AM – 11:00 AM EDT

Learning Lab brought to you by Celerion: The Impact of N-nitrosamine Impurities on Clinical Drug Development: Drug-Drug Interaction Studies

Location: Learning Center

Partner Presenter: – Celerion

10:30 AM – 11:00 AM EDT

Networking Break brought to you by Merck

Location: Centennial Ballroom Foyer

11:00 AM – 11:45 AM EDT

Featured Speaker - Richard Peck

Location: Centennial III

Featured Speaker: – University of Liverpool

Chair: – Gilead Sciences

Biomarkers & Translational Tools (BTT)Drug Utilization & Outcomes (DUO)

11:00 AM – 11:45 AM EDT

Leon I. Goldberg Early Investigator Award Lecture - Jasmine Luzum

Location: Centennial IV

Award Lecturer: – University of Michigan

Award Presenter: – University of California, San Francisco

Pharmacogenomics (PGx)Special Populations (SPO)

11:00 AM – 12:00 PM EDT

Drug Transporter Pharmacogenomics – When it Matters and When it Doesn’t?

Location: Regency VI

Chair: – Genentech

Chair: – The Ohio State University

Speaker: – University of Greifswald

Speaker: – University of California, San Francisco

Speaker: – US Food and Drug Administration

Membrane Transporter (MT)Pharmacogenomics (PGx)

11:45 AM – 12:30 PM EDT

Lunch & Learn brought to you by Certara: Meet Certara’s Quantitative Systems Pharmacology Team

Location: Learning Center

Partner Presenter: – Certara & Leiden University

Partner Presenter: – Certara

12:00 PM – 12:15 PM EDT

Micro-Learning Lounge brought to you by InsightRX: Accelerating Dose Identification with Real-time Clinical Pharmacology Analysis

Location: Regency Foyer

Partner Presenter:

12:00 PM – 1:30 PM EDT

Lunch Break

Location: Grand Hall

1:00 PM – 1:30 PM EDT

Learning Lab brought to you by Labcorp Drug Development: Optimizing Phase 1b Clinical Pharmacology Studies in Patients

Location: Learning Center

Partner Presenter: – Labcorp Drug Development

1:15 PM – 1:30 PM EDT

Micro-Learning Lounge brought to you by Nova Discovery: Efficient Extrapolation Using QSP Models: The Jinkō Platform

Location: Regency Foyer

Moderator: – University of North Carolina at Chapel Hill

Partner Presenter:

1:30 PM – 3:00 PM EDT

Patient Forum

Location: Centennial IV

Moderator: – Health Data Synthesis Institute

Speaker: – University of Chicago Medical Center

Speaker: – Medical College of Georgia at Augusta University

Speaker: – Body Politic

Speaker: – Patient-Led Research Collaborative

Patient:

2:15 PM – 3:15 PM EDT

State of the Art Lecture - Priti Hegde

Location: Centennial III

State of the Art Speaker: – Foundation Medicine Inc.

Chair: – Gilead Sciences

Biomarkers & Translational Tools (BTT)Oncology (ONC)

3:15 PM – 3:30 PM EDT

Micro-Learning Lounge brought to you by Certara: Consulting: 6 Things You Should Know

Location: Regency Foyer

Partner Presenter: – Certara

3:15 PM – 3:45 PM EDT

Learning Lab brought to you by Worldwide Clinical Trials: Sink or Swim: Successfully Executing NDA-Enabling Studies to Avoid Rough Waters

Location: Learning Center

Partner Presenter: – Worldwide Clinical Trials

3:15 PM – 3:45 PM EDT

Networking Break brought to you by Takeda

Location: Centennial Ballroom Foyer

3:45 PM – 4:30 PM EDT

2022 Darrell Abernethy Early Stage Investigator Award Lecture

Location: Regency VI

Award Lecturer: – Children's Mercy - Kansas City

Award Presenter: – Health Data Synthesis Institute

Early Career (EC)Special Populations (SPO)

3:45 PM – 4:30 PM EDT

Sheiner-Beal Pharmacometrics Award Lecture

Location: Centennial IV

Award Lecturer: – Genentech

Award Presenter: – Genentech

Pharmacometrics & Pharmacokinetics (PMK)Oncology (ONC)

3:45 PM – 4:45 PM EDT

Jabbing Clinical Pharmacology with Vaccines Boosted by Modeling and Simulation

Location: Centennial III

Chair: – Quantitative Pharmacology and Pharmacometrics, Merck & Co.

Chair: – Certara

Speaker: – French Institute of Health and Medical Research

Speaker: – Moderna

Speaker: – Merck & Co.

Pharmacometrics & Pharmacokinetics (PMK)Infectious Diseases (INF)

5:00 PM – 6:30 PM EDT

Poster Session II

Location: Grand Hall

5:00 PM – 6:30 PM EDT

President’s Networking Reception & Table Tennis Tournament of Champions brought to you by Gilead

Location: Grand Hall

5:20 PM – 5:50 PM EDT

Poster Walk III: Impact of Pharmacogenomics in Real World Settings

Location: Grand Hall Foyer

Chair: – University of California, San Francisco

Chair: – Cincinnati Children's Hospital Medical Center

5:55 PM – 6:25 PM EDT

Poster Walk IV: Clinical Pharmacology Study Design and Data Analysis to Optimize Drug Utilization in Diverse Patient Populations

Location: Grand Hall Foyer

Chair: – Children's Mercy - Kansas City

Chair: – Cincinnati Children's Hospital Medical Center

6:30 PM – 7:30 PM EDT

Donor Reception (by invitation only)

Location: Spring

7:00 AM – 8:00 AM EDT

Network/Community Networking Breakfast

Location: Grand Hall

7:00 AM – 8:00 AM EDT

Unattended Posters Available for Viewing

Location: Grand Hall

7:00 AM – 12:00 PM EDT

ASCPT Info Desk, CrowdPass, and Registration Open

Location: Centennial Ballroom Foyer

7:00 AM – 2:30 PM EDT

Speaker Ready Room Open

Location: Regency V

8:15 AM – 9:00 AM EDT

Featured Speaker - Anne Heatherington

Location: Centennial III

Featured Speaker: – Takeda

Chair: – Gilead Sciences

Drug Utilization & Outcomes (DUO)

8:15 AM – 9:00 AM EDT

Rawls-Palmer Progress in Medicine Award Lecture

Location: Centennial IV

Award Lecturer: – Washington State University

Award Presenter: – University of Montana

Pharmacometrics & Pharmacokinetics (PMK)Membrane Transporter (MT)

8:15 AM – 9:15 AM EDT

Moving the Needle for Enhancing Oncology Dose Optimization: A Fireside Chat with ASCPT's Scientific Thought Leadership

Location: Regency VI

Chair: – Takeda Pharmaceuticals

Chair: – EMD Serono Research & Development Institute, Inc

Speaker: – Pfizer

Speaker: – Certara

Speaker: – US Food and Drug Administration

Speaker: – Koneksa Health

Pharmacometrics & Pharmacokinetics (PMK)Oncology (ONC)

9:30 AM – 10:30 AM EDT

Developing Therapy for Every Kid with Cancer

Location: Centennial III

Chair: – US Food and Drug Administration

Chair: – St. Jude Children's Research Hospital

Speaker: – Takeda Pharmaceuticals

Speaker: – Children's Hospital Los Angeles

Speaker: – Rally Foundation for Childhood Cancer Research

Oncology (ONC)Special Populations (SPO)

10:30 AM – 11:00 AM EDT

Learning Lab brought to you by Parexel: The Pursuit of Excellence in Clinical Pharmacology, Modeling & Simulation for Rare Diseases Drug Development

Location: Learning Center

Partner Presenter: – Parexel International

10:30 AM – 11:00 AM EDT

Networking Break brought to you by esqLABS

Location: Centennial Ballroom Foyer

11:00 AM – 11:45 AM EDT

Oscar B. Hunter Career Award in Therapeutics Lecture

Location: Centennial III

Award Lecturer: – US Food and Drug Administration

Award Presenter: – US Food and Drug Administration

Regulatory Science (RS)

11:00 AM – 12:00 PM EDT

Diversity and Inclusion of Patient-Centric Clinical Evidence: Opportunities for Clinical Pharmacologists

Location: Regency VI

Chair: – Gilead Sciences

Chair: – Takeda

Speaker: – Emory University

Speaker: – EMD Serono

Speaker: – US Food and Drug Administration

Drug Utilization & Outcomes (DUO)Regulatory Science (RS)

12:00 PM – 1:30 PM EDT

Lunch & Learn brought to you by Certara: A Session on Project Optimus & Pediatric Drug Development

Location: Learning Center

Partner Presenter: – Certara

12:00 PM – 1:30 PM EDT

Lunch Break

Location: Grand Hall

1:30 PM – 2:15 PM EDT

Leon I. Goldberg Early Investigator Award Lecture - Daniel Gonzalez

Location: Regency VI

Award Lecturer: – UNC Eshelman School of Pharmacy

Award Presenter: – US Food and Drug Administration

Pharmacometrics & Pharmacokinetics (PMK)Special Populations (SPO)

1:30 PM – 2:30 PM EDT

Digital Biomarkers - Embracing Their Application to Advocate and Advance Personalized Treatment of CNS Disorders

Location: Centennial IV

Chair: – University of Maryland

Chair: – Takeda

Speaker: – Takeda

Speaker: – Cerevel Therapeutics

Speaker: – US Food and Drug Administration

Biomarkers & Translational Tools (BTT)Mental Health & Addiction (MHA)

1:30 PM – 2:30 PM EDT

Translating QSP Modeling for All: Challenges in Communicating QSP

Location: Centennial III

Chair: – Takeda Development Center Americas, Inc.

Chair: – Mount Sinai

Speaker: – Takeda

Speaker: – GlaxoSmithKline

Speaker: – University of Georgia

Systems Pharmacology (SP)Early Career (EC)

2:30 PM – 2:45 PM EDT

Micro-Learning Lounge brought to you by Pfizer

Location: Regency Foyer

2:30 PM – 3:00 PM EDT

Networking Break brought to you by IntiQuan

Location: Centennial Ballroom Foyer

3:00 PM – 4:00 PM EDT

Real-World Data Enabled by Advanced Data Analytics Towards More Accessible, Targeted, and Personalized Medicine

Location: Centennial IV

Chair: – Merck KGaA, Darmstadt

Chair: – Biogen

Speaker: – Genentech

Speaker: – Lausanne University Hospital (CHUV)

Speaker: – US Food and Drug Administration

Pharmacometrics & Pharmacokinetics (PMK)Drug Utilization & Outcomes (DUO)

3:00 PM – 4:00 PM EDT

Regulatory, Operational, and Clinical Pharmacology Challenges of Conducting Clinical Trials in Low- and Middle-Income Countries

Location: Centennial III

Chair: – GlaxoSmithKline

Chair: – Takeda

Speaker: – Bill & Melinda Gates Foundation

Global Health (GH)Regulatory Science (RS)

3:00 PM – 4:00 PM EDT

Translating Your Story For All: Mastering Effective Communication Skills

Location: Regency VI

Moderator: – University of Minnesota

Panelist: – Janssen R&D

Panelist: – American Society of Clinical Pharmacology and Therapeutics

Panelist: – Pfizer