Full Schedule

7:00 AM - 7:45 AM PT

Meet the ACCP/ISoP Special Interest Group

Location: Grand Ballroom E-H

7:00 AM - 7:45 AM PT

STEP & ESP Gathering

Location: Grand Ballroom I-K

7:00 AM - 8:00 AM PT

ACCP Annual Meeting Program Committee Meeting (Invitation only)

Location: Laurel

7:00 AM - 8:00 AM PT

Continental Breakfast

Location: Grand Ballroom A-D

7:00 AM - 5:00 PM PT

ACCP Registration Desk Open

Location: Grand Ballroom East Foyer

7:00 AM - 7:00 PM PT

Exhibit Hall Open

Location: Grand Ballroom A-D

8:00 AM - 9:30 AM PT

Symposium 5: Contemporary Issues Related to Pediatric Drug Development

Location: Grand Ballroom E-H

Chair & Faculty: – US Food & Drug Administration

Faculty: – US Food & Drug Administration

Faculty: – Univ of California San Diego

Faculty: – F. Hoffmann-La Roche Ltd

Clinical Drug Development & Investigations

CE: 1.5

8:00 AM - 9:30 AM PT

1 - Introduction

Chair & Faculty: – US Food & Drug Administration

8:00 AM - 9:30 AM PT

2 - Food Effect Assessment in Pediatrics: A Few Considerations

Faculty: – US Food & Drug Administration

8:00 AM - 9:30 AM PT

3 - Considerations for Neonatal Clinical Pharmacology Studies

Faculty: – Univ of California San Diego

8:00 AM - 9:30 AM PT

4 - Novel Model-based Approach for Drug-Drug Interaction Risk Assessments in Children

Faculty: – F. Hoffmann-La Roche Ltd

8:00 AM - 9:30 AM PT

5 - Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation

8:00 AM - 9:30 AM PT

Symposium 6: The Tightrope of Substance Abuse Potential: The Preclinical & Clinical Factors that Make or Break the Scheduling of a Substance, Using Kratom (Mitragyna Speciosa) as an Example

Location: Grand Ballroom I-K

Co-Chair & Faculty: – Univ of Florida

Co-Chair & Faculty: – National Inst on Drug Abuse

Faculty: – Johns Hopkins Univ School of Medicine Prediction & Treatment Unit, National Inst on Drug Abuse Intramural Research Program

Clinical Drug Development & Investigations

CE: 1.5

8:00 AM - 9:30 AM PT

1 - Introduction, Brief History & Pharmacology of Kratom

Chair & Faculty: – Univ of Florida

Clinical Drug Development & Investigations

8:00 AM - 9:30 AM PT

2 - The Current Regulatory 8-Factor Analysis & Its Use in Substance Abuse Liability

Faculty: – Johns Hopkins Univ School of Medicine Prediction & Treatment Unit, National Inst on Drug Abuse Intramural Research Program

Clinical Drug Development & Investigations

8:00 AM - 9:30 AM PT

3 - Preclinical & Clinical Data on Kratom as Predictors for Abuse Liability

Chair & Faculty: – National Inst on Drug Abuse

Clinical Drug Development & Investigations

8:00 AM - 9:30 AM PT

4 - Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation

Clinical Drug Development & Investigations

9:30 AM - 10:30 AM PT

Coffee/Networking Break

Location: Grand Ballroom A-D

9:40 AM - 10:00 AM PT

Industry Theater Presentation: Roadmap to Starting a Successful Preclinical/Clinical Pharmacology Consultancy Presented by Patel Kwan Consultancy LLC

Location: Industry Theater in Exhibit Hall

10:00 AM - 11:00 AM PT

1 - Introduction

Chair & Faculty: – Univ at Buffalo, SUNY School of Pharmacy & Pharmaceutical Sciences

10:00 AM - 11:00 AM PT

2 - Benefit vs Risk: What’s the Optimal Dose of Artificial Intelligence in Clinical Pharmacology?

Faculty: – Pfizer Worldwide Research, Development & Medical Clinical Pharmacology & Bioanalytics

10:30 AM - 11:30 AM PT

Invited Keynote: Benefit vs Risk: What's the Optimal Dose of Artificial Intelligence in Clinical Pharmacology?

Location: Grand Ballroom E-K

Chair & Faculty: – Univ at Buffalo, SUNY School of Pharmacy & Pharmaceutical Sciences

Faculty: – Pfizer Worldwide Research, Development & Medical Clinical Pharmacology & Bioanalytics

CE: 1

11:30 AM - 1:30 PM PT

Lunch Buffet

Location: Grand Ballroom A-D

11:45 AM - 1:15 PM PT

Lunch & Awards

Location: Grand Ballroom E-K

11:45 AM - 1:15 PM PT

1 - Roger Jelliffe Individualized Therapy Award: A Personal Account of Paving the Road to Personalized Medicine

Session Speaker: – Certara

11:45 AM - 1:15 PM PT

2 - Hartmut Derendorf Mentorship Award

Session Speaker:

11:45 AM - 1:15 PM PT

3 - Tanabe Young Investigator Award: Mentorship, Networking & Family: The Unsung Heroes of My Journey in Clinical Pharmacology

Session Speaker:

1:30 PM - 5:00 PM PT

Symposium 7: Are Mechanistic Models Necessary or Nice-to-Have in the Development of Multispecific Antibodies?

Location: Grand Ballroom E-H

Co-Chair & Faculty: – Amgen Inc

Co-Chair & Faculty: – Certara

Faculty: – US Food & Drug Administration

Faculty: – Applied BioMath LLC

Faculty: – US Food & Drug Administration

Faculty: – Bristol Myers Squibb

Faculty: – Genentech Inc

Faculty: – Certara

Clinical Drug Development & Investigations

CE: 3.0

1:30 PM - 5:00 PM PT

1 - Mechanistic Models for Multispecific Antibodies: An Introduction

Co-Chair & Faculty: – Certara

Clinical Drug Development & Investigations

1:30 PM - 5:00 PM PT

2 - First-in-Human Dose Selection of Immune-activating Biotherapeutics in Oncology

Faculty: – US Food & Drug Administration

Clinical Drug Development & Investigations

1:30 PM - 5:00 PM PT

3 - A Next Generation Mathematical Model for the In-vitro to Clinical Translation of T Cell Engagers

Faculty: – Applied BioMath LLC

Clinical Drug Development & Investigations

1:30 PM - 5:00 PM PT

4 - Harnessing the Power of Model-informed Drug Development to Support Clinical Development of T Cell Engagers

Faculty: – US Food & Drug Administration

Clinical Drug Development & Investigations

1:30 PM - 5:00 PM PT

5 - Case Studies in Mechanism-based Models for Immune-oncology

Co-Chair & Faculty: – Amgen Inc

Clinical Drug Development & Investigations

1:30 PM - 5:00 PM PT

6 - A Role of Multitherapy Quantitative Systems Pharmacology (QSP) Platforms in Clinical Development of Multispecific Drug Antibodies

Faculty: – Bristol Myers Squibb

Clinical Drug Development & Investigations

1:30 PM - 5:00 PM PT

7 - Predicting Survival in Prospective Clinical Trials Using Weakly-supervised QSP

Faculty: – Genentech Inc

Clinical Drug Development & Investigations

1:30 PM - 5:00 PM PT

8 - The Role of Model-informed Drug Development & QSP in Project Optimus

Faculty: – Certara

Clinical Drug Development & Investigations

1:30 PM - 5:00 PM PT

9 - Faculty Panel Discussion: Panel Discussion: Are Mechanistic Models Necessary or Nice-to-Have in the Development of Multispecific Antibodies?

Clinical Drug Development & Investigations

1:30 PM - 5:00 PM PT

Symposium 8: Use of Real-time Simulation for Decision Making in Clinical Pharmacology

Location: Grand Ballroom I-K

Co-Chair & Faculty: – AbbVie Inc

Co-Chair & Faculty: – Univ of Florida

Faculty: – AbbVie Inc

Clinical Drug Development & Investigations

CE: 3

1:30 PM - 5:00 PM PT

1 - Use of Adaptive Graphics Simulations for Device Selection in Parkinson’s Disease

Chair & Faculty: – AbbVie Inc

Clinical Drug Development & Investigations

1:30 PM - 5:00 PM PT

2 - Real-time Trial Simulations to Understand the Impact of Assumptions & Design Choices on Expected Trial Results for Anti-amyloid Antibody in Alzheimer's Disease

Faculty: – AbbVie Inc

Clinical Drug Development & Investigations

1:30 PM - 5:00 PM PT

3 - Opportunities & Challenges to Implementing Precision Dosing

Faculty: – Univ of Florida

Clinical Drug Development & Investigations

1:30 PM - 5:00 PM PT

4 - Session Recap & Points to Ponder

Co-Chair & Faculty: – AbbVie Inc

Clinical Drug Development & Investigations

1:30 PM - 5:00 PM PT

5 - Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation

Clinical Drug Development & Investigations

3:00 PM - 3:30 PM PT

Coffee/Networking Break

Location: Grand Ballroom A-D

5:00 PM - 5:30 PM PT

STEP & ESP Poster Walk

Location: Grand Ballroom A-D

5:00 PM - 7:00 PM PT

Evening Reception, Exhibits & Poster Session 2

Location: Grand Ballroom A-D

6:00 PM - 6:45 PM PT

STEP & ESP Podium Presentations

Location: Industry Theater in Exhibit Hall

7:00 PM - 9:00 PM PT

JCP & CPDD Editorial Board Dinner (Invitation only)

Location: Larch