Full Schedule

7:00 AM - 8:00 AM MDT

Registration - Workshops & Pre Con

Location: Colorado Foyer

8:00 AM - 8:30 AM MDT

Pre-Con - From Pharmacometrics to registration: accelerating a medicine's path to patients. Welcome, introduction and problem statement

Location: Willow Lake 3 - 5

Co-Chair: – Pharmetheus

Co-Chair: – QUANTIVIS LLC

Preconference

8:00 AM - 5:00 PM MDT

Certara: QSP at Scale with Certara IQ

Location: Red Rock 9

Instructor: – Certara

Workshop

8:00 AM - 5:00 PM MDT

Pharmetheus: FREM in practical use: Implementation and interpretation

Location: Red Rock 3

Instructor: – Pharmetheus AB

Instructor: – Pharmetheus

Workshop

8:00 AM - 5:00 PM MDT

Simulations Plus: End-to-end clinical trial modeling with the Thales QSP software platform

Location: Red Rock 2

Instructor: – Simulations Plus, Inc

Instructor: – Simulations Plus

Workshop

8:00 AM - 5:00 PM MDT

Simulations Plus: From PK-PD Models to Simulations: A Hands-On Workshop using MonolixSuite (Day 2)

Location: Red Rock 4

Instructor: – Simulations Plus

Workshop

8:30 AM - 9:00 AM MDT

Pharmacometrics Phisticuffs 1* – Does Pharmacometrics accelerate or slow down a medicine’s path to patients?

Location: Willow Lake 3 - 5

Chair: – SJTPharm LLC

Speaker: – Human Predictions, LLC

Speaker: – Genentech, Inc.

Preconference

9:00 AM - 10:00 AM MDT

Accelerating a medicine's path to patients - First Registration

Location: Willow Lake 3 - 5

Moderator: – Eli Lilly and Company

Preconference

9:15 AM - 9:30 AM MDT

Pharmacometrics to accelerate first registration

Location: Willow Lake 3 - 5

Speaker: – Gilead Sciences

Preconference

9:30 AM - 9:45 AM MDT

PBPK to accelerate first registration

Location: Willow Lake 3 - 5

Speaker: – Certara

Preconference

9:45 AM - 10:00 AM MDT

QSP to accelerate first registration

Location: Willow Lake 3 - 5

Speaker: – self

Preconference

10:00 AM - 10:15 AM MDT

BREAK

Location: Willow Lake 3 - 5

Preconference

10:15 AM - 11:15 AM MDT

Accelerating a medicine's path to patients - Beyond Registration

Location: Willow Lake 3 - 5

Moderator: – Certara

Preconference

10:30 AM - 10:45 AM MDT

Dose selection and go/no-go decisions in a second indication by leveraging published clinical trial data for drugs/classes approved in multiple indications

Location: Willow Lake 3 - 5

Speaker: – Certara USA, Inc.

Preconference

10:45 AM - 11:00 AM MDT

Early Health Economic Modeling: Preparing for Market Access Challenges

Location: Willow Lake 3 - 5

Speaker: – Regeneron

Preconference

11:00 AM - 11:15 AM MDT

Improving future decisions by evaluating accuracy of past decisions based on pharmacometrics and statistical modeling

Location: Willow Lake 3 - 5

Speaker: – Johnson & Johnson Innovative Medicine

Preconference

11:15 AM - 11:45 AM MDT

Pharmacometrics Phisticuffs 2* – Is Clinical Pharmacology an enabler or a barrier for Pharmacometrics?

Location: Willow Lake 3 - 5

Chair: – SJTPharm LLC

Speaker: – Eli Lilly and Company

Speaker: – Biogen

Preconference

11:45 AM - 12:45 PM MDT

LUNCH - Workshop Attendees

Location: Red Rock 6/7

Preconference

12:45 PM - 1:30 PM MDT

Pharmacometrics's strategic impact in Drug Development

Location: Willow Lake 3 - 5

Moderator: – Human Predictions, LLC

Preconference

1:00 PM - 1:15 PM MDT

Making MIDD Business as Usual: A Strategic Imperative for R&D

Location: Willow Lake 3 - 5

Speaker: – Pfizer

Preconference

1:15 PM - 1:30 PM MDT

Harnessing the Power of Pharmacometrics: Shaping Organizational Strategy to Accelerate Drug Development

Location: Willow Lake 3 - 5

Speaker: – Johnson & Johnson Innovative Medicine

Preconference

1:00 PM - 7:30 PM MDT

ACoP 2025 Conference Registration

Location: Colorado Foyer

1:30 PM - 2:00 PM MDT

Pharmacometrics Phisticuffs 3* – Is Biostatistics a more important partner for drug development than Pharmacometrics, or are they equal partners?

Location: Willow Lake 3 - 5

Co-Chair: – SJTPharm LLC

Speaker: – GSK

Speaker: – Metrum Research Group

Preconference

2:00 PM - 2:45 PM MDT

Pharmacometrics implementation and efficient execution

Location: Willow Lake 3 - 5

Moderator: – Pharmetheus

Preconference

2:15 PM - 2:30 PM MDT

From Silos to Synergy: Optimizing quantitative decision making in cross functional frameworks"

Location: Willow Lake 3 - 5

Speaker: – Gilead Sciences

Preconference

2:30 PM - 2:45 PM MDT

Model-informed drug development with hyper accelerated time to submission - exemplified with depemokimab regulatory submissions in interleukin-5-driven diseases"

Location: Willow Lake 3 - 5

Speaker: – Pharmetheus AB

Preconference

2:45 PM - 3:00 PM MDT

BREAK

Location: Willow Lake 3 - 5

Preconference

3:00 PM - 3:30 PM MDT

Pharmacometrics Phisticuffs 4* – Is AIML or QSP saving the day for Pharmacometrics?

Location: Willow Lake 3 - 5

Chair: – SJTPharm LLC

Speaker: – Pfizer

Speaker: – Genentech

Preconference

3:30 PM - 4:30 PM MDT

The future of Pharmacometrics is ours - Actions to take home

Location: Willow Lake 3 - 5

Co-Chair: – Pharmetheus

Co-Chair: – QUANTIVIS LLC

Preconference

4:15 PM - 5:15 PM MDT

ACoP BUDDY MEET & GREET

Location: Red Rock 6/7

4:30 PM - 4:45 PM MDT

Concluding Remarks

Location: Willow Lake 3 - 5

Co-Chair: – QUANTIVIS LLC

Co-Chair: – Pharmetheus

Preconference

5:30 PM - 7:30 PM MDT

ACoP 2025 Opening Session

Location: Colorado B-D

Speaker: – Genentech

Speaker: – InSilicoTrials

5:30 PM - 5:45 PM MDT

Welcome to ACoP 2025

Location: Colorado B-D

5:45 PM - 6:15 PM MDT

Presentation of ISoP Awards & Induction of Fellows

Location: Colorado B-D

Presenter: – Vertex Pharmaceuticals

6:15 PM - 7:30 PM MDT

Lewis B. Sheiner Award Lecture - Taking on Cracks Only to See Bigger Gaps: Addressing Patient Variability in Pharmacokinetics

Location: Colorado B-D

Speaker: – The University of Manchester - Certara Inc

7:30 PM - 10:00 PM MDT

PRESIDENT'S WELCOME RECEPTION

Location: Colorado Ballroom A & Foyer