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Conference: ACoP 2026

Date: October 11 - 14, 2026

Location: Gaylord National Harbor, Oxon Hill, MD 20745

Booth: 17 & 18

Platinum Sponsor

Certara at ACoP

Certara is proud to sponsor the American Conference on Pharmacometrics (ACoP), the leading global forum for advancing quantitative drug development and Model-Informed Drug Development (MIDD).

As regulatory expectations for model credibility and dose justification continue to evolve, integrated pharmacometrics strategies are more critical than ever. At ACoP, our scientific leaders and consultants will share insights across population pharmacokinetics (PopPK), exposure–response (E-R) modeling, physiologically based pharmacokinetics (PBPK), quantitative systems pharmacology (QSP), and model-based meta-analysis (MBMA), supporting programs from early development through global regulatory submission.

Visit us to discuss how Certara integrates advanced modeling technologies with applied regulatory expertise to strengthen decision-making, reduce development risk, and build submission-ready, regulator-aligned evidence packages.

We look forward to connecting with you in person.

Fellow of ISoP (FISoP)

Honoree:  Samer Mouksassi, Certara

Samer Mouksassi will be recognized as a Fellow of the International Society of Pharmacometrics (FISoP) — one of the Society’s highest honors, a career-achievement award for sustained and substantial contributions to the science of pharmacometrics, to ISoP, and to the broader model-informed drug development community. New Fellows are honored during the ACoP opening ceremony.

Where to hear Certara insights and expertise

Workshops:

Saturday, October 10 | 10:00 AM – 12:00 PM (lunch included)
Room: Chesapeake H
Phoenix Workshop

Certara presenters:  Certara Phoenix team

A hands-on session with the Certara Phoenix team.

Registration link forthcoming

Sunday, October 11 | 1:00 – 5:00 PM
Room: Chesapeake H
QSP at Scale with Certara IQ™

Certara instructors:  Joshua F. Apgar and Andrew Matteson, Certara

With hundreds of FDA and EMA submissions now supported by QSP models, quantitative systems pharmacology has come of age — yet most preclinical and clinical programs still aren’t supported by QSP. This workshop unveils Certara IQ™, an environment built to scale QSP from a handful of projects to the entire pipeline. Through worked, practical examples, instructors demonstrate how to apply Certara IQ across four key decision points: new target feasibility, best-in-class properties, first-in-human dose projection, and recommended Phase 2 dose.

Registration: 
$450 ACoP Attendees
$300 Students with code STUDENTACOP26

Presentations:

Monday, October 12 | 11:00 AM – 12:30 PM | Maryland BD/4-6
Session: Phase Out Animals, Phase In NAMs: The Essential Role of Mechanistic Modeling (Session C1A)

Certara presentation:  “Mechanistic Modeling as the Translational Engine: Converting NAM Data into Predictive Human PK/PD and Safety Insights” (11:40 AM – 12:00 PM)

Certara presenter:  Piet van der Graaf, Certara

Tuesday, October 13 | 8:00 AM – 12:00 PM
Session: From Models to Medicine: Applying the Clinical Utility Index (CUI) for Quantitative Benefit–Risk Assessment in Drug Development Decisions

Certara Chair:  Samer Mouksassi, Certara  (with instructors from AstraZeneca and Eli Lilly)

Certara presenter:  Piet van der Graaf, Certara

Tuesday, October 13 | 12:30 – 2:00 PM
(First Annual) ISoP PBPK SIG Lunch Session

Certara presentation:  Certara contributes “PBPK Models to Medicines” within the session, alongside talks on PBPK in regulatory science and PBPK with AI, and a panel discussion.

Certara presenter:  Amin Rostami-Hodjegan, Certara

Tuesday, October 13 | 2:00 – 3:30 PM | Maryland C
Session: Integrating Models into Decision-Making for Pediatric Rare Diseases: Are We There Yet?

Certara presentation:  “Strengths and Limitations of MBMA as a Tool to Accelerate Drug Development in Rare Diseases” (2:25 – 2:50 PM)

Certara presenter:  Matt L. Zierhut, Certara

Wednesday, October 14 | 10:30 AM – 12:00 PM | Maryland C
Session: PROTACs for ‘Undruggable’ Cancer Targets: From Discovery to Therapy and Reverse Translation via Mechanistic Modeling (QSP / PBPK)

Certara presentation:  “Optimizing PROTACs in Preclinical ADME: From In Vitro Assays to Clinical Translation” (10:30 – 10:50 AM)

Certara presenter:  Sibylle Neuhoff, Certara

Wednesday, October 14 | 3:00 – 4:30 PM | Maryland BD/4-6
Session: Data Enablement for MIDD: Integrating Real-World and Clinical Trial Data with Practical Solutions in Pharmacometrics (Concurrent Session C5A)

Certara presentation:  “Applications of Real-World Data to MIDD: Insights to Surmount Challenges Gained from Ongoing Research in Alzheimer’s Disease and Pediatric Populations” (3:00 – 3:20 PM)

Certara presenter:  Ananth Kadambi, Real World Evidence & Modeling Solutions, Certara

Panel Discussion (4:00 – 4:30 PM) — Certara panelist: Ananth Kadambi.

Thursday, October 15 | 8:00 AM – 12:00 PM | Maryland A
Session: From Models to Medicine: Applying Clinical Utility Index (CUI) for Quantitative Benefit–Risk Assessment in Drug Development Decisions

Chair: Samer Mouksassi, PharmD,PhD,FCP

Presentation within session: Current clinical applications and latest trends in drug development using CUI and other forms of multi-attribute utility approaches- Non-Oncology Case Studies

Presenter: Samer Mouksassi, PharmD,PhD,FCP

Certara Scientific Posters at ACoP 2026

Population PK / PK-PD & Exposure–Response

Model-Informed Dose Selection for TBD11, a Novel Anti-tuberculosis Rv1625c Adenylyl Cyclase Agonist: Translating Phase 1 Single Ascending Dose Data via Population Pharmacokinetics

Presenter:  Anthony Gebhart
Contributors:  Ahmed Abulfathi
Affiliations:  Certara

Population Pharmacokinetic Modeling of TBD09 (MK-7762) in Healthy Participants Describes Food-Dependent Saturable Absorption Pathway and Second Slower Absorption Pathway

Presenter:  Anthony Gebhart
Contributors:  David Salinger, Bill Poland
Affiliations:  Certara

A Population Pharmacokinetic Model of Sibeprenlimab in Healthy Participants and Patients with IgA Nephropathy

Presenter:  Fazlur Rahman
Contributors:  Bo Zheng, Josh Kaullen, Jing Li, Huub Jan Kleijn, Yanlin Wang, Arash Raoufinia
Affiliations:  Certara, Otsuka

Population PK/PD and Exposure-Response Modeling of Sibeprenlimab in Patients with IgA Nephropathy

Presenter:  Fazlur Rahman
Contributors:  Bo Zheng, Josh Kaullen, Shahram Ejtemaei Mehr, Akhilesh Atluri, Jing Li, Huub Jan Kleijn, Yanlin Wang, Arash Raoufinia
Affiliations:  Certara, Otsuka

Population PK/PD Modeling Supporting Accelerated Approval of an Intravenous Brain-Penetrant Enzyme Replacement Therapy for Mucopolysaccharidosis Type II

Presenter:  Mahdiar Sadeghi
Contributors:  Hunter Stephens, Heller Chen, Akhil Bhalla, Lorna Damo, Meng Fang, Fabian Model, Kirk Henne, Mirjam N. Trame, Shyeilla V. Dhuria
Affiliations:  Certara, Denali

Pharmacokinetics and Exposure-Response Relationship of the Anti-TLR7 Monoclonal Antibody DS-7011a in Patients with Systemic Lupus Erythematosus

Presenter:  Li Zhang (Daiichi Sankyo) & Anthony Gebhart (Certara)
Contributors:  Yoshiaki Tomimori, Jun Tanaka, Mirjam N. Trame, Manish Kumar, Masafumi Kumazaki, Samarth Patel, Bernardo Jordan Vargas, Giorgio Senaldi, Tarek Leil
Affiliations:  Daiichi Sankyo, Certara

Physiologically Based Pharmacokinetics (PBPK)

Exploring the Impact of Hepatic Impairment and Changes in Plasma Protein Levels on Peptide PK

Presenter:  Sravani Lanke
Contributors:  Kate L. Gill, Lisa Almond
Affiliations:  Certara

Butorphanol Pharmacokinetics Across Species: Meta-Analysis Integrating Allometric Scaling and Minimal Physiologically-Based Pharmacokinetic Modeling

Presenter:  Ahmed Saeed
Contributors:  William Jusko
Affiliations:  Certara, SUNY Buffalo

Quantitative Systems Pharmacology (QSP)

A Quantitative Systems Pharmacology Model of TL1A-DR3 Signaling to Link Target Neutralization and Clinical Efficacy in Inflammatory Bowel Disease

Presenter:  Diana Marcantonio
Contributors:  Carter L. Johnson, Christie Ciarlo, Ben Lang, David Flowers, Joshuaine Grant, Georgi I. Kapitanov
Affiliations:  Certara

A Quantitative Systems Pharmacology Model of Type 1 Diabetes Progression to Support Immunomodulatory Drug Development

Presenter:  Robert Sheehan
Contributors:  E. Roesch, G. Boka, V. Chelliah, M. Jansen, M. Kumar, M. Peakman, E. Sundermann, L. Knecht, P. van der Graaf, B. Wagenhuber
Affiliations:  Certara, Sanofi

Radiopharmaceutical & Biodistribution Modeling

A Semi-mechanistic Population Biodistribution Model of 89Zr-TLX250-Px for the Diagnosis of Clear Cell Renal Cell Carcinoma

Presenter:  Hunter Stephens
Contributors:  Ammar Adam, Anagha Kakade, Suzanne Bissonnette, Kim Allman, Michael Ferris, David Cade, Mirjam N. Trame
Affiliations:  Certara, Telix

Pharmacometric Methods & Optimal Design

Capturing Effects of Correlations Between Covariates in Pharmacometric Models

Presenter:  Bill Poland
Contributors:  Bill Poland
Affiliations:  Certara

Optimizing Sampling Times on Relative Standard Error Is Superior to Optimizing on the Fisher Information Matrix

Presenter:  Mark Sale
Contributors:  Keith Nieforth, Steve Duffull
Affiliations:  Certara

Meet our experts at ACoP — Booths 17 & 18

Connect with Certara’s scientific and regulatory experts to explore how integrated modeling software and tech-enabled consulting can support confident decision-making across your development program, from early clinical strategy through global submission.

Schedule time with our team at ACoP to discuss your specific challenges and identify practical, model-informed solutions tailored to your program.

Secure your meeting now to ensure dedicated time with our experts onsite.