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Model-Informed Drug Development Solutions

Transforming drug discovery and development through predictive science

Model-Informed Drug Development (MIDD) is transforming how new therapies are discovered, developed, and approved. By applying drug development strategy, advanced modeling capabilities, and AI-enabled technologies, MIDD enables companies to predict drug performance earlier, make faster, data-driven decisions, and reduce the cost and risk of development.​

MIDD is an approach that uses quantitative modeling, simulation, and data integration to inform key decisions throughout the drug development lifecycle. This quantitative framework is now a cornerstone of modern R&D, delivering measurable gains in speed, efficiency, and regulatory confidence. Independent analyses by Pfizer and AstraZeneca demonstrate that MIDD can deliver significant ROI, saving approximately 10 months and $5 million per program, and increasing proof-of-mechanism success by 2.5-fold.

Economic benefits of MIDD includes

$5
Saved per program 1
10
Months reduced per program 1
2.5
increase in success proving proof-of-mechanism with comprehensive modeling package 2

Global regulatory endorsement of MIDD

Model-Informed Drug Development (MIDD) is increasingly endorsed by global regulatory agencies, including the FDA, EMA, PMDA, and NMPA, as a best practice to enhance efficiency, reduce development risk, and improve the probability of regulatory success.​

FDA & UK Government call to action on New Approach Methodologies (NAMs)

Joint initiatives between the FDA and UK Government emphasize MIDD as a core framework of next-generation regulatory science, integrating modeling, simulation, and NAMs to advance more predictive and humane drug evaluation.

FDA Quantitative Medicine Center of Excellence

The creation of this Center of Excellence in 2024 highlights the FDA’s continued investment in model-based approaches, accelerating the adoption of MIDD tools across therapeutic areas and review divisions.

FDA MIDD Pilot Program

The FDA’s Model-Informed Drug Development Pilot Program demonstrated how quantitative models can support dose selection, trial design, and regulatory decision-making. Outcomes from the program established MIDD as a trusted framework for evidence generation and risk-based decision-making.

Global leaders in model-informed drug development

Certara brings together the most experienced Model-Informed Drug Development experts globally, including leaders in pharmacometrics, PBPK, clinical pharmacology, statistics, and regulatory science. Our scientific excellence is reflected in the 11 Certara experts honored on the 2025 Stanford/Elsevier Top 2% Most Cited Researchers list.

700
Certara experts

70+ Market Access and Real World Evidence Professionals

190+ Regulatory Writers, Strategists, and Submissions Experts

25+ Biometricians & Programmers

80+ Operations, QA, Commercial & Business Development Professionals

110+Pharmacometricians & Pharmacokineticists

50+ Drug Development Lead, Project Management, Clinical Operations

40+ Data Scientists

15+ Early Drug Development, DMPK, CMC, Toxicologists

40+ Clinical Pharmacologists

100+ PBPK and QSP Scientists

Certara: powering MIDD from discovery to approval

Certara uniquely offers a fully integrated MIDD ecosystem that combines industry-leading mechanistic and empirical modeling technologies and services from discovery through regulatory approval. This unmatched breadth enables teams to apply the right modeling approach at the right time, driving better decisions, lower risk, and greater confidence with global regulators.

Discovery

Nonclinical

Phase 1: Safety

Phase 2: Activity

Phase 3: Efficacy

Market Access and Commercialization

Discovery > Nonclinical > Phase 1: Safety > Phase 2: Activity > Phase 3: Efficacy > Market Access and Commercialization

Mechanistic Modeling (PBPK, QSP, QST)​

Discovery > Nonclinical

Cheminformatics​

Nonclinical > Phase 1: Safety > Phase 2: Activity > Phase 3: Efficacy > Market Access and Commercialization

Empirical Modeling (PK/PD, NCA)​

Population PK and Exposure/Dose-Response (PMx)​

Discovery > Nonclinical > Phase 1: Safety > Phase 2: Activity > Phase 3: Efficacy > Market Access and Commercialization

MBMA, Real-World Evidence​

AI / ML​

Drug Development Strategy​

MIDD used in lieu of clinical trials

Model-Informed Drug Development (MIDD) enables confident decision-making when traditional clinical trials are impractical or unnecessary. MIDD approaches are increasingly used in lieu of clinical trials to predict drug–drug interactions (DDIs), characterize pharmacokinetics in new or difficult to test populations, and support virtual bioequivalence (VBE) assessments. These model-based strategies have supported regulatory decisions and enabled label claims in lieu of dedicated clinical studies in more than 120 FDA-approved novel drugs.

Certara is the Global Leader in MIDD

With over 20 years of leadership and the largest global team of MIDD experts, Certara delivers end-to-end solutions that optimize decisions and accelerate development from discovery to approval.

21
regulatory agencies license Certara software products
700
drug development scientists and experts to advance your program leveraging tech-enabled decision-making
90
Certara’s customers have received 90% or more of all novel drug approvals by the FDA from 2014 through 2024.
94,000
global users of our solutions

Model-informed drug development resources

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1 / 5
Case Study

Systems Modeling Delivers Efficiencies and Savings in Clinical Development

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2 / 5
Guide

10 Strategic Foundations for Early Drug Development

Discover effective Early Drug Development strategies to navigate early development with confidence and clarity. Download the guide today!
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3 / 5
Guide

A Guide to the FDA Announcement to Phase Out Animal Testing for Drugs

The FDA is phasing out animal testing of new drugs. Learn how Certara’s Non-Animal Navigator™ enables safe, ethical, and predictive drug development.
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4 / 5
Guide

De-Risking Drug Design: How Early Feasibility Assessment Transforms Biotherapeutic Development

Learn how Early Feasibility Assessment and QSP modeling improve drug design, de-risk feasibility studies, & accelerate development decisions.
Read more
5 / 5
On-Demand Webinar

Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights

Watch this on-demand webinar to learn how pharmacometrics supports NDA, BLA, and global regulatory submissions. Discover strategies for dose justification, labeling, expedited timelines, and managing complex PK/PD analyses from Certara’s regulatory and PMx experts.
Watch now

Partner with Certara for Model-Informed Drug Development

Model-Informed Drug Development (MIDD) enables informed, regulator-ready decisions across the drug development lifecycle, reducing reliance on clinical studies while accelerating development timelines.

End-to-end impact: Certara’s MIDD solutions support decisions from early discovery through registration, streamlining development programs and reducing reliance on clinical studies.
Regulatory confidence: Certara brings unmatched regulatory experience in applying model-based approaches that are routinely accepted by regulators and have enabled label claims without dedicated clinical trials.
Unmatched expertise: Certara’s global team includes scientific leaders and former regulators with deep, hands-on experience applying MIDD across various therapeutic areas and types.


1 Pfizer: Sahasrabudhe, V., Nicholas, T., Nucci, G., Musante, C. J., & Corrigan, B. (2025). Impact of model‐informed drug development on drug development cycle times and clinical trial cost. Clinical Pharmacology & Therapeutics, 118(2), 378–385. https://doi.org/10.1002/cpt.3636

2 AstraZeneca: Jansson-Löfmark R, Fridén M, Badolo L, et al. Translational PK/PD: A retrospective analysis of performance and impact from a drug portfolio. Drug Discovery Today. 2025;30(7):104417. doi:10.1016/j.drudis.2025.104417