- Medical Writer at DynaMedex/EBSCO and Biomedical Researcher
Model-Informed Drug Development
- Certificate
Advance Drug Development Through Quantitative Science
Model-informed drug development (MIDD) is transforming how therapies are discovered, evaluated, and brought to patients. UJ’s Graduate Certificate in Model-Informed Drug Development prepares professionals to apply quantitative modeling, simulation, and data-driven decision-making throughout the drug development process.
Through interdisciplinary coursework in pharmacology, computational modeling, clinical trial simulation, and regulatory science, you’ll gain the knowledge and practical skills to support more efficient, evidence-based drug development.
12 Credit Hours | 100% Online | Complete in as little as a year
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Why Study MIDD?
Modern drug development increasingly relies on computational modeling and simulation to improve decision-making, optimize clinical trials, and accelerate regulatory review. Organizations across the pharmaceutical, biotechnology, and regulatory sectors are seeking professionals who understand how quantitative approaches can improve the efficiency and success of drug development.
This graduate certificate provides a focused foundation in pharmacometrics, clinical trial modeling, and regulatory strategy while exploring emerging technologies such as artificial intelligence, digital biomarkers, and multi-modal data integration.
Whether you are expanding your expertise or preparing for advanced roles in clinical development, this certificate equips you with practical skills that translate directly to today’s evolving pharmaceutical landscape.
What You’ll Learn
Throughout the program, you will learn to:
- Apply pharmacokinetic and pharmacodynamic principles to support drug development decisions.
- Develop and interpret computational models used in pharmacometrics.
- Design and evaluate model-informed clinical trial strategies.
- Assess regulatory frameworks supporting model-informed drug development.
- Utilize simulation techniques to optimize dosing and study design.
- Explore emerging applications of artificial intelligence, machine learning, and digital health technologies in drug development.
Career Applications
Graduates will be prepared to strengthen their expertise in areas including:
- Clinical Pharmacology
- Pharmacometrics
- Clinical Development
- Regulatory Affairs
- Drug Development Strategy
- Quantitative Clinical Research
- Pharmaceutical and Biotechnology Research
- Translational Medicine
Why University of Jamestown?
- The University of Jamestown's online graduate programs are designed for working professionals seeking flexible, career-focused education grounded in academic excellence.
- Courses are taught by experienced faculty with expertise in clinical research, regulatory science, and drug development, providing learners with relevant knowledge they can immediately apply within industry, healthcare, and research environments.
Designed for Working Professionals
Complete coursework on a schedule that fits your professional commitments.
Graduate-Level Certificate
Earn a focused graduate credential that builds specialized expertise.
Program Curriculum
The Graduate Certificate in Model-Informed Drug Development consists of four graduate courses (12 credit hours).
DMED 621: Foundations of Model-informed Drug Development
Introduces core principles of model-informed drug development (MIDD), including pharmacokinetics (PK), pharmacodynamics (PD), modeling paradigms, translational science, and regulatory frameworks that guide quantitative decision-making in drug development.
Learning Objectives:
- Explain foundational PK/PD principles and their application in drug development.
- Describe major modeling approaches (population PK, PBPK, exposure–response).
- Interpret modeling outputs to inform dose selection and development decisions.
- Evaluate case studies demonstrating regulatory use of MIDD.
- Assess assumptions, limitations, and validation principles of pharmacometric models.
- Discuss the role of MIDD from preclinical through clinical phases.
DMED 622: Quantitative Pharmacology and Computational Modeling
Develops computational skills required for quantitative pharmacology, including modeling workflows, simulation techniques, and statistical analysis used in pharmacometrics.
Learning Objectives:
- Construct basic PK/PD models using computational tools.
- Apply nonlinear mixed-effects modeling concepts.
- Conduct simulation exercises for dose optimization.
- Analyze variability and uncertainty in pharmacologic models.
- Evaluate model performance and validation strategies.
- Translate computational outputs into clinically meaningful interpretations.
DMED 623: Clinical Trial Simulation and Model-informed Decision-making
Explores the role of modeling in clinical trial design, adaptive studies, precision medicine, and regulatory strategy, emphasizing evidence-based decision frameworks.
Learning Objectives:
- Simulate clinical trial scenarios using quantitative models.
- Evaluate dose selection strategies using exposure–response analyses.
- Apply modeling approaches to special populations (e.g., pediatrics, renal impairment).
- Design adaptive trial frameworks informed by simulation.
- Assess how modeling supports regulatory submissions.
- Integrate real-world data into model-informed decision-making.
DMED 624: Regulatory Science, AI, and Emerging Innovations in MIDD
Focuses on regulatory science, AI applications, digital biomarkers, and emerging technologies shaping the future of MIDD.
Learning Objectives:
- Explain FDA and EMA regulatory guidance relevant to MIDD.
- Evaluate AI and machine learning applications in pharmacometrics.
- Assess digital biomarkers and imaging-derived endpoints in modeling.
- Integrate multi-modal data (omics, imaging, clinical) into quantitative frameworks.
- Develop model-informed regulatory strategy proposals.
- Critically assess ethical, governance, and data integrity considerations.
- Neuroscientist and Industry Expert
- Director of Natural Sciences and Associate Professor of Biology
- Program Director, MSCPDM and MSMS
- Associate Professor
- Founder and CEO, Thrive Foot and Ankle
Financial Aid Available
We believe every student, regardless of their financial situation, should have access to a University of Jamestown education