Develop the skills for success in pre-clinical drug development.
This microcredential will present material related to the processes of drug development (Badge 1, Drug Development) and pre-clinical and in-human testing through Phase I, II and III clinical trials (Badge 2, Clinical Trials) comprising a pathway in Drug Development and Clinical Trials. The goal of the microcredential is to provide the means for learners to become competent in understanding the purpose, processes, and metrics for success for human drug development, and in the design, conduct, and assessment of efficacy of new investigational drugs tested through human clinical trials. It is recommended that the learner follow the Badge 1, Badge 2 sequence as Badge 2 builds upon material presented in Badge 1.
Drug Development Badge
The Drug Development badge will explore the process of drug development. It will use the model of cancer therapeutic development and the development of Gleevec as the example therapeutic. The material will include discussion of the Central Dogma of Biology, target identification with special reference to protein targets, high-throughput screening of combinatorial libraries for identification of lead compounds, optimization of pro-drug structures for optimal activity, and how optimal activity is determined.
Clinical Trials Badge
The Clinical Trials badge will explore in-human drug testing. It will also use the model of cancer therapeutic development and the development of Gleevec as the example therapeutic. This material will discuss what is meant by the Pharmacokinetics (PK) properties of the drug, e.g., what the body does to the drug (Absorption, Distribution, Metabolism, Excretion) and Pharmacodynamics (PD), e.g., what the drug does to the body (including determination of the EC50 and the Therapeutic Index of the pro-drug); the use of in vitro (cell culture) and in vitro (mouse models) in pre-clinical testing; how pre-clinical testing information is used to file an Investigational New Drug (IND) application with the Food and Drug Administration (FDA); how investigational drugs are tested in humans through the processes of Phase I, II, III and IV clinical trials, and why using a broad demographic in human testing is important.
Course runs: July 1 - December 31, 2025
Plan Your Education
Curriculum
Drug Development
Several assessments (quizzes, short essays) are required throughout the course of the instructional pieces, with a final assessment directing the learned to successfully 'design and test a drug in vitro and in vivo' vivo' in the form of a final paper due at the end of the module.
Clinical Trials
Several assessments (quizzes, short essays) are required throughout the course of the instructional pieces, with a final assessment directing the learner to submit a paper that successfully designs, conducts, and analyzes data from Phase I, II, III and IV clinical trials of a hypothetical drug vivo' in the form of a final paper due at the end of the module.
Deadlines & Costs
Registration Deadline:
July 1, 2025
Cost:
$550
How to Register
Click the "Register" button above to begin. You will be redirected to https://catalog.online.umb.edu, our registration platform, to complete the enrollment process.
Learning Outcomes
- Learners will have gained an understanding of the biological underpinning of the drug development process.
- Learners will become familiar with the concepts behind drug target identification and identification of an assay to test for desired target activity.
- Learners will understand the strategies used for high throughput screening of combinatorial libraries to identify target lead compounds and those used for optimization of desired properties to create pro-drugs.
- Learners will comprehend the processes through which pro-drugs are pre-clinically assessed for pharmacodynamic (PD) and pharmacokinetic (PK) properties using in vitro (cell culture) and in vivo (animal) testing.
- Learners will understand the overall importance of population demographics in drug testing.
- Learners will understand the role of the Food and Drug Administration in reviewing and approving pre-clinical studies of New Investigational Drugs.
- Learners will understand the purpose and potential outcomes of first-in-human Phase I Clinical Trials testing of new investigational drugs for PD, PK, and safety (adverse events) / tolerability (maximal tolerable dose, MTD).
- Learners will follow promising new investigational drugs that pass Phase I testing into Phase II Clinical Trials, and how drug dosing and efficacy are determined.
- Learners will follow new investigational drug testing from Phase II into Phase III Clinical Trials, and will understand the concept and importance of Clinical Endpoints (Overall Survival) and Surrogate Endpoints (Partial Response, Progression-Free Survival, biomarkers) in assessing new investigational drugs in these trials.
- Learners will comprehend the criteria by which new investigational drugs achieve clinical and/or surrogate endpoints that exceed those for standard of care therapies.
- Learners will understand the statistical and analytic methodologies used to interpret clinical trial data.
- Learners will learn self-reliance and self-motivation.