HMX Pro Pharmacology
Drug Discovery and Development: Overview of the End-to-End Therapeutic Development Pipeline
Understand advances in drug discovery and development and how new therapeutics are developed.
Drug discovery and development has evolved dramatically over recent decades and the field continues to advance today. More sophisticated approaches and models are being developed, new technology is being incorporated into the entire pipeline of development, and exciting drug modalities continue to emerge. With all the advances in science and with closer collaboration between different scientific disciplines, a multifaceted approach is now being applied to drug discovery and development. Therefore, the likelihood of being able to discover a compound, transform this into a safe and effective therapeutic, and improve the lives of patients has increased.
This course builds on foundational knowledge of pharmacology to explore the latest methodologies in drug development, from preclinical research through the clinical phases. It provides an overview of the drug discovery pipeline, starting with the conception of an idea, advancing through preclinical testing, and progressing through all stages of clinical development. Additionally, this course highlights the role of independent regulatory and review boards in ensuring the safety and ethical conduct of clinical trials.
Learning about the process of drug discovery and development has important implications for anyone working in health care and related sectors. This advanced course offers a unique way for professionals to learn from leading Harvard Medical School faculty about how drugs are discovered and developed and about the advances happening in this field that are ultimately helping to improve the treatment and prevention of disease.
Course Topics
Overview of Drug Discovery and Development
- Introduction to Drug Discovery and Development
- The Promise of Drug Discovery and Development
Project Initiation and Selection
- Introduction to Drug Research and Development
- Understanding the Disease/Indication Being Targeted
- Understanding the Drug being Developed
- Understanding the Mechanism of Action of the Drug
- Understanding the Effect of the Drug on the Disease/Indication
- Having a Clear Plan for Drug Development
- Genetics in Drug Discovery
Drug Discovery
- Pharmacological Principles
- Biochemical Models and Cell Models
- Disease Models
- Small Molecules
- Protein Therapeutics
- RNA Therapeutics
- Clinical Linkage: Cystic Fibrosis
Nonclinical Drug Development
- Goals of Nonclinical Drug Development
- Animal Pharmacology
- Good Laboratory Practice
- Toxicology and Safety Pharmacology
- Toxicology Testing
- Genotoxicity, Carcinogenicity, and Reproductive Toxicity
- Early Clinical Studies
Clinical Drug Development
- Establishing a Causal Pathway
- Chance and Bias
- Confounding and Effect Modification
- Basic Epidemiologic Considerations
- Surrogate Endpoints
- Fundamentals of Randomized Trial Design
- Anatomy of a Randomized Trial
- Clinical Linkage: PCSK9 Inhibitors
Wrap-up
- The Future of Drug Discovery and Development
Download the Drug Discovery and Development course outline
Course Instructors
Kate McDonnell-Dowling, PhD
Lecturer in Biological Chemistry and Molecular Pharmacology, Harvard Medical School
Associate Director of Curriculum, HMX
Mark Goldberg, MD
Lecturer in Medicine, Harvard Medical School
Attending Physician in Hematology, Brigham and Women’s Hospital
Member of Board of Directors at Avacta Group PLC
Mark Namchuk, PhD
Senior Lecturer in Biological Chemistry and Molecular Pharmacology, Harvard Medical School
Executive Director of Therapeutics Translation in Department of Biological Chemistry and Molecular Pharmacology, Harvard Medical School
William Clarke, MD
Professor of Anesthesia, Harvard Medical School
Pediatric Critical Care Physician, Boston Children’s Hospital
Paul Ridker, MD, MPH
Eugene Braunwald Professor of Medicine, Harvard Medical School
Senior Physician, Brigham and Women’s Hospital
Director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital
More Information
Frequently asked questions
Who should take this course?
This course is designed for professionals in health care, life sciences, and related industries who want to have a better understanding of drug discovery and development for their work.
You should participate in this course if you are:
- New to the drug development industry and looking for an introduction to the basic principles and future directions of the drug development pipeline.
- Planning a career in pharmaceutical or medical research.
- A health care professional aiming to deepen your understanding of drug discovery and development.
- Interested in the overall drug development process or are looking for a refresher.
What do participants need to know to succeed in this course?
We recommend basic knowledge of chemistry, biology, and physics, as well as an understanding of key pharmacology concepts. If you need further background in pharmacology, we also offer an introductory course, HMX Pro Pharmacology – Essentials.
Not sure? Take this short quiz to gauge your knowledge of pharmacology concepts.
What is the time commitment?
Most people can expect to spend around 15–20 hours total, but this depends on your baseline knowledge, how carefully you take notes, and how seriously you take the assessments. New course material is released periodically, and remains available until the course period ends, so participants can work at their own pace. There is a final exam at the end of each course that can be taken any time during the final exam period.
Can participants earn certificates from Harvard Medical School?
There are two certification levels, based on participant scores:
- Certificate of Achievement
- Certificate of Completion