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Updated in [March 06th, 2023]

The University of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences Drug Development course provides students with lectures from both faculty and industry experts. This course is designed to give students an in-depth understanding of the different stages of clinical development, including Investigational New Drug Application (IND), New Drug Application (NDA), and product labeling. Additionally, students will learn how to incorporate study design methods for consideration in the design of clinical protocols to assess safety, tolerability, and efficacy in multiple therapeutic areas.

The course covers the different phases of clinical development, such as Phase 1 or early stage clinical trials, which are conducted primarily to determine how the new drug works in humans, its safety profile, and to predict its dosage range. This phase typically involves between 30 and 100 healthy volunteers. Phase 2 or Proof of Concept POC studies test for efficacy as well as safety and side effects in a group of between 30 to 200 hundred patients with the disease for which the new drug is being developed. Phase 3 or late stage clinical development involve much larger group of patients, between a few hundred to thousands, depending on the indication, which will help determine if the new drug can be considered both safe and effective. It will involve control groups using placebo and/or current treatment as a comparison.

Finally, the course covers the product registration and approval process after a drug is considered safe and effective from Phase 3 trials. All data generated about the small molecule or biologic is collected and submitted to the regulatory authorities in the US at the FDA, Food and Drug Administration FDA, in Europe the EMA or European Medicines Agency, Japan Ministry of Health and other countries which may require their own national approvals.

This course is intended as part 2 of a series: Drug Discovery (https://www.coursera.org/learn/drug-discovery), Drug Development and Drug Commercialization (https://www.coursera.org/learn/drug-commercialization). It is highly recommended that students take the courses in order, as it will give them a better understanding of how a drug is discovered in the lab before being tested in clinical trials and then launched in the market place.

[Applications]
Upon completion of the Drug Development course, participants will have a better understanding of the different stages of clinical development, the regulatory process, and the incorporation of study design methods for consideration in the design of clinical protocols. Participants will be able to apply this knowledge to the development of new drugs and the commercialization of existing drugs. Additionally, participants will be able to use the knowledge gained from this course to better understand the drug discovery process and the drug commercialization process.

[Career Paths]
Recommended Career Paths:

1. Clinical Research Associate: Clinical Research Associates (CRAs) are responsible for the planning, implementation, and monitoring of clinical trials. They are responsible for ensuring that the trials are conducted in accordance with the protocol, applicable regulations, and Good Clinical Practices (GCP). CRAs are also responsible for the collection and review of data from clinical trials. This role is expected to grow as the demand for new drugs and treatments increases.

2. Regulatory Affairs Specialist: Regulatory Affairs Specialists are responsible for ensuring that a drug or medical device meets all applicable regulatory requirements. They are responsible for preparing and submitting regulatory documents to the appropriate regulatory agencies, such as the FDA. They also monitor changes in regulations and advise the company on how to comply with them. This role is expected to grow as the demand for new drugs and treatments increases.

3. Clinical Data Manager: Clinical Data Managers are responsible for the collection, management, and analysis of clinical data. They are responsible for ensuring that the data is accurate and complete, and that it meets all applicable regulatory requirements. This role is expected to grow as the demand for new drugs and treatments increases.

4. Clinical Trial Manager: Clinical Trial Managers are responsible for the planning, implementation, and monitoring of clinical trials. They are responsible for ensuring that the trials are conducted in accordance with the protocol, applicable regulations, and Good Clinical Practices (GCP). This role is expected to grow as the demand for new drugs and treatments increases.

[Education Paths]
Recommended Degree Paths:
1. Bachelor of Science in Pharmaceutical Sciences: This degree program provides students with a comprehensive understanding of the pharmaceutical sciences, including drug discovery, development, and commercialization. Students will learn about the various stages of drug development, from pre-clinical research to clinical trials and product registration. They will also gain an understanding of the regulatory environment and the importance of ethical considerations in drug development. This degree program is ideal for those interested in pursuing a career in the pharmaceutical industry.

2. Master of Science in Pharmaceutical Sciences: This degree program provides students with an in-depth understanding of the pharmaceutical sciences, including drug discovery, development, and commercialization. Students will learn about the various stages of drug development, from pre-clinical research to clinical trials and product registration. They will also gain an understanding of the regulatory environment and the importance of ethical considerations in drug development. This degree program is ideal for those interested in pursuing a career in the pharmaceutical industry or in research.

3. Doctor of Pharmacy: This degree program provides students with a comprehensive understanding of the pharmaceutical sciences, including drug discovery, development, and commercialization. Students will learn about the various stages of drug development, from pre-clinical research to clinical trials and product registration. They will also gain an understanding of the regulatory environment and the importance of ethical considerations in drug development. This degree program is ideal for those interested in pursuing a career in the pharmaceutical industry or in research.

4. Master of Science in Clinical Research: This degree program provides students with an in-depth understanding of the clinical research process, including the design, implementation, and analysis of clinical trials. Students will learn about the various stages of drug development, from pre-clinical research to clinical trials and product registration. They will also gain an understanding of the regulatory environment and the importance of ethical considerations in drug development. This degree program is ideal for those interested in pursuing a career in clinical research or in the pharmaceutical industry.

Developing Trends:
1. Increasing focus on personalized medicine: With the rise of personalized medicine, there is an increasing focus on developing drugs that are tailored to the individual patient. This requires a greater understanding of the underlying biology of the disease and the development of more targeted therapies.

2. Growing emphasis on data-driven drug development: With the increasing availability of data, there is a growing emphasis on data-driven drug development. This involves the use of data to inform decisions about drug development, from pre-clinical research to clinical trials and product registration.

3. Increasing use of artificial intelligence and machine learning: With the increasing use of artificial intelligence and machine learning, there is an increasing focus on using these technologies to improve drug development. This includes the use of AI and machine learning to identify potential drug targets, design clinical trials, and analyze data.

Course Syllabus

Welcome!

Regulatory Considerations When Filing an Investigational New Drug Application, Susan Trieu, Pharm.D.

Clinical Study & Start-up Activities, Joseph Ma, Pharm.D.

Clinical Trials: Phase 1, Yazdi Pithavala, Ph.D.