Drug Development from Coursera

The University of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences Drug Development course brings you lectures from both faculty and industry experts. With this course, recorded on campus at UCSD, we seek to share our access to top people in the field who bring an unprecedented range of expertise on drug development.

In this course you will learn the different stages of clinical development as well as the regulatory including but not limited to, an Investigational New Drug Application (IND), New Drug Application (NDA), and product labeling. Additionally you 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.

In this course you will learn the different phases of clinical development:

* Phase 1 or early stage clinical trial are conducted primarily to determine how the new drug works in humans, its safety profile and to predict its dosage range. It 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.

* Product registration and approval process after a drug is considered safe and effective from Phase 3 trials, it must be authorized in each individual country before it can be marketed. 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). We would highly recommend that you take the courses in order since it will give you a better understanding on how a drug is discovered in the lab before being tested in clinical trials and then launched in the market place.

What's inside

Syllabus

Welcome!

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

This week we hear from Dr. Susan Trieu, who in her 12+ years in the industry has worked in regulatory affairs. Since then, Dr. Trieu has gone on to work in Industry at MedImpact as their Drug Information Pharmacist.

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

This module is presented by Dr. Joseph Ma, Associate Professor in the UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences.

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

This module we will hear from Dr. Yazdi Pithavala, Senior Director, Clinical Pharmacology at Pfizer.

Clinical Trials: Phase 2, Kourosh Parivar, M.Pharm.

Next we hear from Kourosh Parivar, M. Pharm, Vice President & Head, Clinical Pharmacology at Pfizer

Industry Considerations with Phase III Clinical Trials, Katie Lyons, Pharm.D. and Kelly Hogan, Pharm. D.

New Drug Application, Filing, Product Labeling, Kelly Hogan, Pharm.D.

Good to know

Know what's good

, what to watch for

, and possible dealbreakers

Teaches processes that guide drug research through clinical trials stages

Provides hands-on overview of drug development process from small molecule or biologics

Well organized

Provides you an advantage in understanding this crucial area in the drug innovation process

Highly topical

Designed for those interested in pharmacology, clinical studies, healthcare

Reviews summary

Thorough drug development course

According to students, Drug Development is a thorough course that provides a comprehensive education in the field. The course excels in educating students on the FDA approval process and the regulatory aspects of drug development. Many learners appreciate that the course allows learners to answer questions in a creative manner. Overall, this course is appropriate for students from medical backgrounds who are interested in transitioning into regulatory affairs roles.

Suitable for students with a medical background.

"Very useful for my background of medical technician and analytical chemistry degrees"

"helpful for students who want to move from science to regulatory affairs as a career without having to do a Masters degree"

Highlights important regulatory aspects of drug development.

"very interesting to learn more about new drug application 2 years before applying to the FDA"

"the week 2 and 3 clinical trials and regulatory aspects were very interesting"

"I had no hesitation in doing this course and would do it again"

Explains the FDA approval process in depth.

"learnt how long the FDA approval process takes"

"thoroughly describes the FDA approval process"

"the FDA approval process was also very interesting and useful"

Activities

Be better prepared before your course. Deepen your understanding during and after it. Supplement your coursework and achieve mastery of the topics covered in Drug Development with these activities:

Review biology textbooks and notes

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Revisiting the fundamental principles of biology will build a solid foundation for understanding the mechanisms involved in drug development.

Browse courses on Cell Biology

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Gather textbooks and notes from previous biology courses
Review sections on cell structure, function, and signaling pathways
Revise concepts in molecular biology, including DNA replication, transcription, and translation

Review Basic Biology and Chemistry

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Enhance your understanding of the scientific principles behind drug development.

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Review basic biology concepts, such as cell structure and function.
Review basic chemistry concepts, such as chemical bonding and organic chemistry.
Study the basics of pharmacology.

Review basic chemistry

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Review basic chemistry concepts to strengthen your foundational understanding of drug development.

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Review periodic trends
Practice balancing chemical equations

14 other activities

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Show all 17 activities

Create a Drug Development Plan

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Prepare for the course by understanding the stages of drug development.

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Research the drug development process.
Identify the target disease or condition.
Develop a hypothesis and design a research plan.

Explore online resources on drug development

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Supplementing course materials with external resources will broaden your understanding of the field and keep you updated on current trends.

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Identify reputable websites and organizations providing information on drug development
Follow webinars, podcasts, or online courses on specific topics

Join a Drug Development Study Group

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Collaborate with peers to discuss and learn about drug development.

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Find a study group or create your own.
Meet regularly to discuss course material.
Work together on projects and assignments.

Attend study group sessions to discuss course topics

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Collaborative learning through peer discussions will foster a better understanding of the various aspects of drug development.

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Form study groups with fellow classmates
Meet regularly to review lecture materials, solve problems, and share insights

Practice Clinical Trial Design

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Develop an understanding of the different phases of clinical trials and how to design them.

Browse courses on Clinical Trial Design

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Review the different phases of clinical trials.
Design a clinical trial protocol.
Conduct a clinical trial simulation.

Interpret clinical trial data

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Hands-on practice in analyzing clinical trial data will enhance your ability to evaluate the safety and efficacy of drugs.

Browse courses on Clinical Trials

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Obtain clinical trial data from reputable sources
Use statistical software to perform data analysis and generate graphs
Interpret the results in the context of drug development

Discuss IND and NDA submissions

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Engage with peers to discuss the requirements and processes for submitting INDs and NDAs.

Browse courses on Regulatory Affairs

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Form a study group or connect with classmates online
Review the FDA guidelines and submission requirements

Use Clinical Trial Simulation Software

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Become proficient in using software to simulate clinical trials.

Browse courses on Clinical Trials

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Find a clinical trial simulation software.
Learn how to use the software.
Conduct a clinical trial simulation.

Attend a Drug Development Workshop

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Gain valuable insights from industry experts and network with professionals in the field.

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Find a drug development workshop.
Attend the workshop and participate in the activities.
Network with other attendees.

Compile a glossary of drug development terms

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Creating a comprehensive glossary will aid in retaining and recalling key terminologies used in drug development.

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Maintain a notebook or spreadsheet to record new terms encountered during the course
Provide definitions and examples for each term
Review the glossary regularly to reinforce understanding

Write a Regulatory Affairs Paper

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Gain practical experience in the regulatory aspects of drug development.

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Research the regulatory requirements for drug development.
Write a regulatory affairs plan.
Submit the plan to the FDA for review.

Develop a short proposal for a hypothetical drug development project

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Engaging in project planning will provide a practical application of the principles learned in the course.

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Choose a therapeutic area of interest and identify an unmet medical need
Outline the proposed drug target, mechanism of action, and therapeutic strategy
Discuss potential challenges and mitigation strategies
Summarize the expected outcomes and potential impact of the drug

Write a mock product label

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Demonstrate your understanding of product labeling by drafting a mock label for a hypothetical drug.

Browse courses on Product Labeling

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Research labeling requirements
Include all necessary information, such as indications, dosage, and side effects

Contribute to open-source drug development tools or projects

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Practical engagement with open-source tools will not only enhance your technical skills but also provide valuable insights into the collaborative nature of drug development.

Browse courses on Computational Biology

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Identify relevant open-source projects or tools in the field of drug development
Contribute to code development, documentation, or user support
Engage with the project community and seek feedback on your contributions

Career center

Learners who complete Drug Development will develop knowledge and skills that may be useful to these careers:

Regulatory Affairs Specialist

Regulatory Affairs Specialists are responsible for ensuring that drugs and medical devices are safe and effective before they are marketed. They work with regulatory agencies, such as the FDA, to review clinical trial data and other information to assess the safety and efficacy of new products. This course can help you prepare for a career as a Regulatory Affairs Specialist by providing you with a strong understanding of the regulatory process, clinical development, and data analysis. You will also learn about the different types of regulatory submissions, such as INDs and NDAs.

See salaries and explore the career path for Regulatory Affairs Specialist

Clinical Research Associate

Clinical Research Associates, also known as CRAs, are responsible for monitoring clinical trials to ensure that they are conducted according to Good Clinical Practice (GCP) guidelines. They work closely with investigators, study coordinators, and other members of the research team to ensure that the trial is conducted safely and ethically. This course can help you prepare for a career as a Clinical Research Associate by providing you with a strong understanding of the clinical development process, regulatory requirements, and ethical considerations. You will also learn about the different phases of clinical trials, study design methods, and data management.

See salaries and explore the career path for Clinical Research Associate

Medical Writer

Medical Writers are responsible for writing and editing scientific documents, such as clinical trial protocols, investigator brochures, and product labels. They work closely with medical experts to ensure that the information is accurate, clear, and concise. This course can help you prepare for a career as a Medical Writer by providing you with a strong understanding of the clinical development process, regulatory requirements, and medical terminology. You will also learn about the different types of medical writing documents and how to write and edit them effectively.

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Pharmacovigilance Associate

Pharmacovigilance Associates are responsible for monitoring the safety of drugs after they have been marketed. They work with healthcare professionals, patients, and other stakeholders to collect and analyze data on adverse events. This course can help you prepare for a career as a Pharmacovigilance Associate by providing you with a strong understanding of the pharmacovigilance process, regulatory requirements, and data analysis. You will also learn about the different types of adverse event reports and how to manage them effectively.

See salaries and explore the career path for Pharmacovigilance Associate

Clinical Data Manager

Clinical Data Managers are responsible for collecting, managing, and analyzing clinical trial data. They work with clinical research associates, statisticians, and other members of the research team to ensure that the data is accurate, complete, and reliable. This course can help you prepare for a career as a Clinical Data Manager by providing you with a strong understanding of the clinical development process, data management principles, and statistical methods. You will also learn about the different types of clinical data management systems and how to use them effectively.

See salaries and explore the career path for Clinical Data Manager

Project Manager

Project Managers are responsible for planning, organizing, and managing clinical trials. They work with a team of researchers to develop a study protocol, budget, and timeline. They also oversee the day-to-day operations of the trial and ensure that it is conducted according to GCP guidelines. This course can help you prepare for a career as a Project Manager by providing you with a strong understanding of the clinical development process, project management principles, and regulatory requirements. You will also learn about the different types of clinical trials and how to manage them effectively.

See salaries and explore the career path for Project Manager

Quality Assurance Auditor

Quality Assurance Auditors are responsible for ensuring that clinical trials are conducted in accordance with GCP guidelines. They work with investigators, study coordinators, and other members of the research team to review study documents and data to assess the quality of the trial. This course can help you prepare for a career as a Quality Assurance Auditor by providing you with a strong understanding of the clinical development process, GCP guidelines, and data analysis. You will also learn about the different types of quality assurance audits and how to conduct them effectively.

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Research Scientist

Research Scientists are responsible for conducting research to develop new drugs and treatments. They work with a team of scientists to design and conduct experiments, analyze data, and write scientific papers. This course can help you prepare for a career as a Research Scientist by providing you with a strong understanding of the drug development process, research methods, and data analysis. You will also learn about the different types of research scientists and how to conduct research effectively.

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Medical Science Liaison

Medical Science Liaisons are responsible for communicating scientific information about drugs and treatments to healthcare professionals. They work with sales representatives, marketing teams, and other stakeholders to develop and deliver educational programs. This course can help you prepare for a career as a Medical Science Liaison by providing you with a strong understanding of the drug development process, medical terminology, and healthcare industry. You will also learn about the different types of medical science liaison roles and how to communicate effectively with healthcare professionals.

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Clinical Trial Manager

Clinical Trial Managers are responsible for managing the day-to-day operations of clinical trials. They work with a team of researchers to develop a study protocol, budget, and timeline. They also oversee the recruitment of patients, data collection, and analysis. This course can help you prepare for a career as a Clinical Trial Manager by providing you with a strong understanding of the clinical development process, project management principles, andregulatory requirements. You will also learn about the different types of clinical trials and how to manage them effectively.

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Data Analyst

Data Analysts are responsible for collecting, cleaning, and analyzing data. They work with a team of researchers to develop statistical models and identify trends. This course can help you prepare for a career as a Data Analyst by providing you with a strong understanding of data analysis methods, statistics, and programming. You will also learn about the different types of data analysis tools and how to use them effectively.

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Biostatistician

Biostatisticians are responsible for designing and analyzing clinical trials. They work with a team of researchers to develop statistical models and identify trends. This course can help you prepare for a career as a Biostatistician by providing you with a strong understanding of statistics, programming, and the clinical development process. You will also learn about the different types of statistical methods and how to use them effectively.

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Pharmacist

Pharmacists are responsible for dispensing medications and providing patient counseling. They work with a team of healthcare professionals to ensure that patients are taking their medications safely and effectively. This course can help you prepare for a career as a Pharmacist by providing you with a strong understanding of the drug development process, pharmacology, and patient care. You will also learn about the different types of medications and how to counsel patients on their use.

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Nurse

Nurses are responsible for providing care to patients. They work with a team of healthcare professionals to provide comprehensive care. This course may be useful in preparing for a career as a Nurse by providing you with a strong understanding of the drug development process and pharmacology. You will also learn about the different types of medications and how they are used to treat diseases.

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Physician

Physicians are responsible for diagnosing and treating patients. They work with a team of healthcare professionals to provide comprehensive care. This course may be useful in preparing for a career as a Physician by providing you with a strong understanding of the drug development process and pharmacology. You will also learn about the different types of medications and how they are used to treat diseases.

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