A Crash Course in the Pharmaceutical Industry R&D Proces

Name: A Crash Course in the Pharmaceutical Industry R&D Proces
Rating: 4.4 (437 reviews)

The pharmaceutical industry; drug discovery, clinical trials, regulations, biotech products, generics, AI, job hunting

Role Play

Created byJames Mitroka

Last updated 7/2025

English

English [Auto],

What you'll learn

Students will learn how modern drugs are discovered, developed and marketed by "Big Pharma" in accordance with FDA regulations.

Course content

6 sections • 27 lectures • 3h 56m total length

Introduction to Drug Regulations5:37
History of Drug Regulations10:32
What do you think?
Current US Drug Regulations11:03
Review and Summary2:12
Check your Knowledge

Discovery: Introduction0:44
Explore how new drugs come to be, focusing on drug discovery and the steps toward development and approval within the pharmaceutical r&d process.
High Throughput Screening10:56
Explore the modern rational approach to drug discovery, from identifying disease targets and lead compounds to in vitro high throughput screening of a chemical library and selectivity assessment.
What do you think?
Role of Serendipity8:44
Explore how serendipity drives drug discovery, from accidental hits like penicillin and morphine to repurposing drugs for new indications, and contrast natural compounds, API concept, and purity in modern drugs.
An Example with Captopril7:26
Discovery Summary2:59
Check your knowledge

Development: Introduction3:28
Preclinical studies and IND filing11:38
The Drug Trial That Went Wrong: What do you think?
Clinical studies to support drug registration15:08
An interesting paper describing how a drug was "repurposed" to become the first drug approved for use in African Americans.
Other development studies and summary9:59
Explore phase four postmarketing studies after approval, including extending indications and assessing risks, while noting concurrent nonclinical reproductive studies and carcinogenicity.
Drug Development: Check your knowledge

Drug Registration: Introduction0:33
Drug Registration: NDA/BLA Filing and FDA review process12:19
Biomarkers: What do you think?
Drug Registration: Expedited Review and Orphan Drugs8:10
Drug Registration: Intellectual Proprerty and Market Excusivity9:28
Pair twenty-year patent life with FDA exclusivity to delay generics, including orphan seven years, pediatrics six months, and biologics twelve years.
Drug Registration: Generics, DTC ads, and Off-label use12:00
Drug Registration: Summary2:07
Drug Registration Quiz

Biotech Drugs I: Introduction and Protein-based products23:51
Discover protein-based biotech drugs, including monoclonal antibodies and hormones, produced by recombinant DNA technologies. Compare their high molecular weight, complex structures, injection administration, and regulatory biosimilar considerations.
Biotechnology II: Gene-based products21:37
Explore gene-based therapeutics, including cell therapy, gene therapy, and gene editing with CRISPR, from cancer to beta thalassemia and RNA vaccines.

Future and perspective: Introduction9:50
Highlight future pharma trends: more biologicals, direct patient involvement, wearables, prevention, and genomics-driven, stratified therapies with companion diagnostics.
Truths and Myths8:24
Perspectives on Working in Pharm R&D2:20
Role of Artificial Intelligence in Pharm R&D11:32
Artificial intelligence accelerates pharmaceutical R&D by leveraging omics data to improve target identification, molecular design, predictive toxicology, and patient recruitment, reducing time and cost.
Tips for Job Hunting in the Pharmaceutical Industry6:16
develop a focused, persistent job strategy in the pharmaceutical industry by defining your target area, aligning education and experience, and leveraging networking and internships to land a role.
Intetrview with a Pharma HR rep
Congratulations and Parting Thoughts2:53
celebrate finishing course and pursue entry roles in the pharmaceutical industry, stay persistent, build networks, attend conferences, and follow the literature, even starting in quality control with a bachelor's degree.

Requirements

High school level understanding of biology and chemistry would be helpful.

Description

Are you interested in learning about the procedures and people involved in the discovery and development of new drugs? Are you considering a career in the pharmaceutical industry? If so, this course is for you!

The pharmaceutical industry is growing every day, providing jobs that are intellectually challenging, pay well, provide a pleasant work environment, and contribute to the health of the nation.

When you complete this course, you will understand the "Big Picture" of the pharma industry and know where you might fit in. You will be able to...

Describe how drugs are discovered and developed, and the role of the FDA
Understand the various job descriptions/roles in pharma
Gain insight into the new tools and techniques employed in pharma R&D, including artificial intelligence (AI) and pharmacogenomics/personalized medicine
Confidently discuss opportunities with career counselors, recruiters, and people working in the pharmaceutical industry.

Your instructor, Dr. Jim Mitroka, has the experience and training to be your guide. He worked as a Research Group Leader in Big Pharma for over 20 years and as a Pharmaceutical Sciences professor for over 10 years.

The course is composed of ...

A series of short fact-filled lectures
A quiz or activity to test your knowledge
An opinion question to get your thoughts on a controversial topic, and
Additional resources for you to deepen your knowledge.
A concluding ROLE-PLAY to help you evaluate your readiness in interviewing for a job in pharma

This course is designed for anyone considering a career in the pharmaceutical industry or just interested in the way modern drugs are discovered and developed. The individual lessons can be used sequentially or individually, according to your personal interests.

Who this course is for:

Anyone interested in knowing how drugs are discovered,developed, and marketed in the US.

A Crash Course in the Pharmaceutical Industry R&D Proces

What you'll learn

Explore related topics

Course content

Overview of Drug Regulations4 lectures • 29min

Drug Discovery5 lectures • 31min

Drug Development and Clinical Studies4 lectures • 40min

Drug Registration and Post-registrational Activities6 lectures • 45min

Biotechnology *New*2 lectures • 45min

Future Trends and Industry Perspective7 lectures • 41min

Requirements

Description

Who this course is for: