Innovate & Regulate: Drug Research, Costs, Clinical Trials & Approval from edX

In this course about the business of the pharmaceutical industry, students will learn how the economic, legal, and regulatory landscape affect the scientific research that leads to the discovery and development of new drugs. The three-week course starts with a general overview of drug regulation, recognition of patient needs, and listing the distinct stages of a drug campaign. The second week covers clinical trials, research costs, and the effect of patents and intellectual property. In the final week, students will learn about biological drugs, drug approval, drug research outside of large pharma, and the makeup of research pipelines in large drug firms.

No previous experience or knowledge is required to enroll. Students only need to have an interest in better understanding the various factors that affect the research of new drugs. The course is designed in modules. Each module opens with a short video on a selected topic. The module continues with a short reading or exercise with an assessment activity. Each module will require approximately 1 hour to complete, and the course includes 15 modules. Two approaches to the course are recommended. One, a student might spend an hour per day on the course and complete all 15 modules in approximately three weeks. Two, a student with additional available time may be able to work through the entire course in just a single week or over an extended weekend.

Students signed up for the Audit Track have access to the instructional video materials. Students enrolled through the Verified Track have access to the instructional videos, the readings and activities, the assessments, as well as selected additional videos related to the primary instructional videos.

What's inside

Learning objectives

The process by which different stakeholders determine unmet medical needs, which drive the creation of new drug campaigns in the pharmaceutical industry
Clinical trial stages and the type of drug safety and efficacy information learned at each stage
The research and development cost of advancing a drug from concept, through discovery and development, and ultimately it patients in the market

Types of intellectual property, including patents and trademarks, that are most relevant to newly marketed drugs
Different approval designations recognized by government regulatory authorities to enable more rapid approval of drug’s that meet particularly critical unmet needs
The approval process for generic drugs after market exclusivity of a branded drug has elapsed

The process by which different stakeholders determine unmet medical needs, which drive the creation of new drug campaigns in the pharmaceutical industry
Clinical trial stages and the type of drug safety and efficacy information learned at each stage
The research and development cost of advancing a drug from concept, through discovery and development, and ultimately it patients in the market
Types of intellectual property, including patents and trademarks, that are most relevant to newly marketed drugs
Different approval designations recognized by government regulatory authorities to enable more rapid approval of drug’s that meet particularly critical unmet needs
The approval process for generic drugs after market exclusivity of a branded drug has elapsed

Syllabus

week 1

the importance of research and development in pharma

drug regulation: what is a drug?

the identification of unmet medical needs

distinctions between drug discovery and drug development

the role of key scientific questions and a drug’s target product profile

stages of clinical trials

the cost of bringing a new drug to market

intellectual property and drugs

drug patents

generic vs. branded drugs

biologic drugs and biosimilars

the importance of early identification of weak drug programs

US FDA drug approval pathways

roles of academia and biotech in drug discovery and development

research pipelines of major pharmaceutical companies

week 2

week 3

Good to know

Know what's good

, what to watch for

, and possible dealbreakers

Examines regulatory and economic dimensions of pharmaceutical drug research and development

Taught by Erland Stevens, known for his expertise in pharmaceutical sciences

Covers clinical trials, intellectual property, and drug approval processes

Suitable for learners with an interest in pharmaceutical industry dynamics

Requires no prior knowledge or experience in the subject matter

Provides pathways for both self-paced and accelerated learning

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 Innovate & Regulate: Drug Research, Costs, Clinical Trials & Approval with these activities:

Read 'The Business of Healthcare Innovation'

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Gain insights from a seminal work on healthcare innovation.

View The Innovator's Prescription: A Disruptive... on Amazon

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Read the book and take notes on key concepts.
Identify connections between the book's ideas and the topics covered in the course.

Review Relevant Skills

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Brush up on foundational knowledge to prepare for the course.

Browse courses on Drug Regulation

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Review principles of drug regulation and safety.
Research the history of pharmaceutical industry.
Explore different aspects of drug development.

Organize Course Materials

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Keep course materials well-organized for easy reference.

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Create a system for organizing notes, assignments, and other course materials.
Review materials regularly to reinforce learning.

Five other activities

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Track Pharmaceutical News

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Stay abreast of industry developments related to the course.

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Identify reputable sources for pharmaceutical news.
Set up alerts for news related to the topics covered in the course.
Regularly review news articles and make notes on key findings.

Attend Industry Conferences

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Connect with professionals in the field.

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Identify relevant industry conferences or events.
Register for the events and make connections with attendees.
Attend presentations and engage in discussions related to course topics.

Analyze Drug Case Studies

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Reinforce concepts through real-world examples.

Browse courses on Clinical Trials

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Identify case studies related to the topics covered in the course.
Analyze the case studies for key concepts such as drug development, regulatory approval, and market dynamics.
Write summaries or presentations based on the analysis.

Write a Blog or Article

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Deepen understanding by explaining concepts to others.

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Choose a specific topic related to the course.
Research and gather information from credible sources.
Write a well-structured blog post or article that presents the topic in a clear and engaging manner.

Develop a Drug Development Plan

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Apply knowledge to a practical project.

Browse courses on Drug Discovery

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Choose a hypothetical or real-world medical condition.
Research existing treatments and identify unmet medical needs.
Develop a comprehensive plan outlining the drug development process, including timelines, milestones, and potential risks.
Present the plan to peers or industry professionals for feedback.

Career center

Learners who complete Innovate & Regulate: Drug Research, Costs, Clinical Trials & Approval will develop knowledge and skills that may be useful to these careers:

Biostatistician

Biostatisticians are responsible for designing and analyzing clinical trials, which are essential for ensuring the safety and efficacy of new drugs. This course provides a comprehensive overview of the clinical trial process, including the different stages of trials, the types of data collected, and the statistical methods used to analyze the data. This knowledge would be invaluable for biostatisticians, who need to be able to design and analyze clinical trials in order to provide accurate and reliable data to support drug development.

See salaries and explore the career path for Biostatistician

Drug Safety Associate

Drug Safety Associates are responsible for monitoring the safety of new drugs after they have been approved for marketing. This course provides a comprehensive overview of drug safety, including the different types of adverse events, the methods used to monitor drug safety, and the regulatory requirements for reporting adverse events. This knowledge would be essential for Drug Safety Associates, who need to be able to monitor the safety of new drugs and ensure that they are safe for use.

See salaries and explore the career path for Drug Safety Associate

Clinical Research Associate

Clinical Research Associates (CRAs) are responsible for managing clinical trials, ensuring that they are conducted in accordance with Good Clinical Practice (GCP) guidelines. This course provides a detailed overview of the clinical trial process, including the different stages of trials, the roles and responsibilities of CRAs, and the regulatory requirements for conducting clinical trials. This knowledge would be essential for CRAs, who need to be able to manage clinical trials effectively and ensure that they are conducted in accordance with GCP guidelines.

See salaries and explore the career path for Clinical Research Associate

Health Economist

Health economists are responsible for evaluating the cost-effectiveness of new drugs and other health care interventions. This course provides a broad overview of health economics, including the different methods used to evaluate cost-effectiveness, the factors that influence the cost-effectiveness of new drugs, and the policy implications of cost-effectiveness analysis. This knowledge would be invaluable for health economists, who need to be able to evaluate the cost-effectiveness of new drugs and other health care interventions.

See salaries and explore the career path for Health Economist

Medical Writer

Medical writers are responsible for writing a variety of documents related to new drugs, including clinical trial protocols, investigator brochures, and patient information leaflets. This course provides a comprehensive overview of medical writing, including the different types of medical writing documents, the style and structure of medical writing, and the regulatory requirements for medical writing. This knowledge would be essential for medical writers, who need to be able to write clear, accurate, and compliant medical writing documents.

See salaries and explore the career path for Medical Writer

Physician Assistant

Physician Assistants (PAs) are responsible for providing a variety of health care services, including diagnosing and treating illnesses, prescribing medications, and performing minor surgeries. This course provides a comprehensive overview of the medical field, including the different types of medical specialties, the different roles of health care professionals, and the ethical issues involved in health care. This knowledge would be invaluable for PAs, who need to be able to provide safe and effective patient care.

See salaries and explore the career path for Physician Assistant

Toxicologist

Toxicologists are responsible for evaluating the safety of new drugs and other chemicals. This course provides a comprehensive overview of toxicology, including the different types of toxicology tests, the different methods used to evaluate toxicity, and the regulatory requirements for toxicology testing. This knowledge would be essential for Toxicologists, who need to be able to evaluate the safety of new drugs and other chemicals.

See salaries and explore the career path for Toxicologist

Pharmacist

Pharmacists are responsible for dispensing medications and providing information about medications to patients. This course provides a broad overview of pharmacology, including the different types of drugs, the mechanisms of action of drugs, and the adverse effects of drugs. This knowledge would be invaluable for pharmacists, who need to be able to understand the pharmacology of drugs in order to provide safe and effective medication therapy.

See salaries and explore the career path for Pharmacist

Sales Representative

Sales Representatives are responsible for selling new drugs to physicians and other health care professionals. This course provides a comprehensive overview of sales, including the different types of sales techniques, the different types of sales presentations, and the different types of sales materials. This knowledge would be invaluable for Sales Representatives, who need to be able to sell new drugs effectively to physicians and other health care professionals.

See salaries and explore the career path for Sales Representative

Regulatory Affairs Specialist

Regulatory Affairs Specialists are responsible for ensuring that new drugs are developed and marketed in accordance with regulatory requirements. This course provides a comprehensive overview of regulatory affairs, including the different types of regulatory requirements, the process of submitting a new drug application, and the post-market surveillance of new drugs. This knowledge would be essential for Regulatory Affairs Specialists, who need to be able to ensure that new drugs are developed and marketed in accordance with regulatory requirements.

See salaries and explore the career path for Regulatory Affairs Specialist

Quality Assurance Associate

Quality Assurance Associates may work in the pharm sector. This course provides a broad overview of quality assurance, including the different types of quality assurance, the different types of quality assurance tools, and the regulatory requirements for quality assurance. This knowledge would be invaluable for Quality Assurance Associates, who need to be able to ensure that products and processes meet quality standards.

See salaries and explore the career path for Quality Assurance Associate

Data Analyst

Data Analysts may work in the pharm sector. This course provides a broad overview of data analysis, including the different types of data analysis, the different types of data analysis tools, and the regulatory requirements for data analysis. This knowledge would be invaluable for Data Analysts, who need to be able to collect, analyze, and interpret data.

See salaries and explore the career path for Data Analyst

Chemical Engineer

Chemical Engineers may work in the pharm sector. This course provides a broad overview of chemical engineering, including the different types of chemical engineering, the different types of chemical processes, and the regulatory requirements for chemical processes. This knowledge would be invaluable for Chemical Engineers, who need to be able to design, develop, and operate chemical processes.

See salaries and explore the career path for Chemical Engineer

Biomedical Engineer

Though the name does not explicitly include the pharm sector, biomedical Engineers may also work in this field. This course provides a broad overview of biomedical engineering, including the different types of biomedical engineering, the different types of biomedical devices, and the regulatory requirements for biomedical devices. This knowledge would be invaluable for Biomedical Engineers, who need to be able to design, develop, and test biomedical devices.

See salaries and explore the career path for Biomedical Engineer

Statistician

Statisticians may work in the pharm sector. This course provides a broad overview of statistics, including the different types of statistics, the different types of statistical methods, and the regulatory requirements for statistics. This knowledge would be invaluable for Statisticians, who need to be able to collect, analyze, and interpret data.

See salaries and explore the career path for Statistician