Beyond the Science: The Business of Drug Development

Course Outline

Course Intro

  1. Course Intro
  2. Course textbook

Topic 1: Small and large drug discovery and development biotechnology companies

  1. Welcome to Topic 1
  2. Lecture 1 - Intro
  3. Lecture 1 - Profile of a Fledgling Biotechnology Company
  4. Lecture 1 - The “Virtual” Company
  5. Lecture 1 - The Role of Clinical Research Organizations (CROs)
  6. Lecture 1 - Medicine-related Biotech Companies & their Focuses
  7. Lecture 2 - Intro
  8. Lecture 2 - The Financial Picture: Sales, Profitability
  9. Lecture 2 - “Burn, Baby! Burn!” Burn rate and its implications
  10. Lecture 2 - How are Biotechs Financed? Past, Present and Future of Biotech Financing
  11. Lecture 3 - Intro
  12. Lecture 3 - Investor’s Valuation of a DD&D company
  13. Lecture 3 - Biotech & Big Pharma Major Issues
  14. Lecture 3 - Partnerships and partnership “players”
  15. Topic 1 Handouts
  16. Topic 1 Complete

Topic 2: The drug discovery and development process

  1. Welcome to Topic 2
  2. Lecture 4 - Intro
  3. Lecture 4 - Steps in the Clinical Trial Process
  4. Lecture 4 - Summary of DD&D Costs and Likelihood of Success
  5. Lecture 5 - Intro
  6. Lecture 5 - A primer on how to Calculate Net Present Value & Internal Rate of Return
  7. Lecture 5 - An Example of Calculating Expected NPV for a Drug Candidate
  8. Lecture 6 - Intro
  9. Lecture 6 - Out-of-pocket-costs & cost of capital from discovery to market
  10. Lecture 6 - Why the cost of DD&D can be very Low for small biotechs
  11. Lecture 6 – FDA programs and government actions aiding DD&D
  12. Topic 2 Handouts
  13. Topic 2 Complete

Topic 3: Intellectual property: the basics and basic strategy

  1. Welcome to Topic 3
  2. Lecture 7 – Intro
  3. Lecture 7 - Philosophy and history of patents, briefly
  4. Lecture 7 - What can and cannot be patented?
  5. Lecture 7 - Patent structure: first page, specifications and claims
  6. Lecture 8 – Intro
  7. Lecture 8 - Kinds of patents: products or processes
  8. Lecture 8 - What makes for a strong patent?
  9. Lecture 8 - Ban of patents on natural products (the U.S. Supreme Court ruling)
  10. Lecture 9 – Intro
  11. Lecture 9 - Building and maintaining patent fences
  12. Lecture 9 - Company patent reviews
  13. Topic 3 Handouts
  14. Topic 3 Complete

Topic 4: Pharmacoeconomics, pharmaceutical pricing, pushback and policy

  1. Welcome to Topic 4
  2. Lecture 10 - Why pharmacoeconomics?
  3. Lecture 10 - The two basic pharmacoeconomic measures: cost-benefit and cost-effectiveness
  4. Lecture 10 - Cost utility, the pharmacoeconomic measure that accounts for outcomes
  5. Lecture 11 - What are clinical-pathway or clinical-states diagrams?
  6. Lecture 11 - A pharmacoanalysis of the new drugs that cure Hepatitis C infections
  7. Lecture 12 - Pushback against high drug prices
  8. Lecture 12 - PhRma's defense regarding drug prices
  9. Lecture 12 - Pricing new drugs
  10. Lecture 13 - US healthcare vs other developed states
  11. Topic 4 Handouts
  12. Topic 4 Complete

Certificate of Completion Exam

  1. Course Exam
  2. Milestone

About the Course

Who is this course for?

This course is designed for anyone looking to gain a foundational understanding of the business of drug discovery and development.

Neither business experience nor pharmaceutical industry experience are needed. The course and textbook are presented at a level easy to understand by scientists, technicians, and business people alike.

What topics does this course cover?

The course covers all the basic business activities, strategies, insights, and issues for biotech/pharma organizations, large and small.

From the role of clinical trials to pharmacoeconomics, drug pricing, and policy, the course will help you connect the dots between the science and business of the biopharma industry.

Enroll in the course to learn:

  • The lingo and role of CROs, CMOs, NDAs, and BLAs.
  • Why small biotech drug discovery & development companies can spend ten-fold less than big pharma on discovery and development
  • Why patent fences are necessary and the role of a company’s intellectual property committee
  • The importance of pharmacoeconomic considerations throughout the entire process-- from drug discovery through sales
  • How overpricing drugs can decimate sales--and how exactly to price drugs to optimize revenue
  • The complex drug development and business behind drugs for rare diseases

What materials does the course come with?

Enrollment in the course includes a 13-chapter e-textbook, as well as several handouts for additional reading. The e-textbook can also be purchased for separately here.

About the Instructors

Lynn Klotz

Lynn Klotz, Co-Managing Director and Chief Science Officer

Lynn C. Klotz was formerly an Assistant and Associate Professor of Biochemistry and Molecular Biology at Harvard University (1971-1979) and a visiting Associate Professor at Princeton University (1979-1981). He was a founder and board member of BioTechnica International (1981-1988)-an agricultural and natural products company. Within BioTechnica, he founded BioTechnica Diagnostics, a periodontal-disease DNA-probe diagnostics company and BioTal a Wales-based environmental-remediation biotechnology company. He recently served as Research Scholar and Adjunct Professor at the Arizona State University’s Walter Cronkite School of Journalism and Mass Communication.

In the fall of 2011 and 2012, Dr. Klotz taught a graduate-level Harvard Extension Course, BIOT E-210, Biotechnology and Drug Development: Tools for Business.

William Diehl

William Diehl, ​Co-Managing Director and Chief Technology Officer

William C. Diehl, Ph.D. is Coordinator of Online Graduate Programs in the Adult Education program and Assistant Professor at The Pennsylvania State University at University Park, PA. Dr. Diehl serves as Interviews Editor for The American Journal of Distance Education, and is an expert reviewer for other academic journals. He is the founder of the International Museum of Distance Education and Technology project.

Additionally, Diehl is a consultant in the corporate, higher education and government sectors. Professional experience also includes work as a K-12 teacher, web designer and developer, instructional designer, and multimedia specialist.