Drug Development, Reimbursement, and regulation–online

Fuqua School of Business

Fuqua School of Business


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Who should attend

This program offers a broad perspective of the issues surrounding the identification and introduction of new drugs, which will be useful to:

  • Mid to senior-level health care leaders who either work in biotechnology and pharmaceuticals or interact with those who do.
  • Within biotech and pharma, those occupying roles in strategy, marketing, R&D, product development, sales, government affairs, and business development.
  • Leaders who have recently switched careers into health care, consultants with health care clients, scientists and MDs who want to commercialize a drug, and health care investors.

About the course

The biotechnology and pharmaceutical industry is complex, not just because of the science, but also because of changing reimbursement practices and regulatory policies. If your organization engages with drug discovery or development at any stage of commercialization, you need to be aware of and understand changes to reimbursement or regulation and their implications for your firm.

Given the industry’s complexity and interdependencies, familiarity with only part of the biotech and pharma industry is not enough for success. Managers involved with drug discovery need to understand what comes after drug development, including whether payers will cover the product and whether providers will adopt the product. Drug makers, payers, providers, regulators, investors, and consultants in this space will find that gaining perspective on interlinkages across the industry enables you to add more value to your stakeholders, and ultimately to your bottom line, through your strategic plans, your drug development operations, your new opportunity identification, etc.

Gain a Broad Perspective

Whether you are inside the biotechnology and pharmaceutical industry or someone who interacts with the industry (for example, a payer, provider, consultant, or investor) Drug Development, Reimbursement, and Regulation will broaden your perspective of the fundamentals and changes in the industry. The course consists of discussion-based class sessions on key trends in biotechnology and pharmaceuticals, such as:

- Increasing pressure on prices

  • Some government factions look to tie U.S. drug prices to foreign prices, while others want to negotiate drug prices. How will these policies affect which drug development and launch strategies you choose?
  • Drug makers are exploring alternate pricing, including an outcomes-based pricing model in which they are paid only if the drug works. Under what conditions should payers and drug makers sign outcomes-based contracts?

- Smaller patient populations

  • Diagnostics are becoming better at identifying which patients respond best to which medicines. Should your organization partner or merge with diagnostic organizations in your vertical? How does the availability of a diagnostic affect your launch price?
  • Many companies are focusing on rare diseases, moving away from the old mass-market model. Will there still be mass-market drugs? If all drugs are for rare diseases, what does this mean for regulation, prices and spending?

- Lifecycle of a drug from innovation to generic competition

  • Drug makers rely on patents and exclusivity, including exclusivity for orphan drugs, for pediatric testing, and for data. Even generic drug makers receive exclusivity protections from other generics. When do these exclusivities apply and how do they change behavior?
  • Faced with patent expiration, drug makers experiment with ways to extend revenue, including launching follow on products, authorized generics, and over-the-counter products. Given increasing pressure from payers to choose cost-effective drugs, can these strategies succeed?


David Ridley

Academic Area: Strategy Teaching / Research Interests Innovation, location, and pricing, especially in health care Bio David Ridley is the Dr. and Mrs. Frank A. Riddick Professor of the Practice of Business. He is also the Faculty Director of Duke''s Health Sector Management program. In his res...

Drug Development, Reimbursement, and regulation–online at Fuqua School of Business

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Coursalytics is an independent platform to find, compare, and book executive courses. Coursalytics is not endorsed by, sponsored by, or otherwise affiliated with any business school or university.

Full disclaimer.

Because of COVID-19, many providers are cancelling or postponing in-person programs or providing online participation options.

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