Adapt to the changing landscape

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.

 

David Ridley's virtual classroom

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?

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.

NOTE: This program will dive deeper into drug development strategies and challenges than our Navigating Health Care Trends program, making it a valuable addition for past NHCT participants - including leaders from pharma, biotech, payers, manufacturers, and hospital enterprises.

More About this Program

Are you ready to gain substantial insights into how the drug development industry works from a range of industry player perspectives? Enhance your contributions to your organization and increase value for your stakeholders by understanding the opportunities and challenges in creating and executing new drug products.

 

This blended learning course consists of:

  • Three 90-minute live-streaming class sessions (held weekly over the three-week period)
  • Twelve supplementary 15-minute videos, which you should review at your convenience prior to the 90-minute faculty-led class
  • Robust class discussions with your instructor and other participants, who come from across the health care industry

Classes will be held using Zoom video-conferencing, which has been extended into a virtual teaching system. This system creates a virtual classroom where you can see the professor and presentation screen, as well as seeing the other participants. Similarly, the professor can see all of the students who engage online during the group session. You’ll be able to communicate with both the professor and your peers through this platform. The professor uses the same technology to teach executive MBA students.

To participate in this course you will need to have a working webcam, built in or attached, and have downloaded the Zoom Cloud Meeting app onto your laptop.

 

If you have any questions about this requirement, call Duke Executive Education team at +1.919.660.8011 or Toll Free +1.800.372.3932, or email us at execed-info@duke.edu.

 

Understand the economics behind different business strategies

Course Topics

Innovation

  • The cost of R&D
  • The stages of drug development
  • Tradeoffs between orphan and blockbuster development
  • Government incentive to devise new drugs

Reimbursement

  • Netflix model
  • Outcomes-based pricing
  • Cost effectiveness analysis
  • Rebates, formularies & pharmacy benefit managers
  • 340B program
  • Medicaid Best Price

Competition

  • Lifecycle management strategies
  • Biosimilars
  • Generics

 

Program Objectives

At the conclusion of the program, you will understand:

  • How researchers estimate the average industry cost of research and development for an approved drug.
  • How to estimate the value of a drug in development in order to make better decisions about which drugs to advance and which drugs to stop.
  • What incentives governments create to reward developers of drugs for rare and neglected diseases.
  • How governments regulate drug makers and the steps drug makers must take to avoid penalties, fines, lost revenue, and embarrassment.
  • How to estimate the cost effectiveness of a drug in order to secure reimbursement.
  • What price regulations have been proposed and which are likely to be implemented.
  • What are the new approaches to pricing, including the “Netflix Model” and outcomes-based pricing, and under what conditions drug makers and payers should adopt them.
  • How to estimate a drug’s peak market share in order to forecast sales.
  • What role intermediaries such as pharmacy benefit managers play in drug access and reimbursement.
  • What ten strategies drug makers use to extend sales of a drug approaching patent expiration.
  • How generic drug makers compete with brand name drug makers.

 

Get Started

This won't take long.



Certificate Requirements: Attendance to the Duke Leadership Program and three electives within a three year period. More

Program Registration Calendar

Registration
$1,000
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Registration
$1,000
Register Now

Upcoming Program Schedule

Wednesday, April 29, 2020

Orientation Session

11:00 am--noon EST

 

Wednesday, May 6, 2020

11:30 am—1:00 pm EST

 

Wednesday, May 13, 2020

11:30 am—1:00 pm EST

 

Wednesday, May 20, 2020

11:30 am—1:00 pm EST

 

REGISTER NOW

Executive Education Certificate Credit

The Drug Development, Reimbursement, and Regulation program, because of its short duration, accounts for a one-half credit (0.5) toward earning the Certificate of Leadership and Management. In order to earn this half-credit, you must:

 

Participate via webcam in a minimum of two of the three group discussion sessions

Complete all three of the video pre-recoded sessions

Score a passing grade on the quiz and final exam for the course

Sample Schedule

Week 1 Session

Drug Discovery and Innovation

  • Research and development
  • Make or buy
  • Incentives for innovation
  • Priority Review Voucher

Week 2 Session

Drug Development and Reimbursement

  • Flow of funds
  • Medicare drug reimbursement
  • Medicaid drug reimbursement
  • Patient cost sharing
  • Global drug reimbursement

Week 3 Session

Biotech / Pharma Industry Competition

  • Forecasting market share
  • Drug prices
  • Lifecycle management
  • Generic drugs and biosimilars

Each week participants will spend an average of 2 hours supplementing the class-time learning by watching professionally produced videos of Professor Ridley and reading relevant articles on the health care industry.

Faculty

Professor David Ridley

David Ridley

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 research, David examines innovation and pricing, especially in health care. He was the lead author of the paper proposing the priority review voucher program to encourage development of drugs for neglected diseases. The voucher program became law in the U.S. in 2007. Voucher sales total more than a billion dollars and the program has encouraged development of many drugs for neglected and rare diseases. David has published in economics journals, medical journals, and scientific journals. David teaches in the daytime MBA, executive MBA, and health analytics programs. He is the principal investigator on a grant from the Gates Foundation for 2018 to 2020 to examine incentives for drug development. He received a PhD in economics from Duke University in 2001.