SLN001SYN - Biotech and Pharmaceutical Management Foundations

Course Description

In the first week of the course, you will describe how the science, R&D, and patent decisions affect the positioning and life cycle of a drug in an uncertain environment. You will describe the research and development of “your” drug: the indication(s) for which the drug is approved, how your drug was tested in Phase 3, the drug’s efficacy and side effects in Phase 3, and any black box warnings. You will also navigate organizational silos to shape the commercial prospects of your drug and assist in the approval process.

In the second week of the course, you will evaluate a lifecycle management strategy for a branded firm and a strategy for a generic and biosimilar firm that is used to expeditiously enter the market. You will also describe the key patents on the drug, when the patents were filed, the expiration dates of those patents, and the date when market exclusivity is expected to end. You will then connect this to the patent being issued to the originating firm.

In the third week of the course, you will describe how biotech and pharma firms set prices and negotiate with health insurers. You will determine the price of a drug and identify the prices of its key competitors. You will then evaluate why the company chose this price and if your drug tends to be covered by private health insurers.

In the fourth week of the course, you will describe how mergers, acquisitions, and alliances can be used to improve R&D productivity. You will investigate how different firms develop drugs either independently or with another firm. You will also evaluate the potential benefits and disadvantages to potential mergers and acquisitions.

In the last week of the course, you will identify the promotion, product, and place of a drug to inform the marketing strategy. You will then describe and critique your company’s marketing strategy for the drug. Your presentation will include an analysis of your drug’s efficacy and side effects relative to the market leader or the company’s nearest competitor, if you are the market leader. You will then evaluate if the company positioning its drug is relative to its competitors via its marketing strategy.

This live, synchronous certificate program provides an exploration of the key management issues facing the pharmaceutical and biotechnology industries. The perspective is global, with an emphasis on the U.S. as the largest and most profitable market.

This 5-week course meets in a live online web-conference format for 90 minutes Mondays and Wednesdays from 6:00 to 7:30pm ET, from Monday, August 21, to Monday, September 25, 2023. There is no class on Monday, September 4 (Labor Day).

Over the course of 5 weeks, Professor Sean Nicholson with guide you through discussions on:

• Rapid technological change and substantial investments in research and development (R&D)
• The role of biotechnology and genomics in transforming the industry
• A complex global marketplace where customers include governments and private health insurers as well as physicians, pharmacists, and individual patients
• Government regulation of every dimension of the business, including the safety and efficacy of drugs, pricing, manufacturing, and marketing
• Continually evolving mergers, joint ventures, and alliances
• Global products and multinational firms with growing tension between the needs and the ability to pay for different market segments

Throughout your experience in this certificate program, you will work on a project that follows the life cycle of a drug of your choosing.

Faculty Author

Benefits to the Learner

• Understand the research and development process for a drug, including how a company makes key drug development decisions
• Articulate the scientific steps needed to get a drug approved by the FDA
• Describe the key patents on a drug, when they were filed, and how the timing affects market exclusivity
• Understand how government policy and legal strategies affect when generic and biosimilar companies can enter the market
• Conduct competitive research in a given drug class or disease area
• Discover how R&D and patent decisions affect the positioning and life cycle of a drug
• Anticipate the pros and cons of a merger, acquisition, or alliance opportunity based on empirical research
• Articulate and critique the market strategy for a given drug class or disease area

Target Audience

• Entry to mid-level pharmaceutical professionals responsible for or looking to move into drug development and discovery
• Pharmaceutical professionals involved in marketing, branding, sales, and business development
• Pharmaceutical professionals involved in medical affairs, managed markets, manufacturing, or distribution
• Health insurance professionals
• Appropriate for domestic and international audiences
• Graduate and undergraduate students in biotech or healthcare-related studies

Applies Towards the Following Certificates

• Biotech and Pharmaceutical Management : Core Courses
• Pharmaceutical Management Foundations : Required Course