About the Program

CURRICULUM FOR THE REAL WORLD

Students complete a core curriculum in Basic Biosciences, choose two electives and take six credits of Departmental Seminars, which feature industry speakers from a range of biotech areas. Finally, each student completes a capstone project, in which they develop a life cycle strategy plan for a real-life drug currently in phase 2 clinical trials. In the team project, teams of two or more develop a go/no-go analysis for a different drug or device to determine whether a product has enough merit to finish drug development with the goal of being submitted for FDA review and approval.

FROM DISCOVERY TO APPROVAL

Through the PharBE program, students gain a clear understanding of the entire drug and device development process, from drug discovery and design to clinical trial phases, market analysis and comparing strategies to get drugs approved. Program courses take a dive into the individual steps in the process, from drug classes to regulatory issues, and a capstone course ties it all together.

“Having detailed knowledge of the overall process allows graduates to participate fully in drug development, understand where they can contribute, and see where their contribution fits into the product life cycle,” says Roberta Wong, co-director of the PharBE program and associate assistant professor in Bioengineering.

WHO IS THE PROGRAM FOR?

The PharBE program is tailored for people in the pharmaceutical industry, such as bench scientists who want to advance their careers or move into another aspect of the biotech industry, or manufacturing associates who want to have more knowledge of drug design and development.

Offered entirely online since 2017 and designed for working professionals worldwide, the part-time program can be completed in less than two years.

Respondents to a recent survey of UW PharBE program alumni shows a large majority moved to a new position or took on more responsibility.

DRUG DEVELOPMENT IN THE BUSINESS CONTEXT

The hallmark feature of the program is the individual capstone project. Each student is assigned a drug that is currently in phase 2 development, meaning that it has shown some results that it works. Then each student designs a phase 3 clinical trial and a development strategy for successfully earning FDA approval and getting the drug on the market. During the course, students also develop a strategic plan for publishing studies and a SWOT (strengths, weaknesses, opportunities and threats) analysis aimed at marketing it throughout its patent life.

“The capstone course is the most unique aspect of the program,” says Robbie Wong, PharBE program director. Other programs go over nuts and bolts – what she calls “a cookbook method” of drug development – but the UW BioE program provides some real-life experience in what it would be like to do this job for a company. I haven’t seen any other program that provides this experience to students,” Wong says.

Notably, the capstone course features a risk-benefit analysis, given the expense of developing and winning marketing approval for a drug, which can exceed $2.5 billion.  The course includes a discussion on the reality of potential drug adoption or use in patients. In drug development, it’s not just about finding a drug that works – people must be able to afford it.

In addition to understanding how drugs are developed, graduates review how diseases are managed and look at how decisions are made in selecting which drugs are used and not used,

Details about the program and answers to frequently asked admissions questions are available on the PharBE Admissions FAQ page.