The evening online master’s degree program in pharmaceutical bioengineering is designed for professionals worldwide who want to know how drugs are designed and brought to market. Learn how graduates have advanced their careers at companies like Genentech, Moderna and Juno/Bristol Myers Squibb.

When Kristen Fetchko was interviewing for a new job last summer, her UW Master’s in Pharmaceutical Bioengineering (PharBE) degree caught the attention of prospective employers.

“Companies seemed excited to learn that because I know the full process of drug development, I can ask the right questions and be efficient and effective in my role,” says Kristen, PharBE ’20.

Kristen Fetchko PharBE 2020

Kristen Fetchko, PharBE ’20, says the degree helped her land a job with more responsibilities. Photo courtesy Kristen Fetchko.

She credits her degree with helping her land a new job with greater responsibilities. The UW PharBE program offered her a breadth and a depth of knowledge that she couldn’t have gotten through industry experience alone, she says. “As with many people early in their career, I was siloed into one small part of the process, without a true understanding of the process as a whole or how I really fit into it.”

Now Kristen works as a clinical study manager overseeing a clinical trial at New Jersey-based CytoSorbents, which develops technologies to purify blood. “The PharBE program is a modern, applicable, interesting and efficient approach to learning the ins and outs of drug development from start to finish,” she says.

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 affiliate assistant professor in Bioengineering.

“The courses were detailed, organized, efficient, and thought-provoking. Everything that I learned really is relevant, and there wasn’t a lot of fluff.”   – Kristen Fetchko

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.

Jeffrey Chu PharBE alumnus

Jeffrey Chu, PharBE ’20, at Genentech’s South San Francisco campus.                      Photo courtesy of Jeffrey Chu.

Jeffrey Chu, who earned his PharBE degree in 2020, recently accepted a position with Horizon Therapeutics in San Francisco as manager of biologics technical development. After working for Genentech in San Francisco, where he characterized and qualified new molecules, Jeffrey is now focusing on formulation work and engaging with contract manufacturing organizations on tech transfer across different sites. He’s also helping build and standardize an analytical lab in south San Francisco.

“Most programs, at least for master’s, are very rare in terms of the breadth that the UW PharBE program offered, from clinical to commercial to process development,” Jeffrey says.

It was that breadth of learning and the process development course in particular that spurred him to enroll at UW, rather than in a similar online program at Johns Hopkins University, he says.

Jeffrey also felt UW was a high value program, especially for the tuition. “It’s very clinical focused but still extremely applicable to what I do, and it actually helped me understand where my interests are and where I want to go.”

As a technical development research associate, Jeffrey has a keen interest in process development, and now he says he understands how his role plays into the greater company and the industry. He hopes to be in a role where he can see that oversight between end-to-end and early-stage to late-stage projects and how they can progress to market.

“The takeaway here is if folks work in the pharmaceutical industry and they’re interested in the overall process, understanding clinical work and progressing in their career – it doesn’t even matter what department they work in – this is the program for them.”

DRUG AND DEVICE DEVELOPMENT, FROM DISCOVERY TO APPROVAL

Mike Maldazys PharBE alumnus

Mike Maldazys, PharBE ’18, now works at Juno Therapeutics in Bothell, Wash. Photo courtesy Mike Maldazys.

“I came to the program looking for a transition,” says Mike Maldazys, PharBE ’18, now a team lead/project specialist in cell manufacturing at Juno Therapeutics, part of Bristol Myers Squibb, in the Seattle area. Working with cells and microscopes in academic labs, he felt “motivated but stuck.” He was curious about what happens after the discovery phase.

“The PharBE program will take you from being excited about cells, as I still am, to a whole new world,” Mike says. “It is like the first time looking through a microscope – one learns to see. Instead of cells, we learn to see the ins and outs of taking something to patients.”

A highlight of the program for Mike was the drug discovery and design course. “The course was essentially a history of the coolest, outside-the-box techniques that cell scientists have used to develop drugs,” he says. “The course was built for problem solvers; answers had many solutions and needed the best defenses.”

Mike has encouragement for anyone considering a move to the biotech arena: “If you love cell science, but feel funneled into research, this is the perfect program to open your perspective,” he says. He points to some of the opportunities in manufacturing beyond cell culture, ranging from warehousing to manufacturing design to quality assurance, to name a few. At the right company, he says, there are ways to channel creativity and passion for cell science into the manufacturing process, which he has grown to love. “If you want to work with a bunch of people connected by their passion for cells, medicine and patients, then biotech is a whole new world for you.”

LEARN FROM EXPERTS IN THE FIELD

UW Bioengineering faculty Patrick Stayton

Patrick Stayton

Edward Kelly Pharmaceutics professor

Edward Kelly

Roberta Wong

Roberta Wong

The program gives students direct access to faculty who have first-hand experiences with the drug development process, both in academia and industry. Wong is a Seattle-based pharmaceutical consultant who previously was senior project manager at Amgen, director of corporate planning at Abraxis Bioscience, and director of research at Agensys. She co-directs the program with Edward Kelly, UW associate professor of pharmaceutics, who managed the Preclinical Bioanalytics group at Targeted Genetics Corporation before joining  UW’s faculty, and Patrick Stayton, Distinguished Career Professor of Bioengineering and director of the Molecular Engineering and Sciences Institute, who has developed therapies and co-founded two companies to move those technologies into market.

The program also features guest instructors from diverse backgrounds, and many are upper-level professionals who have been in the pharmaceutical field for several years, with hands-on knowledge and experience in each step of developing and taking a drug from concept to commercial market. They offer students a breadth of exposure across the industry.

“We were exposed to experts in the field on a regular basis,” says Kristen, the clinical study manager. “Not only did this allow for some great lectures, but it allowed for us students to ask real-world questions and receive answers that you can’t get from a textbook or a pre-recorded lecture.”

The students also learn from each other. The program draws a broad mix of students, from those right out of undergraduate programs to bench scientists, lawyers, medical professionals and those with MBAs. Their diverse experiences create a rich learning environment. Students are encouraged to share insights from their daily work, such as from the manufacturing process, challenges in animal studies or experiments with drug candidates.

STAYING CURRENT

Arisa Cale PharBE alumna

Arisa Cale, PharBE ’19, in San Diego. Photo courtesy Arisa Cale.

“My job is one of the biggest things I gained from the program,” says Arisa Cale, a senior research associate at Arcturus Therapeutics in San Diego, who earned her PharBE degree in 2019. “It helped me to transition to what I was looking for, which is a job related to clinical trials.”

Once she started working after earning her bachelor’s degree, she realized she’d need more education to advance along her chosen path, and the UW PharBE program allowed her to continue working and attend school part time.

Arisa also appreciated the aspects of courses that provided biotechnical expertise and an overview of new trends.

“Every single day the scientific field is going to advance little by little, so keeping up with new techniques and new science was really useful,” she says.

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, students complete 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 capstone project, teams of two develop a go/no-go analysis to determine whether a product has enough merit to finish drug development with the goal of being submitted for FDA review and approval.

Joyce Chan PharBE alumna

PharBE alumna Joyce Chan and her daughter at graduation on the UW campus in 2019. Photo courtesy Joyce Chan.

Joyce Chan, PharBE ’19, is principal research associate at Boston-based Moderna Therapeutics, whose coronavirus vaccine received FDA approval for emergency use in mid-December, showing 94.1 percent effectiveness.

“The program definitely gave me a deeper understanding of drug development and pharmaceuticals, and has helped me better do my job,” Joyce says.

She didn’t know what to expect from an online program at the time, and she preferred UW’s over a Harvard Medical school course she took more recently, which was all prerecorded. “I was very happy with the whole program,” Joyce says. “I got a lot of face-to-face time with the professors and other students, and because of the small size, I felt that I got a lot more interaction out of it even than undergrad programs that are in-person.”

CONVENIENT, BUT CONNECTED

As one of the first all-online PharBE programs, UW BioE developed ways to make online learning engaging and effective, and honed them before the coronavirus pandemic struck.

Live class discussions happen once a week in the evening, and students watch pre-recorded sessions at their convenience. The program uses Zoom video conferencing, so in addition to a main screen with slides, video or a whiteboard, the instructor and all students can see and hear each other via thumbnail video feeds, and use the live chat feature. In addition to drawing on the whiteboard and creative videos, some instructors hold live oral exams. “That was terrifying, but also really good in the end,” Joyce recalls. All live lectures are also recorded, so students can watch the recordings as often as they like.

Wong says some people are concerned that in an online class, you are anonymous, you don’t feel part of a group, and that you may not learn as much because of it. She points out that students in 2019’s graduating class “all felt really connected,” even though they were spread out across the country from upstate New York, Boston, San Diego, Chicago and one in Seattle. Out of 15 that graduated, 12 of them traveled to the graduation ceremony in Seattle. “You’re talking about a pretty big commitment from people feeling connected to the program,” she says. She sought her students out as they gathered on campus before the ceremony. Although students were worried they wouldn’t recognize their peers, they said everyone looks just the same in person as their online video image.

“They were chatting a mile a minute when they saw each other, even though for most of them it was the first time they had seen each other in person,” Wong recalls.

Thanks to her pre-pandemic travel schedule in 2019, Wong was able to personally meet every student who graduated in that class. She also does one-on-one videos with her students to help her get to know them as individuals.

In addition to recorded and live online classes, students also interact with each other through team projects that promote communication and colleague-building skills. Students get practice presenting, listening to their classmates, accepting and offering feedback, dissecting strategy and thinking critically.

“Robbie [Wong] really emphasized team engagement, classroom dynamics and working together, and that was a huge part in getting to know people,” Jeffrey says.

Offering the program entirely online gives students flexibility to fully participate regardless of where they live, how much they may travel for work in the future or even if their company moves,” Wong says.

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.

Pie chart: how job responsibilities changed after PharBE program

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

“The capstone course is the most unique aspect of the program,” Wong says. 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.

“UW PharBE students have to analyze the market, look at the competition and figure out how they can position their product to be potentially a leader in the treatment of that particular disease. I haven’t seen any other program that provides this experience to students,” Wong says.

Wong says most of her students come from a laboratory-based background, working at a stage before drugs are tested in humans, often in process development and manufacturing.

She provides an understanding of what happens when drugs are tested in people, and how the work they’re doing in the lab impacts human trials.

“I also explain to them how business decisions could affect moving a drug product forward or not,” Wong says.

Notably, the capstone course features a health economics component – a kind of risk-benefit analysis, given the expense of developing and winning marketing approval for a drug, which can exceed $2.5 billion. “One of the most important questions arising in the last 5-10 years is: does the development cost for the drug, testing and monitoring, give you a product that will advance the treatment of disease?” Wong says. “Do you get a better quality of life?  Do you extend life, as in the case of cancer or other life-threatening diseases such as hepatitis? And what is that worth – does it cost $100,000 to get four more months of life, or is it a $100,000 investment and we get 20 more years of life and save 10 hospitalizations and their potential complications?”

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 have to be able to afford it.

Insurance companies and clinicians need strong evidence of a drug’s effectiveness, otherwise it might not get used. Many people may not have the resources to pay for expensive drugs without an insurance company’s help. “New drugs not only need strong efficacy that is an improvement over current treatment options, they need to also be affordable, so we don’t waste a drug that could help people but is not accessible to those who most need it,” Wong says. Students often name class discussions about business decisions as one of the highlights of the program, and that knowledge really helps students participate in cross-function teams in their jobs, she adds.

The class is critically important, Wong says, especially as more insurance policies cover fewer conditions and drugs. “You have to be aware of the expense of drug treatment, and the benefit it provides to patients,” she says. “Cost does matter.”

In addition to better understanding how drugs are developed, graduates better understand how diseases are managed and how decisions are made in selecting which drugs are used and not used, Wong says.

Details about the program and answers to frequently asked questions are available on the UW PharBE website.