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 REGENXBIO, Aldeveron and bluebird bio thanks to their PharBE degrees.
Robert Stadelman graduated from the UW PharBE program in 2012 and is currently a senior scientist with REGENXBIO, a company focused on gene therapy in Rockville, Md. Prior to joining REGENXBIO in 2018, Robert worked as a scientist for Medimmune, a former research and development arm of AstraZeneca. He was an associate scientist with Amgen when he started in the PharBE program and moved to BioSolutions as an associate scientist II while in the program.
“I like the impact that gene therapy is having on people, and addressing unmet medical needs,” said Robert.
Before attending the PharBE program, Robert had always been on the early research and development (R&D) side of drug development. “I was familiar with phases one and two of R&D, but I didn’t have much exposure to phase three,” he shared. Given that, his favorite class was one taught by Robbie Wong, affiliate assistant professor of bioengineering and co-director of the PharBE master’s program, that focused on the clinical trials of drug development. Robert enjoyed learning about labeling and the Biological License Application.
When attending the PharBE program, Robert appreciated being able to attend classes while having a career and raising two small children. “Having a PharBE master’s degree helped me move up to the scientist level quicker. I may not have been able to advance as fast without it,” he said.
When he’s not working, Robert stays active with two teenagers. He enjoys being outdoors and runs and hikes the trails near his house.
“Having a PharBE master’s degree helped me move up to the scientist level quicker. I may not have been able to advance as fast without it” – Robert Stadelman
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 Wong.
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.
While attending the UW PharBE program, Sean Malone worked for Waisman Biomanufacturing as a process development & manufacturing specialist. Located in Madison, Wis., Waisman Biomanufacturing focuses on bringing novel therapeutics into the clinic. In 2020, Sean graduated from the PharBE program and joined Catalent as a specialist I, manufacturing protein therapeutics. Catalent is a global company focused on drug delivery technologies and manufacturing solutions. Ten months later, Sean was promoted to a scientist III in the Technical Operations group at North Dakota-based Aldevron, which manufactures biologics. Working in the Madison, Wis. location, Sean focuses on process development for research-grade proteins and enzymes necessary for mRNA synthesis and production.
Sean is currently working on improving yield for specific in vitro transcription (IVT) enzymes for mRNA vaccines. “We have one that is particularly problematic, and we are working on increasing the yield,” Sean said. He enjoys the technical challenges as well as Aldevron’s support for his work and life outside of his job.
At the UW, Sean’s favorite PharBE class was process development taught by Doug Miller, affiliate assistant professor in the Department of Bioengineering. “It allowed me to grow in that area, and that mattered a lot to me because it was the direction I wanted to go in my career,” Sean shared. “The PharBE master’s program allowed me to rapidly move up my career ladder into higher level positions when combined with my previous work experience.”
PharBE students learn about a lot of different cells and molecules while in the program. Sean likes the adeno-associated virus because “having worked with it, I find it fascinating,” he said. “It’s been the key to getting gene therapies out, FDA approved and into the market.”
“The PharBE master’s program allowed me to rapidly move up my career ladder into higher level positions when combined with my previous work experience.” – Sean Malone
Outside of work, Sean enjoys spending quality time with his fiancé and their two dogs, and thanks to the COVID-19 vaccine, now spending time with family and friends.
LEARN FROM EXPERTS IN THE FIELD
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 alumna Kristen Fetchko, clinical study manager at CytoSorbents. “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.
SPRINGBOARD TO THE NEXT LEVEL
When Tracey Stevens (PharBE ’12) learned of the UW PharBE program, she saw it as an opportunity to advance her career. “I was a scientist at Amgen striving to advance through the scientific tree,” she said. “Pursuing this advanced degree kind of springboarded me to the senior scientist level, which is really important because at that level you are managing projects and people.”
Tracey joined bluebird bio, a gene therapy company based in Massachusetts, in 2017 and is now director of site operations at bluebird’s Seattle research facility. Her science background and her experience as a scientist at Amgen helps her to better understand the scientist’s needs at bluebird. She is currently on the global return-to-work team, which is focused on maintaining business continuity while reopening safely after the COVID-19 pandemic. As the Seattle site continues to grow, Tracey is looking at innovative ways to optimize bluebird’s laboratory space so that it continues to be state-of-the-art flexible to allow for different types of research. “It’s interesting and incredibly rewarding to give the scientists everything they need to be successful,” she said.
Being one of the only women on the bluebird leadership team in Seattle, Tracey has a strong connection to all the women who work there. “My position shows them what they can do. This is a path you can take.” – Tracey Stevens
Being one of the only women on the bluebird leadership team in Seattle, Tracey has a strong connection to all the women who work there. “My position shows them what they can do,” she said. “This is a path you can take.” She enjoys mentoring and advocating for the junior staff.
When asked what her favorite cell is, Tracey shared she has always been fascinated by natural killer (NK) cells. “Their job is to kill tumor cells and cells infected by viruses or other microbes to control infection and prevent tissue damage,” she said. “NK cells play a critical role in recognizing cells infected with pathogens.”
Outside of work, one of Tracey’s passions is rescuing discarded orchids that other people have given up on. “I am very patient, and one of the plants I rescued bloomed 10 years after I started caring for it,” she said proudly.
Read about more PharBE alumni experiences
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.
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. 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,” alumnus Jeffrey Chu of Horizon Therapeutics says.
Read about more PharBE alumni experiences
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.
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.
Read about more of our PharBE alumni.