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, Amgen and bluebird bio thanks to their PharBE degrees.
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 affiliate 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.
When UW PharBE graduate Blake Engelbert (’19) started in the program, he worked in a more established area of bioengineering – biologics. After graduating, he moved into gene therapy, starting as a scientist with Seattle-based Shape Therapeutics, where he is now a senior scientist.
“My job requires a lot of creativity,” he said. “I’m doing more research-oriented projects than I did in previous roles before enrolling in the PharBE program.”
Blake’s job entails establishing a framework for analytical development. “I’m focused on the lifecycle of assay development and how to implement it in a streamlined and efficient process,” he said. The data generated from the assay development lifecycle can be used to define assay acceptance criteria which will support regulatory filings including Investigational New Drug (IND) applications or Biologics License Applications (BLA).
Prior to joining Shape Therapeutics in 2019, Blake worked for Halozyme Therapeutics as a senior research associate II. “I utilized the seminar class PharBE 506, which helped with resume and interview preparation,” Blake said. “I made the jump to a scientist role thanks in part to my master’s from the PharBE program.”
The PharBE class that Blake most enjoyed was the capstone project class. “It pulled everything we learned in the program and showed us how to apply it within the pharmaceutical industry,” he said. “Each phase of drug development encompasses different considerations including the studies that need to be completed and how information about the projects is communicated to agencies and the industry. The class helped me to understand the entire process of drug development.”
“I made the jump to a scientist role thanks in part to my master’s from the PharBE program.” – Blake Englebert
Blake, who hails from Seattle and attended the UW as an undergraduate, enjoys outdoor activities including snowboarding, mountain biking and golfing. He also stays busy spending time with his young daughter. He is currently teaching her how to ride a bicycle in the hope that she will be able to join him on rides soon.
Read more about Blake in a full Q & A interview here.
Xochitl Vasquez’s PharBE degree (’21) helped her to discover how much she enjoys participating in hands-on experiments that lead to important drug discovery. Having transitioned from a scientific alliance manager for Vyant Bio in November 2021, Xochitl is now senior research associate at Maze Therapeutics based in San Francisco, Calif. The company translates genetic insights into therapeutic innovations to create precision medicines that fight disease. Xochitl works with the Stem Cell Biology team on cardiovascular diseases, focused primarily on preclinical development.
While in the PharBE program she started at StemoniX, now part of Vyant Bio, as research and development intern; was promoted to research associate and then scientific alliance manager a little over two years after starting at StemoniX.
“One of the great things about the UW PharBE program was how much easier my decision was about going back to lab work,” Xochitl said in discussing her transition from Vyant Bio to Maze Therapeutics. “In the program you get to listen to many guest speakers talk about their experience, and you have a better understanding of what types of roles there are in the pharmaceutical industry.”
Xochitl’s favorite PharBE class was Pharmaceutics I, which focuses on the research and development phase of a therapeutic, because it translates into the work she does now. “Research and development is a difficult area to work in because about 90% of the time things don’t work, but when they do there is nothing more satisfying than knowing you can make a difference in treating a disease,” she said.
For prospective PharBE students, Xochitl shares that any advanced degree can be helpful in advancing one’s career. “My advice is to not think too much about it. Applying for the PharBE master’s program was a bit of an impulse decision but the degree completely transformed my career trajectory, she said.
Outside of work, Xochitl used her scientific background to start a small jewelry business, XoCrafty Jewelry, preserving hand pressed flowers in resin.
“Applying to the PharBE master’s program was a bit of an impulse decision, but the degree completely transformed my career trajectory.” – Xochitl Vasquez
Read more about Xochitl in a full Q & A interview here.
SPRINGBOARD TO THE NEXT LEVEL
Stephanie Baptiste (PharBE ’19) credits the program with helping her to understand the drug development process, which has been helpful in her job as business performance manager at Amgen. She uses this knowledge as a liaison between scientists and those who are more business-focused to ensure everyone she works with is in alignment. When Stephanie started at Amgen in 2018, she was a strategic operations and planning associate with the engineering team. She was promoted to senior associate a year and a half later, and then moved into her current role as business performance manager in July 2021.
Stephanie is currently working on an initiative that is integrating human data with the business side of drug development. Human data focuses on genetics, genomics, proteomics and metabolomics which allows for more precise medicine where a patient’s variability in genes, environment and lifestyle are considered. “This allows us to understand diseases so that we can make more efficient drugs and provide better care to patients,” Stephanie said. Additionally, she is responsible for resource forecasting to ensure Amgen teams have the needed employees for programs.
Stephanie enjoys being involved in the science process that considers medicine in the future. “I’m seeing so many innovative ideas that are making an impact. We want to redefine how healthcare is approached so that it is more preventative rather than reactionary, which gives me the motivation to work in this field,” Stephanie said. Having had the opportunity to hear some patients speak about their experience with drugs Amgen developed, Stephanie feels hopeful that people will benefit from new treatments they are developing.
Stephanie appreciated how robust the PharBE course work was. “The program gave me insight into other biotech experiences and what it means to create large molecule drugs. I learned about biotech companies that are younger and take different approaches to developing and creating medicine,” she said.
“The course work was very robust. My favorite class was also my most challenging class – Clinical Development – because it forced me to put in practice what I was learning.” – Stephanie Baptiste
In her free time Stephanie enjoys boxing. “Every time I move to a new city, I find a new boxing gym because I know I’ll find friends immediately,” she shared.
Read more about Stephanie in a full Q & A interview here.
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.
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.
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.
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.
“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 admissions questions are available on the UW PharBE website.