Pharma and biotech: streamlining the path to health
The industry needs to improve cost and time to market. Innovation is key
“It is very exciting when each piece of data comes back, and bit by bit you see that your design is leading to a potential drug candidate.” – Margaret Chu-Moyer, Amgen
By Sonya Stinson
It typically takes ten to fifteen years to develop a new drug, according to the 2014 Biopharmaceutical Research Industry Profile of the Pharmaceutical Research and Manufacturers Association (PHRMA). Engineers, IT specialists and scientists are working together to shorten the time it takes to make new medicines and get them to market. Their efforts also aim to make the drugs less costly to produce and more affordable for consumers.
“There is pressure on the drug development industry to provide new life-saving, life-extending, life-improving products at a lower cost,” says Peter Abair, director of economic development and global affairs for the Massachusetts Biotechnology Council (MassBio). “A lot of the focus is on reducing the time from discovery and a concept for a new drug product until you have a drug that’s ready to be manufactured.”
The U.S. biopharmaceutical sector provides more than 800,000 direct jobs, according to PHRMA. It includes both traditional pharmaceutical companies that make chemically based drugs and biotechnology companies producing biologic drugs.
Process engineers are in demand to help biotech companies move away from traditional systems and elaborate equipment that must be cleaned after each product run, and to adopt more single-use, disposable technology, Abair says.
“IT is another area of strong demand within our industry, because another way to reduce the timeline and cost is through the better use of information technology in developing drug candidates, getting good information about patient populations, and running clinical trials,” he notes.
Requirements for a nice paycheck
The U.S. Bureau of Labor Statistics’ 2013 figures on employment in the pharmaceutical and medicine manufacturing industry showed engineers earning an average of $88,900 a year, while computer and information analysts earned $85,080. Computer and information systems managers made $126,390, and industrial production managers made $113,500 a year.
Employers are looking for job candidates with experience working in a regulated laboratory or manufacturing environment. For new graduates, that means they must have internships or co-ops on their resumes, says Abair. He notes that, with more than 1,600 job openings on the massbio.org website alone, “it’s a good time here in the greater Boston area for careers in the biopharmaceutical industry.”
But he cautions: “Even with this kind of demand for workers, you’re still not going to be hired unless you have some real-world experience.”
Meet six people who are working in research laboratories, manufacturing plants and data centers on some of the cutting-edge technologies that are changing the way medicine is made.
Anne Zeller focuses on big data’s impact on medicine at Genentech
Since 2012, associate director Anne Zeller has led the data services group of the IT Americas division at Genentech (South San Francisco, CA). She’s in charge of all data warehousing and analytics performed to support both the company’s commercial operations and medical affairs groups.
When she arrived at Genentech in 2004, she was assigned to the IT group, working mainly in process design. “We were trying to transform the IT group to run like a business,” Zeller says. “We worked on project lifecycles, operating models, our strategic planning approach, how we managed software licenses.”
In 2010, she became leader of a division of data services that supported the U.S. commercial operations group. Two years later, she was promoted to head the entire data services group.
Zeller says the most interesting part of her current work centers around the hot topic of big data.
“We are seriously thinking about how one might use real-world evidence – for example, data from electronic medical records – to help speed up understanding the real outcomes of medicine,” says Zeller. She adds that mining the data could lead to additional clinical trials, as well as development of trials for new therapeutic indications for medications.
A longtime fan of programming and data
Zeller received a BS in accounting from the University of Kentucky (Lexington) in 1977. Although the university had no computer science curriculum then, she took several programming classes, which were housed in the School of Engineering. “I thought it was a lot of fun,” says Zeller. She also worked part time at a campus data center.
After college she worked as a computer programmer in the taxation department for the state of Kentucky. Later, she landed at Bank of America, where she worked for eighteen years in technology infrastructure and architecture.
Next, she became chief technology officer of a healthcare startup that was building a service and case management application. By the time the venture capitalists sold that business, Zeller says, “I was pretty hooked on healthcare. I had a friend who worked at Genentech, so I met people who had connections.”
A great environment for openness
Zeller, who is a lesbian, says workplace attitudes about both gender and sexual orientation have undergone seismic shifts since she graduated from college in the late 1970s.
“The environment here at Genentech is extremely open, welcoming everyone regardless of gender, race, sexual orientation, nationality,” Zeller says. “That’s been my experience here since I joined, and it’s been my experience in the Bay Area since around the early 90s.”
That is, she says, when major companies started offering domestic partner benefits and it became more acceptable for lesbians and gays to be completely out at work, instead of only to their clo-sest co-workers.
“When I arrived in California in the early 80s and went to work for Bank of America, it was totally acceptable to be out to your peers, but you just weren’t out in a broad way,” says Zeller. “Your manager or your manager’s manager might not know.” She joined a diversity group at Bank of America working to create a more open and accepting environment for LGBT employees.
At Genentech, which has an active LGBT group, sexual orientation is practically a non-issue among co-workers, according to Zeller.
“It’s almost like it’s not even a topic of conversation anymore,” she says. “It’s just a way of life.”
Kalyani Bulfer: leading and building a team supporting early development at Genentech
Kalyani Bulfer, a group manager and IT solution owner, works in the IT Americas division of Genentech, supporting scientists conducting clinical trials. She has been with the company since 2009, first as a consultant, and full time since 2012.
She leads a team of IT pros including project managers, developers and testers.
“This team is responsible for a portfolio of systems that support clinical operations, clinical sciences, quality compliance and business operations,” Bulfer says.
One system, the Genentech enrollment, measurement and management application, facilitates the creation of data-driven scenarios for scientists to determine the progress of enrollment in clinical trials. A new system in development will allow Genentech to collect and archive site survey data to determine the best location to conduct a clinical trial.
A career takes a turn
Bulfer earned a 2000 BS in business administration, majoring in international business, marketing and political science from the Ohio State University (Columbus). She also received a 2007 masters in public administration, with a focus on statistics and nonprofit management, from Columbia University (New York, NY).
After she finished her bachelors, she spent eight years as a government consultant at management consulting company Accenture. She went on to graduate school, intending to use her public administration degree as a stepping stone to a career in government or nonprofit management. “But my career took a little bit of a different twist,” she notes.
After graduate school, Bulfer returned to work briefly for Accenture before moving to Slalom Consulting in San Francisco, CA. Slalom recommended Bulfer for a project dealing with Genentech’s grants management system.
“It was through my background in nonprofits and compliance systems that I came to Genentech,” she says.
Building a vital support system
Bulfer was hired as a senior project manager in the Genentech commercial IT group, working on a series of projects involving managed care customer operations.
Early in her career as a consultant, Bulfer encountered two women who became her mentors and role models, and she continues to stay in touch with them.
“I also have to say that at Genentech especially, I’ve found some really wonderful men who have cleared the way for me in terms of policies or flexible work arrangements, and who have supported my career development,” Bulfer says.
Managing and motivating her own team is one of the most enjoyable aspects of Bulfer’s job, and that’s where she’s focusing her plans for the future development of her career.
“I’d like to grow as a manager,” Bulfer says. “I’d like to see my team grow, because we have a lot of work we need to do to support Genentech Research and Early Development. Right now I’m focused specifically on business and clinical operations. I’m interested to know what’s happening with other areas of early development and research, and how I can help support those teams.”
Regina Donaldson oversees utility and systems projects at Bayer HealthCare
As the central utilities principal plant engineer at Bayer HealthCare (Whippany, NJ), Regina Donaldson works in Berkeley, CA, where she plans and executes capital projects in utility equipment and systems. She ensures that the company’s utility systems operate in compliance with internal guidelines and government regulations.
A recent project had Donaldson managing the installation of underground compressed air lines to connect satellite utility systems to the centralized system to improve their safety and reliability.
Her job requires her to work on cross-functional teams, and she relishes that role. “I’m able to learn about other processes and how each is necessary to achieve the desired outcome, which is to provide a product that allows our patients to have a better quality of life,” Donaldson says.
As department leader, Donaldson has to ensure that projects stay on schedule, without interrupting utility service to the production department. And that can be a challenge.
“Since I am responsible for several projects with varying complexity and timelines, I wish there were more hours in the day,” she says. “Time management is a critical skill for keeping the project schedule on time without impacting product availability or utility reliability.”
A fan of student networking
Donaldson has a 1998 BS in mechanical engineering and a 2007 MS in chemical engineering, both from the University of Dayton (OH).
She’s a big advocate of groups like the American Society of Mechanical Engineers, the Society of Women Engineers, the National Society of Black Engineers and the American Institute of Chemical Engineers. Groups like these let tech pros and students network and share knowledge with others in their fields.
“There are so many organizations that help students and professionals expand their knowledge of STEM fields, increase their marketability, and collaborate on projects,” Donaldson says.
She remembers her own school science projects fondly, and volunteers for similar events at the school where her son is in seventh grade. She also has tutored local students in math and chemistry through Biotech Partners, a nonprofit educational program jointly founded by Bayer and the city of Berkeley.
Stella Munuo connects R&D; and IT objectives at AstraZeneca
Stella Munuo works in the Gaithersburg, MD biometrics and information sciences group of pharmaceutical and biologics company AstraZeneca (London, England). She helps select the information technology systems the company’s statisticians and programmers use to analyze new drug treatments.
“I serve as a liaison between the business, particularly R&D;, and our IT group, and therefore must have a solid understanding of the needs and objectives of both,” says Munuo. Her title is senior tools specialist.
“Scientists within AstraZeneca’s R&D; function are performing work every day that leads to the discovery of new medicines to treat patients. Part of that discovery process involves a need for statistical analysis of data to help determine the safety and effectiveness of investigational treatments.”
Munuo sees to it that these technological tools comply with company standards and government regulations and remain fully functional throughout their lifecycles. She also coordinates system testing when changes are made and provides end-user support.
A well-rounded second-gen STEM pro
Munuo received a BS in mathematics from Wisconsin Lutheran College (Milwaukee) in 1993. She earned a 1997 MS in systems engineering, with a focus on operations research, and a post-masters professional applied scientist degree in systems in 2007, both from George Washington University (Washington, DC).
The daughter of two scientists, Munuo says her decision to pursue a college degree in math was influenced by a family friend who was a professor of mathematics. She was drawn to systems engineering while working as a programmer after receiving her bachelors degree.
“In other forms of engineering you’re working with tangibles, but systems engineering involves optimization on a more conceptual level, working with elements you can’t necessarily see or touch to solve problems,” Munuo says. “This intrigues me and keeps me challenged while also leveraging my strengths in math and science.”
Munuo has been working on a component of a new program that involves generating graphs, charts and other visual representations of clinical data – a “visualization work stream” – during studies of clinical treatments.
“This has been an interesting challenge and has provided me an opportunity to learn about the interaction of many systems and the need for foresight when embarking on a program of such scale,” she says. “Technical skills are important but so are soft skills of negotiation, collaboration and diplomacy.”
Margaret Chu-Moyer oversees medicinal chemistry research at Amgen Massachusetts
Margaret Chu-Moyer came to biopharmaceutical company Amgen (Thousand Oaks, CA) in 2009 as head of the medicinal chemistry group at the company’s Cambridge, MA site.
Eighteen months later, she was appointed site head of the Cambridge research facility, an assignment that put her in charge of ensuring a safe and productive working environment, as well as representing Amgen to the local community and the broader biotechnology medicines industry.
In 2014, she was given responsibility for overseeing medicinal chemistry research for the company.
“At the most basic level, we use our knowledge of chemistry to make modifications to molecular structures that we hope will become medicines that are safe and effective for the diseases we are targeting,” says Chu-Moyer.
An exciting prospect
She loves everything about her field of research, including the potential and the challenges that each unique molecule presents. “A key event happens when we design the structure of the molecule we want to make, as all of the potential medicinal properties are encoded in the atoms and the bonds represented by that structure,” she says. “When each piece of data comes back about that molecule, and bit by bit you see that your design is leading to a potential drug candidate, it is very exciting indeed.”
One long-term Amgen early-stage research program recently reached a significant milestone, Chu-Moyer says. “We were able to identify molecules that have the potential for moving into the next phase of early-stage clinical development programs,” she says. “We capitalized on different findings across a large chemistry team to achieve this, so it was a great example of teamwork at Amgen.”
Not every effort succeeds in turning biology into the “game-changing therapeutic” Chu-Moyer says this project will produce. “Nature is powerful, and not all biological processes are ‘druggable,’” she says. “Other times, it is just plain difficult to find the right molecules to get started.”
Driven to achieve
Chu-Moyer got her BS in chemistry from the University of California-Berkeley in 1987. After graduating, she spent two years as a laboratory associate at Abbott Laboratories, synthesizing compounds for treating cardiovascular disease.
From there she went to Yale University (New Haven, CT) to pursue her doctorate. She earned a PhD in organic chemistry in 1993, doing her research and thesis in total synthesis of natural products.
Following her PhD, she went to work as a laboratory head in the cardiovascular, metabolic and endocrine diseases group at Pfizer in Groton, CT. She advanced to group director, leading a group of about forty medicinal chemists.
A childhood question leads to a career
Chu-Moyer’s career in the medicines industry is part of her quest to solve a childhood mystery.
“When I was young I always wondered how it was that when I was sick, I could take some medicine and feel better,” she says. “What was going on? How did that little pill do all that?”
Chu-Moyer would love to be involved in a formal mentoring program for students who are just as fascinated by science and technology as she was. She has promoted STEM education at her children’s school and through Amgen’s community volunteer program. She’s become a part of similar efforts in the American Chemical Society and other professional organizations.
Chu-Moyer recalls having a female postdoctoral fellow as a mentor in graduate school. Later, the same woman became a friend and colleague at Pfizer. “She was a great role model as a medicinal chemist, a people leader and a wife and mother,” Chu-Moyer says. “She was going through the same things I was, just four years before I did. I could always turn to her for advice and see in real time what it might be like for me in the future.”
Mary Ellen Urick does cutting-edge cancer research at Thermo Fisher Scientific
“My job involves analyzing genomic data to find genes that are changed in cancer tissue samples,” says Mary Ellen Urick, a staff scientist in bioinformatics for the Ann Arbor, MI translational medicine department of Thermo Fisher Scientific (Waltham, MA).
The information Urick culls from her research helps pharmaceutical companies develop effective drug treatments for cancer. She notes that information technology, from the use of computer applications to the incorporation of big data, is essential to her work as a scientist.
“Information technology plays a huge role in what I do here,” says Urick. She arrived at Thermo Fisher in 2013 after finishing the second of two postdoctoral research programs. “That’s something I learned once I started my position here, because before that I was a bench scientist.” One of her greatest challenges, she says, was “learning to think more in the clinical space as opposed to the investigational space.
“But I think that over the past year and a half I’ve learned to incorporate both considerations in my decision making and analyses, and I only expect to get better as I progress in my career,” she says.
An impressive educational foundation
Urick received a BS in animal behavior from Bucknell University (Lewisburg, PA) in 2003. She got her PhD in reproductive physiology and biochemistry from Cornell University (Ithaca, NY) in 2009, with a research focus on ovarian cancer.
She spent five years doing post-doc studies, first at the National Cancer Institute, then at the National Human Genome Research Institute, both in Bethesda, MD. At the National Cancer Institute, she examined the use of drugs as potential radio sensitizers, enhancements of the curative effects of radiation therapy.
At the National Human Genome Research Institute, she studied whole exome sequencing of endometrial cancer, involving all the protein-coding genes in its genome, and did functional work with mutated endometrial cancer genes. She believes the expertise she gained in genetics and genomics in working on that project was the key to landing a position at Thermo Fisher.
Recently Urick participated in work on Thermo Fisher’s Oncomine Cancer Research Panel, a sequencing tool. “The panel can be used to pass cancer tissues through hundreds of genetic aberrations at one time,” says Urick. She was involved in the preparation of the project and meetings with high-profile clients to discuss it. “I truly believe this product may be a game changer for cancer research. It gives me a real sense of pride when I get the opportunity to contribute to such an important program.”
Throughout her career, the vast majority of Urick’s co-workers have been male, but her graduate and post-doc mentors, and her mentor at Thermo Fisher, have all been women. Seeing other women in high-level posts has inspired her to strive for similar achievements.
“One of them told me something that resonated with me: that I should ‘act like a lady, think like a man and work like a dog.’ It was really the last part of that saying that stuck with me,” Urick says. “I think it has helped shape my work ethic and led to the success I’ve had in my work life.”
DIVERSITY-MINDED PHARMA & BIOTECH COMPANIES
Check websites for current openings.
|Company and location
|Amgen (Thousand Oaks, CA)
|AstraZeneca (London, England)
|Bayer HealthCare (Whippany, NJ)
|Genentech (South San Francisco, CA)
|Thermo Fisher Scientific (Waltham, MA)
|Life sciences research and lab equipment
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