THE 2011 FISCHELL FESTIVAL:
A Celebration of Bioengineering's Potential to Improve Life for Millions of People
On October 20, 2011, the Fischell Department of Bioengineering (BioE) held its fifth Fischell Festival, featuring a variety of presentations and activities, including a morning keynote address by U.S. Food and Drug Administration Chief Scientist Jesse L. Goodman, panel discussions on bioengineering career paths and entrepreneurship, a poster session, a career fair and information expo, and a Whiting-Turner Business and Entrepreneurial lecture presented by Jenny Regan, co-founder and CEO of Key Tech, a Maryland firm specializing in the commercialization of new technologies into medical devices and precision instruments.
Unfortunately, our scheduled live hip replacement surgery was canceled due to an emergency. We would like to thank Drs. Vincent D. Pellegrini, Jr. and Theodore T. Madson (Department of Orthopaedics, University of Maryland School of Medicine) for planning this portion of the Fischell Festival, and hope they are able to join us in the future.
After welcoming guests, BioE Professor and Chair William E. Bentley announced the department's role in the establishment of a Center of Excellence in Regulatory Science and Innovation (CERSI), funded by an initial $1 million grant from the U.S. Food and Drug Administration (FDA). The center will focus on modernizing and improving the ways drugs and medical devices are reviewed and evaluated. The new center will be a collaborative partnership between the University of Maryland, College Park and the University of Maryland, Baltimore. Researchers from both campuses will work with FDA scientists to develop new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.
This year, we were pleased to welcome the FDA Chief Scientist and Deputy Commissioner for Science and Public Health, Jesse L. Goodman, M.D., M.P.H., as our Keynote speaker.
Goodman's presentation, "Advancing Regulatory Science: Opportunities to Transform Product Development and Evaluation," introduced guests to the FDA's new strategic plan for advancing regulatory science, and how building partnerships with academia and industry—like the establishment of the new CERSIs with the UM and Georgetown University—will be critical to advancing its goals.
Addressing the criticisms leveled against the agency, Goodman explained how difficult its job can be. "The FDA regulates products that relate to 25% of the nation's economy," he told the audience, "so you can see how the potential to do good in terms of promoting innovation, to do harm if you unnecessarily slow it, or to do harm if you make decisions that allow unsafe products on the market, is tremendous."
Releasing a therapy that doesn't work well or for enough people but doesn't do any harm can be problematic, he said, because it wastes money and time that might otherwise be invested in something better. A successful clinical trial does not always lead to a product on the shelves, because it might encounter difficulties in manufacturing, transportation, and patient use.
The FDA's new strategic plan and vision, Goodman explained, is to speed innovation, improve decision making, and get safe and effective products to people in need by focusing on eight key areas: Modernizing toxicology by replacing animal testing with sophisticated human models, improving clinical trials through better prediction of long-term effects, improving manufacturing, preparedness for handling the evaluation of emerging technologies, compiling health data from multiple sources, food safety, addressing the threats of new and emerging diseases, and patient education.
"We have tremendous opportunities," Goodman concluded, "…but to really transform them into things that help people is going to require partnerships…We really welcome the University of Maryland and scientists present and future to join us in that."
The morning session concluded with the introduction of the department's newest Fischell Fellow, first-year graduate student Anthony Melchiorri, by Professor Bentley and Dr. Robert E. Fischell. Melchiorri, who engaged in cardiovascular research and internships as an undergraduate, plans to continue pursuing his interest in treating congenital cardiovascular defects, ultimately moving on to found his own company.
"One of the major reasons I came to Maryland was because I immediately recognized the difference between going to a university that has…an entrepreneurship institute or office, and [one that is] really practicing the spirit of entrepreneurship," he said.
In the afternoon's first panel discussion, three alumni shared stories about the diverging career paths they have taken after completing their bioengineering education: D.T. Howarth (B.S. '09) is currently a third-year medical student at the University of Maryland School of Medicine; former Fischell Fellow Dan Janiak (Ph.D. '09, materials science and engineering) is an associate at the bio-oriented venture capital firm DFJ Mercury; and Theresa Smith (B.S. '01, biological resources engineering) is a Research Program Analyst in the Division of Musculoskeletal Diseases at the National Institutes of Health.
All of the alumni stressed the importance of getting involved in research and internships as early as possible to hone one's interests and stand out when applying to jobs or graduate schools, as well as networking with professors, doctors and professional societies. They also agreed that while they often couldn't wait to be done with group projects, good teamwork skills are essential for a successful career.
"You can't get rid of people after a semester," Smith pointed out, noting that workplace teams are far more diverse in terms of backgrounds and skills.
Good communications skills are also essential: Janiak needs to be able to explain concepts to non-technical people—a skill he says is often overlooked in engineering curriculums—while Smith must be able to review and discuss grant applications and proposals from many different kinds of research groups. Howarth must not only communicate with patients, but also navigate the complex hierarchy of medical school and hospitals.
Asked for their best piece of advice for current students, Smith recommended reading What Color Is Your Parachute? to prepare for entering the job market.
"Relax and enjoy," said Janiak, "It'll all work out."
Howarth agreed. "Take a fun class," she said. "Network. Don't freak out. When you finish [a degree in] engineering, you can do anything."
Janiak stayed on for our second panel, in which he was joined by BioE graduate student Irene Bacalocostantis, whose startup company PolyVec Systems, which she co-founded with her advisor, Professor Peter Kofinas, won big at the 2011 UM $75K Business Plan Competition; Craig W. Dye, Director of the Maryland Technology Enterprise Institute's (Mtech) VentureAccelerator program; and Michael Gutch, Managing Director of MedImmune Ventures.
Dye, Gutch, and Janiak represented three stages of entrepreneurship and product development. Mtech, based in the A. James Clark School of Engineering, is designed to work with students, faculty and staff whose ideas are in the earliest stages of development, providing them with the guidance they need to conceptualize a company and its product, write proposals and business plans, and meet with investors. DFJ Mercury works with companies and products in the early development stage, often concentrating on higher-risk, emerging platform technologies such as drug targeting systems. Young companies that are more established might get the attention of MedImmune Ventures, which works with more validated technologies such as cell and gene therapies, making them less risky investments.
Bacalocostantis is an example of a member of the Clark School community who has taken advantage of the opportunities and mentoring Dye and Mtech provide to prepare new entrepreneurs for landing funding and working with companies like DFJ Mercury and MedImmune Ventures. Her goal is to transition her creation of a targeted drug delivery system for the treatment of breast cancer into a marketable business.
Panelists offered advice for aspiring entrepreneurs. "Relationships are weighted very heavily," said Janiak, adding that while the process of finding and receiving venture capital "is not mythical," it does require a lot of networking in the community.
"Get your story tight—it's how you're differentiated," said Gutch. "You need someone with management or advisory experience on your team."
Bacalocostantis and Dye said that taking advantage of mentoring resources and entering business plan competitions were great ways for new entrepreneurs to get their feet wet.
"Do your homework," said Dye. "[The field of] venture capital is highly specialized. Start by asking for advice, not money."
Asked what biotechnologies or markets they felt would see the most growth in the next five to ten years, the panelists suggested areas including the treatment of neurodegenerative, cardiac and obesity-related diseases, technologies for the aging population, and companion diagnostics used to streamline clinical trials.
Fourteen companies and organizations were on hand to demonstrate products and discuss services, education and careers in bioengineering, biomedical engineering, and biotechnology with interested students, faculty and guests:
The Fischell Department of Bioengineering would like to thank the Clark School's office of Engineering Co-op and Career Services for organizing the career fair and information expo, as well as all of the companies and organizations that participated.
The Fischell Festival concluded with a Whiting-Turner Business and Entrepreneurial lecture delivered by Jenny Regan, co-founder and CEO of Key Tech, a Baltimore-based prototyping and development firm specializing in medical devices and precision instruments.
Regan kicked off her presentation, titled "Homeward Bound: Medical Devices as Home Appliances," with a question: "If you can't make a therapy that a patient can take effectively, then what good is the therapy?"
Patient-administered drugs and health monitoring are gaining in popularity due to the rapid advancement of biotechnology, consumer electronics, wireless networking, nanotechnology, and microfluidics. More and more portable devices are capable of serving patients in ways that used to require visits to the doctor's office. This form of personalized medicine greatly reduces the cost of the treatment of chronic conditions, but comes with its own challenges.
Speaking from her experience designing home healthcare devices, Regan explained that the largest demographic for them—patients over 65—are also the least likely to feel comfortable using new technology. A diagnostic device for this audience must be able to do as much as possible, consistently and repeatedly, in as simple a way for the patient as possible. User interfaces might need to take issues such as declining vision or hearing into account. Repeated prototyping, Regan said, is essential.
Designers, she continued, must always put the patient first, and realize that it's about what they need, not what designers want to create. "Don't get caught up in a gee-whiz technology dream," she said, adding that "it takes guts" to walk away from amazing technology that one actually doesn't need to produce a successful product.
In addition to the challenges of designing for the patient, inventors must also be able to navigate regulatory requirements and working on a long-term project while technology continues to advance around them.
Key Tech's other strategies for effective product design include creativity in design, software, and science; identifying and overcoming high-risk factors early in the design process; being able to admit failure; accepting criticism; and having an excellent interdisciplinary team of on- and off-site partners.
The Fischell Department of Bioengineering would like to thank the Fischell family, all of the Fischell Festival's speakers, exhibitors, volunteers, and guests; and University of Maryland students, faculty and staff, for a wonderful and informative event. We hope to see you all next year!
Were you unable to attend one of our previous Fischell Festivals?
Through a $31 million gift, Robert E. Fischell and his sons Tim, Scott and David established the Fischell Department of Bioengineering and the Robert E. Fischell Institute for Biomedical Devices at the Clark School of Engineering.
"The greatest achievement that engineering can make is to improve the quality of life for millions of people. Our gift will help young engineers develop their ideas to improve healthcare for human beings throughout the world."
Robert E. Fischell, M.S. '53, Physics
"We're really starting to gain traction on new ways of doing bioengineering that are permeating the nation...What we're trying to do is develop a culture that recognizes innovation and develops different types of processes and products that will affect human health. Why is that the case? It's largely because of the influence of our catalyst, Bob Fischell."
BioE Professor and Chair William E. Bentley.
"I looked on [becoming the FDA's Chief Scientist] as a wonderful opportunity to articulate, develop and support both the importance of science at the FDA, and the importance of collaborating with partners in academia and industry to accomplish goals which are otherwise far too complex for any one individual organization to deal with."
FDA Chief Scientist and Deputy Commissioner for Science and Public Health Jesse L. Goodman, M.D., M.P.H.
"If you're a sophomore and you want to go to med school, your two assignments are find a lab job, and shadow a doctor."
D.T. Howarth, B.S. '09, currently a third-year student at the University of Maryland School of Medicine.
"If you can't make a therapy that a patient can take effectively, then what good is the therapy? ...It's fascinating, but not easy, to develop these home-use devices."
Jenny Regan, co-founder and CEO, Key Tech.