A ROUNDUP OF NEWS AND INFORMATION FROM OUR COMMUNITY By Carrie Printz

Meeting Roundup

Photo courtesy of Brigham and Women’s Hospital

esearchers from across the country gathered in Washington, D.C., April 16–18, for Translational Science 2015. Sponsored by the Association for Clinical and Translational Science, the annual meeting brought together all of the clinical and translational research disciplines to share the benefits of networking and education. In The News recently asked some of the meeting’s presenters to share important takeaway points from their sessions.

Shutterstock.com

R

NIH K24 Grants Help Investigators Mentor Junior Faculty

entoring junior faculty helps boost career advancement and satisfaction for clinical and translational science investigators, but finding time for “I previously trained it is challenging for most midcareer investigators. One 1 to 2 people per funding source that supports mentoring is the National year, but with this Institutes of Health (NIH) Midcareer Investigator support, I was able Award in Patient-Oriented Research (K24) grant. to expand to 3 to 5 mentees per year,” How to successfully apply for K24 funding was Dr. Seely says. the focus of a Translational Science 2015 session copresented by Ellen Seely, MD, director of the clinical research, endocrinology, diabetes, and hypertension division at Brigham and Women’s Hospital in Boston, and Barbara A. Woynarowska, PhD, scientific review officer of NIH’s National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Seely, who received the grant funds for 10 years through 2 funding cycles, presented the recipient’s perspective, while Dr. Woynarowska offered the NIH’s perspective on how K24 grants are reviewed.

“I previously trained 1 to 2 people per year, but with this support, I was able to expand to 3 to 5 mentees per year,” Dr. Seely says. “I helped them launch independent careers and find positions here at Brigham and Women’s Hospital and other institutions.” The K24 grant can support up to 50% of an investigator’s NIH salary to carry out mentoring and also provides up to $50,000 for research expenses per year. Applicants must have their own independent research funding, as well as a track record of mentoring. For Dr. Seely, who studies women’s cardiovascular risk factors in pregnancy and menopause, the grant enabled her to spend less time on administrative tasks and more time meeting regularly with mentees and helping them with grant applications and presentations. “The grant supports midcareer investigators’ time to teach mentees how to conduct patient-oriented research in which you interact directly with a human subject,” says Dr. Seely.

Scientists Discuss Role of Intellectual Property in Translational Science

U

nderstanding different types of intellectual property and how they play out in specific case studies was the focus of discussion at a Translational Science 2015 session chaired by Susan Perkins, PhD, associate professor of biostatistics at the Indiana University School of Medicine in Indianapolis. Identified as patents, trademarks, trade secrets, and copyrights, each type of intellectual property has different federal rules and regulations that govern its applicability and usage. Patents, as they relate to start-up companies, can be particularly complex, says Dr. Perkins. “The idea of what’s patentable is ever-changing,” she says. “There have been some new U.S. Supreme Court rulings that affect how patentability is decided.” A specific biomarker, for example, cannot be patented because it is a law of nature. However, if scientists develop a technique for deciding how that biomarker might be used in determining treatment for a disease, that method is potentially patentable, Dr. Perkins says. Session presenter Christopher Lindsell, PhD, associate dean for clinical research at the University of Cincinnati College of Medicine in Ohio, discussed his experience patenting a risk-assessment model for predicting mortality in pediatric patients with septic shock. He and colleagues used

gene expression data to identify proteins in the blood that might be associated with bad outcomes, then used a mathematical model to determine which proteins could be used to determine those patients “The idea of what’s at increased risk of mortality. The investigators patentable is everrealized they could potentially commercialize changing,” says Dr. their finding. Perkins. However, they did not have the necessary protection in place when they published their data using a gene map to tell the difference between patients who typically respond to steroid treatments and those who don’t. For physicians treating patients with septic shock, that could be lifesaving information, says Dr. Lindsell. “Because we didn’t protect that intellectual property, assay manufacturers are less likely to work with us because there isn’t as much commercial potential,” Dr. Lindsell says. “The most important thing I learned is that scientists don’t make the best businessmen, but there are a lot of great entrepreneurs out there willing to teach us.”

Photo courtesy of Indiana University School of Medicine

M

DOI: 10.1111/cts.12271

WWW.CTSJOURNAL.COM

VOLUME 8 • ISSUE 3

169

T

Stage Play Educates Researchers on Responsible Conduct

R

esearchers from the Children’s National Medical Center, based in Washington, D.C., doubled as actors during a stage play presented at Translational Science 2015 to help educate attendees about the responsible conduct of research. The “actors” presented a play based on an original script involving a principal investigator who takes a shortcut and performs a procedure without “We wanted to highlight the ethical getting prior approval from his institutional review decision making that board. He then decides to exclude certain eligible happens when you’re people from participating in the clinical trial for the conducting research sake of convenience. to help investigators “The concept is to incorporate elements of be ready to make the the performing arts to address and discuss this proper decisions,” Brigatti says. topic,” says Adriana Brigatti, director of research regulatory affairs at Children’s National, where she was involved in a similar staged presentation. “The researcher tries to move forward with this project and recruit participants but is doing so in a way that raises ethical concerns.” The play was originated by scientists, researchers, and investigators at the Clinical and Translational Science Institute at Children’s National who collaborated on the play’s key messages and performed it in public. A team of scientists from George Washington University later replicated the performance for researchers at their institution. “We wanted to highlight the ethical decision making that happens when you’re conducting research to help investigators be ready to make the proper decisions,” Brigatti says. “We also wanted to make something that was interactive and fun, as well as to provide an opportunity for discussion.” Brigatti and colleagues plan to develop more interactive training techniques that incorporate video, as well as plays in which the audience determines the final outcome.

Panelists Discuss Career Opportunities in Translational Science

D

uring a career session at Translational Science 2015, several panelists spoke of the pros and cons “We say all the time of their own experience in clinical translational science. that we have some “When we talk about career development, we tend degree of autonomy to think about academics only,” says Emma Meagher, over what we do MD, associate professor of medicine at the University of when working in Pennsylvania in Philadelphia, who chaired the session. academia,” Dr. Meagher says. “But because translational science is more commonly a team sport, where you work with many specialties, we wanted to highlight different career trajectories of individuals engaged in different aspects of the field.” The speakers included Christopher Leptak, MD, PhD, biomarker and companion diagnostic lead at the Office of New Drugs at the U.S. Food and Drug Administration; Marcela Maus, MD, PhD, assistant professor of medicine at the University of

Pennsylvania in Philadelphia; and Francisco Leon, MD, PhD, chief executive officer and chief medical officer at Celimmune based in Bethesda, Maryland. They spoke of work-life balance in their careers, why they chose their field, and the specific paths they took to get there. They also discussed potential roadblocks, and strategies for successful career planning. “We say all the time that we have some degree of autonomy over what we do when working in academia,” Dr. Meagher says. “The idea of clocking in and out, you don’t have that conversation in academics. The downside is you’re responsible for generating your own salary.” “I encourage [students] to write down on a piece of paper the things they like to do and then meet with people who are potential role models and see if they line up with any of them,” she adds. “I personally like academics because I feel like I’m contributing and have the ability to be creative. The dollar sign isn’t always in front of us.” CTS

Get Caught Up For more information about this year’s meeting, visit translationalsciencemeeting.org.

170

VOLUME 8 • ISSUE 3

© Vectomart | Dreamstime.com

Photo courtesy of Scott Spitzer, Manager, Web Design and Photographic Content, University of Pennsylvania

Photo courtesy of Megan Mack

o advance clinical translational science research, researchers need better training and understanding of regulatory science, says Scott Steele, PhD, director of the Rochester Center of Excellence in Data Science in New York, who moderated a session on the topic at Translational Science 2015. “The competencies As defined by the U.S. Food and Drug and proposed expeAdministration (FDA), regulatory science is the science riential training opbehind developing new tools and methods to assess portunities will help FDA-regulated products. But no guidelines or core ensure current and competencies for regulatory science training exist yet. future researchers are well-prepared to In the absence of such guidelines, members conduct regulatory of the Clinical Translational Science Awards science–informed program initiated a broader working group to help research,” develop them and share best practices. Composed says Dr. Steele. of representatives from the University of Rochester and Georgetown University in partnership with the Washington, D.C.–based Pharmaceutical Research and Manufacturers of America Foundation, the group is addressing not only training but also a variety of regulatory science issues, Dr. Steele says. “The competencies and proposed experiential training opportunities will help ensure current and future researchers are well-prepared to conduct regulatory science–informed research, thereby developing and integrating new approaches for rapidly advancing safe and effective medical products,” Dr. Steele says. Meanwhile, a new 2-year master’s degree program in regulatory science training is set to launch in July 2015 at the University of Pennsylvania in Philadelphia. Created by Emma Meagher, MD, associate professor of medicine at the University of Pennsylvania and a presenter at the session, the program will feature coursework in regulations, research study design, ethical conduct of research, and financial management. “There’s a general feeling that we’ve become so entrenched in the rules and the regulatory process that we forget about the science, and we need to imbed the science into the evaluation of our approaches to the development of new therapies and diagnostics,” Dr. Meagher says.

Photo courtesy of Daniela Brigatti

Regulatory Science Training Vital for Translational Researchers

WWW.CTSJOURNAL.COM

NIH K24 Grants Help Investigators Mentor Junior Faculty.

NIH K24 Grants Help Investigators Mentor Junior Faculty. - PDF Download Free
650KB Sizes 4 Downloads 5 Views