YCCI Receives CTSA Renewal in Continued Support of Clinical and Translational Research

Conducting an experiment

The Yale Center for Clinical Investigation (YCCI) has been awarded $45.4 million from the National Institutes of Health to renew its five-year Clinical and Translational Science Award (CTSA) in support of clinical and translational research.

One of the first 12 institutions awarded a CTSA in 2006, YCCI helped pioneer the program. It is among 10 of the original 12 centers to receive a renewal of the grant this year. "I'm delighted that the NIH has once again put its faith in Yale science and medicine," said Robert J. Alpern, MD, Dean of the School of Medicine. "I'm especially pleased at the ways in which YCCI and the CTSA have brought together our community of translational researchers, presenting wider opportunities throughout their career development and providing core support that ensures their success."

YCCI remains a work in progress but has made tremendous strides toward fulfilling its goals of providing robust infrastructure for clinical and translational research and educating the next generation of investigators. Substantial support has come from the School of Medicine in addition to the CTSA. 

Highlights of the first five years include:

  • The Scholars program, which provides training and salary support for junior faculty members, postdoctoral fellows and KL2 awardees committed to careers in clinical or translational research. The 63 Scholars who have received awards thus far have received more than $50 million in independent grant funding.
  • The Office of Research Services (ORS), which has created "one-stop shopping" infrastructure to support clinical and translational research.
  • The creation of the Yale Center for Analytical Sciences (YCAS) in partnership with the Yale Cancer Center and the School of Public Health to provide comprehensive biostatistical support for investigators.
  • Substantial investment in state-of-the-art core technologies on the medical and West Campuses to carry out transformative science and advance the knowledge of basic biology and human disease.
  • The purchase and implementation of OnCore, a totally integrated research management system that connects all research data, regulatory support and reporting on a new level.
Kevan Herold, MD, Rajita Sinha, PhD, and Margaret Grey, DrPH, RN, FAAN

Kevan Herold, MD (left), Rajita Sinha, PhD (center), and Margaret Grey, DrPH, RN, FAAN (right)

Expanded Leadership and New Structure

YCCI is constantly refining its programs and services to better support the needs of investigators. One of the ways of accomplishing this task has been to appoint key faculty leaders to move initiatives forward. This effort has included expansion of the leadership team to create a new structure to guide research more effectively.

Renewing the CTSA grant offered an opportunity to take stock of Yale's strengths, which include basic science and the interdisciplinary nature of our programs. Last year, Kevan Herold, MD, professor of immunobiology and medicine and a member of the Human and Translational Immunology program, was appointed deputy director for translational research. His expertise in basic science research makes him an ideal leader for the task of expanding this area of Yale's research portfolio and moving science forward in a new way during the next five years.

More recently, Rajita Sinha, PhD, professor of psychiatry and director of the Yale Interdisciplinary Research Consortium on Stress, Self-Control and Addiction, was appointed deputy director for interdisciplinary research.

A pioneering researcher in psychiatry— a discipline that lends itself particularly well to interdisciplinary collaborations—Sinha is well qualified to direct Yale's team approach to science, which is especially important given the NIH's increased focus on center-based research.

Herold and Sinha join renowned clinical investigator William Tamborlane, MD, professor of pediatrics, in overseeing YCCI's research activities. Tamborlane has done an outstanding job helping to create YCCI and build programs to centralize services. As deputy director for clinical research, and director of YCCI's Office of Research Services (ORS), he will focus on reevaluating the center's infrastructure to use resources in supporting all types of research effectively.

To ensure that ORS supports faculty engaged in community-based research, Tamborlane will work closely with Margaret Grey, DrPH, RN, FAAN, dean of the Yale School of Nursing, who joined YCCI's leadership team as director, T3 translational research core, effective October 1, 2011. Grey's research has focused on the development and efficacy of behavioral interventions that improve metabolic management of diabetes and quality of life, as well as preventing type 2 diabetes in high-risk youth.

 Richard Lifton, MD

CTSA investments in the latest gene sequencing tools are allowing scientists like Richard Lifton, MD, PhD, (far left) to find rare genetic variants that contribute to disease in ways that were impossible just a few years ago. For example, for a study published in the August 7, 2009, issue of Cell, Lifton and Jesse Rinehart, PhD, associate research scientist in genetics, led a team that used innovative quantitative proteomics technologies to show how a protein within most cell membranes maintains normal cell size — a breakthrough that has implications for a variety of diseases including sickle cell anemia.

In its first five years, YCCI's community-based research and engagement efforts were focused on community outreach. The name change to T3 Translational Research Core reflects the expectation that translational research will have a positive impact on clinical practice in the community. The emphasis in the next five years will be on expanding the program to make it more accessible to faculty engaged in research. Grey's vision includes working with investigators in the Schools of Medicine, Public Health, Nursing and elsewhere in the institution to improve health in local communities by promoting research that supports rapid dissemination, implementation, and sustained use of effective interventions to prevent and treat common health problems. "We intend to bring together scientists from all disciplines with clinicians in our community health centers and community-based practice research networks to expand the ability to adapt innovative approaches to delivery in the community and conduct effectiveness trials to test outcomes," said Grey. Lois Sadler, PhD, RN, PNP-BC, FAAN, professor in the Yale School of Nursing and the Yale Child Study Center will continue to serve as associate director of the program. Sadler will be joined by Rafael Perez-Escamilla, PhD, (YSPH), and Patrick O'Connor, MD (YSM) as associate directors. For more information on the YCCI's T3 translational research core, click here.

Sara Rockwell, PhD

Sara Rockwell, PhD

The appointment of Sara Rockwell, PhD, as director for program evaluation in 2008 completed the changes in YCCI's program leadership. Rockwell, professor of therapeutic radiology, was appointed to this position to take advantage of her overlapping responsibilities as associate dean for scientific affairs for YSM. She leads the assessment of performance and progress for all aspects of YCCI, and is aided in these efforts by input from YCCI's external scientific advisory board.

"The diverse leadership team we now have in place will play a vital role in helping us more effectively support and expand innovative, interdisciplinary clinical and translational research," said YCCI Director Robert Sherwin, MD.

Kurt Roberts, MD preparing for a procedure

Kurt Roberts, MD, assistant professor of gastrointestinal surgery, prepares for a procedure in which he will use a device he developed with the help of a CTSA-funded pilot award. The device facilitates single-incision laparoscopic surgery (SILS) and natural orifice transluminal endoscopic surgery (NOTES) to give him easy access to the abdominal cavity.

Looking Ahead

The renewal of the CTSA grant coincides with a pivotal time in NIH history. Under the leadership of NIH Director Francis Collins, the CTSA program will be part of the newly created National Center for Advancing Translational Sciences (NCATS). As currently envisioned, NCATS will devise an integrated approach to streamline the process of linking basic research to the development of therapeutics. The new center is intended to fill the gap between advances in scientific understanding of disease that point to promising new targets and the development of new treatments that have been slow to materialize.

YCCI is likewise exploring avenues to widen the net of translational research. Sinha's leadership has the potential to integrate the Schools of Medicine, Public Health and Nursing in creating interdisciplinary science programs in a number of such areas as epigenetics, child health, neuroscience and asthma. YCCI has already taken steps to engage basic scientists under the leadership of Herold as well as through such initiatives as its pilot program. Future areas of focus include creating a steering committee of basic scientists: expanding collaborations with bioengineering: and establishing joint initiatives with such translational centers as the Stem Cell Center.

"I'm very excited about the next five years," said Sherwin. "We have an opportunity to translate Yale's strengths in basic biology into drug discovery and other clinical advances, and we have excellent educational programs for up-and-coming investigators. Our hope is that expanding these initiatives will lead to medical breakthroughs that will improve health."

A Stronger Administrative Infrastructure to Support Investigators

YCCI has also expanded its administrative team in order to provide the expertise investigators need to succeed in today's research landscape. Two newly created positions are being shared with the Yale Cancer Center; they have been filled by two staff members who bring a wealth of expertise to their new roles.

Henry Durivage, PharmD, the new associate director for regulatory affairs and clinical research systems, now oversees regulatory, IND support, budgeting, compliance with clinical trials.gov, the Medicare Coverage Office and the implementation of OnCore, Yale's new clinical research management system.

Kathleen Uscinski, MBA, CIP, has joined YCCI and the Cancer Center as associate director of clinical trial operations. Although her initial focusing is the renewal of the Cancer Center support grant, her responsibilities also include bolstering the infrastructure that supports clinical trials: identifying and implementing procedures that will aid Yale and its investigators: and maintaining reporting requirements.

"Due to the changes in the regulatory environment and reduced budgets, strong administrative leadership is more important now than ever before," said Tesheia Johnson, MBA, MHS, chief operating officer of YCCI. "It's imperative for Yale to institute these changes to support clinical and translational research."