August 2012

Hollings Researchers Study Ways to Improve Outcomes for African American Patients with

Non-Small Lung Cancer African Americans in South Carolina with early stage non-small cell lung cancer (NSCLC) are significantly less likely than Caucasians to receive surgical treatment for their disease, thus significantly reducing chances of survival. This reflects a national trend that the Hollings Cancer Center at the Medical University of South Carolina (MUSC) and statewide partners hope to change with a $1.8 million federal grant. The study, led by Nestor F. Esnaola, MD, MBA, MPH, a surgical oncologist and medical director of MUSC’s oncology service line; and Marvella E. Ford, PhD, associate director for Cancer Disparities at the Hollings Cancer Center, will be conducted at MUSC and five other cancer centers across South Carolina: McLeod Regional Medical Center (Florence), Palmetto Health (Columbia), Self Regional Healthcare (Greenwood), Spartanburg Regional Healthcare System (Spartanburg), and The Regional Medical Center of Orangeburg and Calhoun Counties (Orangeburg). Lung cancer is the leading cause of cancer deaths in the US. While surgery is the standard of care for early stage NSCLC and offers the best chance for long-term survival, fewer than half of African -Americans diagnosed undergo surgery. This study, funded by the NIH’s National Institute on Minority Health and Health Disparities, will test whether statewide patient navigation intervention improves receipt of surgery, time to surgery, and survival in African Americans with early stage NSCLC. Dr. Marvella E. Ford stated, “our hope is that this study will uncover modifiable causes of underuse of lung cancer surgery among African Americans. The patient navigation intervention may prove to be a practical and powerful strategy for use by other health care providers, institutions, and communities seeking to reduce persistent racial disparities in lung cancer surgery and outcomes.” “This project has the potential to transform the care of African American lung cancer patients in our state and demonstrates our cancer center’s commitment to improving the health of all South Carolinians facing cancer,” said Dr. Nestor F. Esnaola. To learn more about research at the Hollings Cancer Center, please review the Cancer Center Overview booklet.

Research INKlings

Inside this Issue

P2 New Faculty Orientation

P2 Grantsmanship Workshops: Summer Series

P2 Research Project Grant (RPG) Retreat

P3 Phase I Clinical Trials Director Joins MUSC

P3 NIH Peer Review Process Changes

P4 Biomedical Research Workforce Group Report

Research INKlings is an on-line newsletter prepared by the Office of Research Development providing research news, policy changes and other relevant information for MUSC faculty, staff and students. Research INKlings is published in August, October, December, February and April.

Research Inklings Page 2

Grantsmanship Workshops:

Summer Series During the week of July 23, the Office of Research Development (ORD) offered a special summer Grantsmanship Workshop: One on One Consultation Series with Dr. Israel Goldberg. Members of the MUSC community had the opportunity to meet with Dr. Goldberg, president of Health Research Associates, individually or as a team, to receive feedback on their grant proposals. Regardless of whether they were in the early or advanced stage of their proposals, this was a valuable opportunity to receive independent and experienced feedback. This was also a useful avenue to help evaluate a summary statement and plan a strategy for revising and resubmitting a proposal. Consultations with Dr. Goldberg have received an overwhelmingly positive response from MUSC faculty.

The Office of Research Development (ORD) invites you to participate in the Research Project Grant (RPG) Retreat scheduled for August 27, 2012. These interactive half-day sessions give individual investigators the opportunity to gain constructive criticism on a specific research concept or proposal. These retreats also provide an objective review and suggestions for competitive research proposals that will be submitted to NIH or another peer-review sponsor. The retreat format involves three to four presentations, each lasting no more than 20 minutes, followed by 25 minutes of critique and discussion with review panelists and audience members. Presentations should summarize the project’s hypothesis and specific aims and provide a brief overview of scientific approach, anticipated results and potential problems. These retreats “mimic” the NIH study

sections with a primary reviewer providing a description of the proposal and critique of the strengths and limitations. Also, a biostatistician will evaluate each presentation to ensure the proposal includes a sound statistical plan. A statistical plan is a fundamental component to any NIH proposal to reproducible science, whether laboratory-based, translational, patient-oriented or randomized clinical trials. To register to present for the August 27th Research Project Retreat or to suggest a faculty member’s participation, please contact: Wanda Hutto, Assistant Director of the Research Development at 792-0867 or email huttow@musc.edu. The RPG retreat is scheduled from 1:00-4:30 pm, August 27, in Gazes Room 125. To participate as an audience member, please register using this REDCap link.

New Faculty Orientation MUSC Office of the Provost & MUSC Faculty Senate plan to host the New Faculty Welcome and Orientation for new faculty joining MUSC this year. During the orientation, one will learn about MUSC, the different departments, its resources and meet key and important leaders at MUSC. The general session begins at 12 pm. Following the general session, two valuable 45 minute sessions on Research, Education, and Clinical Resources will be held from1:05-1:50 pm and again from 1:55-2:40 pm. The orientation will take place on Tuesday, August 7th at the College of Health Professions, Building A, Room 204. Please join the President, Provost, Deans for the dessert reception from 2:45 to 4:00 pm in the Atrium. New faculty members are strongly encouraged to attend; this is a good opportunity to establish connections with other MUSC faculty. For questions regarding this please contact Julie Woolworth at woolworj@musc.edu.

Research Project Grant (RPG) Retreat

Research Inklings Page 3

Carolyn D. Britten, MD, a recognized expert in drug development, has joined the MUSC faculty and will lead Hollings' growing Phase I Clinical Trials Program. Britten, an associate professor of Medicine, was at UCLA's Jonsson Comprehensive Cancer Center from 2001-2012. Her leadership positions there included serving as director of Protocol-Specific Research Support and associate director of the Signal Transduction and Therapeutics Program. "We are glad to have Dr. Britten join the MUSC Hollings team. Known for her knowledge and experience in Drug Discovery and Phase I clinical trials, she will work closely with our clinicians, researchers and industry partners to build a renowned Phase I program," said Hollings Director Dr. Andrew S. Kraft. "Her contributions will lead to more novel early-phase treatment options for our cancer patients and help transition promising laboratory research into the clinic."

Phase I Clinical Trials Program Director Joins MUSC

scientific appropriateness of the proposed cell line(s). If the proposed cell line(s) is approved by the NIH Stem Cell Registry at least 30 days prior to the peer review meeting, the SRO can include this update to the reviewers as part of the post-submission materials (see NOT-OD-10-115). This evaluation will be allowed to affect individual criterion scores, assessments of overall merit, and overall impact scores during initial peer review. As before, if an hESC application proposes research for which the specified hESC line(s) has not yet been approved, only restricted awards will be issued until the specified hESC line(s) is approved. For additional information, please contact the Office of Research and Sponsored Programs at 792-3838 or at orsp@musc.edu.

This Notice (NOT-OD-12-111) is intended to inform potential NIH applicants of impending changes in the PHS 398 and SF424(S&R) instructions for applications involving the use of human embryonic stem cells (hESC). The NIH Stem Cell Registry now lists over 160 approved cell lines. Therefore, beginning with applications submitted for the September 25, 2012 due date and thereafter, applications proposing the use of hESC must: Specify a cell line(s) from the NIH Stem Cell

Registry that will be used in the proposed research, or

Provide a strong justification for why an appropriate cell line cannot be chosen from the Registry at this time and a certification that one from the Registry will be used. The justification should be included in the Research Strategy section of the application.

Reviewers will be instructed to evaluate the

Impending Change in Peer Review Criteria and Submission Requirements for NIH Applications Involving Human Embryonic Stem Cells

Research inklings AUGUST 2012

A working group of the NIH Advisory Committee to the Director (ACD) was tasked with developing a model for a sustainable and diverse US biomedical research workforce that can inform decisions about training the optimal number of people for the appropriate types of positions that will advance science and promote health. Based on this analysis and recognizing that there are limits to NIH’s ability to control aspects of the training pipeline, the working group was asked to make recommendations for actions that the NIH should take to support a future sustainable biomedical research infrastructure. The working group met 11 times in 2011 and 2012, including 4 in-person meetings and 7 teleconferences, with a goal to provide recommendations to the ACD in June 2012. In addition, a subcommittee consisting of social scientists (primarily economists) with expertise in the scientific enterprise and NIH-funded investigators with expertise in mathematical models was formed to gather and analyze data on the biomedical research workforce and develop a model. This report summarizes the workforce data collected and the working group’s recommendations. The working group did not have either the time or the expertise to propose details on how the recommendations should be implemented. This will require thoughtful consideration by NIH. The working group recommends that changes to existing programs be phased in gradually and pilot programs be conducted to test new ideas. The outcomes of all changes should be evaluated rigorously. The overall purpose of the recommendations is to ensure future US competitiveness and innovation in biomedical research by creating pathways through undergraduate, graduate and postdoctoral training that provide excellent preparation in a timely fashion to:

• attract and retain the best and most diverse scientists, engineers and physicians from around the world to conduct biomedical research as well as increase the number of domestic students from diverse backgrounds who excel in science and become a part of the Science Technology Engineering and Mathematics (STEM) workforce

• prepare biomedical PhD students and postdoctoral researchers to participate in a broad- and evolving economy

The working group appreciates that K-12 and undergraduate education are major factors that influence the success of building the biomedical research workforce but has confined its recommendations to graduate training and beyond as NIH funding and training focuses on those stages. The Executive Summary of the report is available at: http://acd.od.nih.gov/bwf.htm.

Biomedical Research Workforce Group Report