Inaugural Meeting of the California CTSA Education Consortium
The first meeting of the California CTSA Education Consortium was held at UC San Diego on September 28. It was the culmination of many months of planning by Dr. Dilip V. Jeste, Director of the Education Division of the UCSD Clinical and Translational Research Institute, and his colleagues. All eight CTSA-funded institutes in California—at five University of California campuses and three private institutions—were represented by their Education Directors. As noted by Dr. Gary S. Firestein, Dean and Associate Vice Chancellor of Translational Medicine and Director, UCSD Clinical and Translational Research Institute, the size of the group is ideal for accomplishing collective goals—large enough to allow cross-fertilization of ideas, but small enough to be efficient. Indeed, the daylong meeting ended with the identification of the first working groups.
The complete list of Education Directors is as follows: Joel Diamant, MD, The Scripps Research Institute; Steven Goodman, MD, MHS, PhD, Stanford; Deborah Grady, MD, MPH, UC San Francisco; Dilip V. Jeste, MD, UC San Diego; Carol Mangione, MD, MSPH, UCLA; Frederick Meyers, MD, MACP, UC Davis; Oladele Ogunseitan, MD, UC Irvine; and Jonathan Samet, MD, MS, University of Southern California. Also in attendance were other faculty and staff members who have ongoing roles in their education divisions.
Presenters described their KL2, CREST curriculum program, TL1, and other pipeline components, including successful approaches to infrastructure: an administrative umbrella over all K programs; recognition of the need for a brick-and-mortar place for education with one-stop shopping; and a comprehensive online home for all educational and training opportunities, with course descriptions, evaluations, and locations of classes. Regarding pedagogy, the multidisciplinary approach has been successful (e.g., UCLA’s breast cancer conference and Stanford’s biodesign program). UCSF is moving away from the traditional classroom experience, and toward small student groups focused on projects. Scripps offers innovative courses and a certificate on wireless medicine. Along these lines, attendees recognized the growing importance of social media and digital devices in instruction. Some institutes, such as those at UC Davis and UC Irvine, have formalized the training of their mentors; the latter also awards Distinguished Mentors.
California CTSAs use a variety of ways to reach and retain learners from underrepresented groups. Recognizing the importance of engaging such students early, UCSD operates the HS-STAR (High School-Summer Training in Aging Research) program at its on-campus high school (Preuss), while UC Irvine uses the COSMOS (California State Summer School for Mathematics and Science) program. Further down the pipeline, all undergraduates in health sciences at UC Berkeley are encouraged to enroll in the UCSF Pre-Health Undergraduate Program (PuP; a summer clinical research training program). The M-STREAM (Medical students’ Sustained Training and Research Experience in Aging and Mental health) program at UCSD attracts medical students from all over the U.S. to specialties that are particularly needed in underserved communities.
The challenges that are particularly relevant to California CTSAs include the need for training programs to better reflect California’s rich racial and ethnic diversity, and the administrative obstacles to setting up collaborations between UC campuses. Funding for new researchers is difficult all across the nation at this time; this poses unique challenges for the current recipients of the institutional KL2 awards. It is increasingly difficult for them to receive independent funding.
Participants voiced the need for developing regional cross-training resources; e.g., curriculum (informatics, tele-training, genomics, comparative effectiveness research, diagnostic markers) and a shared database of available online courses. The California Consortium also needs a mechanism for handing off early-stage students and seamlessly monitoring those who transfer to other CTSAs. Other needs include: a cooperative pipeline for increasing diversity; a mentoring database; identification of external reviewers using a “broker” at each CTSA; common metrics for evaluation; new standards for academic appointment and advancement; and improvement of the general public’s literacy on the benefits of translational research.
In order to increase diversity among students and trainees, CTSAs need to start early, and revisit their entire K-16 pipelines, because there are not many underrepresented minorities in medical school. Even after enrolling trainees, the problem of “leaky pipelines” remains. Mentoring needs to be improved and expanded, especially since some education programs find it difficult to draw mentors in. Many attendees felt that pedagogy needs to be revamped, as medical students vote with their feet. Better research on education and training is needed, including new ideas for exploiting face time; perhaps nontraditional approaches, such as immediate feedback (“clickers” in the classroom) should be considered. In all of these areas, California CTSAs would benefit from sharing best practices.
Based on these discussions, the California CTSA Education Consortium generated a list of possible collaborations, from which three initial working groups were formed: (1) KL2 Working Group, chaired by Joel Dimsdale of UC San Diego, to develop common metrics for these programs; (2) Online Learning Working Group, chaired by Deborah Grady of UCSF, which will address both synchronous and asynchronous learning; and (3) Mentoring Working Group, chaired by Fred Meyers of UC Davis, for which Maureen Curran of UC San Diego will help collect data on mentoring programs. The California Education Directors look forward to embarking on new collaborations, and on sharing the insights they gain with other members of the national CTSA consortium.
The NCRR awarded the CTRI two one-year funding supplements of $500,000 each on September 1, 2011. One of the funded project focuses on the genomics of breast cancer and the other project looks at increasing community engagement in clinical research in 4 specific community groups.
The project summaries are listed below:
Project Director - Kelly Frazer, PhD
Abstract: The application of genomic sequence data for routine clinical cancer care is at the cusp of feasibility. Here we propose to develop within the Moores UCSD Cancer Center and the UCI Chao Family Cancer Center ultra-deep targeted sequencing (UDT-Seq) of cancer genes to guide the care of cancer patients. A growing number of somatic mutations in cancer genes are proven biomarkers predicting sensitivity or resistance to therapy. Current assays to detect somatic mutations are not comprehensive. The overall objective of this project is to leverage the emerging technology of targeted high-throughput sequencing to implement an assay that can reliably detect somatic mutations in a panel of clinically relevant genes without arduous sample requirements. This assay could be used to improve the selection of adjuvant and metastatic treatments, in both clinical trials and clinical care. The UDT-Seq assay is cost-effective and capable of detecting somatic mutations that are present in as few as 1% of tumor cells. Specifically we will perform UDT-Seq of ~50 cancer genes in each tumor. We have piloted this approach with RainDance Technologies (a microfluidic company) to develop a streamlined sample preparation to facilitate clinical implementation with next-gen sequencing. Going forward we will update the sequencing platform to the new Ion Torrent (Life Technologies) instrument: its low cost and 2.5 hr run time will further accelerate the clinical implementation of the UDT-Seq assay. For this project we will assay tumor samples from 40 subjects with resectable breast cancer who are enrolled in the UC-wide ATHENA Breast Health Network. When possible assays will be run on germline, the primary tumor and on lymph node metastases to generate novel data on the clonal evolution of actionable mutations. These data will enable future work on adjuvant therapy to target rare subpopulations of cancer cells predisposed to metastatic recurrence. During the project period we will plan a master trial of metastatic solid tumors using UDT-Seq to guide the testing of targeted agents in cancers from differing sites of origin, potentially altering the paradigm of cancer treatment. Our UCSD and UCI teams will leverage the strong UC-wide ATHENA collaboration to include the five UC medical centers in future trials.
Project Director - Howard Taras, MD
Abstract: A major goal of the Clinical Translation Research Institute (CTRI) at University of California-San Diego (UCSD ) is to enhance enrollment in clinical trials and increase the trials' successful completion. This will accelerate the translation of research to the availability of safe, effective, and novel drugs, devices, and diagnostic tools. To achieve this goal, the proposed projects aims to (1) make many more individuals aware of clinical trials (particularly those who suffer from health disparities), (2) understand and overcome logistical barriers to participation that face many populations, and (3) shape the understanding that community members have of research so that there is basic trust in science, scientists, and clinical trials in particular.
The methods to achieve these aims are based on the premise that community-based organizations ("agencies") serve and represent different constituencies of the general population and are ideal venues to reach many sub-populations that comprise the general public. Community agencies are created and thrive because they are trusted by the portion of the public they serve; because they provide resources that are useful to their clientele; and because often leadership are, themselves, members of the very community they serve. As a proof of principle that agencies can endorse promotion of clinical trials to their clientele and adopt this as a permanent role, we propose to engage four local agencies that represent different kinds of populations (persons with epilepsy, rural population, veterans, and Asian-Pacific Islanders). Methods: The project will begin with bi-directional conversations between CTRI leaders and community agency leaders, and be followed by reaching community members themselves through focus groups and through hosted interactive social and educational events that spotlight clinical research. One tangible outcome of the proposal will be tailored recruitment materials and strategies that clinical investigators can use (tailored to be appreciated and understood by potential human subjects). Another outcome will be novel community agency policies and practices that are designed to promote research participation to their clientele and designed to maintain a bidirectional communication and partnership with CTRI.
A Bacterium, a Virus and a Parasite: Tackling a Formidable Global Health Triad
5:30–7:00 p.m. Tuesday, April 24, 2012
Medical Education/Telemedicine Building Auditorium
School of Medicine
Issues and innovations in infectious disease research and global health will be discussed by a panel of distinguished UC San Diego faculty.
“Evolution of UCSD’s Global Health Initiative: Think – Act - Impact”
Steffanie Strathdee, PhD
Harold Simon Professor of Medicine
Associate Dean of Global Health Sciences
“Innovative Strategies Against the Global Threat of the Drug-Resistant Superbug MRSA”
Victor Nizet, MD
Professor of Pediatrics & Pharmacy
Chief, Division of Pediatric Pharmacology & Drug Discovery
“The Global Threat of Influenza: Spreading With Boeing Rather Than Birds”
Robert Schooley, MD
Professor of Medicine
Chief, Division of Infectious Diseases
Why Isn't There a Malaria Vaccine?”
Joseph Vinetz, MD
Professor of Medicine
Program Director, Peru/Brazil Center of Excellence in Malaria Research
A light reception will be held in the courtyard following the event.
Please RSVP to: Dolores Santana firstname.lastname@example.org (619)471-0466
Please see this opportunity for a useful, educational and fun mentoring opportunity. We are looking for faculty to work with the next generation of researchers and help us meet important educational and outreach goals of the CTRI:
- Request from High Tech High (Chula Vista) science teacher
- Students looking for one-month, half-time internships in May 2012
- Extraordinarily motivated and bright students (Based on firsthand experience: Mike Kalichman met in November with each of her 3 classes of students)
If you are interested in hosting an intern, please contact
See More Details on the Brochure
The Sixth Annual Bench-to-Bedside Frontiers of Clinical Investigation Symposium was held at the Estancia La Jolla Hotel in La Jolla, California, on October 13-15, 2011. The Symposium is jointly produced by Nature Medicine and the UC San Diego Clinical and Translational Research Institute (CTRI). It brings together people who do not typically share the same conference room—basic, clinical, and translational investigators, as well as physicians—to discuss recent advances on subjects of broad interest.
The 2011 Symposium explored the vascular system in terms of normal development, pathological states, and novel diagnostics and therapeutics, particularly strategies to personalize treatments to individuals. The Course Directors were David Cheresh, PhD, Professor of Pathology and Associate Director for Translational Research at the UC San Diego Moores Cancer Center; Juan Carlos Lopez, PhD, Chief Editor of Nature Medicine; and Gary S. Firestein, MD, Professor of Medicine, Dean and Associate Vice Chancellor of Translational Medicine and Director of the CTRI.
Speakers from the United States and Canada presented both published and unpublished work, as well as current controversies, in six sessions: Angiogenic Triggers and Regulation, Vascular Inflammation and Remodeling, Vascular Malformation, Vascular Homeostasis and Injury, Clinical Cardiovascular Studies, and Mechanisms of Atherosclerosis and Heart Disease. As with previous Symposia, clinicians could obtain Continuing Medical Education credit for participating.
The Scientific Keynote, “New Insights in the Regulation of Angiogenesis”, was delivered by Napoleone Ferrara, MD, PhD (Genentech), whose research on vascular endothelial growth factor (VEGF) led to the development of bevacizumab, an anti-VEGF monoclonal antibody, which was the first anti-angiogenic therapy approved for cancer. A few examples from other speakers illustrate the variety of topics and approaches covered:
- The different molecular “zip codes” of blood vessels in various organs are being studied as targets for diagnosing and/or treating cancer, obesity, and lung disorders
- Epigenetics might play a role in the pathogenesis of vasculitis, possibly by causing inappropriate expression of neutrophil autoantigen genes
- Carboxyalklypyrroles generated as end products of inflammation-induced phospholipid oxidation have VEGF-independent roles in wound healing, tumor angiogenesis, revascularization of ischemic tissues, and age-related macular degeneration
- Small-molecule metabolites can correlate with myocardial ischemia well before the rise in troponin. Elevated levels of certain amino acids strongly correlate with the risk of diabetes, years before the onset of disease
A supplement of Nature Medicine focusing on the vascular system is expected to be published in November.
For more information on the Bench-to-Bedside Symposium series, visit http://ctri.ucsd.edu/education/Pages/symposium.aspx
Dr. Andrew Wiseman Named Director of Corporate Business Development
The CTRI and Health Sciences are pleased to announce that, after a nationwide recruitment, Andrew Wiseman, PhD has been named Director of Corporate Business Development for UC San Diego Health Sciences.
Dr. Wiseman has extensive experience in business development for the pharmaceutical and biotech industries. He has held management positions at several local firms, including La Jolla Pharmaceutical Company, which focused on new drugs for antibody-mediated autoimmune diseases such as lupus. He was a founding member of that company’s management team, and served as Senior Director of Investor Relations. Dr. Wiseman had prior research experience at Cal Tech and Scripps Clinic and Research Foundation, where he investigated human mitochondrial genetics and disease. Both his undergraduate degree in Zoology and his doctoral degree in Genetics were obtained at Duke University.
As Director of Corporate Business Development, Dr. Wiseman will improve UC San Diego Health Sciences’ interactions with industry and expand our portfolio of private sponsored research. He will report to Dr. Gary S. Firestein, Dean and Associate Vice Chancellor, Translational Medicine and Director, CTRI. Working closely with Dr. Firestein and other Health Sciences leaders, Dr. Wiseman will head efforts to build Health Sciences’ corporate partnerships. These collaborations will involve translational medicine, research, and education with a variety of new and established partners, including corporate, government, academic, and health care organizations. Such strategic alliances will promote UCSD Health Sciences both nationally and internationally.
“Dr. Wiseman has particular strength in building and implementing highly effective programs in business development, investor relations, and medical marketing,” said Dr. Firestein. “His skills will be especially valuable as the CTRI and Health Sciences continue to fulfill their missions in an era of declining federal funding.”
Please join us in welcoming Dr. Wiseman.
UC CENTER FOR HEALTH QUALITY AND INNOVATION
Request for Proposals. Issued by the UC Division of Health Sciences and Services. more...
The UCSD Human Research Protections Program (HRPP) and the Clinical and Translational Research Institute (CTRI) are pleased to announce innovations in policy and procedures for 2011. They are designed to enhance compliance and facilitate human subjects research at UCSD, and include:
1. Increase in life span for Institutional Review Board (IRB) projects to 7 years: All active human research projects (those with valid IRB approval) will now enjoy a 7-year life span. In 2004, HRPP extended the life span from 2 to 4 years of continuing approval. HRPP is now extending this life span to 7 years. This means that once approval is granted for a project, the investigator may submit up to six (instead of three) annual continuing review applications in order to ensure ongoing IRB approval. Investigators are still required to submit their annual (within 365 days of IRB approval) continuing review applications 45 days before project expiration to ensure that the study remains active.
2. Exemptions from IRB Review: Most research on existing tissue samples or data for which personal identifiers or records are not needed would qualify as exempt from IRB review. IRB exemption means that the project does not undergo IRB review. Furthermore, once certified as exempt, the project will not require continuing review applications. A certification process is required to determine if the project satisfies the criteria for IRB exemption. The following link provides more information on IRB exemption for certain categories of human subjects research: (See more Information).
3. Rapid Cycle Review: For some industry-sponsored clinical trials, HRPP has developed a “Rapid Cycle Review” IRB process to reduce approval delay for these trials. Rapid Cycle Review ensures that all federal and local regulatory requirements governing IRB approval are met, while taking steps to facilitate approval within 3 weeks of a complete IRB submission. Qualifying trials are those that include the following attributes: (1) Phase III or IV, multi-site, non-VA clinical trial; (2) industry-sponsored study; (3) a Data and Safety Monitoring Board (DSMB) or Plan (DSMP) in place; and (4) no participants with cancer or under the age of 18 years. If you believe your IRB submission qualifies for this rapid review process, include a Request for Rapid Cycle Review in the cover letter accompanying your new IRB application.
4. Tracking the Status of a Submission Online: In early 2011, HRPP will begin implementing an online resource that permits research staff to track the status of their submission in the review process.
5. New IRB Documents and Instructions: HRPP posted an updated biomedical application Research Plan and instructions as well as other updated documents. The update to the Research Plan is a significant expansion of the existing Research Plan and includes requests for information now required to comply with Federal and accreditation guidelines.
For further information, please contact Dr. Michael Caligiuri (email@example.com).
New La Jolla Office Building “Tilted Up” Overnight
Employees in the East Campus Health Sciences Neighborhood did a double take when they arrived at work on February 17. Where the construction site of the new La Jolla Office Building (LJOB) had been essentially flat the day before, the three-story building seemingly had sprung up overnight. More accurately, the construction contractor C.W. Driver had “tilted up” the exterior walls—one step in an efficient construction strategy that will allow the CTRI to move into its new home less than a year after construction began. Designed by the architecture firm Gensler, LJOB will make clinical research and administrative operations much more efficient and integrated when it is completed in August of this year, by consolidating activities that are currently scattered on- and off-campus.
The tilting-up method begins with the laying of the foundation, followed by casting the concrete walls in a flat position on the ground. Each wall is temporarily held in place with buttress-like steel braces while a crane pivots (“tilts”) the wall up so that it stands erect. The walls and other components of the building are welded together as construction proceeds. In addition to having a short construction schedule, LJOB has earned a LEED Silver rating based on its green features, including natural ventilation, vertical and horizontal fins to shade exterior windows, and mechanical efficiency.
LJOB is situated just east of Interstate 5, southwest of Thornton Hospital, the UC San Diego Moores Cancer Center, and other East Campus facilities. In fact, Thornton and LJOB will be physically and programmatically connected via an extension of the Health Sciences Walk. The front entrance of LJOB will face the northeast and will have a semicircular driveway in which clinical trial participants can be dropped off and picked up.
The three floors of LJOB comprise 75,000 square feet. The CTRI will occupy the first floor. The Clinical Research Center will be one of the key components, including examination and consultation rooms, infusion rooms, and procedure rooms. Many other clinical research functions, including the Human Research Protections Program, Office of Clinical Trial Administration, nurses and clinical coordinators, biostatistics, and Informatics support will be housed in the facility, along with an auditorium for educational activities. The second floor will serve as offices for clinical research groups and the third floor will be occupied by Cardiovascular Center personnel.
In 2017, the CTRI clinical and administrative operations will move to a much larger CTRI building, which is currently in the design phase. But recently, seeing a crane hoist a three-story wall into position was pulse-quickening for some CTRI staff members. It’s one thing to write grants and draw organization charts on paper, but quite another to see the future rising before one’s eyes.
UC Board of Regents Gives Approval for New Clinical and Translational Research Institute Building on UC San Diego's La Jolla Campus
The University of California Board of Regents on Tuesday approved the budget for capital improvements and external financing for the Clinical and Translational Research Institute (CTRI) building, to be constructed on the medical campus of UC San Diego in La Jolla. The CTRI building will be in close proximity to Thornton Hospital, Moores Cancer Center, the soon-to-open Sulpizio Cardiovascular Center and the recently announced Jacobs Medical Center. “The CTRI building will create a unique multidisciplinary environment that brings together laboratory scientists and clinical investigators to understand disease, develop new methods of treatment and translate clinical research results into clinical practice,” said Gary S. Firestein, MD, professor of medicine, dean and associate vice chancellor of Translational Medicine and director of the Clinical and Translational Research Institute at UCSD School of Medicine. The new building, currently slated for completion in late 2016, will comprise 311,000 gsf and 189,000 asf (assignable square feet) including wet and dry research space, and clinical research space to support investigators in the School of Medicine. The projected cost of the project is $269 million, which will be primarily paid for with external funding sources rather than state dollars, according to UC San Diego administrators. UCSD News on the web at: http://ucsdnews.ucsd.edu
CTRI and Nature Medicine Hold Their 5th Annual Frontiers of Clinical Investigation Symposium
The Clinical and Translational Research Institute (CTRI) and Nature Medicine held their 5th Annual Frontiers of Clinical Investigation Symposium on October 14-16, 2010 at the Estancia La Jolla Hotel. The theme for the meeting was "Pain 2010", which explored innovative approaches to bridge laboratory investigation and clinical research in pain.
This year’s Symposium brought together 180 attendees from cities, states and countries near and far. Attendees were from all over the Unites States as well as from the following countries: Australia, Austria, Canada, Germany, India, Israel, Italy, Japan, Korea, Mexico, New Zealand, Poland, Sweden, & the United Kingdom. Twenty eight different attendees were from the Biotech Industry. As in the past the number of trainees outnumbered all other registrant categories. There were 45 residents, fellows, and postdoctoral scholars who were in attendance. Next year’s Symposium will be on the theme of “Cardiovascular “ and will be held October 13-15, 2011 at the Estancia La Jolla Hotel.