Training Translators in the PENN CTSA

The University of Pennsylvania (Penn) has been an international leader in medical education, biomedical research, and research training for over 240 years. In concert with this commitment, and in response to the CTSA initiative, we developed a comprehensive training program to recruit, train, and nurture a new cadre of professionals with defined expertise in clinical and translational research (CTR). ¹ , ² The absence of such professionals is an identified barrier to the timely translation of basic discoveries to the clinical realm. ³ , ⁴ Additionally, we have striven to create one academic home that would permit the integration of existing and future training initiatives and create an academic identity for our trainees and graduates. We have worked to achieve these objectives across the spectrum of potential and existing trainees, from undergraduates to graduate and professional students, and from fellows to faculty, recognizing that while each population requires unique needs they must be interconnected in a continuum of training and mentorship. We strove to create a program that would be complimentary yet distinct from existing programs in clinical epidemiology and health services research. Our approach to address the first goal has been the development of three targeted and interrelated CTSA training components, undergraduate, graduate, and postgraduate training, as depicted in Figure 1 . Recognizing that individuals need different levels and types of training at each stage of their academic development, we have provided multiple training options for each level of trainee: undergraduate, graduate, and postgraduate trainee ( Figure 1 ).

Figure 1.

The CTSA training components.

The CTSA program elements are distinguishable by their depth of learning: (i) preview/awareness opportunities for uncommitted trainees; (ii) certification programs for trainees who plan to function as translational research project team members; and (iii) a degree program for the training of independent investigators in translational research. As can be seen from Figure 1 individual elements are available to different constituencies of students. Thus the “awareness program” is designed for undergraduates, the certificate and degree programs are designed for pre‐ and postdoctoral trainees.

The CTSA has been catalytic, permitting the growth and development of novel programs and the expansion of existing programs. Specifically, the award has permitted and supported: (i) refinement of existing programs and incorporation of the recently established national CTR education competencies as developed by the CTSA Education Strategic Goal (SGC) and Key Function Committees (KFC); (ii) expansion of existing programs to provide novel graduate educational opportunities in the domain of translational therapeutics; (iii) implementation of a comprehensive mentoring program for all level of trainee and facilitated continued collaboration on national CTSA mentoring initiatives; and (iv) integration of all existing education programs to maximize resources, optimize training flexibility, minimize duration of training, and strengthen the caliber and breadth of the learning experience. The CTSA training program which extends from undergraduate to postgraduate trainees and faculty has successfully connected experience in basic science with clinical training and has permitted the intertwining of all facets of training. Our efforts thus far have fostered the emergence of a new integrative discipline whose “academic home” is in the Institute for Translational Medicine and Therapeutics (ITMAT). The institute was founded in 2005 as the first institute of translational medicine in the world and was originally housed in the school of medicine. In response to the CTSA, it has expanded to embrace all of the Penn CTSA partner institutions (Children’s Hospital of Philadelphia (CHOP), The Wistar Institute, The Monell Institute, and the University of the Sciences in Philadelphia) and 9 of the 12 constituent schools of the University of Pennsylvania.

The CTSA Training Program

The CTSA award permitted the development and implementation of three innovative CTSA educational initiatives that have served to advance clinical and translational research nationally, regionally, and at Penn and our partner institutions in the CTSA.

The CTSA Undergraduate Student Training Program was established to stimulate the awareness and interests of college/university undergraduates in health sciences and translational research and to mentor the development of talented undergraduate students with regard to careers in CTR at Penn, its partner institutions, and other national postgraduate training programs. The key features of the existing undergraduate program are: (i) seminars and didactic upper level courses led by Penn health science faculty, to raise awareness and stimulate the interest of undergraduates in CTR, (ii) an annual colloquium in translational research targeted to regional undergraduate students, (iii) funded summer internships in translational research offered to students from five regional schools, and (iv) translational research faculty mentors that provide mentorship to undergraduates in career development.

The CTSA Graduate and Post Graduate Training Programs are designed to recruit, train, and mentor highly talented and motivated graduate students (doctoral and professional), post‐doctoral, and clinical fellows and faculty in Penn’s health science schools in CTR. These programs emphasize a multidisciplinary team environment and build on interdisciplinary PhD and Masters‐level programs. The program is designed to include clinical trainees from Medicine, Nursing, Dental, and Veterinary Medicine, and doctoral students in Penn’s integrated Biomedical Graduates Studies (BGS) program. The Graduate program is supported by a CTSA TL1 award and the Post Graduate program is supported by a KL2 award. As shown in Figure 1 these include a CTSA awareness program, a CTSA Certification Program, and a formal Masters in Translational Research (MTR) degree program. Key features of this existing program are: (i) an introductory curriculum to expose students to translational research, (ii) a CTSA certificate program, whereby PhD students who pursue translational research for their thesis are also immersed in ethics and regulatory components of human subject research and in the methodology of clinical trial design; thereby obtaining PhD with a translational research concentration (Table 1), (iii) a CTSA dual‐degree program, whereby medical, veterinary, dental, and nursing students are immersed in the methodology of translational research; thereby jointly obtaining the MTR along with their primary doctoral degrees, (iv) an academic home for UPenn translational research scholars, (v) the provision of protected time and resources such that clinical fellows and faculty may complete their research project and degree in a time efficient manner, (vi) a structured individualized mentoring program that includes setting goals for completing the educational program, obtaining funding, and publishing data, (vii) elective rotations (on and offsite) in translational research, including in the Clinical and Translational Research Center (CTRC), biotechnology companies, the FDA, and the Pharma industry, and (viii) integration of CTSA training components with clinical and graduate training to maximize the diversity of experiences, minimize curriculum overlap, and shorten time to degree.

The MTR, the flagship program of the translational research training initiative at Penn was established in 2004.The primary goal of this training program is to prepare trainees for careers as independent clinical investigators in academia through the provision of in‐depth instruction in the fundamental skills, methodology, and principles of translational research; specifically to improve the quality of translational research training by providing didactic course work, laboratory skills labs, and a mentored research experience in mechanism‐based studies of human physiology and disease. The mission of the program ab initio was to produce a new cadre of translational scientists who are competitive in seeking research support and are knowledgeable about the complex issues associated with conducting sound translational research. The development of this program, which preceded the CTSA program, was supported initially by institutional funds and a Clinical Research Curriculum Award (K30). Anon‐categorical K12 provided salary and tuition support for up to five MTR trainees. This limited the initial growth of the program. The CTSA KL2 which supports seven trainees, the TL1 program which supports five trainees and matching institutional funds has permitted significant growth of the program. Prior to the CTSA (2007) being awarded 12 students had matriculated into the MTR program. As of August 2011, a total of 90 students have matriculated into the MTR program and 37 have graduated. Trainees include 41 faculty (29 MD, 3 VMD, 2 PhD, and 7 MD PhD), 32 clinical fellows, six postdoctoral fellows, and 11 combined MD‐MTR students. Trainees have been supported by the CTSA KL2 (n = 28) and TL1 (n = 11) matching institutional funds (n = 22), categorical T32 (n = 10) and categorical K12 (n = 10), and faculty tuition benefits (n = 9). Fourteen of our graduates have secured individual mentored career development awards, four have secured R01’s, and an additional 19 have other federal or state funds as part of program or center grants.

The curriculum is designed to be completed in 2 to 3 years. The essential elements are: (1) six core courses, (2) two elective courses, (3) two lab rotations, and (4) a thesis project. Each trainee works closely with a mentoring team to develop a program tailored to his/her individual interests (Table 2). Examples of lab rotations include, but are not limited to: a traditional wet bench experience, a rotation in a bioinformatics or imaging laboratory or a clinical lab rotation to learn how to perform/analyze a technique in a specialty area. The objectives for the laboratory rotation are to teach trainees: (i) the basic components of the translational research experience; (ii) that disease mechanisms provide the framework for translational research; and (iii) the subtleties of measurement of disease process and the complexity this brings to human research. Each MTR trainee has an individualized mentoring committee. Trainees are required to complete a research project that involves designing a project, writing a formal research proposal, performing and analyzing the proposed study, preparing a comprehensive scholarly scientific paper reporting the results, and presenting and defending the thesis at a public seminar.

Given the Penn focus on T1 research and translational therapeutics we have developed a concentration within the MTR program on Translational Therapeutics. The content focuses on discovery of new treatments in an academic setting and transfer of this technology to industry for implementation in clinical practice. The track includes three main components; a core didactic course in Therapeutics Development; an internship in industry; and an internship in commercialization. The purpose of the internships is to offer unique training in commercialization and collaboration with industry to implement academic discoveries.

Internships in industry have been arranged in collaboration with the Penn office of Corporate Alliances. This elective rotation provides an opportunity for students to train in industry for 10 weeks under the shared guidance of a Penn faculty mentor and a designated supervisor at the collaborating site. Internships are available in a range of activities within the pharmaceutical industry, including basic science discovery, clinical trials design, and regulatory affairs. Students gain hands on experience for translating technology while companies foster greater interactions with academia as well as being able to teach MTR students the roles they can play in the pharmaceutical industry as a potential career path.

An Internship at the Center for Technology Transfer (CTT) teaches students how to evaluate actual disclosures from Penn faculty for commercial potential based on clinical need, prior art, patentability, freedom to operate, and finding commercial partners. This course begins with 16 hours of lecture‐based instruction during the first two weeks, which is followed by 10 cases‐based exercises in which students perform evaluations and present their findings at weekly CTT meetings. Each case evaluation requires approximately 5 hours of research and preparation.

Integration of the CTSA Training Program

A major objective of the CTSA training program was to create an academic home for trainees with the establishment of a research identity and to attain centralized organization and supervision of all CTSA training programs at Penn and its partner institutions under a single leadership structure. This has been achieved by the creation of ITMAT.

The three CTSA training components, housed within ITMAT, blends our existing expertise, resources, experience, leadership, and institutional commitment and has positioned Penn and its partners to continue to respond in an innovative manner to the educational challenges in the arena of CTR. Full integration of these programs—within ITMAT—has also permitted close collaboration between CHOP and Penn and closure of the gap between local translational research training environments for the enormous betterment of our trainees. Our CTSA efforts have fostered the emergence of a new novel discipline—as Translational Medicine and Therapeutics—which blends the projection of hypothesis‐based research from model systems into humans, harvests the value of unbiased technologies in compound selection, and integrates a thorough knowledge of human pharmacology.