The University of Pittsburgh School of Medicine supports a two- to three-year postdoctoral program titled “Training in Translational Research and Entrepreneurship in Pulmonary Vascular Biology,” funded by the National Heart, Lung, and Blood Institute (NHLBI). The Program is intended for M.D. and Ph.D. fellows from fields of pulmonary and cardiovascular science. The Program features initial development of a ‘translational research tool set,’ individually-prescribed development plan, paired mentorship teams of basic and clinical researchers, emphasis on high impact publications, and preparation of a career development award (K-series or equivalent). Trainees may also participate in the Biomedical Entrepreneurship Track program.

Translational Track

A two-year intensive training fellowship with our translationally-oriented vascular biology mentors.  The fellowship mentorship may include a basic-science-oriented mentor or a clinical-science-oriented mentor; trainees are highly encouraged to develop a mentorship team comprised of mentors across the translational spectrum, allowing for comprehensive training in basic science with the necessary application to the clinical and patient environment. Projects will require the learning of cutting-edge scientific methodologies (e.g., mass spectrometry, flow cytometry, molecular biology, etc.) applied to a clinical problem, leading to potentially novel therapeutic approaches or clinical studies in patients (e.g., development of human subjects protocols for specimen collection, pharmacological infusions, or development of patient cohorts or interventions).  In addition to the two-year fellowship, an optional third year will be offered to allow for advanced career development.

‘Translational Research Tool-Set’:  Immersion in an initial core competency training period in translational research including an intensive 2-week accelerated introduction to bench-to-bedside research and laboratory techniques at the University of Pittsburgh and an introduction to understanding and managing regulatory issues for human and animal research.  Throughout the first six months, trainees will complete the ‘Introduction to Translational Research’ (CLRES 2140) course offered through the CTSI.  A unique aspect of our translational training is the incorporation of full-time elective rotations at the FDA, intramural NIH Clinical Center Regulatory and Pharmacy Development Program, and Industry.  This intensive exposure allows the trainee to develop the elemental tools for translational research: basic science methodology, clinical translational methodologies, and key regulatory tools.

Entrepreneurial Track

Trainees interested in the entrepreneurial track may pursue an MBA at the University of Pittsburgh Katz Business School, contingent on acceptance into their MBA program. Students in this program will enroll in either the part-time or full-time MBA program. All students will be immersed for a minimum of 15 months in a T1 translational research environment within laboratories at the University of Pittsburgh School of Medicine to acquire hands-on biomedical experience in preparation for moving novel drugs, devices, or informatics solutions from the laboratory to clinical practice work. Students will be enrolled in the ICRE Entrepreneurial MBA Translational Research Training Program, acquiring knowledge in research techniques, literature review, drug and device commercialization processes, institutional regulatory bodies, clinical trials, and funding opportunities.

Core Competencies:  Entrepreneurial trainees will undertake one-week rotations in a minimum of three of the entrepreneurial institutes and programs available within the UPitt system, including the Drug Discovery Institute, The Innovation Institute, UPMC Enterprises, the Institute for Entrepreneurial Excellence, and the Coulter Translational Research Partners II Program.  Trainees will also be provided the opportunity to participate in our successful elective summer program (e.g., FDA Cardio-Renal Program and intramural NIH Clinical Center Regulatory and Pharmacy Development Program), as well as new hands-on entrepreneurship and commercialization training opportunities with the tPPG industry partners MAST Therapeutics and Complexa, Inc.

Research Project

Each trainee will be expected to complete at least one major research project during the training program.  Ideally, the project will provide the basis for subsequent NIH grant applications such as an F32 or K series career development award.  Each Fellow is also expected to publish a minimum of 2-3 peer-reviewed papers (with at least one as first author) within the two-year training period.

Individualized Development Plan

Trainees are likely to enter the Program with varying degrees of experience and sophistication in research methods, design, and statistics.  Therefore, formal coursework will need to be individualized for each trainee.  Examples of University of Pittsburgh courses most likely to be recommended for trainees are 1) CLRES 2010 Clinical Research Methods; 2) CLRES 2020 Biostatistics: Statistical Approaches in Clinical Research; 3) CLRES 2040 Measurement in Clinical Research; and 4) CLRES 2050 Ethics and Regulation of Clinical Research.  Typically, one or two of the courses per year will be required for each trainee based on individual needs.

Evaluation

Each Fellow will present an oral progress report to the Training Committee annually, to facilitate evaluation of progress and focus in future direction. Written evaluations by trainees and mentors will be completed each year. More frequent informal education is recommended. For trainees interested in the entrepreneurial track, the Entrepreneurial MBA program has developed formalized evaluation documents for trainees, and the trainees’ performance within this program will be evaluated based on a rubric that includes ethics and professional standards, oral and written communication, multidisciplinary team work, research expertise, scholarship, and entrepreneurial acumen.

Program Leadership

Program Director: Sruti Shiva, PhD

Program Co-Directors: Stephen Chan, MD, PhD and Adam Straub, PhD

Training Faculty: Stephen Chan, Bill Chen, Partha Dutta, Bruce Freeman, Mark Gladwin, Alison Morris, Anne Newman, Chris O’Donnell, Solomon Ofori-Acquah, Patrick Pagano, Frank Sciurba, Iain Scott, Steven Shapiro, Sruti Shiva, Thomas Smithgall, Adam Straub, Prithu Sundd, Flordeliza Villanueva, Yadong Wang, Brian Zuckerbraun