T32 PIRE Elements

Postdoctoral Training

The core training for the Program for Immunology Research and Entrepreneurship (PIRE) fellows is the research experience in the laboratory setting complemented by specialized training in entrepreneurship. The following components form a structured, integrative training experience not found elsewhere at MUSC.

Mentoring

A novel aspect of PIRE is the engagement of an Individual Development Plan for Entrepreneurship (IDPE) Committee, whose primary purpose is to work with the trainee to customize an Individual Development Plan that includes and achieves appropriate entrepreneurial objectives and experiences. While MUSC encourages the use of IDPs to guide all postdoctoral fellows, the special purpose of the “IDPE” is to incorporate and optimize entrepreneurial perspectives and activities into the career trajectory of the postdoctoral trainees.

The 6-member IDPE is composed of the trainee’s primary mentor and 5 standing members, 3 of whom are PIRE Program Faculty (Rohrer, Gilkeson, Tomlinson). (If the primary mentor is one of the standing members of the committee, a Co-Mentor will be designated to serve as well.) These 3 faculty are highly collaborative academic researchers with hands-on entrepreneurial experience in product commercialization and biotech startup; among them, they have filed 49 invention disclosures, 326 patent applications (combined US and international) and have 19 patents issued (US and international). Two additional members bring a full complement of expertise to the IDPE Committee:

• Scott Davis, Ph.D., is the Senior Licensing Manager in MUSC’s Foundation for Research Development (FRD). In this role, Dr. Davis evaluates, manages, markets and licenses MUSC technologies. Dr. Davis also works closely with MUSC startups on commercializing early stage technologies. Before joining MUSC, Dr. Davis spent three years in technology transfer at Oklahoma State University and The University of Texas at Austin. Dr. Davis completed his doctoral work at The University of Texas at Austin in Neuroscience, studying the molecular mechanisms of intoxication using the model organism C. elegans. He also became a Registered Patent Agent in 2013.
• Kelly G. Shaver, Ph.D., is Professor of Entrepreneurial Studies in the School of Business at the College of Charleston. He has been a highly valued collaborator with MUSC faculty and students for the past 7 years, beginning with the NSF Partnerships for Innovation (PFI) award that led to a course in Biomedical Commercialization, and most recently the Burroughs Wellcome Fund award for design of an on-line curriculum in entrepreneurship. He is internationally recognized for his contributions on the psychological characteristics of entrepreneurs, and is founder of a company, MindCette, LLC, that offers data-based assessments of entrepreneurial capabilities to individuals, teams or potential investors.

Each PIRE fellow will work with the IDPE Committee to develop an Individual Development Plan for Entrepreneurship based on a needs assessment conducted at the start of each fellowship. This process will tailor each fellow’s training plan to his/her specific needs, interests and goals, allow for adjustments to target deficiencies, and establish the necessary timetable and framework to achieve short- and long-term goals. Each trainee will have his/her own unique IDPE. They all will participate in key program activities that provide a core skillset and opportunities for interaction with other fellows and faculty by completing the required elements described below.

In addition to assessing proficiencies to achieve their research and career goals, the IDPE will address skills needed for success as an entrepreneur in the biotech industry. These skills include innate personality qualities (e.g., ability to persist, passion, risk-taking, vision or instinct) and attributes that can be developed or learned (e.g., communication skills, sales/marketing, team-building, knowledge/domain experience, business, accounting). The psychological characteristics that facilitate an individual’s “entrepreneurial persistence” can be measured using the Panel Studies of Entrepreneurial Dynamics (PSED), publicly available from the University of Michigan’s Survey Research Center. Dr. Kelly Shaver, one of our IDPE Committee members, was a leader in supervising the psychological variables used in the PSED longitudinal studies. Thus, “entrepreneurial tests” of personal characteristics available through his company, MindCette, LLC, will be used to guide the career plans of the PIRE fellows. The PIRE didactic curriculum described below addresses many of the entrepreneurial skills that can be taught/learned. Such IDPE activities might include joining and participating in professional organizations such as SC BIO, reading business books on leadership, marketing etc, or attending relevant meetings or lectures. These types of activities will be incorporated into each fellow’s IDPE based on their individual needs assessment.

The IDPE committee will meet semi-annually with the PIRE fellow to review the trainee’s research progress and career path and provide a written assessment to the trainee, mentor and Program Steering Committee, though IDPE members will be available at any time on an individual basis for education and advice. The meetings also provide a forum for discussing the adequacy of the mentor/mentee relationship, and whether enhancement or remedial actions may be indicated. We expect trainees will view these meetings and reports as positive experiences that provide valuable opportunities to obtain constructive criticism, facilitate efficient training and serve as an excellent avenue for guidance and scientific assistance.

Laboratory Training

Within the laboratory of the primary mentor, the PIRE fellow will learn to define research objectives and specific aims, develop research methodologies, perform experiments and evaluate experimental results. He/she also will be mentored in the mechanics of laboratory management in preparation for running an independent laboratory in the future. Issues to be covered include human/animal/biosafety compliance, financial management, human resources and issues related to responsible conduct of research. The PIRE fellow’s progress on his/her research project(s) will be presented and discussed with the primary mentor at least weekly. Finally, prior to completing the program, the PIRE fellow will be expected (and mentored) to: (1) write and present the original version of a manuscript dealing with his/her laboratory-based work for publication in a peer-reviewed journal, (2) present his/her findings at a national meeting, and (3) submit an extramural grant application to advance their career, such as an F32, K99 or other K-type award (K-type).

Didactic Training

An important complementary focus of this program is training in entrepreneurship. MUSC is committed to supporting new venture activity and entrepreneurship involving MUSC technologies. Both the MUSC Foundation for Research Development (FRD) and the Center for Innovation and Entrepreneurship (CIE) serve as partners for the faculty, staff and trainees, as well as local and regional entrepreneurs who are exploring new ventures based on MUSC technologies. The Microbiology & Immunology Program has a long history of entrepreneurial activity. Trainees will gain an understanding of research development from the intellectual property perspective, including patenting and licensing, startup guidelines and funding resources. The following required curriculum will provide skills necessary for trainees to succeed in competitive science careers, whether in academia, biomedical industry or business.

Entrepreneurship Course for Trainees in the Biomedical Sciences. Established by a Career Guidance Training Award from Burroughs Welcome Fund (1 of 5 awarded nationally), this course is offered via a web-based portal. Online content is available starting Fall 2016, with full content available by May 2017. Modules will be used as a foundation for a certificate program available to students, postdocs and faculty at MUSC and elsewhere, and will be required for PIRE fellows. The online program will be enhanced by 2 face-to-face conferences at the beginning and end of the certificate program. At the first session, participants will bring forward an idea for a novel technology that they will use as the foundation for a virtual “company.” They will receive feedback from the faculty that will help guide them as they progress in the program. At the final session, participants will participate in a Pitch Session that will test their ability to present their idea in a compelling fashion to a non-science audience. These conferences will include presentations from various entrepreneurs/business people on a variety of topics relevant to developing new technologies and companies. In addition, workshops will be held on developing an “elevator pitch,” writing a resumé, and interviewing skills.

Biomedical Commercialization (CGS-729). All PIRE fellows will take this course, which is co-taught by faculty from MUSC and the College of Charleston’s School of Business. Offered semi-annually to MUSC students and fellows and College of Charleston business majors, this 3-credit hour course resulted from an NSF-funded Partnerships for Innovation (PFI) award (NSF-0917987). Topics include industry analysis, competitive advantage, market segmentation and targeting, fixed and variable costs, debt, equity, cash flow and the basics of business plan construction. The course (Appendix 4) has been a staple for many postdoctoral trainees at MUSC, and will serve as a “post-requisite” or supplementary course to the online instruction described above.

Experiential Training: FRD Internship

(encouraged)

As a “capstone experience,” PIRE fellows will be encouraged to do an internship with MUSC’s technology transfer office, the Foundation for Research Development (FRD). The internship will comprise on average 1 full day per week for a 3-month period. Each fellow will engage in developing a commercial feasibility assessment of a technology in a field relevant to their scope of research. This assessment will address numerous components crucial for commercial success, including primary market research, market analysis, competitive analysis, patentability assessment, regulatory pathway evaluation, assessment of potential reimbursement challenges, steps to translational advancement, identification of possible funding sources for next steps of development, and exit strategy/partnering opportunities. This structure entails ~8 hours per component (does not necessarily require on-site presence), with an introductory week and 2 weeks for compiling the final report. FRD staff will advise our fellows as they complete the feasibility assessment and augment what they have learned through the educational components of the training program.

M&I-Sponsored Activities

The Department of Microbiology and Immunology (M&I) provides multiple structured opportunities for PIRE fellows to engage across scientific disciplines. Fellows will be actively involved in the following activities:

• Immunology Journal Club (MBIM-856). PIRE fellows will be required to participate in this weekly journal club, instituted in 2011 to meet the needs of our growing group of faculty immunologists and their trainees to interact scientifically on a regular basis. PIRE fellows will attend the 24 sessions per year unless specifically excused, and present at least twice.
• Microbiology & Immunology Seminar Series (MBIM-770). PIRE fellows will be required to attend this weekly seminar series which includes presentations by guest speakers, departmental faculty, students and postdoctoral fellows. 
• Scientific Retreats on Immunotherapy Research. The inaugural retreat for the Department of Microbiology and Immunology was held in January 2012, with the keynote presentation by Ethan M. Shevach, M.D., Chief of the Cellular Immunology Section at NIAID, who spoke on “T Regulatory Cells, What Do They Really Do?” In 2015, the department partnered with SCTR/CTSA to host a statewide Scientific Retreat on Immunotherapy Research to develop new regional collaborations and stimulate innovative pilot projects. All PIRE fellows will be required to participate in this scientific retreat. In addition to the training experience, these venues also give external advisors the opportunity to meet with all current trainees and the Program Steering Committee to review the program. 

Responsible Conduct of Research (RCR) Postdoctoral Retreat

Dr. Edward L. Krug, Associate Dean for Postdoctoral Affairs, oversees RCR instruction for postdoctoral trainees at MUSC. He has more than 16 years of experience as a member of the MUSC Research Integrity Committee and more than 11 years as the RCR course instructor. Dr. Krug directs the postdoctoral RCR training with participation from >20 faculty (including PIRE Program Faculty), professional staf, and clinicians. The training spans 2 full days (17 contact hours) with topical sessions lasting 45-90 minutes and consisting of a short lecture followed by small group discussion of case studies with faculty facilitators. Literature and online resources are provided to encourage continued study of each topic. Videos are used to emphasize the complexity of issues that can arise from miscommunication. More information about RCR training, including a sample syllabus, is included in the Plan for Instruction in the Responsible Conduct of Research section.

Instruction in Methods for Enhancing Reproducibility

All PIRE fellows will receive instruction in scientific rigor, transparency and reproducibility in compliance with NIH guidance and requirements. University leaders from SCTR and the College of Graduate Studies are currently planning implementation in Spring 2017 in accord with NIH policy (NOT-OD-16-034). An NIGMS administrative supplement to T32 GM008716 (P. Halushka, PI) has facilitated the design of a mandatory curriculum for university-wide adoption for both pre- and postdoctoral trainees. Although still in development, the curriculum will provide trainees with a solid understanding of: (1) statistical tools, analysis and other quantitative approaches appropriate to their research project; (2) design considerations to account for relevant biological variables including sex; and (3) the importance of authenticating key biological and/or chemical resources for ensuring reproducibility of biomedical research data.

Career Development “Toolkit”

MUSC is an institutional member of the National Postdoctoral Association and supports an active local Postdoctoral Association under the aegis of the College of Graduate Studies (CGS). Established in 2005, MUSC’s Office of Postdoctoral Affairs is directed by Dr. Edward Krug, Associate Dean for Postdoctoral Affairs and a member of the PIRE Program Steering Committee. This office administers and approves all postdoctoral research trainee appointments at MUSC. It provides a database of past and present postdoctoral trainees, assists faculty with salary information, and provides resources for postdoctoral trainees on funding sources, careers, seminars and other events. In collaboration with other research support offices at MUS, this office offers a range of training and career development enhancement activities that constitute a virtual “trainee career toolkit.” Below are examples of toolkit activities in which PIRE fellows may participate to advance their career transitions and optimize their probability of success towards independent research careers.

• Grantsmanship Workshop Series (required). MUSC’s Office of Research Development offers Research Project Grant Retreats several times a year. Researchers at all career stages present draft proposals for competitive extramural research grants and receive local peer-review commentary from a review panel and an audience of peers. This is an insightful venue for junior investigators to observe discussion of grant preparation, development of specific aims, and the critique process for grants. PIRE fellows will be expected to submit their first potential post-program funding application (e.g., F32 or K99) while supported by the T32. Other special workshops, also sponsored by the Office of Research Development, provide instruction in finding appropriate funding sources and guidance in preparing applications for a variety of NIH grants.
• Teaching (encouraged). The College of Graduate Studies offers a Teaching Techniques course (CGS-725) that provides an introduction to teaching and classroom instruction. It is conducted over 9 weeks in 2-hour sessions (total 18 hours) that include lectures, small groups, assigned readings and class presentations. This course is open to graduate students and postdoctoral fellows. The aim is to equip trainees with basic teaching skills suitable for an academic career or other professional work. The didactic course may be supplemented with onsite mentored teaching internships at local or statewide undergraduate colleges. PIRE fellows will be encouraged to take the course if this is a specific goal identified within their IDPE; however, it will not be uniformly required for all PIRE fellows.
• Career Planning (required). The College of Graduate Studies sponsors an Annual Career Day for that includes external speakers from a wide range of non-academic careers coupled with a Life Sciences Jobs Fair on campus. The goal is to offer valuable exposure to the breadth of career opportunities outside of academia. The 2015 event included appropriate scientist role models in pharma, patent law, science writing and science policy. The 2014 keynote speaker was Kathie Olsen, Ph.D., Founder and Managing Director of ScienceWorks, Inc. (Washington, D.C.), who addressed “Transitioning to Non-academic Career Paths.” Participants have the opportunity to sign-up for lunch with the invited speakers followed by one-on-one career consultations and informational interviews. In the afternoon, local panelists showcase MUSC resources and partnerships. This annual event is well attended by both graduate students and postdoctoral fellows.

Optional Courses / Activities Available to PIRE Fellows

In general, PIRE fellows will not be expected to take additional coursework but may be encouraged to audit appropriate classes, depending on their backgrounds, interests and deficit. The College of Graduate Studies has a rich portfolio of biomedical science graduate courses. For example, the Department of Microbiology and Immunology provides a series of immunology-based courses as part of the graduate training program, and these courses are available to PIRE fellows. Additionally, SCTR’s TL1 program offers a course that provides a solid foundation for individuals seeking additional training in clinical and translational research.

• MBIM-735. Molecular & Cellular Basis of Inflammation & Immunity. This course offers intensive study of areas of cellular immunology, immunogenetics, clinical immunology, and immunobiology of tumor development. Each area is presented with the intent of developing a sound understanding of experimental and theoretical observations. Emphasis is on current research involving sophisticated methodology.
• MBIM-775. Special Topics in Microbiology and Immunology. This elective course provides a continuous update in immunology to students who have completed Basic and Advanced Immunology and taken their qualifying examination. It is a seminar course during which the students meet with instructors for 2 hours/week over a semester to discuss the most recent publications and new insights. To ensure a broad coverage, any faculty member in Immunology and Microbiology may suggest a topic to be discussed.
• MBIM-779. Immunogenetics. The principal focus of the course is genetics of human MHC and immunoglobulin allotypes. Major blood genes also are discussed. Statistical methods employed in delineating the genetic contribution to human diseases are reviewed.
• CGS-714. Core Clinical Research Training. This course prepares research team members to coordinate cost-effective healthcare research and, at the same time, promote the rights and safety of human subjects, achieve recruitment and retention outcomes, and contribute to the science of healthcare in compliance with Good Clinical Practice Guidelines and federal regulations. The training prepares participants to manage all phases of healthcare research from study initiation to close-out. The course is offered online or in-person.
• Women’s Innovation Symposium. Outstanding female clinicians and investigators make presentations on invention and entrepreneurship and attendees learn how to recognize innovation in their work and receive tips on resources to help move their projects forward. This symposium is co-sponsored by the Center for the Advancement, Recruitment and Retention of Women in Science (ARROWS), SCTR, the Foundation for Research Development and Center for Innovation and Entrepreneurship. The next event will be in early 2017.

Summary of PIRE Expectations

• PIRE fellows will be required to attend the Immunology Journal Club (MBIM-856) and the Microbiology and Immunology Seminar Series (MBIM-770). They must present at the Immunology Journal Club twice a year, and present in the Microbiology and Immunology Seminar Series at least once a year. The trainees also will have an opportunity to meet with visiting Seminar Series speakers and External Advisors, individually or as a group. These meetings will cover the visitor’s philosophy of investigation as well as specific research questions, and provide additional means for trainees to network within the profession. PIRE fellows also will be required to attend the Responsible Conduct of Research Postdoctoral Retreat and instruction in Rigor and Transparency. Additionally, in a recent study [15] it was shown that graduate students who had research and teaching responsibilities had enhanced skills in hypothesis generation and experimental design compared to students with only research responsibilities. Therefore, PIRE Fellows will be encouraged to take the Teaching Techniques course.
• PIRE fellows will be required to attend the Grantsmanship Workshop Series, as well as the 1-day Scientific Retreat on Immunotherapy Research. They also must present their work each year at MUSC Student Research Day and attend at least 1 national scientific meeting. Attending and presenting research results at a national meeting are an essential component of a well-rounded research-training program. Much can be accomplished at national meetings, including making new professional connections, learning about trends in the field and grant opportunities, meeting leaders in the field, and conducting organizational business.
• A goal of PIRE is to ensure that fellows are aware of how to patent, develop and market intellectual property that results from their discoveries. Accordingly, PIRE fellows will be required to complete the entrepreneurial regimens: the on-line Entrepreneurship Course for Trainees in the Biomedical Sciences and the Biomedical Commercialization course. Fellows may also choose to conduct the FRD Internship. As an integral part of their training, PIRE fellows will meet formally at least twice a year with the IDPE committee to review their progress.
• PIRE fellows will be required to submit a written report of their work to the Program Director and Associate Program Director at the end of each year of training. The report will become part of the annual noncompeting progress report submitted to the NIH, and will include scientific progress to date, presentations made, publications in preparation, submitted or in press, and other training-related activities. A distinct component of this report will consist of details of the fellows’ individual development plan in entrepreneurship (IDPE), which will include information on ongoing and completed coursework and related activities. Included in this section of the report will be an evaluation from the IDPE committee on the fellow’s progress in this area.
• PIRE mentors will be expected to participate in the Immunology Journal Club, whose regular structure for presentation and discussion includes 2 faculty referees, 2 graduate students or postdoctoral trainees, and the presenter.
• PIRE mentors will be expected to participate in the Responsible Conduct of Research course as a lecturer or panel discussant. They also are expected to play active roles throughout the training of their postdoctoral fellow in providing instruction about the elements of appropriate scientific conduct and to serve as examples and role models of appropriate scientific conduct.