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Training the Translational Scientist

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Science Translational Medicine  22 Dec 2010:
Vol. 2, Issue 63, pp. 63mr2
DOI: 10.1126/scitranslmed.3001632

Abstract

A Clinical and Translational Science Awards Industry Forum titled “Promoting Efficient and Effective Collaborations Among Academia, Government, and Industry” was held in February 2010. A session at this forum was organized to address the training and skills needed to develop a biomedical scientific workforce that interfaces academia, government agencies, and industry to support the process of translating science into applicable means to improve health. By examining the requisite competencies and training resources for scientists in each of these sectors, opportunities for collaboration and adoption of new educational strategies were identified that could help to address barriers to translational research education and career development.

Introduction

Effective integration of diverse scientific disciplines, incorporating perspectives of academia, industry, and government, and rapid translation of discoveries to best clinical practices is essential for realizing the potential of the next era of biomedical research. At the core of this remodeling of translational science is the redefinition of the educational architecture by which members of the biomedical scientific community are trained.

Many successful approaches are used to prepare clinical and translational scientists with the requisite skills to become independent investigators. Unique training programs are also used in industry and government that provide scientists in these sectors with the necessary expertise to perform their jobs. However, few training programs have been established that address the competencies needed to participate in collaborative scientific efforts between academia, industry, and government. To inform the discussion of the training transformations needed to facilitate interdisciplinary team science, a session on the topic of “Educational Curriculum in Translational Research: Opportunities Among CTSAs, NIH, and Industry” was held at a Clinical and Translational Science Awards (CTSA) Industry Forum titled “Promoting Efficient and Effective Collaborations Among Academia, Government, and Industry,” which took place in Bethesda, Maryland, in February 2010. This session explored the current state of curricula and educational experiences by which the National Institutes of Health (NIH) CTSA training programs prepare trainees to collaborate with or pursue research career tracks that span industry and government sectors and began a dialogue regarding ways to enhance the training of translational clinician-scientists.

Perspectives from the CTSA Training Programs

A major goal of the CTSA training program is to create flexible and dynamic curricula that prepare trainees and scholars with a diverse range of backgrounds and career goals to become innovative clinical and translational investigators who work in interdisciplinary teams. Recognizing that these teams not only cross disciplines that range from discovery and clinical research to public policy but also cross research sectors that include academia, industry, and government, CTSA training programs have developed courses that explore interactions with industry and government agencies that might occur during the course of an academic career.

Two examples of such courses—developed by the Mayo Clinic and the University of Iowa CTSA programs—were presented to highlight the current status of translational research training. These courses, aimed at graduate (for example, M.D. and Ph.D.) and postgraduate students as well as young faculty members, identified multifaceted issues, opportunities, and skills needed for scientific collaboration with industry partners. Both courses placed major emphasis on scientific and operational issues associated with innovation and translational research in an academic environment. Although primarily focused on the academic perspectives of translational research, the CTSA courses were particularly strong in enhancing knowledge about regulatory, commercial, intellectual property, and contracting issues and in defining the stages of progression of the development pipeline, from discovery to commercialization.

The courses showed a consistency in themes, skills, and knowledge, suggesting consensus on many fundamental topics in translational research education. It was acknowledged, however, that the courses’ content was limited to the perspective of academia with little first-hand exposure of trainees to industry (or government) and their points of view. The speakers concluded that the establishment of educational programs that leverage the knowledge and perspectives of industry and government sectors are critical to enhancing academia-industry-government collaborations.

Perspectives from Pharma

To address the need for clinical and translational investigators to understand the mindsets and priorities of industry during the process of drug discovery, development, and approval, scientists from Merck Research Laboratories developed a course at Columbia University, key features of which were described during the session. In addition to examining pharmaceutical research designs, trends, and strategies, the course also provided secondary benefits, including enhanced communication with industry partners and the development of skills to enhance collaboration with or prepare one for a career in industry.

The curriculum focused on the stages of target and drug discovery and optimization, preclinical development, drug safety, and clinical development, including design of early, proof-of-concept, and pivotal studies of efficacy and safety, reporting and publication of results, and the regulatory application process. It also explored intervening interactions with academia, investigators, and government agencies for the design and performance of research and the economic aspects of drug development, ranging from the risks and failures to the successes and rewards. By bringing an industry perspective to drug development, the course highlighted challenges that occur during industry interactions with academia, including issues associated with confidentiality and intellectual property.

The unique strengths of the course were (i) exposure and insight into the reasons underlying pharmaceutical industry priorities and approaches, (ii) analysis of real-world applications that go beyond the lab to the subsequent steps in drug development, and (iii) an introduction to economic analyses that play an important role in determining the feasibility of continuing on a pathway of drug development. Discussions surrounding the CTSA-designed courses indicated a desire for the curriculum to expand to include a two-way conversation between academia and industry to articulate the industry perspective in collaborative scientific relationships with academia. In addition, that conversation should help define what academia needs from industry and what industry can do to help.

Perspectives from Government: Training in the U.S. Food and Drug Administration

Educational opportunities at the U.S. Food and Drug Administration (FDA) were also discussed. The FDA has a robust training environment for FDA reviewers—individuals who have parallel functions to those in industry (for example, chemists, toxicologists, clinicians, and statisticians), who review and can advise about all phases and aspects of drug development, and who ultimately recommend the approval or not of a drug based on its risks and benefits—as well as courses that are made available to investigators, members of industry, and other stakeholders in the translational research enterprise. Training in the FDA is based on core competencies with a focus on regulations and drug law, statistical methodology, other disciplines (such as animal pharmacotoxicology and clinical pharmacology), and computational analyses such as data analysis, mining, and modeling.

The rigorous training program to support acquisition of skills necessary for new reviewers at the Center for Drug Evaluation and Research (CDER) at the FDA currently takes place over the first 2 to 3 years of employment and consists of internal training with CDER core courses, curricula specific for clinical review of new drugs, and training in information technology. In addition, external training opportunities provide access to requisite expertise that addresses specific subject matter. The training program also includes on-the-job mentoring and participation in scientific seminars. CDER is presently modifying its training to provide greater emphasis on (i) computational support, (ii) adaptive trial designs [which go beyond the traditional clinical study phases and determine progression (for example, doses to be developed) within the same study by use of accumulating data to decide on how to modify aspects of the study as it continues, without undermining the validity and integrity of the trial], (iii) statistical analysis, (iv) pharmacogenomics (the use of genomic technologies in drug discovery or characterization), and (v) biomarker discovery.

The FDA’s commitment to education and training is not only internal for FDA-employed reviewers and scientists. The FDA has a robust program to enhance communication and translation of regulations with stakeholders in academia and industry through its participation in and/or sponsorship of training programs that are available to the translational scientific community. These programs provide an overview of the major issues associated with the continuum of drug development from the perspective of the FDA.

Opportunities to Enhance Training in Translational Research

Building on the examples of educational resources described by the speakers and additional opportunities shared by the breakout session participants, a set of action items was developed in response to the following question: How do we integrate the best practices in training from industry, government, and academia to support career development for members of the broad biomedical research enterprise?

To enhance engagement of all such members, an underlying tenet of education and training resource development is to include all stakeholders from academia, industry, and government (as well as the community) in the process of creating an education and training resource for translational research. This process can be facilitated through the development of an Academic-Industry-Government Roundtable that would focus on understanding the strengths, capabilities, assets, needs, risks, and liabilities of members from each sector; the goal would be to create a blueprint for training to support the creation of the translational research workforce of tomorrow.

Second, it is critical that education and training programs define core competencies in translational research through the formal examination of the skills and knowledge that are needed for participation in translational research from the collective perspectives of the individual stakeholders.

Third, knowledge of the different domains in clinical and translational research should be increased by expanding the availability, accessibility, and openness of established courses. To facilitate this effort and avoid duplication, a repository of courses created by academia, government agencies (such as NIH and FDA), and industry should be established. By enhancing access to courses taught by biomedical researchers from other sectors, there will be increased exposure to the perspectives of the primary source on the topic and opportunities to support collaboration efforts.

Fourth, new courses should be developed that specifically address gaps in the clinical and translational research continuum. There is a critical need to focus on teaching concepts of disease mechanisms and pharmacology to support drug discovery and development. Furthermore, it is important to promote the development of skill sets for clinician-scientists that include insightful protocol design and the ability to create proof-of-concept studies. With the paradigm shift in translational science toward the interaction of interdisciplinary teams to address complex biomedical problems, training programs must also address competencies that will enhance success at leading scientific teams, which include project management and communication strategies.

Fifth, opportunities for hands-on practical experiences with different stakeholders should be developed to facilitate and support the collaborations necessary in the continuum of translational research. In academia, these practicums can provide insight into the challenges and processes involved in basic science discovery and clinical research activities. A better understanding of the similarities and differences in perspectives of the various team members involved in the biomedical research enterprise will improve collaboration and enhance communication.

Conclusion

In summary, the ultimate benefit of a robust training and career development initiative will be to ensure a well-trained biomedical translational research workforce. By enhancing communication skills and teamwork, scientists trained with an appreciation for the multifaceted roles of the stakeholders in the research continuum will have a marked and positive impact on changing the collaborative culture. Through recognition of the range of career paths and the integrated and complementary roles of highly trained biomedical researchers from academia, government, and industry, the efficient translation of new knowledge to improved treatments and better patient outcomes can be realized.

Footnotes

  • Citation: R. D. Jackson, S. Gabriel, A. Pariser, P. Feig, Training the Translational Scientist. Sci. Transl. Med. 2, 63mr2 (2010).

Note

  1. Acknowledgments: This conference was presented by the National Center for Research Resources. Competing interests: P.F. holds options and stock of Merck. The other authors declare that they have no competing interests.

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