5


Career Paths Within Academia and Industry

Key Messages

•  The lack of defined funding and other career support mechanisms for regula-tory scientists presents challenges to attracting qualified candidates to the field.

•  Though regulatory science is a multidisciplinary field with a broad set of core competencies, it may be a more effective career path for a scientist-investigator to associate with a particular established discipline, which can provide the means for obtaining funding, publication, and recognition needed for a suc-cessful academic career.

•  Regulatory scientists can fill a gap in expertise at their home academic insti-tution, offering the opportunity to demonstrate the importance of regulatory science and build institutional support for the field.

Attracting talent to the field of regulatory science requires that there be solid career paths for regulatory scientists. The workshop examined career paths and career development opportunities, both within and outside of academia, that are currently available—or that would need to be available—to strengthen and support regulatory science in therapeutics development. William Chin, Executive Dean for Research, Harvard Medical School; David DeMets, Professor, Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison; and Kathy



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5 Career Paths Within Academia and Industry Key Messages • he lack of defined funding and other career support mechanisms for regula- T tory scientists presents challenges to attracting qualified candidates to the field. • hough regulatory science is a multidisciplinary field with a broad set of core T competencies, it may be a more effective career path for a scientist-investigator to associate with a particular established discipline, which can provide the means for obtaining funding, publication, and recognition needed for a suc- cessful academic career. • egulatory scientists can fill a gap in expertise at their home academic insti- R tution, offering the opportunity to demonstrate the importance of regulatory science and build institutional support for the field. Attracting talent to the field of regulatory science requires that there be solid career paths for regulatory scientists. The workshop examined career paths and career development opportunities, both within and out- side of academia, that are currently available—or that would need to be available—to strengthen and support regulatory science in therapeu - tics development. William Chin, Executive Dean for Research, Harvard Medical School; David DeMets, Professor, Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison; and Kathy 43

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44 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE Giacomini, Professor and Co-Chair, Department of Bioengineering and Therapeutic Sciences, UCSF, presented their ideas on academic career paths for regulatory scientists. Henrietta Ukwu, Senior Vice President for Global Regulatory Affairs, PPD, Inc., then offered comments on regula - tory science career paths in industry. CAREER PATHS IN ACADEMIA Barriers and Opportunities in Academia1 Given the lack of established programs in regulatory science in academia, this gap could be addressed by increasing opportunities for exchanges among academia, industry, and government, as described in this chapter and in Chapter 7. Such collaborative approaches would sup - port an ecosystem that will foster the development of career paths within all three sectors. Chin listed questions for consideration in defining a regulatory science career path: • Is there a clear definition of the field? • Are tools and technologies available to answer research questions? • Are multiple training options available that involve innovative research? • Who are the role models? • Is the career track clear, and is there a clear path for professional development and promotion in an academic home? • What is the availability and sustainability of research funding? • Are academic societies and publications available that provide opportunities for impact and recognition? • Are alternative career pathways available? The biggest barrier to the development of an academic discipline is that the nature of academia does not lend itself to a regulatory mind- set, said Chin. Furthermore, the unsupportive funding climate makes it unlikely that many universities would commit the resources needed to create the necessary educational and research programs that would cross disciplinary boundaries. There are, however, opportunities to associate regulatory science with areas that are getting support, such as translational science and therapeutics, or with rapidly developing fields whose progress eventually will depend on good regulatory science, including personalized medi - 1 This section is based on the presentation by William Chin, Executive Dean for Research, Harvard Medical School.

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45 CAREER PATHS WITHIN ACADEMIA AND INDUSTRY cine, regenerative medicine, and gene therapy. For example, biologically inspired engineering is an emerging discipline that applies biological principles to develop new engineering solutions that meet real-world needs, with potential to produce tissues-on-a-chip that accelerate drug development and replace animal tissues. Regulatory science advances are needed to advance development of such devices as drug development tools. Moreover, associating regulatory science with such scientific fields can help raise the visibility of the discipline and ultimately overcome the barriers, such as lack of acceptance and credibility, impeding the develop- ment of regulatory science as an academic discipline. Issues Confronting Academic Regulatory Scientists2 DeMets offered remarks geared toward establishing credibility for expertise in regulatory science in academic institutions. Because regula- tory science is inherently multidisciplinary, it is unreasonable for any one person to be well versed in all the involved fields of science. Given that the structure of academic institutions is still based overwhelmingly on single disciplines, investigators with an interest in regulatory science should structure their approach to research in such a way as to put an established discipline, such as biostatistics, at the center of their work. A key to this approach is to find problems in a given field that tie directly into regula- tory science. As an example, DeMets discussed several important and interesting gaps in biostatistics, such as the need for tools for comparative effectiveness research or for assessing composite and surrogate outcomes. DeMets also noted that most universities have a real need for expertise in regulatory science even if they do not acknowledge it. Few universities have faculty who are well versed in regulatory requirements and guide- lines. Being the expert who joins research teams can be one way to build support for regulatory science in academic institutions. Demonstrating the value of such expertise can then open the door to creating training oppor- tunities for other members of a multidisciplinary research team, which in turn can help start the process of institutionalizing regulatory science. Building a Home for Regulatory Science in Academia3 Giacomini provided observations about the relationship between the disciplines of regulatory science and translational medicine and thera - 2 This section is based on the presentation by David DeMets, Professor, Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison. 3 This section is based on the presentation by Kathy Giacomini, Professor and Co-Chair, Department of Bioengineering and Therapeutic Sciences, UCSF.

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46 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE peutic sciences and, in that context, presented a case study from her own institution illustrating the challenges of recruiting and retaining regula- tory scientists. She commented that the already-defined core competen- cies for translational medicine and therapeutic sciences can provide a framework in which would reside a subset of competencies needed for the regulatory sciences. As with any inherently broad-based field, such as sys- tems pharmacology or pharmacogenomics, the field comprises multiple core competencies, but each regulatory scientist would acquire a deeper understanding in a defined, smaller area, and that discipline would serve as the base for developing an academic career. Giacomini cited an example from her home department, the UCSF Department of Bioengineering and Therapeutic Sciences, a multidisci - plinary department that came about through the merger of three depart - ments spanning pharmacy, biopharmaceutical sciences, and bioengineer- ing. The department confronted challenges recruiting and retaining a regulatory scientist for an identified position. In recruiting they found that the pipeline for training regulatory scientists for academic research careers is sparse. Moreover, concerns arose relating to academic sustain- ability, both in terms of grant support and opportunities for publication and recognition that are essential to building an academic career. UCSF at one time had a core group of pharmaceutical scientists doing research in physiologically based pharmacokinetics and drug delivery. Seven of these individuals left academia not because they were unsuccessful but because there was no NIH support for creative research in these fields, she said, adding that, to be successful, regulatory science as a discipline needs to encourage funding from NIH, FDA, and other parties to make this a sustainable academic career track. Giacomini also cited the lack of departmental homes for regulatory scientists as a key barrier to develop - ment of a workforce in the field. Advancing Academic Regulatory Science It was emphasized by several of the panelists that regulatory science workforce development is dependent on career advancement opportuni - ties and visibility and credibility of the work. Otherwise, training pro- grams are for naught. Moreover, to ensure that teaching and training is current, training opportunities and programs could have mechanisms to evolve in parallel with the anticipated growth in regulatory science and research. Workshop discussants noted that to seed the practice of regula - tory science, support the advancement and credibility of the discipline, and provide clear, discernible career paths, it is important to identify, fund, and pursue the “big questions” in regulatory science. Chin char- acterized these as the problems or questions that are of ultimate impor-

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47 CAREER PATHS WITHIN ACADEMIA AND INDUSTRY BOX 5-1 A Nonexhaustive List of the “Big Questions” Identified by Participants • eed for appropriate science experiments that will define risk and benefit in N better ways. • Evaluate and better understand the preclinical to clinical transition. • eed for better predictions of human clinical outcomes. Need for better selec- N tion of animal models and improved correlation with whole animal studies to human disease outcomes. • How to develop and regulate drug combinations. • ow to address drug-drug interactions. Developing in vitro methodologies for H predicting drug-drug interactions is suited to academic research, for example. • eed for a collaboratively developed national research agenda in regulatory N science. • evelop better understanding of methods to analyze huge volumes of data and D use big databases to answer questions in regulatory science. • Need for a science-based process to identify and qualify biomarkers. • Develop and refine novel approaches to clinical trial design. tance for the innovation ecosystem. Discussion at the workshop collected a nonexhaustive list of those potential big questions, which are com - piled in Box 5-1 as an integrated summary of speakers’ and participants’ remarks and discussions, and which should not be construed as reflecting consensus or endorsement by the participants, planning committee, the Forum, or the National Academies. Several participants noted that further work could be done to compile and catalog these “big questions” to help advance the discipline. CAREER PATHS IN INDUSTRY4 Ukwu identified the locus of the emergence of regulatory science in the “perfect storm” of 2006, in which industry saw a decline in productivity and rise in product failures, which highlighted that the current paradigm for drug development was unsustainable (Figure 5-1). She stated that the challenges plaguing industry forced introspection, leading to iden- tification of a number of emerging regulatory trends, such as the use of adaptive trial designs and the ability to collaborate more closely with regulatory agencies during the development process. 4 This section is based on the presentation by Henrietta Ukwu, Senior Vice President for Global Regulatory Affairs, PPD, Inc.

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48 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE Regulatory Demands and Responsibilities Regulatory Science Demands 1980s 1990s 2000 2002 2004 2006 2008 2010 Current EMERGING REGULATORY Drug Safety Drug Safety PERFECT PERFECT ! Biotech / Pharma Mergers and Mergers and Biotech / Pharma TRENDS: TRENDS: Concerns Concerns STORM Acquisitions Blockbuster Boom STORM! 2004 ICH to Local Heterogenicity Blockbuster Boom Acquisitions 1990s – 2000s 1980 – 1990s ICH to Local Heterogenicity 2004 (ex. Vioxx) Decline in 1980–1990s 1990s–2000s Agencies Productivity ; (ex. Vioxx) Collaboration Trial Designs Adaptive Among Decline in CV Outcomes Studies Regulatory Agencies Productivity; Failures ; REMS Development Adaptive Trial Designs Unsustainable - Personalized Medicine 1983 Paradigm Orphan Drug Indications Rise in CV Outcomes Studies Orphan Outsourcing Emerging Product REMS Development Drug Act (CRO, CMO) Markets Failures; Advanced Therapeutic 1983 2000s 2004–2005 Pipelines Unsustainable Personalized Medicine Paradigm Orphan Drug Indications FIGURE 5-1 Trends in the pharmaceutical industry led to a “perfect storm” lead- ing to increased regulatory science demands. Figure 5-1 NOTE: CMO, Contract Manufacturing Organization; CRO, Contract Research Organization; CV, cardiovascular; ICH, The International Conference on Harmoni- sation of Technical Requirements for Registration of Pharmaceuticals for Human Use; REMS, Risk Evaluation and Mitigation Strategies. SOURCE: Ukwu, 2011. Presentation at IOM workshop on Strengthening a Work- force for Innovative Regulatory Science in Therapeutics Development. Regulatory science could lead to better incorporation of scientific, translational, and clinical knowledge into regulatory development planning for industry. Regulatory scientists could liaise between multi- disciplinary groups and could bring clinical reasoning and scientific meth- odology to a process-driven field. The need for precision, prediction, and intelligence in adapting the regulatory process to product development then could introduce proactive approaches to drug development and lead to the incorporation of better analytical processes. Regulatory scientists also could contribute to the business development process by providing input to licensing and outsourcing strategies and to partnerships in con- tract research organizations (CROs). Regulatory scientists working in industry typically have a terminal

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49 CAREER PATHS WITHIN ACADEMIA AND INDUSTRY clinical or scientific degree, with a background in translational research or medicine and expertise in a therapeutic area. A regulatory scientist should also have experience in data review and actively participate in relevant professional organizations. A regulatory scientist’s responsibilities would combine strategic and operational excellence in program development planning, strategic regulatory intelligence, regulatory meetings, clinical trial design using advanced methodologies, global regulatory issues, and supervising in a matrix-organization environment. In this regard, Ukwu observed, industry highly values regulatory agency fellowship programs because they turn out regulatory scientists who meet these needs. Ukwu also described career development paths for regulatory scien- tists in a CRO. Because CROs provide advice and guidance to industry, there is a clear need for regulatory scientists who can help a client identify gaps in a development plan and strengthen the position of products early in the development process. These efforts increase the odds of the client’s product succeeding both with regulators and in the marketplace.

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