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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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