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4
Education and Training of a
Regulatory Science Workforce
Key Messages
• ome successful regulatory science education and training programs offer a
S
menu of educational opportunities that build core competencies while allowing
participants to focus on aspects of regulatory science relevant to their specific
areas of interest.
• ultiple levels of recognized training could be employed, including professional
M
certificates, master’s degrees, doctoral degrees, and fellowships and rotations
that blend work and training.
• broad range of training and fellowship programs are available at FDA and
A
within other agencies that create opportunities for scientists at all career stages
to become more well versed in regulatory science and to have careers in regu-
latory science.
Defining a workforce that, taken as a whole, fosters the core competen-
cies in regulatory science calls for a concerted effort to educate and train
the existing and next generation workforce. The workshop discussions
on education and training sought to identify current gaps and specific
opportunities, including collaborative approaches, to strengthen the edu-
cation and training of a regulatory science workforce. The workshop also
examined barriers to implementing education and training strategies and
potential ways to overcome these barriers.
31
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32 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE
Carl Peck, UCSF, presented an overview of certain existing train-
ing programs in regulatory science. Emma Meagher, Director of Transla -
tional Research Education, University of Pennsylvania Perelman School
of Medicine, and Annette Mollet, Head of Training and Education, Euro-
pean Center of Pharmaceutical Medicine (ECPM), University of Basel,
discussed the necessary components of an effective education and train-
ing strategy and how to develop those components. A panel discussion
focused on fellowship and exchange programs.
AN OVERVIEW OF EXISTING TRAINING PROGRAMS1
Training Opportunities Within FDA
FDA is the major locus of regulatory research and training in the
United States, Peck observed. Peck noted that the so-called “Subpart E
Regulation,” passed by Congress in 1989, included a provision that gave
FDA authority to conduct regulatory research: “At the discretion of the
agency, FDA may undertake focused regulatory research on critical rate-
limiting aspects of the preclinical, chemical/manufacturing, and clinical
phases of drug development and evaluation.”2
Regulatory research is an inherent component of FDA’s activities, and
the agency has contributed to the advancement of the drug development
field through its work with sponsors to advance development and evalu -
ation of products more rapidly. FDA advancements span a wide range
and include, for example, evaluation of diagnostic biomarkers for HIV/
AIDS. FDA has innovated in clinical trial design and in modeling and
simulation. FDA’s Critical Path Initiative also has led to the establishment
of numerous consortia for advancing the development of predictive safety
biomarkers and advanced physiologically based modeling. Over the past
3 years, FDA scientists have published more than 1,000 papers. 3
Peck commented that FDA has created a university-like environment
that generates both debate and important science. And, as with any good
university, FDA has developed strong training programs, according to
1 This section is based on the presentation by Carl Peck, Professor of Pharmacology and
Medicine, UCSF. The section is intended to offer a broad but brief look at certain regula -
tory research and training opportunities currently available. It is not necessarily complete
or exhaustive.
2 21 CFR § 312.86, Focused Regulatory Research, available at http://www.gpo.gov/fdsys/
pkg/CFR-2011-title21-vol5/pdf/CFR-2011-title21-vol5-sec312-86.pdf (accessed November 28,
2011).
3 Vicki Seyfert-Margolis, Senior Advisor for Science Innovation and Policy, Office of the
Commissioner, FDA, commented that, as of September 2011, there was a total FDA work -
force of 13,800.
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33
EDUCATION AND TRAINING OF A REGULATORY SCIENCE WORKFORCE
Peck. The Center for Drug Evaluation and Research (CDER) Staff College
includes over 50 courses covering a wide range of graduate-level subjects.
A committee on advanced scientific education certifies these courses and
the faculty members who teach them. CDER also has a program that has
defined the competencies necessary for regulatory scientists working at
FDA who review drug applications and provide counsel to drug devel-
opers. In 2011, FDA expanded this latter effort and created the CDER
Federated Training Model, which has published a public list of the com-
petencies expected by discipline.4 The agency has developed an outreach
program to educate consumers, clinical investigators, and other key con -
stituencies. In addition, FDA has established the Commissioner’s Fellow -
ship Program (CFP), a 2-year program for academics to come to FDA,
learn the craft of regulation, and become engaged in a research project.
Additional information about FDA fellowships and training oppor-
tunities is provided below.
Training Opportunities Outside FDA
Peck described a number of courses offered outside of FDA, most of
which fall within the category of regulatory affairs (rather than innovative
regulatory science or regulatory research).5 Specific training programs in
regulatory research are rare, said Peck, though many universities have
produced new methodologies and good scientists who have contributed
to advances in regulatory science. These advances have come largely from
pharmaceutical science departments at schools of pharmacy in the United
States and Europe, clinical pharmacology research fellowships, clinical
investigator fellowships, and some NIH programs (such as the year-long
clinical pharmacology course that has a regulatory framework), as well as
the University of Liverpool CDSS and the UCSF Center for Drug Develop-
ment Science, he said.
ECPM has a two-decade history of developing and offering sophis -
ticated courses in drug development science and regulatory science. An
offshoot of this effort is the American Course on Drug Development and
Regulatory Sciences offered by UCSF, which was launched in 2007 and
modeled after the program developed by ECPM. It is offered by the UCSF
Department of Bioengineering and Therapeutic Sciences and operates
with substantial input from FDA, other universities, and industry. This
4 See http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedical
ProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM263365.pdf (accessed No -
vember 28, 2011).
5 Both the Regulatory Affairs Association and Drug Information Association have a large
catalog of courses on specific issues pertaining to regulatory affairs.
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34 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE
intensive, 2-year course is given at the UCSF Mission Bay campus and in
Washington, DC, with the participation of 120 faculty members drawn
largely from industry and FDA. The course has been given three times in
Washington and twice in San Francisco. The course consists of six “ses-
sions” (each containing 4 days of lectures and case studies), and a 3-hour
final exam.
Master’s degree programs offering a research training component
include the Regulatory Science Program at the University of Southern
California (USC), as well as similar programs at Temple University,
the University of Maryland, and the Liverpool CDSS. A participant
added that USC School of Pharmacy has developed international M.S.,
Pharm.D./M.S., and D.R.Sc. (Doctorate in Regulatory Science) programs,
with an initial three doctoral students graduating in 2011.
DEVELOPING EDUCATION AND TRAINING PROGRAMS
IN REGULATORY SCIENCE6
Meagher described an approach to developing education programs in
regulatory science that leverages what has been learned in the develop -
ment of training programs for translational scientists, and this model for
regulatory science program development is being refined and adopted by
all of the institutions that are part of the CTSA network.
The target audience for such an education program is broad, and
Meagher noted that it is necessary to break out of the mindset that regula-
tory science resides totally with FDA and that the field’s obligation is to
create a workforce that will function within the confines of FDA. Regula -
tory science is a collaborative effort that goes beyond FDA.
To better identify their audience, the Department of Translational
Research Education at the University of Pennsylvania Perelman School of
Medicine surveyed the many constituencies that have a stake in regula -
tion and drug development. Meagher noted the following findings from
the survey:
• Geographic location should not limit opportunities for educational
encounters or for training programs.
• Attrition is a significant problem; the lack of a defined career path
and professional recognition are the major reasons for the high rate
of attrition the field is experiencing.
• Different groups have differing definitions of regulatory science; cur-
ricula need to be flexible and heterogeneous although still integrated.
6 This section is based on the presentation by Emma Meagher, Director of Translational
Research Education, University of Pennsylvania Perelman School of Medicine.
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35
EDUCATION AND TRAINING OF A REGULATORY SCIENCE WORKFORCE
Critical needs for a regulatory science training program include
understanding research and scientific methodology, pharmacology, toxi -
cology, therapeutics, and the science that underpins the regulatory pro -
cess. Competency areas include
• Biostatistics, decision theory, and information technology
• Fundamentals of pharmacology
• Scientific methodology
• Clinical trial design
• Drug and device discovery and development
• Clinical research
• Monitoring and quality assurance
• Food, drug, and device law and regulation
Effective training programs will incorporate rapidly changing sci -
ence. As new technologies drive the development of many technological
platforms capable of evaluating drugs efficiently, training programs could
adapt and evolve to incorporate understanding of these new technologies
and how they might be used in a regulatory setting.
Meagher suggested that programs include both professional certifi-
cate programs that would be suitable for such professionals as quality
assurance specialists, regulatory coordinators, research nurses, project
managers, research directors, and lawyers, as well as master’s degree pro-
grams that would be suitable for FDA scientists, investigators, research
directors, and lawyers. These types of tangible achievement-oriented pro -
grams help define a career path for professionals interested in regulatory
science. The survey found, too, that most professionals prefer part-time
programs that enable them to mix work responsibilities and interests with
training opportunities; they prefer to be trained while remaining a part
of the workforce.
Incorporation of opportunities to create and participate in internships
outside of the university setting is a valuable component of a training pro-
gram because it offers research training opportunities at FDA and within
the pharmaceutical and biotechnology industries.
Evaluation will help determine if the programs are valuable and are
meeting the needs of the stakeholders in regulatory science. Metrics would
assess whether training increases the ability of the research workforce to
meet the needs of the regulatory science initiative, whether the programs
create a viable career structure, and whether the training improves the
quality of research management. At the individual level, metrics can show
if a program enables a student to demonstrate knowledge in core concepts
and to apply that knowledge through completion of a mentored project
designed to enhance the individual’s professional abilities.
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36 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE
MODELS FOR EDUCATION AND TRAINING7
In 1999 Europe established the Bologna Process to harmonize higher
education across the continent. Curricula for training developed within
the Bologna system include programs for bachelor’s and master’s degrees
as well as postgraduate training leading to a diploma of advanced studies,
a master’s of advanced studies, and a Ph.D. The Bologna system allows
students mobility and flexibility to complete different training modules
at different universities. The system includes common quality assurance
standards for continuing professional education and training, which pro -
vides employers with the means to assess the quality of training prospec -
tive employees have received regardless of where they received their
degree.
ECPM established a three-tier modular approach through its
training curricula that were originally founded in 1991. Over the past
20 years, ECPM’s program has trained more than 1,200 participants from
31 countries, with current enrollment standing at 147 participants. Like
the UCSF program, there are multiple modules consisting of 4 days of
training—3 days that cover state-of-the-art drug development science
and 1 day that addresses current hot topics.
The Innovative Medicines Initiative (IMI) Training Excellence
Programme is a large 5-year collaborative program run jointly by the
European Union (EU) and the European Federation of Pharmaceutical
Industries Association in partnership with academia and regulatory
agencies. Funding for the IMI, which totals 2 billion euros (with 1 billion
euro contribution from industry and 1 billion euro contribution from
the EU), pays for training and collaborative research projects that cover
safety, efficacy, education and training, and knowledge management.
The following four education and training programs currently receive
IMI funding: the European Medicines Research Training Network, the
European Modular Education and Training Programme in Safety Sci -
ences for Medicine, the European Programme of Pharmacovigilance
and Pharmacoepidemiology, and the Pharmaceutical Medicine Training
Programme (PharmaTrain).
PharmaTrain was started in May 2009 with a goal of harmonizing
the syllabus for training, teaching, and examination across the European
Union. Currently, 25 universities, 13 learned societies, and 15 compa -
nies participate in PharmaTrain. PharmaTrain has established a three-tier
postgraduate track that builds core competencies through a set of base
courses, creates expertise through a series of extension modules, and
7 This section is based on the presentation by Annette Mollet, Head of Training and Educa-
tion, ECPM, University of Basel.
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37
EDUCATION AND TRAINING OF A REGULATORY SCIENCE WORKFORCE
Extension Work-Project
Base-
Modules
Courses • Thesis (10 ECTS)
• Electives
• (Research) Project
Molecule to
Marketplace
CPD
Lifelong
learning
30 ECTS 90 ECTS
60 ECTS
Knowledge Competence
Expertise
1
FIGURE 4-1 PharmaTrain has a three-tier program of postgraduate training with
optional extension after completing each level.
NOTE: CPD, continued professional development; ECTS, European Credit Trans -
fer and Accumulation System.
Figure 4-1
SOURCE: Mollet, 2011. Presentation at IOM workshop on Strengthening a Work -
force for Innovative Regulatory Science in Therapeutics Development.
develops expertise through electives and research experience (Figure 4-1).
Students can choose to stop upon completion of each level, and they
can return for further modular education and training at a later date. A
mechanism for lifelong learning or continued professional development
also exists.
FELLOWSHIPS AND EXCHANGE PROGRAMS
Fellowships and Exchange at FDA
Leslie Wheelock, Director, Office of Scientific Professional Develop -
ment, Office of the Chief Scientist, FDA, described FDA’s CFP. This 2-year
training fellowship program, which began in October 2008, has three pri-
mary goals: attracting scientists to FDA, training scientists in regulatory
science, and retention of those scientists at FDA. FDA has recruited up
to 50 fellows annually. The fellows are hired into the Office of the Chief
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38 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE
Scientist and then placed with preceptors across the agency. During the
2-year program, fellows complete about 210 hours of classroom training
in four content areas, including content specific to the center and office
in which they will carry out their research projects. Each project is identi-
fied by the centers as being of critical importance to address a scientific
regulatory issue. Wheelock noted that FDA promotes this program widely
to academic institutions and trade organizations in recognition that the
agency presents a nontraditional career path for scientists calling for
broad promotion and efforts to increase understanding and familiarity
with science careers at FDA.
Among the first class of fellows, which graduated in fall 2010, all 48
fellows completed the program, and 38 accepted permanent positions at
FDA (a retention rate of 79 percent), according to Wheelock. Five of the
fellows took positions in industry, putting them in a position to serve
as “ambassadors” between industry and FDA. The remaining fellows
returned to academia.
Uros Djekic, Senior Regulatory Reviewer/Policy Analyst, CBER,
FDA, provided the perspective of someone who participated in the CFP
(as a member of the inaugural group of fellows from 2008 to 2010). He
described the CFP as a collaborative paradigm for supporting regula-
tory science. Fellows apply their scientific expertise to a specific project
directed by a “sponsor” at FDA. The fellow and sponsoring FDA staff
member commit to finish the project during the 2 years in which the
fellow continues to receive training. At the moment, he said, there are
only about 30 fellows—a number limited by funding, not by opportu -
nity. About half of the projects, he noted, are laboratory based, while the
other half are examining issues of regulatory policy. A list of past, current,
and proposed projects is available on FDA’s website.8 Example projects
include
• Djekic’s project, which looked at policy issues involving over
the-counter HIV tests, particularly concerning the clinical trials
that would be necessary for such products to receive regulatory
clearance.
• A project to develop the proposed International Consortium of
Orthopedic Registries.
Carolyn Wilson, of FDA’s CBER, added that FDA’s staff fellowship
program is an umbrella program that incorporates the CFP as well as two
8 See http://www.fda.gov/AboutFDA/WorkingatFDA/FellowshipInternshipGraduate
FacultyPrograms/CommissionersFellowshipProgram/default.htm (accessed November 28,
2011).
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39
EDUCATION AND TRAINING OF A REGULATORY SCIENCE WORKFORCE
additional tracks: (1) a support-scientist fellowship that starts as a 4-year
postdoctoral fellowship, with the possibility of extension of an additional
3 years and opportunity to be considered for conversion to a perma-
nent support scientist; and (2) a senior staff fellowship track that recruits
investigators to develop their own independent research, also with the
opportunity after a 7-year period to be considered for permanent hiring as
a senior investigator. These positions require that the fellows spend about
half of their time engaged in regulatory review activities. In that regard,
the fellows engage in all of the same activities that full-time reviewers do,
including conducting inspections, reviewing submissions, participating
in advisory committees, writing guidance documents, and developing
policy. FDA also offers more traditional postdoctoral fellowships that can
last up to 5 years, which do not include any regulatory duties.
CTP has created a Tobacco Regulatory Science Fellowship Program,
which Laurence Deyton, FDA, described. The program, which is CTP’s
first initiative to help build its workforce, is designed to incorporate the
best practices of the FDA’s CFP, the NCI’s Cancer Prevention Fellow -
ship, and others. The fellowship will involve a core curriculum related
to regulatory science and FDA operations. It also will include a research
component that will require fellows to take charge of projects. CTP
hopes to attract midcareer professionals for the first few of the program’s
cycles to develop a cadre of experienced professionals who then can
advise CTP on how best to build and expand its efforts while also serv -
ing as mentors.
Kate Ahlport, Executive Director, Health Research Alliance (HRA),
described two new collaborative models at FDA that grew out of the
HRA. The HRA is a national consortium of 48 nonprofit, nongovernmental
funders of biomedical research and training that are interested in maxi -
mizing the impact of the nation’s investment in biomedical research. The
HRA has decided to fund the two new initiatives at FDA to further its
interest in and support for regulatory science:
• New Frontiers in Science Distinguished Lectureship Program. The pur-
pose of this program is to bring scientific expertise to the agency
in the priority areas identified in FDA’s strategic plan for regula-
tory science in the form of quarterly guest lecturers. Lecturers will
spend 1 to 3 days at FDA giving seminars, meeting with staff, and
providing tutorials in their area of scientific expertise. Lecturers
will receive an honorarium and reimbursement of travel expenses.
• Distinguished Scholar’s Pilot Program (proposed). A distinguished
scholar’s pilot program is in the discussion and planning stage.
This program would be similar to the FDA’s CFP but focused
on senior-level scholars who would be selected competitively to
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40 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE
spend up to a year at FDA and work on special regulatory science
projects that cut across disease areas. It is expected that benefits
will flow both directly to FDA (in the exchanges with scholars)
and to the broader scientific community (as scholars bring back to
their home institutions or companies a new level of knowledge and
understanding of FDA).
Fellowships and Exchange Sponsored by NIH
Juan Lertora, Director, Clinical Pharmacology Program, NIH Clini -
cal Center, described the NIH Clinical Center’s Rotations for Clinical
Research Fellows at FDA. This program identifies scientists from the
NIH Clinical Center for placement in short-term rotations in FDA’s Office
of Clinical Pharmacology or the Office of New Drugs. The rotations last
a minimum of 8 weeks and provide learning experiences focused on the
issues that would enable fellows to file an IND application. Fellows are
assigned to mentors at FDA in their areas of interest, and they participate
in the review of preclinical and clinical data on investigational drugs.
They also attend specialized therapeutic team meetings, participate in
IND 30-day safety review approvals and in meetings with sponsors, and
enroll in a curriculum of educational modules and courses at FDA. Since
the program’s inception in 2008, 10 fellows from a number of NIH insti-
tutes and the Clinical Center have completed rotations. Three of the initial
10 rotating fellows have since joined the Office of New Drugs as medical
review officers, said Lertora.
Jonathan Wiest, Director for Training and Education, NCI, NIH,
described a postdoctoral training program that emerged from work of
the FDA-NCI Interagency Oncology Task Force (IOTF). The IOTF Joint
Fellowship Program, which is a direct collaboration between the NCI
Director’s Office and the FDA Commissioner’s Office, aims to increase
the number of reviewers capable of handling the large number of cancer
drugs that are moving through the development pipeline by recruiting
individuals trained in cancer biology into the program. A second program
goal is for some fellows to go to industry, where they can build awareness
of regulatory requirements into the early stages of the product develop-
ment process and improve planning throughout the research and regula-
tory review process.
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41
EDUCATION AND TRAINING OF A REGULATORY SCIENCE WORKFORCE
Four types of fellowships are included in the program.9 NCI funds
the program and develops a training plan for each fellow. FDA pro-
vides the mentors and the regulatory training opportunities. Fellows are
required to take courses in drug law, reviewer training, statistics, and clin-
ical trial design. Depending on background and experience, fellows also
take classes on risk assessment and risk management, good manufactur-
ing practice and good laboratory practice, technical writing, presentation
skills, IND regulations, and NDA regulations. Fellows also participate in
the review process, with at least 50 percent of a fellow’s time being spent
on research under the supervision of a mentor. Mentors also must meet
certain requirements, including having an active regulatory research pro-
gram, evidence of productivity, and a record of outstanding mentoring.
Currently, there are 12 fellows, with 4 getting ready to transition out,
said Wiest. Two of these fellows will be staying at FDA, and one will be
joining a biotechnology company. Twelve past fellows work at FDA, four
have joined pharmaceutical companies, one joined NCI, one went into
consulting, and one works in the health care industry.
9 The first two programs are targeted to cancer researchers with an M.D. or M.D./Ph.D.;
one offers a medical oncology residency (for up to 3 years) and the other is for board-
certified or board-eligible oncologists (for up to 1 year). The second two are targeted to M.D.
scientists; one is for basic scientists and molecular biologists (for up to 2 years) and the other
is a cancer prevention fellowship (for up to 3 years).
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