Clinical Research and Regulatory Affairs

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Increasing the odds of effective drug development:

Elevating regulatory affairs professionals to
strategic partners

Daniela Drago, Markus Yap & Ozgur Ekmekci

To cite this article: Daniela Drago, Markus Yap & Ozgur Ekmekci (2016): Increasing the odds
of effective drug development: Elevating regulatory affairs professionals to strategic partners,
Clinical Research and Regulatory Affairs, DOI: 10.3109/10601333.2016.1152661

To link to this article: http://dx.doi.org/10.3109/10601333.2016.1152661

Published online: 16 Mar 2016.

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 CLINICAL RESEARCH AND REGULATORY AFFAIRS, 2016
http://dx.doi.org/10.3109/10601333.2016.1152661

RESEARCH ARTICLE

Increasing the odds of effective drug development: Elevating regulatory affairs

professionals to strategic partners
Daniela Dragoa, Markus Yapa,b,c and Ozgur Ekmekcia
a
School of Medicine and Health Sciences, George Washington University, Washington, DC, USA; bKrieger School of Arts and Sciences,
Johns Hopkins University, Baltimore, MD, USA; cUS Food and Drug Administration, Silver Springs, MD, USA

ABSTRACT ARTICLE HISTORY

In today’s globalized drug development landscape, the need for regulatory professionals to be Received 20 September 2015
more seamlessly integrated into strategic decisions is evident. Whereas a few companies see the Revised 10 December 2015
benefit of involving regulatory affairs professionals in strategic business decisions, many still lag Accepted 5 February 2016
behind. Limited literature and scholarly discussion is available on whether regulatory affairs Published online 15 March
professionals are given the stature and power to make a meaningful contribution during strategy 2016
formulation across all stages of the product development, launch, and life-cycle management. This KEYWORDS
article examines the current business environment for the regulated industries; discusses why it is
Downloaded by [Gazi University] at 09:17 30 March 2016

Regulatory strategy;
important that regulatory affairs play an active and strategic role in this sector; and proposes a new regulatory education;
educational perspective to facilitate the recognition and acceptance of regulatory affairs competencies
professionals as strategic partners.

Introduction Some companies, however, seem to have already

There is growing consensus that effective regulatory
strategy is critical to an organization’s success (1–3).
Regulatory professionals argue that, if a pharmaceutical
company wants to flourish, the regulatory affairs function
must be a fully integrated strategic partner (4,5). Through
articles in the trade press and talks at international
regulatory conferences, members of the profession have
lobbied to elevate the representation level of the
regulatory function within the broader business govern-
ance structure. Regulatory affairs professionals, they
argue, should be given executive recognition for their
specific expertise similar to the way marketing directors
are offered recognition for their marketing expertise.
Many pharmaceutical companies seem to be oblivious
to the added value of involving regulatory affairs
professionals in strategic business decisions during all
stages of the product development, launch, and life-
cycle management. Examples that illustrate how dama-
ging and shortsighted such an approach can be are the
cases of 23andMe and Theranos. The two companies,
both located in the US, have recently faced regulatory
challenges due to insufficient inclusion of regulatory
strategy into the company’s business decisions. To its
credit, 23andMe, a direct-to-consumer genetic testing
services firm, has since remedied its regulatory deficien-
cies, while Theranos, a direct-to-consumer diagnostics
blood testing startup, is still in the midst of a crisis.
unlocked the potential of having the regulatory function
fully engaged in conversations that involve strategic
vision and direction (6). Needless to say, being involved
in strategy formulation increases the chances of effect-
ively integrating regulatory constraints and opportu-
nities into a company’s long-term vision. Nonetheless,
there is still scarce literature on whether regulatory
affairs professionals are given the stature and power to
make a meaningful contribution during strategy
formulation.
The central premise of our argument is that, in today’s
landscape, the need for the regulatory function to be
more seamlessly integrated into strategic decisions is
evident. In this paper, we: (1) examine the current
business environment for the regulated industries; (2)
discuss why it is important that regulatory affairs play an
active and strategic role in this sector; and (3) propose a
new educational perspective to facilitate the recognition
and acceptance of regulatory affairs professionals as
strategic partners.
Overview of current biopharmaceutical business
environment for the regulated industries
Greater competition, globalization, and a rapidly evol-
ving business environment have started forcing compa-
nies to focus on added value, effectiveness, and

CONTACT Daniela Drago drago@gwu.edu George Washington University, 2100 Pennsylvania Avenue, Suite 362, 20037 Washington, DC, USA

ß 2016 Taylor & Francis

 2 D. DRAGO ET AL.
reduction of costs (7). This change is visible in many
organizations, including the pharmaceutical and biotech
industries (8,9). Companies operating in a high-regulated
environment must face additional challenges.
Mainly in response to new technologies, increasing
regulations, and improved understanding and expect-
ations of patients’ needs, the regulatory landscape has
evolved dramatically (10). From a technology perspec-
tive, recent years have seen a remarkable drive towards
personalized medicine, advancements in genomic map-
ping, and novel mAb therapies for oncology, which
initiated a number of changes.
Box 1. 23andMe and Personalized Genetic Testing (PGT)
services.
After 13 years of multiple international teams’ collaborations, in 2003 the
Human Genome Project to sequence the entire human genome was
completed, opening the pathway for Personalized Medicine, defined as
customized diagnostics and therapy based on an individual’s unique
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genome sequence. Genetic tests for BRCA1/BRCA2 and Huntington’s disease,
for example, were particularly predictive. As the technology matures and
competition rises to provide direct-to-consumer genetic testing services, the
price of sequencing a full genome fell from a few hundred thousand dollars
in 2007 to a few thousand dollars currently. Making the technology more
accessible is the rise of lower cost SNP (Single Nucleotide Polymorphism)
chips, which sample the genome at specific locations in DNA known for their
high correlation with hundreds of diseases and conditions. These correl-
ations were mostly far less predictive of future disease than the rare variants
detected by sequencing genes such as BRCA1/BRCA2. In 2007, 23andMe and
several other competitors announced their intention to sell SNP chip genetic
testing kits directly to consumers, even before obtaining pre-market
clearance/approval from regulatory agencies such as the Food and Drug
Administration (FDA), and the European Medicines Agency (EMA) (11). The
intent to sell directly to consumers was particularly alarming for clinicians
and the regulators, since the accuracy of the tests had not been validated,
leaving uncertain the rates of false positives and false negatives.
Furthermore, since the tests can be ordered directly by consumers, the
risk increased for consumers to take drastic medical actions based on a
potentially false test, without consulting with medical professionals.
Focusing on meeting patients’ needs, the patient
center benefit-risk framework published by MDIC
(Medical Device Innovation Consortium) outlines a
framework for the incorporation of information on
patient preferences into the regulatory Benefit-Risk
assessment (12). Such initiatives represent selected
examples, which are leading to the development of
the domestic and international regulatory landscape.
Over time, the FDA, the EMA, the Pharmaceuticals &
Medical Devices Agency (PMDA), and other regulatory
agencies around the world have increased their over-
sight of the products they regulate. As a result, reporting
and evaluating data on quality, safety, potency, and
efficacy of medical products have become increasingly
complex (13). Additionally, increasing demands from
payers for affordable quality healthcare are also
encouraging a revision of traditional business models
(14).
To stay abreast of competition, it is now more critical
than ever to succeed in shortening a drug’s R&D cycle.
Although the estimation of the cost of drug develop-
ment is not yet grounded in a uniformly accepted
standard, the reported development cost for the average
drug may reach up to USD 2.6 billion (the figure is based
on information provided by 10 pharmaceutical compa-
nies stating an investment of $1.4 billion in R&D
development plus $1.2 billion investment in ‘time
cost’) (15).
At a time when R&D costs continue to increase, and
business models continue to change, the ability to
obtain first-cycle product approvals is probably one of
the most significant indicators of the performance of a
pharmaceutical company. In 2010, a white paper pub-
lished by Parexel Consulting estimated that getting a
new drug through the approval process at first attempt
in the US is worth, on average, almost USD400 million in
sales (16). Additionally, the increased attention to
effective risk management at a governance level would
also call for a more strategic role of regulatory affairs
professionals, as reputational risks constitute one of the
focuses of the strategic agenda of senior executives. The
case of 23andMe helps substantiate this claim. In the
regulated medical product industry, ignoring the regu-
lators may not be a viable strategy; instead, a compliant
and collaborative relationship is often a more productive
path. Medical product executives would be better served
actively engaging and trusting their regulatory affair
professionals in their commercialization planning, such
as introducing new products in the market or embarking
on a major marketing campaign.
Strategic regulatory professionals acting as business
partners are critical in successfully implementing mer-
gers and acquisitions, providing recommendations to
navigate the regulatory pathway for personalized medi-
cine, and ensuring the inclusion of patients’ perspectives
into regulatory filing.
Box 2. Co-development of Herceptin and its companion
diagnostics.
Genentech developed Herceptin—the first therapeutic antibody targeted to
a specific cancer-related molecular marker (HER2) to receive FDA approval—
and filed the first Investigational New Drug Application (IND) in 1992 (17).
Subsequently, the company partnered with Dako to develop a commercial
test to identify patients who over-express the HER2 protein. The HercepTest
is a semi-quantitative immunohistochemical assay for determination of HER2
protein (c-erbB-2 oncoprotein) over-expression in breast cancer tissues (18).
The biologic license application (BLA) for Herceptin and pre-market approval
(PMA) for HercepTest were filed simultaneously in May 1998. In September
1998, Herceptin’s BLA was approved under priority review, which concluded
1 month earlier than planned. The Dako HercepTest was approved on the
same day as the drug (17). A critical success factor for the Herceptin/
HercepTest case was the continuous engagement between the regulatory
functions in both companies and the two responsible centers at FDA. Senior
management in both companies recognized early on the pivotal role of the
regulatory functions and provided them with the authority, latitude, and
flexibility that ultimately enabled the submission to be approved in a record
time of 5 months.

Given this overall context, it is puzzling that leaders of
regulatory functions in many organizations do not report
directly to the CEO. An analysis of the organizational
structure of large and mid-size pharmaceutical compa-
nies located in the US, conducted in 2012 by KPMG,
revealed that less than 25% regulatory affairs functions
report to a C-level executive (19). Since, for similar
compliance and ethics functions from both private and
public companies, in addition to non-profits, this percent-
age does not fall below 40% (19,20), it is fair to suggest
that regulatory affairs functions do not receive adequate
representation in board rooms, as strategic partners.
Importance for regulatory affairs professionals
to play an active and strategic role in the
biopharmaceutical industry
When ties to the C-suite are weak, a function risks being
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removed from key business decisions. Such disconnec-
tions can be detrimental, since the executive decision-
makers are likely to lack key information required to
make meaningful strategic decisions. A healthy govern-
ance structure in an organization cannot be established
at the exclusion of a major stakeholder. Without
regulatory professionals at the table, the risks and
opportunities of new initiatives cannot be thoroughly
analyzed, anticipated and—if appropriate—mitigated, or
enhanced.
Box 3. The curious case of Theranos.
Theranos is a private Silicon Valley start-up company with ambitions to
provide faster, cheaper, less painful, and highly accurate blood-based
diagnostic testing to American consumers. Given its potential to change the
business model of the diagnostics industry in the US (dominated by
companies such as Quest Diagnostics and LabCore), Theranos has recently
achieved a valuation of $9–10 billion and became one of the very few Silicon
Valley Unicorns (private start-up companies with multi-billion dollar
valuations, such as Uber and AirBNB). What is the secret recipe of
Theranos? Instead of drawing blood from the median cubital vein through
the typical venipuncture technique (filling one or more vacutainers),
Theranos uses small nanotainers from a finger prick (21). Hence, less
blood is drawn, the procedure is less painful for the patients, fewer reagents
are used to test the blood, and there is a quicker turnaround of the results.
Theranos also attempts to provide transparency in its low pricing (listed on
their website, some tests are priced almost an order of magnitude less than
competitors) and has been instrumental in getting state legislations passed
in Arizona allowing consumers to order their blood test without clinicians
orders (21). However, recently the Wall Street Journal has published several
expose articles that shine some light on Theranos operations and truth in
their claims, including recent unannounced inspections by US FDA and
findings that the nanotainers have been marketed in the US without prior
clearance/approval from the FDA (except for Herpes test use) (22–24). The
company founder has vigorously fought back against the allegations and
attributed the situation as temporary fixes while Theranos is ‘moving from
CLIA regulatory framework into FDA regulatory framework’. The saga
continues, since the company has multiple pre-market submissions currently
under review by FDA.
During the last few decades, the evolution of a more
complex business environment has necessitated C-suite
executives to include additional functions in the
CLINICAL RESEARCH AND REGULATORY AFFAIRS 3
governance structure. As a result, the role of a number
of functions (such as Finance, Human Resources (HR),
and Information Technology (IT)) has shifted dramatic-
ally. Although leadership has traditionally viewed these
departments as merely operational areas, the mentioned
departments have transformed into functions with ever
increasing influence to become key strategic partners
(25–27). Professionals in these functions have become
valued members of the executive management team
and active participants in the decision-making process.
Inclusion of HR and IT in strategic planning has also
improved employees’ and the leadership teams’ percep-
tions of such functions. In the early 1990s, Schuler (28)
had already emphasized the opportunity for the HR
function to transition from an ‘employee advocate’ to a
‘member of the management team’. To be successful in
this shift, he recommended to HR professionals to be
concerned with the bottom line, profits, and organiza-
tional effectiveness.
Similar to the way HR and IT have progressed in their
transformation from a support function to a strategic
partner, regulatory professionals also need a seat at the
table. The conditions present throughout the current
landscape on which regulatory professionals operate,
present a strong case for such transformation, and
demand the need to recognize professionals in this field
as strategic partners. Companies that view regulatory
affairs as a strategic partner, and have processes to
ensure that they work closely with this function, also
possess a competitive advantage (29). In high perform-
ing companies, the regulatory intelligence and the
competitive intelligence functions collaborate closely
(30). This synergy allows companies to have a better
view of the competition in the market place. For these
reasons, including broader recognition of regulatory
affairs, as a strategic business partner, across the industry
would enable better decision-making because it would
meaningfully integrate pivotal constraints and opportu-
nities through collaborative practice to advance the
organization’s development of human capital.
The ability to collaborate across functions on regula-
tory issues is not only key for developing and elevating
talent, but it also has a substantial impact on the bottom
line. As exemplified by the 23andMe and Theranos
stories, when regulatory affairs professionals are not
perceived as partners, they may encounter challenges in
helping the business:
 engage with regulators;
 monitor regulatory landscape, effectively providing
valuable regulatory intelligence;
 co-ordinate the development of positions pro-
actively; and
 provide vital insights on competitors.
 4 D. DRAGO ET AL.
In organizations where the regulatory affairs function
is involved only in a passive manner—for example by
asking this function to fix a problem after the fact, rather
than help preventing it from happening—professionals
working in this function may become alienated. Failing
to consider the regulatory implications of a specific
course of action can be disastrous for an organization.
Making mid-course corrections when trying to get
products on the market not only wastes valuable time,
but also it may lead to significant economic costs. There
are many where the lack of regulatory professionals’
imprint may have resulted into a substantial impact on
the business outcome of regulated products. The
majority does not catch the media’s attention, or even
surface to the public’s knowledge, or can be substan-
tiated by publicly available information. They are less
apparent than 23andMe or Theranos and tend to be
intertwined with proprietary knowledge that is not
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disclosed.
Companies might realize only after spending a
substantial amount of money, time, and resources, that
elevating the regulatory function to a true business
partner is the best way to ensure successful
commercialization.
Box 4. 23andMe Rebounds.
In the summer of 2012, after receiving a Warning Letter from FDA for
marketing its Direct to Consumers (DTC) PGT kit without FDA’s approval,
23andMe announced a 510(k) submission seeking marketing clearance for
the 200+ genetic tests its PGT kit offers (31,32). By summer of 2013 it
became obvious that the company was having difficulty in getting the
510(k) clearance, since it was unable to comply with FDA’s request for
additional information on the clinical validity of the tests. Instead of
withdrawing its PGT offering, 23andMe decided to ignore FDA and embark
on a massive marketing campaign with the goal to sell a million PGT kits in
the US by yearend (33). In November 2013, FDA issued a Warning Letter to
the firm and 23andMe soon thereafter withdrew its PGT offering from the US
market (34).
Subsequently, for the next 2 years 23andMe worked hard to patch up
relations with FDA and to obtain clearance/approval for a sub-set of its test
offering by providing clinical test results. In October 2015, 23andMe’s PGT
offering came back to the US market, albeit with a reduced number of tests
(35).
An educational perspective to facilitate the
recognition and acceptance of regulatory affairs
professionals as strategic partners
Regulatory professionals require a strong and credible
voice to earn and maintain a seat at the table. To be
effective in a strategic partner role, they need to excel at
working collaboratively with other function leaders and
demonstrate business acumen. Today’s regulatory pro-
fessionals need to present themselves as educators,
ambassadors, negotiators, problem-solvers, and not only
as gatekeepers. In doing so, regulatory professionals can
better balance executive’s perceptions from ‘overly
cautious’ gatekeepers to going to market enablers.
In the last several years, there have been positive
developments regarding the perceived role of regulatory
affairs professionals. For example, in a report of the
Regulatory Affairs Professional Society (RAPS) in 2010,
the organization published data on self-perception of
regulatory professionals, in which respondents rated the
‘perceived value and importance of regulatory profes-
sionals by senior and executive management in their
organization’ (p. 1) (36). Results indicate that the image
of the profession improved over the years. On average,
regulatory professionals working in industry reported
that they believed senior and executive management in
their organization perceived them as ‘valuable’ (using a
5-point scale from ‘highly valuable’ to ‘not at all
valuable’). In spite of what seem to be promising
recent developments, overcoming a negative image
and past reputation, while building new credibility, is
challenging. As Guido and McEmber (37) state:
‘In that not-too distant past, the regulatory affairs role
seemed to only be comfortable with the application and
interpretation of black-and-white rules. The regulatory
practitioner was typically seen as the policeman [. . .]. In
many cases, the designation of the regulatory affairs
function as registrations signaled the attitude that this
was solely a mail stop that received completed product
(that is, documentation) for subsequent transmission to
regulators for approval’ (p. 188).
We believe that one of the obstacles for the regula-
tory affairs functions to rise to a role of strategic partners
is image. The image that one projects becomes the
perception that others hold about that particular entity.
Perceptions are key, as they are difficult to modify.
However difficult it might be, transforming an entity’s
image in the positive direction is not impossible and, as
discussed earlier, other functions—such as HR and IT—
have been successful and somewhat already paved the
way.
Based on Social Identity Theory (38) one of the
fundamental ways through which professional entities
can transform their image—in a manner that promotes
and advances its public perception—is how the entity
defines the distinguishing set of competencies that sets
the entity apart from others. The same theory suggests
that there is mutual dependency between the self-
concept of the entity and the perceived image—that is
the public perception—of the entity. In other words,
the more highly an entity thinks about its own image,
the more the public perception improves (and vice
versa). Therefore, it is critical that—when defining the
set of competencies for regulatory affairs profes-
sionals—these competencies are defined in a manner

that promotes and fortifies the profession’s strategic
role.
So, what types of competencies should today’s
regulatory affairs professionals focus on developing as
they strive to be recognized as strategic partners? The
trends may vary, although not substantially, by geog-
raphy, product categories (e.g. medical devices vs
pharmaceuticals), and by company (due to different
companies’ cultures and priorities). Nevertheless, we
have seen some clear signals about how regulatory
affairs jobs are evolving and can identify some of the key
skills that companies seek now.
The luxury of educating new regulatory affairs
professionals only internally—by way of on-the-job
exposure training—is no longer a sustainable model
for many companies, which is why alternative avenues,
including elevating the role of academic institutions in
formally educating the next generation of regulatory
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professionals, has been explored (39). To help prepare
regulatory affairs professionals for the new challenges
facing them, some academic institutions have begun to
incorporate new competencies into their curricula and
to offer innovative Regulatory Affairs/Science programs.
For that matter, as we glance at the future of the
profession, strategy has been identified as one of the five
key competency domains that should drive the way
regulatory affairs professionals receive their formal
education (39). The ability to function effectively as
part of inter-professional teams; apply lessons learned
from the past towards solving future problems; partici-
pate in the formulation of approaches to support
strategic enterprise-level objectives; and walk the fine
line between ensuring compliance and promoting
innovational thinking constitute the principle elements
of a comprehensive educational foundation on which
regulatory affairs professionals can build careers that
involve valuable strategic contributions.
While the changes in regulatory landscape may seem
daunting, they provide an opportunity for the commu-
nity of regulatory educators, academics, and practi-
tioners. Indeed, the growing belief that regulatory
strategy is vital to increase the odds of drug develop-
ment sets forth a new vision wherein regulatory educa-
tion plays a decisive role. We believe in the need for a
transformation in regulatory education, beyond the
traditional on-the-job training, and invite our colleagues
to join us in creatively envisioning it. Clearly defining
how regulatory professionals are academically prepared,
their competencies, and their scope of practice is a
pivotal step.
Competency-based regulatory education, which must
include a strategy domain, helps the regulatory field to
chart its educational expectations in response to the
CLINICAL RESEARCH AND REGULATORY AFFAIRS 5
evolving demands placed on today’s workforce.
Additionally, it puts the regulatory field on the same
type of trajectory as other healthcare disciplines (40–42).
This vision inspires a blueprint to ensure that the
regulatory function is seen as a consistent strategic
member of the drug development team. The trend is
that members of these teams, similarly to healthcare
teams, focus on a culture of competency-based educa-
tion with both discipline-specific and, beyond that,
shared, team-based, inter-professional competencies.
There is a strong call for the educational regulatory
community to put the strategy domain at the forefront
of the core curriculum for regulatory educational
programs. With this article, we hope to stimulate
discussion about the status and future direction of
regulatory education and how it will contribute to
advancing drug development globally. Such dialogue
will hopefully lead to action that strengthens regulatory
education. We believe this is key to equip the next
generations of regulatory professionals not only with
core competencies to succeed in their respective fields,
but also to allow them to lead change and play a key
role in the delivery of safe, high quality, effective, and
accessible medicinal products.
Disclosure statement
M. Yap is a staff member at the FDA. The views and
opinions expressed in this paper are those of the authors
and do not represent FDA’s views or policies. The
authors have no other relevant affiliations or financial
involvement with any organization or entity with a
financial interest in or financial conflict with the subject
matter or materials discussed in the manuscript apart
from those disclosed.
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