1. WHITE PAPER
Executive Summary
True value in oncology care is the result of focused collaboration across all stakeholders, but most notably, physicians,
payers, pharmaceutical companies, and patients. Each of these groups has a central role in defining the cost of and
access to future cancer therapies. Given the increasing spend to develop effective drugs in an environment of tighter
regulation yet lower profit margins, value-based medicine must now meet aggressive cost expectations as well as provide
enhanced outcomes. Herein, we describe the current factors and perspectives that are shaping the value of oncology drug
development now, and how these elements can be leveraged such that the new patient-oriented model can deliver real
benefit and sustainability, as well as access, in the global marketplace. Through the innovative design of clinical studies
and increased focus on quality outcomes, regulators have begun to reward central stakeholders engaged in the pursuit
of this new delivery model. Coupled with the evolution of de-identified “big data” sets and its use to motivate and inform
the practice of value-based oncology, evidence of and expectations for accelerated progress have never been higher.
We provide here some thoughts on how to get the most out of these current developments and advances.
Oncology Molecule Value Demonstration:
The Shifting Sands of Stakeholder Expectations,
and the Role of Real-World Evidence
John Doyle, Dr.P.H., M.P.H. Harish P. Dave, M.D., MBA Jean-Louis Merot, M.D.
Tanja Hadzic, MS, Ph.D Chris A. Learn, Ph.D, PMP
2. www.quintiles.com | 2
Executive Summary 1
Introduction 3
Information as Medicine: Equitable Access and Enhanced Value 4
Value Derived from Real-world Performance 4
Comparative Effectiveness Research 5
Reforming Value and Valuing Reform 6
The Changing Face of Fundamentals 7
Slow to Rise No Longer 7
Oncology Real World Research in Practice 8
New Challenges of Such Alternative Designs to Oncology Research Teams 9
Navigating the Shifting Sands and Adaptation to “Fast Tracking” Process 9
References 11
About the Authors 13
table of contents
3. 3 | www.quintiles.com
INTRODUCTION
Real-world evidence development and value demonstration in the broader context of
healthcare system reform is a continued, daunting challenge for all stakeholders in the
biopharmaceutical industry. Furthermore, this transformation is in its early stages, making
its further progression and sustainability uncertain. Even when earnest attempts are made
to focus on and evaluate just a few of the variables in play, the myriad inter-connected
components in the system complicate the picture quickly. The growing costs and intensified
scrutiny on pricing in oncology reflect increased incidence and prevalence of many tumor
types. Changing lifestyles and demographic shifts, such as rise of the middle class in
emerging markets, are compounding the epidemiologic changes currently being observed.
New market entrance into the biologics space, for instance biosimilars, is also altering
the oncology landscape. Due to reform in the United States, Europe, and the emerging
markets, there is a catalyst for change that is changing the focus of decision-making. Health
Technology Assessments (HTAs) and related risk-management decisions are devolving from
the national level to regional and local levels in both public and private sectors. This effect
precipitates a change in strategy for biopharmaceutical companies and their approach to the
market, as understanding the fine detail and granularity of treatment patterns and patient
outcomes at a local level is a must in order to support the decision-making process by policy
makers at a global level.
A new approach to healthcare delivery is thus expected, and is currently underway in
the United States. Given the advent of reform with new models like Accountable Care
Foundations (ACOs) and Patient Center Medical Homes (PCMHs), there is a fundamental
a shift in how payers and providers interact. As evidenced by new payment models being
rolled out, payers are not only shifting risk to providers but also to patients. Accordingly,
patients are acting more like consumers as they assume more financial risk in their healthcare
choices. This empowerment of patients can lead to a very profound consolidation of market
forces for various stakeholders in the system, such that improved patient outcomes become
a reality, with real-world consumer data helping to deliver those outcomes.
Currently, there appears to be a shift in the way oncology value is perceived. This is
manifest through the numerous changes of reform and in benefit designs by many private
payers. Naturally, the increased prevalence of specialty tiers results in increased economic
burden and out-of-pocket expenses borne by patients, such that there is justifiable concern
regarding affordability and accessibility to new technology in an equitable way.
The increased prevalence of oncology specialty tiers results in
increased economic burden and out-of-pocket expenses borne by
patients, such that there is justifiable concern regarding affordability
and accessibility to new technology in an equitable way.
4. www.quintiles.com | 4
Information as Medicine: Equitable Access and Enhanced Value
This paradigm shift is occurring globally, even in the emerging markets where discord arises
between the populations with and those without proper access to new oncology therapies.
Beyond the price of oncology therapies, improving equitable access across all facets of
public health must be considered by viewing the healthcare system as a whole and not just
by considering individual actors in the system. Rather, the challenge here is more about
interdependent parts of the system that have to act in a cohesive manner for the system to
operate optimally.
To this end, the hub of an envisioned cohesive system is real-world information garnered
from data and analysis from all reaches of the healthcare system. This approach requires not
only intense focus at the patient level point of care to precipitate change, but also evaluation
of macro-level variables to better understand outcomes at a population level. To be both
effective and efficient, public health thinking must be adopted to spur cohesive partnerships
between all of the different actors on a global stage: patients, pharmacists, biopharma
companies, managed-care organizations, and providers.
As with evidence-based medicine, providers and payers are beginning to interact in a new
way that is more data-driven, because payers want to provide reimbursement based on
quality-metrics and outcomes. This way, real-world data are helping to align incentives
between providers and payers around patients. As a result, biopharma companies and
managed-care organizations in the United States are partnering in real-world research
for the express purposes of better understanding value-driven patient outcomes.1
In integrated care management, ACOs and PCMHs are not just becoming established
in the United States, but, in varied forms, internationally as well. There is new alignment
between the providers and the patients with a focus on patients as consumers. As patients
are treated more as consumers, there is an accepted understanding that these consumers
will need to make decisions based on better data in concert with their advocates and agents
(i.e., providers of the healthcare). The real-world data and their transparent sharing in a way
that permits patients, their agents, and their advocates to make better informed decisions is
what makes this system so highly functional.
When examining the United States healthcare system and some of the changes that will
significantly alter the mountainous landscape for the way drugs in oncology are developed
and commercialized, it becomes evident that there is incentive for more ACOs. In its earliest
stages, this is primarily catalyzed by government and efforts brought through reform,
as about half of all ACOs formed today are really contracted by the Centers for Medicaid
and Medicare Services (CMS). The true importance of this development is that it is now
cascading throughout the marketplace as a private sector phenomenon. For example,
executives at CIGNA and AETNA, two of the leading payers in the United States, have
suggested that their companies are going to grow their business going forward through
the use of ACOs.2
Value Derived from Real-world Performance
A question bound to arise from these developments is “what does this means for oncology?”
The line between payers and providers is blurring, and providers are beginning to act more
like payers while payers are beginning to act more like providers. The system is becoming
To be both effective
and efficient, public
health thinking must
be adopted to spur
cohesive partnerships
between all of the
different actors
on a global stage:
patients, pharmacists,
biopharma companies,
managed-care
organizations, and
providers.
5. 5 | www.quintiles.com
more patient- and consumer-oriented, such that newly formed ACOs have to assume risk
with reimbursements essentially based on the quality of the care provided and measured in
a variety of ways. Notably, risk can be adopted across the entire spectrum, from the acute to
the lifelong chronic. ACOs and other integrated models, however, are beginning to govern
risk, and to understand the way they do so is to understand how their care is being provided
and what the metrics look like at a granular level.
Additional challenges arise in the possible discordance between how a drug performs in
the experimental setting versus its application in the open market. Often when the product
is launched, the patients who take the product, especially in oncology, are older and sicker
than the individuals taking part in the clinical trials that led to the drug’s approval, and
fail to adhere to dosing and care regimens. In addition, providers do not provide care
in the manner that is consistent with the randomized clinical trial setting. Under these
circumstances, uncertainty becomes very prevalent. Only when the data of real-world
performance in oncology are gained can we enable the payers, the providers, and, most
importantly, the patients to make better data-driven decisions.
Both the United States Food and Drug Administration (FDA) and the European Medicines
Agency (EMA) have undertaken a focused initiative to become more patient-oriented and
more quantitative in how they assess products’ risk-benefit profiles. The positive change
that is occurring today in terms of regulation is rooted in additional checkpoints in the
development and commercialization process, specifically in the regulatory appraisal of the
risk-benefit of a new product, whom make decisions differently based on their risk tolerance,
their current health state and their own personal appraisal of outcome and quality of life.
From the payer perspective, the work by Porter3
et al. on measuring the value of healthcare
was particularly valuable as it focused on inputs and outputs from a business standpoint.
However, there are numerous variables that remain poorly defined, including patient
compliance and genomics. Despite the fact that even the most sophisticated analysis can
demonstrate an oncology product to be cost effective, if behavior in the provider and patient
networks of members remains unchanged, then true value will not be realized regardless
of the effort.4
Given this limitation, there is an implicit need to gather the right intelligence
from real-world data and translate that intelligence into packets of information for providers
and patients, so that they understand the incentives to change their behavior.
Comparative Effectiveness Research
To further investigate one aspect of these behaviors, approximately half of the payers
in the United States engage in Comparative Effectiveness Research (CER). According to
this research, about half of these payers believe that CER initiatives will improve patient
outcomes.5,6
However, participants interviewed about CER studies and supporting health
technology assessments are not as confident that CER studies are actually translating into
cost savings. Unfortunately, this then becomes a critical impasse to improving the treatment
process and patient behavior as it suggests that cost savings will likely not be achieved if
behavioral change is also not achieved.5,6
The positive change
that is occurring
today in terms
of regulation is
rooted in additional
checkpoints in the
development and
commercialization
process.
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In terms of payer behavior, approximately half of payers polled believe that there should be a
patient-oriented approach that looks at quality of life, rather than just looking at product features
and attributes.5,6
To facilitate this conversion, real-world data focused on patients at the point
of care are needed to better equip providers with tools to help patients make better informed
decisions. Real-world data at the population level are also critical in helping payers and policy
makers make necessary decisions. There is another set of macro-variables at the population level
that do not exist at the patient and provider level. Pharma is just beginning to embrace this new
level of complexity when trying to empower agents of change in the marketplace.5,6
Reforming Value and Valuing Reform
In the United States, and now expanding globally, the concept of the “Triple Aim” is
becoming established. Championed by Don Brewerick and CMS a few years ago, the “Triple
Aim” states its first tenet is that (1) individuals have goals and payers want to improve the
quality of the experience for the individuals as they journey through the system. In addition,
the need to improve patient population health outcomes in a measurable way
(while reducing cost) are the second and third elements of this concept, respectively.7
In the United States, the FDA and CMS, and in Europe the EMA and Health Technology
Assessment (HTA), are beginning to talk more about how to converge around these aligned
incentives. Questions that arise from efforts to align incentives include “What type of real-
world data can be shared to measure real-world drug performance so that the risk-benefit
profile can be quantified and assessed?” and “Can those measurements be sustained over
time and translated into an evaluation?”
Great effort is required in uncovering the disadvantaged and rare disease populations
in the healthcare system to accurately measure unmet medical needs. Increasing the
level of real-world data will directly support analyses regarding the level of unmet medical
need. That is important going forward, because the FDA and EMA are experimenting with
adaptive licensing, which should be done in concert with coverage of evidence development.
Global healthcare reform has engaged new requirements on spending levels by insurance
companies on the quality of care and that has spurred more partnerships between
biopharma companies and manage-care organizations. And while risk sharing agreements
and value based insurance design appear very promising at face value, they are not without
their own challenges. Collecting real-world data, for instance, is not only an administrative
burden, it is costly. Thus, it is not only necessary to be highly selective with the method of
execution but also alignment of incentives for different stakeholders in the healthcare system
to (1) use market intelligence to inform study design, (2) ensure quality in the system, and
(3) improve patient outcomes. Only when these aspects are achieved is it reasonable to
consider that value in oncology can be improved.
Questions that arise from efforts to align incentives include “What
type of real-world data can be shared to measure real-world drug
performance so that the risk-benefit profile can be quantified and
assessed?” and “Can those measurements be sustained over time
and translated into an evaluation?”
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The Changing Face of Fundamentals
Over the last 20 years, the key change in oncology research and treatment development
has been in the molecular revolution, through the advancement of genomics, proteomics,
and metabolomics. The field, in general, has moved from observational pathobiology
to molecular characterization, thus changing how oncology is fundamentally viewed,
researched, and clinically tested. The research community has begun to segment the
oncology field into 1,000 or more oncology diseases based on molecular criteria, which
require developing therapies for niche indications. Some specific molecular features of the
diseases that give rise to clinical characteristics are well understood, but others remain
unclear. It is overly simplistic to equate one mutation to one disease. Though this may be
the case in a small number of instances, more often than not the collective effects of specific
molecular features remain unknown.
The consequence of fragmentation in oncology classification is difficulty in developing
a blockbuster drug capable of effectively treating a large number of cancers based on
histological type. Instead of a blockbuster drug a series of niche-busters can be developed
with the same eventual outcome. Large monolithic diseases, such as breast cancer or non-
small cell lung cancer, which are now sub-divided based on their mutation patterns, could
qualify as orphan diseases. These indications then automatically become candidates for
orphan drug development or other opportunistic approval mechanisms that regulators
put in place to allow drugs to come to market faster. However, with more rapid entry
into the market, the onus then falls on analyzing application and value, through real-world
data as previously described.
Slow to Rise No Longer
Historically, oncology drug development and drug entry into the marketplace has been
slow paced and labored. However, as we move into the era of targeted therapies, a better
understanding of the molecular basis of cancer has led to a large number of tyrosine kinase
inhibitors and biologics coming to market that specifically target a particular mutation
or a marker. So what are the different approaches that can be taken in accelerating drug
development? Orphan drug designation in oncology is a large and growing market of $30
billion in annual sales. Thirty-six percent of the global market in oncology drug development
is already within the orphan designation with a still increasing pipeline classified as orphan
drug.8
These developments support the notion of increasing governmental incentives and
accelerating regulatory timelines to move orphan drugs forward.
Other means of accelerating drug approvals is to simply show meaningful therapeutic
benefit over other treatments, even if overall survival is not superior. The key here, as with
all available accelerated mechanisms, is to successfully perform post-approval studies to
verify the predicted effect on morbidity, mortality, or other clinical benefit. This cannot be
done in isolation, so emphasis on phase IV studies is paramount. “Fast Track” designation
by regulatory bodies is predicated on new drugs that have limited data but are thought to
significantly improve outcome for serious or life-threatening conditions without the standard
requirements for more extensive testing in pursuit of approval. “Fast Track” approvals
accounted for over half of all approvals in oncology in 2011 and the submissions rate under
this designation is growing, having included the much heralded Zelboraf™
(vemurafenib),
Xalcori™
(crizotinib), or Adcetris™
(brentuximab).9
Orphan drug
designation in
oncology is a large
and growing market
of $30 billion in
annual sales.
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In terms of newer mechanisms to expedite development, the FDA’s “Breakthrough”
designation, launched in 2011, is not specific to oncology. Since its launch, FDA has given
Breakthrough designation to only 13 drugs in oncology.10,11
Requirements for Breakthrough
designation, similar to “Fast Track” criteria, include having the drug provide clinically
significant benefit in serious or life-threatening conditions or be substantially better than
existing therapies in terms of one or more clinically significant endpoints. The FDA may
assign this designation at any time following the submission of an Investigational New
Drug application.10,11
Therefore, regulatory timelines for drug development are getting shorter and mechanisms
for expedited drug development are increasing. Going forward, additional data submitted
to regulators will be the key and renewed emphasis is likely to be placed on phase IV studies.
The critical requirement of phase IV studies is mandatory supportive data throughout
periodic reporting, which can be challenging since rapid approvals may not necessarily
lead to long-term understanding and/or approvals. At this intersection, the focus should
be on “big data” to help coordinate information and collective understanding across
the continuum.
Oncology Real World Research in Practice
In terms of real-world data and value in oncology, two case studies are illustrative of the
points just mentioned. The first study was aimed at evaluating Health Resource Utilization
(HRU) in patients suffering from bone metastases and was undertaken by a pharma company
developing a drug with a beneficial effect on skeletal clinical events, which were defined as
episodic fractures, skeletal bone compression, surgery, or radiation.
The goal was to provide multiple stakeholders, such as reimbursement authorities, HTA
bodies, or payers in several European nations with meaningful recent data specific to skeletal
events. In terms of study design, the specific objective of this study resulted in having an
alternative design from the classical randomized clinical trial. This real-world study design
offered oncology teams a new and different approach to combining a new observational
design with no investigational drugs, no mandatory procedures, and fixed schemes.
In addition, prospective and retrospective data collection, based on the occurrence of
skeletal events, enabled the capture of HRU before the event occurred, at the time related
to the diagnosis of the event and with the prospective follow-up related to the management
of these skeletal events. The patient selection was based on chart selection from a hospital
list, either computerized or paper-based, unlike patient selection in a standard clinical trial.
Lastly, data collection was not focused on clinical outcome but primarily on HRU, including
patient hospital stays, outpatient visits, medications, and procedures.
Since launching the new “Breakthrough” designation in 2011,
FDA has given the designation to only 13 drugs in oncology.
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New Challenges of Such Alternative Designs
to Oncology Research Teams
The challenges and some of the key aspects that bring such studies to success are
resigned to the fact that there are highly specialized experts in oncology used to working
on interventional clinical trials. The first challenge resides in the start-up phase of the study.
The submission and approval process may not be straightforward and may require strong
justification for undertaking such a study. As requirements for start-up are not unique, the
approval process often varies significantly across countries. Given this, anticipating start-up
activities and their corresponding difficulties through the guidance of experts in the field of
observational research has proven to be of great help. Specific challenges related to start-
up notably include site-selection, where highly specialized research centers are often not
targeted: rather, “treatment” centers are targeted to enroll by study timelines and ensure
representativeness of the usual care setting. This too can vary across countries, and even
regions within a country.
Another challenge is site motivation since such studies do not provide new treatment
opportunities. The Sponsors should stress the importance of pricing and reimbursement
data to get the drug available to patients as early as possible. Site motivation can also be
achieved with the help of local key opinion leaders and the Sponsor experts, as necessary.
Another aspect of site motivation is ensuring that suitable site fees for trial conduct are in
place because most of this work falls to nurses or study coordinators and not to the principal
investigator as clinical outcome is not the focus but rather compiling cumulative HRU
data. Finally, clinical data processing must be simple and focused on key criteria to avoid
overloading the site staff with data management activities.
Navigating the Shifting Sands and Adaptation
to “Fast Tracking” Process
In oncology, situations where no suitable treatment alternatives are readily available for
life-threatening conditions occur frequently. It is one of therapeutic areas where Expanded
Access Programs (EAPs) are implemented and used to provide patients with treatment
opportunities while the drug is still in development or awaiting market availability. The
intent is to provide isolated patients with a treatment opportunity and not to demonstrate
efficacy, which differentiates such real-world studies from pivotal studies used for traditional
regulatory filing purposes.12,13
The study design of EAP is close to the classical clinical trial for some aspects, as it is
interventional, prescribes a non-approved or marketed treatment, and has a prospective
follow-up according to a minimally imposed fixed scheme. However, it still has most features
of real-world study design, such as being non-comparative and open-label. As often in
oncology studies, the duration of the follow-up is not fixed but variable due to the variability
in treatment responses and survival.12,13
The field of oncology is a rapidly evolving landscape with dynamic demands, where the study
objectives may change from a treatment providence opportunity to a regulatory supportive
one. In such situations, there is a high clinical demand and study teams must be ready
to adapt and deliver constantly during the active phase of the study in support of the
participating countries, sites, and patients. The Sponsor also needs to be ready to adapt,
as necessary, study plans, budget, drug products, and the protocol.
Oncology
research in a
multi-stakeholder
environment is a
rapidly evolving
space.
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Another challenge related to high clinical demand is the risk of protocol deviations and the
expectations of clinicians willing to treat patients outside of a defined population. Additional
efforts from Sponsors and Contract Research Organizations are necessary to determine the
specific need for protocol amendments, in parallel with close follow-up of patient inclusion,
on an ongoing basis and detect deviations as soon as they occur. The goal here is to work
in a very disciplined and structured manner to control the risk of deviations and enable
the Sponsor to best fulfill the real-world study’s needs by providing treatment opportunities
to maximum number of candidate patients, supportive data to regulatory authorities,
and helpful information to the research community.
This scenario is a perfect example of the “shifting sands” situation with the project starting
as an EAP and moving to being a regulatory supportive study based on the demonstrated
benefits to the targeted population in real-world settings.
In summary, oncology research in a multi-stakeholder environment is a rapidly evolving
space. Regulatory scrutiny works diligently to increase focus on accelerated approvals,
such that real-world and late phase evidence development throughout the product lifecycle
is maximized. With these forces working in concert, the dynamic evolution that is required
for demonstration of efficiency and value in the oncology setting is likely to occur for
patients and payers.
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References
1. Bender, U. The Need for More Certainty in Reimbursement Strategies: Integrating
Health Outcome Parameters with Clinical Development. Regulatory Focus. 2012.
Available at: http://www.incresearch.com/news/InTheNews/RF-2012-12-Reimbursement-
Strategies.pdf. (Accessed 19 October 2013).
2. Cigna (CI) and Aetna (AET) Create, Acquire and Develop Businesses to Meet Growing
Health Care Needs. The Wall Street Transcript. 2012. Available at: http://www.twst.com/
news/693-cigna-ci-and-aetna-aet-create-acquire-and-develop-businesses# . (Accessed
19 October 2013).
3. Porter, M.E. What is Value in Healthcare? N Engl J Med. 2010; 363:2477-2481.
4. Oncology Management Trends, Strategies and Resources. Washington, DC: Atlantic
Information Services, Inc. 2012. AIS Health. Available at: http://aishealth.com/sites/all/
files/pharm_gonc_ch7.pdf. (Accessed 21 October 2013).
5. “Draft Methodology Report: Our Questions, Our Decisions: Standards for Patient-
centered Outcomes Research.” Patient-Centered Outcomes Research, Institute
(PCORI). Available at: http://pcori.org/assets/MethodologyReport-Comment.pdf.
(Accessed 19 October 2013).
6. Berger M.L., Dreyer N., Anderson F., Towse A., Sedrakyan A., Normand S.L. Prospective
Observational Studies to Assess Comparative Effectiveness: The ISPOR Good Research
Practices Task Force Report. Value Health. 2012;15(2):217-230.
7. Berwick D.M., Nolan T.W., Whittington J. The triple aim: care, health, and cost.
Health Affairs. 2008; 27(3):759-769.
8. Sharma A., Jacob A., Tandon M., Kumar D. Orphan drug: Development Trends and
Strategies. J Pharm Bioallied Sci. 2010; 2(4):290-299.
9. Fauntleroy, G. Medications on the Fast Track. Oncology Street. Available at: http://
oncologystreet.com/index.php/fda-talk/2-medications-on-the-fast-track. (Accessed 20
October 2013).
10. Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review. The
U.S. Food and Drug Administration. Available at: http://www.fda.gov/forconsumers/
byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.
htm#breakthrough. (Accessed 20 October 2013).
11. FY 2011 Innovative Drug Approvals. The U.S. Food and Drug Administration. 2011.
Available at: http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/reports/
ucm278358.pdf. (Accessed 20 October 2013).
12. www.quintiles.com | 12
References continued
12. Access to Investigational Drugs Outside of a Clinical Trial (Expanded Access). The
U.S. Food and Drug Administration. Available at: http://www.fda.gov/ForConsumers/
ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/ucm176098.htm.
(Accessed 20 October 213).
13. Guideline on Compassionate Use of Medicinal Products, Pursuant to Article 83 of
Regulation (EC) No726/2004. Ref EMEA/27170/2006. Evaluation of Medicines for
Human Use. Medicines Agency. 2007. Available at: http://www.ema.europa.eu/docs/
en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/
WC500004075.pdf. (Accessed 21 October 2013).
13. 13 | www.quintiles.com
John Doyle, Dr.P.H., M.P.H.
Senior Vice President and Managing Director for Global Market Access
& Commercialization with Consulting at Quintiles
Dr. Doyle is Senior Vice President and Managing Director for Global Market Access &
Commercialization with Consulting at Quintiles. Dr. Doyle’s consulting practice leads
the focus on helping life sciences companies maximize the commercial success of their
products through market access strategy and evidence-based research. Functional areas
of expertise include health economic and outcomes research, pricing and reimbursement,
health technology assessment, and comparative effectiveness research.
Over the last two decades, Dr. Doyle has authored over 100 abstracts and original
research articles in a variety of therapeutic areas, with a special concentration in oncology.
He has lectured in the U.S., Canada, Europe, Latin America, and Asia on topics including
biosimilars, rare disease, and comparative effectiveness research.
Dr. Doyle received a Bachelor of Science degree in Applied Economics with a
concentration in the Life Sciences from Cornell University. He received a Master of Public
Health degree and a Doctor of Public Health degree in Epidemiology from the Mailman
School of Public Health at Columbia University where he maintains a faculty position.
Harish Dave, MD, MBA
Vice President, Global Medical Strategy Head,
Hematology and Oncology, Quintiles
With fifteen years of academic hematology-oncology experience, Dr. Dave oversees a
number of hematology and oncology studies at all phases of drug development, and
provides strategy and guidance. His areas of therapeutic experience include cancers of
lung, breast, colorectal, brain, sarcoma, pancreas, prostate, melanoma and liquid tumors.
Dr. Dave has served as a P.I. on multiple studies, served as Chairman of an NIH Study
Section and chaired the Research and Development Committee at a major academic
medical institution. In the latter capacity, Dr. Dave oversaw all research and IRB-related
activity, reviewing and managing over 170 protocols annually.
He received his medical degree from the University of Sheffield Medical School, England
and his residency training at Royal Medical Postgraduate Medical School System,
University of London, England. He conducted basic research in gene regulation and gene
therapy at the NIH. He is board certified in internal medicine, medical oncology and
hematology and was previously Associate Professor of Medicine at George Washington
University and Assistant Chief of Hematology and Chief of Laboratory of Molecular
Hematology at the Veterans Affairs (VA) Medical Center in Washington, DC.
About the Authors
14. www.quintiles.com | 14
Jean-Louis Merot, M.D.
Title TBD
Bio content TBD
Tanja Hadzic, MS, Ph.D
Clinical Research and Drug Development Fellow, Quintiles
Dr. Hadzic joined Quintiles in 2013 under a drug development fellowship in collaboration
with the University of North Carolina Eshelman School of Pharmacy, bringing extensive
experience in oncology clinical research. Prior to joining Quintiles, she has conducted
postdoctoral research at the University of North Carolina Lineberger Comprehensive
Cancer Center and also worked as a clinical oncology freelance writer and editor for
Medscape Continuing Medical Eduation. Dr. Hadzic received an MS and a Ph.D from the
University of Iowa.
About the Authors continued
Chris Learn, Ph.D, PMP
Senior Clinical Project Manager, Oncology, Quintiles
Dr. Learn has over 10 years of experience leading investigator led oncology trials in
academic settings and in industry. His expertise includes the development of molecular
immunotherapies for malignant glioma. Prior to joining Quintiles, he held senior positions
in clinical research at Surgical Review Corporation, The Hamner Institutes for Health
Sciences and Duke University Medical Center.
