wp_oncology_molecule_value_d01

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

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 | 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.


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.


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 ReseaRchTo 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.


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 RefoRmIn 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?”


the changIng face of fUnDamentalsOver 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 longeRHistorically, 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.


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 PRactIceIn 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.


new challenges of sUch alteRnatIVe DesIgns to oncology ReseaRch teamsThe 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” PRocessIn 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.


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.


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).


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).


John Doyle, Dr.P.H., M.P.H.

Senior Vice President and Managing Director for Global Market Access & Commercialization with Consulting at QuintilesDr. 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, QuintilesWith 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


Jean-Louis Merot, M.D.

Title TBDBio content TBD

Tanja Hadzic, MS, Ph.D

Clinical Research and Drug Development Fellow, QuintilesDr. 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, QuintilesDr. 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.

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