An astute marketer will tell you that success of any product is dependent on the wants and needs of the end user. In health care, we need a similar mindset. By collaborating with patients early in drug development, there is an opportunity to improve the success rates in the preclinical stage of the development, which could ultimately accelerate the delivery of new treatments to patients and enhance patient adherence to their treatment plans. The end result will be a win for all stakeholders.
To effectively integrate the patient voice throughout the research and regulatory processes, we need to first develop a consistent definition and shared expectations for engagement. We know that some companies have already expanded their programs to more comprehensively intertwine the patient voice; we need to learn which tools and methods have achieved their intended goals. We also need to differentiate when and how the individual with a chronic condition can be an effective partner in the development and regulatory processes and at what point the patient advocacy organization should be engaged.
There is little guidance on how to conduct or assess whether an approach to engagement will yield meaningful results. To address this challenge, the NHC and its member patient advocacy organizations are devising a plan to bring together all stakeholders to generate consensus about how to best to advance methods for meaningfully engaging the end user - the patient - in drug research, development, and regulation.
Marc Boutin is the executive vice president and chief operating officer of the National Health Council, an organization that brings together all segments of the health care community to provide a united voice for the more than 133 million people with chronic diseases and disabilities and their family caregivers.
In addition to overseeing financial management and operations at the National Health Council, Boutin builds consensus among member patient advocacy organizations enabling them to speak with one voice on systemic health research and health care policy initiatives. This united effort results in legislation and regulations that address the collective needs of patients and their family caregivers. In addition, he provides guidance to patient organizations on various association issues, including corporate structure, government relations, fundraising, and outreach.
Boutin has been actively involved in health advocacy, policy, and both federal and state legislation throughout his career. He is a member the International Alliance of Patients’ Organizations Governing Board, Community Health Charities Board of Directors, PCORI Advisory Panel on Patient Engagement, Sanofi Partners in Patient Health Global Council, and the North America Advisory Board to the Drug Information Association.
The most recent reauthorization of the Prescription Drug User Fee Act (PDUFA) included new efforts by the Food and Drug Administration (FDA) to enable patients and patient groups to become actively involved in FDA evaluations of new medicines. Two programs in particular--the Patient-Focused Drug Development (PFDD) Initiative and Benefit/Risk Assessment--work in tandem to inform the FDA's decisions on whether or not to approve a medicine for patient use.
There’s no doubt that the feedback gained through the PFDD Initiative gives the FDA deeper insight into patient preferences, especially regarding the benefits and risks of already-approved medicines. However, in order for it to have a meaningful impact on drug development review, the Agency now needs to articulate how this feedback will be incorporated into the benefit/risk assessments of new individual therapies being actively reviewed.
So far, the FDA has held PFDD meetings with representatives from 11 disease states, including fibromyalgia, lung cancer, and sickle cell disease. These meetings have illuminated some of the day-to-day difficulties of living with a particular condition and offered critical perspective into what some individual patients think about the benefits and risks of available treatment options. The FDA is a science-driven organization, and also needs mechanisms to efficiently obtain input from large, targeted, and representative cohorts of patients in order to more effectively use patient data in informing their regulatory decisions about potential new therapies. Establishment and communication of these mechanisms, informed by experts in the social sciences, will ensure that patients with many more diseases have the opportunity to be heard than would be possible under the current meeting structure.
With these guiding principles in place, the FDA should develop a multi-year pilot program to explore the science of patient input in benefit/risk assessment. The goal should be to identify a standardized and representative way of collecting and evaluating data that could be incorporated into the FDA’s overall assessment of a medicine’s benefits and risks. A pilot program would provide the FDA with valuable, scientifically significant patient data to support its decisions. What’s more, such a program could also give the pharmaceutical industry better macro-level data to guide and streamline its development of new medicines that will benefit patients by ensuring the endpoints most relevant to patients are included in clinical trials.
The PFDD and benefit/risk assessment programs have the potential to gather and utilize patient-provided information in a valuable and truly innovative way. Advancing the science of patient input will enable the FDA to incorporate this feedback in a meaningful and transparent way and bring essential context and efficiency to the development and review of important new medicines.
Robert is Vice President, Global Regulatory Affairs – US and Global Medical Quality. He is responsible for interactions with the FDA supporting new drug development and marketed products, including US product labeling, advertising and promotion, and regulatory policy. Robert also has responsibility for, global label management, global submission management, and global Chemistry, Manufacturing and Control for Lilly. He also has responsibility for the Quality organizations supporting clinical development, regulatory, and product safety.
After completing his Ph.D. in Pharmacology and Toxicology at Queen’s University in Canada, Robert joined Eli Lilly Canada in the Regulatory Affairs organization where he led successful approval efforts, for neuroscience and anti-infective new chemical entities. His next opportunity led him to the Lilly Corporate Center in Indianapolis where, as a member of the Global Project Management organization, he led cross-functional teams in the global development and registration of new molecular entities in Lilly’s diabetes and osteoporosis portfolios. Following this opportunity, Robert returned to Lilly Canada where he had leadership responsibility for Regulatory Affairs, Health Outcomes, and Quality. In 1998, Robert was transferred to Japan where he led the Project Management and Pharmaceutical Development organizations for Lilly Research Laboratories, Japan. Robert returned to Indianapolis in 2002 as a Director in Project Management with responsibility for the Project Management organizations supporting early and late stage drug development. In 2005, Robert was named Executive Director, Global Patient Safety with worldwide responsibility for adverse event case management, pharmacovigilance, and quality systems in support of product safety. In June of 2009, Robert was name Vice President, Global Ethics and Compliance where he had responsibility for providing Ethics and Compliance leadership to functional and geographic areas across Eli Lilly, included implementation of an effective compliance program. In February of 2011, Robert was named Vice President Global Regulatory Affairs-US and Global Medical Quality, responsible for the organization and activities noted above.
We at NORD believe that patients need to play a central and much more active role in the drug development process, from start to approval. Until very recently, the process has largely ignored the patient as an active participant.
Drug developers, whether researchers, industry or government, would benefit immensely from understanding better the needs of patients -- what symptoms trouble them most, what is their tolerance for risk, how do their diseases progress and how do patient needs change as a disease progresses. The issue is especially important for patients with rare diseases, since there often is a lack of information and understanding of rare diseases.
At NORD’s recent Rare Diseases and Orphan Products Breakthrough Summit, Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, set the tone for the entire conference when – in the opening session – she stated that an environment that provides earlier and more frequent patient input into the process would help to accelerate and de-risk orphan product development.
Specifically, Dr. Woodcock called for a system that encourages rigorous pre-clinical research and collection of important patient data in registries and natural history studies.
NORD agrees with Dr. Woodcock, and we are working with FDA, NIH and our academic and industry partners to facilitate earlier and more frequent patient input throughout the drug development process.
One example of this is the new platform NORD has created for patient registry/natural history studies. With the VHL Alliance, we recently launched the first of what we hope will be many disease-specific communities on this platform. Dr. Woodcock cited it in a recent blog as an example of the type of resource that will help spur progress in rare disease research.
Today’s current emphasis on patient-focused drug development stems, in part, from an initiative that NORD led beginning in 2011 to increase the patient voice and role in the drug development process. We held meetings with the FDA at several levels, and FDA subsequently adopted an aggressive program to formalize the role of the patient. .
We appreciate FDA’s welcoming response to patients, and we also want to facilitate greater collaboration between pharma companies and patient organizations. For patient advocates to work directly with drug sponsors in a constructive and trusted relationship will benefit all parties.
We would welcome industry support for our rare disease registry projects with the goal of expanding the number and importance of registries and natural history studies for patients with rare diseases. Rare disease patient organizations are very motivated to provide the resources that are essential for good research, but the cost of creating such resources may be beyond their means.
We at NORD are strong advocates for collaboration in the drug development process and we believe a structure that makes possible and encourages patient input at all phases of the process will be a win for all in the end.
Peter L. Saltonstall is the President and CEO of the National Organization for Rare Disorders (NORD). He joined NORD in 2008 after having served for more than 30 years as a senior official in both for-profit and not-for-profit healthcare environments.
Under his leadership, NORD has forged new relationships between the patient community and the Congress, FDA, NIH and Social Security Administration, as well as with drug/device companies and the medical/academic and investment communities. His efforts to build collaborations stems from his view that advances for the rare disease patient can be achieved best through joint efforts.
Peter is also committed to globalization of the rare disease patient community, as diseases do not recognize geographical boundaries and research can be expedited when patients from many counties are involved. He has established collaborative programs with patient communities in Europe and Japan.
Under Peter’s leadership, NORD also has updated and expanded its Patient Assistance Programs, which include assistance to patients in need of medications that they cannot afford; and has recommitted to facilitate research into new therapies and assure access by patients.
Before joining NORD, Peter held senior positions with several major academic medical centers and organizations, including Harvard's Brigham and Women's Hospital, Tufts-New England Medical Center and St. Elizabeth's Medical Center of Boston. He helped launch Harvard Risk Management Foundation's startup venture, Risk Management Strategies, and the University of Pittsburgh Medical Center’s private equity arm, Strategic Business Initiatives.
In addition, Peter was the co-founder and CEO of SafeCare Systems, LLC, which developed one of the country's first patient safety management systems. He played an active role on Capitol Hill in the development of the Patient Safety Act of 2005, which dramatically improved the reporting of events that adversely affect patients.
As important stakeholders in the drug development and approval process, patients provide a unique and valuable perspective when considering the benefits and risks of potential new and innovative medicines. Patients can identify areas of unmet medical need, provide critical perspective on the impact of a disease and its manifestations, and uniquely inform the development of outcome measures that are meaningful to patients. A scientific approach to gathering patient input is necessary to realize the shared goal of a patient-centered approach to drug development and regulatory review. PhRMA believes that advancing the science of patient input should be a collaborative, multi-stakeholder effort. We must combine the best knowledge and experience to identify ways to improve the efficiency of bringing new medicines to patients in need through an enhanced understanding of the patient perspective on their disease or condition, and unmet medical needs.
A scientific approach to patient-centered drug development would allow for the systematic consideration of the views of patients – their perception of the acceptable balance of known and possible risks and benefits of a potential new medicine in the face of known and possible risks of their disease or condition – when regulators and sponsors are faced with difficult benefit-risk decisions. Further, a robust, scientific understanding of the patient perspective on burden of disease, the symptoms that have the most profound impact on daily living, and what is most urgently needed in terms of new treatment options can facilitate the development and promote the use of patient-centered drug development tools, such as patient-centered outcomes.
As all stakeholders engage collectively in advancing the science of patient input, it is of critical importance that there is a clear path for integration of the patient perspective into regulatory decision-making. PhRMA encourages the FDA to put forward a comprehensive proposal, as outlined in the PDUFA V Goals Letter, for how the input gathered during the patient-focused drug development meetings will be used in regulatory decision-making. We look forward to ongoing, collaborative discussions and to working with all stakeholders to enhance the patient-centeredness and efficiency of the drug development and regulatory review processes.
Sascha Haverfield is the Senior Vice President for Scientific and Regulatory Affairs at PhRMA. He leads PhRMA's activities on global regulatory policy issues and is the architect of our engagement on the implementation of the Prescription Drug User Fee Act (PDUFA). He previously worked in the biopharmaceutical industry on drug discovery, translational medicine and regulatory affairs with a focus on global drug development issues.
Sascha completed his undergraduate studies in biological sciences at the University of Marburg, Germany and received a doctorate in genetics and cell biology from the University of Oxford, UK.
In his free time, he enjoys hiking the mountains and glaciers of Iceland with his wife and, closer to home, walking their dachshunds.
Parent Project Muscular Dystrophy has long held the belief that new approaches are required to expedite the development of treatments for rare diseases like Duchenne. Patient advocates have worked tirelessly with Congress, over time through legislation, to increase the engagement of the patient voice within the regulatory review process for therapeutics. Passed in 2012, The Food and Drug Administration Safety and Innovation Act (FDASIA) was a culmination of those advocacy efforts by patients. The legislation included a number of provisions under the patient-focused drug development and patient preference headings that aim to more systematically gather patients’ perspectives on their condition and bring the patient voice to the table like never before. Within the user fee package, FDA agreed to hold 20 disease specific hearings to begin creating a framework for incorporating the patient voice into the review process. Along with over 7,000 other rare diseases, Duchenne was not one of the “chosen” conditions to be taken up by the agency within the five-year authorization. With a Duchenne pipeline full of potential therapies in or heading to clinical testing, we knew we had little choice but to try and come up with novel approaches to inform the FDA about our patient population and the current state of research. In 2013, PPMD embarked on the first-ever rigorous scientific survey of benefit/risk. While patient testimonies and stories are critical to educating industry and the FDA about diseases, this study aimed to translate the patient voice into usable data for the agency to consider when reviewing potential drug applications. PPMD worked closely with industry and the patient community to create a meaningful survey that reflected the current state of research and drug development. The data from the study illustrates a relatively high level of risk tolerance if the potential benefit is slowing or stopping the progression of muscle weakness. The preliminary survey data was presented to FDA leadership and published in Clinical Therapeutics in June. With encouragement from the agency regarding this approach we are now looking to expand the study into harder-to-reach, less connected caregivers, and adults living with the disease.
In another effort to enhance the science of patient input to improve the efficiency of developing therapies, this year PPMD led the development of the first ever patient-initiated draft guidance on Duchenne for Industry, submitted to the FDA in June following an intensive 6-month process that involved over 80 stakeholders from the Duchenne community. The FDA is currently reviewing the document and have indicated they will produce their own Duchenne guidance in 2015. PPMD plans to publish the methodology for drafting the document to help inform other rare disease groups who hope to use the same model, and the FDA has again publicly acknowledged the efforts of the Duchenne community as an example of how best to work with industry and the agency to provide much needed data. How these will translate into impact on approvals remains to be seen. The agency will hopefully have several Duchenne-specific new drug applications in front of them in the coming year.
PPMD is now engaging Congress on the 21st Century Cures Initiative and proposing the development of a patient engagement assessment tool in order to quantify how FDA reviewers use – or do not use – available patient-focused drug development tools and data. The patient community needs transparency about whether increased engagement is yielding an impact on outcomes. Otherwise, we are wasting time and resources that could be directed elsewhere in drug development. In a catastrophic illness like Duchenne, time is too precious of a commodity to lose.
Ryan Fischer serves as the Vice President of Advocacy and Community Outreach for Parent Project Muscular Dystrophy and has been with the organization for 10 years. Parent Project Muscular Dystrophy is the leading organization in the fight to end Duchenne.
Ryan oversees strategic community engagement and advocacy, educating the patient community on the best ways to interact with members of Congress and federal agencies. He acts as an interpreter for Duchenne patients and families, explaining complex issues in public policy and about federal legislation with the goal of making them stronger advocates. Since the passage of landmark legislation – the MD-CARE Act – in 2001, Ryan has played a pivotal role in ensuring the reauthorization of the bill in 2008 and the passage of updated amendments this past September.
This is not rocket science! Running a molecule through all of the traps is really hard. Understanding what people feel and think and experience with regard to the drugs they take and those they need is simple. In most other areas of our lives, various industries know quite well what features we want on our smartphones, that we suddenly all want Greek yogurt, and that we don’t want to pay to use the bathroom on a plane. In medicine, we have not yet realized the same dynamic and robust methods, tools and studies for understanding the needs and values of the end user. The needs, wants, values and goals of the end user are a point of emphasis that is lacking in the current medical, drug development, and regulatory review systems. Yet, there are countless unmet medical needs that need to be addressed in a way that meets the need from the viewpoint of the people with the need. We must work together in a coordinated, collaborative and focused way to create a system that is dedicated to achieve the shared goal of a more efficient drug development and regulatory review process through advancements in the science of patient input.
I believe that those entities in the ecosystem that believe that the consumers of healthcare can actually be active participants can collaborate to advance the critical science of patient input. Collaborators must include those who have most frequent encounters with individuals including healthcare providers, pharmacists, schools, community organizations and advocacy organizations. Researchers who are expert in human behavior must also collaborate to use the tools that have already been honed in other industries and experiences to understand preference and how to ascertain it. These tools need to be put to use in the drug development and regulatory arenas. People should be engaged where they live – in communities, affinity groups, pharmacies, clinics, schools, work places – and invited to share their lived experience. In addition, they should be and can be invited to participate by giving explicit access to various kinds of data that will flesh out their input into the process.
Genetic Alliance, in partnership with PhRMA and a handful of disease advocacy organizations solicited input for the FDA’s Patient Focus Drug Development work. Our results, using an interactive, gamified, system were remarkable. In just sickle cell disease and trait, for example, our Platform for Engaging Everyone Responsibly engaged 3 times the number of people who were able to either attend the in person meeting at FDA or submit comments to the docket. In another engagement we invited the Duke Clinical Research Initiative to analyze and summarize the data we collected on idiopathic pulmonary fibrosis with our partner the Coalition for Pulmonary Fibrosis. These small experiments convinced us that excellent methods exist, that can help pharmaceutical companies and regulatory agencies understand what consumers need and want.
The science of patient input is coming of age. Early work in participatory research and community engagement led by groups such as the Community Campus Partnership has opened the door. It is time to apply these principles and refine them. Technology makes that easier since there are many ways to listen to people. Let’s make the listening active and explicit and here what we can do together to improve both the drug development and regulatory process!
Sharon F. Terry is President and CEO of Genetic Alliance, a network of more than 10,000 organizations, of which 1,200 are disease advocacy organizations. Genetic Alliance engages individuals, families and communities to transform health.
She is the founding CEO of PXE International, a research advocacy organization for the genetic condition pseudoxanthoma elasticum (PXE). PXE affects Terry’s two adult children. As co-discoverer of the gene associated with PXE, she holds the patent for ABCC6 to act as its steward and has assigned her rights to the foundation. She developed a diagnostic test and conducts clinical trials. She is the author of 140 peer-reviewed papers, of which 30 are PXE clinical studies.
Terry is also a co-founder of the Genetic Alliance Registry and Biobank. In her focus at the forefront of consumer participation in genetics research, services and policy, she serves in a leadership role on many of the major international and national organizations, including the Accelerating Medicines Partnership, Institute of Medicine (IOM) Science and Policy Board, the IOM Roundtable on Translating Genomic-Based Research for Health, the PubMed Central National Advisory Committee, the PhenX scientific advisory board, the Global Alliance for Genomics and Health, the International Rare Disease Research Consortium Executive Committee and as Founding President of EspeRare Foundation of Geneva, Switzerland. She is on the editorial boards of several journals and is an editor of Genome. She led the coalition that was instrumental in the passage of the Genetic Information Nondiscrimination Act. She received an honorary doctorate from Iona College for her work in community engagement in 2006; the first Patient Service Award from the UNC Institute for Pharmacogenomics and Individualized Therapy in 2007; the Research!America Distinguished Organization Advocacy Award in 2009; and the Clinical Research Forum and Foundation’s Annual Award for Leadership in Public Advocacy in 2011. In 2012, she became an honorary professor of Hebei United University in Tangshan, China, and also received the Facing Our Risk of Cancer Empowered (FORCE) Spirit of Empowerment Advocacy Award. She was named one of FDA’s “30 Heroes for the Thirtieth Anniversary of the Orphan Drug Act” in 2013. In 2012 and 2013, Terry won $400,000 in first prizes in three large competitions for the Platform for Engaging Everyone Responsibly (PEER). PEER was awarded a $1M contract from PCORI in 2014.
Terry is an Ashoka Fellow. With her husband Patrick, she is an avid paragliding pilot, rock climber and weekend farmer.
A paradigm shift is occurring. Patients were once viewed as passive, deferential recipients of medical products and services developed for them. Today, there is growing recognition that patients are a vital force for transformative change to address serious unmet medical needs and improve public health.
To deliver on the promise of a patient-focused biomedical system, stakeholders across the research and care enterprise are working – mostly independently – to define and scale effective patient engagement, develop instruments to measure patient-reported outcomes, quantify preferences, and incorporate patient perspectives and insights into decision-making processes and work flows. A science of patient input is emerging, borrowing methods from health economics, marketing, social science, and epidemiology. In these early days though, there is little documented evidence of successful practices or failed experiments to inform programs, guide resource allocations, or shape policy. Maturing the nascent stage of patient input can be accelerated by the three Cs outlined below.
Collaboration: More collaboration will help establish and expand best practices, standardize methods, and demonstrate the value proposition for engaging with patients in continuous, reciprocal relationships. FasterCures’ Benefit-Risk Advisory Council, comprised of key opinion leaders from patient, academic, industry, and trade organizations, provides one forum for such collaboration. In September, Council members formed the faculty of a one-day Benefit-Risk Boot Camp designed to educate participants about methods to enhance patient-centered decision-making. Our upcoming Partnering for Cures conference is another venue to continue the exchange of information and deepen collaborative efforts. We also need to create broader, more sustained forums to foster co-learning.
Clarity: Like most of the participants in this paradigm shift, FDA is building its capacity to engage with patients more directly and in ways that ultimately help reviewers understand how patients assess the benefit-risk tradeoffs at the heart of regulatory decision-making and healthcare decisions. CDER’s Patient-Focused Drug Development initiative has so far provided 11 patient communities with the opportunity to share perspectives about symptoms that affect their daily lives and how well available therapies meet their needs. It’s unclear how FDA will utilize the patient testimony it receives. Communities gearing up for future meetings or considering holding similar sessions outside the set of 20 planned under PDUFA-V eagerly await signals that these efforts factor meaningfully into industry plans and regulatory decisions. Other communities are amassing data from surveys and studies to complement personal stories. CDRH is taking a different approach for devices with its Patient Preference Initiative. A forthcoming catalog of patient input methods and a framework for incorporating patient input into the total product lifecycle may be useful models for drug development and regulation as well.
Constancy: Change takes time. There is a lot to learn and do. There will be progress and setbacks. Those at the forefront of this paradigm shift must continue working together to shepherd the movement and build the science. Let’s close the gap between the rhetoric of patient-centricity and reality.
Kim McCleary is FasterCures’ Director of Strategic Initiatives. She leads a new FasterCures program to expand patient engagement in FDA’s assessment of benefits and risks for medical products. Kim also works closely with FasterCures’ network of patient-focused venture philanthropy organizations, The Research Acceleration and Innovation Network (TRAIN). Prior to joining FasterCures’ staff, Kim was President & CEO of the CFIDS Association of America from 1991 until 2013. She has participated in every opportunity organized by the FDA to shape its Patient-Focused Drug Development Initiative (PFDDI) and has worked with several patient organizations to prepare for their PFDDI meetings. Kim is a member of the Patient Engagement Advisory Panel to the Patient-Centered Outcomes Research Institute and she serves on the steering committee for the Medical Device Innovation Consortium’s Patient-Centered Benefit Risk project. Kim is a graduate of the University of North Carolina at Chapel Hill.
For many, terms like patient-centered outcomes research and patient-focused drug development are new. For others, they are simply buzzwords that are aimed at putting a new spin on existing practices. As a researcher who has dedicated the majority of my career to the scientific study of the patients’ point of view, I rejoice in renewed interest in the patients’ perspective.
The formal study of patient preferences emerged in the 1990s as a more scientific alternative to qualitative approaches to patient input. Using methods like conjoint analysis and discrete-choice experiments, this early literature challenged traditional approaches to outcomes research. This literature grew rapidly, aided by a greater acceptance of the theory and statistical methods used in choice experiments after Daniel McFadden was award the Nobel Prize in Economics in 2000 for his contribution to this field. Within the International Society of Pharmacoeconomics and Outcomes Research (ISPOR), a working group was formed to advance the science of measure patient preferences in 2006. This group went on to develop the first consensus-based standards for the application of stated-preference methods in health, published in 2011, for the optimal experimental design of such experiments, published in 2013, and is currently working on a report detailing best practices for statistical analysis.
While there was certainly a great deal of interest in studies that apply stated-preference methodologies, traditional outcomes research journals found them difficult to review and to be out-of-the-scope of their typical publications. To address this gap in the published research literature, I decided to develop a new journal that would be focus only on the patients’ perspective. In partnership with ADIS, I created The Patient – Patient-centered Outcomes Research in 2008. The journal was conceived as the first medical journal to be completely focused on the patients’ perspective in medicine.
In recent years I have had the opportunity to work with regulators, health technology assessment agencies, patient groups, clinicians and other policy makers to apply and advance stated-preference methods. I welcome that there is now so much interest in these methods and I am happy to see signals from the FDA and EMA about the value of rigorous science detailing the patients perspective, especially as it pertains to benefit-risk analysis. In response to the question on how we advance the science of patient input, I think the solution is simple: make it clear that such data is valuable in the regulatory content.
Currently, the biggest barrier to the science of patient input, whether is be via involving patients and patient groups more or through the formal study of patient preferences, is a lack of a clear mechanism to ensure that it reaches decision makers and can impact regulatory decision making. Once this issue is resolved, I think that field will rapidly progress.
John F P Bridges, PhD is an international leader in the application of stated-preference methods. He is the founding editor of The Patient – Patient Centered Outcomes Research and has worked with numerous patient groups, health technology assessment agencies, regulators and international aid agencies to advance and apply these methods to document the preferences of patients and other stakeholders. Within the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) he founded the Conjoint Analysis Working Group (2006-2011), the Conjoint Analysis Task Force (2008-2010) and was the first author on the ISPOR checklist conjoint analysis. In 2006 he received ISPOR’s Bernie O’Brien New Investigator Award and in 2011 received an ISPOR Distinguished Service Award for his leadership of conjoint analysis methods. He is the author of over 100 publications and a frequent speaker on patient engagement, patient preferences and benefit-risk analysis. John is an associate professor at the Johns Hopkins Bloomberg School of Public Health, a Faculty Research Fellow at the National Bureau of Economic Research (NBER) and a Senior Fellow at the Center for Medicine in the Public Interest (CMPI).