At Janssen, we are committed to delivering transformational medical innovation that can change the trajectory of health for humanity. To achieve this purpose, we combine our strong internal capabilities with the most compelling available external science to transform how diseases are prevented, intercepted, treated, and cured. We focus our research and development (R&D) investments on serious unmet medical needs where we can make an enduring, meaningful impact, including oncology, immunology, cardiovascular and metabolic diseases, neuroscience, infectious diseases and vaccines, and pulmonary hypertension.
Here, we describe our investments in R&D, including our efforts to improve the process and make it more transparent. We also demonstrate that the investments we make in R&D far exceed what we spend to market our medicines.
Research & Development
Developing new and innovative medicines that extend and enhance the quality of people’s lives is our greatest reward. The process to develop a new medicine is expensive, financially risky, and entails several stages of research conducted over many years. Typically, it takes 10–15 years7 to discover and develop a medicine and gain approval from the U.S. Food and Drug Administration (FDA), enabling us to make it available to patients. This process includes:
We start by working to understand the molecular and cellular pathways together with the genetic and environmental influences that drive disease. In the early stages of discovery, scientists evaluate millions of compounds to identify those with the most promise to stop or alter a disease process. Extensive design, optimization, and investigation of the molecules is undertaken to determine their mechanism of action and assess any undesirable effects before advancing to clinical development.
Each potential new medicine undergoes “preclinical” laboratory research to determine whether it is reasonable to proceed with human clinical trials.8 Many potential medicines do not proceed past this point.9
Clinical trials for the development of new medicines are typically conducted in phases and often involve thousands of patients from multiple countries. Through these studies, we obtain preliminary information about whether a potential medicine is safe and effective — that is, whether its benefits exceed its risks. In Phase I, we study the medicine in a small group of volunteers, usually healthy, to learn more about the safety of the medicine and how it interacts in the body. In Phase II, we evaluate the medicine’s effectiveness and side effects, often in several hundred patients who have the disease the medicine is intended to treat. In Phase III, the medicine is given to larger groups of people with an aim to confirm its effectiveness, evaluate how it works in different populations, compare it to commonly used treatments, and collect information that will allow the medicine to be used safely. For some medicines, such as oncology treatments, these development phases may be blended in order to get medicines to patients faster, with traditional Phase III studies sometimes completed after regulatory approval. A potential new medicine may fail at any stage of clinical trial development — for example, in Phase I if it proves to be unsafe, or in Phase II or III if it is not effective or is found to have an unsatisfactory side effect profile.
If research shows that a medicine makes a real difference to patients facing serious illness, and its benefits outweigh its risks, we seek approval from the FDA to introduce the medicine to patients. The FDA’s team of scientists, physicians, statisticians, and other experts analyze the condition for which the medicine is intended and patient experience with the condition, assess the medicine’s benefits and risks based on the manufacturer’s research data and proposed labeling, and consider strategies for managing risk. If the FDA determines that the medicine’s benefits outweigh its risks, it approves the medicine, which then can be made available to patients.10 During this stage, we may also conduct additional research to determine the impact of the new medicine on a patient’s quality of life, how it compares to existing therapies or treatments, and other ways the medicine could affect the health care system — information payers can use to compare treatment choices and make decisions about coverage.
After we receive FDA approval to bring a medicine to patients, we conduct studies to: understand how the product works in a real-world setting; explore expanded indications, dosages, or product formulations; monitor safety; and better understand the value our medicine has for patients, providers, and the health system at large. Investments in this stage of research may lead to product improvements or expanded indications that deliver additional benefits to patients.
Our Leaders Discuss
Mathai Mammen, Global Head of R&D at Janssen, discusses our strategy for bringing forward new medicines that make a real difference for patients.
We recognize that the best science does not always reside in a single company. Bringing new medicines to patients requires collaboration and partnership. A large part of our success stems from the work we do with dynamic, diverse partners, including startup companies, academic centers, hospitals, government agencies, biotech organizations, and other large pharmaceutical companies.
These collaborative opportunities allow us to accelerate the process of developing breakthrough medicines to create real value for patients within Janssen’s defined therapeutic areas. Of the seven new medicines that we have brought to market in the last five years, many were the result of collaborations. Today we have approximately 150 active collaborations from discovery to late stage development.
In 2017, Janssen invested $7.9 billion in R&D — an increase of $0.9 billion from 2016.16 This investment has enabled us to research and develop more than 100 medicine candidates. Over the past five years (2013-2017), we have been an industry leader in New Molecular Entity (NME) approvals with a total of seven new medicines approved by FDA during this time.17 During this same time period, we received eight FDA Breakthrough Therapy Designations for indications for three of our investigational medicines.18 A Breakthrough Therapy Designation is a process that expedites the development and review of an investigational medicine that is intended to address a serious condition when preliminary clinical evidence indicates that the medicine may demonstrate a substantial improvement over other available treatments.19
Janssen's investment represents a portion of Johnson & Johnson's overall 2017 R&D investment of $10.1 billion — an increase of $1 billion from 2016, a year in which Johnson & Johnson was among the top ten investors in R&D in the world and number one among U.S. health care companies.20
We are excited by the potential in our current pipeline, and we are working to make our R&D process more efficient. By streamlining our process, we can better leverage our investment resources, increase the speed of innovation, and potentially bring more transformational medicines to patients. In fact, between 2011 and 2015, we more than tripled the rate at which our potential new medicines under study were ultimately approved for use as new medicines.21 During this period, our success rate was more than double the industry average.22 Here are some examples of what we are doing:
- We are working to embed biomarker strategies early in clinical trial designs to enable rapid, efficient, and economical drug development as well as better targeted use. Biomarkers, which are measurable characteristics of biological processes, help us understand how well a medicine is working and if a disease is progressing.23 For example, we can use HbA1c as a marker for diabetes control.24 We are a member of The Biomarkers Consortium, a public-private partnership managed by the Foundation of the U.S. National Institutes of Health that brings together the expertise and resources of various partners to rapidly identify, develop, and qualify potential high-impact biomarkers particularly to enable improvements in drug development, clinical care, and regulatory decision-making.
- We are adopting different technologies to optimize workflow, improve communication, and expedite data reporting, all of which play critical roles in the success of clinical trials.
- We are members of a number of collaborative initiatives focused on accelerating biopharmaceutical innovation across the continuum of R&D, from basic science to pre-clinical research to clinical development. These initiatives convene diverse partners, including pharmaceutical manufacturers, venture capitalists, nonprofits, and governments, to solve key R&D challenges. For example, we are a founding member of TransCelerate Biopharma, a not-for-profit industry collaborative that aims to identify and overcome common challenges in the medicine development process; we are a part of the Accelerating Medicines Partnership, a public-private venture with the National Institutes of Health focused on identifying biological targets for new medicines; and we are affiliated with the Duke Margolis Real-World Evidence Collaborative focused on advancing methods and policies related to the regulatory acceptability of real-world evidence.
Partnering with Patients
Patients have always been at the heart of everything we do, and we are partnering with them and their caregivers to better understand and meet their needs as we develop medicines, improve clinical trials, and create educational materials and support programs. We are incorporating patient perspectives early and often in the following ways:
Incorporating patient perspectives into clinical trial procedures.
Only 3 to 5 percent of patients who are eligible to participate in clinical trials actually enroll, which is why we want to design trials that are less burdensome for patients and rooted in the reality of their day-to-day lives. Our efforts led one Janssen R&D team to cut the length of patient visits in half, provide transportation to and from the trial site, and make informed consent available on a computer monitor and paper instead of a tablet to reduce glare for visually-impaired patients. After seven months, no trial drop-outs were reported. Fifteen similar projects are underway, which may lead to better data collection and accelerate our ability to bring therapies to the patients who need them.
Our Leaders Discuss
Katherine Capparella, Global Patient Engagement Leader at Janssen, shares how we’re using patient feedback to improve our medicines.
Including patient-reported outcomes in medicine labels.
When our researchers were developing a plaque psoriasis medicine, they worked with patients and other stakeholders to create the Psoriasis Symptoms and Signs Diary (PSSD), a tool that measures symptoms that matter to patients and lets them record their own symptoms. In clinical studies of moderate to severe plaque psoriasis, clinician-reported outcomes are typically used to assess the extent and severity of the disease as well as the patients’ response to therapy. But plaque psoriasis often comes with symptoms that are best assessed by patients themselves, such as itching, pain, stinging, burning, and skin tightness. The PSSD tool, several years in the making, was a significant development in our quest to develop and convey patient-focused product information. The information we gathered from patients who used PSSD in clinical trials is now part of the FDA-approved U.S. Prescribing Information for the medicine.28
Modifying product design for administering a medicine currently in development based on patient input.
One Janssen team worked with patients and health care professionals through studies to optimize the design of a device for administering a particular type of medicine. The modified design helps patients insert the device properly, shows whether the full dose has been administered, and comes with improved instructions, including questions and answers based on patient insights.
Clinical Data Transparency
The patients and health care professionals who rely on our medicines place their trust in our clinical research and development.
We believe making clinical trial data available advances science and benefits public health in important ways: it promotes the understanding of disease, expands the knowledge needed to develop new treatments, and generates new insights and more complete evidence that lead to better health care decisions for patients. Like others in our industry, we disclose information about our clinical trials on clinicaltrials.gov, the largest U.S. public registry, and we seek to publish the results of company-sponsored trials and health economic studies in peer-reviewed medical journals.
We have also pioneered new initiatives to further enhance clinical trial data transparency. In a first-of-its-kind agreement with the Yale University School of Medicine, we share pharmaceutical, device, and consumer product clinical trial data through the Yale Open Data Access (YODA) Project; its mission is to advocate for the responsible sharing of clinical research data, open science, and research transparency.
The YODA Project serves as an independent review panel, evaluating researchers' requests for access to participant-level trial data and research reports, which provide extensive details about the methods and results of a clinical trial. Researchers can use these clinical trial data in their own scientific or medical research to increase medical knowledge and improve public health. Launched in 2014 to share pharmaceutical clinical trial data, the YODA Project expanded to include Johnson & Johnson medical devices and consumer clinical trial data in 2016 and 2017 respectively.
In 2017, the YODA Project received 23 requests for data from researchers and physicians at institutions and academic centers in the U.S. and around the world, all of which were approved. Additionally, two papers were published this past year as a result of data we shared.30 For more information about the YODA Project and to request access to data from Janssen’s clinical trials, please visit yoda.yale.edu.
Our leadership in clinical data transparency has been recognized by external organizations like Bioethics International. For the second consecutive year, Johnson & Johnson achieved the highest overall clinical trial transparency score — 100 percent — from Bioethics International in its second Good Pharma Scorecard (GPS), an annual index that ranks large pharmaceutical companies and new drugs on their clinical trial transparency.31 The 2017 GPS report evaluated clinical trial registration, results reporting, clinical study report synopsis sharing, and journal article publication rates for new drugs approved by the FDA in 2014 that were sponsored by large drug companies.32
We’re honored to be recognized in the top spot for the Good Pharma Scorecard for the second year in a row. At Johnson &Johnson, we believe sharing clinical trial data honors the patients who participated in the trial, and contributes to improving patient care.
Sales & Marketing
We also disclose payments we make to physicians and teaching hospitals for their R&D-related work, which can include helping us design and conduct clinical trials. Research activities account for more than 65 percent of our 2016 payments to physicians and teaching hospitals. While these are not marketing activities, payments related to these activities are also disclosed through the Open Payments database.
We anticipate that 2017 Open Payments data will be available through CMS on June 30, 2018. Here, we include information on Janssen’s 2016 Open Payments disclosures.36
After we have FDA approval to bring an innovative medicine to patients, we invest in providing accurate, up-to-date information about the medicine to health care professionals and to patients. These activities include communications with health care professionals about the medicine's effectiveness, approved uses, side effects, benefits and risks, as well as patient education and direct-to-consumer communication.
We follow all laws and regulations regarding the promotion of prescription medicines and submit all promotional materials to the FDA. We have a robust medical review process to ensure the quality and accuracy of information, and our marketing and sales activities adhere to industry ethics standards and codes of conduct, including the Pharmaceutical Research and Manufacturers of America’s Code on Interactions with Health Care Professionals.
In addition to the marketing and sales figures we are required to disclose by law, which include payments we make to physicians in accordance with the Physician Payment Sunshine Act (see “Open Payments”), in this report we voluntarily disclose global and U.S. marketing and sales figures. In 2017, our global pharmaceutical marketing and sales expenditures were $4.2 billion. Of the $4.2 billion, $2.5 billion were U.S. pharmaceutical marketing and sales expenditures.33
We disclose global and U.S. sales and marketing in this report because we are sometimes asked how much we spend on these activities, and our standard financial reporting does not cover these expenses specifically. Johnson & Johnson financial statements combine marketing and sales expenses with other items in a line item described as “Selling, Marketing and Administrative Expenses” (SM&A).
In other words, the SM&A figure accounts for much more than marketing and sales expenses. It includes administrative and overhead activities that are not related to marketing or sales, such as expenses for insurance, legal, finance, and distribution; it pertains to all of the businesses in the Johnson & Johnson Family of Companies, which, in addition to pharmaceuticals, include medical devices, consumer products, and over-the-counter medicines; and it is a global, not U.S., figure.
Our Relative Investment
88% morein R&D than we spent on marketing and sales.35
We spent $4.2 billion on global marketing and sales activities in 2017. When compared to our global R&D investment of $7.9 billion, our disclosures demonstrate that in 2017 we spent 88 percent more on R&D than we did on marketing and sales.34
We make this comparison using global figures because our investment in R&D cannot be segmented by region. The R&D activities we undertake around the world collectively contribute to medicine development, regardless of market.