Partnerships are a mainstay in drug development, but the pharmaceutical industry is entering into a new era of innovation as it forges new models with non-traditional players and emerging technologies. So what might be in store for the industry? DCAT Value Chain Insights (VCI) looks at new models in R&D and the potential impact on the industry.
The pharmaceutical majors are partnering with non-traditional players, such as IBM Watson, a new IBM business focused on cognitive, cloud-based computing, and the venture arm of Google to drive digital-based solutions in a push to improve R&D productivity. Also, the US Food and Drug Administration has accepted its first new drug application for a digital medicine, paving the way for a new era in drug development.
IBM Watson Health: cognitive computing and cloud-based data
Earlier this month, IBM Watson Health, a business unit of IBM focused on cloud-based cognitive computing for healthcare solutions, selected Teva Pharmaceutical Industries Ltd. as its first Foundational Life Sciences Partner for the Watson Health Cloud. As part of this new strategic partnership,Teva becomes the first global pharmaceutical company to use the Watson Health Cloud. Teva has chosen the IBM Watson Health Cloud as a preferred global technology platform, and a joint Teva-IBM Research team will deploy Big Data and machine learning technology to create disease models and advanced therapeutic solutions.
IBM Watson is a cognitive computing platform with capabilities to interact in natural language, process vast amounts of Big Data for understanding patterns and insights, and learning from each interaction. The Watson Health Cloud provides an open development platform for physicians, researchers, insurers, and companies. Teva will work with IBM on long-range platform and solutions development, with experts collaborating to enhance IBM Watson Health Cloud capabilities and to explore synergies with existing Watson Health ecosystem partners. IBM's Global Business Services will work with a Teva analytics team to assess the data and the analytics model requirements for a real-world evidence e-health solution.
IBM launched the IBM Watson unit in January 2014. as a dedicated business for developing and commercializing cloud-delivered cognitive computing technologies. The move signified a strategic shift by IBM to deliver a new class of software, services, and apps that improves by learning and that discovers insights from massive amounts of Big Data. As part of the unit, IBM increased the number and diversity of cognitive computing services delivered to its partners, adding new beta Watson services in February 2015, and scalable deep learning application programming interfaces (APIs) with the acquisition of AlchemyAPI in March 2015. In April 2015, the company launched IBM Watson Health and the Watson Health Cloud platform. The new unit aims to help improve the ability of doctors, researchers, and insurers to innovate by surfacing new insights from the massive amount of personal health data.The Watson Health Cloud allows this information to be anonymized, shared, and combined with a dynamic, aggregated view of clinical, research, and social health data that clients choose to share.
IBM Watson Health's partnership with Johnson & Johnson
While Teva is partnering with IBM Watson Health for advancing knowledge around disease states and related patient information, Johnson & Johnson is partnering with IBM in a patient-centric model for chronic disease management, particularly for its medical devices. In April 2015, Johnson & Johnson and IBM announced plans to collaborate around a new generation of intelligent virtual coaching solutions and applications designed to transform the patient experience and deliver improved health outcomes. The planned collaboration is intended to provide healthcare systems with holistic virtual coaching and rehabilitation solutions for enhancing the patient experience and healthcare delivery model by creating an integrated view of patient care.
Specifically, Johnson & Johnson and IBM Watson Health unit intend to use advanced data analysis and insights to help develop personalized patient engagement and coaching solutions that span consumer wellness and chronic condition management. Through the collaboration, Johnson & Johnson would also leverage IBM’s relationship with Apple, Inc. to deliver new iPhone and iPad applications. As a first step, Johnson & Johnson envisions the launch of next-generation health and wellness coaching solutions centered on preoperative and postoperative patient care for joint replacement and spine surgeries. These mobile solutions would build on the Patient Athlete program, recently launched by the DePuy Synthes Companies of Johnson & Johnson and the Johnson & Johnson Human Performance Institute, which specializes in applying sport science principles and holistic energy-management training, These mobile solutions would draw on data, analytics, and insights from the IBM Watson Health Cloud and Watson cognitive technology, including predictive analytics, machine learning, and healthcare provider connectivity, to improve clinical and financial results. The companies are also exploring ways to harness Watson Health’s data sets to create new models that will better predict patient responses to various medical interventions.
IBM Watson Health's other pharma partnerships
The contract research organization, ICON, also recently partnered with IBM Watson Health to advance its clinical-trial management. ICON will use Watson's cognitive computing power to help automate the process of identifying patients who meet the criteria for a clinical trial and to analyze protocols to assess trial feasibility and identify optimal trial sites.
Initially, ICON is applying Watson Clinical Trial Matching to its breast, lung, colon , and rectal cancer trials. The solution enables ICON to advise sponsors how many patients match their trial criteria, where they are located, and how they will recruit them. IBM’s Watson Health Cloud will facilitate access to de-identified patient data, including 50 million patient records contained in the data set from Explorys, a healthcare intelligence cloud company that IBM acquired in April 2015. At the same time, ICON enhances IBM Watson’s capabilities by providing expertise into clinical trial protocols and clinical operations.
The impetus for employing cognitive computing and cloud-based computing is to reduce costs and improve the efficiency of clinical trial management. According to information from ICON, more than $1.3 billion is spent on patient recruitment by drug developers each year, but fewer than 5% of cancer patients participate in a clinical trial. It typically takes 6-12 months to start up a global Phase III drug trial and another 12 months to enroll the required number of patients.
IBM Watson Health: building capabilities
In addition to forming partnerships, IBM Watson Health its leveraging its cognitive computing and cloud-base data with other healthcare informatics providers, as evidenced by IBM’s pending $1 billion acquisition of Merge Healthcare, a provider of medical image handling and processing, interoperability and clinical systems. The deal, announced in August 2015, is subject to regulatory review, shareholder approval, and other customary closing conditions, and is anticipated to occur later this year. It is IBM’s third major health-related acquisition, and the largest, since launching its Watson Health unit in April 2015, following Phytel (population health), and Explorys (cloud-based healthcare intelligence).
The planned acquisition of Merge Healthcare bolsters IBM’s strategy to add image analytics with deep learning to the Watson Health platform to advance Watson beyond natural language and giving it the ability to “see.” IBM points to medical images as the largest and fastest-growing data source in the healthcare industry, estimating that they account for at least 90% of all medical data, but that there are challenges to accessing and using such data. These challenges include the sheer volume of images that hospitals and specialists process, limited data tools for images that are often manual, and a disconnect of medical images from mainstream health information, such as medical records, laboratory tests, and genomic data.
IBM plans to leverage the Watson Health Cloud to analyze and cross-reference medical images against lab results, electronic health records, genomic tests, clinical studies. and other health-related data sources, already representing 315 billion data points and 90 million unique records. Merge’s clients could compare new medical images with a patient’s image history as well as populations of similar patients to detect changes and anomalies. Insights generated by Watson could then help healthcare providers in fields, including radiology, cardiology, orthopedics and ophthalmology to pursue more personalized approaches to diagnosis, treatment and monitoring of patients. Additional projects underway in IBM Research’s global labs offer additional areas where progress can be made. They include teaching Watson to filter clinical and diagnostic imaging information to help clinicians identify anomalies and form recommendations, which could help reduce physician viewing loads and increase physician effectiveness.
IBM Watson Health opened its new global headquarters earlier this month in Cambridge, Massachusetts, introduced a pair of new cloud services, and announced several new partnerships. The Cambridge site houses 700 IBM employees, and it also will serve several important functions. For entrepreneurs and start-ups, Watson Health's Cambridge headquarters will provide technology, tools and talent to create and launch new products and businesses based on Watson's cloud-delivered cognitive intelligence. IBM intends to open an interactive Watson Health Experience Center in Cambridge, which will serve as a place for IBM clients to undertake immersive leaning about Watson and how it can help transform their businesses. In addition, IBM Research will establish a dedicated Health Research lab at the headquarters.
With regard to its offerings, IBM has expanded its solutions portfolio with the introduction of IBM Watson Health Cloud for Life Sciences Compliance and IBM Watson Care Manager. The IBM Watson Health Cloud for Life Sciences Compliance will help biomedical companies fast-track the deployment of a GxP compliant infrastructure and applications while adhering to stringent requirements for hosting, accessing and sharing regulated data. IBM Watson Care Manager is a population health solution that integrates capabilities from Watson Health, Apple's HealthKit and ResearchKit, a software framework designed by Apple to make it easy for researchers to conduct studies using an iPhone. It allows medical professionals’ to factor a broad range of determinants into a personalized patient engagement program, with the intent to improve individual health outcomes.
In addition to its recent partnerships with Teva and ICON, IBM announced that Boston Children’s Hospital, Columbia University, and Sage Bionetworks will partner with Watson in areas such as drug discovery and development, personalized medicine, chronic disease management, pediatrics, and digital health. Boston Children’s Hospital has been named Watson Health’s foundational pediatrics partner, building on an existing relationship between the two entities. IBM will integrate Watson’s deep and iterative question and answer capability to enhance and scale the OPENPediatrics initiative, an initiative which aims to bring medical knowledge to pediatric caregivers worldwide.
Columbia University Medical Center’s departments of Pathology & Cell Biology and Systems Biology will collaborate with IBM to test using IBM Watson to help oncologists in the Columbia Herbert Irving Comprehensive Cancer Center translate DNA insights into personalized treatment options for patients. Columbia is the sixteenth cancer center to test the use Watson Genomic Analytics. As Columbia and other institutions evaluate Watson’s ability to help clinicians in identifying actionable mutations in cancer, Watson’s rationale and insights will continually improve to provide combined insight in a scalable, cloud-based solution.
Sage Bionetworks’ Open Biomedical Research Platform will be powered by the IBM Watson Health Cloud, with the intent to make the IBM Watson Health Cloud the platform of choice for Sage to aggregate, store, curate, and analyze data collected via apps using ResearchKit. Sage currently has active ResearchKit projects in breast cancer and Parkinson’s disease. Further, Sage and IBM will collaborate to integrate the IBM Watson Health Cloud with Sage’s BRIDGE server and Synapse, an informatics platform for large-scale pooling of data, knowledge, and expertise across institutions. IBM Watson is also partnered with CVS Health, Medtronic, and Yale University.
Google and pharma
Google is another non-traditional player seeking to use digital technology and identify new technologies to advance drug development, commercialization, and overall health outcomes. In August 2015, Sanofi and the life sciences team at Google formed a collaboration for developing better ways to collect, analyze, and understand multiple sources of information impacting Type 1 and Type 2 diabetes. The collaboration will pair Sanofi's expertise in diabetes treatments and devices with Google's expertise in analytics, miniaturized electronics, and low-power chip design. The companies will explore how to improve diabetes care by developing new tools that bring together many of the previously siloed pieces of diabetes management and enable new kinds of interventions. This includes health indicators, such as blood glucose and hemoglobin A1c levels, patient-reported information, medication regimens, and sensor devices.The goal is that it will be easier for patients to successfully manage their diabetes, which would reduce the risk of complications, improve outcomes and ultimately lower costs.
In January 2015, Biogen and Google[x] Life Sciences began a partnership to explore drivers of multiple sclerosis disease progression through investigational technologies and methods, such as novel sensor platforms, advanced laboratory science, and bio-analytical tools. Google[x], is a part of Google that is devoted to finding new solutions to large global problems, which includes a life sciences focus.
In 2014, Alcon, the eye-care division of Novartis, partnered with Google to in-license Google's "smart lens" technology for ocular medical uses.The agreement with Google[x] provides Alcon with the opportunity to develop and commercialize Google's "smart lens" technology with respect to eye care and further enhance Alcon's pipeline and position in contact lenses and intraocular lenses.The smart lens technology involves non-invasive sensors, microchips, and other miniaturized electronics that are embedded within contact lenses. Novartis' interest in this technology is currently focused in two areas. The first area is to helpdiabetic patients manage their disease by providing a continuous, minimally invasive measurement of the body's glucose levels via a "smart contact lens," which is designed to measure tear fluid in the eye and connects wirelessly with a mobile device. The second application is for people living with presbyopia who can no longer read without glasses, and the "smart lens" has the potential to provide accommodative vision correction to help restore the eye's natural autofocus on near objects in the form of an accommodative contact lens or intraocular lens as part of the refractive cataract treatment.
Also in 2014, AbbVie formed a $1.5-billion R&D collaboration with Calico, a Google-backed life sciences company that is led by Arthur D. Levinson PhD. (former chairman and CEO of Genentech) and Hal V. Barron, MD. (former executive vice president and chief medical officer of Genentech). Under the pact, the companies will work to discover, develop, and market new therapies to treat age-related diseases, including for neurodegeneration and cancer. The deal included funding for to establish a research and development facility in the San Francisco Bay Area. AbbVie and Calico initially provided up to $250 million to fund the collaboration with the potential for both sides to contribute an additional $500 million. Calico will be responsible for research and early development during the first five years and continue to advance collaboration projects through Phase IIa for a ten-year period. AbbVie will support Calico in its early R&D efforts and, following completion of Phase IIa studies, will have the option to manage late-stage development and commercial activities. Both parties will share costs and profits equally.
First digital medicine under FDA review
These new partnerships and the applications of digital technologies to advance pharmaceutical development has reached an important milestone, namely the filing of a new drug application (NDA) to the US Food and Drug Administration (FDA) for the first so-called digital medicine. Earlier this month, Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health reported that the FDA has accepted the NDA filing for the combination product of the Abilify (aripiprazole), a drug to treat schizophrenia, bipolar disorder, and depression, embedded with a Proteus ingestible sensor in a single tablet. According to Proteus Digital Health, this is the first time an FDA-approved medication (Abilify) has been combined and submitted for approval with a sensor within the medication tablet (the Proteus ingestible sensor) to measure actual medication-taking patterns and physiologic response. This objective information is communicated to the patient, and with the consent of the patient, to the patient’s physician and/or caregiver. Digital medicines may enable improved patient medication adherence and better informed physician decision-making to tailor treatment to the patient’s needs. The Abilify tablet contains an ingestible sensor that communicates with a wearable sensor patch and a medical software application for measuring adherence in the treatment of adults with schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and as adjunctive therapy for the treatment of major depressive disorder in adults.
If approved by the FDA, healthcare professionals will have the ability to prescribe Abilify tablets with the Proteus ingestible sensor embedded in the tablet. This drug-device product can provide the patient with a treatment option to help manage symptoms while allowing the caregiver and healthcare professional to measure medication adherence and other patient metrics. This system is filed as an NDA, where the FDA Center for Devices and Radiological Health (CDRH)-cleared ingestible sensor from Proteus will be embedded at the point of manufacture with the FDA Center for Drug Evaluation and Research (CDER)-approved Abilify as a combination drug-device, communicating with the Proteus patch and associated medical software.