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Speeding Innovation to Practice |
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Raymond N. DuBois, M.D., Ph.D., Provost and Executive Vice President: The University of Texas M.D. Anderson Cancer Center
In medicine, and certainly in cancer research, we are on the brink of change in practice and technologic advancement. We are now able to collect thousands of bits of information about each individual tumor at a single point in time. In fact, we are able to collect data more quickly than we can analyze the findings and determine their significance. For each individual tumor, we will soon be able to obtain the entire sequence of every gene and determine key changes in the genetic structure that led to the development of disease. Not only that, we will also be able to measure every single protein molecule that is present in each individual tumor sample and in the bloodstream of each individual patient. At M. D. Anderson, we recently established a Department of Bioinformatics to go along with our Department of Systems Biology. The strategic plan for the innovations in research organization and structure that will occur at M. D. Anderson over the next 10-20 years will be discussed. In order to tackle the new problems and accelerate our progress from the research bench to the bedside, new ways of interpreting this data (in real time) will need to be developed. The most exciting aspect of this work is that we should be able to personalize the medical treatment for each individual patient based on the data we obtain from their cancer tissue. Another innovation that will develop from these approaches will be our ability to predict future diseases and identify diseases that will occur several years in advance, so that the most effective treatment can be deployed in time to prevent and decrease morbidity and mortality.
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New Realities for Drug/device Development and Commercialization |
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Wayne A. Rosenkrans, Jr., Ph.D, Head of Strategy, Business Architecture & Innovation Merck Research Laboratories, Information Technology Division
There is a new refrain in public healthcare spending coming from patients, providers, payers, and politicians, “Pay for What Works,” which elicits a series of collateral questions such as: What Works Best? For Whom? Under What Circumstances? These in turn are generating new expectations for developers of healthcare products.
To meet these new expectations, new thinking is required. Meeting the first three hurdles in drug/device development (safety, efficacy, manufacturing assurance) is no longer sufficient to ensure commercial success. Meeting the next three hurdles (Effectiveness/Utility, Coverage, Reimbursement) with evidence is the new standard expected of the product development sector in healthcare.
The generation of evidence confirming real-world comparative clinical effectiveness must constitute a core element of clinical development plans, developed not only in consultation with the FDA, but with CMS, AHRQ, and private payers. The meaningful segmentation of patient populations, by whatever technology is appropriate (genomic, imaging, informatic), in order to increase the benefit of therapy – Personalized Healthcare – offers a unique opportunity to demonstrate superior clinical utility. A case study in antidiabetic therapy will be used to exemplify an informatic approach to personalized healthcare.
However, retrofitting an effectiveness strategy and/or a personalized healthcare strategy to an existing development plan is inefficient and difficult to do. Both must be part of new development thinking that looks beyond market approval toward greater embedment in clinical practice and attendant commercial success.
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Using IT to Speed Innovation into Practice - Networking the Biopharmaceutical Value Chain |
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Dr. Leonard Lerer, M.D., MBA, Managing Editor of the Journal of Medical Marketing
The landscape of biopharmaceutical research and development is changing rapidly with the advent of new technologies and approaches. A lot more needs to be done to more rapidly move this innovation into products and applications in day-to-day clinical practice. The vision of seamless collaboration across the value chain requires more than simply a series of technological solutions. There is an urgent need to create informal, global technology transfer networks that focus on sharing and the promotion of a seamless value chain between R&D and entrepreneurship in life science. It is indeed timely to explore the role of new IT and networking technologies in connecting academic institutions, research institutes, investors and biotechnology, pharmaceutical and life science industry partners across the world acting as a knowledge and experience resource - a talent pool of researchers, entrepreneurs and finance and business development partners. In order to promote sustainable diffusion of innovation, the life science sector must devote more resources to harnessing the synergies within the local, national and regional science and technology sources and clusters and build global technology transfer capacity by connecting people, knowledge, technologies and resources.
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u-SMART; the Evolution of Intelligent Severance Hospital |
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Byung-Chul Chang, MD, Ph.D., Chief Information Officer, Yonsei University Health System, Professor, Department of Thoracic and Cardiovascular Surgery
Yonsei University Health System (YUHS) recently opened a ubiquitous hospital system named u-SMART(Severance Medical-information Archiving and Retrieving Technology) with integration of CPOE/EMR/PACS/ERP in order to pursue a customer-centric medical culture through advanced medical information systems to enhance patient care and service standards. In order to achieve its goal of becoming a future-oriented, world-class institution, YUHS embarked on the u- Hospital project to actively embrace Korea’s medical service market liberalization and rapidly changing paradigms in the medical environment. The project is an ambitious mid- to long-term one and involves the introduction of intelligent systems, the expansion of infrastructure and security systems, and the actualization of digital management. Its goals are the integrated management of information for hospitals, increased operational efficiency through the standardisation of user interfaces, care process with critical pathway, and business processes, and the establishment of management support and scientific cost control and analysis systems. YUHS prepared and successfully implemented u-SMART which consists of computerized physician’s Order Communication System (OCS) and structured Electronic Health Records (EHR) system, Picture Archiving and Communications Systems (PACS), Enterprise Resources Planning (ERP), secure management information support through data warehousing, stimulate communication and improve workflow, as well as reinforce services for internal and external
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