Analysing stratified medicine business models and value systems: innovation-regulation interactions.
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Summary
Two convergence models for co-development of a therapy and diagnostic before market authorisation are explored, highlighting the regulatory requirements and policy initiatives within the broader value system environment that have a key role in determining the probable success and sustainability of these models.
- Type
- review
- Published
- 2012-09-15
- Cited by
- 28
- References
- 38
- Access
- Open access
- OpenAlex
- https://openalex.org/W2074061898
- Semantic Scholar
- https://api.semanticscholar.org/CorpusID:11388860
Keywords
Business model, Business, Value (mathematics), Health care, Process (computing)
References
- The changing structure of the pharmaceutical industry.
- Personalized medicine and disruptive innovation: Implications for technology assessment
- Quantifying factors for the success of stratified medicine
- Realizing the promise of personalized medicine.
- Personalized Medicine: Challenging Pharmaceutical and Diagnostic Company Business Models
- Global health public-private partnerships: IAVI, partnerships and capacity building.
- Evolution Along the Government-Governance Continuum: FDA's Orphan Products and Fast Track Programs as Exemplars of "What Works" for Innovation and Regulation
- GlaxoSmithKline: Reorganizing Drug Discovery (A)
- Health Biotechnology to 2030
- Tailored medicine: whom will it fit? The ethics of patient and disease stratification.
- Context, ethics and pharmacogenetics.
- Deconstructing the Drug Development Process: The New Face of Innovation
- The microeconomics of personalized medicine: today's challenge and tomorrow's promise
- The governance of agro- and pharmaceutical biotechnology innovation: Public policy and industrial strategy
- The cost of biopharmaceutical R&D: is biotech different?
- The life science industry sector: Evolution of agro-biotechnology in Europe
- Stratified medicine: strategic and economic implications of combining drugs and clinical biomarkers
- Life Science Innovation and the Restructuring of the Pharmaceutical Industry: Merger, Acquisition and Strategic Alliance Behaviour of Large Firms
- Personalized medicine: factors influencing reimbursement.
- Developing tools for stratified medicine
Cited by
- Combining the scenario technique with bibliometrics for technology foresight: The case of personalized medicine
- Companion Diagnostics Development and Commercialization : A Case Study from the Diagnostics’ Perspective
- Methodology for the Analysis of Life Science Innovation Systems (ALSIS) and its Application to Three Case Studies
- Regional innovation policies in a globally connected environment
- Pursuing a biotechnology system of innovation in Lithuania: a conceptual framework for effective policy intervention
- The new pig on the block: modelling cancer in pigs
- Novel GM animal technologies and their governance
- Formalizing an integrative, multidisciplinary cancer therapy discovery workflow
- Repairing the 'Broken Middle' of the Health Innovation Pathway: Exploring Diverse Practitioner Perspectives on the Emergence and Role of 'Translational Medicine'
- The Development of a Recombinant scFv Monoclonal Antibody Targeting Canine CD20 for Use in Comparative Medicine
- Patent cliff and strategic switch: exploring strategic design possibilities in the pharmaceutical industry
- Conceptualising and practising multiple knowledge interactions in the life sciences
- Mapping the Patent Landscape in the Field of Personalized Medicine
- Development of biologics for use in translational medicine
- Konfiguracja wartości dla klienta w sektorze uzdrowiskowym w Polsce
- Policy support for disruptive innovation in the life sciences
- Learning loops in sustainable design : applying Social Return on Investment (SROI) to buildings
- Proposal of Value for Customer of Spas: Expectations of Spa Patients and Tourist in Polish Spas
- Mind the gap! A survey of the challenges of biomarker commercialization.
- Understanding the emergence and evolution of new business models in the UK regenerative medicine sector
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