References
- Eichler HG, Bloechl-Daum B, Abadie E, Barnett D, König F, Pearson S. Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers. Nat. Rev. Drug Discov. 9(4), 277–291 (2010).
- Henshall C, Mardhani-Bayne L, Frønsdal KB, Klemp M. Interactions between health technology assessment, coverage, and regulatory processes: emerging issues, goals, and opportunities. Int. J. Technol. Assess. Health Care 27(3), 253–260 (2011).
- Villeneuve PJ. The placebo standard in regulatory market approval: why the Declaration of Helsinki has been ignored for 35 years. McGill J. Med. 6, 52–55 (2001).
- Stewart A, Aubrey P, Belsey J. Addressing the health technology assessment of biosimilar pharmaceuticals. Curr. Med. Res. Opin. 26(9), 2119–2126 (2010).
- van Nooten F, Holmstrom S, Green J, Wiklund I, Odeyemi IA, Wilcox TK. Health economics and outcomes research within drug development: challenges and opportunities for reimbursement and market access within biopharma research. Drug Discov. Today 17(11-12), 615–622 (2012).
- Eichler HG, Abadie E, Breckenridge A et al. Bridging the efficacy-effectiveness gap: a regulator’s perspective on addressing variability of drug response. Nat. Rev. Drug Discov. 10(7), 495–506 (2011).
- ICH harmonised tripartite guideline: choice of control group and related issues in clinical trials (E10). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Geneva, Switzerland (2000).
- Garrido MV, Kristensen FB, Nielsen CP, Busse R. Health Technology Assessment and Health Policy Making- Current Status, Challenges and Potential. World Health Organization, on behalf the European Observatory on Health Systems and Policies, Copenhagen (2008).
- Sorenson C, Drummond M, Kanavos P. Ensuring Value for Money in Health Care: The Role of Health Technology Assessment in the European Union. World Health Organization, on behalf of the European Observatory on Health Systems and Policies, Geneva (2008).
- Centre for Innovation in Regulatory Science. Evidentiary Requirements in Clinical Development: Synchronising Phase III Requirements to Meet Multiple Needs. (Workshop synopsis). The Centre, Geneva, Switzerland (2011).
- Barker R. A flexible blueprint for the future of drug development. Lancet 375(9712), 357–359 (2010).
- Liberti LE, Pichler F, Walker SR. Preparing for regulator review and reimbursement decisions- a case for cooperation between regulatory authorities, sponsors and health technology assessment agencies. Pharm. Med. 23(5–6), 263–267 (2009).
- Lehner J-P, Epstein RS, Salimi T. Integrating new approaches for clinical development: translational research and relative effectiveness. J. Comp. Eff. Res. 1(1 Suppl. 1), 15–21 (2012).
- Martin M, Lensberg B, Drummond M, McGuire A. Relative efficacy- towards a new frontier? ISPOR Connections 17(5), 8–10 (2011).
- Berger ML, Grainger D. Comparative effectiveness research: the view from a pharmaceutical company. Pharmacoeconomics 28(10), 915–922 (2010).
- Frønsdal K, Pichler F, Mardhani-Bayne L et al. Interaction initiatives between regulatory, health technology assessment and coverage bodies, and industry. Int. J. Technol. Assess. Health Care 28(4), 374–381 (2012).
- European Medicines Agency. Road Map to 2015: The European Medicines Agency’s Contribution to Science, Medicines and Health. European Medicines Agency, London, United Kingdom (2010).
- European Medicines Agency. European Medicines Agency and EUnetHTA Joint Action start collaboration on European Public Assessment Report (EPAR) Contribution to Relative Effectiveness Assessments [press release]. European Medicines Agency, London, United Kingdom (2010).
- Luria X. Regulatory Science Workforce Needs to Maintain a Robust Global Therapeutics Pipeline [Presentation]. Institute of Medicine Workshop, Washington, DC (2011).
- Moseley GB 3rd. The prospects for medical technology in the next decade. Stud. Health Technol. Inform. 118, 15–31 (2005).
- Institute for Regulatory Science. Regulation and Reimbursement: Two Sides of the Same Coin? The Institute, Alexandria, VA (2008).
- Backhouse ME, Wonder M, Hornby E, Kilburg A, Drummond M, Mayer FK. Early dialogue between the developers of new technologies and pricing and reimbursement agencies: a pilot study. Value Health 14(4), 608–615 (2011).
- Tapestry Networks. Pilots of Multi-Country, Multi-Stakeholder Consultations in Drug Development: Promoting Clarity on Sources of Medicinal Value. Tapestry Networks, Waltham, MA (2011).
- Leader M. Calling for six standards to value innovation in healthcare. J. BioLaw Bus. 11(1), 49–51 (2008).
- Keja J. HTA moves center stage. AccessPoint IMS Health Econ. Outcomes Res. 1(2), 15–17 (2011).
- Tapestry Networks. Pilots of Multi-Country, Multi-Stakeholder Consultations in Drug Development: From Proof of Concept to Tangible Benefits: From Proof of Concept to Tangible Benefits. Tapestry Networks, Waltham, MA (2012).
- Tapestry Networks. Alzheimer’s Disease Working Group: Advancing Progress in the face of Dynamic Science and Constrained Resources. Tapestry Networks, Waltham, MA (2012).
- Tapestry Networks. Improving Health Outcomes in Type 2 Diabetes: Putting a Shared Value Framework into Practice. Tapestry Networks, Waltham, MA (2010).
- Australian Government Department of Health and Ageing. Memorandum of understanding with medicines Australia. (2010).
- Canadian Agency for Drugs and Technologies in Health. CDR Update. The Agency, Ottawa (2012).
- Association bilateral meeting – BIOTECanada - Meeting Minutes – 2009-11-18. Health Canada, Ottawa (2009).
- Canadian Agency for Drugs and Technologies in Health. CDR Update. The Agency, Ottawa (2009).
- Department of Health and Human Services. Memorandum of understanding between United States Food and Drug Administration and the Centers for Medicare and Medicaid Services. Fed. Regist. 75, 48699–48700 (2010).
- MaRSEXCITE. Application Guide. MaRSEXCITE, Toronto (2012).
- PriceWaterhouseCoopers. Pharma 2020: Which Path will you Take? PriceWater house Coopers, Hamilton, ON (2012).
- Woosley RL, Rice G. A new system for moving drugs to market. Issues Sci. Technol. 21(2), 63–68 (2005).
- Eichler HG, Oye K, Baird LG et al. Adaptive licensing: taking the next step in the evolution of drug approval. Clin. Pharmacol. Ther. 91(3), 426–437 (2012).
- Eichler HG. Adaptive Licensing: A Useful Approach for Drug Licensing in the EU [Presentation]. European Medicines Agency, London, UK (2012).
- NEWDIGS (New Drug Development Paradigms). Catalyzing the Transformation of Healthcare Innovation. MIT Center for Biomedical Innovation, Cambridge, MA (2010).
- Institute of Medicine. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. The National Academies Press, Washington, DC (2012).
- Health Canada. The Progressive Licensing Framework: Concept Paper for Discussion. Health Canada, Ottawa (2007).
- Health Canada. Progressive Licensing Project. Health Canada, Ottawa (2012).
- Usdin S. Progressive Thinking for FDA. BioCentury Publications, Inc, San Carlos, CA (2011).
- Guyatt G, Rennie D, Meade MO, Cook DJ. Users’ Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice. McGraw Hill Medical, New York (2008).
- Canadian Agency for Drugs and Technologies in Health. CDR Update. The Agency, Ottawa (2008).
- Drummond M, Griffin A, Tarricone R. Economic evaluation for devices and drugs–same or different? Value Health 12(4), 402–404 (2009).
- Trueman P, Hurry M, Bending M, Hutton J. The feasibility of harmonizing health technology assessments across jurisdictions: a case study of drug eluting stents. Int. J. Technol. Assess. Health Care 25(4), 455–462 (2009).
- Tolley K. Pharmaceutical market access and the challenges of health technology assessment in the United Kingdom. Drug Dev. Res. 71(8), 478–484 (2010).
- European Medicines Agency. Implementing the European Medicines Agency’s Road map to 2015: the Agency’s contribution to Science, Medicines, Health. European Medicines Agency, London, UK (2011).
Websites
- Lakemedelsverket Medical Products Agency. Routine for scientific advice. Uppsala, Sweden (2011). http://www.lakemedelsverket.se/english/product/Medicinal-products/Scientific-advice/
- National Institute for Health and Clinical Excellence. NICE Scientific Advice. London, United Kingdom (2012). http://www.nice.org.uk/aboutnice/scientificadvice/AboutScientificAdvice.jsp
- Green Park Collaborative. Green Park Collaborative Home (2012). http://www.greenparkcollaborative.org/
- Lakemedelsverket Medical Products Agency. Pilot project of joint scientific advice meetings will be evaluated. Uppsala, Sweden (2010). http://www.lakemedelsverket.se/english/All-news/NYHETER-2010/Pilot-project-of-joint-scientific-advice-meetings-Medical-Product-Agency-MPA-and-the-Dental-and-Pharmaceutical-Benefits-Agency-TLV/
- Lakemedelsverket Medical Products Agency. Joint scientific advice meetings between the Dental and Pharmaceutical Benefits Agency (TLV) and the Medical Products Agency (MPA). Uppsala, Sweden, (2010). http://www.lakemedelsverket.se/english/product/Medicinal-products/Scientific-advice/Pilot-project-of-joint-scientific-advice-meetings-arranged-by-the-TLV-and-the-MPA/
- National Institute for Health and Clinical Excellence. Standard process. London, United Kingdom (2012). http://www.niceorg.uk/aboutnice/scientificadvice/StandardProcess.jsp
- National Institute for Health and Clinical Excellence. Advice alongside the regulators. London, United Kingdom (2012). http://www.nice.org.uk/aboutnice/scientificadvice/AdviceAlongsideTheRegulators.jsp
- U.S. Food and Drug Administration. FDA-CMS parallel review., Silver Spring, MD (2011). http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ucm255678.htm
- MaRSEXCITE. What is EXCITE. Toronto, ON (2012). http://excite.marsdd.com/what-is-excite/
- MaRSEXCITE. Why EXCITE. Toronto, ON (2012). http://excite.marsdd.com/why-excite/
- National Institute for Health and Clinical Excellence. NICE Scientific Advice Team. London, United Kingdom (2012). http://www.nice.org.uk/aboutnice/scientificadvice/NICEScientificAdviceTeam.jsp
- National Institute for Health and Clinical Excellence. NICE Scientific Advice events and seminars. London, United Kingdom (2012). http://www.nice.org.uk/aboutnice/scientificadvice/EventsAndSeminars.jsp
- Australian Government Department of Health and Ageing. Framework for the introduction of parallel TGA and PBAC processes. (2011). http://www.pbs.gov.au/info/industry/useful-resources/memorandum