Zobrazeno 1 - 10 of 15 pro vyhledávání: '"Lynn G. Baird"'
1
Comparison of Stakeholder Metrics for Traditional and Adaptive Development and Licensing Approaches to Drug Development
Autor: Gigi Hirsch, Ernst R. Berndt, Mark R. Trusheim, Hans-Georg Eichler, Lynn G. Baird
Publikováno v: Therapeutic innovationregulatory science. 47(4)
This study evaluates whether an adaptive development and licensing approach to drug development, compared with approaches widely used today, might have tangible advantages across stakeholder groups, thereby facilitating the future adoption. Details i
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::926dddd3834fb5c4c8fc3baf9575d095
https://pubmed.ncbi.nlm.nih.gov/30235525
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2
Medicines Adaptive Pathways to Patients (MAPPs): A Story of International Collaboration Leading to Implementation
Autor: Murray Lumpkin, Mark R. Trusheim, Gigi Hirsch, Richard Bergstrom, Pamela Gavin, Nathalie Seigneuret, Anton Hoos, Magda Chlebus, Michel Goldman, Karin Van Baelen, Duane Schulthess, Lynn G. Baird, Sarah Garner, Thomas F. Unger
Publikováno v: Therapeutic innovationregulatory science. 50(3)
After nearly a decade of discussion, analysis, and development, the Medicines Adaptive Pathways to Patients (MAPPs) initiative is beginning to see acceptance from regulators, industry, patients, and payers, with the first live pilot project initiated
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8e0779b5e220d87c761d1b6702f4d8c2
https://pubmed.ncbi.nlm.nih.gov/30227070
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3
The Janus initiative: A multi-stakeholder process and tool set for facilitating and quantifying Adaptive Licensing discussions
Autor: Gigi Hirsch, Robyn Lim, Sarah Garner, Nitin R. Patel, Mark R. Trusheim, Lynn G. Baird
Publikováno v: Health Policy and Technology. 3:241-247
Successfully advancing Adaptive Licensing requires coordinated planning and action across multiple stakeholders. The Janus Initiative combines a safe haven multi-stakeholder process with an integrated, best-of-breed quantitative simulation toolset to
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::e0b7ab0d8fb0ebf29f723f1674f99409
https://doi.org/10.1016/j.hlpt.2014.10.004
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4
Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval
Autor: Lynn G. Baird, E. V. Sigal, Jeffrey S. Brown, D. Tan, Robyn Lim, H. G. Eichler, Kenneth A. Oye, Vicki L. Seyfert-Margolis, E Pezalla, J Ferguson, Brian O'Rourke, Sarah Garner, J. Sobotka, John C W Lim, Chester L. Drum, Thomas F. Unger, P. Honig, Diane Shoda, Mathias Hukkelhoven, G. Neil, E. Abadie, M. M. Lumpkin, Gigi Hirsch
Publikováno v: Clinical Pharmacology & Therapeutics. 91:426-437
Traditional drug licensing approaches are based on binary decisions. At the moment of licensing, an experimental therapy is presumptively transformed into a fully vetted, safe, efficacious therapy. By contrast, adaptive licensing (AL) approaches are
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::245a5f02aea1ed485744329305690ab5
https://doi.org/10.1038/clpt.2011.345
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6
Legal Foundations of Adaptive Licensing
Autor: David K Lee, A. Chia, P. B. Hutt, S. Hocking, Lynn G. Baird, Kenneth A. Oye, L. Norwalk, Vincenzo Salvatore
Publikováno v: Clinical Pharmacology & Therapeutics. 94:309-311
In April 2012, MIT's Center for Biomedical Innovation and the European Medicines Agency (EMA) cosponsored a workshop on legal foundations of adaptive pharmaceuticals licensing. Past and present attorneys from the US Food and Drug Administration (FDA)
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9676edcaa28d4f41a63b15cfa78a47f5
https://doi.org/10.1038/clpt.2013.95
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7
DX-88 and HAE: a developmental perspective
Autor: Anthony Williams, Lynn G. Baird
Publikováno v: Transfusion and Apheresis Science. 29:255-258
An example of an approach to the developmental philosophy of novel recombinant products is explored by using the exemplar of Hereditary Angioedema (HAE). Plasma kallikrein is believed to be an important mediator of angioedema in patients with genetic
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0f0b9099b7efda3b02feb0b490b419f4
https://doi.org/10.1016/s1473-0502(03)00170-8
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8
Accelerated access to innovative medicines for patients in need
Autor: D. Samaha, Gigi Hirsch, S. Tunis, Finn Børlum Kristensen, R. Banken, Tomas Salmonson, Lynn G. Baird, John C W Lim, H G Eichler, Carole Longson, Robyn Lim, David K Lee, E Pezalla, Janet Woodcock
Publikováno v: Clinical pharmacology and therapeutics. 96(5)
There is broad agreement among health-care stakeholders that more must be done to ensure that patients have timely access to new and innovative medicines. Assuming that industry will continue to develop such medicines at a sustainable rate, regulator
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3c114848adb62fe0114702fda61f2452
https://pubmed.ncbi.nlm.nih.gov/25006877
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9
Voluntary Guidance for the Development of Tissue-Engineered Products
Autor: Ross Tubo, Deirdre D. Maxted, Gary C. Du Moulin, James Davis, Frank T. Gentile, Daniel R. Omstead, Lynn G. Baird, Lisa Christenson
Publikováno v: Tissue Engineering. 4:239-266
Tissue Engineering is an emerging field of medical research in which there is tremendous activity. Many of these products rely on the use of a cellular component co-formulated with a natural or synthetic biomaterial. At this time, though, there are n
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6fd2019e463a08b7dc8a1a43b321a917
https://doi.org/10.1089/ten.1998.4.239
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