Medicines Adaptive Pathways to Patients (MAPPs): A Story of International Collaboration Leading to Implementation

Author:

Schulthess Duane,Baird Lynn G.,Trusheim Mark,Unger Thomas F.,Lumpkin Murray,Hoos Anton,Garner Sarah,Gavin Pamela,Goldman Michel,Seigneuret Nathalie,Chlebus Magda,Van Baelen Karin,Bergstrom Richard,Hirsch Gigi

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Reference17 articles.

1. European Medicines Agency. European Medicines Agency launches adaptive licensing pilot project. http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2014/03/WC500163410.pdf. Updated March 19, 2014. Accessed March 25, 2014.

2. Baird LG, Trusheim M, Eichler HG, et al. Comparison of stakeholder metrics for traditional and adaptive licensing approaches to drug development. Therap Innov Regul Sci. 2013;47;474–483.

3. Baird LG, Teagarden R., Unger T, Hirsch G. New medicines eight years faster to patients: blazing a new trail in drug development with adaptive licensing. Scrip Regulatory Affairs, May 24, 2013.

4. Schulthess D. Innovation requires a new regulatory framework to improve research and development of new medical therapies. Health Policy Technol. 2013;4:178–180.

5. Longly M, Simpson A. New medicine for serious conditions: how patients would weigh the risks and benefits. Genetic Alliance UK. 2014:28.

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