Christopher-Paul Milne, DVM, MPH, JD
Director of Research
Identifying and evaluating problems and solutions affecting innovation efficiency and the globalization of R&D; tracking the progress of incentive programs for special patient populations (pediatric and orphan diseases) and neglected diseases of the developing world; assessing the impact of emerging regulatory and reimbursement trends, such as risk evaluation and mitigation strategies (REMS) in the US and Europe’s risk management plan (EU-RMP) program, comparative effectiveness, and risk-sharing arrangements; and, updating developments in new science and policy initiatives, such as personalized medicine, FDA’s Regulatory Science initiative, the EU’s Innovative Medicines Initiative, and Translational Medicine.
- Milne C-P, Kaitin KI. Impact of the New U.S. Health Care Reform Legislation on the Pharmaceutical Industry: Who are the Real Winners? Clin Pharm Ther 2010 Nov;88(5):589-592.
- Zycher B, DiMasi JA, Milne C-P. Private sector contributions to pharmaceutical science: thirty five summary case histories. Am J Ther 2010 Jan-Feb;17(1):101-20.
- Milne C-P. Can translational medicine bring us out of the R&D wilderness? Personalized Med 2009;6(5):543-553.
- Milne C-P, Tait J. Evolution along the government-governance continuum: FDA’s Orphan Products and Fast Track programs as exemplars of “what works” for innovation and regulation. Food & Drug Law J 2009;64(4):733-753.
- Milne C-P, Bruss JB. The economics of pediatric formulation development for off-patent drugs. Clin Ther Nov 2008;30(11):2133-2145.
- Faden L, Milne C-P. Pharmacovigilance activities in the United States, European Union, and Japan: harmonic convergence or convergent evolution? Food & Drug Law J 2008:63(3):683-700.
- Milne C-P. Fixing the paradigm for biopharmacutical R&D: Where to start? Internat’l J Biotech 2008;10(5):404-415.
- Milne C-P. Paediatric assessment: an essential part of standard drug development. Internat’l J Pharm Med 2006;20(5):297-301.
- Milne C-P. US and European regulatory initiatives to improve R&D performance. Expert Opin Drug Discov 2006; 1(1):11-14.
- Milne C-P. Status critical at the FDA or a case of the Socratic problem? Johns Hopkins Advanced Studies in Medicine 2005;5(10):514-17.
- Milne C-P. Racing the globalization of infectious diseases: lessons from the tortoise and the hare. N Engl J Internat’l & Comparative Law 2004 Fall;11(1):1-36.