IRGC, Transatlantic Regulatory Patterns and Implications for International Trade, Sections 23.4 and 25.4, scheduled for release February 2017.
“Pharmaceuticals Licensing and Reimbursement in the European Union, United States and Japan,” (with KA, Eichler HG, Hoos A, Mori Y, Mullin TM and Pearson M),Volume 100 Number 6 December 2016. Received 26 July 2016; accepted 28 August 2016; advance online publication 12 September 2016, doi: 10.1002/cpt505.
"The Next Frontier: Fostering Innovation by Improving Health Data Access and Utilization" Oye, KA, Jain G, Amador, M, Arnout R, Brown, JS, Crown W, Ferguson, J, Pezalla, E, Rassen JA, Selker JP, Trusheim, M and Hirsch G, Clinical Pharmacology and Therapeutics. 98 (5) Nov 5, 2015, pp 515-521.
“From adaptive licensing to adaptive pathways: Delivering a flexible life-span approach to bring new drugs to patients.” (with Hans Georg Eichler et al), Clinical Pharmacology & Therapeutics, 95 (3), Feb 4, 2015, pp 234-246.
“Regulate Home Brew Opiates,” (with JC Lawson and T Bubela), Nature. 521 (7552), May 21, 2015, pp.281-283.
“Regulating Gene Drives,” (with Kevin Esvelt, Evan Appleton, Flaminia Catteruccia, George Church, Todd Kuiken, Shlomiya Bar-Yam Lightfoot, Julie McNamara, Andrea Smidler, James Collins), Science. 345 (6197), August 8, 2014, pp. 626-628.
“A Proposal for Integrated Efficacy-to-Effectiveness (E2E Clinical Trials).” (with H.P. Selker), Clinical Pharmacology & Therapeutics, 2014, 95 2, pp. 147-153.
“Designing Safety Policies to Meet Evolving Needs: iGEM as a Testbed for Proactive and Adaptive Risk Management.” (with Julie McNamara, Shlomiya Bar-Yam Lightfoot, Kelly Drinkwater, Evan Appleton) ACS Synthetic Biology. (12) December 3, 2014, pp. 983-985.
“Shaping Ecological Risk Research for Synthetic Biology.” (with T. Kuiken, G. Dana, D. Rajeski), Journal of Environmental Studies and Sciences. 2014, 4:191-199.
“Legal Foundations of Adaptive Licensing” K Oye et al (September 2013) and “Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval,” H Eichler, K Oye et al (March 2012), Nature Clinical Pharmacology & Therapeutics.
“Proactive and Adaptive Governance of Emerging Risks: The Case of DNA Synthesis and Synthetic Biology, Kenneth A. Oye, International Risk Governance Council, June 2012.
“Guide to US Federal Regulations Governing Synthetic Biology,” Kenneth Oye et al in Markus Schmidt (ed), Assessing Synthetic Biology Applications, Wiley, 2012, 17 pages.