Jordan Paradise

Associate Professor of Law

PUBLICATIONS

LAW REVIEW ARTICLES

Synthetic Biology: Does Re-Writing Nature Require Re-Writing Regulation?, 117 Penn. State L. Rev. (forthcoming 2012) (with Ethan Fitzpatrick)

Reassessing 'Safety' for Nanotechnology Combination Products: What Do 'Biosimilars' Add to Regulatory Challenges for the FDA?, 56 St. Louis U. L.J. 1-55 (2012)

Claiming Nanotechnology: Improving USPTO Efforts at Classification of Emerging Nano-Enabled Pharmaceutical Technologies, 10(3) Northwestern Journal of Technology and Intellectual Property 169-207 (2012)

The Devil is in the Details: Health Care Reform, Biosimilars, and Implementation Challenges for the Food and Drug Administration, 51 JURIMETRICS 279-292 ((2011))

Follow-On Biologics: Implementation Challenges and Opportunities, 41 Seton Hall L. Rev. 501-509 (2011)

Exploring Emerging Nanobiotechnology Drugs and Medical Devices, 63(2) Food and Drug L.J. 407-420 (2008) (with Gail M. Diliberto, Alison W. Tisdale, & Efrosini Kokkoli)

Developing Oversight Frameworks for Nanobiotechnology, 9(1) Minnesota J. L. Science & Tech. 187-203 (Winter 2008) (with Susan M. Wolf, Gurumurthy Ramachandran, Efrosini Kokkoli, Ralph Hall, & Jennifer Kuzma)

Tales from the Crypt: Scientific, Ethical, and Legal Considerations for Biohistorical Analysis of Deceased Historical Figures, 26 Temple J. Of Science, Tech. & Environ. Law 223-299 (Fall 2007) (with Lori Andrews)

Lessons from the European Union: The Need for a Post-Grant Mechanism for Third Party Challenge to U.S. Patents, 7(1) Minnesota J.L. Science & Tech. 315-326 (2005)

Gene Patents: The Need for Bioethics Scrutiny and Legal Change, 5 Yale J. Health Pol'y, L. & Ethics 403-412 (2005) (with Lori Andrews)

European Opposition to Exclusive Control Over Predictive Breast Cancer Testing and the Inherent Implications for United States Patent Law and Public Policy: A Case Study of the Myriad Genetics’ BRCA Patent Controversy, 59(1) Food and Drug L.J. 133-154 (2004)

OTHER JOURNAL ARTICLES

Recommendations for Oversight of Nanobiotechnology: Dynamic Oversight for Complex and Convergent Technologies, Journal of Nanoparticle Research DOI: 10.1007/s11051-011-0233-2 (February 2011) (Gurumurthy Ramachandran, Susan M. Wolf, Jennifer Kuzma, Ralph Hall, Efrosini Kokkoli and Leili Fatehi)

The Challenge of Developing Oversight Approaches to Nanobiotechnology, 37(4) J.L. Med. & Ethics 543-545 (2009) (with Susan M. Wolf, Jennifer Kuzma, Gurumurthy Ramachandran, and Efrosini Kokkoli)

Evaluating Oversight of Human Drugs and Medical Devices: A Case Study of the FDA and Implications for Nanobiotechnology, 37(4) J.L. Med. & Ethics 598-624 (2009) (with Alison W. Tisdale, Ralph Hall, & Efrosini Kokkoli)

Developing U.S. Oversight Strategies for Nanobiotechnology: Learning from Past Oversight Experiences, 37(4) J. L. Med. & Ethics 688-705 (2009) (with Susan M. Wolf, Jennifer Kuzma, Aliya Kuzhabekova, Alison W. Tisdale, Gurumurthy Ramachandran, and Efrosini Kokkoli)

Patient Advocacy Group Collaboration in Genetic Research and The Scope of Joint Inventorship under U.S. Patent Law, 3(2) Int'l J. OF INTELLECTUAL PROPERTY MANAGEMENT 97-109 (2009)

An Integrated Approach to Oversight Assessment for Emerging Technologies, 28(5) RISK ANALYSIS 1197-1220 (2008) (with Jennifer Kuzma, Gurumurthy Ramachandran, Jee-Ae Kim, Adam Kokotovich, & Susan M. Wolf)

The Law of Incidental Findings in Human Subjects Research, 36(2) J.L.Med. & Ethics 361-383 (2008) (with Susan M. Wolf & Charlisse Caga-anan)

Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations, 36(2) J. L. Med. & Ethics 219-248 (2008)

When Patents Threaten Science, 314 Science 1395-96 (2006) (with Lori Andrews, Timothy Holbrook, & Danielle Bochneak)

Decoding the Research Exemption, 7(2) Nature Reviews Genetics 148-154 (2006) (with Christopher Janson)

Problems in Patenting Human Genes, 308 Science 1869 (2005) (with Lori Andrews & Timothy Holbrook)

Call for Biohistory Guidelines, 2 PLOS MEDICINE e192 (2005)

Patents on Human Genes: An Analysis of Scope and Claims, 307 Science 1566-1567 (2005) (with Lori Andrews & Timothy Holbrook)

Constructing Ethical Guidelines for Biohistory, 304 Science 214-215 (2004) (with Lori Andrews, Nancy Buenger, Jennifer Bridge, Laurie Rosenow, David Stoney, R.E. Gaensslen, Theodore Karamanski, Russell Lewis, Amy Inlander, & David Gonen)

OTHER PUBLICATIONS

Nanobiotechnology and the FDA, Food and Drug Law Institute's UPDATE MAGAZINE (March/April 2010)

Banning Gene Patents Can Bring Benefits, 1(39) BIOWORLD TODAY (September 20, 2007) (with Lori Andrews)

National Conference on Research Cloning, PERSPECTIVES: THE MAGAZINE FOR THE UNIVERSITY OF MINNESOTA LAW SCHOOL (Spring 2007)

BOOKS AND BOOK CHAPTERS

Genetic Sequence Patents: Historical Justification and Current Impacts, in in Jean-Paul Gaudillière, Daniel J. Kevles, Hand-Jörg Rheinberger, eds., MAX PLANCK INSTITUTE FOR THE HISTORY OF SCIENCE, LIVING PROPERTIES: MAKING KNOWLEDGE AND CONTROLLING OWNERSHIP IN THE HISTORY OF BIOLOGY 137- 163 (2009) (with Lori Andrews)

Gene Patents and Bioethics, in TOWARDS A DECLARATION ON UNIVERSAL NORMS ON BIOETHICS EXTRAORDINARY SESSION OF THE INTERNATIONAL BIOETHICS COMMITTEE, in (2004) (with Lori Andrews)

PRESENTATIONS

Assessing FDA Regulation of New Drugs, Animal Drugs, and Cosmetics As Applied to Microbes Modified Using Synthetic Biology, J. Craig Venter Institute, Rockville, MD (January 31, 2012)

Sottera v. FDA: Electronic Cigarettes and the Tobacco Control Act of 2009, Food & Drug Law Institute, 54th Annual Conference , Washington, DC (April 6, 2011)

Synthetic Biology Meets the Law, AALS Annual Meeting, Biolaw Section, San Francisco, CA (January 5, 2011)

The Devil is in the Details: Health Care Reform, Biosimilars, and Implementation Challenges for the Food and Drug Administration, 3rd Annual Pharmaceutical Reimbursement & Market Access Conference, Philadelphia, PA (October 28, 2011)

The Biologics Price Competition and Innovation Act: FDA and Biosimilars , Seton Hall University School of Law, Follow-On Biologics: Implementation Challenges and Opportunities Roundtable, Newark, NJ (October 29, 2010)

Developing Oversight for Nanobiotechnology: Human Drugs and Medical Devices, University of Massachusetts,, Nanotechnology & Society: Emerging Organizations, Oversight, and Public Policy Systems Conference, Amherst, MA (September 24, 2010)

Current Legal Status of Follow-On Biologics, American Society of Law, Medicine and Ethics 33rd Annual Health Law Professors Conference, Austin, TX (June 4, 2010)

Consensus Recommendations on Nanobiotechnology Oversight, Governing Nanobiotechnology: Reinventing Oversight in the 21st Century Conference, U. of Minnesota, Minneapolis, MN (April 15, 2010)

The FDA, Nanodrugs, and Implications for Healthcare, American Society of Law, Medicine & Ethics 32nd Annual Health Law Professors Conference, Cleveland, OH (June 5, 2009)