Title/s: Georgia Reithal Professor of Law
Office #: Corboy 1326
Jordan Paradise researches and publishes on the intersection of law, science, and technology. Her primary focus is in the life science realm, examining legal and policy issues in the development and regulation of pharmaceuticals, medical devices and innovations in medicine. Recent interests span nanotechnology, synthetic biology, precision medicine, gene editing, and electronic cigarettes. Her publications have appeared in both peer-reviewed and legal publications.
Previously, Professor Paradise served as the Schering-Plough Professor of Law at Seton Hall University School of Law in New Jersey where she was a faculty member of both the Center for Health & Pharmaceutical Law & Policy and the Gibbons Institute for Law, Science & Technology. From 2005-2009, she was the Associate Director of Research & Education for the Joint Degree Program in Law, Health & the Life Sciences and the Consortium on Law and Values in Health, Environment & the Life Sciences at the University of Minnesota Law School. She was also an adjunct associate professor of law, a research associate in the Center for Bioethics, and the faculty editor-in-chief of the Minnesota Journal of Law, Science & Technology during her time at the University of Minnesota.
JD, Chicago-Kent College of Law, 2003 (Intellectual Property Law Certificate)
BS, University of Michigan, Ann Arbor, 1999
Food & Drug Law
Professional & Community Affiliations
Association of American Law Schools, Law, Medicine & Health Section, Board Member; Biolaw Section, Board Member
American Bar Association, Science and Technology Section
American Health Lawyers Association, Editorial Board Member
American Society of Law, Medicine & Ethics
Food and Drug Law Institute
SSRN Author page: http://papers.ssrn.com/author=512260
Law Review Articles
Insulin Federalism, forthcoming Boston U. J. Sci. & Tech. L. (2021).
FDA Publicity and Enforcement in the COVID Era, forthcoming Washburn L. Rev. (2021)(with Elise Fester).
Pandemic Politics, Public Health, and the FDA, forthcoming Belmont L. Rev. (2021)(with Becky Bavlsik).
Patent Opacity in Biopharmaceutical Innovation, forthcoming Am. J. Law & Med. (2021).
COVID-IP: Staring Down the Bayh-Dole Act with 2020 Vision, 7 Journal of Law & the Biosciences 1 (2020).
Three Framings of “Faster” at the FDA and the Federal Right to Try, 11 Wake Forest J. Law & Pol’y 53 (2020).
COVID-IP: Staring Down the Bayh-Dole Act with 2020 Vision, forthcoming 7 J. L & Biosciences 1 (2020).
Public Health Preparedness & Response: An Exercise in Administrative Law, 20 DePaul J. Health Care L. 1 (2019)(with John Blum).
Nanomedicine & the FDA, forthcoming AMA J. Ethics (2019).
Regulatory Frameworks for Precision Medicine, 15(1) ABA SciTech Lawyer 12 (2018).
Revisiting Regulatory Evasion, 2018 Ill. L. Rev. online 93 (2018).
Regulatory Silence at the FDA, 102 Minn. L. Rev. 2383 (2018).
21st Century Citizen Pharma, 44 Am. J. L. & Med. 309 (2018).
Exploring Precision FDA, an Online Crowdsourcing Platform for Genomics, 58 Jurimetrics 267 (2018).
Cultivating Innovation in Precision Medicine through Regulatory Flexibility at the FDA, 11 NYU J. Law & Liberty 672 (2017).
A Profile of Bio-Pharma Consolidation Activity, 25 Annals of Health law 34 (2016).
REMS as a Competitive Tactic: Is Big Pharma Hijacking Drug Access and Patient Safety?, 15 Hous. J. Health L. & Pol’y 43-82 (2015).
The Legal and Regulatory Status of Biosimilars: How Product Naming and State Substitution Laws May Impact the United States Healthcare System, 41 Am. J. L. & Med. 49-84 (2015).
No Sisyphean Task: How the FDA Can Regulate Electronic Cigarettes, 13 Yale J. Health Pol’y, L. & Ethics 326-74 (2013).
Synthetic Biology: Does Re-writing Nature Require Re-writing Regulation?, 117 Penn. St. L. Rev. 53-88 (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) Nw. J. Technol. & Intell. Prop. 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 & Drug L. J. 407-420 (2008)(with Gail M. Diliberto, Alison W. Tisdale & Efrosini Kokkoli).
Developing Oversight Frameworks for Nanobiotechnology, 9(1) Minn. J. L. Sci. & Tech. 187-203 (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. Sci., Tech. & Env’tl L. 223-299 (Fall 2007)(with Lori B. Andrews).
Gene Patents: The Need for Bioethics Scrutiny and Legal Change, 5 Yale J. Health Pol’y, L. & Ethics 403-412 (2005)(with Lori B. Andrews).
Lessons from the European Union: The Need for a Post-Grant Mechanism for Third Party Challenge to U.S. Patents, 7(1) Minn. J. L. Sci. & Tech. 315-326 (2005).
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 & Drug L. J. 133-154 (2004).
Case Note: Sandoz v. Amgen, FDLI Update 32 (July/August 2017).
U.S. Regulatory Challenges for Gene Editing, 13 SciTech Lawyer 10 (2016).
Electronic Cigarettes: Smoke-Free Laws, Use Restrictions, and the Public Health, 104 Am. J. Pub. Health e17 (2014).
Recommendations for Oversight of Nanobiotechnology: Dynamic Oversight for Complex and Convergent Technologies, 13(4) J. Nanoparticle Res. 1345-71(April 2011)(with Gurumurthy Ramachandran, Susan M. Wolf, Jennifer Kuzma, Ralph Hall, Efrosini Kokkoli, & Leili Fatehi).
The Challenge of Developing Oversight Approaches to Nanobiotechnology, 37(4) J. Law, Med. & Ethics 543-545 (2009)(with Susan M. Wolf, Jennifer Kuzma, Gurumurthy Ramachandran & Efrosini Kokkoli).
Evaluating Oversight of Human Drugs and Medical Devices: A Case Study of the FDA and Implications for Nanobiotechnology, 37(4) J. Law, 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. Law, Med. & Ethics 688-705 (2009)(with Susan M. Wolf, Jennifer Kuzma, Aliya Kuzhabekova, Alison W. Tisdale, Gurumurthy Ramachandran & Efrosini Kokkoli).
Patient Advocacy Group Collaboration in Genetic Research and The Scope of Joint Inventorship under U.S. Patent Law, 3(2) Internat’l J. Intell. Prop. 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. Law, 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. Law, Med. & Ethics 219-248 (2008)(with Susan M. Wolf, Frances P. Lawrenz, Charles A. Nelson, Jeffrey P. Kahn, Mildred K. Cho, Ellen Wright Clayton, Joel G. Fletcher, Michael K. Georgieff, Dale Hammerschmidt, Kathy Hudson, Judy Illes, Vivek Kapur, Moira A. Keane, Barbara A. Koenig, Bonnie S. LeRoy, Elizabeth G. McFarland,Lisa S. Parker, Sharon F. Terry, Brian Van Ness & Benjamin S. Wilfond).
When Patents Threaten Science, 314 Sci. 1395-96 (2006)(with Lori B. Andrews, Timothy Holbrook & Danielle Bochneak).
Decoding the Research Exemption, 7(2) Nat. Rev. Genet. 148-154 (2006)(with Christopher Janson).
Problems in Patenting Human Genes, 308 Sci. 1869 (2005)(with Lori B. Andrews & Timothy Holbrook).
Call for Biohistory Guidelines, 2 PLoS Medicine e192 (2005).
Patents on Human Genes: An Analysis of Scope and Claims, 307 Sci. 1566-1567 (2005)(with Lori B. Andrews & Timothy Holbrook).
Constructing Ethical Guidelines for Biohistory, 304 Sci. 214-215 (2004)(with Lori B. Andrews, Nancy Buenger, Jennifer Bridge, Laurie Rosenow, David Stoney, R.E. Gaensslen, Theodore Karamanski, Russell Lewis, Amy Inlander & David Gonen).
Biopharmaceutical Compliance Trends, in D. Daniel Sokol and Benjamin van Rooji, Eds., Cambridge Handbook of Compliance (Cambridge University Press, forthcoming 2021).
Introduction to Biologics, Chapter 3 in The Fundamentals of Life Sciences Law: Drugs, Devices, and Biotech, 2nd Ed. (American Health Lawyers Association, 2014).
Genetic Sequence Patents: Historical Justification and Current Impacts, in Jean-Paul Gaudillière, Daniel J. Kevles, Hand-Jörg Rheinberger, eds., Living Properties: Making Knowledge and Controlling Ownership in the History of Biology 137- 163(Max Planck Institute for the History of Science: Paris 2009)(with Lori B. Andrews).
Gene Patents and Bioethics in Towards a Declaration on Universal Norms on Bioethics Extraordinary Session of the International Bioethics Committee, Paris, April 27-29, 2004 (with Lori B. Andrews).
Comparing Domestic Regulatory Regimes in Big Data and AI in Healthcare, Hastings Center and NYU Langone Health, virtual December 14, 2020.
Faculty Panelist, Together in Loyola Faculty Webinar Series: Ethical Issues in Science and Technology Innovation, via Zoom webinar, October 22, 2020.
Finding A Cure for COVID: Regulatory and IP Issues, Loyola University School of Law, virtual July 16, 2020.
Health Law and the COVID-19 Pandemic, Loyola Beazley Institute for Health Law & Policy, virtual April 28, 2020.
Three Framings of “Faster” at the FDA and the Federal Right to Try Act, Pennsylvania State University Law School, University Park, PA, March 5, 2020.
Moderator, Legal and Regulatory Issues in Life Sciences Law 2020, AAL Biolaw section, Washington, D.C., January 2020.
Patient Perspectives in FDA Regulation, Right to Try Laws: The Benefits and Burdens of Balancing Protection with Access in Human Subject Research, Wake Forest School of Law, Nov. 1, 2019.
Law & Ethics of Citizen Science, Participant-Driven Research, and Precision Medicine,Democratizing Medicine in Data and Tech-Driven World, DePaul University, Chicago, IL, Mar. 14, 2019.
Regulation of Biosimilars at the FDA: Current Trends and Challenges, Biosimilar Innovation, University of California Irvine School of Law, Feb. 8, 2019.
Regulating Biotechnology, AALS Annual Meeting, Biolaw Section, New Orleans, LA, Jan. 5, 2019.
21st Century Citizen Pharma, FDA: Past, Present & Future, American University Washington School of Law, Washington, D.C., Oct. 19, 2018.
Health Law Grand Rounds, Indiana University Robert H. McKinney School of Law, Indianapolis, IN, Oct. 4, 2018.
FDA Medical Countermeasures, Jaharis Symposium on Health Law and Intellectual Property: Technological and Emergency Responses to Pandemic Diseases, DePaul University School of Law, Chicago, IL, Feb. 22, 2018.
21st Century Citizen Pharma, The 21st Century Cures Act: A Cure for the 21st Century?, Boston University School of Law, Boston, MA, Jan. 26, 2018.
Regulatory Silence at the FDA, University of Minnesota Law Review Symposium, Minneapolis, MN, Oct. 27, 2017.
Panel Member, FDA Challenges for a New Century, Medical Innovation and the Law, New York University School of Law, New York, NY, Feb. 22, 2017.
First Amendment Update: Reconciling Case Law and FDA Policy, Pharmaceutical Compliance Forum (PCF) Spring Meeting, Boston, MA, April 13, 2016.
Consolidation in the Life Sciences, Ninth Annual Symposium on Health Law & Policy: Consolidation and its Impact on Quality, Accessibility, and Cost, Loyola University Chicago School of Law, Chicago, IL, November 13, 2015.
Panelist, Protecting Drug Franchises, Life Sciences Symposium, Mayer Brown, Newark, NJ, October 30, 2015.
Biotech and Biopharma Law & Regulation, Innovations in Health Law & Policy: Legal Challenges & Strategies, University of New Hampshire Law School, Concord, NH, October 26, 2015.
Introduction to New Drug Development and Approval, Seton Hall Health Care Compliance Program, Newark, NJ, October 13, 2015.
Introduction to New Drug Development and Approval, Seton Hall Health Care Compliance Program, Newark, NJ, June 9, 2015.
Panel Member, FDA Hot Topics, Sidley Austin Life Sciences College, New York, NY, May 7, 2015.
REMS as a Competitive Tactic: Is Big Pharma Hijacking Drug Access and Patient Safety?, Hofstra Law School Faculty Workshop, Hempstead, NY, Oct. 29, 2014.
REMS as a Competitive Tactic: Is Big Pharma Hijacking Drug Access and Patient Safety?, University of Houston, Houston, TX, Oct. 16, 2014.
Introduction to New Drug Development and Approval, Seton Hall Health Care Compliance Program, Newark, NJ, Oct. 14, 2014.
Keynote Address: Three Challenges to Pharmacovigilance, Sidley Austin Pharmacovigilance (pv) Legal, Whippany, NJ, July 16, 2014.
Nanotechnology Law & Policy, Earth Justice, New York, NY, June 11, 2014.
Emerging Life Sciences, Lafayette College, Easton, PA, April 29, 2014.
Panel Member, FDA Hot Topics, Sidley Austin Life Science College, New York, NY, April 3, 2014.
The BRAIN Initiative: Law, Policy, Ethics, Lehigh University, Bethlehem, PA, Nov. 21, 2013.
The BRAIN Initiative: Law, Policy, Ethics, New Jersey Institute of Technology, Newark, NJ, Nov. 6, 2013.
Working in the Food and Drug Law Space: Challenges and Opportunities, Food and Drug Law Institute Annual Conference, Washington, D.C., Apr. 24, 2013.
Gene Patents at the Supreme Court, New Jersey Institute of Technology, Newark, NJ, Apr. 17, 2013.
FDA I & II: Pharmaceutical Regulatory and Compliance Fundamentals, Sidley Austin Life Sciences College, New York, NY, Feb. 26, 2013.
Implementation of the Biologics Price Competition and Innovation Act, Gibbons PC and Institute for Law, Science & Technology, Newark, NJ, Feb. 19, 2013.
An Overview of the Food & Drug Administration, Seton Hall MSJ Open House, Newark, NJ, Oct. 20, 2012.
Panel Moderator, CBER Developments, Food & Drug Law Institute, 55th Annual Conference, Washington, D.C., Apr. 24, 2012.
Assessing FDA Regulation of New Drugs, Animal Drugs, and Cosmetics As Applied to Microbes Modified Using Synthetic Biology, J. Craig Venter Institute, Rockville, MD, Jan. 31, 2012.
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, Oct. 28, 2011.
Sottera v. FDA: Electronic Cigarettes and the Tobacco Control Act of 2009, Food & Drug Law Institute, 54th Annual Conference, Washington, D.C., Apr. 6, 2011.
Panel Member, Synthetic Biology Meets the Law, AALS Annual Meeting, Biolaw Section, San Francisco, CA, Jan. 5, 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, Oct. 29, 2010.
Health Care Reform Challenges for FDA -- Follow-On Biologics, Seton Hall MSJ Open House, Newark, NJ, Oct. 23, 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, Sept. 24, 2010.
Consensus Recommendations on Nanobiotechnology Oversight, Governing Nanobiotechnology: Reinventing Oversight in the 21st Century Conference, University of Minnesota, Minneapolis, MN, Apr. 15, 2010.
Joe Camel, The Marlboro Man, and the FDA: Implementing the 2009 Tobacco Legislation, Seton Hall MSJ Open House, Newark, NJ, Mar. 6, 2010.
Regulating Nanotechnology, Panel member, Food and Drug Law Institute Second Annual Nanotechnology Conference, Washington, D.C., Feb. 19, 2009.
Crowdsourcing Genomics, Pennsylvania State University & AALS Property Law section, Property Law in the Sharing Economy, State College, PA, Oct. 6, 2017.
Cultivating Innovation in Precision Medicine through Regulatory Flexibility at the FDA, American Society of Law, Medicine & Ethics 39th Annual Health Law Professors Conference, Atlanta, GA, June 10, 2017.
Precision Medicine at the FDA, Arizona State University Sandra Day O’Connor School of Law, 5th Annual Governance of Emerging Technologies: Law, Policy, and Ethics, Phoenix, AZ, May 18, 2017.
The Precision Medicine Initiative, American Society of Law, Medicine & Ethics 38th Annual Health Law Professors Conference, Boston, MA, June 3, 2016.
Companion Diagnostics and the Precision Medicine Initiative, AALS Annual Meeting, Biolaw section, New York, NY, Jan. 8, 2016.
REMS as a Competitive Tactic: Is Big Pharma Hijacking Drug Access and Patient Safety?, American Society of Law, Medicine & Ethics 38th Annual Health Law Professors Conference, St. Louis, MO, June 6, 2015.
The Gen-Nano-Neuro Convergence, Food & Drug Law Institute and Harvard Law School, Emerging Issues and New Frontiers for FDA Regulation, Washington, D.C.,Oct. 20, 2014.
Is One of These Things Not Like the Other?: Biosimilar Naming and Substitution Challenges, American Society of Law, Medicine & Ethics 37th Annual Health Law Professors Conference, San Francisco, CA, June 7, 2014.
Different Risk, Different Name?: The Debate over Nonproprietary Naming of Biosimilar Biologics, Arizona State University Sandra Day O’Connor School of Law, 1st Annual Governance of Emerging Technologies: Law, Policy, and Ethics, Phoenix, AZ, May 21, 2013.
A Sisyphean Task?: How the FDA Can Effectively Utilize the Tobacco Control Act to Regulate Electronic Cigarettes, AALS Annual Meeting, New Voices in Administrative Law, New Orleans, LA, Jan. 5, 2013.
Is it Science? Is it Engineering? Is it Safe?, American Society of Law, Medicine & Ethics 35th Annual Health Law Professors Conference, Tempe, AZ, June 8, 2012.
Current Legal Status of Follow-On Biologics, American Society of Law, Medicine & Ethics 33d Annual Health Law Professors Conference, Austin, TX, June 4, 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.