Emily Marden

• Co-author, “Cell & Gene Therapies: Will 2025 Represent A Continuation Of FDA's 2024 Developments?,” Cell & Gene, February 28, 2025.
• Co-author, “New FDA Guidance Addresses Regulatory Review of Foods Produced from Genome-Edited Plants,” Food Safety Magazine, October 1, 2024.
• Co-author, “Cell & Gene Therapies: An Overview Of FDA Regulatory Considerations For 2024,” Cell & Gene, April 17, 2024.
• Co-author, “Assessing FDA Pathways For Genome-Edited Plant Foods,” Law360, March 21, 2024.
• Author, “Accelerated Approval and the Promise of Gene Therapy, Applied Clinical Trials,” Applied Clinical Trials, September 7, 2023.
• Co-author, “International Agreements and the Plant Genetics Research Community: A Guide to Practice,” PNAS, March 27, 2023.
• Co-author, “Regulatory Frameworks Applicable to Food Products of Genome Editing and Synthetic Biology in the United States, Canada, and the European Union,” Genomics and the Global Bioeconomy, September 23, 2022.
• Author, “Sharing and Reporting Benefits From Biodiversity Research,” Molecular Ecology, November 6, 2020.
• Co-author, “The Nagoya Protocol's Impact on Research and Development,” Swiss Life Sciences Briefing, November 2020.
• Co-author, “Mobilizing Crop Biodiversity,” Molecular Plant, October 5, 2020.
• Quoted in, “Industry Seeks Clarity as Decentralized Trials Take Hold,” Inside Health Policy, July 9, 2020.
• Quoted in, “FDA Dictates on Gene Therapy Sameness,” Nature Biotechnology, March 9, 2020.
• Co-author, “Gene Therapy — FDA Takes Steps Toward Clarifying Scope of Orphan Drug Exclusivity,” Food and Drug Law Institute, December 2018/January 2019.
• Co-author, “Reflections on FDA Draft Guidance for Products Containing Nanomaterials: Is the Abbreviated New Drug Application (ANDA) a Suitable Pathway for Nanomedicines?” American Association of Pharmaceutical Scientists Journal, August 20, 2018. 
• Co-author, “USDA’s Bioengineered Disclosure Standard a First Step But Questions Remain,” Bloomberg Law, July 2018.
• Author, “International Agreements May Impact Genomic Technologies,” Nature Plants, January 2018.
• Co-author, “Plant Genetic Resources for Food and Agriculture: Opportunities and Challenges Emerging from the Science and Information Technology Revolution,” New Phytologist, January 2018.
• Co-author, “Regulatory Pathways Emerge For Gene-Edited Products,” Law360, March 20, 2017.
• Co-author, “The Intellectual Property – Regulatory Complex: Overcoming Barriers to Innovation in Agricultural Genomics,” UBC Press, March 5, 2016. 
• Author, “Intellectual Property and Sharing Regimes in Agricultural Genomics: Finding the Right Balance for Innovation,” Drake Journal of Agriculture Law, 2012.
• Co-author, “Alternative Intellectual Property for Genomics and the Activity of Technology Transfer Offices: Emerging Directions in Research,” Boston University Journal of Science and Technology Law, 2010.
• Author, “Risk and Regulation: U.S. Policy on Genetically Modified Food and Agriculture,” Boston College Law Review, 2003.
• Author, “The Neem Tree Patent: International Conflict Over the Commodification of Life,” Boston College International and Comparative Law Review, May 1, 1999.

Selected Sidley Updates:

• Co-author, “MAHA Commission Report: Broad Review of Food, Agriculture, and Pharmaceutical Drivers of Human Disease with a Self-Described Call to Action,” Sidley Update, May 28, 2025.
• Co-author, “Regulatory Rollback and Rebrand of FDA’s Human Food Program,” Sidley Update, May 22, 2025.
• Co-author, “FDA Dietary Ingredient Master File Draft Guidance a Promising Step in Improving New Dietary Ingredient Notification Process, but Additional Work Remains,” Sidley Update, April 5, 2024.
• Co-author, “FDA’s New Guidance Confirms FDA Pathway to Market for Foods from Gene Edited Plants,” Sidley Update, February 27, 2024.
• Co-author, “Important New Developments in the Cell-Based Meat Landscape,” August 2, 2023.
• Co-author, “Final FDA Guidance Reinforces the Importance of Sponsor Oversight and Quality Risk Management in All Clinical Trials,” Sidley Update, April 19, 2023.
• Co-author, “The Future of Food: European Regulators Taking Action?,” Sidley Update, March 28, 2023.
• Co-author, “FDA Focus on Food Safety: Human Food Programs Restructuring and New FDA Guidance on ‘Generally Recognized as Safe,’” Sidley Update, February 22, 2023.
• Co-author, “Executive Order on Advancing Biotechnology and Biomanufacturing Innovation: Modernizing Regulation Under the Coordinated Framework,” Sidley Update, October 5, 2022.
• Co-author, “FDA Articulates High Benefit-Risk Expectations For Drug Developers,” Sidley Update, November 23, 2021.
• Co-author, “Statutory Change to New Chemical Entity Exclusivity Provision May Have Impacts for Scope of Patent Term Extension,” Sidley Update, April 30, 2021.
• Co-author, “U.S. Department of Agriculture's Proposed National Bioengineered Food Disclosure Standard Raises More Questions Than It Answers,” Sidley Update, May 9, 2018.

Recent speaking engagements include:

• Speaker, “Transatlantic Animal Health Legal Forum,” London, November 6, 2025.
• Speaker, “Extending the Hatch-Waxman Act Model,” Health Care at Reasonable Cost: The Hatch-Waxman Act at 40 and Beyond, Engelberg Center on Innovation Law & Policy at NYU School of Law, New York, NY, September 26, 2024.
• Speaker, “Connecting the Dots: Quantifying Benefit Sharing From Scientific Research,” Leibniz Institute DSMZ & the Molecular Ecology Editorial Board Online Workshop, May 2–3, 2023.
• Speaker, “New Frontiers in Food Ingredients,” ACI Food Law – Regulation, Compliance and Litigation, April 2023.
• Speaker, “The Promise and Future of Real World Evidence (RWE) in the European Market Access Landscape,” Life Sciences College, February 25, 2021.
• Speaker, “How COVID-19 Has Transformed the Way FDA Regulates—And What Regulated Industry and the Public Expect Going Forward,” Sidley Austin LLP, San Francisco, CA, May 29, 2020. 
• Interviewer, “How Ag Biotech Innovation Creates Healthier Food Systems,” CleanTechIQ’s Sustainable AgTech Investment Forum, Boston, MA, October 29, 2019. 
• Speaker, “Control & Access: Intellectual Property and CRISPR-Cas Gene Editing for Innovation in Crop Agriculture,” Keystone Policy Center Conference, Fort Collins, CO, October 24–25, 2019.
• Speaker, “Introduction to Biologics and Biosimilars Law and Regulation,” Food and Drug Law Institute, Washington, D.C., October 1–2, 2019.
• Speaker, “Innovative Technologies and FDA: Navigating Pathways to Success,” Sidley Austin, San Francisco, CA, July 25, 2019.
• Moderator, “Genome Editing and Regulatory Harmonization: Progress and Challenges,” Bio International Convention, Philadelphia, PA, June 5, 2019.
• Speaker, Agriculture: Panel Discussion, 2019 Canada SynBio Conference, Toronto, ON, Canada, March 6, 2019.
• “USDA Proposed Rule on National Bioengineered Food Disclosure Standard: Overview and Critical Insights,” Sidley Austin LLP Webinar, May 18, 2018.
• Speaker, “Risk and Regulation Redux: Revisiting Frameworks in Light of New Biotechnologies,” International Consortium on Applied Bioeconomy Research Annual Conference, Berkeley, CA, June 1, 2017.
• Moderator, “Beyond Brexit: Navigating the Changing EU Landscape,” 2nd Annual Bay Area Lifesciences Roundtable, May 24, 2017.
• Regulation in AgInnovation: Navigating Pathways to Commercialization,” Larta Institute Webinar, February 14, 2017.
• “Biologics and Biosimilars,” Presentation, FDLI Introduction to Law and Regulation - Drug and Medical Devices, October 2015.
• Moderator, Orphan Drug Regulation: Panel Discussion, Global Life Sciences European Law Seminar, Sidley Austin LLP, July 2015.
• Moderator: FDA Science and Policy: Panel Discussion, California Healthcare Institute Annual Meeting, November 2013.
• Speaker, Presentation before the Senate Standing Committee on Agriculture and Forestry, Ottawa, Canada, October 25, 2012.
• Speaker, “Intellectual Property and Sharing Regimes in Agricultural Genomics: Finding the Right Balance for Innovation” Asia Pacific Innovation Conference, Seoul National University, Korea, October 14, 2012. 
• Organizer, Moderator and Speaker, “Changing Goals of Governance for Agricultural Genomics: An Examination of Current Regulatory and Intellectual Property Regimes,” University of British Columbia, November 17–18, 2011. 
• Speaker, “Agricultural Biotechnology and Intellectual Property” UBC Course APBI 125: Biotechnology in Agricultural Food Production, April 6, 2010 and May 28, 2011.
• Speaker, “Genomics Research and Intellectual Property,” GPS Ottawa GELS Series, Genome Canada, April 28, 2011.
• “Objectivity and Regulation: Systemic Impacts of Law and Regulation” at Objectivity in Science Conference, University of British Columbia, June 19, 2010.
• Speaker, “Open Source Drug Development” Ten Years After – Mapping the societal landscape of genomics. The Royal Tropical Institute, Amsterdam International Scientific Conference, Amsterdam, Netherlands, May 27–28, 2010.
• Organizer, Moderator and Speaker, Workshop, “Patent Pools & Open Source Licensing: Reflections on Genomics Research and Alternative Intellectual Property,” Genome British Columbia, Vancouver, April 30, 2010. 
• Speaker, “Intellectual Property and Gene Patents: Ethics Entangled,” BRIDGE Program Course, University of British Columbia, March 24, 2010.
• Speaker, “Intellectual Property and the Translation of Genomics Discoveries: Issues and Alternatives,” BC Cancer Research Centre, December 2, 2009.
• Co-organizer and Moderator, Workshop, “Alternative Intellectual Property for Genomics and the Activity of Technology Transfer Offices: Emerging Directions in Research,” Vancouver, May 8–9, 2008.