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Cassie J. Edgar

Cassie is a creative connector integrating people, science, and legal solutions to drive business growth. She is a scientist and a registered patent attorney with over a decade of experience in intellectual property, regulatory, licensing & corporate law, and IP due diligence. Cassie has global experience protecting IP and driving regulatory approvals in the areas of biotechnology and bioengineering from plants to animals, across agricultural and pharmaceutical applications.

Cassie is Chair of the Regulatory Law Practice Group and Co-Chair of the Data Privacy and Cybersecurity Practice Group.

Prior to joining MVS, Cassie was Chief IP & Regulatory Officer for Genus, PLC. Cassie joined Genus in September 2014 from Pioneer DuPont, where she served for 14 years in research, legal and management roles including IP Counsel, Senior Regulatory Counsel, and Director in the Agricultural Biotechnology group.

With her direct scientific, IP, regulatory and business leadership experience, Cassie is able to advise clients in product life-cycle management. From discovery through post-product launch, including intellectual property, crisis management, compliance, stewardship, regulatory data package generation, lobbying, and obtaining regulatory permits and approvals with USDA, FDA, EPA, Cassie’s experience is well equipped to answer your business questions and help fulfill your strategic business goals. Careful coordination of IP and regulatory strategies is critical for biotechnology products. Cassie’s unique background allows her to coordinate patent prosecution, patent marking, enforcement, licensing, freedom to operate, and IP litigation programs while keeping potential regulatory implications in mind.

Cassie is an active speaker on gene editing IP and regulatory issues. She is heavily involved in industry group policy and regulatory committees including IowaBio. Cassie is also a mentor for the Iowa Agritech Accelerator in Des Moines, and serves on the finance council for the Diocese of Des Moines.

Cassie completed Harvard Business School’s General Management Program, adding academic training to the global business perspective she brings having served as in-house counsel for U.S. and U.K. publicly traded companies. She holds a B.S. in Molecular Genetics with honors from The Ohio State University, an M.S. in Crop Science with an emphasis on Biomathematics from North Carolina State University, and obtained her law degree with honors from Drake University.

Representative Deals

I’ve had the honor of serving as counsel across plant and animal agriculture applications as well as human health, both for multinational publicly traded companies and startups. Below are examples of agricultural transactions – this list isn’t intended to be a complete accounting of what I’ve worked on, but to provide context for general scope of experience.

These representative deals include multimillion-dollar global IP licenses, research collaborations, funding rounds, JV formation, and M&A activity. In a few cases, I’ve linked to the press release.

  • Biotechnology Patents
  • Chemical Patents
  • Data Privacy and Cybersecurity
  • Design Patents
  • Licensing
  • Regulatory Law
  • Software & Business Methods Patents
  • Trade Secrets
  • Agritech
  • Animal Health
  • Fashion and Beauty
  • Financial Technology
  • Food and Beverage Technologies
  • Medical Devices
  • Pharma and Nutra

Professional Associations

American Health Law Association

Iowa Society of Healthcare Attorneys

The American Association of Nurse Attorneys

FIN Capital Investor Association – Vice President

CRISPRCon advisory council

Food & Drug Law Institute

IowaBIO

BIO

AIPLA

Iowa State Bar Association

Education

Harvard Business School Cambridge, General Management Program, Executive Education

Drake University Law School, J.D., cum laude

North Carolina State University, M.S., Crop Science, emphasis in Biomathematics

The Ohio State University Columbus, B.S., Molecular Genetics, cum laude, with honors

Publications & Presentations

“IP & Regulatory Strategies for Licensing Regulated Technologies,” AUTM Central Virtual Meeting, July 2021

“Best Practices for Hiring and Working with IP Counsel,” Iowa Biotech Showcase & Conference, Virtual Event, March 2021

“Legal Q&A with Startup and Healthcare Attorneys” – Healthcare Startups, Clubhouse, March 2021

Iowa State University Crop Bioengineering Center Dinner Keynote Speaker: Gene Editing and Agriculture: Exploring the legal implications of CRISPR Technology. December 5, 2019.

Keystone Policy Center, “Control and Access: Intellectual Property and CRISPR-Cas Gene Editing for Innovation in Crop Agriculture.” October 2019.

Drake Law School guest lecture for Mark Bennett, Justice Reform & Innovation: “Genetic technologies: changing IP & Regulatory legal frameworks & social dialogue.” October, 2019.

CRISPRCon Madison Roundtable: Gene Editing and impact on global commodity trade, October, 2019.

American Chemical Society, Chemistry & the Law Series. “IP & Regulatory Issues in Gene Editing.” August, 2019.

Business Record Women of Influence event: award introduction, 2019.

BIO World Congress, IP/Regulatory issues in gene editing, July 2019.

BIO World Congress, gene editing in banana and coffee: regulatory opportunities, July 2019.

Drake Law School guest lecture for Jennie Zwagerman, Agricultural Law: IP and Regulatory Framework in Ag Biotechnology. February, 2019.

Drake Law Symposium. Regulatory & IP Considerations for Biotechnology. April, 2019.

Des Moines Partnership: Top 10 IP Tips. November, 2018.

CRISPRCon World Food Prize Roundtable: IP and licensing considerations for gene editing. October, 2018.

Iowa Bar presentation: IP & Regulatory matters in gene editing, 2018.

Bar & Court Admissions

Iowa

United States Patent and Trademark Office

U.S. District Courts, Northern and Southern Districts of Iowa

Awards & Recognition

“All Star Mentor” designation from Techstars

CropLife International, Leadership and Excellence in Advancing Ag-Biotech and Food Issues Award for Global Priority Projects

Iowa Women of Innovation, Business Innovation & Leadership Award Finalist

Biotechnology Law Report, Women in Biotechnology Law & Regulation

Small business owner? Prepare for compliance with new “wise but unconstitutional” Corporate Transparency Act

Attention Small Business Owners: The enactment of the Corporate Transparency Act (CTA) marks a significant shift in the regulatory landscape for businesses across the United States. This pivotal piece of legislation, primarily aimed at combating financial deception such as money laundering and tax evasion, requires a clear disclosure of beneficial ownership information to the Financial […]

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Unraveling EPA’s New Gene Edited Plant Rules – Effective July 31, 2023

Today, the EPA’s new gene editing rules go into effect, with noteworthy implications for the use of biotechnology in agriculture. This finalizes draft rulemaking that was proposed back in 2020, and these new rules clarify the broad scope of the agency’s jurisdiction over gene-edited crops, specifically those defined as plant-incorporated protectants (PIPs) under 40 CFR […]

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Luddites, Lawyers, Illustrators: Embrace AI as a Tool

The Unhappy Painter, by Theodor Hosemann, 1843, illustrating a painter as a victim of technology, made obsolete by photography. Artificial intelligence (AI) is disruptive and will change the way we create and innovate – similar to disruption from the printing press, the camera, Photoshop, and gene editing. Use of any tool does not remove the […]

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FDA’s New Pathway for CBD Products: What Businesses Need to Know

The CBD industry is buzzing with today’s news that the U.S. Food and Drug Administration (FDA) is working with Congress to develop a new regulatory framework for cannabidiol (CBD) products. This is great news for businesses developing CBD products, as it means that there will be a clear path forward for the lawful marketing of […]

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AI in Healthcare: What You Need to Know About the FDA’s Regulatory Role

Artificial intelligence (AI) technology is increasingly being used in the healthcare field, and the US Food and Drug Administration (FDA) plays a crucial role in regulating these applications. Below, we examine the different ways that the FDA regulates AI technology in healthcare and look at some of the challenges and opportunities presented by this rapidly […]

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Patent Fees for Small and Micro Entities Reduced

Small and micro businesses can now take advantage of lower patent fees thanks to the Consolidated Appropriations Act, 2023 and the Unleashing American Innovators Act of 2022. These new laws were recently signed into law by President Biden and aim to support small and micro entities by increasing small entity discounts from 50% to 60% […]

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Who is monetizing your online presence? Commercial surveillance and the FTC’s new rules

The Federal Trade Commission just posted notice of its intent to increase federal regulations regarding commercial surveillance, data security and privacy. The FTC defines commercial surveillance as “the business of collecting, analyzing, and profiting from information about people.” Currently, the FTC’s ability to deter unlawful conduct is limited because the agency generally lacks authority to seek financial […]

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Engagement announcement: USPTO and Regulatory Agencies Tie the Knot

After many years of casual data sharing between agencies, the USPTO has formally announced its intentions to marry the duty of disclosure for patent prosecution with the regulatory process.  Today’s notice clarifies the scope of duties of inquiry and disclosure to the Patent Office, including for statements made to the FDA and other regulatory agencies […]

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The Great Dichotomy: Patent Protection vs. Regulatory Approval

As a scientist in discovery mode, the primary focus is often on points of novelty and seeking patent protection for the invention.  The supporting data in the patent application serves as proof that this is a unique innovation, has never been seen before, and overcomes key challenges.  However, when the product is regulated, converse arguments […]

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A Blizzard and a Regulatory Freeze

For those in the Midwest today, I hope you are staying warm & are ready for the predicted snowfall and wind gusts currently in progress. There’s been a lot of news in recent months about agricultural biotechnology regulatory changes underway at various stages of public comment and implementation (7 CFR part 340, proposed EPA rules […]

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EPA Provides Draft Guidance for Regulation of Gene Edited Plants

Background Although the USDA gets the most attention related to the regulation of gene edited plants, in the United States products of biotechnology are regulated by the USDA, FDA and EPA under the Coordinated Framework for the Regulation of Biotechnology, updated most recently in 2017. Under this framework, the USDA, FDA and EPA each regulate in […]

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USDA’s new Part 340 and impact on gene edited plants

The USDA published a new version of agricultural biotechnology regulations (7 CFR Part 340, aka “Part 340”) which is the culmination of several years of revision and public review. In this revised rule, which will begin implementation 90 days from May 18th, developers now have more definitive guidelines on where plants will be exempt from […]

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Farm Bill Amendments to Enable CBD Oil and Hemp Industry

On June 27th, the Senate published the latest version of amendments to the Farm Bill which contain updates to the regulatory framework for hemp and derived products including CBD (cannabidiol) oil. Cannabidiol oil has documented health benefits such as effectiveness in treating certain types of seizures, and the U.S. Department of Health and Human Services […]

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National Bioengineered Food Disclosure Standard rules publish May 4: Ties to patent protection and gene editing

National Bioengineered Food Disclosure Standard rules publish May 4: Ties to patent protection and gene editing   In 2016 Congress passed an amendment to the Agricultural Marketing Act of 1946 to establish a national bioengineered food disclosure standard. This law was an important milestone in establishing transparency for consumers, ensuring labeling certainty for innovators developing […]

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Patent Covering Methods of Advanced Genomic Selection from Guinea Pigs to Corn Survives Opposition in EU

Effectively protecting improved genetics requires a multi-pillared strategy considering the biological organisms themselves, methods of use, methods of breeding, and any regulatory data protection. The EPO recently upheld a patent (EP 2813141, granted August 5, 2015) drawn to methods of breeding using genome-wide estimated breeding values (EBVs) to identify combinations of individuals in a population […]

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