Colleen M.Heisey

Partner

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With more than 20 years of experience focused on Food and Drug Administration (FDA) regulated products, Colleen Heisey has a strong understanding of the legal, regulatory, and compliance issues facing drug, biologics, medical device/diagnostic, and food/dietary supplement clients. Her practice involves strategic counsel to clients navigating near-market and post-market opportunities and obligations, including matters related to product jurisdiction, pathways to market, regulatory exclusivities, accelerated approvals, orphan drug status, adverse event reporting, recalls, and managing federal agency inquiries and enforcement actions.

A business-oriented problem solver, Colleen evaluates and advises on product advertising and promotion and has helped life sciences companies launch dozens of prescription and over-the-counter (OTC) drug and device products. She has worked with regulated industries to develop and implement right-sized comprehensive compliance programs. Colleen's distinct skills and experiences are deployed to serve clients as they perform due diligence on products and targets and negotiate license, collaboration, acquisition, and other commercial agreements. She also supports robust teams in contract disputes and arbitration arising from commercial agreements involving regulated products and in litigation arising under the Federal Food, Drug, and Cosmetic Act (FDCA).

Colleen maintains an active presence in the Food and Drug Law Institute, speaking and writing for the organization, as well as serving on planning and products committees. As a first-generation college graduate, she is a proud member of the Board of Trustees of Lycoming College.

担当案件

  • STERIS sells dental segment to an affiliate of Peak Rock CapitalJones Day is advising STERIS Plc in the $787.5 million sale of Dental segment to Peak Rock Capital, a leading middle-market private investment firm.
  • Direct lender provides $87 million senior secured credit facility to large private equity-backed provider of medical supplies to companies in commercial cruise and shipping industriesJones Day advised a direct lender, as administrative agent, collateral agent, sole lead arranger, and lender, in connection with a $87 million senior secured credit facility provided to a large private equity sponsored company that provides medical supplies to companies in the commercial cruise and shipping industries.
  • Shiseido Americas acquires Dr. Dennis Gross Skincare for $450 millionJones Day is advising Shiseido Americas Corporation, a subsidiary of Shiseido Co., Ltd., regarding its definitive agreement to acquire DDG Skincare Holdings LLC, the owner of Dr. Dennis Gross Skincare, for $450 million in cash.
  • EagleTree Capital acquires Summit Hill FoodsJones Day advised EagleTree Capital in the acquisition and financing of Summit Hill Foods, Inc., a leading branded food company producing nationally recognized, premium brands, including Better Than Bouillon and The Original Louisiana Hot Sauce.
  • Leading financial services company provides $380 million syndicated senior secured credit facility to global supplier of technologies for security, healthcare, and other industrial end-marketsJones Day represented a leading financial services company, as left lead arranger and administrative agent, in connection with a $380 million syndicated senior secured credit facility, consisting of a $340 million term loan and a $40 million revolving credit facility, provided to a leading global supplier of advanced imaging, power, and motion control technologies for security, healthcare, and other industrial end-markets.
  • Sumitomo acquires assets and rights related to lefamulin from NabrivaJones Day advised Sumitomo Pharma Co., Ltd. in the acquisition of assets from Nabriva Therapeutics plc and various wholly-owned subsidiaries. This acquisition includes assets from the U.S., Ireland, and Austria in support of the development, manufacture, marketing and commercialization of lefamulin in the People’s Republic of China, Hong Kong, Macau and Taiwan.
  • ONCAP sells medical division to BiomericsJones Day advised ONCAP in the sale by portfolio company Precision Concepts International of its medical division to Biomerics, a portfolio company of Wasatch Equity Partners.
  • Astellas acquires Iveric bioJones Day advised Astellas Pharma Inc. in the $5.9 billion cash acquisition of Iveric bio, Inc., a science-driven biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs.
  • Labcorp completes spin-off of FortreaJones Day represented Labcorp (NYSE: LH), a leading global life sciences company, in the spin-off of Fortrea, the newly formed independent Contract Research Organization providing Phase I-IV clinical trial management, market access and technology solutions to pharmaceutical and biotechnology organizations around the world.
  • Fortrea completes $570 million private placement of Senior Secured Notes and obtains $1.5 billion credit facilityJones Day represented Fortrea Holdings Inc., a leading global contract research organization (“CRO”) that provides comprehensive phase I through IV biopharmaceutical product and medical device services, patient access solutions and other enabling services, in connection with the Rule 144A and Regulation S offering of $570 million aggregate principal amount of 7.500% Senior Secured Notes due 2030 and a $1.5 billion senior secured credit facility as part of its spin-off from Laboratory Corporation of America Holdings.
  • Sky Island Capital acquires Kaufhold's KurdsJones Day represented Sky Island Capital in the acquisition and financing of Kaufhold's Kurd's, Inc., a wholesale food manufacturer that primarily sells direct to food service distributors across the United States.
  • UPL sells stake in Advanta Enterprises to KKRJones Day advised UPL Limited in its $300 million sale of a 13.33% stake in its subsidiary, Advanta Enterprises Limited, to KKR.
  • CDPQ leads $125 million Series D financing of Soli OrganicJones Day advised CDPQ as lead investor in the $125 million Series D financing of Soli Organic, the nation's only soil-based, indoor farming company delivering 100% USDA certified organic produce.
  • Riverside portfolio company acquires BloodHubJones Day represented The Riverside Company in connection with the acquisition and financing by portfolio company InVita Healthcare Technologies of BloodHub, a leading software provider of blood and biologics supply chain automation solutions.
  • Eurobio Scientific acquires GenDxJones Day advised Eurobio Scientific SA in the acquisition and financing of the Dutch company Genome Diagnostics BV (GenDx) from its founder and its shareholders for €135 million (net of adjusted cash).
  • Patent owner challenges FDA regulatory review determinationJones Day represents a patent owner in challenging the U.S. Food and Drug Administration's (FDA) regulatory review period determination for its drug.
  • STERIS sells renal business to EvoquaJones Day advised STERIS in the $196.3 million sale of its Renal Care business to Evoqua Water Technologies, a leading provider of mission-critical water and wastewater treatment solutions.
  • American Pacific Group acquires Gym Launch and Prestige LabsJones Day advised American Pacific Group, a San-Francisco Bay Area-based private equity firm, in the acquisition of Gym Launch, a provider of coaching programs and business training materials to help gym owners increase revenue and improve profitability, and Prestige Labs, a provider of premium fitness and health supplements.
  • Morgan Stanley Capital Partners portfolio company acquires MacArthur CorporationJones Day advised Morgan Stanley Capital Partners in connection with the acquisition by portfolio company AWT Labels & Packaging, Inc. (AWT) of MacArthur Corporation, a world-class manufacturer of innovative labels, tags, decals, and functional film components for the mobility, electronics, health technology, and industrial sectors.
  • Misonix merges with BioventusJones Day represented Misonix, Inc. (Nasdaq: MSON) in its acquisition by Bioventus Inc. (Nasdaq: BVS).
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    March 2024 Alert

    FDA's Final Device Manufacturing Rule—Not Quite Harmonious With Status Quo

    MARCH 2024 Commentary

    New York's Recipe for Food Marketing: Next Course of Restrictive State Actions?

    February 2024 Alert

    FDA on Board With Continuing Remote Inspections

    January 2024 Alert

    FDA Final Rule: IRB Waiver of Informed Consent for Minimal-Risk Investigations

    December 2023 Reprint

    FDA's Recent Litigation Records Are Strong, But Imperfect (Law360)

    November 2023 Alert

    FDA Issues Revised Off-Label Communications Guidance

    OCTOBER 2023 Alert

    FDA Announces Proposed Rule Regarding Laboratory Developed Tests

    September 2023 Alert

    FDA Announces Delayed Enforcement of Looming Supply Chain Requirements for Drugs Until 2024

    August 2023 Alert

    Industry Anticipates Impending FDA Proposed Regulation Addressing Laboratory Developed Tests

    August 2023 Alert

    Clarifying Cosmetics Reform: FDA Issues Draft Guidance on Registration and Product Listings
    インサイト一覧

    出版物情報

    • May 2022
      Are Your Labels Up to Date? Ensuring Compliance With the USDA’s National Bioengineered Food Disclosure Standard

    講演

    • November 2023
      All Roads Lead to Compliance: Enforcement Trends from Agencies and Consumer Protection Organizations (FDLI, Advertising & Promotion for Medical Products Conference)
    • October 14, 2022
      Recent Trends in Enforcement and Practical Examples to Ensure Compliance (FDLI, Advertising and Promotion for Medical Products Conference)
    • March 16, 2022
      FDLI Careers Over Coffee March: Hiring Process Tips & Tricks (FDLI)
    • October 13, 2021
      Closed Doors Lead to Open Windows: Emerging Trends in Virtual Sales Force Tools (FDLI, Advertising and Promotion for Medical Products Conference)
    • September 29, 2021
      Exploring FDA’s Expedited Programs: Applicability and Eligibility (ACI’s 37th FDA Boot Camp: American Conference Institute)
    • February 4, 2021
      Fundamentals of Vaccine Regulation: Pathways to Market (FDLI)
    • October 28, 2020
      Practical Considerations for Successful Remote-Based Marketing and Compliance Strategies - Health Care Provider Access and Sales Training (FDLI, Advertising and Promotion for Medical Products Conference)
    • August 20, 2020
      How to Introduce Clients to the FDA-Regulated Space: A Sharing Session (FDLI, Law Over Lunch)
    • April 24, 2020
      Face Masks and Their Use in the Workplace (Original Equipment Suppliers Association)
    • January 2019
      Blockchain in Healthcare, New York State Bar Association Annual Meeting
    • December 4, 2018
      Drug Quality and Security Act, Title I – Inspections and Enforcement in the Compounding World (FDLI)
    • October 10, 2018
      Regulation of Medical Products in the EU and Combination Products (Drug Information Association)
    • May 4, 2016
      Compliance in the Precision Medicine Era: Legal Considerations for the Contemporary Life Sciences Industry
    • December 9-10, 2015
      Enforcement, Litigation, & Compliance The Food and Drug Law Institute (FDLI)
    • October 15-16, 2015
      ABA/MDMA/FDLI Medical Device Law 2015
    • October 1-2, 2015
      Advertising and Promotion for the Pharmaceutical, Medical Device, Biological, and Veterinary Medicine Industries, The Food and Drug Law Institute
    • July 16, 2015
      ABA's FDA Drug Law Fundamentals, Webinar
    • November 12, 2014
      ABA's Off-label Marketing and Free Speech: Caronia and the Future of Speech in Therapeutic Product Promotion webinar
    • September 10, 2014
      Presentation to Mansfield-PhRMA Fellows: How U.S. Law Firms Help Their Clients Bring Pharmaceuticals and Biologics to Market
    • May 18, 2014
      ATA Telemedicine Venture Summit 2014
    • May 6, 2014
      Executive Roundtable Series: New Frontiers in Health Care and Life Sciences; A Look at the Legal Implication
    • February 20, 2014
      The Digital Health Revolution: How Law is Shaping the Next Frontier in Health Care Delivery, Health Law and Justice Society
    • November 13, 2013
      2013-2014 Life Sciences Webinar Series: Intellectual Property, Regulatory, and Antitrust Issues in Life Sciences M&A and Capital Markets Transactions
    • October 24, 2013
      FDA Fundamentals: FDA Drug Approval and Oversight, American Bar Association
    • September 11, 2013
      Healthcare Technology Approvals, Clearances and Commercialization, Angel Venture Forum’s Cyber Security & Healthcare Investment Conference
    • August 1, 2013
      Successfully Navigating FDA Citizen Petitions and Responses

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