CristianaSpontoni

Practice Leader Health Care & Life Sciences

布鲁塞尔 + 32.2.645.14.48

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Cristiana Spontoni is co-leader of the Firm's Health Care & Life Sciences Practice. She is internationally recognized as a leader in life sciences, including biotechnology, pharmaceuticals, medical devices, food and cosmetics, as well as in general EU product and industries regulation. She is also actively involved in the shaping and interpretation of EU legislation affecting many different regulated industries and has successfully argued a number of important cases before the Court of Justice of the European Union.

Cristiana frequently coordinates large international assignments and provides comprehensive one-stop-shop solutions for cross-border regulatory issues affecting clients' operations. She has coordinated projects in more than 80 countries worldwide.

Cristiana advises clients from the pre-market phase, including clinical trials and pre-market authorizations, to post-market issues, including product liability, marketing/advertising, distribution, and compliance (including sector-specific antibribery and data privacy).

Cristiana handles safety and compliance issues for a large variety of clients both in the life sciences and consumer products sectors, including in regards to product regulation, crisis management (e.g., recalls), regulatory enforcement and media attacks, as well as in marketing/advertising/claims and associated substantiation matters.

Cristiana frequently speaks at and chairs major international conferences. She is recognized in the leading lawyer directories including Chambers, Legal 500, Best Lawyers, and International Who's Who and has received several important awards, including "Life Sciences Lawyer of the Year"(Corporate LiveWire 2018 Global Awards) and the ILO Client Choice Award for EU-wide Healthcare & Life Sciences. She has been named a "Star" by LMG Life Sciences and Acritas.

经验

  • Reneo Pharmaceuticals announces reverse merger with OnKureJones Day represented Reneo Pharmaceuticals, Inc. (NASDAQ: RPHM) in an all-stock reverse merger between Reneo and OnKure, Inc., a privately-held, clinical-stage biopharmaceutical company valued at $170 million that is focused on the development of novel precision medicines in oncology.
  • Accelmed Partners acquires Bioventus Advanced Rehabilitation businessJones Day is advising Accelmed Partners in its acquisition of Bioventus Inc.'s Advanced Rehabilitation business.
  • Riverside acquires CRIO, Inc.Jones Day advised The Riverside Company in the acquisition of CRIO, Inc., a leading provider of eSource and other eClinical software for clinical trial sites, CROs and the pharmaceutical/biotech market.
  • 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.
  • 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.
  • Parker Hannifin sells Human Motion and Control Business Unit to Ekso Bionics Holdings, Inc.Jones Day represented Parker Hannifin Corporation in the sale of its Human Motion and Control Business Unit to Ekso Bionics Holdings, Inc. for an aggregate purchase price of $10 million.
  • J.M. Huber acquires Biolchim GroupJones Day advised J. M. Huber Corporation in the acquisition of Biolchim Group, a leading producer and distributor of specialty plant nutrition and biostimulants, from private equity firms NB Renaissance and Chequers Capital and the Biolchim Group management team.
  • Misonix merges with BioventusJones Day represented Misonix, Inc. (Nasdaq: MSON) in its acquisition by Bioventus Inc. (Nasdaq: BVS).
  • Bridge to Life announces first close of $56 million growth financingJones Day advised Bridge to Life, Ltd. in its $56 million capital raise consisting of a secured credit facility and a Series A preferred equity investment.
  • STERIS acquires Cantel Medical for $3.6 billionJones Day advised STERIS plc in its acquisition of Cantel Medical Corp, a global provider of infection prevention products and services primarily to endoscopy and dental customers, for $3.6 billion.
  • Large international health care grantmaking foundation establishes governance structure and policiesJones Day is advising a large international health care grantmaking foundation on policies and procedures to guide all of its activities and its governance.
  • Sumitovant Biopharma acquires remaining stake in Urovant SciencesJones Day advised Sumitovant Biopharma in its acquisition of all of the outstanding shares of Urovant Sciences Ltd. not already owned by Sumitovant at a price of $16.25 per share in cash.
  • H.C. Wainwright underwrites Nasdaq IPO by Biophytis, including issuance of 1.2 million American Depositary SharesJones Day advised H.C. Wainwright, as underwriter, in connection with the Nasdaq IPO by Biophytis S.A., a French Euronext Growth-listed biotech company, including the issuance of 1.2 million American Depositary Shares (ADSs).
  • Astellas returns rights to Eligard® in Europe, Middle East, CIS, and Asia to TolmarJones Day represented Astellas Pharma Europe Ltd. in connection with a series of transactions, including the sale of related assets, in which Astellas returned its in-licensing rights to Eligard® (leuprorelin acetate for injectable suspension), a treatment for advanced prostate cancer, sold by Astellas in Europe, the Middle East, the Commonwealth of Independent States (CIS) and Asia, to Tolmar International Limited.
  • Nanobiotix completes $113.3 million IPO on NasdaqJones Day represented Nanobiotix S.A., a French clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, in connection with its $113.3 million initial public offering in the United States and listing on Nasdaq.
  • Inmarsat and Ofcom prevail in appeal regarding Inmarsat's European Aviation NetworkJones Day represented Inmarsat Ventures Limited as intervener in a UK appeal by Viasat UK Ltd of The Office of Communication's ("Ofcom") decision to authorize Inmarsat to use complementary ground components as part of its European Aviation Network providing in-flight mobile communication services.
  • Sumitomo Dainippon Pharma acquires late stage biopharma companies and forms alliance with Roivant Sciences Ltd. worth $3 billionJones Day advised Sumitomo Dainippon Pharma Co., Ltd. ("Sumitomo") in an acquisition of late stage biopharma companies and formation of alliance with Roivant Sciences Ltd.
  • Shiseido acquires Drunk Elephant™ for $845 millionJones Day advised Shiseido Americas Corporation in its $845 million acquisition of Drunk Elephant™.
  • ICON acquires Symphony Clinical ResearchJones Day advised ICON plc as health care, clinical trial regulatory, and data privacy diligence counsel in its acquisition of Symphony Clinical Research, a leading provider of at-home patient and site support services.
  • Arsenal Capital Partners acquires HistoGeneX and Caprion BiosciencesJones Day advised Arsenal Capital Partners on major investments in HistoGeneX and Caprion Biosciences and the subsequent combination of the two businesses.

    • The following represents experience acquired prior to joining Jones Day.

    Advised a pharma and medical device manufacturer in connection with product liability claims associated with participation in a clinical trial in Europe.

    Coauthored a report, on behalf of the Kuwaiti government, on the legal implications of the creation of a high-technology hub, addressing issues such as cybersecurity laws and biotechnology regulation.

    Advised a fashion giant in the sale and marketing of cosmeto-textile products on a pan-European basis.

    Led a global due diligence exercise in connection with the successful US$800 million sale of the diagnostic business of a major Japan-based medical device manufacturer.

    Advised a major satellite operator in the successful bid to obtain frequencies for the operation of mobile satellite services in the first ever EU-wide award procedure launched by the European Commission.

    Acted as strategic and regulatory counsel to one of the world's leading clinics in connection with the internationalization of its activities in Europe.

    August 2024 Newsletters

    EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 116

    June 2024 Newsletters

    EU Emergency Response Update – Key Policy & Regulatory Developments No. 115

    July 2024 Newsletters

    Vital Signs: Digital Health Law Update | Spring 2024

    May 2024 Newsletters

    EU Emergency Response Update – Key Policy & Regulatory Developments No. 114

    April 2024 Newsletters

    EU Emergency Response Update – Key Policy & Regulatory Developments No. 113

    February 2024 Newsletters

    EU Emergency Response Update – Key Policy & Regulatory Developments No. 112

    March 2024 Alert

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

    March 2024 Newsletters

    Vital Signs: Digital Health Law Update | Winter 2024

    December 2023 Newsletters

    EU Emergency Response Update – Key Policy & Regulatory Developments No. 111

    November 2023 Newsletters

    EU Emergency Response Update – Key Policy & Regulatory Developments No. 110
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    December 2022 Webinars

    Webinar Series: Cross-Practice Issues in the Life Sciences

    • September 24, 2024
      Jones Day Webinar: Women in IP speaker series - The Inflation Reduction Act, March-In Rights, FTC Challenges, and Changes to Regulatory Exclusivities: Need-to-Know Recent Developments for the Life Sciences Industry, Speaker, Brussels, Belgium
    • September 2-6, 2024
      Annual European Pharma Law Academy, Pharmaceutical Law, Downing College, Cambridge University, Speaker "Clinicals Trials: What You Need to Know" Cambridge United Kingdom
    • September 4-8,2023
      Annual European Pharma Law Academy, Pharmaceutical Law, Downing College, Cambridge University, Speaker "Clinical Trials: What You Need to Know"
    • June 1, 2023
      Jones Day Annual Life Sciences Seminar 2023: "The New EU Pharma Package: How will the proposed legislative reform affect pharma companies and investors in the sector?", Speaker, Brussels, Belgium
    • May 23-25, 2023
      EU Pharmaceutical Law Forum 2023, "Key Updates on Behavioural Advertising through the Internet", Speaker, Brussels, Belgium
    • December 7, 2022
      Jones Day Webinar: Cross-Practice Issues in the Life Sciences, Health Care Regulatory: Trends and Issues in Enforcement and Whistleblower Claims, Speaker
    • September 5-9,2022
      Annual European Pharma Law Academy, Pharmaceutical Law, Downing College, Cambridge University, Speaker "Clinicals Trials: What You Need to Know" Cambridge United Kingdom
    • May 17-19, 2022
      EU Pharmaceutical Law Forum 2022, "New Development for Data and Legal Implications in the European Healthcare Landscape", Speaker, Brussels, Belgium
    • March 7, 2022
      Medicines development and access to medicines after the COVID-19 pandemic: EU regulatory law and upcoming changes, Speaker, HELA Spring Conference, Harvard University
    • January 17-21, 2022
      Annual European Pharma Law Academy, Pharmaceutical Law, Downing College, Cambridge University, Speaker
    • December 1, 2021
      Jones Day Webinar: Cross-Practice Issues in Life Sciences M&A, Regulatory: Doing a Global Deal: The Regulatory Dimension, Speaker
    • June 8 - 9, 2021
      "Global Regulatory Harmonization of Cell and Gene Therapies", Food and Drug Law Institute, Session Chair, Washington, D.C., USA
    • May 19, 2021
      "Digital Innovation", EU Pharmaceutical Law Forum 2021, Session Chair, Brussels, Belgium
    • September 15-17 & 23-24, 2020
      13th Annual European Pharma Law Academy, Pharmaceutical Law, Downing College, Cambridge University, Speaker
    • September 9-12, 2019
      12th Annual European Pharma Law Academy, Pharmaceutical Law, Downing College, Cambridge University, Speaker
    • June 18, 2019
      EU Regulations, Annual Life Sciences Seminar, Speaker
    • September 26, 2018
      Annual Congress of the Dutch Clinical Research Foundation, Keynote Speaker
    • September 10-13, 2018
      11th Annual European Pharma Law Academy – Pharmaceutical Law Downing College, Cambridge University
    • June 19-20, 2018
      "Recognizing Your Own Leadership Style and Learning How to Be Perceived as a Leader", Women Leaders in Life Sciences Law
    • March 6-7, 2018
      CTR, MTR and GDPR – The Big Bang of New EU Regulations Impacting The EU Clinical Regulatory Landscape, CBI’s EU Clinical Trial Regulation Summit
    • November 28-29, 2017
      EU Clinical Trial Regulation, Speaker, Informa's Clinical Trial Supply
    • March 14-15, 2017
      New personal data protection regulation in the EU and potential applications to the plasma collection, Speaker, International Plasma Protein Congress 2017
    • November 9, 2016
      Jones Day Global Life Sciences Conference – 2016 Issues & Trends
    • June 9, 2016
      Transparency in the Pharmaceutical Sector, Pharmaceutical Contract Management Group Annual Conference, Speaker
    • March 30, 2016
      "Driving Resilient Partnerships for Growth", Pharmacon China, Speaker
    • March 22-23, 2016
      International Plasma Protein Congress, Speaker
    • February 2, 2016
      "Conflict resolution", Pharmaceutical Contract Management Group, Speaker
    • September 17, 2015
      “Sunshine Act”, “Doctor-Initiated Clinical Study” and“Off-label Promotion and FCA claims”, Jones Day Conference on Enforcement and Compliance Trends in the Life Sciences Industry, Speaker
    • September 9, 2015
      “M&A in Life Sciences”, Annual Conference of China’s Private Equity Association, Speaker
    • June 15, 2015
      Plasma Protein Forum, Speaker
    • June 10, 2015
      Advertising and Food Products - Which Rules and Which Trends in Europe? - The European Rules of Food Communication, Speaker
    • April 22, 2015
      Pharmaceuticals Regulatory Developments Including New Clinical Trials Legislation, Women Leaders in EU Life Sciences Law, Speaker
    • March 4, 2015
      Negotiating an Effective Clinical Trial Agreement and Limiting Litigation Exposure, ABA Life Sciences Legal Summit, Speaker

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