McDermott Will & Schulte, a global law firm

Kristian (Krist) Werling is the global head of McDermott’s Health & Life Sciences practice, which provides regulatory and transactional counsel to health and life sciences industry leaders, changemakers, and investors.

Krist and the McDermott Health & Life Sciences team lead the most significant transactions, critical regulatory issues, and litigation matters that shape the health and life sciences industry. In his own practice, Krist represents life sciences companies, health service providers, private equity firms, and venture capital investors in a wide variety of transactional and regulatory matters. He has led cutting-edge industry transactions that have introduced cancer and gene therapy products to the global market, expanded access to fertility services, increased the availability of cost-effective outpatient surgical services, and transformed the delivery of physician services in a broad range of specialties.

Krist's decades of experience on the buy-side and sell-side of health and life sciences dealmaking spans the healthcare and life sciences landscape. He leads cross-disciplinary teams and delivers business-focused legal guidance to help clients pursue their most innovative strategies, working across borders and health and life sciences subsectors to connect and advise industry stakeholders. Krist is also skilled at developing creative transaction structures, conducting sector-specific due diligence, and providing forward-looking counsel to mitigate issues that can derail transactions or stunt long-term growth. His deep understanding of sector-specific regulatory nuances allows him to efficiently close transactions and maximize client outcomes.

Representative PE clients include Ampersand Capital Partners (buy-side and sell-side); Amulet Capital Partners (buy-side and sell-side); Windrose Health Investors (buy-side and sell-side M&A, and joint venture matters); Iron Path Capital (investments, carve-out acquisitions and new platform formations), Quad-C (new platform formation and investment and sell-side), PPC (buy-side).

Representative healthcare and life sciences companies include Baxter International and Vanda Pharmaceuticals (cross-border sales and acquisitions; licensing); REGENXBIO (strategic partnership with AbbVie); Cleveland Clinic, Hospital for Special Surgery and Northwestern Medicine (strategic innovation investments and joint ventures); numerous founder-owned businesses in strategic transactions with investors.

Emmanuelle Trombe is the co-head of the Firm’s Life Sciences industry practice. She represents pharmaceutical, medical device and bio-pharmaceutical companies globally in transactional matters in relation to M&A and divestitures, joint ventures and strategic partnerships, large-scale projects, outsourcing projects, product development, licensing agreements and regulatory matters. She also advises venture capital funds and bio-pharmaceutical companies in connection with a broad range of financing activities. As well as co-heading the Firm’s Life Sciences Group, Emmanuelle serves as an elected member of the Firm’s Management Committee.

Emmanuelle is distinguished in Chambers Europe and Legal 500 EMEA in life sciences transactions, where she is highly recommended for her experience in the pharmaceutical, healthcare, biotech and medical devices industries and described as very responsive, smart, flexible and business-minded. She has been distinguished as the Lawyer of the Year in Life Sciences for 2024.

James (Jamie) Ravitz is the co-head of the firm’s Life Sciences industry practice and head of the Food and Drug Administration (FDA) practice. He works alongside clients across the entire spectrum of life sciences and healthcare law, including regulatory counsel, compliance, and investigations and government enforcement. He is particularly focused on Food and Drug Administration (FDA) regulatory counseling. Jamie works in partnership with companies and investors across the complete ecosystem of FDA-regulated products — drugs, devices, health technologies, biologics, food, cosmetics and cannabis — to help them achieve their business goals.

Jamie works with manufacturers and distributors of FDA-regulated products, with deep experience on novel drugs, biologics, and cutting-edge products, from the product concept stage through to post-market and product marketing to facilitate market success and reduce enforcement risk. Jamie is a valuable addition to healthcare and life sciences transaction matters, assisting clients with FDA-related due diligence to maximize value and minimize risk and roadblocks during the transaction.

When compliance or enforcement matters arise, Jamie takes a proactive, business-focused approach to address the issues with minimal business disruption. He also works with clients on the regulatory components of internal investigations, enforcement activity, and consumer protection litigation when they arise. He has worked with clients on numerous internal investigations and responses to Office of Inspector General (OIG) and US Department of Justice (DOJ) subpoenas and has assisted in the defense and settlement of qui tam whistleblower suits alleging violations of the False Claims Act.

Jamie is a recognized thought leader in the health law and medical device spaces. He is a regular speaker at health and life sciences industry conferences and has served as an advisory board member to bio-innovation centers and trade media editorial boards.

Prior to joining McDermott Will & Schulte, Jamie served as leader of the FDA, healthcare, and consumer products compliance practice at a large international law firm.

Jiayan Chen is an industry leader on matters relating to health data, technology and research. She represents clients on regulatory and compliance matters, commercial transactions, and investments and acquisitions that require deep knowledge of privacy, data strategies, artificial intelligence (AI) and other healthcare technologies, or research compliance. Clients turn to Jiayan for her practical, industry-informed guidance as they seek to develop, improve, deploy, or acquire solutions or businesses that harness the power of data or technology. Jiayan has extensive experience advising on investments and acquisitions in the life sciences sector, particularly with respect to businesses that conduct clinical research or offer solutions designed to accelerate research or research recruitment. Her practice includes working with patient safety organizations (PSOs) on listing applications, compliance, and strategies for appropriately creating and sharing patient safety work product.

Jiayan’s subject matter and industry insights come from advising a broad range of clients, including AI and other healthcare technology companies; data companies; hospitals and health systems; academic medical centers; genetics companies; digital health companies; PSOs; drug, device, and biotech companies; private equity funds; and platform companies.

Jiayan regularly counsels clients on data privacy requirements under US federal and state privacy law, including the Health Insurance Portability and Accountability Act (HIPAA) and various state genetic, health information, and consumer privacy laws. She works with clients on mapping and implementing data use and sharing strategies with appropriate data governance and programmatic safeguards. Well before the proliferation of generative AI, Jiayan was working with AI developers and deployers on compliance with privacy and research laws, efforts to leverage data to train and validate AI tools, and transactions involving the licensing of AI tools and AI-enabled platforms. These days, Jiayan also guides clients in developing AI governance and advises on proposed regulatory and legislative changes impacting AI.

Jiayan represents clients on a wide array of matters related to biomedical research, including negotiating the full range of agreements impacting research, building research compliance infrastructure, preparing protocols and informed consent and authorizations, and conducting transactions involving research site networks, providers of research solutions and other stakeholders in the biomedical research space. Jiayan’s regulatory practice includes counseling clients on state and federal “sunshine” and gift ban laws. She analyzes proposed arrangements and corporate organizational structures to identify and inform reporting obligations, and helps clients develop compliance mechanisms for managing their reporting obligations.

Hunter Sharp focuses his practice on complex domestic and cross-border transactional matters. He represents private equity firms, family offices and strategic investors in the structuring and negotiation of leveraged buyouts, mergers, acquisitions, joint ventures, growth equity and venture capital investments, divestitures and other general corporate and governance matters.

Hunter has experience across a variety of industries, including healthcare, life sciences, basic industries, consumer goods, packaging, IT outsourcing, real estate services, manufacturing and business services.

Prior to joining McDermott, Hunter served as Vice President and Assistant General Counsel at Newmark Group Inc. (NASDAQ: NMRK), a commercial real estate firm, and as an associate at an international law firm. He brings an understanding of working closely with and advising senior management teams both internally and as an outside advisor.

Mark J. Mihanovic, head of the Firm’s Bay Area Transactions Group, primarily focuses his practice on corporate finance matters and mergers and acquisitions (M&A). He represents companies in a broad range of industries, with particular emphasis on the technology, life sciences and healthcare sectors.

Mark serves as lead counsel on behalf of issuers and underwriters in public offerings and private placements of equity and debt securities. He handles stock and asset acquisitions, divestitures, mergers, proxy fights and joint ventures and has had primary oversight responsibility for the regional and worldwide acquisition programs of multiple clients. Mark represents early-stage companies in connection with formation and organizational issues and venture capital and has also represented investors in complex venture capital transactions involving equity and debt.

Mark has substantial experience advising corporate boards of directors and management regarding fiduciary duties, including in connection with potential change in control transactions and consideration of “poison pill” stockholders rights plans, and corporate governance issues. He assists publicly traded companies with their U.S. Securities and Exchange Commission (SEC) filings and other securities compliance matters. He also advises investment banks on securities compliance issues and in acting as a financial adviser and delivering fairness opinions in the context of acquisitions and restructurings.

Mark has lectured at various external and McDermott-sponsored programs on topics such as public offerings, emerging company and venture capital issues and corporate governance matters. He has also spoken on mergers and acquisitions and other corporate-law-related topics in various client seminars and has served as a guest lecturer for transaction-related courses at the University of Michigan Law School and Stanford Law School.