McDermott Will & Schulte, a global 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.

Marshall E. Jackson, Jr. focuses his practice on transactional and regulatory counseling for clients in the healthcare and life sciences industries. Leveraging his transactional background and deep healthcare regulatory experience, Marshall provides practical and comprehensive counsel on the complex strategic and operational issues facing healthcare and life sciences companies and their investors.

He advises investors, including private equity, growth equity, venture capital firms, and their portfolio companies, on mergers and acquisitions, joint ventures, and strategic affiliations, as well as on a wide range of corporate, regulatory, and governance matters. Marshall is also deeply experienced on the company side, representing physician practices and other health organizations in their corporate, regulatory compliance, and governance needs.

Additionally, Marshall is particularly experienced in the digital health and health tech space — the intersection of healthcare and life sciences, software, analytics, technology, AI, and electronic data. He advises investors, healthcare and life sciences companies, and technology companies across the full scope of their transactional opportunities and complex legal, regulatory and compliance issues.

Byron S. Kalogerou is the founder of the Firm’s Life Science Industry Group and the senior partner in the Boston Corporate Practice. He helps clients execute on their growth strategies by guiding them through complex domestic and cross-border mergers and acquisitions and joint ventures and alliances. He also assists early stage life science companies in their capital raising efforts. Byron has extensive industry background in the life science, industrial and manufacturing sectors. He also acts as outside general counsel to a number of companies.

Byron spent 18 years in-house, where he served in various general counsel roles at Tyco International, including as general counsel of its fire and security and telecom businesses, and as general counsel of its international legal department, a function he created. Byron led many of Tyco’s largest acquisitions, including the $12 billion acquisition of AMP Inc. and the $850 million purchase of AT&T Submarine Systems, and handled hundreds of middle-market deals around the globe. Byron also handled Tyco’s initial foray into medical devices and led many of the deals that formed Covidien, now part of Medtronic.

Byron returned to law firm life 18 years ago with a desire to bring his keen sense of the “voice of the customer” to drive predictability, value and efficiency into the deal process. Byron is a legal project management pioneer and co-chair of the American Bar Association (ABA) Committee on Mergers and Acquisitions’ Task Force on Legal Project Management. He is co-editor of the ABA Guidebook “Using Legal Project Management in Merger & Acquisition and Joint Venture Transactions”, now in its third edition. Byron also created the first-of-its-kind web-based collaborative deal management portal, which the Firm adopted and embraced as part of Client Central. He is also one of the Firm’s primary contacts with the Association of Corporate Counsel.

Sharon Lamb focuses her practice on transactional and regulatory advice in the health and life sciences sector and leads McDermott’s UK Health and Life Sciences Practice Group.

Sharon advises on global transactional mandates, including mergers and acquisitions and joint ventures in health services, pharma and life sciences, digital health and health technologies. Sharon also provides strategic, regulatory and commercial support to UK and international clients on UK health and life sciences with a focus on health services, pharmaceuticals, medical devices, digital health and health data.

Sharon is widely recognized for her expertise on NHS and public law procurement, regulatory and contracting matters, including payment and reimbursement and market access. She has particular experience advising strategic and private equity investors in transactions and investments in health and life sciences.

Sharon is also well-versed in health care services governance and regulatory matters, NHS public private partnerships, procurements, joint ventures and shared working arrangements, mergers, acquisitions, health data and competition issues.

Sharon has practiced health and life sciences law in the UK since 2002 and is recognized in Chambers and Legal 500. Sharon has written and lectures widely on health and life sciences issues and has a wealth of experience with NHS law and policy, having worked on a 4-year part time secondment with the NHS and national health bodies in London.

Advises clients on telehealth, remote patient monitoring, AI-enabled tools, consumer wellness and other virtual care or digital health companies on product development, compliance, commercialization, and reimbursement strategies

Guides clients on structuring compliant care delivery models, navigating multi-state licensure, and advising on fraud and abuse, data privacy, cybersecurity, and other key areas

Advises mail order, retail and other types of pharmacies, suppliers and manufacturers on partnerships with healthcare companies and related compliance considerations

Develops compliance frameworks for consumer wellness programs and mobile health solutions

Leads retailers, tech companies and other non-healthcare companies through their development and launch of healthcare products or offerings

Structures provider networks and strategic collaborations among hospitals, health centers, and physicians

Counsels investors on healthcare trends, reimbursement opportunities and changes in laws to assist with designing their investment strategies

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.

Michael (Mike) Ryan advises manufacturers, healthcare providers, and investors on the legal, regulatory, and reimbursement/market access issues that arise during the development and commercialization of medical devices, clinical laboratory testing services, biological products, and drugs. He helps clinical laboratories and life sciences companies maintain regulatory compliance and evaluate, develop, and implement strategies to optimize coding, coverage, and payment for novel technologies.

Additionally, Mike helps innovative companies identify and navigate applicable Food and Drug Administration (FDA) regulatory requirements for new technologies, particularly in vitro diagnostics and digital health products. He regularly advises clients on the FDA’s evolving requirements for laboratory developed tests (LDTs) and reviews promotional and marketing materials for FDA-regulated medical products.

Mike also counsels clinical laboratories on state and federal compliance issues, including those under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), state laboratory licensure laws, and billing and reimbursement rules.

David M. Santangelo represents life sciences and biopharmaceutical companies in a variety of corporate transactions and commercial undertakings with peer companies, universities and academic institutions, including licenses and collaborations, product acquisitions and dispositions, distribution arrangements, development agreements, manufacturing and supply agreements, services agreements, clinical trial agreements, sponsored research agreements, quality agreements and technology transfers. He advises industry clients at all stages of the product life cycle on their strategic alliances and all manner of commercial contracting relevant to both their daily operations and long-term planning. David serves as an outside general counsel to many early stage and smaller clients, and as a trusted advisor to more mature, middle market and large cap companies, both public and private.

Prior to making the life sciences sector his key area of focus, David also counseled public and private companies in the energy, technology, telecommunications and consumer goods industries, advising clients on an array of transactions, including stock and asset acquisitions, mergers, spin-offs, tender offers and joint ventures. David also represented public companies in connection with public offerings and private placements of debt securities, high-net-worth individuals and family offices in connection with venture capital and early stage ventures and investments, and counseled various other clients on corporate governance and compliance matters.

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.

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.

Eleanor (Ellie) West centres her practice on private equity transactions and mergers and acquisitions.  Ellie works across a wide range of sectors, and has particular expertise in the health care and life sciences industries.

Ellie regularly advises domestic and international private equity sponsors on transactional matters (including leveraged buy-outs, growth capital investments, add-on acquisitions and the implementation of management incentive plans).  She also advises a range of multi-national corporations on cross-border acquisitions, disposals and restructuring transactions.