Managing Regulatory Risks Through Medical Device Transactions: Best Practices for Regulatory and Compliance Diligence - AdvaMed

Events

November 14, 2024 1:00 PM – 2:00 PM

Register now

November 14, 2024 1:00 PM – 2:00 PM

Register now

November 14, 2024 1:00 PM – 2:00 PM

Register now

This in depth webinar presented by Arnold & Porter explores how the life sciences industry is heavily regulated and complex with unique regulatory, legal, and business challenges that present both substantial risk and upside. Arnold & Porter partners Phil Desjardins, Hemmie Chang and senior associate Phil DeFedele will discuss how to best mitigate and address major FDA regulatory, compliance, and business risks in medical device transactions, including:

Join us virtually on November 14 at 1:00 PM ET to understand that whether you are focused on medical device M&A or licensing deals, this program will provide you with insights on how to navigate these complex regulatory and business issues.

Philip R. Desjardins, Partner

Philip Desjardins brings nearly two decades of experience working with the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and serving in pivotal leadership roles in Johnson & Johnson’s MedTech businesses. His comprehensive insights into the intricacies of the FDA’s operational framework and regulatory expectations and broad knowledge of the MedTech ecosystem position Phil as a leading authority on MedTech regulatory affairs and compliance. He has consistently delivered successful outcomes to a broad spectrum of clients, from emergent biotech startups to established global healthcare giants.

As CDRH Associate Director for Policy, Phil was key in formulating the FDA’s current policies on medical devices and drug-device combinations, including legislation, regulations, and enforcement actions. He helped develop and implement CDRH policies in the MedTech space on clinical trials and audits. As Regulatory Counsel, Phil advised FDA leaders on the legal implications of potential compliance actions, pending litigation, enforcing post-market regulatory requirements, and responses to congressional inquiries. Phil rejoined the firm’s Life Sciences & Healthcare Regulatory practice after serving as counsel earlier in his career.

Hemmie Chang, Partner

Hemmie Chang, head of the firm’s newly launched Boston office, is a leading lawyer in the life sciences industry. She regularly advises life sciences companies on high-profile intellectual property transactions, finding creative solutions for their complex needs, and helping them navigate the legal landscape as they develop their innovative IP and look to commercialize it globally.

Hemmie is recognized by clients and within the legal community as an experienced advisor with a keen and strategic business sense, deep substantive knowledge and sharp strategic business perspective and legal acumen, developed more than two decades of experience representing innovators and investors in the biopharmaceutical, medical device, diagnostics, gene and cell therapy, and genomics sectors. She advises both established and emerging companies on a wide variety of licensing matters — from development to marketing deals — all of which involve a broad range of intellectual property assets, including patents, trade secrets, brand names, and copyright.

In recent years, Hemmie has closed more than $20 billion in deals across diverse therapeutic areas on behalf of such clients as Alexion*, Daewoong, Dicerna*, Genevant*, HiFiBiO*, H.I.G. Capital*, LegoChem Biosciences, and Tiger Management*. She also has an active pro bono practice, including work for the Asian American Legal Defense and Education Fund and Franklin Square House Foundation, which serves homeless women and children in the Greater Boston area.

Phillip V. DeFedele, Senior Associate

Phillip DeFedele counsels clients in the life sciences industry on regulatory, transactional, compliance, and enforcement matters. His areas of focus include FDA regulation of drugs, devices, and biologics, fraud and abuse, research and development, advertising and promotion, and compliance programs. Phil assists life sciences companies with regulatory matters throughout the entire product life cycle, including FDA inspections and enforcement and advisory actions as well as matters that are essential for FDA approval, clearance, or licensure. Phil also conducts regulatory due diligence in connection with business transactions and assists in drafting and negotiating various contractual arrangements. He has worked on a significant number of life sciences transactions at, and prior to joining, Arnold & Porter that have collectively exceeded US$100 billion in value. His experience in this area includes applying and analyzing applicable FDA requirements while accounting for general contractual, practical, and business considerations in order to draft contractual provisions and revise agreements from a regulatory perspective.

Event / Digital Health / research & policy papers

November 20, 2024 2:00 PM – 3:00 PM

Join McAndrews, Held & Malloy for this webinar to hear about the current trends in patent litigation and their potential impact for medtech companies involved in or considering patent litigation.

Event / Digital Health / research & policy papers

November 19, 2024 2:00 PM – 3:00 PM

Join EPAM Systems, Inc., and AdvaMed for an engaging webinar that explores the cutting-edge intersection of digital transformation and surgical innovation.

Event / Digital Health / research & policy papers

October 22, 2024 12:00 PM – 1:00 PM

Join AdvaMed and Sunrise Labs for this timely webinar on the medtech industry, its breakthroughs and challenges.

Event / Digital Health / research & policy papers

September 18, 2024 10:00 AM – 11:00 AM ET

Join AdvaMed and Avania for this timely webinar on the overall direction for remote technologies, artificial intelligence, and physiologic monitoring systems.

News / Digital Health

August 1, 2024

In the first episode of the new Medtech POV series “From AI to Z”, AdvaMed President and CEO Scott Whitaker sat down with Troy Tazbaz, Director of the Digital Health Center of Excellence (DCHoE) within FDA’s Center for Devices and Radiological Health.

Event / Digital Health / Regulatory Affairs

November 13, 2024 8:15 AM – 6:00 PM

Join us in Washington, D.C. for our Cybersecurity Summit that will address the future of medical device cybersecurity and changes in the industry landscape related to FDA requirements.

Event / Digital Health / research & policy papers

November 6th, 2024 12:00PM-1:00PM ET

Join AdvaMed and MIDI for this timely webinar on the transformative power of Artificial Intelligence (AI) in the medical and healthcare industries.

News / Digital Health

May 16, 2024

Scott Whitaker, President and CEO of AdvaMed, the Medtech Association, released the following statement regarding the bipartisan “Roadmap for Artificial Intelligence Policy in the U.S. Senate” released yesterday by Senate Majority Leader Chuck Schumer (D-NY), Senator Mike Rounds (R-SD), Senator Martin Heinrich (D-NM), and Senator Todd Young (R-IN).

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