RopesTalk

This episode of Ropes & Gray’s podcast series Non-binding Guidance examines the regulatory landscape for drug compounding and how it has evolved over the last 10 years since a 2012 nationwide fungal meningitis outbreak caused by contaminated drugs from the New England Compounding Center (NECC) rocked the industry and led to a legislative overhaul. Listen to FDA regulatory partner Josh Oyster and associate Becca Williams as they discuss the continuing ramifications of the outbreak, the challenges faced by FDA and drug compounders, the opportunities presented to investors in the life sciences industry, and key areas of regulatory development to watch.

In this Ropes & Gray podcast, health care partners Margaux Hall and Stephanie Webster and counsel David Ault explore drug pricing reforms and limits on agency action. In the months leading up to the midterm elections, we saw a flurry of activity around drug pricing, and now, in the wake of midterms, we see heightened bipartisan interest in the topic. Listen in to hear about some of the key recent events and a discussion on the fundamental question of how far agencies can go in regulating drug pricing.

In this episode of the R&G Tech Studio, technology and intellectual property transactions partner Regina Sam Penti sits down with technology, media & telecommunications co-lead Ed Black to discuss her practice and how she, as an MIT-trained engineer, leverages her background to counsel clients on technology transactions.

In many cases, ITC investigations are not stand-alone proceedings—Section 337 complaints are often accompanied by complaints filed in federal district court. These parallel complaints often are based upon the very same unfair acts underlying the alleged Section 337 violation, such as patent infringement, trademark infringement, or trade secret misappropriation. In this episode of Talkin’ Trade, Ropes & Gray IP litigators Matt Rizzolo, Matt Shapiro, and Brendan McLaughlin explore the issues created by such parallel complaints, including the potential for litigation on two fronts and the possible preclusive effect—or lack thereof—of Commission determinations.

This episode of Ropes & Gray’s podcast series Non-binding Guidance examines FDA’s final guidance on Clinical Decision Support (“CDS”) software, released in September, and its implications for the life sciences and health care industries. The final guidance represents a substantial change in FDA’s approach to CDS software regulation from the agency’s 2019 draft guidance and may prompt many software developers to reassess their CDS products in light of the new guidance. Join Ropes & Gray FDA regulatory partners Greg Levine and Kellie Combs and counsel Sarah Blankstein as they discuss FDA’s new CDS guidance and provide an overview of key changes, practical implications, and some of the challenges posed by the guidance.

In this episode of Women @ RopesTalk, Ropes & Gray health care partners Jenn Romig and Christina Bergeron interview Lisa Mango, chief legal officer and general counsel of One Medical, a human-centered, technology-powered U.S. primary care organization on a mission to make quality health care more affordable, accessible, and enjoyable through a seamless combination of in-person, digital, and virtual care services. Lisa talks about the evolution of her career, beginning at a mid-sized law firm and then moving to in-house legal roles at early dot-com and design software companies before starting at One Medical in 2016. In looking back at her career, Lisa encourages junior lawyers to embrace the unknown, reflects on an important mentor, and shares her approach to working and parenting. Finally, she talks about the exciting past few years at One Medical, including the company’s recent agreement with Amazon.

In this Ropes & Gray podcast, partners Ama Adams and Brendan Hanifin, counsel Emerson Siegle, and associate Kurt Fowler discuss FinCEN rulemaking implementing the beneficial ownership reporting requirements of the Corporate Transparency Act. The rule will significantly expand the scope of information that certain legal entities must disclose under U.S. law, and compliance with the rule’s requirements may present particular complexity for traditional tiered holding company structures.

In this Ropes & Gray podcast, health care partner Stephanie Webster and litigation & enforcement partner Jane Willis discuss recent rulemakings by the Centers for Medicare and Medicaid Services (“CMS”) regarding Competition and Transparency in health care. They address how this rule is part of a broader effort by the Biden Administration to aggressively enforce the antitrust laws, and in particular, what hospitals, health care systems, and other health care providers might expect from this rulemaking and the broader trend it signals.

In this episode of the R&G Tech Studio, venture capital & emerging companies co-lead Brad Flint sits down with technology, media & telecommunications co-lead Ed Black to discuss his practice and to share his thoughts on the evolving tech and regulatory landscape impacting the venture community.

Following the first action filed by a U.S. federal regulator against a DAO and its members, asset management attorneys Melissa Bender, Jeremy Liabo and Glen Chen discuss the Ooki DAO case and its implications on the potential liability of DAO token holders, DAO legal wrappers and the CFTC’s role in regulating digital assets.