RopesTalk

The seventh installment of Ropes & Gray’s podcast series, Non-binding Guidance, dives into the closely watched administrative law case, Kisor v. Wilkie. This Supreme Court case addresses the continued validity of the doctrine articulated in the 1997 Supreme Court case Auer v. Robbins, regarding judicial deference to federal administrative agency interpretations of their own regulations. In this episode, Ropes & Gray partner Greg Levine interviews his colleagues, Doug Hallward-Driemeier and Beth Weinman, about the factual background, opinions, and potential implications of Kisor, with particular emphasis on its significance for FDA-regulated life sciences companies seeking to challenge FDA or other federal agency regulatory interpretations. Among other things, Beth and Doug discuss the signals the Kisor case sends about the future of Chevron deference, which addresses the related question of judicial deference to agency interpretations of statutes. Tune in to this discussion to learn about key takeaways from the Supreme Court’s Kisor ruling and its potential impact on FDA-regulated companies.

In this Ropes & Gray podcast, Alyson Gal, Matt Roose and Jill Kalish Levy discuss recent developments in loan and bond documentation in response to market concerns with how credit default swaps may affect the likelihood of defaults being triggered under the underlying debt instruments, including the advent of so called “net-short holder” provisions. As the backdrop to the market concerns that are leading to these provisions, we discuss two recent situations, Hovnanian and Windstream, as examples of transactions where the fact that market participants held CDS protection or, conversely, were CDS protection sellers, affected how events played out. We then review the various “net-short holder” provisions in loan documents and indentures seen to-date, and discuss how the market response to these concerns continues to evolve.

In this Ropes & Gray podcast, asset management partners Melissa Bender and Isabel Dische discuss the recently published revised edition of the UK Stewardship Code. In particular, the revised Code specially requires that UK asset manager signatories explain how their investment policies enable them to practice stewardship and adds related ESG-related reporting obligations.

In the second installment of Ropes & Gray’s alumni podcast series, Alumni @ RopesTalk, strategic transactions partner Megan Baca is joined by Ropes & Gray alum Sabrina Ross for a wide-ranging conversation about Sabrina’s journey from Ropes & Gray associate to global head of policy for Uber’s ridesharing marketplace. This candid and engaging conversation touches upon the myriad challenges—and opportunities—involved with transitioning from big law into an in-house position.

In this Ropes & Gray podcast, asset management partner Isabel Dische and finance partner Patricia Lynch dive into the use of capital call facilities by private investment funds. Specifically, they go into detail on some of the pros and cons for limited partners of such subscription facilities, recent ILPA guidelines relating to their use, the market response to the ILPA guidelines, and their predictions for the future of the market following the adoption of these ILPA guidelines.

In this Ropes & Gray podcast, asset management counsel Brynn Rail and David Tittsworth discuss the SEC’s new rules and interpretations that deal with standards of conduct for brokers and investment advisers. Specifically, they cover the topics of Regulation Best Interest (Reg BI), Form Customer Relationship Summary (Form CRS), and the SEC’s fiduciary duty interpretation under the Advisers Act.

The sixth installment of Ropes & Gray’s podcast series, Non-binding Guidance, continues our two-part discussion on FDA expedited review programs. In this episode, Ropes & Gray lawyer Kellie Combs interviews her partner Greg Levine, who provides an overview of FDA’s new Breakthrough Devices Program. This program, which was finalized in late 2018, aims to expedite the development and FDA premarket review of devices used in the treatment or diagnosis of serious or life-threatening conditions. The Breakthrough Devices Program provides a variety of benefits to manufacturers, including priority review and more frequent and efficient feedback from FDA during the submission and review process, so that devices receiving breakthrough designation can reach the patients who need them quickly and efficiently. In this episode, Greg dives into the program’s eligibility criteria, benefits, when to apply, and some of the practical considerations associated with the program. Additionally, Kellie and Greg discuss recent trends and developments affecting breakthrough devices and provide examples of devices that have recently received breakthrough device designation or that were approved or cleared as breakthrough devices. Tune in to this discussion to learn more about the program and its impact on the medical device industry.

The fifth installment of Ropes & Gray’s podcast series, Non-binding Guidance, is the first part of a two-episode discussion of FDA expedited review programs. In this episode, Ropes & Gray lawyer Greg Levine interviews his partner Kellie Combs, who provides an overview of the four expedited review programs for drugs and biologics: the Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval programs. These programs, which are broadly intended to address unmet needs in the treatment of serious or life-threatening conditions for which existing therapies are insufficient, are associated with significant benefits for manufacturers, such as earlier and more frequent FDA interactions, streamlined clinical development requirements, and a shorter FDA review clock—all of which may accelerate time to market and improve the bottom line. In this episode, Kellie discusses the eligibility criteria and benefits associated with each program, and describes timing and other practical issues for product manufacturers to consider. Tune in to this discussion to learn more about the expedited review programs and how to secure the benefits. Next week, we’ll release the second episode of this two-part series, which will focus on the Breakthrough Devices Program. Please stay tuned.

In this Ropes & Gray podcast, litigation & enforcement partners Amy Roy and Rob Skinner discuss the recent decision of a federal court in Los Angeles, rejecting claims of allegedly excessive mutual fund advisory fees against Metropolitan West Asset Management. They discuss the key arguments raised in the trial over the claims, and the evidence relied upon by the court in finding in MetWest’s favor across the board.

The fourth installment of Ropes & Gray’s podcast series, Non-binding Guidance, dives into the use of real-world evidence in drug development. In this episode, Ropes & Gray lawyers Kellie Combs and Sarah Blankstein discuss FDA’s current thinking on real-world evidence and how industry has been using real-world evidence studies in FDA submissions, as well as with payors and in product promotion. The speakers highlight key takeaways from FDA’s framework for real-world evidence, issued in December 2018, including the types of data sources and study designs that FDA considers to be “real-world,” and the Agency’s approach to assessing real-world evidence intended to support a determination of effectiveness. Additionally, our presenters discuss highlights from FDA and the Duke-Margolis Center’s public workshop on real-world evidence, which took place on July 11-12. Tune in to this discussion to learn more about FDA’s approach to real-world evidence, the impact on industry, and what companies should be thinking about in this space.