RopesTalk

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.

In this Ropes & Gray podcast, asset management partners Laurel FitzPatrick and Joel Wattenbarger discuss the Risk Alert published on May 23, 2019 by the SEC’s Office of Compliance Inspections and Examinations, which addresses the obligation to safeguard customer records and other information in cloud-based or network storage solutions.

In this ESG-focused podcast, asset management partners Isabel Dische and Eve Ellis discuss the United Kingdom’s recently published Green Finance Strategy, the European Union’s Action Plan on Sustainable Finance and how these initiatives may impact asset managers.

The third installment of Ropes & Gray’s podcast series, Non-binding Guidance, highlights two recent federal district court decisions implicating enforcement efforts in the stem cell and compounding arenas. This episode, Ropes & Gray lawyers Greg Levine and Beth Weinman first explore the D.C. District Court’s decision to grant summary judgment to FDA in its efforts to enjoin a Florida clinic from administering unapproved adipose derived stem cell injections to patients to treat a number of serious diseases. Next they address a loss for the government in the decision by the Federal District Court for the District of Massachusetts to overturn the convictions of two former employees of the New England Compounding Center (NECC) for conspiracy to defraud FDA, on the basis of legal impossibility. Tune in to this discussion to learn more about these federal district court decisions, their impact on the industry, and how the Agency will move forward as a result of these findings.

We are pleased to introduce a new podcast series, Alumni @ RopesTalk, for our alumni interviews. Today’s podcast features Ropes & Gray alum Jeff Gleason in conversation with IP litigation partner Matt Rizzolo. Jeff and Matt were summer associates together back in 2007, and have stayed in touch over the years since Jeff left the firm to go in-house. Most recently, Jeff joined Delaware North, a global leader in hospitality and food services management, as assistant general counsel for gaming. Jeff discusses the challenges associated with moving in-house and offers advice to attorneys who may be looking to make the transition. Additionally, Jeff and Matt reminisce about their early days at Ropes & Gray. Tune in to hear more!

In this podcast, Jill Kalish Levy and Joel Wattenbarger discuss the impending cessation of LIBOR at the end of 2021 and its proposed replacement, SOFR, and how they differ. Market participants are already taking different approaches to the replacement of LIBOR from the documentation and logistical perspectives. This podcast explains the pros and cons of the various approaches, including the advantages and challenges associated with the “amendment approach” and the “hardwired approach” in documentation, and what actions credit fund managers may want to consider taking in 2019 to begin the transition away from LIBOR.

This new Ropes & Gray podcast series, The PEP Talk, Ropes & Gray’s Private Equity Podcast, focuses on legal issues of interest to the private equity industry. In the first episode of the series, asset management partners Peter Laybourn and Debra Lussier are joined by Keith Higgins, chair of the firm’s securities and governance practice and former SEC director of corporation finance, to discuss the opportunity for private equity funds to engage in general solicitation during fundraising under Rule 506(c) of Regulation D of the Securities Act.

In this podcast, Isabel Dische and Melissa Bender discuss the recent impact investing standards published by the International Finance Corporation (IFC), an arm of the World Bank. This discussion provides a high-level overview of the IFC impact investing framework and related considerations for asset owners and managers.