Shows
RopesTalkMultidimensional Data Reversion: E-Discovery Evolution—From Paper Trails to AIWelcome to Multidimensional Data Reversion, a four-part podcast series from Ropes & Gray’s Insights Lab where data analysis intersects with the law. On this first episode, join Shannon Capone Kirk, managing principal and global head of Ropes & Gray’s advanced e-discovery and AI strategy group, and David Yanofsky, director of data insights, analytics and visualization at the R&G Insights Lab, as they delve into the evolving world of e-discovery, data governance and the impact of generative AI (“GenAI”) on legal practices. Discover how technology is transforming the way legal professionals handle electronic data and learn about best practices for mana...2025-03-2619 minRopesTalkAlumni @ RopesTalk: DeepSeek Deep Dive with Dr. Vasanth Sarathy, Tufts UniversityOn this special edition of Ropes & Gray’s Alumni @ RopesTalk podcast series, technology and IP transactions partner Regina Sam Penti is joined by Dr. Vasanth Sarathy, a professor of computer science at Tufts University and a Ropes & Gray alum. Together, they delve into the technical and business implications of DeepSeek, a Chinese app and model that has generated significant buzz in the AI world. They explore whether DeepSeek is a game-changer in AI, its cost advantages, and the potential impact on AI investments and startups. Dr. Sarathy also addresses the privacy and security concerns associated with DeepSeek, especially given it...2025-02-2626 min
Alumni @ RopesTalkDeepSeek Deep Dive with Dr. Vasanth Sarathy, Tufts UniversityOn this special edition of Ropes & Gray’s Alumni @ RopesTalk podcast series, technology and IP transactions partner Regina Sam Penti is joined by Dr. Vasanth Sarathy, a professor of computer science at Tufts University and a Ropes & Gray alum. Together, they delve into the technical and business implications of DeepSeek, a Chinese app and model that has generated significant buzz in the AI world. They explore whether DeepSeek is a game-changer in AI, its cost advantages, and the potential impact on AI investments and startups. Dr. Sarathy also addresses the privacy and security concerns associated with DeepSeek, especially given it...2025-02-2626 minRopesTalkWelcome to the R&G Dugout: Sports Investing—It's a Whole New BallgameWelcome to the R&G Dugout, a new Ropes & Gray podcast series that delves into the dynamic world of sports investing, with a particular focus on the evolving ecosystem of media, entertainment, and private capital ventures. On this inaugural episode, Ropes & Gray partners Amanda Persaud, Patrick Dorime, and Erica Han discuss the transformative changes occurring in the sports industry, from the recent updates in ownership rules in professional leagues to the burgeoning interest in college athletics and private capital investments. This episode provides a foundational background in the sports investment landscape, addressing key questions about structuring investments, navigating regulatory...2024-12-1215 min
R&G Tech StudioVenture Capital and Emerging Companies Partner Raj BanerjeeOn this episode of the R&G Tech Studio podcast, host Brad Flint, co-leader of Ropes & Gray’s venture capital and emerging companies practice, is joined by Raj Banerjee, a partner in both the venture capital and emerging companies practice, as well as the IP transactions group at Ropes & Gray. Raj shares insights from his extensive experience as a life sciences lawyer, focusing on the intersection of AI and life sciences. He discusses the significant trends in AI investment, the impact of AI on corporate America, and how these developments are reshaping the venture investing world. Raj also highlights th...2024-10-1610 minRopesTalkR&G Tech Studio Presents: Venture Capital and Emerging Companies Partner Raj BanerjeeOn this episode of the R&G Tech Studio podcast, host Brad Flint, co-leader of Ropes & Gray’s venture capital and emerging companies practice, is joined by Raj Banerjee, a partner in both the venture capital and emerging companies practice, as well as the IP transactions group at Ropes & Gray. Raj shares insights from his extensive experience as a life sciences lawyer, focusing on the intersection of AI and life sciences. He discusses the significant trends in AI investment, the impact of AI on corporate America, and how these developments are reshaping the venture investing world. Raj also highlights th...2024-10-1610 minRopesTalkHealth Care Transaction Laws Unwrapped: Navigating Expanding Government Oversight of Health Care InvestmentsRopes & Gray is pleased to introduce our latest podcast series, Health Care Transaction Laws Unwrapped, which continues our exploration of critical developments in health care regulation of health care transactions. In this six-part series, our team will delve into the evolving landscape of state health care transaction laws and their implications for health care entities and private equity investors. In this introductory episode, Ropes & Gray health care partners Debbie Gersh, Tim McCrystal and Jenn Romig analyze the current regulatory climate and its implications for investments in health care, including: Federal oversight: recent federal initiatives, including the FTC...2024-09-1719 minRopesTalkCulture & Compliance Chronicles: The FEPA Factor—Will the DOJ's Latest Tool Reshape the Landscape of Anti-Corruption Enforcement and Compliance?What on earth is FEPA (the Foreign Extortion Prevention Act)? On this episode of Culture & Compliance Chronicles, Amanda Raad and Nitish Upadhyaya from Ropes & Gray’s Insights Lab, and Richard Bistrong of Front-Line Anti-Bribery, ask guest Ryan Rohlfsen, a former federal prosecutor at the U.S. Department of Justice (DOJ) and now partner and co-chair of Ropes & Gray’s anti-corruption and international risk practice, to share his views on the DOJ’s latest tool. They discuss the implications of FEPA on enforcement, corporate compliance, and the cultural context of international jurisdictions. The conversation also touches on the potential impact on U.S...2024-08-1331 minRopesTalkAlumni @ RopesTalk: Conversation with Charles Soule, Comic Book Writer & NovelistOn this episode of Ropes & Gray’s Alumni @ RopesTalk podcast, private equity partner Carl Marcellino interviews #1 New York Times-best-selling novelist, comic book writer and musician Charles Soule, who was an associate at Ropes & Gray from 2000-2004. They discuss how Charles built a creative life while practicing as a lawyer. Charles shares his experiences working on comics for DC and Marvel, as well as publishing three novels, including some in the Star Wars universe. For anyone trying to improve their networking, Charles’s description of how he broke into the comic book business is a master class. 2024-06-2424 minAlumni @ RopesTalkConversation with Charles Soule, Comic Book Writer & NovelistOn this episode of Ropes & Gray’s Alumni @ RopesTalk podcast, private equity partner Carl Marcellino interviews #1 New York Times-best-selling novelist, comic book writer and musician Charles Soule, who was an associate at Ropes & Gray from 2000-2004. They discuss how Charles built a creative life while practicing as a lawyer. Charles shares his experiences working on comics for DC and Marvel, as well as publishing three novels, including some in the Star Wars universe. For anyone trying to improve their networking, Charles’s description of how he broke into the comic book business is a master class. 2024-06-2424 minRopesTalkFalse Claims Act Trends: Q&A with Former DOJ Civil Frauds Attorney and Ropes & Gray Partner Amy KossakOn this Ropes & Gray podcast, Amy Kossak, who recently joined Ropes & Gray after a decade investigating and litigating FCA cases at the Department of Justice (“DOJ”), talks with Andrew O’Connor and Michael Lampert, co-leaders of the firm’s False Claims Act (“FCA”) practice. Together, they explore the latest trends, potential risks, and effective strategies for navigating the complex FCA landscape. Amy shares her insights, based on her time at DOJ, on what steps companies can take to reduce the likelihood of becoming involved in an FCA inquiry, how companies should think about potential self-disclosures and compliance program investments, and what is—...2024-05-3019 minRopesTalkDecoding Digital Health: AI/ML Webinar Recap—U.S. FDA & European PerspectivesOn this episode of Ropes & Gray’s podcast series, Decoding Digital Health, host Kellie Combs, a partner in the life sciences regulatory and compliance group and co-chair of the firm’s cross-practice digital health group, is joined by Greg Levine, chair of the firm's global life sciences regulatory and compliance practice, and Lincoln Tsang, head of the European life sciences practice. They unpack some key insights from a recent webinar on regulatory issues surrounding artificial intelligence (“AI”) and machine learning (“ML”) devices, hosted by Ropes & Gray and HLTH. The conversation covers the boundaries of AI and ML regulation as a medical de...2024-05-2118 min
Decoding Digital HealthAI/ML Webinar Recap—U.S. FDA & European PerspectivesOn this episode of Ropes & Gray’s podcast series, Decoding Digital Health, host Kellie Combs, a partner in the life sciences regulatory and compliance group and co-chair of the firm’s cross-practice digital health group, is joined by Greg Levine, chair of the firm's global life sciences regulatory and compliance practice, and Lincoln Tsang, head of the European life sciences practice. They unpack some key insights from a recent webinar on regulatory issues surrounding artificial intelligence (“AI”) and machine learning (“ML”) devices, hosted by Ropes & Gray and HLTH. The conversation covers the boundaries of AI and ML regulation as a medical de...2024-05-2118 minRopesTalkAlumni @ RopesTalk: Conversation with Eric Yecies, LifeMDOn this episode of Ropes & Gray’s Alumni @ RopesTalk podcast, health care partner Christina Bergeron interviews alum Eric Yecies, chief legal officer and general counsel at LifeMD. Eric discusses his journey from practicing IP litigation as an associate at Ropes & Gray from 2004–2008 to becoming a key figure in a publicly traded telehealth company. Gain insights into the unpredictability of his day-to-day responsibilities, the strategic thinking essential for in-house roles, and the impact of telehealth on LifeMD's rapid growth.2024-03-2612 minAlumni @ RopesTalkConversation with Eric Yecies, LifeMDOn this episode of Ropes & Gray’s Alumni @ RopesTalk podcast, health care partner Christina Bergeron interviews alum Eric Yecies, chief legal officer and general counsel at LifeMD. Eric discusses his journey from practicing IP litigation as an associate at Ropes & Gray from 2004–2008 to becoming a key figure in a publicly traded telehealth company. Gain insights into the unpredictability of his day-to-day responsibilities, the strategic thinking essential for in-house roles, and the impact of telehealth on LifeMD's rapid growth.2024-03-2612 minRopesTalkControlling Opinions: Current Developments in Cannabis ResearchWelcome to the second installment of Ropes & Gray’s podcast series, Controlling Opinions, focused on current trends and developments related to controlled substances that affect the health care and life sciences industries. On this episode, hear a cross-practice team of Ropes & Gray attorneys—Josh Oyster, David Peloquin, and Beth Weinman—discuss current developments related to research with cannabis. Discussion points include how researchers aim to understand the impact of consumer-level cannabis use on the overall health of individuals and their communities, why research with cannabis is different from research with other drugs, and what the regulatory landscape for cannabis resear...2024-03-0724 minRopesTalkNon-binding Guidance: Preview of the Second Annual Ropes & Gray Rare Disease ForumIn honor of Rare Disease Day, join Ropes & Gray attorneys Kellie Combs, Josh Oyster, and Sarah Blankstein for a special edition of Non-binding Guidance, a podcast series that focuses on current trends in life sciences regulatory law as well as other important developments affecting the life sciences industry. On this episode, they provide a preview of the Second Annual Ropes & Gray Rare Disease Forum, which will be held in Cambridge, Massachusetts on May 7, 2024.2024-02-2908 min
Non-binding GuidancePreview of the Second Annual Ropes & Gray Rare Disease ForumIn honor of Rare Disease Day, join Ropes & Gray attorneys Kellie Combs, Josh Oyster, and Sarah Blankstein for a special edition of Non-binding Guidance, a podcast series that focuses on current trends in life sciences regulatory law as well as other important developments affecting the life sciences industry. On this episode, they provide a preview of the Second Annual Ropes & Gray Rare Disease Forum, which will be held in Cambridge, Massachusetts on May 7, 2024. 2024-02-2908 minRopesTalkThe Data Day: Protecting Your Company and Your Data in the Wake of a Cyber IncidentTune in to Ropes & Gray's podcast series, The Data Day, brought to you by the firm’s data, privacy & cybersecurity practice. This series focuses on the day-to-day effects that data has on all of our lives as well as other exciting and interesting legal and regulatory developments in the world of data, and features a range of guests, including clients, regulators and colleagues. On this special episode, in honor of World Data Privacy Day coming up on January 28, hosts Fran Faircloth, a partner in Ropes & Gray's Washington, D.C. office, and Edward Machin, counsel in the London office, discuss th...2024-01-2620 minRopesTalkAlumni @ RopesTalk: Conversation with George Kopcsay, Atlas AirIn this installment of Ropes & Gray’s Alumni @ RopesTalk podcast, strategic transactions group co-leader Marko Zatylny interviews alum George Kopcsay, general counsel of Atlas Air. George was an associate at Ropes & Gray for five years before going in-house at Atlas, where he has been for 13 years. George talks about the experience of taking the company private in 2023 and the differences between being a lawyer at a public company versus a private one. In thinking about the role of a corporate generalist, he explains the “quarterbacking” skill that is essential to his job. George also shares a valuable (and easy) thing...2023-12-1217 minAlumni @ RopesTalkConversation with George Kopcsay, Atlas AirIn this installment of Ropes & Gray’s Alumni @ RopesTalk podcast, strategic transactions group co-leader Marko Zatylny interviews alum George Kopcsay, general counsel of Atlas Air. George was an associate at Ropes & Gray for five years before going in-house at Atlas, where he has been for 13 years. George talks about the experience of taking the company private in 2023 and the differences between being a lawyer at a public company versus a private one. In thinking about the role of a corporate generalist, he explains the “quarterbacking” skill that is essential to his job. George also shares a valuable (and easy) thing...2023-12-1217 minRopesTalkControlling Opinions: Introducing Ropes & Gray’s Controlled Substances Compliance UpdateWelcome to the first installment of Ropes & Gray’s new podcast series, Controlling Opinions, which is focused on current trends and developments related to controlled substances that affect the health care and life sciences industries. In this inaugural episode, hear a cross-practice team of Ropes & Gray attorneys—Andrew O’Connor, Josh Oyster, Stephen Warnke, and Beth Weinman—discuss the controlled substances issues that have their attention, including the potential federal rescheduling of marijuana; regulatory and legislative developments related to psychedelic drugs; litigation and enforcement developments involving opioids and ADHD medications; and enforcement trends and investigation best practices for diversion incident...2023-11-2018 minRopesTalkNon-binding Guidance: FDA’s Draft Guidance on Communication of Scientific Information on Unapproved Uses of Medical ProductsThis installment of Ropes & Gray’s podcast series Non-binding Guidance focuses on FDA’s recently issued draft guidance, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products – Questions and Answers.” In this episode, hear from Kellie Combs, Josh Oyster, and Sarah Blankstein, industry-leading attorneys from Ropes & Gray’s life sciences regulatory and compliance team, as they delve into FDA’s new draft guidance to discuss key changes, constitutional considerations, and practical implications for the medical products industry.2023-11-1424 minNon-binding GuidanceFDA’s Draft Guidance on Communication of Scientific Information on Unapproved Uses of Medical ProductsThis installment of Ropes & Gray’s podcast series Non-binding Guidance focuses on FDA’s recently issued draft guidance, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products – Questions and Answers.” In this episode, hear from Kellie Combs, Josh Oyster, and Sarah Blankstein, industry-leading attorneys from Ropes & Gray’s life sciences regulatory and compliance team, as they delve into FDA’s new draft guidance to discuss key changes, constitutional considerations, and practical implications for the medical products industry.2023-11-1424 minRopesTalkNon-binding Guidance: FDA’s Proposed Rule on Laboratory Developed TestsThis installment of Ropes & Gray’s podcast series Non-binding Guidance focuses on FDA’s proposed rule that would affirm the Agency’s position that laboratory developed tests (“LDTs”) are in vitro diagnostic products regulated as medical devices under the Federal Food, Drug, and Cosmetic Act (“FDCA”). In this episode, hear from Greg Levine, Josh Oyster, and Beth Weinman, industry-leading attorneys from Ropes & Gray’s life sciences regulatory and compliance team based in Washington, D.C., as they discuss FDA’s proposal to phase out the enforcement discretion policy it has historically applied to most LDTs. 2023-10-3023 minNon-binding GuidanceFDA’s Proposed Rule on Laboratory Developed TestsThis installment of Ropes & Gray’s podcast series Non-binding Guidance focuses on FDA’s proposed rule that would affirm the Agency’s position that laboratory developed tests (“LDTs”) are in vitro diagnostic products regulated as medical devices under the Federal Food, Drug, and Cosmetic Act (“FDCA”). In this episode, hear from Greg Levine, Josh Oyster, and Beth Weinman, industry-leading attorneys from Ropes & Gray’s life sciences regulatory and compliance team based in Washington, D.C., as they discuss FDA’s proposal to phase out the enforcement discretion policy it has historically applied to most LDTs. 2023-10-3023 minRopesTalkA Word for Our Sponsors: Philanthropy & Giving Strategies by Fund SponsorsOn this episode of Ropes & Gray’s podcast series A Word for Our Sponsors, hosts Deb Lussier and Paul Van Houten, the co-leaders of the sponsor solutions practice, are joined by Ropes & Gray tax partner Kendi Ozmon as well as tax counsel Gil Ghatan to discuss a topic of increasing interest among fund sponsors: establishing a vehicle for implementing their philanthropic and charitable giving goals. 2023-10-1811 minRopesTalkThe Sponsor’s Edge: Insights on Growth and Venture Investing—Alternatives to Down Rounds and Bridging Valuation Gaps (Part II)On this episode of Ropes & Gray’s podcast series, The Sponsor’s Edge: Insights on Growth and Venture Investing, asset management counsel Catherine Skulan hosts the second of a two-part conversation between Brad Flint, partner and co-lead of Ropes & Gray’s venture investing & emerging companies practice, and Raj Banerjee, a senior associate in that practice. Brad and Raj cover some traditional means of bridging valuation gaps before discussing the emergence of additional terms and investor protection mechanisms recently taking root in the market.2023-08-1710 minRopesTalkThe Sponsor's Edge: Insights on Growth and Venture Investing ”Alternatives to Down Rounds and Bridging Valuation Gaps (Part I)We are pleased to introduce a new Ropes & Gray podcast series, The Sponsor’s Edge: Insights on Growth and Venture Investing, which explores a variety of subjects of importance to growth and venture fund sponsors. This series will feature attorneys from a number of practice groups at Ropes & Gray, including private funds, venture investing & emerging companies, and restructuring, as they examine issues germane to growth and venture fund sponsors in the current investment environment.On this opening episode, asset management counsel Catherine Skulan hosts the first of a two-part conversation between Brad Flint, partner and co-lead of Ro...2023-08-0710 minRopesTalkNon-binding Guidance: Introducing the U.S. Medical Device Recalls Resource ManualJoin partners Greg Levine and Josh Oyster from Ropes & Gray’s life sciences regulatory and compliance practice group for a special edition of Non-binding Guidance, a podcast series which focuses on current trends in life sciences regulatory law as well as other important developments affecting the life sciences industry. On this episode, Greg and Josh discuss the publication of Ropes & Gray’s U.S. Medical Device Recalls Resource Manual, a reference tool to guide medical device companies considering, planning, or executing product recalls and other field actions.2023-07-1707 minNon-binding GuidanceIntroducing the U.S. Medical Device Recalls Resource ManualJoin partners Greg Levine and Josh Oyster from Ropes & Gray’s life sciences regulatory and compliance practice group for a special edition of Non-binding Guidance, a podcast series which focuses on current trends in life sciences regulatory law as well as other important developments affecting the life sciences industry. On this episode, Greg and Josh discuss the publication of Ropes & Gray’s U.S. Medical Device Recalls Resource Manual, a reference tool to guide medical device companies considering, planning, or executing product recalls and other field actions. 2023-07-1707 minRopesTalkDigital Assets Discussion: Consequences of the Proposed Safeguarding Rule for Crypto Asset CustodyOn this Ropes & Gray podcast, asset management attorneys Melissa Bender and Charlie Humphreville discuss the SEC’s proposed amendments to Rule 206(4)-2 under the Investment Advisers Act of 1940, the so-called “custody rule,” and how they will impact registered investment advisers that hold and invest in crypto assets. Ropes & Gray has a number of resources regarding the proposed changes to the custody rule and how they will impact registered advisers. If you would like to learn more about these matters please contact your usual Ropes & Gray attorney contacts. 2023-06-2815 minRopesTalkAlumni @ RopesTalk: Conversation with Heidy King-JonesIn the latest installment of Ropes & Gray’s Alumni @ RopesTalk podcast, life sciences partner Amanda Austin, who’s also a member of the firm’s alumni committee, interviews alum and friend Heidy (Abreu) King-Jones, former chief legal officer at Provention Bio. Heidy was an associate at Ropes & Gray from 2008 – 2013, after which she took in-house roles at Sarepta Therapeutics, Axcella and Provention Bio. As a self-described “student of law, student of biotech and student of life,” Heidy talks broadly about her career, with detours into the experience of working at Provention Bio during its acquisition by Sanofi. She shares what she learned...2023-06-2728 minAlumni @ RopesTalkConversation with Heidy King-JonesIn the latest installment of Ropes & Gray’s Alumni @ RopesTalk podcast, life sciences partner Amanda Austin, who’s also a member of the firm’s alumni committee, interviews alum and friend Heidy (Abreu) King-Jones, former chief legal officer at Provention Bio. Heidy was an associate at Ropes & Gray from 2008 – 2013, after which she took in-house roles at Sarepta Therapeutics, Axcella and Provention Bio. As a self-described “student of law, student of biotech and student of life,” Heidy talks broadly about her career, with detours into the experience of working at Provention Bio during its acquisition by Sanofi. She shares what she learned...2023-06-2728 min
Trainee InsightsLondon Private Capital Transactions Partner – Libby ToddOn this episode of Trainee Insights, Ropes & Gray private equity partner, Libby Todd, speaks about her journey into law, current trends in the private equity market and how that affects the work of a transactional lawyer, as well as her work on the Ropes & Gray London Women’s Forum. Libby also offers some sage life advice: “Don’t worry—just give things a go,” the worst that can happen is that they “don’t respond or they say no.” 2023-06-2321 minRopesTalkTreacherous Shoals—Navigating Growing Anti-ESG Sentiment: Recent Developments Impacting Asset ManagersOver the last year-plus, there has been a growing anti-ESG movement in the United States. Most of the focus has been on asset managers. As the leading asset management practice, Ropes & Gray has been in the trenches advising clients on these issues on a daily basis. On this podcast, Ropes & Gray thought leaders come together for a timely in-depth discussion of the most recent anti-ESG developments and the demands asset managers are navigating. During the podcast, they discuss fiduciary duties, antitrust, proxy advisors, state legislation, greenwashing and consumer protection claims and ERISA considerations. The participants provide concrete c...2023-06-081h 03RopesTalkWhy Conduct a GP-Led Secondary?On this Ropes & Gray podcast, asset management attorneys Amanda Persaud and Kevin White discuss reasons why a sponsor would consider conducting a GP-led secondary transaction. Ropes & Gray has recently been ranked as the #1 firm in the 2023 Secondaries Investor Annual Survey, and the market for these transactions has grown significantly over the last several years. Many sponsors who have not previously been involved in this market have entered this market and found the transactions to be highly appealing. Amanda and Kevin explore several of the rationales for why sponsors have found these transactions so appealing.2023-05-2310 minRopesTalkNon-binding Guidance: Recent Developments in Oncology Drug DevelopmentThis installment of Ropes & Gray’s podcast series Non-binding Guidance explores recent regulatory developments related to the development and approval of oncology drugs in the U.S. and Europe. On this episode, hear from Ropes & Gray FDA regulatory partner Josh Oyster and head of the European life sciences practice Lincoln Tsang as they compare approaches from FDA and E.U. legislation, and discuss what that means for companies researching and developing new oncology products for a global market.2023-05-1021 minNon-binding GuidanceRecent Developments in Oncology Drug DevelopmentThis installment of Ropes & Gray’s podcast series Non-binding Guidance explores recent regulatory developments related to the development and approval of oncology drugs in the U.S. and Europe. On this episode, hear from Ropes & Gray FDA regulatory partner Josh Oyster and head of the European life sciences practice Lincoln Tsang as they compare approaches from FDA and E.U. legislation, and discuss what that means for companies researching and developing new oncology products for a global market.2023-05-1021 minRopesTalkThe Data Day: Tracking Cybercriminals and Nation-State Actors in the World of Cryptocurrency—A Conversation with Jackie Koven of ChainalysisTune in to the third episode of Ropes & Gray's podcast series, The Data Day, brought to you by the firm’s data, privacy & cybersecurity practice. This series focuses on the day-to-day effects that data has on all of our lives as well as other exciting and interesting legal and regulatory developments in the world of data, and features a range of guests, including clients, regulators and colleagues. On this episode, hosts Fran Faircloth, a partner in Ropes & Gray's Washington, D.C. office, and Edward Machin, a London-based associate, are joined by special guest Jackie Koven, who is head of cy...2023-04-2522 minRopesTalkAlumni @ RopesTalk: Conversation with Beibei Sun, SanofiIn the latest installment of Ropes & Gray’s Alumni @ RopesTalk podcast, strategic transactions partner Abby Gregor interviews Beibei Sun, senior corporate counsel of global licensing and business development at Sanofi. Beibei was an associate in the life sciences group at Ropes & Gray before joining Sanofi in 2021. At Sanofi, she supports the specialty care business unit on licensing transactions and the ventures team on venture capital transactions. In this interview, Beibei talks about the differences between being a deal lawyer at a big firm versus in-house. In thinking about her career, she shares the three pieces of advice she would gi...2023-03-0627 minAlumni @ RopesTalkConversation with Beibei Sun, SanofiIn the latest installment of Ropes & Gray’s Alumni @ RopesTalk podcast, strategic transactions partner Abby Gregor interviews Beibei Sun, senior corporate counsel of global licensing and business development at Sanofi. Beibei was an associate in the life sciences group at Ropes & Gray before joining Sanofi in 2021. At Sanofi, she supports the specialty care business unit on licensing transactions and the ventures team on venture capital transactions. In this interview, Beibei talks about the differences between being a deal lawyer at a big firm versus in-house. In thinking about her career, she shares the three pieces of advice she would gi...2023-03-0627 minRopesTalkThe Data Day: A Deeper Look Into the California Consumer Privacy Act (CCPA) & California Privacy Rights Act (CPRA)Tune in to the second episode of Ropes & Gray's podcast series The Data Day, brought to you by the firm’s data, privacy & cybersecurity practice. This series focuses on the day-to-day effects that data has on all of our lives as well as other exciting and interesting legal and regulatory developments in the world of data, and will feature a range of guests, including clients, regulators and colleagues. On this episode, hosts Fran Faircloth, a partner in Ropes & Gray's Washington, D.C. office, and Edward Machin, a London-based associate, discuss recent enforcement by the California Attorney General, including a ne...2023-03-0223 minRopesTalkThe Data Day: World Data Protection Day and 2023 Trends & Hot TopicsTune in to the first episode of Ropes & Gray's new podcast series, The Data Day, brought to you by the firm’s data, privacy & cybersecurity practice. This series will focus on the day-to-day effects that data has on all of our lives as well as other exciting and interesting legal and regulatory developments in the world of data, and will feature a range of guests, including clients, regulators and colleagues. This edition celebrates World Data Protection Day, which took place on January 28, by answering questions submitted by our clients and contacts about the landscape of the data, privacy and cy...2023-01-3016 minTrainee InsightsPro Bono Mini-Series – Felicity KirkIn this special edition of Trainee Insights, Ropes & Gray London’s head of international pro bono, Felicity Kirk, provides an insight into the London office’s pro bono efforts and the variety of projects that Ropes & Gray’s lawyers can get involved in. Felicity also provides useful advice on how trainees can maximise their involvement in pro bono.2023-01-1311 minRopesTalkThe DOL’s Latest Guidance on ESG Investing and Proxy Voting—Key Implications for Plan FiduciariesIn the latest installment of our Ropes & Gray podcast series addressing emerging issues for fiduciaries of 401(k) and 403(b) plans to consider, Josh Lichtenstein, head of the ERISA fiduciary practice, Ellen Benson, benefits consulting group principal, and Sharon Remmer, ERISA and benefits counsel, analyze the Department of Labor’s (“DOL”) recently amended regulation governing ERISA investment duties and its application to environmental, social, and corporate governance (“ESG”) considerations and proxy voting. The amended regulation generally adheres to the re-proposal the DOL introduced over a year ago, in that it removes the anti-ESG bias of the Trump Administration’s prior rule. Instead, the...2022-12-1626 minRopesTalkNon-binding Guidance: Key Takeaways from FDA’s Final Guidance on Clinical Decision Support SoftwareThis 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...2022-11-2120 minNon-binding GuidanceKey Takeaways from FDA’s Final Guidance on Clinical Decision Support SoftwareThis 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...2022-11-2120 minTrainee InsightsLondon Director of Human Resources – Beverley SorsbyIn this episode of Trainee Insights, Ropes & Gray director of human resources, Beverley Sorsby, shares her experience of nine years at Ropes & Gray in London. Beverley speaks about the nature of the trainee recruitment process, provides insights into the upcoming recruitment campaign, and discusses what Ropes & Gray looks for in prospective applicants.2022-11-0422 minNon-binding GuidanceContinued Global Pressure on Drug Pricing & Reimbursement and the Next Frontiers for Effective Market AccessFollowing the recent publication relating to continued global pressure on drug pricing, this episode of Ropes & Gray’s podcast series Non-binding Guidance focuses on the significant changes to global business and legal environments for drug pricing brought about by the COVID-19 pandemic and the impacts on the pharmaceutical supply chain and patient access to innovative cutting-edge therapies. Hear from Ropes & Gray’s head of European life sciences practice Lincoln Tsang and health care partner Margaux Hall as they discuss the trend of rising health care drug costs in the U.S. and the UK, significant implications of the Inflation Reduction Act...2022-10-1322 min
Talkin’ TradeAll About Ancillary ProceedingsRopes & Gray’s podcast series Talkin’ Trade explores the world of Section 337 unfair import investigations at the U.S. International Trade Commission. Much of the focus of Section 337 litigation at the ITC is on the “violation” phase, where the Commission determines in the first instance whether to issue an exclusion order or cease and desist order. But ITC litigants should not lose sight of follow-on proceedings where these remedial orders can be modified or rescinded, or the ITC can impose civil penalties to enforce these orders. In this episode, Ropes & Gray IP litigators Matt Rizzolo, Matt Shapiro, Brendan McLaughlin, and Becca Ge...2022-09-0620 minRopesTalkAlumni @ RopesTalk: Conversation with Erin Abood, Stanford UniversityIn the latest installment of Ropes & Gray’s Alumni @ RopesTalk podcast, health care partner Ben Wilson interviews Erin Abood, senior university counsel at Stanford University. Erin was a health care associate at Ropes & Gray for five years before joining the in-house team at Stanford in 2010. Her practice focuses on digital health, international medicine, fraud and abuse, and privacy issues for Stanford Medicine. In this interview, Erin discusses her transition from Big Law to a small in-house team, what her team at Stanford values most about outside counsel, how her secondment to Stanford while still an associate helped smooth the path fo...2022-08-3019 minAlumni @ RopesTalkConversation with Erin Abood, Stanford UniversityIn the latest installment of Ropes & Gray’s Alumni @ RopesTalk podcast, health care partner Ben Wilson interviews Erin Abood, senior university counsel at Stanford University. Erin was a health care associate at Ropes & Gray for five years before joining the in-house team at Stanford in 2010. Her practice focuses on digital health, international medicine, fraud and abuse, and privacy issues for Stanford Medicine. In this interview, Erin discusses her transition from Big Law to a small in-house team, what her team at Stanford values most about outside counsel, how her secondment to Stanford while still an associate helped smooth the path fo...2022-08-3019 minNon-binding GuidanceA Recall Readiness Rundown and Recent FDA ActionsThis episode of Ropes & Gray’s podcast series Non-binding Guidance explores recent FDA guidance on recall readiness and other recall-related hot topics. In recent months, we have seen a trend of increased FDA inspection and enforcement activity as the impact from COVID-19 starts to lessen. Earlier this year, FDA also finalized guidance on the Initiation of Voluntary Recalls under 21 CFR Part 7, Subpart C, which explores FDA expectations regarding the process companies should already have in place ahead of a potential recall situation. Join Ropes & Gray FDA regulatory attorneys Josh Oyster and Beth Weinman as they provide a quick refresher on re...2022-05-1921 minTalkin’ TradeEnforcement of Section 337 Exclusion Orders at U.S. Customs and Border ProtectionRopes & Gray’s podcast series Talkin’ Trade explores the world of Section 337 unfair import investigations at the U.S. International Trade Commission. All too often, little attention is paid to what happens after the ITC issues an exclusion order in a Section 337 investigation. In this episode—the third in a three-part series on remedies at the ITC—Ropes & Gray intellectual property litigators Matt Rizzolo, Matt Shapiro, Brendan McLaughlin, and Rebecca Gentilli address the myriad of issues surrounding enforcement of Section 337 exclusion orders by U.S. Customs & Border Protection, and discuss the procedural options available to both complainants and respondents.2022-04-0724 minNon-binding GuidanceReal-World Evidence in Drug DevelopmentThis episode of Ropes & Gray’s podcast series Non-binding Guidance continues our exploration of recent trends and updates on the use of real-world evidence in drug development. Join Ropes & Gray FDA regulatory attorneys, Kellie Combs and Sarah Blankstein, as they discuss four new draft guidance documents released by FDA in 2021 addressing the use of real-world evidence to support FDA decision-making on safety and effectiveness. Tune in to this episode to learn more about FDA’s current approach to real-world evidence, these recent draft guidances, and what we can expect from FDA looking ahead in 2022 and beyond.2022-03-3017 minAlumni @ RopesTalkConversation with Ryan Dickey, DOJ & GW LawIn the latest installment of Ropes & Gray’s Alumni @ RopesTalk podcast series, IP litigation partner Matt Rizzolo interviews Ryan Dickey, a cybercrime and intellectual property prosecutor with the U.S. Department of Justice. Ryan started his legal career at Ropes & Gray with plans to become a patent litigator. He talks about how his career goals shifted along the way, leading him to a federal clerkship in Hawaii, the U.S. Attorney’s Office, and now, working at the DOJ and teaching at GW Law. Ryan shares what initially drew him to Ropes & Gray and how his time at the firm prep...2022-03-0320 minRopesTalkAlumni @ RopesTalk: Conversation with Ryan Dickey, DOJ & GW LawIn the latest installment of Ropes & Gray’s Alumni @ RopesTalk podcast series, IP litigation partner Matt Rizzolo interviews Ryan Dickey, a cybercrime and intellectual property prosecutor with the U.S. Department of Justice. Ryan started his legal career at Ropes & Gray with plans to become a patent litigator. He talks about how his career goals shifted along the way, leading him to a federal clerkship in Hawaii, the U.S. Attorney’s Office, and now, working at the DOJ and teaching at GW Law. Ryan shares what initially drew him to Ropes & Gray and how his time at the firm prep...2022-03-0320 minTalkin’ TradeThe Powerful General Exclusion OrderRopes & Gray’s podcast series Talkin’ Trade explores the world of Section 337 unfair import investigations at the U.S. International Trade Commission. In this episode—the second in a three-part series on remedies at the ITC—Ropes & Gray intellectual property litigators Matt Rizzolo, Matt Shapiro, and Nicole Pobre explore the unique and rarely issued General Exclusion Order remedy that is available in ITC Section 337 investigations, and discuss the unique aspects that set this remedy apart from the other types of ITC remedial orders.2022-02-2325 minRopesTalkNon-binding Guidance: Recent Developments in FDA Inspection Policy and Implications for Drug and Device ManufacturersThis installation of Ropes & Gray’s podcast series Non-binding Guidance focuses on recent developments in FDA inspection policy, including implications of the pandemic-related slowdown on product quality and approval delays as well as progress FDA has been making in clearing the inspection backlog. In March 2020, many routine inspections, such as foreign pre-approval and for-cause inspection assignments not deemed “mission-critical,” were temporarily postponed, but FDA has recently restarted some inspections. In this episode, Ropes & Gray life sciences regulatory & compliance practice group leader, Greg Levine, and Ropes & Gray counsel and former FDA Office of Chief Counsel attorney, Beth Weinman, discuss the significance of the...2022-01-0623 minNon-binding GuidanceRecent Developments in FDA Inspection Policy and Implications for Drug and Device ManufacturersThis installation of Ropes & Gray’s podcast series Non-binding Guidance focuses on recent developments in FDA inspection policy, including implications of the pandemic-related slowdown on product quality and approval delays as well as progress FDA has been making in clearing the inspection backlog. In March 2020, many routine inspections, such as foreign pre-approval and for-cause inspection assignments not deemed “mission-critical,” were temporarily postponed, but FDA has recently restarted some inspections. In this episode, Ropes & Gray life sciences regulatory & compliance practice group leader, Greg Levine, and Ropes & Gray counsel and former FDA Office of Chief Counsel attorney, Beth Weinman, discuss the significance of the...2022-01-0623 minTalkin’ TradeWhat Remedies Can The International Trade Commission Impose?Ropes & Gray’s podcast series Talkin’ Trade explores the world of Section 337 unfair import investigations at the U.S. International Trade Commission. In this episode, which is part one of a three-part discussion on ITC remedies, Ropes & Gray intellectual property litigators Matt Rizzolo, Matt Shapiro, and Rebecca Gentilli discuss the various types of remedies that the ITC can impose when it finds a violation of Section 337 of the Tariff Act, and the unique aspects of these differing remedial orders that ITC litigants and practitioners should be aware of.2022-01-0525 minTalkin’ TradeWho’s Adjudicating Section 337 Investigations?Ropes & Gray’s podcast series Talkin’ Trade explores the world of Section 337 unfair import investigations at the U.S. International Trade Commission. One way in which ITC Section 337 investigations differ from district court litigation is that the day-to-day activities of ITC actions are overseen not by an Article III judge, but by one of six administrative law judges. In this episode, Ropes & Gray IP attorneys Matt Rizzolo, Matt Shapiro, Brendan McLaughlin, and Mike Morales delve into the role and responsibilities these ALJs play in managing a fast-paced Section 337 proceeding, including how the individual ALJs may differ in presiding over their part...2021-11-3024 minRopesTalkHealth Care Compliance Check-up: BelgiumThe Ropes & Gray Global Health Care Compliance Initiative’s virtual trip around the world podcast series highlights our collaboration with our local counsel contacts, in particular the Local Law Comparison Guide. The Local Law Comparison Guide (the “Guide”) is a resource tool providing country-specific surveys that analyze legal, regulatory and industry requirements governing industry interactions with health care professionals. As part of this series, Ropes & Gray attorneys interview our local counsel partners, who are based around the world and helped develop the Guide. These discussions highlight notable health care regulations and developments impacting compliance in our various countries. In this episod...2021-11-1816 minNon-binding GuidanceRolling Back the Medicare Coverage of Innovative Technology (MCIT) RuleThis installation of Ropes & Gray’s podcast series Non-binding Guidance focuses on the Biden administration's recent proposal to repeal the Medicare Coverage of Innovative Technology ("MCIT") final rule, which was published in January 2021 and initially scheduled to become effective on December 15, 2021. This proposed rule, although published by the Centers for Medicare and Medicaid Services ("CMS"), relates directly to FDA regulation of medical devices because it would provide automatic Medicare coverage to products that FDA approves or authorizes under its Breakthrough Device Program. In this episode, Ropes & Gray life sciences regulatory & compliance head, Greg Levine, and health care partner, Tom Bulleit, wi...2021-11-0816 minTalkin’ TradeWhen Section 101 Meets Section 337Ropes & Gray’s podcast series Talkin’ Trade explores the world of Section 337 unfair import investigations at the U.S. International Trade Commission. Historically, challenges to patent subject matter eligibility under Section 101 of the Patent Act have been rare at the ITC, as the Commission’s Section 337 proceedings necessarily involve tangible, physical goods. But recent changes in the case law from the Federal Circuit and the Supreme Court have led to a noticeable uptick in the numbers of times the Commission and its ALJs have been forced to grapple with patent eligibility issues. Ropes & Gray attorneys Matt Rizzolo, Matt Shapiro and Brenda...2021-10-2528 minRopesTalkAlumni @ RopesTalk: Conversation with Julie Constable, BlackstoneIn the latest installment of Ropes & Gray’s alumni podcast series, Alumni @ RopesTalk, life sciences and health care partner Michael Beauvais interviews Julie Constable, vice president of legal and compliance at Blackstone. Julie spent almost a decade at Ropes & Gray as an associate before taking a senior legal role at Blackstone. Julie talks about what a typical day looks like in-house as she leads transactions emerging from the Blackstone Life Sciences team. She reflects on how Ropes & Gray prepared her for her position now by training her to think more critically. Julie also talks about the unique pro bono partnership be...2021-10-2016 minAlumni @ RopesTalkConversation with Julie Constable, BlackstoneIn the latest installment of Ropes & Gray’s alumni podcast series, Alumni @ RopesTalk, life sciences and health care partner Michael Beauvais interviews Julie Constable, vice president of legal and compliance at Blackstone. Julie spent almost a decade at Ropes & Gray as an associate before taking a senior legal role at Blackstone. Julie talks about what a typical day looks like in-house as she leads transactions emerging from the Blackstone Life Sciences team. She reflects on how Ropes & Gray prepared her for her position now by training her to think more critically. Julie also talks about the unique pro bono partnership be...2021-10-2016 minRopesTalkHealth Care Compliance Check-up: MexicoThe Ropes & Gray Global Health Care Compliance Initiative’s virtual trip around the world podcast series highlights our collaboration with our local counsel contacts, in particular the Local Law Comparison Guide. The Local Law Comparison Guide (the “Guide”) is a resource tool providing country-specific surveys that analyze legal, regulatory and industry requirements governing industry interactions with health care professionals. As part of this series, Ropes & Gray attorneys interview our local counsel partners, who are based around the world and helped develop the Guide. These discussions highlight notable health care regulations and developments impacting compliance in our various countries. In this episod...2021-10-1818 minNon-binding GuidanceFDA’s Intended Use Final RuleThis edition of Ropes & Gray’s podcast series, Non-binding Guidance, focuses on one of the most fundamental concepts in FDA regulatory law: intended use. On August 2, FDA issued a final rule amending its drug and medical device regulations describing the types of evidence the Agency considers relevant to determining a product’s “intended use.” The new regulations just took effect on September 1. Join Kellie Combs, a partner in Ropes & Gray’s life sciences regulatory and compliance practice, Doug Hallward-Driemeier, a partner in the litigation & enforcement practice and head of the firm’s appellate & Supreme Court practice, and Josh Oyster, a senior assoc...2021-09-2124 minRopesTalkHealth Care Compliance Check-up: NetherlandsThe Ropes & Gray Global Health Care Compliance Initiative’s virtual trip around the world podcast series highlights our collaboration with our local counsel contacts, in particular the Local Law Comparison Guide. The Local Law Comparison Guide (the “Guide”) is a resource tool providing country-specific surveys that analyze legal, regulatory and industry requirements governing industry interactions with health care professionals. As part of this series, Ropes & Gray attorneys interview our local counsel partners, who are based around the world and helped develop the Guide. These discussions highlight notable health care regulations and developments impacting compliance in our local counsel partners’ respective countrie...2021-09-0817 minTrainee InsightsLondon Private Equity Associate – Matt MartindaleIn this episode of Trainee Insights, Ropes & Gray London private equity associate and trainee supervisor, Matt Martindale, speaks with trainees Kwasi Yeboah and Emilio Fabrizi about Ropes & Gray’s unique training program and provides some tips and guidance on how to succeed as a trainee at the firm, and how to start to develop into effective associates from an early stage.2021-09-0719 minTrainee InsightsLondon Trainee Recruitment Partner – Rohan MasseyIn this episode of Trainee Insights, Ropes & Gray London training principal and data, privacy & cybersecurity partner, Rohan Massey, speaks with trainees Kwasi Yeboah and Emilio Fabrizi about what makes Ropes & Gray unique, developments in the cybersecurity space, and reveals a past life as an actor listed on the International Movies Database.2021-08-1714 minRopesTalkHealth Care Compliance Check-up: BrazilThe Ropes & Gray Global Health Care Compliance Initiative’s virtual trip around the world podcast series highlights our collaboration with our local counsel contacts, in particular the Local Law Comparison Guide. The Local Law Comparison Guide (the “Guide”) is a resource tool providing country-specific surveys that analyze legal, regulatory and industry requirements governing industry interactions with health care professionals. As part of this series, Ropes & Gray attorneys interview our local counsel partners, who are based around the world and helped develop the Guide. These discussions highlight notable health care regulations and developments impacting compliance in our local counsel partners’ respective countrie...2021-08-0524 minNon-binding GuidanceCOVID-19 Vaccine Mandate LitigationThis installment of Ropes & Gray’s podcast series Non-binding Guidance explores the current legal challenges relating to vaccine mandates for public and private sector employers and institutions of all types. Join Greg Levine, head of Ropes & Gray’s life sciences regulatory and compliance practice, Megan Bisk, a partner in the employment, executive compensation, and employee benefits practice and lead of the employment specialty group, and David Peloquin, a partner in the health care practice group, as they discuss ongoing lawsuits related to COVID-19 vaccine mandates, the context of approvals through Emergency Use Authorizations, the PREP Act and data privacy implications, and...2021-07-2926 minTrainee InsightsLondon Trainee Recruitment Partner – Ruchit PatelWelcome to Trainee Insights, a new Ropes & Gray podcast series that’s home for discussions about life as a trainee or junior lawyer at Ropes & Gray London. In this inaugural episode, Ropes & Gray London trainee recruitment partner, Ruchit Patel, speaks with trainees Kwasi Yeboah and Emilio Fabrizi about the Ropes & Gray London training programme and application process, the importance of the antitrust practice within the firm, and '90s hardcore gangster rap.2021-07-2311 minRopesTalkHealth Care Compliance Check-up: Czech RepublicThe Ropes & Gray Global Health Care Compliance Initiative’s virtual trip around the world podcast series highlights our collaboration with our local counsel contacts, in particular the Local Law Comparison Guide. The Local Law Comparison Guide (the “Guide”) is a resource tool providing country-specific surveys that analyze legal, regulatory and industry requirements governing industry interactions with health care professionals. As part of this series, Ropes & Gray attorneys interview our local counsel partners, who are based around the world and helped develop the Guide. These discussions highlight notable health care regulations and developments impacting compliance in our local counsel partners’ respective countrie...2021-07-0126 minNon-binding GuidanceThe Defense Production Act and the COVID-19 PandemicThis installation of Ropes & Gray’s podcast series Non-binding Guidance focuses on The Defense Production Act (DPA), a wartime production law that gives the president a broad set of powers to influence and mobilize domestic industry in the interest of national defense, and its implications for life sciences companies. Over time, Congress has expanded the DPA’s scope to include civil crises resulting from national disasters, terrorist attacks, and other national emergencies—most recently, the COVID-19 pandemic. In this episode, Ropes & Gray life sciences regulatory & compliance attorneys Beth Weinman and Jessica Band discuss the history of the DPA, how it has be...2021-05-2718 minDecoding Digital Health2021 Developing Trends and Hot Topics in Digital HealthThe Ropes & Gray Decoding Digital Health podcast series discusses the digital health industry and related legal, business and regulatory issues. In this inaugural episode, the co-leads of the Ropes & Gray Digital Health Initiative, Megan Baca, Kellie Combs and Christine Moundas, take a multidisciplinary approach to exploring trends and hot topics for 2021 related to their transactional, FDA regulatory and health care practices. Many of the topics covered in this initial episode will be further discussed and explored throughout the series, including developments in artificial intelligence, big data and interoperability considerations, as well as regulations and guidance around telehealth, software as a...2021-05-1921 minNon-binding GuidanceEuropean Life Sciences Regulatory Trends with Dr. Lincoln TsangThis installation of Ropes & Gray’s podcast series Non-binding Guidance introduces Dr. Lincoln Tsang, a new Ropes & Gray lateral partner based in London, and head of the firm’s European life sciences practice. Join Greg Levine, partner and chair of the life sciences regulatory and compliance practice at Ropes & Gray, as he interviews and explores Lincoln’s unique career path as well as Lincoln’s thoughts on Brexit and other regulatory developments that may affect the life sciences industry in the UK and Europe in the coming years.2021-04-2823 minRopesTalkNon-binding Guidance: European Life Sciences Regulatory Trends with Dr. Lincoln TsangThis installation of Ropes & Gray’s podcast series Non-binding Guidance introduces Dr. Lincoln Tsang, a new Ropes & Gray lateral partner based in London, and head of the firm’s European life sciences practice. Join Greg Levine, partner and chair of the life sciences regulatory and compliance practice at Ropes & Gray, as he interviews and explores Lincoln’s unique career path as well as Lincoln’s thoughts on Brexit and other regulatory developments that may affect the life sciences industry in the UK and Europe in the coming years.2021-04-2823 minAlumni @ RopesTalkConversation with Jacob Comer, NovaQuest Capital ManagementIn the latest installment of Ropes & Gray’s alumni podcast series, Alumni @ RopesTalk, asset management partner Jason Brown interviews Jacob Comer, general counsel and chief compliance officer at NovaQuest Capital Management, a leading investor in life sciences and health care companies. Jacob began his career at Ropes & Gray in 2003 as an investment management associate and has since taken on legal, regulatory and compliance roles for a private equity firm, venture capital firm and hedge fund. Now at NovaQuest, Jacob talks about the challenges of moving in-house, interviewing for and accepting a new job during the pandemic, his experience working at Ro...2020-12-1427 minRopesTalkAlumni @ RopesTalk: Conversation with Jacob Comer, NovaQuest Capital ManagementIn the latest installment of Ropes & Gray’s alumni podcast series, Alumni @ RopesTalk, asset management partner Jason Brown interviews Jacob Comer, general counsel and chief compliance officer at NovaQuest Capital Management, a leading investor in life sciences and health care companies. Jacob began his career at Ropes & Gray in 2003 as an investment management associate and has since taken on legal, regulatory and compliance roles for a private equity firm, venture capital firm and hedge fund. Now at NovaQuest, Jacob talks about the challenges of moving in-house, interviewing for and accepting a new job during the pandemic, his experience working at Ro...2020-12-1427 minNon-binding GuidanceFDA Regulation of COVID-19 Diagnostic Tests and “Return to Work”The tenth installment of Ropes & Gray’s podcast series, Non-binding Guidance, focuses on FDA regulation of COVID-19 diagnostic tests, with a particular focus on employee testing. In this episode, chair of Ropes & Gray’s FDA regulatory practice, Greg Levine, interviews Lauren Silvis, a former FDA official and currently Senior Vice President of External Affairs for Tempus, a clinical molecular technology company, to hear her input on the role employee testing can play in maintaining a safe workplace. Topics covered include the role of antibody tests, testing of asymptomatic persons, pooled sample testing, and evolving technologies such as Next Generation Sequencing (NGS...2020-07-2123 minRopesTalkInsiders' Perspectives on the Ins and Outs of the 2020 DOJ FCPA Guide: A Conversation with Ropes & Gray’s Anti-Corruption and International Risk LeadersThe Criminal Division of the U.S. Department of Justice (DOJ) and the Enforcement Division of the U.S. Securities and Exchange Commission (SEC) released the Second Edition of A Resource Guide to the U.S. Foreign Corrupt Practices Act (FCPA) on July 3, 2020 (the “2020 Resource Guide”), updating the first edition released in November 2012 (the “2012 Resource Guide”). The 2020 Resource Guide does not make fundamental changes to its predecessor, but serves as a repository of various legal and regulatory developments since 2012. This includes highlighting developments in case law such as United States v. Hoskins, as well as new sections dedicated to discussing guidance...2020-07-1532 minAlumni @ RopesTalkConversation with Jason Idilbi, PassportIn the latest installment of Ropes & Gray’s alumni podcast series, Alumni @ RopesTalk, IP litigation partner Matt Rizzolo interviews Jason Idilbi, general counsel at Passport Labs, a mobility software platform that facilitates mobile parking and transit ticketing applications. Jason reflects on his “non-linear” legal career path, which began at Ropes & Gray in 2008 and led to roles as a judicial clerk, litigator and in-house counsel. Now at Passport, Jason talks about the most difficult project he’s had to tackle in the last three years, and also what he looks for when engaging outside counsel.2020-06-0327 minAlumni @ RopesTalkConversation with Alex Roberts, UNH LawIn the latest episode of Ropes & Gray’s alumni podcast series, Alumni @ RopesTalk, IP litigation partner Matt Rizzolo interviews Alex Roberts, who left the firm eight years ago and is now an associate professor at the University of New Hampshire School of Law. In this lively conversation, Alex gives a vivid picture of her life as a professor—from teaching courses on trademark law and the intersection of pop culture and the law, to publishing cutting-edge scholarship about deceptive practices in influencer marketing. Reflecting on her time at Ropes & Gray, Alex also shares how her experience as an associate at Rope...2020-03-1828 minRopesTalkAlumni @ RopesTalk: Conversation with Alex Roberts, UNH LawIn the latest episode of Ropes & Gray’s alumni podcast series, Alumni @ RopesTalk, IP litigation partner Matt Rizzolo interviews Alex Roberts, who left the firm eight years ago and is now an associate professor at the University of New Hampshire School of Law. In this lively conversation, Alex gives a vivid picture of her life as a professor—from teaching courses on trademark law and the intersection of pop culture and the law, to publishing cutting-edge scholarship about deceptive practices in influencer marketing. Reflecting on her time at Ropes & Gray, Alex also shares how her experience as an associate at Rope...2020-03-1828 minAlumni @ RopesTalkConversation with Jennifer Bealer, ProgynyIn the latest installment of Ropes & Gray’s alumni podcast series, Alumni @ RopesTalk, health care partner Christine Moundas interviews her former colleague, Jennifer Bealer, who left Ropes & Gray in 2017 to become executive vice president and general counsel of Progyny, a leading fertility benefits management company. Within two years of joining Progyny, the company went public. In this engaging conversation, Jen shares her insights about the challenges and rewards of transitioning to an in-house position, executing an IPO and running the day-to-day legal operations of a mission-driven startup—all at the same time.2020-02-1215 minNon-binding GuidanceSEC Disclosure Issues for Life Sciences CompaniesThe eighth installment of Ropes & Gray’s podcast series Non-binding Guidance looks at SEC disclosure issues for life sciences companies. In this episode, Ropes & Gray partners Kellie Combs and Emily Oldshue discuss when to disclose, how to frame the disclosure, and how the responses to both of these questions are informed by SEC enforcement actions and securities litigation, as well as their experience working with life sciences companies in various stages of development. Emily and Kellie will dive into how to craft SEC disclosures involving a variety of FDA regulatory issues, such as clinical trial results, adverse findings from regulatory au...2020-01-0913 minNon-binding GuidanceA Discussion of Kisor v. WilkieThe 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 in...2019-11-1227 minRopesTalkAlumni @ RopesTalk: Conversation with Sabrina Ross, UberIn 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.2019-10-2522 minAlumni @ RopesTalkConversation with Sabrina Ross, UberIn 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.2019-10-2522 minNon-binding GuidanceBreakthrough Devices ProgramThe 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 proc...2019-09-1215 minNon-binding GuidanceExpedited Review Programs for Drugs and BiologicsThe 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 in...2019-09-0513 minNon-binding GuidanceReal-World Evidence in Drug Development and FDA SubmissionsThe 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...2019-08-1216 minNon-binding GuidanceExamining FDA’s Enforcement Authority Over Stem Cell Clinics and CompoundersThe 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 over...2019-06-2825 minAlumni @ RopesTalkConversation with Jeff Gleason, Delaware NorthWe 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, Je...2019-06-1819 minNon-binding GuidanceFormer FDA Commissioner Scott Gottlieb’s Unfinished BusinessThe second installment of Ropes & Gray’s new podcast series, Non-binding Guidance, addresses the departure of former FDA Commissioner Scott Gottlieb, who resigned from his position last month. During his time at FDA, Commissioner Gottlieb employed an ambitious policy agenda, taking significant steps to combat the opioid crisis, improve access to generic drugs and biosimilars, confront the use of e-cigarettes by minors, and more. In this episode, Ropes & Gray lawyers Greg Levine, Kellie Combs, and Beth Weinman explore several areas of uncertainty that remain in the wake of Dr. Gottlieb’s resignation: the regulation of laboratory developed tests, dietary supplements, and...2019-05-0222 minNon-binding GuidanceFDA’s Regulation of Products Containing CBDRopes & Gray’s new podcast series, Non-binding Guidance, highlights FDA regulatory developments and trends affecting the life sciences industry. In this inaugural episode, Ropes & Gray lawyers Al Cacozza, Sarah Blankstein and Joshua Oyster discuss how the FDA is currently regulating products containing cannabidiol, or CBD, and what to expect from FDA and Congress in the wake of FDA Commissioner Scott Gottlieb’s surprise resignation this month. The 2018 Farm Bill, signed into law last December, legalized hemp and its non-psychoactive ingredient CBD and distinguished both from marijuana, which is still considered by the federal government to be an illegal narcotic. But the...2019-03-2916 min