Non-binding Guidance: Clinical Trial Diversity In Focus RopesTalk podcast

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Get ready to step inside the world of The Electric State! Starting Friday, March 7th, join host Francesca Amiker as she takes you behind the scenes of Anthony and Joe Russo’s epic new Netflix adventure. Over six in-depth episodes, explore how the filmmakers transformed Simon Stålenhag’s stunning graphic novel into a cinematic experience like no other. Exclusive interviews from the cast and crew—including Millie Bobby Brown, Chris Pratt, Stanley Tucci, and the Russo Brothers—will help break down the film’s jaw-dropping visuals, emotional core, groundbreaking technology AND the creative secrets that make The Electric State. Join us in the countdown to The Electric State premiering exclusively on Netflix on March 14th. State Secrets: Inside The Making of The Electric State coming March 7th.

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Non-binding Guidance: Clinical Trial Diversity in Focus

rok temu 15:11

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Treść dostarczona przez Ropes & Gray LLP and Gray LLP. Cała zawartość podcastów, w tym odcinki, grafika i opisy podcastów, jest przesyłana i udostępniana bezpośrednio przez Ropes & Gray LLP and Gray LLP lub jego partnera na platformie podcastów. Jeśli uważasz, że ktoś wykorzystuje Twoje dzieło chronione prawem autorskim bez Twojej zgody, możesz postępować zgodnie z procedurą opisaną tutaj https://pl.player.fm/legal.

On this episode of Ropes & Gray’s podcast series Non-binding Guidance, health care partner David Peloquin and life sciences regulatory and compliance counsel Sarah Blankstein discuss the FDA's recent draft guidance on diversity action plans (DAPs) aimed at improving the enrollment of underrepresented populations in clinical studies. They examine the implications and challenges sponsors may face in setting and meeting enrollment goals, as well as the potential impact of the recent presidential election on the final guidance. They also address key open questions related to the draft guidance.

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Non-binding Guidance: Clinical Trial Diversity in Focus

published rok temu

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Treść dostarczona przez Ropes & Gray LLP and Gray LLP. Cała zawartość podcastów, w tym odcinki, grafika i opisy podcastów, jest przesyłana i udostępniana bezpośrednio przez Ropes & Gray LLP and Gray LLP lub jego partnera na platformie podcastów. Jeśli uważasz, że ktoś wykorzystuje Twoje dzieło chronione prawem autorskim bez Twojej zgody, możesz postępować zgodnie z procedurą opisaną tutaj https://pl.player.fm/legal.

On this episode of Ropes & Gray’s podcast series Non-binding Guidance, health care partner David Peloquin and life sciences regulatory and compliance counsel Sarah Blankstein discuss the FDA's recent draft guidance on diversity action plans (DAPs) aimed at improving the enrollment of underrepresented populations in clinical studies. They examine the implications and challenges sponsors may face in setting and meeting enrollment goals, as well as the potential impact of the recent presidential election on the final guidance. They also address key open questions related to the draft guidance.

… continue reading

446 odcinków

#Business News #News #Gray LLP #Business #Ropes & Gray LLP #Law #Legal #Legislator #Regulations #Court

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Alumni @ RopesTalk: DeepSeek Deep Dive with Dr. Vasanth Sarathy, Tufts University 26:14

10 dni temu26:14

26:14

On 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 its origins in China. Tune in to understand the reality behind the hype and what it means for businesses considering AI adoption.…

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Women @ RopesTalk: Conversation with Katy Motiey, Extreme Networks 27:40

17 dni temu27:40

27:40

On this episode of Women @ RopesTalk hosted by health care and data partner Christine Moundas, IP transactions and licensing partner Megan Baca is joined by Katy Motiey, the chief legal, administrative and sustainability officer at Extreme Networks. Katy shares her inspiring journey from her early life experiences during the Iranian Revolution to her multifaceted career in the legal industry. She discusses her new book, Imperfect , which is based on her mother's quest for equality and their family's struggles against the patriarchal customs of Iran. Katy also delves into her role in driving corporate social responsibility and sustainability initiatives at Extreme, offering valuable insights for aspiring leaders and authors.…

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Antitrust Insights: New HSR Rules Now in Effect 15:47

23 dni temu15:47

15:47

On this episode of Ropes & Gray’s Antitrust Insights podcast series, seasoned antitrust partners and former FTC and DOJ prosecutors Jonathan Klarfeld and Samer Musallam discuss significant changes—and their substantial impact on businesses—to the Hart-Scott-Rodino (“HSR”) rules, which went into effect on February 10, 2025, with private equity transactions partner Chau Le. The discussion covers expanded data and disclosure requirements, enhanced business and competition documents, and increased scrutiny of prior acquisitions. They also offer practical advice on navigating these new rules, emphasizing the importance of early engagement with antitrust counsel and diligent compliance efforts. *Since the recording of this podcast, the new FTC Chair, Andrew Ferguson, has publicly endorsed the new HSR rules.…

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Culture & Compliance Chronicles: How Cultural Understanding Empowers Compliance with Tal Freilich 36:56

24 dni temu36:56

36:56

On this episode of Culture & Compliance Chronicles , Nitish Upadhyaya from Ropes & Gray’s Insights Lab and Richard Bistrong of Front-Line Anti-Bribery, are joined by Tal Freilich, the vice president of group governance, risk and compliance at DKSH. The discussion delves into the complexities of managing compliance across diverse markets, the impact of cultural differences on compliance practices, and the innovative use of AI and data analytics in compliance programs. Tal shares his insights on building trust, fostering open communication, and enabling business operations through effective compliance strategies. Tal notes some great examples of both successful initiatives, and ideas that haven’t worked, embracing the idea of learning from failures.…

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Controlling Opinions: The Outlook for Controlled Substances in 2025 30:39

25 dni temu30:39

30:39

On this episode of Ropes & Gray’s podcast series Controlling Opinions , life sciences regulatory and compliance partner Josh Oyster and counsel Beth Weinman are joined by health care partner Brett Friedman and litigation and enforcement partner Andrew O’Connor to discuss what’s to come in 2025 under the new Trump administration on key issues relating to controlled substances. The discussion covers: The DEA’s potential rescheduling of cannabis and the ongoing administrative hearing process. Updates on telemedicine flexibilities for prescribing controlled substances, including new rules and proposed regulations. Latest enforcement developments from the DOJ related to controlled substance prescribing via telemedicine, including notable cases and implications for the future. Tune in for an insightful conversation on these critical topics and stay informed about the latest legal and regulatory changes in the life sciences and health care industries.…

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R&G Dugout: Show Me the Money—Fund Formation & Management 16:51

rok temu16:51

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On this episode of the R&G Dugout podcast, Ropes & Gray asset management partners Amanda Persaud, Lindsey Goldstein, and Jon Rash explore the upsurge of private funds raising capital for investment in sports teams and businesses. They discuss the various structures of sports funds, the challenges of valuing sports assets, and the unique considerations for investing in U.S. sports leagues and teams. Tune in to understand how private capital is navigating this dynamic industry and the innovative fund structures emerging in response.…

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Culture & Compliance Chronicles: Bridging and Cultures—Contextualizing Global Compliance with Letitia Adu-Ampoma 31:06

rok temu31:06

31:06

On this episode of Culture & Compliance Chronicles , Nitish Upadhyaya from Ropes & Gray’s Insights Lab and Richard Bistrong of Front-Line Anti-Bribery, are joined by Letitia Adu-Ampoma, a seasoned compliance professional with extensive experience in designing and implementing ethics and compliance programs across multiple continents. Letitia shares her invaluable insights on the importance of contextualizing and operationalizing global compliance to local cultures. She emphasizes the need for organizations to understand and adapt to cultural nuances, including demographics, linguistic nuances, and technology, to ensure the effectiveness of their compliance programs. Through engaging anecdotes and practical examples, Letitia illustrates how cultural differences can impact compliance outcomes and the importance of localizing training and policies. Tune in to learn how to navigate the complexities of global compliance, the significance of cultural awareness, and strategies for integrating local insights into your compliance framework.…

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Antitrust Insights: New HSR Rules—Impacts to the Pharma Industry 18:19

rok temu18:19

18:19

On this episode of Ropes & Gray’s Antitrust Insights podcast series, strategic transactions partner Hannah England is joined by antitrust partners Jackie Grise and Zak Goodwin to discuss the practical implications of the new Hart–Scott–Rodino (“HSR”) Act rules, which go into effect on February 10, 2025, and the challenges faced by pharmaceutical clients and the strategic adjustments required for compliance. Tune in to understand how these changes will affect acquisitions, licensing and collaboration transactions and other strategic transactions, as well as the overall regulatory landscape.…

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Welcome to the R&G Dugout: Sports Investing—It's a Whole New Ballgame 15:13

rok temu15:13

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Welcome 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 complexities, and leveraging cross-disciplinary legal experience. Tune in to learn how Ropes & Gray and industry insiders are shaping the future of sports transactions.…

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Culture & Compliance Chronicles: Building a Culture of Fairness and Transparency with Danny Mayhew of Sanofi 33:12

rok temu33:12

33:12

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, are joined by Danny Mayhew, the global head of organisational justice and smart assurance at Sanofi. Danny shares his unique journey from law enforcement to the corporate world, emphasizing the importance of empathy in investigations and the role of organisational justice in fostering a fair and transparent workplace. They explore how data, behavioral insights, and innovative tools like AI and machine learning are being leveraged to predict and prevent misconduct ensuring a proactive approach to compliance that helps protect and support employees and gets the business on side.…

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A Word for Our Sponsors: GP-Led Secondary Perceptions Report with Campbell Lutyens 21:07

rok temu21:07

21:07

On this episode of Ropes & Gray’s podcast series A Word for Our Sponsors , Deb Lussier, partner and co-leader of the sponsor solutions practice, and Marc Migliazzo, counsel in the sponsor solutions practice, are joined by Darren O’Brien and Chirag Shah, managing directors on the secondary advisory team for Campbell Lutyens. Together, they examine the results of a “North America Private Equity GP-Led Secondary Perceptions” survey they jointly conducted this year, and explore the booming GP-led secondaries market, discussing key trends, the importance of LP-GP alignment, and the strategic use of continuation funds. Tune in to gain valuable insights on how these transactions are shaping the future of private equity.…

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Health Care Transaction Laws Unwrapped: Recent Antitrust Developments 16:28

rok temu16:28

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Join us for the final episode of our Health Care Transaction Laws Unwrapped podcast series, where Ropes & Gray antitrust partner Jane Willis and counsel David Young explore the intersection of health care transaction laws and antitrust enforcement. They discuss major trends influencing health care transactions, the impact of political changes on antitrust enforcement, and specific issues such as community hospital acquisitions, system-to-system mergers, and private equity investments in health care. The episode provides insights into how these factors shape the regulatory landscape and what health care providers and investors can expect moving forward.…

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Non-binding Guidance: Clinical Trial Diversity in Focus 15:11

rok temu15:11

15:11

On this episode of Ropes & Gray’s podcast series Non-binding Guidance , health care partner David Peloquin and life sciences regulatory and compliance counsel Sarah Blankstein discuss the FDA's recent draft guidance on diversity action plans (DAPs) aimed at improving the enrollment of underrepresented populations in clinical studies. They examine the implications and challenges sponsors may face in setting and meeting enrollment goals, as well as the potential impact of the recent presidential election on the final guidance. They also address key open questions related to the draft guidance.…

Artwork

1
Controlling Opinions: Navigating DEA Diversion Investigations 20:38

rok temu20:38

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On this episode of Ropes & Gray’s podcast series Controlling Opinions , Josh Oyster, a partner in the life sciences regulatory and compliance practice group, is joined by colleagues Andrew O’Connor, a litigation and enforcement partner, and Beth Weinman, life sciences regulatory and compliance counsel. Together, they delve into the complexities of DEA diversion investigations and how health care entities can prepare for these challenging situations. They discuss the risks involved, the various players in these investigations, and the enforcement consequences that can result. They also provide practical advice on navigating DEA audits and share insights from recent enforcement matters.…

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Culture & Compliance Chronicles: Innovative Compliance Strategies with Katie Daniels 38:27

rok temu38:27

38:27

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, are joined by Katie Daniels, managing director and head of compliance at CPP Investments. Katie shares her journey in using tools such as behavioral science to think differently about compliance challenges. Hear how you can harness the human factor in investigations, learn lessons to be a better partner with business stakeholders, and understand how vulnerability can be a strength. Katie reflects on her most impactful behaviorally-informed compliance interventions (and areas where things didn’t go so well too), as well as factors that influence trust in a compliance team. And no conversation with Katie is complete without delving into the world of theatre and music! Discover how Katie's innovative thinking and experiences have shaped her approach to compliance, and gain practical tips to rethink your own challenges.…

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