JONES DAY TALKS®: The CNPV Pilot Program – FDA’s High-Speed Lane for Drug Approval

In one of the most aggressive regulatory shake-ups in modern pharmaceutical history, the Commissioner’s National Priority Voucher Pilot Program, or CNPV, can dramatically reduce approval times for new drug introductions. Jones Day’s Jessica Tierney and Melissa Mannion explain how the program works and what potential applicants need to know.

Jones Day’s Miguel Eaton talks with associates Stephen Collier and Anthony Kim about moving from law school to life as a lawyer. They look back at the recruiting and interview process and share some valuable tips and insights. The conversation concludes with a focus on the value of building a professional brand.

The funding and operational models attendant to college and university infrastructure and facilities have remained largely unaltered for nearly 100 years. But shifts in demographics, new economic and financial challenges, and changing attitudes toward higher education have raised numerous questions. Partner Brian Sedlak welcomes Christopher Good, a managing director at RBC Capital Markets, and Mike Mitchell, a research administrator at The Ohio State University. They discuss the evolving higher education landscape, pressures on the traditional revenue streams, and P3s (Public Private Partnerships) in university settings.

Sometimes overlooked or minimized, intellectual property matters should be carefully considered in the assessment of venture capital and early-stage deals. Artificial intelligence-related issues, geopolitical concerns, including China, a constantly evolving regulatory landscape, and numerous other factors continue to underscore the importance of effective IP due diligence. In this episode of our Emerging Growth and VC series, Ka-on Li, co-leader of Jones Day’s Intellectual Property Transactions team, joins Tim Curry and Taylor Stevens to discuss important issues to consider when preparing for IP diligence in venture deals.

Complexities like the war in Ukraine and the push to net zero have created both challenges and investment opportunities in the European energy market. A changing dynamic has affected the long-term viability of this historically stable regulatory environment. Host Brian Sedlak and his panel of Jones Day partners Michelle Davies, Paul Jones and Vica Irani discuss the future of energy transition in the United Kingdom in this fifth installment of the Real Assets Roundup.

Different legal frameworks, enforcement priorities, and investigations procedures across jurisdictions all present regulatory and compliance challenges for multinational corporates. Jones Day’s Investigations and White Collar Practice leader Ted Chung and partner Veronica Dragalin, former Chief of the Anti-corruption Prosecution Office for the Republic of Moldova and Assistant U.S. Attorney in Los Angeles, talk about global trends in cross-border investigations and enforcement.

The demand for data centers driven by AI and cloud migration have strained the energy infrastructure. As power consumption exceeds availability, the legal and business challenges of securing power, building out infrastructure and allocating risk have become key issues for the industry. In this episode of the “Real Assets Roundup,” Jones Day partners Brian Sedlak, Paul Jones, Jeff Schlegel and Melissa Vandewater discuss the energy and utility issues facing the data center industry and where future solutions may be found.

The “One Big Beautiful Bill Act” (or OB3) is overhauling policy for tax, real estate, energy and infrastructure investment. It brings changes to energy tax credits, on-shoring incentives, and real asset financing, creating new risks and opportunities for investors and developers. In this “breaking news” edition of Jones Day’s “Real Assets Roundup” program, Jones Day partners Brian Sedlak, Sean Jackowitz, James Kinnebrew and Colleen Laduzinski talk about what to expect as a result of the OB3.

Digital infrastructure assets provide and support communications and networking, data transfer and storage, and online services. They enable internet access, cloud computing, and emerging technologies including AI. Digital infrastructure assets are so critical, that some observers have labeled them the “fourth utility.” In the second in a series of Jones Day’s “Real Assets Roundup” programs, Jones Day partners Brian Sedlak, Marta Lahuerta Escolano, Melissa Vandewater, and Elizabeth Dominguez Yaeger talk about what’s driving this important transition.

Institutional investors are redefining investments in “hard assets,” such as real estate, energy, and infrastructure into a combined “real assets” category. This change is driven by numerous factors and presents significant opportunities and challenges, which will be examined by Jones Day partner Brian Sedlak and his colleagues from across the Firm in an extended series of Jones Day Talks programs. In this kickoff episode of “Real Assets Roundup,” Brian, along with partners Vica Irani and Kit Rockhill, discuss the new definition of “real assets” and talk about the issues, themes, and legal considerations to be addressed in subsequent programs.