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Government Contract Pricing Summit Podcasts

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Government Contract Pricing Summit

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Conversations on protecting U.S. national security, by improving government acquisition efficiencies on multiple fronts. Hosted by Tim Templeton. See live discussions of this fascinating topic at the Government Contract Pricing Summit in June. For information & registration, visit gcpsummit.com.
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Government pricing assessments are an important tool to help pharmaceutical manufacturers review their government price reporting function. They can also help uncovering strategic benefits and opportunities. In this episode of Connected With Latham, Eliza Biedziak, Managing Director at Ernst & Young LLP, joins Washington, D.C. partner Chris Schott …
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The new FDA Commissioner's National Priority Voucher (CNPV) pilot program promises to reduce recipients' application review times from 10-12 months to just 1-2 months. As part of the Trump administration's push for most favored nation (MFN) pricing, drug affordability is one criterion for vouchers, marking FDA's entry into the drug pricing fray. In…
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Stakeholders from across the healthcare industry — from manufacturers and consultants to outside counsel and government officials — recently convened in Chicago for the Medicaid Drug Rebate Program Summit 2025. In this episode of Connected With Latham, Washington, D.C. partner Chris Schott, counsel Nicole Liffrig Molife, and associate Danny Machado…
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In this episode of Connected With Latham, London partner Fiona Maclean, Paris partner Jean-Luc Juhan, and London counsel Alain Traill discuss significant new switching requirements due to take effect for data processing services under the EU Data Act. This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not …
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In this episode of Connected With Latham, London partner Gail Crawford and Frankfurt partner Tim Wybitul discuss the EU Data Act, and what this means for data privacy and cybersecurity practices. This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and L…
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In this episode of Connected with Latham, London partners Rob Moulton and Nicola Higgs discuss the UK government's plans for the financial services sector, and key takeaways for financial services firms. This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between y…
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Current developments, such as most favored nation (MFN) pricing, grabbed much of the spotlight when key industry stakeholders met in Philadelphia for the Pricing and Contracting USA Conference. In this episode of Connected With Latham, Allan Thoen, Director & Associate General Counsel with Sandoz, joins Washington, D.C. partner Chris Schott and ass…
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Stakeholders from across the healthcare industry, including members of Congress, the US Food and Drug Administration, and the Center for Medicare and Medicaid Services, recently convened in Washington D.C. for the Medical Device Manufacturers Association (MDMA) Annual Meeting. In this episode of Connected With Latham, Washington, D.C. partners Chri…
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The "Lowering Drug Prices by Once Again Putting Americans First" Executive Order addresses various FDA matters, such as importation from Canada and accelerated approval of generics and biosimilars. In this episode of Connected With Latham, Washington, D.C. partners Chris Schott, Ben Haas, and Bill McConagha analyze these FDA implications, and explo…
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Founded in 2015, Shield AI uses technology and intelligence systems to protect service members and civilians. The venture-backed unicorn's flagship autonomy software, Hivemind, powers aircraft, drones, and other platforms to reliably support complex missions in contested environments. Latham represented Shield AI on its US$240 million strategic fun…
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The initial months of the Trump administration have been marked by a flurry of executive orders and significant activity by the Department of Government Efficiency (DOGE). The US Food and Drug Administration is a key target of these efforts. In this episode of Connected With Latham, Washington, D.C. partners Chris Schott and Ben Haas and associate …
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Stakeholders from across the healthcare and biopharmaceutical industry recently convened in San Francisco for the annual J.P. Morgan Healthcare Conference. In this episode of Connected With Latham, Washington, D.C. partners Chris Schott and Jason B. Caron and associate Danny Machado share key takeaways from the conference, including a renewed optim…
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The deadline for the EU's Digital Operational Resilience Act (DORA) has arrived. This regulation applies to most financial entities operating in the EU market and impacts a broad range of third-party providers of technology-related services. In this episode of Connected with Latham, Christian McDermott and Alain Traill explore the key changes intro…
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In this episode of Connected with Latham, the final of three episodes complementing Latham's "10 Key Focus Areas for UK-Regulated Financial Services Firms in 2025" report, London partners Rob Moulton and Nicola Higgs and counsel Becky Critchley discuss the key cross-sector trends for financial services firms in 2025. They provide their thoughts on …
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In this episode of Connected with Latham, the second of three episodes complementing Latham's "10 Key Focus Areas for UK-Regulated Financial Services Firms in 2025" report, London partners Rob Moulton and Nicola Higgs and counsel Becky Critchley discuss the upcoming reform agenda for retail markets in 2025. They break down the difficult challenge o…
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In this episode of Connected with Latham, the first of three episodes complementing Latham's "10 Key Focus Areas for UK-Regulated Financial Services Firms in 2025" report, London partners Rob Moulton and Nicola Higgs and counsel Becky Critchley discuss what will likely appear on the reform agenda for wholesale markets in 2025. They examine capital …
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In this episode of Connected With Latham, Haim Zaltzman, Global Vice Chair of Latham's Emerging Companies & Growth Practice, sits down with BridgeBio's Co-Founder and Chief Executive Officer Neil Kumar and Chief Financial Officer Brian Stephenson. Since 2015, BridgeBio, a commercial-stage biopharmaceutical, has maintained a mission to discover, cre…
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FDA enforcement activities range from administrative actions like conducting establishment inspections and issuing warning letters to judicial enforcement through the Department of Justice, which can take the shape of civil or criminal actions. While we can expect the agency's core activities to continue, its priorities may shift under the incoming…
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The Centers for Medicare & Medicaid Services (CMS) recently published its final rule to implement the Medicaid Services Investment and Accountability Act of 2019 (MSIAA). The final rule significantly deviates from the agency's 2023 proposal, with CMS backing off from "follow the pill" best price stacking, subjecting certain vaccines to Medicaid reb…
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Manufacturers, government officials, and other stakeholders recently convened in Chicago for the annual Medicaid Drug Rebate Program Summit. In this episode of Connected with Latham, Washington, D.C. associate Danny Machado interviews partner Chris Schott about takeaways from the conference, including thoughts on the new Medicaid regulation that CM…
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Recent Supreme Court decisions, such as the opinions in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce that overruled the long-standing Chevron doctrine, will likely impact how federal agencies interpret ambiguous statutes when regulating the pharmaceutical industry. And in Securities & Exchange Commission v. Jarkesy,…
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In this episode of Connected with Latham, we explore the remarkable story of Shabir Kabiri, an Afghan refugee who secured asylum in the United States with the help of a Latham pro bono team. Shabir shares his harrowing journey, his time as a cadet at West Point, and the dangers he faced upon returning home. When Kabul fell to the Taliban in 2021, S…
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The US healthcare landscape is undergoing significant changes as the Centers for Medicare & Medicaid Services (CMS) continues to implement the Inflation Reduction Act (IRA). One key stakeholder group affected by the IRA drug price negotiations and Medicare Part D redesign are health insurance companies. In this episode of Connected with Latham, we …
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Current developments grabbed much of the spotlight when key industry stakeholders met in New Orleans for the Pricing and Contracting USA Conference. In this episode of Connected With Latham, Washington, D.C. partner Chris Schott and associates Danny Machado and Elisabeth Crusey share their observations from the conference, concluding with four call…
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The Centers for Medicare and Medicaid Services (CMS) recently updated its portal for Average Sales Price (ASP) reporting under Medicare Part B. Data collection portals are also essential for manufacturer compliance with the Inflation Reduction Act and for price reporting under the Medicaid Drug Rebate Program. The 340B program operates yet another …
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As the energy tech sector continues to mature, venture capital offers an increasingly a viable path to growth as emerging energy tech companies seek to disrupt the energy space, often following a fundraising and growth trajectory similar to software and AI. Energy tech provides opportunities for financial institutions and strategic partners to inve…
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Latham's recently released 2023 Pro Bono Annual Review highlights our public service initiatives around the world, including our ongoing relationship with Trees for Life. This conservation charity is dedicated to rewilding the Scottish Highlands through the restoration of the Caledonian Forest, which supports wildlife found nowhere else in Britain.…
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Following an array of ESG-focused regulation and escalating concerns of greenwashing risks in 2023, the year ahead looks to deliver significant industry developments at a rapid pace. In the UK, the FCA's Sustainability Disclosure Requirements (SDR), investment labelling regime, and anti-greenwashing rule will take effect during 2024. The FCA also p…
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In 2023, the FCA brought more charges for fraud offences against individuals than any other year in the regulator's history, and secured several convictions related to fraudulent investment schemes. Yet while the FCA has signaled that economic crime is on its radar, recent years have been defined by relative inactivity, as the higher burden of proo…
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The UK's announcement of the Edinburgh Reforms in 2022 made clear the government's intention to chart its own course in rulemaking for the UK financial services sector, and no longer prioritise equivalence with EU legislation. The UK is currently in the process of repealing and restating all retained EU legislation, which will result in divergence …
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Two new Joint Executive Directors of Enforcement and Market Oversight appointed by the FCA in 2023 will settle into their roles over the year ahead. Following a period of enforcement defined by increased investigations and a willingness to push the envelope of legal interpretation, firms will look toward the coming year to resolve which areas of fo…
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With the UK financial services regulators due to publish Policy Statements to their consultations on diversity and inclusion (D&I) this year, conduct and culture remain high on the regulators' agenda and connect closely to their other regulatory priorities. The regulators have proposed new D&I reporting and disclosure requirements for larger financ…
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The coming year looks poised to act as a pivotal junction for the UK financial services regulators in deciding how to approach the regulation of artificial intelligence (AI), as the financial services industry sees the continued expansion of AI-related capabilities and use cases. To avoid stifling innovation, the UK government plans to take an "agi…
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Since the announcement of the Edinburgh Reforms in 2022, the UK government has made progress on an assortment of measures spanning financial services regulation, with more developments expected in 2024. Though tabled initially as an ambitious suite of reforms, many of the proposals have not been particularly radical in reality. A recent Treasury Co…
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The pressure and uncertainty of 2023 will likely continue for drug manufacturers in 2024, with the election cycle bringing added scrutiny. At the federal level, continuing implementation of the Inflation Reduction Act, including publication of the so-called negotiated prices, may be disruptive. The states, meanwhile, will likely move forward with t…
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The UK's decision to scrap compulsory research unbundling, following the final recommendations of the Investment Research Review, marked one of the most striking developments for financial services firms in 2023. Permitting rebundling across the board with no market capitalisation threshold comes as part of a wider approach to reinvigorate UK capit…
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As part of the FCA's continued focus on retail markets, updates to several key regimes are due to progress over the next year. In addition to further implementation of the FCA's Consumer Duty, the government plans to present detailed proposals on modernising the consumer credit regime, develop proposals to address the "advice gap", and bring in a n…
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The National Institute of Standards and Technology (NIST) recently published a draft guidance framework for considering the exercise of march-in rights. Under the Bayh-Dole Act, government agencies can "march in" on patents resulting from government-funded research if the patent licensee is not sufficiently developing the patented invention, based …
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Cyberattacks targeting well-resourced businesses, especially those with institutional backing, financial support, and deep insurance coverage, have become increasingly prevalent. PE portfolio companies in particular find themselves in the crosshairs of sophisticated attackers — a heightened risk that underscores the need for boards to devote attent…
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For the last three years, UK regulatory authorities have commissioned an array of reviews and consultations to address friction points in the UK's primary markets, culminating in reforms to the listing regime scheduled to take place in 2024. In addition to simplifying listing segments, these reforms signal a shift to a more disclosure-based regime,…
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Regulatory drivers and stakeholder demands have put environmental, social, and governance (ESG) considerations at the forefront of their agendas, with PE firms adopting ESG strategies across funds, investments, due diligence, and portfolio company management. This strong focus has prompted certain stakeholders to argue that ESG factors are receivin…
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As companies feel heightened pressure from stakeholders to adopt environmental, social, and governance (ESG) measures, greenwashing allegations continue to rise in tandem. Complex regulatory environments in the US and across Europe increase the likelihood of enforcement actions and demands for leadership teams to validate their public statements an…
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Regulators in the US, EU, and UK have increasingly scrutinized non-compete and no-poach clauses in employment agreements and M&A deals. The US Federal Trade Commission proposed a rule to ban non-competes in most situations, while several US states seek to implement complete or partial non-compete bans. In Europe, the European Commission and the UK'…
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Following a number of challenges to administrative enforcement on First Amendment grounds, the Food and Drug Administration (FDA) released a new draft guidance document addressing truthful and non-misleading communications regarding product uses not approved or cleared by the FDA. Notably, the document updates the standard for using scientific or m…
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In November, the Department of Health and Human Services' Office of the Inspector General (OIG) issued new compliance program guidance that affirms OIG's long-standing focus on the seven elements of an effective compliance program, first published in 2003. In this episode of Connected With Latham, partner Chris Schott and associate Danny Machado ar…
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The UK's Competition and Markets Authority (CMA) has increasingly asserted its jurisdiction to review private equity buy-and-build transactions, including completed deals, citing competition concerns and protection against perceived threats to consumers. With regulators in the US and elsewhere voicing similar concerns, PE firms and portfolio compan…
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On March 21, 2023, the US Supreme Court ruled for Miguel Luna Perez, a Latham pro bono client, in Perez v. Sturgis. Perez, who is deaf, was repeatedly denied reasonable accommodations, including a qualified sign-language interpreter, by Sturgis Public Schools and the Sturgis Public Schools Board of Education. Lower courts had held that Perez could …
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As security interests have become increasingly important in Europe and globally, comprehensive investment control reviews are now an unavoidable element of any cross-border acquisition – with complex legal standards that vary greatly from country to country. In this episode of Connected With Latham, London private equity partner Tom Evans speaks to…
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Not surprisingly, the Inflation Reduction Act (IRA) and its impact on the pharmaceutical industry was a key topic when manufacturers, government officials, and other stakeholders convened in Chicago for the annual Medicaid Drug Rebate Program Summit. The conference's wide-ranging agenda spotlighted key questions and trends emerging from the Centers…
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The buoyant market of 2021 and early 2022 resulted in compressed deal timelines and frenzied competition, causing many deals to be signed with fewer buyer protections and less information about target businesses. The aftermath of this M&A surge has seen a rise in post-closing discoveries of target company issues, compounded by ongoing macroeconomic…
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