The Allen & Overy Podcast

The regulatory interplay between medical devices and medicines – focus on companion diagnostics in the EU and U.S.(Part 2)

Companion diagnostics are classed in the U.S. and in the EU as medical devices, usually in-vitro medical devices (IVDs). They are a class of products which are rapidly gaining in importance, particularly in treating patients with cancer. About one third of marketing authorisations in the field of oncology in the EU between 2010 and 2020 required a diagnostic test for patient identification. The Global Oncology Companion Diagnostic Market Size was valued at 2.2 billion in 2019. 
  
In this podcast, Sapna Palla, Tine Carmeliet and Rafi Allos discuss the regulation of IVDs in the EU and the U.S. and how they are authorised in these jurisdictions. 

Vroon group restructuring - our key takeaways

In this podcast, Partners Sigrid Jansen and Nick Charlwood sit down with Associate Ella Richards to discuss the recent landmark Vroon restructuring and their experience of this USD900 million restructuring which involved the first ever parallel use of the new Dutch WHOA and an English scheme of arrangement.

Voices for Change: a community of inclusive thinkers and doers - Wim Dejonghe

A new video podcast series by Allen & Overy called Voices for Change, for inclusive thinkers and doers.  Join Justin Farrance, A&O’s DE&I Ambassador, as he interviews colleagues from across A&O, as well as clients and alumni about their personal stories, commitment on DE&I and advice for others to learn from. Stay up to date with new episodes announced each month.

First up, Senior Partner Wim Dejonghe talks to Justin about his early years in law, as well as why “the biggest risk for any successful organisation is to become complacent with DE&I, because the world will catch up with you.”

Voices for Change: a community of inclusive thinkers and doers - launch episode with Senior Partner, Wim Dejonghe (video)

A new video podcast series by Allen & Overy called Voices for Change, for inclusive thinkers and doers.  Join Justin Farrance, A&O’s DE&I Ambassador, as he interviews colleagues from across A&O, as well as clients and alumni about their personal stories, commitment on DE&I and advice for others to learn from. Stay up to date with new episodes announced each month.

First up, Senior Partner Wim Dejonghe talks to Justin about his early years in law, as well as why “the biggest risk for any successful organisation is to become complacent with DE&I, because the world will catch up with you.” 

The regulatory interplay between medical devices and medicines in clinical trials - EU and U.S. focus (Part 1)

The regulatory frameworks for medicines and medical devices have historically grown up on separate tracks, but increasingly, medicines and medical devices are being used together in patients as drug device combinations, companion diagnostics and medical devices used in clinical trials.

Join Sapna Palla, Eda Zhuleku and Rafi Allos in part one of this podcast series to discuss the use of medical devices in clinical trials and the different perspectives between the EU and U.S., as well as the regulatory requirements that may apply.

Private capital perspectives: the dynamics of NAV financing for APAC investors and fund managers

Net Asset Value or NAV financing is gaining popularity among private equity and other alternative asset managers seeking liquidity in a challenging market.

In the first episode of Private Capital Perspectives, Hong Kong banking and finance partner Patrick Wong and structured finance lawyer Jamie Taylor discuss how NAV financing works, why it is increasingly in vogue among APAC investors, and the issues to consider when structuring and executing NAV deals.

The European Commission’s proposal for EU pharmaceutical legislation – a deep dive by our life sciences experts

The European Commission have published the long awaited proposals for major revision of  pharmaceutical law in the European Union.

In our latest life sciences podcast, Rafi Allos and Tine Carmeliet discuss the new directive and new regulation under the legislation with much anticipated change to happen.

Episode 7: Deconstructing Crypto – What next after Ripple?

In the latest podcast, Todd Fishman and Gene Ingoglia discuss the impact of the long-awaited decision on the Ripple Labs case. Read here for our client alert on this decision.

In SEC v. Ripple Labs, the U.S. Securities and Exchange Commission (“SEC”) alleges that Ripple Labs, Inc. and two of its executives raised over $1.3 billion through an unregistered and ongoing digital asset securities offering (XRP). Almost immediately, this decision created a number of waves and cross-currents across the crypto ecosystem.

Soon after, in SEC v. Terraform Labs, District Judge Jed Rakoff issued a decision that alleged the Terraform (UST) stablecoin and the related Luna token are investment contracts for all purposes within the meaning of the US securities laws.

So where does this leave us and what do businesses need to pay attention to?

Tune in to the podcast, where Todd and Gene shares their views on what next after Ripple.

Women in Funds: Conversation with Anna Budd and Ruth Jackson at Hines

In this episode of Women in Funds, Funds & Asset Management partner Emma Danforth (London) and associate William Michell (London) have an insightful discussion with Anna Budd, Senior Managing Director and Co-Head of Legal at Hines, and Ruth Jackson, Managing Director and Deputy Fund Manager at Hines. The conversation revolves around a range of diversity, equity & inclusion and career development topics, including the value of mentorship, how to thrive in a male-dominated industry, career advice to junior female professionals, and generational diversity in the workplace.

About speakers

Anna Budd is a Senior Managing Director and Co-Head of Legal at Hines overseeing a global team of over 40 people. Since joining the firm in 2017, she now has prime responsibility for all legal operations outside the US spanning Europe and APAC, as well as overseeing legal support for Hines’ global investment management business. Anna has significant experience in real estate investments, developments, financing, corporate transactions, as well as real estate funds and joint ventures. Anna plays a key role in Hines’ D&I efforts, most notably through her role as Co-Chair of the One Hines Women’s Network. Anna is also part of Hines’ mentoring programme, mentoring several women both inside and outside Hines.

Ruth Jackson is a Managing Director and Deputy Fund Manager at Hines. She joined Hines in July 2018 and is the Deputy Fund Manager for the flagship Hines European Value Fund Series which manages c.€1.8bn of equity across the first two funds and is fundraising now for HEVF 3, raising over €1.45bn to date with final closing in November. Prior to Hines, she was the Portfolio Manager on a +€3.0 billion pan-European open-ended Fund at Invesco Real Estate for approximately 5 years. Ruth started her career, after graduating from Cambridge University, at JLL advising clients on investments and developments in central London.

The recent regulatory and enforcement developments regarding Artificial Intelligence usage in the financial services sector

Join Allen & Overy partners Gene Ingoglia and Claire Rajan as they analyze the regulatory enforcement developments in the world of AI. In this podcast,  Gene and Claire  dive into SEC Chair Gary Gensler’s speech to the National Press Club on July 17, and provide their insight on the four key areas discussed by Mr Gensler; (i) The potential for conflicts of interest; (ii) The potential for fraud and deception; (iii) The impact on privacy and intellectual property issues - so, whose data is it?; (iv) The impact on financial stability. This speech was soon followed by the SEC’s new proposed rulemaking, which Gene and Claire give their view on and how this will affect the regulation of the AI space moving forward.

Gene and Claire also discuss the Fed weighing in on AI’s impact on the financial sector and the probe launched into the use of AI in the securities industry by Massachusetts Secretary of State William Galvin, by seeking information from firms using or developing AI on what supervisory procedures are in place and how they plan to use AI.