Talking the Cure by Hogan Lovells

Talking The Cure: Exploring the industry with Lowell Zeta

In this episode, Lowell M. Zeta, who just rejoined the firm after serving as Senior Counselor to the Commissioner at FDA, is going to talk to Philip Katz about his work on cross-cutting and high-priority initiatives promoting innovation and addressing public health issues, including the COVID-19 pandemic response and the decision to make the move back to Hogan Lovells.

Talking The Cure: Discussing the impact of Covid-19 on cell, tissue, and gene therapy products

In this episode, I talk with Michael Druckman, Jane Kalinina and Bert Lao about the the impact of Covid-19 on cell, tissue, and gene therapy products. We touch base on the enforcement discretion for tissue products and those transitioning under explicit enforcement and approval to satisfy good manufacturing practices under the FDA. In addition, we focus on orphan drug sameness and individualized therapies issues. Overall an interesting overview on the cell, tissue, and gene therapy products and its market developments.

Talking The Cure: Discussing advertising and promotion of COVID-19 test kits

In this episode, I talk with Suzanne Levy Friedman and Michael Penners about how both U.S. and Germany have seen a lot of legal/regulatory activity around advertising and promotion of COVID-19 test kits. Suzanne and Michael are giving an overview of efforts/authority with respect to regulating advertising and promotion of medical devices/products in the two jurisdictions, especially one area where this comes up frequently with clients is the increasing trend of promoting devices on social media. It was interesting to hear about these two jurisdictions and how both markets are regulated.

Talking The Cure: Discussing hand sanitizers and their way to the market

In this episode, I talk with David Horowitz about his work around bringing hand sanitizers onto the market in the US. Understanding FDA’s expectations for the guidance that opened up hand sanitizer manufacturing, including denaturants; impurities; pharmaceutical grade vs. food or industrial grade ingredients. And his pre-covid-19 regulatory over the counter drug work, overall a super interesting conversation about David's career.

Talking The Cure: Discussing the current ”surge” of Digital Health Innovations in Europe

In this episode, I talk with Fabien Roy and Jonas Albert about the current "surge" of Digital Health Innovations in Europe, receiving the CE-Marking, getting reimbursed for their product, and what that means for Start-Ups as well as established companies. Obviously, we touched on the ongoing Covid-19 pandemic, due to the fast developments, a few things are unfortunately already outdated, but that doesn't take away anything from this conversation and I hope you'll enjoy this as much as I did.

Talking The Cure: Exploring the industry with Jodi Scott

In this episode, Jodi Scott, a partner at Hogan Lovells in Denver, is going to talk about her time spent as an in-house FDA counsel with the world's largest medical device manufacturer, the state of the industry, her decision to make the move to Hogan Lovells, and her overall career.

Talking The Cure: Exploring the industry with the leads of our associate committee

In this episode, I talk with Jeff Jay and Tina Welter about their involvement in the life sciences and health care associate committee. This position was created about 18 months ago to give associates more insight into the developments coming out of the leadership team. In addition, Tina and Jeff talk about their experiences with the role, their work in the life sciences and health care industry group, and how they are pursuing their career at Hogan Lovells.

Talking The Cure: Discussing artificial intelligence in drug discovery and the possible legal issues that result from this usage.

In this episode, Jason Lohr and Imogen Ireland, are going to explore some interesting questions to do with whether or not patent law is set up to deal with innovations developed by AI. In the second half of the podcast, we’ll do a practical assessment of the potential legal issues stemming from the way in which AI is being used today