Podcast: Talking the Cure

Stand Juli 2021
Podcasts
Die entscheidenden Herausforderungen der Life Sciences Branche vorhersehen undherausfinden, wie diese am besten gemeistert werden können: dieser Aufgabe stellt sich unser
Team täglich. In unserem Podcast Talking the Cure sprechen wir daher über topaktuelle Themen
wie Digitale Gesundheit, Klinische Studien, Lieferketten, Brexit und vieles mehr.
Folgen Sie uns auf LinkedIn and Twitter, hinterlassen Sie uns ein "Gefällt mir" oder einen
Kommentar. Lassen Sie uns wissen, welche Themen Sie interessieren und was Sie in den
nächsten Folgen gerne erfahren möchten.
Dieser Podcast ist auch verfügbar auf Apple Podcasts, Google Podcasts und Spotify.
In this episode, Thierry Meillat, Stefan Martin, Eckard Schwarz, and Zachary Siegel talked about
the various return to work policies, testing at work sites, mask mandates, and vaccinations. Dueto the fast developments of the situation, a few comments are already outdated, but this didn't
take away any of the essences of the conversation.
In this episode, Lowell M. Zeta, who just rejoined the firm after serving as Senior Counselor tothe Commissioner at FDA, is going to talk to Philip Katz about his work on cross-cutting andhigh-priority initiatives promoting innovation and addressing public health issues, including theCOVID-19 pandemic response and the decision to make the move back to Hogan Lovells.

In this episode, I talk with Michael Druckman, Jane Kalinina and Bert Lao about the the impact ofCOVID-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 tosatisfy good manufacturing practices under the FDA. In addition, we focus on orphan drugsameness and individualized therapies issues. Overall an interesting overview on the cell, tissue,and gene therapy products and its market developments.

In this episode, I talk with Suzanne Levy Friedman and Michael Penners about how both U.S. andGermany 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 ofpromoting devices on social media. It was interesting to hear about these two jurisdictions andhow both markets are regulated.

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 handsanitizer manufacturing, including denaturants; impurities; pharmaceutical grade vs. food orindustrial grade ingredients. And his pre-covid-19 regulatory over the counter drug work, overall
a super interesting conversation about David's career.

In this episode, I talk with Fabien Roy and Jonas Albert about the current "surge" of Digital HealthInnovations in Europe, receiving the CE-Marking, getting reimbursed for their product, and whatthat means for Start-Ups as well as established companies. Obviously, we touched on theongoing 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.

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

In this episode, we give you a look behind the scenes of our life sciences and health care industry
group. Tina Welter-Birk and Jeff Jay are the two leaders of our industry associate committee,which is unparalleled in our world as far as we know. Tina and Jeff attend and can participate inall leadership meetings. We talk about this role and how the industry group also gives younger
lawyers the opportunity to contribute in innovative ways. Of course, we also talk about their rolesin the different practice groups and how they perceive the developments in the industry.

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 thesecond half of the podcast, they’ll do a practical assessment of the potential legal issues
stemming from the way in which AI is being used today.

In this episode, Randy J. Prebula, Susan D. Tiedy-Stevenson, and Erkang Ai, Ph.D. are talking
about the "world" of what is considered to be in in vitro diagnostics, the current SARS-CoV-2
situation and the various IVDs that are being granted Emergency Use Authorization by the FDA.

In this episode, Jon Wasserman, a new partner at Hogan Lovells and former Bristol Myers Squibbvice president, is going to talk about his past, the state of the industry, his decision to make themove to Hogan Lovells, and a potential dinner with two British gentlemen and Abraham Lincoln.

On August 6, 2020, U.S. President Donald Trump issued his much-anticipated "Buy American"
Executive Order (EO), aimed at shoring up domestic manufacture of "essential medicines","medical countermeasures", and "critical inputs" (API and other raw materials), and decreasing
dependency on non-domestic sources.
Philip Katz leads a discussion with Joy Sturm, Mike Heyl, Kelly Ann Shaw, and David
Horowitz about what they're seeing, what they expect, and what actions companies are – orshould be – taking or considering.

In this episode, Arne Thiermann and Dr. Julian Braun, director of legal at Heartbeat Labs, discuss
the opportunities and risks for international companies planning to enter the German market in
the digital health sector, especially with regard to reimbursement and the impact of regulatorychanges in Germany.

In this episode, May Lyn Yuen and Hein Van den Bos discuss the balance of innovation in drug
development, the competitive aspects and affordability of medicines in Europe, and the changes
in the regulatory environment at the EU Level as well as the EU Member State level.

In our latest episode, you will get to know members of our Science Unit Dr. Marion
Palmer and Dr. Rachel Gribben, who talk about their experience working in this unit for over 20years, as well as their latest work on COVID-19 related matters. We also discuss how they areproviding pro bono work and what they do to relax.
As mentioned in the podcast, here is the link to support the crowdfunding campaign to fund theCOVID-19 airways procedures box, which was created by Dr. Palmer and Mr. Declan CostelloFRSC.

In this episode our partners Brooke Bumpers and William Ferreira talk about the growth of thetelehealth industry during the COVID-19 pandemic and the opportunities and challenges forcompanies and providers in the United States and internationally. We also discuss how providers
and patients are reacting to the increased use of telehealth.
As mentioned in the podcast, we just launched a new publication titled "What's on the horizon
for virtual health?". In this report, members of our Global Digital Health team explore theopportunities and potential legal hurdles for companies involved in telehealth and remotemonitoring – addressing both the regulatory exceptions that exist now, and the risks that will
endure.

In this two-part interview with Philip Katz, head of the Hogan Lovells Pharmaceuticals andBiotechnology Regulatory Practice, we discuss developments in the pharmaceuticals andbiotechnology industry, the global practice of law in this space, his approach, when it comes
down to managing his team and we also get to learn about Phil and his career journey.

In this episode our partners Jörg Schickert and Nikolas Zirngibl talk with Jörn Bungartz, anadviser in the digital health sector, about opportunities and barriers for venture capital in the life
sciences and health care industry in Germany.

In this episode, Elisabethann Wright, Jane Summerfield, and Hein Van den Bos talk aboutdevelopments in Belgium, the UK and the Netherlands and how the Covid-19 pandemic impacts
clinical trials and the authorization process of the local authorities.

In this episode, Charlotte Damiano and Fabien Roy talk about reimbursement issues, early accessand the collection of clinical data in France. In the end they both address general developmentsof the medical device regulation.

In this episode, Phil Katz and Jim Johnson continue their conversation about the impact of

COVID-19 on FDA’s drug inspection program and the steps companies should take now and in
preparation for when the pandemic is coming to an end.
For more information about the coronavirus and its impact, visit our COVID-19 topic center.

In this episode, Phil Katz, David Horowitz, and Jim Johnson explore the impact on industry andFDA of the agency’s decision to halt foreign inspections and take other steps that reduce
international activities. They anticipate further steps by the agency, and talk about how
companies can strategically address the implications, which create obstacles but also
opportunities.

In this episode, Michael S. Heyl and Jonathan S. Kahan explore questions around FDA’s
Emergency Use Authorization authorities, how it has been used historically, and how it may be
used for the coronavirus. They highlight very recent FDA actions and project how theseauthorities could be applied to address supply chain issues, in addition to the development of
new technologies/devices to aid in the diagnosis and treatment of the virus.

In this episode, Arne Thiermann and Mike Druckman explore questions around the supply chain
in the life sciences and health care industry. They highlight the reality and the expectation when it
comes down to the draft of a contract in this kind of situations.

In this episode, Jörg Schickert, one of the leading life sciences and health care lawyers forregulatory and commercial issues in Europe, is going to talk about his work, his views on theindustry and why he wouldn't change anything, if he had the chance to start his journey all overagain.

In our first episode, Elisabethann Wright and Robert F. Church from our Global Regulatory
practice explore questions around the use of digital tools in clinical trials and how they are
regulated by international authorities. They highlight the confusion around clinical trials within
the European GDPR framework.

Kontakt

Dr. Jörg
Schickert

PartnerArneThiermann,
LL.M. (LSE)
PartnerDr. Nikolas
Zirngibl
Partner> Read the full article online