Bedste Hogan Lovells-podcasts (2024)

1
Pharma – The Last Word – Breaking Barriers: The FDA’s Evolving Approach to Biosimilars and Interchangeability 22:28

3M ago22:28

22:28

In this episode, host Phil Katz sits down with Deborah Cho, to discuss the evolving landscape of biosimilarity and interchangeability. They dive into the FDA's changing approach, highlighting the shift towards treating biosimilars and interchangeable biosimilars as a single category. Deborah explains how advancements in technology and experience ha…

1
Drafting the Future: Unpacking the FDA's Clinical Trial Diversity Action Plan 14:03

6M ago14:03

14:03

In the third part of our clinical trial diversity series, Deborah Cho, Stephanie Agu, and Ashley Grey dissect FDA's new draft guidance on Diversity Action Plans for clinical trials, released on June 28, 2024. Discover what this pivotal document means for clinical trial design and conduct, and its implications for drug and biologic sponsors. Tune in…

1
Pharma – The Last Word – Early Access Unlocked, navigating EU programs for pre-approval drug access 17:40

6M ago17:40

17:40

In this episode Phil Katz and Hein van den Bos discuss early access programs in the EU, exploring the various types of programs, their practical implications, and the regulatory challenges. They delve into compassionate use programs, named patient supply, and the nuances of implementing these programs across different EU countries. The conversation…

1
Pharma – The Last Word – Regulatory and legal trends in the pharma and biotech industries 13:14

7M ago13:14

13:14

In this episode host Phil Katz, discusses regulatory and legal trends in the pharma and biotech industries with Komal Karnik Nigam. They delve into the FDA's evolving approach to data packages required for drug approval, highlighting the increased flexibility in accepting alternative forms of evidence. Komal explains how FDA's guidance has shifted …

1
Pharma – The Last Word - The inaugural episode 7:37

8M ago7:37

7:37

Welcome to the inaugural episode of "Pharma – The Last Word", a podcast hosted by Partner Phil Katz from Hogan Lovells. This series aims to dive into the intricate world of pharmaceuticals and biotech regulatory and legal landscapes, exploring new innovations, trends, and their practical impacts. Join Phil and his first guest, Lynn Mehler, co-head …

1
Securing the Crown Jewels: Navigating IP and cybersecurity in the life science industry 32:27

9M ago32:27

32:27

In this episode of Talking the Cure Hogan Lovells Life Sciences and Health Care Podcast Ruud van der Velden and Chantal Van Dam highlight the importance of protecting intellectual property and trade secrets in the life sciences and health care industry. They discuss the legal framework for trade secrets in the EU, the increasing focus of cybercrimi…

1
Discussing UK medical device regulations 17:07

9M ago17:07

17:07

In this episode Jane Summerfield and Owen Robinson discuss UK medical device regulation, focusing on the regulatory roadmap published by the MHRA, its implications for businesses, and the process for legislation development. They highlight the delay in core regulation target dates, the importance of stakeholder consultations, and the potential impa…

1
Talking the Cure - Exploring the industry with Richard Backhaus and Lars Cornels (Drägerwerk AG & Co. KGaA) - Part 2 27:19

10M ago27:19

27:19

In the second part of the episode, ⁠⁠Arne Thiermann⁠⁠ is leading the conversation with ⁠⁠Richard Backhaus⁠⁠, and ⁠⁠Lars Cornels⁠⁠ discussing the integration and implications of digital health, artificial intelligence, and legal considerations in the medical device industry. They explore how traditional companies like ⁠⁠Drägerwerk AG & Co. KGaA⁠⁠ ad…

1
Talking the Cure - Exploring the industry with Richard Backhaus and Lars Cornels (Drägerwerk AG & Co. KGaA) - Part 1 29:24

11M ago29:24

29:24

In this first part of the episode, Arne Thiermann is leading the conversation with Richard Backhaus, and Lars Cornels discussing the integration and implications of digital health, artificial intelligence, and legal considerations in the medical device industry. They explore how traditional companies like Drägerwerk AG & Co. KGaA adapt to digital i…

1
Talking the Cure - Exploring the industry with Robert F. Church 36:30

11M ago36:30

36:30

In this episode, Robert F. Church⁠ takes the time to look back on his career with us. We talk about what ultimately led him to become a lawyer, how he ended up at Hogan Lovells, and how he became the institution in clinical trials. Of course, we also talk about what it means to manage such a heavy workload, how he takes time to switch off, and what…

1
Talking the Cure - Exploring the industry with Alice Valder Curran 39:08

1y ago39:08

39:08

In this episode, Alice Valder Curran sits down with us to talk about her impressive career, why she ultimately chose Hogan Lovells as her employer, and what it takes to be successful in this area of the industry, even in times when you can only work part-time. Alice gives us a behind-the-scenes look at how to create your own niche and surround your…

1
Talking the Cure - Exploring the industry with Randy Prebula 46:28

1y ago46:28

46:28

In this episode, Randy Prebular sits down with us and we talk about his impressive professional career, how he actually wanted to be a pediatrician at the beginning of his career, and how he then went from being a research scientist to a partner in a major law firm. We hear many exciting anecdotes, Randy gives us a behind-the-scenes look and tips o…

1
Talking the Cure - Discussing the implications of the Inflation Reduction Act (IRA) 31:28

1+ y ago31:28

31:28

In this podcast episode, Alice Curran and Cullen Taylor discuss the implications of the Inflation Reduction Act (IRA) on the life sciences and healthcare sector. They explore how IRA can impact drug pricing, development, collaboration, and partnerships. The episode covers assessing IRA’s impact, economic provisions in agreements, launch strategies,…

1
Talking the Cure - Discussing latest developments іn clinical trials diversity, driven by FDORA 19:58

1+ y ago19:58

19:58

In this episode оf 'Talking the Cure,' we dive into the latest developments іn clinical trials diversity, driven by the Food and Drug Omnibus Reform Act (FDORA). Join Stephanie Agu, Akosua Tuffuor and Deborah Cho as we explore FDORA's key provisions related to diversity action plans.We'll briefly summarize the history оf FDA's efforts іn th…

1
Talking the Cure - Discussing Artificial Intelligence in Medical Devices 34:45

2y ago34:45

34:45

Arne Thiermann and Nicole Saurin talk about the current state and development of artificial intelligence in the medical device industry. How will AI medical devices be classified by the AIA Proposal? What is the relationship between the AIA Proposal and the MDR? What laws apply to the liability of medical AI products? Who is liable if the AI applic…

1
Talking the Cure - Discussing MedTech Color with Kwame Ulmer 21:18

2y ago21:18

21:18

In this episode, Beth L. Roberts (Partner, Washington, D.C.) is talking to Kwame Ulmer (Founder and Executive Director) about MedTech Color, its mission, programs, and resources they provide. In addition, they’re discussing which hot topics in diversity and inclusion should medical devices, pharma, and other healthcare companies should be aware of,…

1
Talking the Cure - Exploring the industry with Ina Brock 48:44

2+ y ago48:44

48:44

In this episode, Ina Brock invites us to her home and tells us that she actually wanted to become a journalist, but chance brought her to law. And the result of this decision is an impressive career, which we review together, Ina gives us insights into her daily work and how she sees the future of the Life Sciences & Healthcare Industry.…

1
Talking the Cure - Discussing diversity in clinical trials 36:02

2+ y ago36:02

36:02

Robert F. Church, Sarah Thompson Schick, Stephanie Agu, and Akosua Tuffuor, J.D. discuss recent developments in FDA’s and industry’s approaches towards clinical trials and ensuring meaningful trial participation from members of historically underrepresented populations.Af Hogan Lovells

1
Talking the Cure - Discussing the repurpose of existing UK offices/retail to laboratory space? 32:09

2+ y ago32:09

32:09

What to expect if you want to repurpose existing UK real estate, in particular, offices/retail to laboratory space? Graham Cutts will give an overview of potential building reconfigurations, occupier profiles, and the current industry hot topic for building owners: who bears the risk of a power outage and potential data breach?…

1
Talking the Cure - Discussing what’s on the horizons for orthopedic devices 31:26

2+ y ago31:26

31:26

What’s on the horizons for orthopedic devices? In this episode, Michael Kasser and Jemin Jay Dedania talk about their journey in the field of orthopedic devices, why orthopedics is still a little like the wild west of the FDA, how new technologies will reshape the conduct of clinical trials, and the do’s and don’ts, when working with the FDA.…

1
Talking the Cure - Exploring the industry with Andreas von Falck 34:34

2+ y ago34:34

34:34

In this episode, Andreas von Falck will tell us that he actually wanted to work for an NGO, but then followed his father’s path and became one of the most successful patent attorneys in Germany. Andreas will tell us how he came to his Life Sciences mandates, which case influenced him the most, and what he considers to be the three most important po…

1
Talking the Cure: Discussing Digital Health Applications in Germany 34:44

3y ago34:44

34:44

In this episode, Dr. Victor Stephani, Chief Of Staff at the German digital health high flyer HelloBetter, and Arne Thiermann, a life sciences partner in the Hamburg office and very familiar with the regulations of digital health applications, discuss the exciting yet rocky road bringing a digital health application into reimbursement by German soci…

1
Talking the Cure - Exploring the industry with Jonathan S. Kahan 44:37

3y ago44:37

44:37

In the first episodes of Season 3, Jonathan S. Kahan, partner and passionate lawyer in the Medical Device and Technology Regulatory practice, took the time to talk to our host, Julius Bülow, about his work as a lawyer, how he built his practice from the ground up and what talents he discovered along the way, what continues to excite him about his w…

1
Talking the Cure: Discussing Early Access Programs (EAPs) in the US and Germany 33:18

3y ago33:18

33:18

In this episode, I talk with Dr. Tina Welter-Birk and Komal Karnik Nigam about the Early Access Programs (EAPs), known as Expanded Access Programs in the US, in Germany, and the United States, which allow pre-approval access to medicines for certain patients. While the name of EAPs varies by country, there are two main types of early access program…

1
Talking The Cure: Exploring the industry with Christian Di Mauro 30:10

3y ago30:10

30:10

In this episode, Christian Di Mauro, who is heading the Italian litigation and arbitration practice talk about his 17 years of experience working with the Life Sciences and Health Care industry and being involved in products including pharmaceuticals, vaccines, medical devices. He is also discussing the interesting role he is in, including his abil…

1
Talking The Cure: Discussing return to work policies, testing at work sites, and vaccinations 33:14

3+ y ago33:14

33:14

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. Due to 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.You can fi…

1
Talking The Cure: Exploring the industry with Lowell Zeta 30:59

3+ y ago30:59

30:59

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 b…

1
Talking The Cure: Discussing the impact of Covid-19 on cell, tissue, and gene therapy products 53:30

3+ y ago53:30

53:30

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 …

1
Talking The Cure: Discussing advertising and promotion of COVID-19 test kits 39:50

3+ y ago39:50

39:50

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 i…

1
Talking The Cure: Discussing hand sanitizers and their way to the market 31:18

4y ago31:18

31:18

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 th…

1
Talking The Cure: Discussing the current ”surge” of Digital Health Innovations in Europe 52:47

4y ago52:47

52:47

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 th…

1
Talking The Cure: Exploring the industry with Jodi Scott 29:51

4y ago29:51

29:51

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.Af Hogan Lovells

1
Talking The Cure: Exploring the industry with the leads of our associate committee 40:35

4y ago40:35

40:35

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 wo…

1
Talking The Cure: Discussing artificial intelligence in drug discovery and the possible legal issues that result from this usage. 38:16

4y ago38:16

38:16

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…

1
Talking The Cure: Discussing in vitro diagnostics (IVD) in times of a pandemic 34:43

4y ago34:43

34:43

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 IVD’s that are being granted Emergency Use Authorization by the FDA.Af Hogan Lovells

1
Talking The Cure: Exploring the industry with Jonathan Wasserman 37:26

4y ago37:26

37:26

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

1
Talking The Cure: Discussing the “Buy America” Executive Order 54:27

4y ago54:27

54:27

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 S…

1
Talking The Cure: Discussing opportunities and risks for international digital health companies engaging in Germany 35:58

4y ago35:58

35:58

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 regulatory changes in Germany.…

1
Talking The Cure: Discussing innovation in drug development, the competitive aspects and affordability of medicines in Europe 14:51

4y ago14:51

14:51

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.Af Hogan Lovells

1
Talking The Cure: Discussing recent industry developments with the Hogan Lovells Sciences Unit 44:32

4y ago44:32

44:32

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 20 years, 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.…

1
Talking The Cure: Discussing the rise of telehealth in the life sciences and health care industry 29:50

4y ago29:50

29:50

In this episode, our partners Brooke Bumpers and William Ferreira talk about the growth of the telehealth industry during the COVID-19 pandemic and the opportunities and challenges for companies and providers in the United States and internationally. We also discuss how providers and patients are reacting to the increased use of telehealth.…

1
Talking The Cure: Exploring the industry with Philip Katz - Part 2 22:37

4y ago22:37

22:37

In the second part of our two-part interview with Philip Katz, head of the Hogan Lovells Pharmaceuticals and Biotechnology Regulatory Practice, we discuss team management, diversity and we also get to learn about Phil, when he shuts down his blackberry. We had a lot to cover in our conversation with Phil, so if you haven't checked out yet, listen t…

1
Talking The Cure: Exploring the industry with Philip Katz - Part 1 23:30

4y ago23:30

23:30

In the first episode of our two-part interview with Philip Katz, head of the Hogan Lovells Pharmaceuticals and Biotechnology Regulatory Practice, we discuss developments in the pharmaceuticals and biotechnology industry, the global practice of law in this space, and we also get to learn about Phil and his career journey. We had a lot to cover in ou…

1
Talking the Cure: Discussing venture capital in the life sciences and health care sector in Germany 25:29

4y ago25:29

25:29

In this episode, our partners Jörg Schickert and Nikolas Zirngibl talk with Jörn Bungartz, an adviser in the digital health sector, about opportunities and barriers for venture capital in the life sciences and health care industry in Germany.You can find additional thought leadership and information regarding venture capital in the life sciences an…

1
Talking The Cure: Discussing European developments on Covid-19 25:55

4y ago25:55

25:55

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

1
Talking The Cure: Discussing reimbursement issues in France and the MDR 11:16

4y ago11:16

11:16

In this episode, Charlotte Damiano and Fabien Roy talk about reimbursement issues, early access and the collection of clinical data in France. In the end they both address general developments of the medical device regulation.You can find additional thought leadership and information regarding Medical Devices and Technology Regulatory on HL Engage.…

1
Talking the Cure: Discussing COVID-19’s impact on FDA’s inspection program and next steps after the pandemic 27:02

4y ago27:02

27:02

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 all updates around COVID-19, visit our COVID-19 hub.You can find additional thought leadership and information r…

1
Talking The Cure: Discussing how the coronavirus pandemic is affecting the pharmaceutical industry and FDA 18:24

4y ago18:24

18:24

In this episode, Phil Katz, David Horowitz, and Jim Johnson explore the impact on industry and FDA 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…

1
Talking The Cure: Discussing FDA authorities for handling a global pandemic for medical devices 27:28

4y ago27:28

27:28

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 these authorities could be applied to address supply chain issues, in addition to the dev…

1
Talking the Cure: Discussing the supply chain and its potential downfalls 27:13

4y ago27:13

27:13

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.You can find additional thought leadership and information regarding Medical Devices and Te…

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