Talking the Cure by Hogan Lovells

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

In the third part of our clinical trial diversity series, Deborah Cho, Stephanie Agu, and Ashley Grey dissect FDA's new draft guidance on Diversity Action Plans for clinical trials, released on June 28, 2024.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 for an insightful discussion on the future of clinical trials and FDA recommendations to ensure diverse participant inclusion.
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Pharma – The Last Word – Early Access Unlocked, navigating EU programs for pre-approval drug access

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 also touches on the benefits and risks of early access, including potential ethical and reputational concerns.
The future episodes will focus on specific areas of the law, such as drug development, clinical trials, FDA compliance, and more, providing listeners with a detailed look at the complexities of pharmaceutical regulations and practical strategies for navigating them.
You can find additional thought leadership and information regarding digital health on Engage.
If you are interested in more information about Life Sciences and Health Care, follow us via ⁠⁠⁠⁠LinkedIn⁠⁠⁠⁠ and ⁠⁠⁠⁠Twitter⁠⁠⁠⁠.

Pharma – The Last Word – Regulatory and legal trends in the pharma and biotech industries

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 from demanding large, multicenter trials to considering confirmatory evidence such as natural history studies, mechanistic data, and data from other products in the same class. The episode emphasizes the importance of strategic planning and early consideration of data presentation in regulatory interactions.
The future episodes will focus on specific areas of the law, such as drug development, clinical trials, FDA compliance, and more, providing listeners with a detailed look at the complexities of pharmaceutical regulations and practical strategies for navigating them.
You can find additional thought leadership and information regarding digital health on Engage.
If you are interested in more information about Life Sciences and Health Care, follow us via ⁠⁠⁠⁠LinkedIn⁠⁠⁠⁠ and ⁠⁠⁠⁠Twitter⁠⁠⁠⁠.

Pharma – The Last Word - The inaugural episode

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 of the Life Sciences and Health Care industry sector, and Lead of the Pharmaceuticals and Biotech Regulatory Practice, as they discuss the unique insights and deep expertise their team brings to the table, the largest of its kind outside the FDA. They will share the inner workings of their practice, how they stay ahead of industry trends, and their passion for the field.
Each episode will focus on specific areas of the law, such as drug development, clinical trials, FDA compliance, and more, providing listeners with a detailed look at the complexities of pharmaceutical regulations and practical strategies for navigating them.
You can find additional thought leadership and information regarding digital health on Engage.
If you are interested in more information about Life Sciences and Health Care, follow us via ⁠⁠⁠⁠LinkedIn⁠⁠⁠⁠ and ⁠⁠⁠⁠Twitter⁠⁠⁠⁠.
 

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

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 cybercriminals on valuable company data beyond personal information, and provide key recommendations for companies to safeguard their most critical assets against theft and unauthorized disclosure.
You can find additional thought leadership and information regarding digital health on Engage.
If you are interested in more information about Life Sciences and Health Care, follow us via ⁠⁠⁠⁠LinkedIn⁠⁠⁠⁠ and ⁠⁠⁠⁠Twitter⁠⁠⁠⁠.

Discussing UK medical device regulations

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 impacts of the upcoming general election on the roadmap's timeline and policy direction.
You can find additional thought leadership and information regarding digital health on ⁠⁠⁠⁠HL Engage⁠⁠⁠⁠.
If you are interested in more information about Life Sciences and Health Care, follow us via ⁠⁠⁠⁠LinkedIn⁠⁠⁠⁠ and ⁠⁠⁠⁠Twitter⁠⁠⁠⁠.

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

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 adapt to digital innovation, the role of AI and software in life sciences, and the challenges and opportunities presented by regulatory environments. They delve into specific legal frameworks, such as the European Union's data strategy and the AI Act, discussing their impact on innovation and data access. The conversation also touches on the practical use of AI in legal work, the future of the profession, and the broader implications of AI on society and human behavior.
You can find additional thought leadership and information regarding digital health on ⁠⁠⁠HL Engage⁠⁠⁠.
If you are interested in more information all around Life Sciences and Health Care, follow us on ⁠⁠⁠LinkedIn⁠⁠⁠ and ⁠⁠⁠Twitter⁠⁠⁠.

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

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 innovation, the role of AI and software in life sciences, and the challenges and opportunities presented by regulatory environments. They delve into specific legal frameworks, such as the European Union's data strategy and the AI Act, discussing their impact on innovation and data access. The conversation also touches on the practical use of AI in legal work, the future of the profession, and the broader implications of AI on society and human behavior.
You can find additional thought leadership and information regarding digital health on ⁠HL Engage⁠.
If you are interested in more information all around Life Sciences and Health Care, follow us on ⁠LinkedIn⁠ and ⁠Twitter⁠.