Helping you get acquainted with the most pressing EU policy files on pharmaceuticals and biotechnologies.
Brought to you by EUCOPE, the European Confederation of Pharmaceutical Entrepreneurs.
EUCOPE's Sounds of Science
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19 episodes
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Podcast Overview
Helping you get acquainted with the most pressing EU policy files on pharmaceuticals and biotechnologies. Brought to you by EUCOPE, the European Confederation of Pharmaceutical Entrepreneurs.
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Publishing Since
4/7/2021
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Recent Episodes
May 6, 2024
The Revision of the General Pharmaceutical Legislation: European Parliament Reports
<p><strong>EUCOPE's Sounds of Science - Episode 18</strong></p> <p>On this episode, we talk about the revision of the General Pharmaceutical Legislation (GPL). We discuss the reports adopted on 10 April by the European Parliament, less than a year after the Commission’s proposal was released, focusing on the incentives framework and the regulatory provisions. Not only we will discuss the proposals adopted by the Parliament, but we’ll compare them with the Commission’s approach. We will also share our thoughts on how the revised framework might impact small and mid-sized companies and their investments in innovative treatments in Europe.</p> <p> </p> <p>The guests of this episode are:</p> <ul> <li>Victor Maerterns, EUCOPE’s Government Affairs Director.</li> <li>Dr Seán Byrne, EUCOPE’s Senior Manager Legal and Regulatory Affairs.</li> <li>Stefano Romanelli, EUCOPE's Senior Government Affairs Director.</li> </ul>
August 18, 2023
Real-World Evidence (RWE): The need for a multi-stakeholder approach
<p><strong>SOUNDS OF SCIENCE - EPISODE 17</strong></p> <p>On this episode, we explore the topic of Real-World Data and Real-World Evidence – that is data that is collected in a real-world setting, such as in healthcare institutions rather than through controlled experiments. We examine how and why this information can be useful for biopharma companies and health authorities, in order to bring new innovative therapies to patients. We will also look into some of the challenges with using this type of data, and view how a multi-stakeholder initiative - <a href="https://rwe4decisions.com/" target="_blank" rel="noopener noreferer">RWE4Decisions</a> - is tackling those issues. Our special guests include:</p> <ul> <li><strong>Karen Facey, Senior Advisor HTA, RWE4Decisions</strong></li> <li><strong>Carlos Martin Saborido, Scientific Officer, </strong><a href="https://www.sanidad.gob.es/en/home.htm" target="_blank" rel="noopener noreferer"><strong>Spanish Ministry of Health</strong></a></li> <li><strong>Alexander Natz, Secretary General, </strong><a href="https://www.eucope.org/" target="_blank" rel="noopener noreferer"><strong>EUCOPE</strong></a></li> </ul> <p>=================================================================================================================== </p> <p>For more information on EUCOPE’s initiatives with Real-World Evidence or how your organisation can contribute to it, please contact Matias Olsen <a href="mailto:olsen@eucope.org">olsen@eucope.org</a></p> <p>If your company would like to put forward a topic for us to discuss or to participate in a future podcast episode, please reach out to our producer, <a href="mailto:diiulio@eucope.org">Dante Di Iulio.</a></p> <p><br></p>
July 11, 2023
Rare Reflections: Impact of the OMP revision on rare disease companies in Europe
<p><strong>EUCOPE's Sounds of Science - Episode 16</strong></p> <p>On today’s episode, we explore the revision of the Orphan Medicinal Products (OMP) Regulation as part of the Pharmaceutical Package, and its impact on small and mid-sized pharmaceutical companies, the key drivers of innovation in Europe.</p> <p>We’d like to deep-dive into the implications of specific Commission proposals, and how innovative pharmaceutical companies see the introduction of concepts such as high unmet medical need as the basis for a modulated incentive framework.</p> <p>EUCOPE is no stranger to proposals to modulate the orphan incentive, having worked with the multi-stakeholder Expert Group on Orphan Drug Incentives to establish an alternative model, and today’s guest played an important role in developing that approach.</p> <p>Building on the success of the past 20 years, and establishing a system that continues to drive research, and crucially address the 95% of rare diseases that have no established treatments is no small task. This requires creative and alternative solutions, and small and mid-sized innovative pharmaceutical industry is keen to play its role.</p> <p>To help us understand the impact of this review, and how the European Innovative pharmaceutical industry sees the current proposal, we’ve got two rare disease experts joining us today:</p> <ul> <li>Diego Ardigò, Head of Research & Development, <a href="https://chiesirarediseases.com/" target="_blank" rel="noopener noreferer">Chiesi Global Rare Diseases</a></li> <li>Alexander Natz, Secretary General, <a href="https://www.eucope.org/" target="_blank" rel="noopener noreferer">EUCOPE</a> </li> </ul> <p>=============================================================================================================</p> <p> For more information on EUCOPE’s efforts on rare diseases and orphan drugs or how your organisation can contribute to it, please contact Victor Maertens <a href="mailto:maertens@eucope.org">maertens@eucope.org</a></p>
19 total episodes available
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