Shows
Drug SolutionsAll About Data: Looking at the EHDS in More DetailIn this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, chats with Alexander Natz, Secretary-General of EUCOPE, about the European Health Data Space (EHDS), which was formally adopted by the European Parliament in April 2024. The EHDS aims to improve access to and control of health data by individuals and also allow for secondary use of data in research, innovation, policy-making, and regulatory activities.
SPONSORS: Solvias2024-05-2813 min
EUCOPE's Sounds of ScienceReal-World Evidence (RWE): The need for a multi-stakeholder approachSOUNDS OF SCIENCE - EPISODE 17
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 - RWE4Decisions - is tackling those issues. Our special guests include:
Ka...2023-08-1851 min
Der Profcast - Seltene Erkrankungen und ihre Therapien#14 Update aus Brüssel - Zwischen EU-HTA und Pharmapaket
Dr. Alexander Natz ist Partner der auf die Life Sciences-Industrie spezialisierten Rechtsanwaltskanzlei NOVACOS in Düsseldorf und Generalsekretär der European Confederation of Pharmaceutical Entrepreneurs, kurz EUCOPE. Im Profcast „Seltene Erkrankungen und ihre Therapien“ spricht er mit Prof. Dr. Matthias P. Schönermark über die neuesten Entwicklungen der gemeinsamen Neubewertung von Gesundheitstechnologien (EU-HTA), den Einfluss der deutschen Behörden und die kommenden Neuerungen des „EU-Pharmapakets“ für Hersteller von Orphan Drugs.
Der Profcast ist eine Produktion der SKC Beratungsgesellschaft mbH. We are the market access special forces. 2023-07-3128 minEUCOPE's Sounds of ScienceRare Reflections: Impact of the OMP revision on rare disease companies in EuropeEUCOPE's Sounds of Science - Episode 16
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.
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.
EUCOPE is no stranger to proposals to modulate the orphan incentive, having worked with the...2023-07-1140 minEUCOPE's Sounds of ScienceMDR/IVDR: Recent changes and their implications for EU medical device companiesSOUNDS OF SCIENCE - EPISODE 15
On today’s episode, we focus on the EU’s Medical Device Regulation (MDR) which came into full effect on 26 May 2021 and followed by the In
Vitro Diagnostic Device Regulation (IVDR) the following year. The idea of both regulations is to balance the regulatory review and approval processes of medical devices and IVDs across all EU Member States, essentially harmonizing the European market for medical devices.
However, the Medical Device Regulation is causing some problems, and stakeholders and politicians at both the national and EU levels are warning that the MDR...2023-04-1034 minEUCOPE's Sounds of ScienceTrans-Atlantic Innovation : Building bridges between the EU and US life sciences industrySOUNDS OF SCIENCE - EPISODE 14
With the passing of the Inflation Reduction Act, significant changes are coming for drug pricing and payment in the United States. At the same time, the upcoming revision of the EU Pharma Package will have a significant impact on the competitiveness and predictability of the EU biopharmaceutical landscape.
There are several gaping differences between the biopharma ecosystems of the US and the EU. For instance, it takes on average 150 days longer to get an innovative medicine approved in Europe than in the US – time that could be crucial for some pa...2023-03-1344 minEUCOPE's Sounds of ScienceRare Disease Day 2023: Improving equitable access and diagnosis for people living with a rare diseaseSOUNDS OF SCIENCE - EPISODE 13
This year’s Rare Disease Day comes at a crucial time, weeks before we expect the publication of the pharmaceutical package which will revise the General Pharmaceutical Legislation, Paediatics, and OMP Regulations, which will set the tone for the EU rare disease ecosystem for at least the next 2 decades.
The theme for this year’s Rare Disease Day is equity, so we wanted to take the opportunity to dive into some of these debates and asses what the EU can do in this space, especially against the backdrop of the legi...2023-02-2247 minEUCOPE's Sounds of ScienceThe new EU HTA Procedure: Getting it right to improve patients' access to innovative therapiesSOUNDS OF SCIENCE - EPISODE 12
With the entry into force of the EU HTA Regulation in January 2022, the European Commission and EUnetHTA21, a consortium of Member States HTA bodies, have been racing to develop the procedural rules and the methodology for EU Health Technology Assessment (HTA). This is before the first medicinal products will be subject to the new procedure starting 12 January 2025.
The new EU HTA procedure will significantly change the requirements before placing innovative medicinal products on the market, with certain new products having to go through a joint European assessment as a first...2023-01-3020 minEUCOPE's Sounds of Science2022 Year in Review: Perspectives & Resolutions from the EUCOPE Policy TeamSOUNDS OF SCIENCE - EPISODE 11
Throughout 2022, there have been successes, challenges, delays and change within the European pharmaceutical industry and we expect more to come in 2023. On the final episode of the year, hear the EUCOPE Policy team - Victor Maertens, Matias Olsen and Leander Vranken - unravel the past year in European pharma and biotech, looking at everything from rare diseases to ATMPs to EU HTA to Digital Health, sharing key highlights and what to expect in 2023.
We will be back with more amazing episodes and insights next year, so stay tuned and stay...2022-12-2131 min
P4A Let's Talk Rare: The Life Science PodcastWorld Orphan Drug Congress Europe 2022 SpecialDid you miss the World Orphan Drug Congress Europe 2022, held in Sitges, Barcelona in November? If you did, don't worry P4A have you covered!
This month's special podcast was part recorded live at the conference and part recorded back in London with members of the team that attended! We will be speaking to a few presenters & sponsors to discuss their presentations, key learnings and their personal highlights from the conference. Also the P4A team will be talking about our favourite sessions and the key takeaways from the conference.
Special thanks t...2022-12-2042 minEUCOPE's Sounds of ScienceLaunch Conditionality: The Impact on Small and Mid-Sized CompaniesSOUNDS OF SCIENCE - EPISODE 10
Within the European Commission’s ongoing review of the General Pharmaceutical Legislation and Orphan Medicinal Products (OMP) Regulation, there are several potentially controversial policy options that aim to enhance access to medicine and overcome unmet medical need, including launch conditionality. Under the proposed system, companies would only receive their full Regulatory Data Protection if they meet a number of predefined conditions.
Two conditions under consideration are that companies must launch the product in most, if not all, EU Member States within a fixed timeframe and address a yet unspecified unmet me...2022-12-1637 min
The SGI PodcastWomen Who Lead - Episode 4: Vulnerability in the WorkplaceWomen Who Lead - Episode 4: Vulnerability in the WorkplaceEpisode 4 of Women Who Lead: Post-Covid welcomes a returning guest to the podcast, Dr Martine Zimmermann. Martine Zimmermann is Senior Vice President and Head of Regulatory & Quality Affairs at Alexion, AstraZeneca Rare Disease. Dr Zimmermann has over 25 years of combined R&D and global regulatory strategy experience. She joined Alexion Pharmaceuticals (part of AstraZeneca since 2021) in 2009 and has since then been dedicated to the registration of several orphan medicinal products across the globe, as well as to the shaping of t...2022-11-2245 min
Xplore TalksWomen Who Lead - Episode 4: Vulnerability in the WorkplaceWomen Who Lead - Episode 4: Vulnerability in the WorkplaceEpisode 4 of Women Who Lead: Post-Covid welcomes a returning guest to the podcast, Dr Martine Zimmermann. Martine Zimmermann is Senior Vice President and Head of Regulatory & Quality Affairs at Alexion, AstraZeneca Rare Disease. Dr Zimmermann has over 25 years of combined R&D and global regulatory strategy experience. She joined Alexion Pharmaceuticals (part of AstraZeneca since 2021) in 2009 and has since then been dedicated to the registration of several orphan medicinal products across the globe, as well as to the shaping of t...2022-11-2245 minEUCOPE's Sounds of ScienceAdvanced Therapy Medicinal Products (ATMPs): How they will be affected by the General Pharmaceutical LegislationSOUNDS OF SCIENCE - EPISODE 9
On today’s episode, we will be exploring the topic of Advanced Therapy Medical Products, or ATMPs. This covers a wide range of therapies, but we’ll be using it as shorthand for gene and cell therapies for today’s conversation.
ATMPs have been receiving significantly more attention in recent years as a growing number of them come to market. As a potentially one-off, transformative treatment, these therapies are different from many therapies currently available or in development. However, much like all other therapies, ATMPs will be impacted by the ongoin...2022-10-1338 minEUCOPE's Sounds of ScienceEnsuring a robust European Health Data Space (EHDS): Working to create a fit-for-purpose regulatory frameworkSOUNDS OF SCIENCE - EPISODE 8
On 3 May 2022, the European Commission published the proposal for a regulation introducing the European Health Data Space (EHDS). The proposal aims to enable better exchange and access to different types of health data (think about genomics data, data from patient registries, electronic health records, etc.).
And what does it want? Well, It intends to create a common space where natural persons can easily control their data which should enable individuals to gain better digital access to their personal health data and support free movement. This is commonly referred to as...2022-09-1923 min
EUCOPE's Sounds of ScienceUnmet Medical Needs (UMN): Towards a new understanding with a focus on underserved areasSOUNDS OF SCIENCE - EPISODE 7
The topic of unmet medical needs (UMN) is quite high up on the agenda in European health policy these days.
Recent literature has identified no less than 15 different definitions of unmet medical needs. These include various elements ranging from the absence of therapeutic options to disease burden and severity, just to name a few.
UMN is not a foreign concept in EU Legislation and national assessment, but now it has become quite central to the discussion on the revision of the Orphan, Paediatric and General Pharmaceutical Legislation.
2022-07-1834 min
P4A Let's Talk Rare: The Life Science PodcastSpecial Episode with EUCOPE-Part 2 with Alexander NatzIn this episode Chloe & Alexander will be starting the discussion with an overview of EU HTA regulation, looking at the harmonization debate and how this came about. We then discuss JCA evaluation methodology (e.g. comparator selection, acceptability of clinical evidence), the potential new role of individual country agencies and how the joint HTA process will link to national processes. EUnetHTA21 and how the methodology is evolving with G-BA & IQWIG increasingly involved, will this be a major influence in the development of final methodology? Finally, we look at how Pharma companies should be best preparing for the implementation of...2022-06-3028 minEUCOPE's Sounds of ScienceOvercoming Barriers: Improving Access for Rare Disease Patients through Cross-Border HealthcareSOUNDS OF SCIENCE - EPISODE 6
The Cross-Border Healthcare Directive (Directive 2011/24/EU) marked a milestone for European patients. It created a legal framework for the patient’s right to seek healthcare in another Member State and to be reimbursed. It also provided a legal basis for enhanced European cooperation in key areas of healthcare – including quality and safety, Health Technology Assessment and eHealth, and rare diseases.
On May 12, the Commission published their long awaited evaluation of the Cross-Border Healthcare Directive. The report outlines several areas for improvement, but does not call for a reopening of the Dire...2022-06-0629 minP4A Let's Talk Rare: The Life Science PodcastSpecial series with Eucope: Part 1 featuring Victor MaertensPart 1 featuring Victor Maertens, Government Affairs Manager at EUCOPE
In this episode Victor and Aparna will be focusing on Advanced Therapy Medicinal Products (ATMPs). We will start by looking at the main challenges for manufacturers in the ATMP approval process and what is required from an HTA perspective. We then discuss EUCOPE’s position paper on the different payment models, including the motivation for the report and key learnings. We look at sustainable patient access and whether the report addresses the affordability issues surrounding ATMP’s drug pricing and if this is even possible in the current land...2022-05-3124 min
EMJ GOLD: Pharma marketing, medical & moreS02 E16: Pharma in South Africa, access, pricing and reimbursementIn this episode, GOLD speaks to Lenias Hwenda, Founder and CEO, Medicines for Africa, and Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE). Following on from GOLD’s recent ‘Pharma in South Africa’ feature, Lenias explains what the implementation of South Africa’s new healthcare system will mean for global pharma, as well as exploring genomics and market access. Alexander discusses his interest in pricing and access of pharmaceuticals, shares how value-based reimbursement is evolving and offers his thoughts on the new EU Health Technology Assessment procedure. If you’re interested in learning more about th...2022-05-3148 minEUCOPE's Sounds of ScienceIncreasing Access to Genomic Testing in Europe: The role of national genomics initiatives in increasing uptake of Advanced DiagnosticsSOUNDS OF SCIENCE - EPISODE 5
On today’s episode, we’ll be following up last year’s discussion on genomic sequencing, by looking at some of the measures that leading EU Member States have taken to pave the way toward wider access to genomic testing and discuss what else can be done to ensure wider patients access with some very knowledgeable experts as well as some of the world’s leading advanced diagnostics developers.
Our guests today are:
· Richard Charter, Vice President MedTech Market Access - Europe & Asia Pacific, Alira Health. He has 15 years of...2022-05-1025 min
Back Bay Life Science ReportThe Evolving Regulatory Framework for Novel Medicines in the EUBiopharma companies looking to establish a footprint in Europe face country-specific decision-making processes. The health technology assessments (HTAs) in France and Germany, for example, look very different.Does this regional level of thinking make it easier or potentially more difficult to get medicines to market and into the hands of patients who need them?In this episode of Back Bay’s Life Science podcast, Pete Bak is joined by Alexander Natz, Secretary-General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Europe’s principal trade body for companies working in the field of pharma, biot...2022-04-2525 minEUCOPE's Sounds of ScienceWhat's next for EU Rare Disease Legislation? Its potential implications for patients and pharma entrepreneursSOUNDS OF SCIENCE - EPISODE 4
In today’s episode, we discuss upcoming developments in the field of rare diseases, a timely matter as Rare Disease Day approaches on 28 February. Rare disease is a topic which is very close to the heart of our organisation, as almost half of our 130 members work in the field of medicines for rare diseases, also called orphan medicinal products or orphan drugs.
Rare diseases have an important place on the EU agenda, with the French presidency positioning it as one of their priorities plus there continues to be an increasing le...2022-02-2122 min
The New Horizon TalksEpisode 2: Transforming the Future of Healthcare TogetherIn this episode, we look at the unique policy challenges presented by cell and gene therapies from research & development through to patient access; and the role of multi-stakeholder collaborations, in particular those active in supporting European policymaking. How can we, together, deliver these innovative therapies to patients and society, efficiently and safely?
Guests:
• Amanda Bok, Chief Executive, European Haemophilia Consortium (EHC)
• Alexander Natz, CEO, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
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Abbreviations:
• ATMPs: Advanced therapy medicinal products
• EBMT: European Society for Blood and Marrow Transplantation
• G...2021-09-2728 min
EUCOPE's Sounds of ScienceThe European Pharmaceutical Strategy: A patient-centred and future-proof framework?SOUNDS OF SCIENCE - EPISODE 3
A lot is currently happening in terms of health policy and discussions around how to organise our healthcare systems. The European Commission's proposal for a Pharmaceutical Strategy certainly holds a lot of potential, however, what can be done to make this initiative a real catalyst for a patient-centred and future-proof framework?
A transparent and dynamic Q&A with EUCOPE in-house experts Victor Maertens and Matias Olsen.2021-09-2322 minEUCOPE's Sounds of ScienceFostering an EU Advanced Diagnostics EcosystemSOUNDS OF SCIENCE - EPISODE 2
In our 2nd episode, we will discuss the promise of advanced diagnostics, for personalised medicine, for the benefits of patients and healthcare systems at large. And we will discover what remains to be done for the EU to lead in this exciting field. #AdvancedDx2021-05-2723 minEUCOPE's Sounds of ScienceA Future-proof HTA System in Europe?SOUNDS OF SCIENCE - EPISODE 1
While the European Commission proposal for a HTA Regulation set the basis for a streamlined and harmonised approach towards HTA, the recent Council compromise text somehow dashed hopes of many HTA experts. How is it different from the initial EC proposal and why it is a matter of concern? How will it impact the small and medium-size companies and the patients they serve?
Where do we go now? What do we want? How can we ensure the HTA system is future-proof, adapted to the next technologies (OMP, ATMPs, Digital Health...2021-04-2119 minEUCOPE's Sounds of ScienceSounds of Science - TrailerA short introduction to EUCOPE Sounds of Science, a new series of podcast focusing on important EU policy files in the field of health and pharmaceuticals.2021-04-0700 min
Biotech 2050 Podcast20. Diego Ardigò, MD, PhD, Head of Research and Development, Global Rare Diseases, Chiesi GroupDiego is currently the Head of Research & Development of Global Rare Diseases at the Chiesi Group. Before this role, he was leading Chiesi’s development projects in rare diseases and advanced therapies and has more than 10 years experience in drug development, spanning from pre-clinical to commercial phase.
Diego is an MD with a specialization in Internal Medicine. He obtained a PhD at the University of Parma (Italy) in cardiovascular pathophysiology and a post-doctoral fellowship in cardiovascular genomics at Stanford University (California, US).
Before joining the industry, he worked at the University of Parma (Italy) in the field of cardiovascular and me...2020-07-0122 min
Biotech2050 Podcast20. Diego Ardigò, MD, PhD, Head of Research and Development, Global Rare Diseases, Chiesi GroupDiego is currently the Head of Research & Development of Global Rare Diseases at the Chiesi Group. Before this role, he was leading Chiesi’s development projects in rare diseases and advanced therapies and has more than 10 years experience in drug development, spanning from pre-clinical to commercial phase.
Diego is an MD with a specialization in Internal Medicine. He obtained a PhD at the University of Parma (Italy) in cardiovascular pathophysiology and a post-doctoral fellowship in cardiovascular genomics at Stanford University (California, US).
Before joining the industry, he worked at the University of Parma (Italy) in...2020-07-0122 min