Dan Ollendorf’s Post

📰 Health technology assessment and regulatory methodologists came together for a webinar titled “Understanding evidence challenges, managing uncertainties, and exploring potential solutions”. 📣 There was huge interest from the community with over 350 participants registered, and balanced representation from HTA and regulatory perspectives. The webinar was hosted by the NCPE - National Centre for Pharmacoeconomics in collaboration with the HTA Coordination Group Methodology and Procedures Subgroup, the Heads of HTA Agencies Group and the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) and Methodology Working Party (MWP). 👩🏫 Presentations described the distinct remit of HTA and EMA but also where the synergies lie and how through discourse on the challenges, uncertainty can be better understood in the context of these remits. A common understanding will allow for more successful employment of methodologies and solutions to manage uncertainty. 👉 This is the first of an ongoing scientific collaboration between HTA and regulators and we look forward to more fruitful discussions in Autumn.

📰 Health technology assessment and regulatory methodologists came together for a webinar titled “Understanding evidence challenges, managing uncertainties, and exploring potential solutions”.

Today, #generics play a crucial role in our healthcare system, providing unprecedented savings worldwide. But is there more to generics than just cost-cutting?   Join @Medicines for Europe for an insightful webinar on April 10 to discuss the new study #BeneathTheSurface and discover the long-term benefits of #generics for the sustainability and availability of essential medicines.   Arnaud Mahéas, Public Affairs Head Europe at Sandoz and Chair of the Generic Market Access Committee at Medicines for Europe, will be sharing his thoughts on the topic. Register now!   #GenericMedicines #AccessForAll

🚀 Boosting health with FDA’s diversity guidance Achieving diversity in clinical research has been a challenge and many trials are falling short of their diversity goals daily. The FDA - La Administración de Alimentos y Medicamentos has offered a light at the end of the tunnel by pushing concrete plans to further diversity in clinical trials. Why is this crucial? Testing drugs across diverse populations helps ensure safety and efficacy in various of patients. Lokavant CEO Rohit Nambisan shares his insights with PharmaVoice alongside Julie Ozier from Advarra and Pamela Tenaerts, MD, MBA from Medable, Inc on how the FDA’s new guidance can address the underrepresentation of minority patient populations in clinical research and its impact in the health industry. 📰 Read the full article here. https://lnkd.in/dxESeiH8 #clinicalresearch #clinicaltrials

CIOMS Group XIII - Real-world data and real-world evidence in regulatory decision making. The intended audience for this report includes medicinal product regulators, healthcare payers, health care and medicinal products industries, researchers, bioethicists, patients and health care professionals. This report was developed to inform discussions about the use of RWD and RWE for regulatory and health care decision making, including decisions to make a product available for use (authorisation), to cover the costs of its use (reimbursement), and to use a product for a particular patient (clinical use). This report reflects the opinions of the Council for International Organizations of Medical Sciences (CIOMS) Working Group XIII on Real-world data and real-world evidence in regulatory decision making, and it was finalised after considering comments received during a public consultation. Download Free PDF Book: https://lnkd.in/d-zWCkDW #CIOMS #RWE #RWD

What impact would Public Pharma have in Europe? Ana Vračar, Program Coordinator at the Organization for Workers’ Initiative and Democratization (Croatia), and Coordinator for the People's Health Movement (PHM) Europe – both members of the Public Pharma for Europe Coalition – shares her insights on this question. #PPfE #PublicPharma  #publicpharmaeurope  #publicpharmaforeurope

How do we expect the potential disclosure of confidential net prices will affect the pharma industry and the Spanish National Health System? Learn about the potential impacts, challenges, and what it means for future access to pharma innovations in our latest article https://lnkd.in/dYT3d_PC

The pressure is always higher when you’re on the first panel of a three-day conference! We had a great discussion last week about access and innovation.   It was a privilege to learn from fellow panelists Rifat Atun, Michael Sherman and Christopher Stokes. And thank you to the Financial Times' Global Health Editor, Sarah Neville, for moderating and challenging us with topical questions.   A few reflections I took away: 1. Innovation and access are part of the same continuum. Providing access at a value that rewards innovation enables companies to fulfil their responsibility to bring tomorrow's medicines to patients. 2. Industry, payers and governments share a common goal— securing the broadest possible access. 3. The intent of EU General Pharmaceutical Legislation is to secure access and improve health systems, but there are risks. For example, reducing Regulatory Data Protection is not likely to foster innovation. Having all parties together to have a constructive conversation is crucial to ensure patients in Europe have access to treatments. #FTPharma #BMS_Employee  

𝟭𝟬 𝗔𝗽𝗿𝗶𝗹 📅 𝐒𝐀𝐕𝐄 𝐓𝐇𝐄 𝐃𝐀𝐓𝐄📅 #BeneathTheSurface 🌊 : Unravelling the True Value of Generic Medicines our upcoming study unravelling the long-term benefits of #GenericMedicines to ensure sustainability and availability of essential medicines 💊   Deep dive into this topic during our online panel and discover all the societal and economic values that generic medicines bring to the healthcare sector and society as a whole – register now and do not miss all the updates! https://lnkd.in/dxfHgEwp

What clinical and economic evidence do US payers prefer to drive formulary decisions? Join Clare Foy (Director – Global Market Access, Mtech Access) as she interviews colleagues, Nicole Lodowski (Managing Director, Petauri Evidence) and Bob Nordyke (Senior Advisor, Petauri Evidence), on Thursday 24th October at 4.00pm (BST)/5.00pm (CEST)/8.00am (PDT)/11.00am (EDT) about US payer evidence challenges. Register now at: https://lnkd.in/e9tSK8u5 In this live webinar, they will explore: ✅ The evolving payer evidence landscape in the US ✅ Preferences for clinical and economic evidence by US payers ✅ Key differences between the US and other global markets with regard to evidence, HEOR and market access ✅ Opportunities and challenges when launching new medicines/medical devices/diagnostics in US ✅ Innovative perspectives on evidence planning and strategy for the US market ✅ US payers’ perspectives with exclusive insights from Petauri Evidence’s 2024 US payer survey Learn more at https://lnkd.in/eYJY7QFD If you're unable to join us live, please register and we will send you a link to the recording shortly after the webinar airs: https://lnkd.in/e9tSK8u5 #marketaccess #evidence #payerevidence #USpayers #pharma #medtech #pharmaceutical #GlobalWhispers