CIRS - Centre for Innovation in Regulatory Science

What have we learned from various models of collaboration among regulators and HTA agencies? How should these models evolve? CIRS brought together a diverse group of stakeholders, including regulators, HTA agencies, companies, payers, academics and patient organisations, to discuss the impact of these collaborative models. A series of excellent presentations and panel discussions highlighted the benefits and challenges of different ways of collaborative working between and among regulatory and HTA agencies. We hope that the insights and recommendations from this meeting will inform and shape the future of regulatory and HTA collaborations. Read the workshop synopsis >> https://lnkd.in/emrktTUf #RegulatoryScience #HTA #HEOR #pharmaceuticals #ProjectOrbis #AccessConsortium #ILAP #HTAR #RegulatoryAffairs

What have we learned from various models of collaboration among regulators and HTA agencies? How should these models evolve? CIRS brought together a diverse group of stakeholders, including regulators, HTA agencies, companies, payers, academics and patient organisations, to discuss the impact of these collaborative models. A series of excellent presentations and panel discussions highlighted the benefits and challenges of different ways of collaborative working between and among regulatory and HTA agencies. We hope that the insights and recommendations from this meeting will inform and shape the future of regulatory and HTA collaborations. Read the workshop synopsis >> https://lnkd.in/emrktTUf #RegulatoryScience #HTA #HEOR #pharmaceuticals #ProjectOrbis #AccessConsortium #ILAP #HTAR #RegulatoryAffairs

🎉 Happy New Year from the CIRS team! 🎉 We’re looking forward to continuing our mission to identify and apply scientific principles to advance regulatory and #HTA policies and processes. Stay tuned to hear about our plans for 2025! #RegulatoryScience #NewYear #pharmaceuticals

📣Incase you missed it, here's our latest newsletter ✉ 🎄From everyone at CIRS, we hope you have a happy festive season and we look forward to seeing you in 2025🎉 Sign up to our mailing list >> https://lnkd.in/eREqpwCF #RegulatoryScience #HTA #HEOR #pharmaceuticals

Having the same technical guidelines ensures that regulatory agencies have similar processes and practices, which builds trust and ultimately increases opportunities for reliance.   CIRS has been working closely with DIGEMID in Peru on the implementation of good reliance practices, so it’s great to see that the agency has been accepted as an official ICH observer – congratulations DIGEMID! 🎉   #RegulatoryScience #RegulatoryAffairs #pharmaceuticals #regulatoryreliance #ICH #DIGEMID #Peru

With EU joint clinical assessments (#JCA) just around the corner, we had a look at #EMA stop-clock data for #oncology products to get initial insight into how the parallel JCA and EMA timelines may impact one another. Our analysis showed that both the first and second clock-stops were used in almost all of the analysed oncology products, with additional clock-stops being less likely. The variation of clock-stop durations makes the EMA review process less predictable, therefore, early awareness and preparation of JCA is required within companies to ensure the parallel process is aligned and efficient. This study was presented in a poster at #ISPOR2024 in Barcelona recently. Download the poster >> https://lnkd.in/edqwwd4w #RegulatoryScience #HTA #HEOR #HTAR #pharmaceuticals

The vaccine landscape was already changing prior to COVID-19, with new technologies such as mRNA, DNA, and viral vector vaccines, and novel populations for their use, including many vaccines being developed for adults. Then #COVID-19 brought forward strides in development and a whole series of new challenges. It reignited interest in #vaccines among regulators, vaccine developers, and the wider health system. However, vaccines are still underappreciated and undervalued. Despite being one of the cornerstones of public health, vaccines are approved across the world for only 34 pathogens, though many more pathogens lead to serious disease. Unfortunately, vaccines only attract a small proportion of government funding compared to medicines.   In this DIA Global Forum article, we summarise key messages and recommendations from our multi-stakeholder workshop on regulatory and access approaches for vaccines.   Key recommendations: 🌎 International collaboration on evidence generation 🏛 Evolution of regulatory, #HTA and National Immunization Technical Advisory Group frameworks 📕 Common lexicon of definitions 💬 Clear and consistent communication of value to society   Read the full article >> https://lnkd.in/e_YTRMrq #RegulatoryScience #HEOR #vaccinedevelopment #lifesciences

👀 Look out for CIRS at #ISPOREurope! 👋 Anna Somuyiwa (Adedeji) and our HTA team will be attending ISPOR Europe in Barcelona from 17-20th November – it would be great to see you there, especially for Penélope Cervelo’s poster session on Day 2! ⏱ Poster HPR86: Frequency and Variation of Clock-Stop During EMA Assessment for Oncology Products: Implication on JCA Timelines #HEOR #HTA #pharmaceuticals #reimbursement #oncology #JCA Tina Wang Belén Sola Barrado

Is collaboration between regulatory and HTA agencies the solution to access challenges? Healthcare decision-makers face growing pressure to assess complex new interventions, using limited resources. Could greater collaboration among regulatory and HTA agencies be the key to improving efficiency and access? Horizontal Collaborations: 🔹 Regulatory agencies worldwide are leveraging shared expertise through collaborative review models. A 2022 CIRS survey found that 56% of surveyed agencies used collaborative reviews, while 72% had work-sharing setups. 🔹 HTA collaborations, although newer, are gaining traction with initiatives like the Commonwealth collaboration addressing shared challenges. Vertical Collaborations: 🔹 In Europe, the EMA-HTA advice started in 2010 and, as part of the EU HTA Regulation, Joint Scientific Consultation (JSC) will commence in 2025. 🔹 The UK’s ILAP integrates regulatory, HTA, and payer roles to fast-track patient access, benefiting developers and fostering understanding across systems. Real-world Examples: 🔹 Commonwealth collaboration: Potential for method alignment and resource efficiency, but faces challenges in stakeholder engagement and reconciling national policies. 🔹 ILAP: Recently revamped to target transformative medicines, improving governance and strategic alignment with the NHS and NICE. Success depends on clear communication, priority alignment, and resource commitment. Stronger links between horizontal and vertical efforts are essential for better, timely access to innovations. Find out more from Tina Wang, CIRS, and Martina Garau, Office of Health Economics here: https://lnkd.in/eRVaDp_d #RegulatoryScience #HTA #HEOR #pharmaceuticals #HTAR #ILAP

Collaborative regulatory review models like Project Orbis aim to accelerate patient access to therapies, but what is happening to Orbis-approved products at the HTA stage? Our latest HTADock briefing helps to answer this question, and more! The briefing focuses on performance metrics of #HTA agencies in Australia, Canada and the UK, including regulatory and HTA review sequence, common products appraised by all the included agencies, as well as the HTA outcome and timing for products approved via the Access Consortium and Project Orbis. Download the briefing >> https://lnkd.in/e5KR95nY #RegulatoryScience #AccessConsortium #ProjectOrbis #HEOR #pharmaceuticals #oncology