Therese Keohane’s Post

Publication of NIBRT’s Annual Report 2023 NIBRT today published its Annual Report for 2023 which highlights a 7% growth in revenue bringing research and training activity to the highest level in the Institute’s history. The success of the Irish biopharma industry is well documented, with biopharma firmly established as a key pillar of the Irish economy. There are 84,000 highly skilled people directly and indirectly employed in the sector and the expectation is that this will increase by up to 10,000 jobs over the next 5 years. 2023 saw continued strong performance of the sector with significant new developments including Astellas, Lilly, MSD, Novo Nordisk and others. NIBRT continued its strong support of the sector throughout 2023 with some of the key achievements in the year including: • A 7% growth in overall revenue, bringing research and training activity to the highest level in the Institute’s history. • 9% increase in training activity with client companies based in Ireland. • 28% growth in research activity, underpinned by the joint appointment of new Principal Investigators in partnership with Irish and international universities. • The signing of two new NIBRT global partnerships in the US. • The opening of the Advanced Therapies building and the CONCEPT facilities. Download and read full press release here -https://hubs.la/Q02j66Fd0

We're excited to have Annick de Bruin, Chief Research and Insights Officer, Center for Information and Study on Clinical Research Participation (CISCRP), USA sharing the results from CISCRP's 2023 Perceptions & Insights Study this September at Patient Perspectives and Partnering! This study found that “Information critical to participant decision-making includes knowing potential risks and benefits, study purpose, how the investigational treatment is believed to work, as well as knowing involved procedures, potential out-of-pocket costs, physical clinic location, and study duration”. Join Annick in Amsterdam to learn more about these crucial study findings, as well as experts from Novartis, Regeneron, use MY data, Sanofi, GSK, Boehringer Ingelheim, James Lind Care, FibroFlutters, Genentech, FDA, braintust and many more. And gain leading advice that will help you address these pivotal considerations early, improve patient engagement and maximise your trial outcomes. 📅 Download the agenda to learn more: https://lnkd.in/eJwWvV3N 👉 Register today: https://lnkd.in/eGH7Jqi5 #PatientPerspectives24 #PatientEngagement #ClinicalTrials #ClinicalResearch #PatientPartnerships

Today, we at Cencora PharmaLex and SwedenBIO, hosted a Brain & Breakfast event on the EU joint HTA process that sparked engaging conversations and valuable insights! A big thank you to all participants for contributing to the lively discussions, and special appreciation to our esteemed panelists Niklas Hedberg and Hanna Zirath, Ph.D. from TLV and Sofia Heigis, CEO at Oncopeptides, for transparently sharing your invaluable insights. The discussion was excellently moderated by Herbert Altmann, head of Marcet Access and Pricing and Reimbursement Europe, Cencora PharmaLex. Thank you Jessica Martinsson, Johanna Assadi Rissanen, Marjo Puumalainen and Frida Eriksson at SwedenBIO for a great collaboration.   Here are some key takeaways from our enriching discussion: 👉 Prioritize Preparation: It's essential for pharma/biotech companies to familiarize themself with the available information and materials continuously published by the EC and other competent experts to be adequately prepared. 👉 Emphasize Communication: Effective communication, interaction, and knowledge-sharing are pivotal both internally within organizations and externally between companies and regulatory authorities, especially 2025/26 during the implementation phase. 👉 X-functional collaboration: Implementing and integrated launch plan supported by research and development (R&D), market access, regulatory and other departments focusing on evidence generation for the new EU HTA process. 👉 Engage with Joint Scientific Consultation (JSC): Engaging in early scientific consultations presents a valuable opportunity to consider an optimal and robust evidence generation plan satisfying both regulatory and HTA bodies' requirements. 👉 PICO Considerations: The Joint Clinical Assessment (JCA) relies on the Population, Intervention, Comparator, and Outcome (PICO) framework for assessments. However, variations in healthcare systems and treatment guidelines among different nations will significantly influence how PICO criteria are applied in drug assessments. High quality input from Swedish affiliates or SMEs is critical to ensure a good discussion with TLV in Sweden.   Let's continue to foster collaboration and knowledge sharing for a brighter future in the pharmaceutical landscape!   Want to learn more? This can be a start: https://lnkd.in/dqSij-rt #EUHTA #JCA #JSC #BrainAndBreakfast #PanelDiscussion #TLV #SwedenBIO #CencoraPharmalex #Collaboration #Pharmaceuticals

🎉 Exciting news from DOCARE! They have been awarded $273,188 by the National Science Foundation (NSF) Foundation under the National Science Foundation (NSF) Foundation subagency. This SBIR Phase I project aims to revolutionize clinical trial communication by developing dynamic prediction tools to enhance participant engagement and retention. By leveraging unsupervised machine learning and operations research models, Docare is set to improve clinical trial success rates and reduce economic losses in the pharmaceutical industry. #SBIR #STTR #Innovation 📅 This groundbreaking research will span 11.5 months, starting on September 15, 2024, and concluding on August 31, 2025. The project will focus on optimizing communication strategies to prevent trial failures and improve patient outcomes. Kudos to Docare for their innovative approach to enhancing healthcare delivery quality! #Healthcare #ClinicalTrials #MachineLearning

Experts gather at LSX - partnering for Life Science eXecutives Congress to discuss the impact of the new EU HTA regulation on biotech and pharma in Europe. From their perspective, trying to streamline 27 member states into one initiative is a mighty endeavour, which will include trial and error, but one that will hopefully result in a more unified system for all member states.

Today Cencora PharmaLex and SwedenBIO hosted a Brain & Breakfast event on the EU joint HTA process that sparked engaging conversations and valuable insights! A big thank you to all participants for contributing to the lively discussions, and special appreciation to our esteemed panelists Niklas Hedberg and Hanna Zirath, Ph.D. from TLV and Sofia Heigis, CEO at Oncopeptides, for transparently sharing your invaluable insights. The discussion was excellently moderated by Herbert Altmann, head of Market Access and Pricing and Reimbursement Europe, Cencora PharmaLex.   Here are some key takeaways from our enriching discussion: 💡 Prioritize Preparation: It's essential for pharma/biotech companies to familiarize themself with the available information and materials continuously published by the EC and other competent experts to be adequately prepared. 💡 Emphasize Communication: Effective communication, interaction, and knowledge-sharing are pivotal both internally within organizations and externally between companies and regulatory authorities, especially 2025/26 during the implementation phase. 💡 X-functional collaboration: Implementing and integrated launch plan supported by research and development (R&D), market access, regulatory and other departments focusing on evidence generation for the new EU HTA process. 💡 Engage with Joint Scientific Consultation (JSC): Engaging in early scientific consultations presents a valuable opportunity to consider an optimal and robust evidence generation plan satisfying both regulatory and HTA bodies' requirements. 💡 PICO Considerations: The Joint Clinical Assessment (JCA) relies on the Population, Intervention, Comparator, and Outcome (PICO) framework for assessments. However, variations in healthcare systems and treatment guidelines among different nations will significantly influence how PICO criteria are applied in drug assessments. High quality input from Swedish affiliates or SMEs is critical to ensure a good discussion with TLV in Sweden.   Let's continue to foster collaboration and knowledge sharing for a brighter future in the pharmaceutical landscape!   Want to learn more? This can be a start: https://lnkd.in/dhG3mhrX #EUHTA #JCA #JSC #BrainAndBreakfast #PanelDiscussion #TLV #SwedenBIO #CencoraPharmalex #Collaboration #Pharmaceuticals

#euhta update by PD Dr. Michael Hennig and Cencora | Pharma solutions team. I'm at #BIO2024 this week, let me please know if you would like us to discuss what does it mean for your phase III clinical trial and evidence generation plan.

The Simcyp Consortium Celebrates 25 Years: Join Our Open Day! 📅 Date: Tuesday, September 24, 2024 📍 Location: Radisson RED Hotel, London Heathrow, UK Every year, the Simcyp Consortium—comprising over 30 leading biopharmaceutical companies—convenes to discuss Physiologically Based Pharmacokinetic (PBPK) initiatives in drug development and their regulator impacts. Our members collaborate closely with Simcyp scientists, shaping the scientific evolution of the Simcyp Simulator—a powerful platform utilized by prominent regulators such as the US FDA, EMA, Health Canada, and PMDA. For the first time in history of the Simcyp Consortium, non-members are invited to join our "Open Day". This is a unique opportunity to connect with industry leaders, regulatory experts, and academics as we reflect on and celebrate Simcyp’s remarkable 25-year journey prior to the start of the Consortium meeting. Event Highlights: History of the Consortium: Formation of the consortium and its progress. Simcyp PBPK Modeling Impact: Discover Simcyp's influence on drug development and regulatory sciences focusing on drug-drug interactions, biopharmaceutics, and special populations. 👉 If you’re not already a consortium member, you may register here: https://ow.ly/OBSM50SEyuG. Create a new account by clicking on the blue ‘Sign up now’ text. After registering, you’ll receive a confirmation email. Then, click ‘Register now’ to confirm your participation. #Simcyp #PBPK #DrugDevelopment #SimcypConsortium #SimcypSimulator

✴ Unlock the Insights from Pharma Integrity Conference 2024 - Get Your Video Access Now! ✴ It’s hard to believe it's been over a month since the Pharma Integrity Conference 2024. Did you miss this year’s conference? We’ve got you covered! We are excited to announce that the full video of the conference, themed Digital Frontiers: Exploring Pharmaceutical Companies’ Strategies in Digital Media is now available for purchase. The video includes:   ✅ Inspirational Keynotes: Gain access to the powerful keynotes delivered by industry leaders and learn from their experiences and insights on Digital Strategies.  ✅ An Interactive Session with the HPRA led by Dr Emer O’Shaughnessy, MSD, with Q&A 📽 Our video includes all sessions, ensuring you don’t miss out on any part of the event. Whether you want to watch a specific session or the entire conference, you’ll have it all at your fingertips. Don’t miss this opportunity to gain valuable knowledge and insights from the Pharma Integrity Conference 2024. Email info@pharmaintegrity.com for more information Thank you to everyone who made the Pharma Integrity Conference of 2024 a huge success. 💫 We’re excited to share these incredible moments with you! #PharmaIntegrityConference2024 #PharmaIntegrity #VideoAccess #ProfessionalDevelopment #IndustryInsights #Innovation #Networking

CROs of all types can change – what happens if they do so during your project...... Anyone who has been working in outsourcing management will be aware that CROs of all types can change. This can be particularly challenging when your project is already committed to the CRO. This workshop will look at how sponsors can be better prepared from a contractual perspective for when change happens. Changes including acquisition, organisational change or even when a CRO ceases to operate. In all cases there are challenges, and this is exactly what this PCMG Workshop is about. The PCMG October Workshop is kindly sponsored by Allucent Contributors include (L-R on graphic): > Desiree Hammerstad from Nykode Therapeutics > Lindy Bosch from Allucent > Raymond Hoffmans from Allucent > Michael Engsig from Nykode Therapeutics > Jacqui Gatehouse from Gatehouse Thirteen > Morten Pedersen from Lundbeck > Pia Sauer Larsen from Novo Nordisk > Sandra Olthof from Allucent > Gitte Lykke Knudsen from LIENCE LAW The PCMG October Workshop "Foresight, not Hindsight: Best preparation for a worst-case scenario" takes place on the 3rd October in Copenhagen. Find out more here: https://lnkd.in/gSwndK8G Gill Slater, Richard Scaife, David Davies, Olena Goloborodko #clinicaltrials #clinicalresearch #clinicaloperations #pharma #PCMG