As the implementation of the EU HTA Joint Clinical Assessment (JCA) regulation in 2025 draws nearer, we continue to reflect on the challenges and opportunities the JCA brings to our industry clients. We will be sharing our reflections each Wednesday over the month of July. With advanced therapy medicinal products (ATMPs) amongst the first treatments to undergo mandatory JCA in 2025, our specialist Rare Diseases team has been reflecting on the challenges that may be faced by manufacturers leading ATMPs through the JCA process, and how these challenges can be addressed with early planning, empowering patients and use of artificial intelligence to aid productivity. The full article can be read here: https://lnkd.in/dspyYAb2 If you are interested in exploring how our team could support you with EU HTA for ATMPs or rare disease therapies, please reach out to Isabelle Newell, Deputy Head of Rare Diseases, or Keval Haria, Consultant.
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Section Head - Health Data Sciences at Botnar Research Centre and Professor at University of Oxford and Erasmus MC
I am looking forward to speaking at this workshop on how linked genetics and real world / routinely collected health data can move the field of pharmacogenomics forward. Watch this space!
Join our workshop to learn about the importance of pharmacogenomics in health and medicine regulation and explore how it can guide personalised treatments. You'll have the chance to: ✔explore how genomic data can improve healthcare for European patients; ✔learn how pharmacogenomic data can guide treatment decisions and contribute to the safety of medicines; ✔discuss how to promote the integration of pharmacogenomics in clinical practice. The workshop is organised by EMA, the European Commission and the Heads of Medicines Agencies. 🗓️ 24 September 2024, 09:00–17:00 (CEST) 🔔 Register for virtual participation by 13 September 2024 💻 No need to register to follow the live broadcast 🔗 More information: https://lnkd.in/dBafqeJR
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Join our workshop on #Pharmacogenomics on September 24th. We will discuss how to improve and promote the implementation of pharmacogenomics in clinical practice. Register before September 13th using the link below!
Join our workshop to learn about the importance of pharmacogenomics in health and medicine regulation and explore how it can guide personalised treatments. You'll have the chance to: ✔explore how genomic data can improve healthcare for European patients; ✔learn how pharmacogenomic data can guide treatment decisions and contribute to the safety of medicines; ✔discuss how to promote the integration of pharmacogenomics in clinical practice. The workshop is organised by EMA, the European Commission and the Heads of Medicines Agencies. 🗓️ 24 September 2024, 09:00–17:00 (CEST) 🔔 Register for virtual participation by 13 September 2024 💻 No need to register to follow the live broadcast 🔗 More information: https://lnkd.in/dBafqeJR
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Discover a smarter approach to healthcare! 🙌 Did you know that Adverse Drug Reactions (ADRs) are responsible for 1 in 20 hospital admissions in the UK, costing the NHS a staggering £2.2 billion each year (BMJ, 2022)? 🤔 With Pharmacogenomics (PGx), we're revolutionising healthcare by tailoring medication plans to your unique genetic profile. Research shows that PGx testing can reduce clinically significant adverse drug reactions by 30% (The Lancet, 2023), so you can feel confident that you are being prescribed the right medicine for you. 💊 Say goodbye to one-size-fits-all prescriptions and hello to personalised treatment that minimises risks and maximises effectiveness. Learn more about the game-changing benefits of PGx testing on our website! 💙 #Pharmacogenomics #PrecisionMedicine #Healthcare
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It is so important for HCPs and patients alike (some are both, of course😉), to be aware of the importance of PGx testing! It is a simple saliva test that will be converted into a personalised report telling the patient and their prescriber (relevant for now or in the future) which drugs will match their gene variants associated with drug metabolism. A one off test to receive the information that will be relevant for the rest of your life! At only £399, it’s a small price to pay for the knowledge that could just save your life! See mantara.co for more information. #mantara #personalisedmedicine #pharmacogenomics #pharmacogenetics
Discover a smarter approach to healthcare! 🙌 Did you know that Adverse Drug Reactions (ADRs) are responsible for 1 in 20 hospital admissions in the UK, costing the NHS a staggering £2.2 billion each year (BMJ, 2022)? 🤔 With Pharmacogenomics (PGx), we're revolutionising healthcare by tailoring medication plans to your unique genetic profile. Research shows that PGx testing can reduce clinically significant adverse drug reactions by 30% (The Lancet, 2023), so you can feel confident that you are being prescribed the right medicine for you. 💊 Say goodbye to one-size-fits-all prescriptions and hello to personalised treatment that minimises risks and maximises effectiveness. Learn more about the game-changing benefits of PGx testing on our website! 💙 #Pharmacogenomics #PrecisionMedicine #Healthcare
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Article 3 in our 7-Part Series, 'Cracking the EMA Code' is now live over at Partner Rare. Professor Boris Kramer, MD. PhD shares his extensive experience in designing and conducting clinical trials with a focus on rare disorders. Discover: 💚 The collaborative approach to clinical trial design that ensures patient-centricity and regulatory compliance. 💚Strategies for selecting meaningful endpoints that resonate with regulatory authorities and payers. 💚Key considerations for navigating the unique challenges of rare disease trials. This is not one to miss! If you're approaching your planning phase for a clinical trial and would like to discuss your requirements with Professor Kramer, get in touch and we'll arrange for you and your team to have a complimentary discussion with our team of rare disease experts. #raredisease #clinicaltrials #drugdevelopment #EMA #EUPharma #patientadvocacy #biotech #USbiotech
Cracking the EMA Code: Week 2 - Expert Insights on Clinical Trials for Rare Diseases Unlock the secrets to successful rare disease clinical trials in Europe with the latest release in our 7-part series, article 3! Professor Boris Kramer, MD, PhD, a renowned expert in neonatology and translational science, shares his extensive experience in designing and executing effective trials. Discover: 💚The collaborative approach to clinical trial design that ensures patient-centricity and regulatory compliance. 💚Strategies for selecting meaningful endpoints that resonate with regulatory authorities and payers. 💚Key considerations for navigating the unique challenges of rare disease trials. This is not one to miss! Head to our website to read the full article: https://lnkd.in/e2PZnDJ9 Don't miss the opportunity to discuss your clinical trial strategy with a leading expert. Contact Partner Rare today to schedule a free consultation with Professor Boris Kramer. https://lnkd.in/gRJHVmnZ #raredisease #clinicaltrials #drugdevelopment #EMA #EUPharma #patientadvocacy #healthequity #biotech
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Charles-Schoeman, et al. present their results of their post hoc analysis of pooled data from upadacitinib clinical trials, where they investigated MACE and VTE event incidence in patients with RA and PsA. TEAEs were reported for upadacitinib 15 and 30 mg, adalimumab 40 mg and MTX monotherapy. They found that rates of MACE and VTE events with upadacitinib were consistent with previously reported data, and that these rates were comparable with adalimumab and MTX. You can find the full paper summary on the CSF completely free along with the latest updates in #RhematoidArthritis https://lnkd.in/eJbt-azF
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Cracking the EMA Code: Week 2 - Expert Insights on Clinical Trials for Rare Diseases Unlock the secrets to successful rare disease clinical trials in Europe with the latest release in our 7-part series, article 3! Professor Boris Kramer, MD, PhD, a renowned expert in neonatology and translational science, shares his extensive experience in designing and executing effective trials. Discover: 💚The collaborative approach to clinical trial design that ensures patient-centricity and regulatory compliance. 💚Strategies for selecting meaningful endpoints that resonate with regulatory authorities and payers. 💚Key considerations for navigating the unique challenges of rare disease trials. This is not one to miss! Head to our website to read the full article: https://lnkd.in/e2PZnDJ9 Don't miss the opportunity to discuss your clinical trial strategy with a leading expert. Contact Partner Rare today to schedule a free consultation with Professor Boris Kramer. https://lnkd.in/gRJHVmnZ #raredisease #clinicaltrials #drugdevelopment #EMA #EUPharma #patientadvocacy #healthequity #biotech
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🎊 We would like to invite you to read an #article "Clinical Response and Hospital Costs of Therapeutic Drug Monitoring for #Vancomycin in Elderly Patients" by Howard Lee, et al. Journal of Personalized Medicine MDPI link here: https://lnkd.in/gid4AY6V
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Explore the latest therapeutic strategies to enhance outcomes in patients with #MacularDegeneration and #DiabeticMacularEdema. Free #CME #CNE offers expert analysis of new key data and more. https://bit.ly/4cZc9Om
Rare Diseases Analyst at Costello Medical
2moA very insightful read, Keval! 👍