NCODA’s Post

What's next in 2024 as a health policy and systems researcher in Thailand? Our Value-Based Healthcare Policy Lab is dedicated to strengthening cancer care in the Thai context, engaging multiple stakeholders from both the private and public sectors, including healthcare organizations, policymakers, the pharmaceutical industry, and patients. Our efforts will continue in 2024 to create a higher quality of care for cancer patients in our country. #VBHC #cancercare #healthpolicy #healthsystemsresearch

EU Leads in Biosimilar Market Access While US Faces Challenges At the 2024 ATOPP Summit, Andre Harvin, Chief Pharmacy Officer at Cone Health, highlighted the EU's superior biosimilar market, with 22 molecules brought to market versus the US's 10. The EU boasts 79 competitors in the biosimilar space, while the US has only 38. Harvin emphasized the critical role of biosimilars in reducing cancer treatment costs, noting that 44% of commercial medical benefits and 55% of Medicare Part B drug spending are on oncology. Despite this, only 5.5% of patients are treated with these high-cost therapies. Biosimilars have saved the US healthcare system over $20 billion from 2015 to 2022, with projected savings of $180 billion by 2027. However, Harvin pointed out the barriers in the US, such as PBM practices inflating drug costs and hindering biosimilar adoption. For more sustainable healthcare, addressing these economic challenges is essential. #Biosimilars #Healthcare #Pharmacy #Oncology #PBMs #CostSavings #HealthcareEconomics Link to article-https://lnkd.in/ejUy_9yM

Last week, the French National Authority for Health (HAS) released its annual report, highlighting a ground-breaking new doctrine from the Transparency Commission. This doctrine aims to accelerate the development of new medications, particularly for #rarediseases and #oncology, by allowing non-comparative studies and conditional market authorisations (AMM). It seeks to balance rapid clinical development with managing uncertainties to benefit patients. This shift could significantly impact how new drugs reach the market. 𝐒𝐨 𝐰𝐡𝐚𝐭 𝐝𝐨𝐞𝐬 𝐭𝐡𝐢𝐬 𝐦𝐞𝐚𝐧? 💨 𝐅𝐚𝐬𝐭𝐞𝐫 𝐦𝐚𝐫𝐤𝐞𝐭 𝐚𝐜𝐜𝐞𝐬𝐬: This new approach allows for quicker introduction of innovative treatments, particularly in areas with urgent needs such as rare diseases and oncology 🎯 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐚𝐝𝐚𝐩𝐭𝐚𝐭𝐢𝐨𝐧: Manufacturers must now focus on providing robust methodological plans and justifying indirect comparison data to meet the new requirements, including high-quality indirect evidence and pre-planned external comparators Explore more insights here 🔗 https://lnkd.in/ee7u5_gQ #Pharmaceuticals #DrugDevelopment #MarketAccess #HAS #PatientAccess #Healthcare #Innovativetreatments * 𝒘𝒓𝒊𝒕𝒕𝒆𝒏 𝒃𝒚 Solen Monteil

𝐀𝐂𝐑𝐒 𝐢𝐧𝐜𝐫𝐞𝐚𝐬𝐞𝐬 𝐢𝐭 𝐟𝐢𝐫𝐞𝐩𝐨𝐰𝐞𝐫 𝐛𝐞𝐲𝐨𝐧𝐝 𝐂𝐚𝐥𝐢𝐟𝐨𝐫𝐧𝐢𝐚 𝐚𝐧𝐝 𝐓𝐞𝐱𝐚𝐬 American Clinical Research Services (ACRS) has acquired Elixia a clinical trial network focused on challenging metabolic conditions. The deal, announced on May 8, expands ACRS's operations beyond California and Texas to include Missouri, Michigan, Massachusetts, and Florida. Elixia's expertise includes trials at a specialized facility in Tampa for patients with liver or kidney impairments. Past clients include major pharmaceutical companies. ACRS, launched in 2022 by Latticework Capital Management, conducts trials in neuroscience, nephrology, infectious diseases, and metabolic health. This acquisition follows ACRS's previous purchase of Clinical Site Services and Patient Advertising Guru in May 2023. https://lnkd.in/emd8sEDY

🌟 𝐄𝐱𝐜𝐢𝐭𝐢𝐧𝐠 𝐍𝐞𝐰𝐬 𝐢𝐧 𝐭𝐡𝐞 𝐖𝐨𝐫𝐥𝐝 𝐨𝐟 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐁𝐫𝐞𝐚𝐤𝐭𝐡𝐫𝐨𝐮𝐠𝐡𝐬!🌟 We are thrilled to kick off the 𝐌𝐞𝐝𝐢𝐜𝐞𝐩𝐭𝐢𝐨𝐧 𝐍𝐞𝐰𝐬 𝐜𝐚𝐦𝐩𝐚𝐢𝐠𝐧 by sharing a remarkable development in the field of healthcare. The U.S. Food and Drug Administration has just granted accelerated approval to 𝐏𝐟𝐢𝐳𝐞𝐫'𝐬 𝐠𝐫𝐨𝐮𝐧𝐝𝐛𝐫𝐞𝐚𝐤𝐢𝐧𝐠 𝐭𝐡𝐞𝐫𝐚𝐩𝐲, 𝐄𝐥𝐫𝐞𝐱𝐟𝐢𝐨, for the treatment of a challenging form of blood cancer - 𝐦𝐮𝐥𝐭𝐢𝐩𝐥𝐞 𝐦𝐲𝐞𝐥𝐨𝐦𝐚. This approval signifies a new ray of hope for patients battling this complex condition, especially those who have struggled with treatment resistance or have experienced relapse after multiple prior lines of therapy. #Elrexfio's accelerated approval is a testament to the dedication and innovation of researchers, scientists, and healthcare professionals who tirelessly strive to push the boundaries of medical science. This achievement highlights the potential of #precisionmedicine, where #therapies are tailored to address specific patient needs. As we move forward, this success story serves as a reminder of the transformative impact that collaboration between pharmaceutical companies, regulatory bodies, and the medical community can have on patients' lives. Let's celebrate this remarkable stride forward in the fight against #multiplemyeloma, and keep our eyes peeled for more groundbreaking developments that promise to shape the future of healthcare. Stay tuned to #Mediception #News for more updates on #drugapprovals, cutting-edge medications, and the #latesttrends in the medical world. Together, we can empower ourselves with knowledge and inspire positive change in the healthcare landscape. 💪🏥 #MediceptionNews #HealthcareInnovation #MedicalBreakthroughs #PrecisionMedicine #FDAApproval #pfizer #cancer #breakthrough

FDA looks to revolutionize rare disease research and announced the "Support for Clinical Trials Advancing Rare Disease Therapeutics Pilot Program" ("START"). It aims to facilitate more rapid and effective communication between the FDA and sponsors of drug development programs for rare diseases. The program is designed to address specific needs in the development of therapies for rare conditions, particularly those that may lead to significant disability or death within the first decade of life. The pilot program aims to augment existing formal meetings with more ad-hoc communications to address issues like clinical study design, choice of control group, patient population selection, appropriate endpoints for efficacy trials, statistical methodology, and product characterization. https://buff.ly/3PX82tB #Clinicalresearch #rarediseases #raredisease #clinicaltrial

There are no FDA/EMA/etc approved therapies for mitochondrial disease. We need to work together to thoughtfully collect and integrate data to inform clinically meaningful endpoints and de-risk clinical trial design. This task force is dedicated to advancing the regulatory science needs so that individuals living with mitochondrial and inherited metabolic diseases can finally see some drug development they so desperately need and want. #missiondriven #collaboration #publicprivatepartnership #regulatory

Read our Access to Medicine Stories and share yours!   Access to medicine is a global problem. Even more so for the global South. Inspire2Live supports the research conducted by the Access to Medicine Foundation. Through their comprehensive assessments and analysis of pharmaceutical companies' practices, policies, and commitments, the Foundation sheds light on areas where improvements are needed to enhance access to vital cancer treatments.   Ultimately, it is only together that we can make such big changes a reality. It is through our narratives on access to medicine that we know where we are able to deliver or why we need to act.   Read all our patient stories on Access to Medicine here: https://lnkd.in/ePi9ceiM   Share your Access to Medicine story too with us and join the movement. Write to EveryPatientCounts@Inspire2Live.org and raise your voice with us.   While we understand that people experience anger, sadness and frustration linked to the reality of the lack of access to medicines, it is important to know that this is not the forum for hate. We need companies to manufacture and distribute medicines across the globe. Every day is an opportunity for them to do better and we want to work with them towards a world where every cancer patient receives the medicines they need. We want to stay engaged.   #InactionKills #ShareYourAccesstoMedicinesStory #EveryPatientCounts #ClosetheCareGap #WCD #UICC #AccesstoMedicinesFoundation #Inspire2Live #PatientsFirst #EquitableAccess #AccessForAll

FDA looks to revolutionize rare disease research and announced the "Support for Clinical Trials Advancing Rare Disease Therapeutics Pilot Program" ("START"). It aims to facilitate more rapid and effective communication between the FDA and sponsors of drug development programs for rare diseases. The program is designed to address specific needs in the development of therapies for rare conditions, particularly those that may lead to significant disability or death within the first decade of life. The pilot program aims to augment existing formal meetings with more ad-hoc communications to address issues like clinical study design, choice of control group, patient population selection, appropriate endpoints for efficacy trials, statistical methodology, and product characterization. https://buff.ly/3PX80lt #Clinicalresearch #rarediseases #raredisease #clinicaltrial