Servier’s Post

🗺️ To Attend an Upcoming Symposium on Advanced Therapy Medicinal Products (ATMPs) I am thrilled to be part of a special symposium that marks a significant milestone-15 years of groundbreaking advancements in Advanced Therapy Medicinal Products (ATMPs). This event will not only celebrate this remarkable journey but also highlight how the work of the Committee for Advanced Therapies (CAT) has been instrumental in shaping the regulatory framework in Europe. Their efforts have led to the approval of 27 innovative gene- and cell-based therapies, offering new hope for patients with unmet medical needs. This symposium will give a unique opportunity to gain valuable insights into the evolution of CAT, discuss regulatory developments, and explore upcoming innovations that could revolutionize patient care in the next 15 years. - Learn about the evolution of CAT and how it has adapted to meet the challenges of emerging ATMP technologies. - Discuss with experts the regulatory developments that continue to shape the future of ATMPs. - Explore the upcoming innovations that have the potential to revolutionize patient care in the next 15 years. I’m looking forward to engaging with Frontier to develop drugs and other industry leaders, scientists, and regulatory experts. These conversations are essential as we work together to ensure that high-quality, safe, and effective therapies continue transforming the healthcare landscape. I will share insights from the symposium with my network and continue building collaborations that will help advance these revolutionary treatments. I encourage you to do the same and look forward to staying connected as we collectively shape the future of medicine! #ATMPs #GeneTherapy #CellTherapy #HealthcareInnovation #ClinicalTrials #RegulatoryAffairs #CAT #EMA #MedicalInnovation #CNRResearch

Delighted to announce the publication of my latest article in the prestigious Future Journal of Pharmaceutical Sciences: "A comprehensive review comparing conventional versus traditional remedies in the treatment of endometriosis with futuristic insights" Endometriosis poses a significant challenge to millions worldwide, demanding innovative approaches to treatment. In this comprehensive review, I meticulously explore the efficacy of conventional and traditional remedies, offering futuristic insights that pave the way for transformative healthcare solutions. As the pharmaceutical landscape evolves, it's crucial to critically assess existing treatment modalities and unearth novel synergies. Through rigorous analysis and forward-thinking perspectives, this article aims to bridge the gap between conventional medicine and traditional remedies, unlocking new avenues for personalized patient care. Join me on a journey through the realms of endometriosis treatment, where historical practices meet cutting-edge pharmaceutical advancements. By dissecting the strengths and limitations of each approach, we uncover invaluable insights that have the potential to revolutionize healthcare delivery. Whether you're a pharmaceutical scientist, healthcare professional, or advocate for women's health, this article offers a wealth of knowledge to enrich your understanding of endometriosis treatment paradigms. I would like to thank and congratulate all my co-authors for their constant efforts in publishing of this review. Dr. Nisha Parikh, Mansi shah, Dr. Avinash Khadela, Shivam Bhagat, Bhavarth Dave I invite you to delve into the full article and join the conversation on the future of pharmaceutical sciences in tackling complex medical conditions like endometriosis. Together, let's embark on a journey towards innovative, patient-centric healthcare solutions. Article link: https://lnkd.in/dUFaa-zf DOI: https://lnkd.in/dF8S73PF #EndometriosisTreatment #PharmaceuticalInnovation #FutureHealthcare

🚀 Exciting News for Advanced Therapy Medicinal Products (ATMPs) Enthusiasts! On 30 December 2008, the Advanced Therapy Medicinal Products Regulation (EC No 1394/2007) came into effect, marking the beginning of a new era for ATMPs. Since then, these therapies have grown significantly, offering revolutionary treatments for unmet medical needs. To celebrate 15 years of progress, the European Medicines Agency (EMA) is hosting a symposium on 10 October 2024, at their headquarters in Amsterdam (also available remotely). 💡 This event will highlight: How the Committee for Advanced Therapies (CAT) has shaped the regulatory framework for ATMPs in Europe. The approval of 27 groundbreaking gene- and cell/tissue-based medicines that are now offering transformative treatment options for conditions previously considered untreatable. These therapies address critical unmet medical needs, providing hope for patients with rare and serious diseases. 👥 Who should attend? CAT members EMA committees & regulatory authority members Industry & academia representatives Healthcare professionals & patients Policymakers Anyone interested in the future of ATMPs 🗓️ Important Dates: In-person registration deadline: 24 September 2024 Remote attendance registration deadline: 1 October 2024 Register your interest and join the conversation on the future of ATMPs! 🎯 #ATMP #RegulatoryAffairs #InnovativeTherapies #EMA #Healthcare #AdvancedTherapies

We catch up with Shahid Hanif to learn what the GetReal Institute has achieved over the past year and what attendees can expect from the GetReal Institute 2024 Annual Conference. Read at The Evidence Base® #heor #healtheconomics #outcomesresearch #rwe #rwd #realworldevidence #realworlddata #marketaccess #pharma #biopharma #medicalaffairs #regulation #regulatoryaffairs #hta #healthtechnologyassessment #healthdata #healthequity #healthpolicy

Clinical Trials Market Size to Hit US$ 73.2 Billion by 2028 𝐃𝐨𝐰𝐧𝐥𝐨𝐚𝐝 𝐅𝐫𝐞𝐞 𝐒𝐚𝐦𝐩𝐥𝐞 𝐏𝐚𝐠𝐞𝐬:https://lnkd.in/dHR9QaiK The global clinical trials market in terms of revenue was estimated to be worth $48.2 billion in 2023 and is poised to reach $73.2 billion by 2028, growing at a CAGR of 8.7% from 2023 to 2028. 𝐓𝐡𝐞 𝐜𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬 𝐟𝐞𝐚𝐭𝐮𝐫𝐞𝐝 𝐢𝐧 𝐭𝐡𝐢𝐬 𝐫𝐞𝐩𝐨𝐫𝐭 𝐢𝐧𝐜𝐥𝐮𝐝𝐞 Thermo Fisher Scientific IQVIA ICON plc Laboratory Corporation of America Holdings Syneos Health WuXi AppTec Charles River Laboratories Fortrea Medpace Frontage Laboratories, Inc ACM Global Laboratories Advanced Clinical PSI CRO AG Bioagile Therapeutics Pvt Ltd CTI Clinical Trial and Consulting Services Worldwide Clinical Trials Pepgra Clinical Research Organization (CRO) for Medicines and Healthcare products CTI Clinical Trial and Consulting Services Dove Quality Solutions Firma Clinical Research Celerion Novotech Linical

Yesterday I had the pleasure of presenting at Future Pharma 2024, Boston US, on the topic "Empowering Patients: Unveiling the Empirical Value of Fixed-Dose versus Mono-Combinations Therapies in Hypertension”. We examine the comparative importance of fixed-dose combinations (FDCs) versus combinations of MONOs (monotherapies) from the patient's perspective. In addition, we evaluate the relative importance of mechanisms of action (MOAs) versus FDCs. In terms of patient satisfaction, the choice between FDC and MONO is significantly more important than the prescribed MOAs. We also examine the impact of MOAs, FDCs, and MONOs on patients' ability to independently manage their treatment regimen and their emotional response to therapy, satisfaction, and adherence. The Patient Matrix (PM) model I presented serves as an extended framework to elucidate the empirical significance of FDC prescribing, where applicable. These findings provide valuable insights for pharmaceutical companies to further empower patients and adopt a more patient-centric approach.

Exciting new research sheds light on the clinical development landscape for high-spend Medicare Part D small molecule drugs and the potential impact of the Inflation Reduction Act of 2022 (IRA) on subsequent indications. Among the top 50 drugs by Medicare Part D spending in 2020, 30 were multi-indication small molecule drugs, with subsequent indications often receiving FDA approval within 2 years of initial approval. However, those based on postapproval research typically weren't approved until more than 7 years post approval. These findings suggest that the IRA may affect time to first launch, post approval research investments, and patient access. Understanding these dynamics is crucial for navigating the evolving healthcare landscape. Check out the full study here: https://lnkd.in/ecmmbFdv #MedicarePartD #MJHxAJMC AJMC - The American Journal of Managed Care MJH Thought Leaders

Genmab: Morgan Stanley 22nd Annual Global Healthcare Conference Regarding Rina-S: - A Phase 3 trial is expected to begin in 2024. - A relatively promising safety profile may allow for long-term dosing, which is expected to extend the duration of response. - There is potential for combination therapy with ADC drugs and immune activation agents. Regarding GEN3014: - Clinical data may be shared as early as this year or next year at the latest. - Depth of response and duration of response are crucial. - Genmab mentioned that if Johnson & Johnson exercises its option for HexaBody-CD38, the FDA's frontrunner program and MRD-negative status may be used in clinical development. The focus will be on 4 to 5 top clinical programs expected to deliver robust data over the next few years, emphasizing clinical development and commercialization.

C. Ola Landgren, MD comments: 1- 15% to 35% of patients are lost in each line of treatment. 2- Currently PFS is the endpoint to demonstrate clinical benefit of a new regimen for full approval. 3- Comparative studies may now require over 8 years to show a statistically significant effect of a new therapy. 4- Dr suggestions: a- Implementation of accelerated approval pathway: approval may be granted based on intermediate endpoints. b- Launching of project FrontRunner: allow early access of investigational drug in clinical trial, avoiding the sequencial approach of first seeking approval ofr patients in the R/R setting who have received numerous prior lines of therapy. My comments: the logic is reasonable, but if we want to implement this rapid access of new investigational drug the safety must be assured first and more tightly than before with larger sample of testing subjects and longer observational period for side effects, since most anticancer trials begins with phase I/II fused model with secuencial administration design in patients. PFS: Progression-Free Survival OS: Overall Survival ORR: Overall response rate FDA press release: https://lnkd.in/gZ8rytzT Drs PPT materials: https://lnkd.in/grGQbrS4