PharmaLex’s Post

The rare disease market has grown consistently over the past ten years and is expected to continue to grow, however, recent barriers have emerged, including an increasing pricing pressure and emphasis on cost-effectiveness proven through comparative clinical trials. Our latest white paper delves into the current trends shaping the rare disease landscape, offering insights into emerging therapies, evolving regulatory environments, and the critical role of patient advocacy. Download your copy now to learn more: https://lnkd.in/du7bPnQJ #RareDisease #Pharma #Biotech #HealthcareInnovation #WhitePaper

The Pharmabiotics Conference & Partnering event is still going strong and we want to thank all organizers, presenters, and panelists for sharing their expertise about the most innovative approaches in microbiome-specialized drug development. This year marks the 9th edition of the conference, and its theme, "An Evolving Regulatory Landscape", underscores the dynamic changes in the regulatory environment. This has been a great opportunity for gaining insights, learning about cutting-edge tools and resources, and planning for successful clinical trials in the microbiome health field. #clinicaltrials #microbiome #microbiomeresearch #pharmabiotics

Sue O'Leary Executive Vice President, Evidence & Access, Prime will be moderating a panel discussion tomorrow on ‘Optimising Value Demonstration and Evidence in Rare Disease’!    🗓️ Date: Thursday, 24th October 🕒 Time: 11:55 AM 📍 Location: Theatre 6, WODC Please join her alongside industry expert panelists Stuart Mealing, Jennifer Quinn, Mukesh Sharma, PhD and Simon S. for a deep dive into this critical topic. This session will explore how access bodies like NICE assess rare disease evidence during health technology assessments. The discussion will also delve into innovative methods beyond clinical trials that pharma companies can leverage to demonstrate product value. Additionally, we will discuss how pharmaceutical companies can internally organize their processes to ensure efficient and effective evidence planning while adapting to changing roles and responsibilities. We’re looking forward to an insightful discussion! #WODC #RareDiseases #ValueDemonstration #RealWorldEvidence #PanelDiscussion

Market Access teams need to make sure to create and disseminate cross-functional understanding of the evidence needs of payers and HTA bodies, what kind of evidence they are asking for and how they will look and interpret this data. There also needs to be a shared understanding of what the implications are if certain evidence is not available in time so that strategic trade-off decisions can be taken consciously. For further insights on achieving market access excellence through a strategic integrated evidence generation plan, click the link below. https://lnkd.in/dh8fQzcG #MarketAccess #BusinessGrowth #Pharma #LifeScience

🚀 Discover the latest advancements in biosimilar development! 🚀 In our latest blog, Christian K. Schneider, M.D., explores the European Medicines Agency's (EMA) new Concept Paper on confirmatory clinical studies for biosimilars. This pivotal document paves the way for more flexible and science-driven approaches to biosimilar development, potentially easing the burden on manufacturers while ensuring safety and efficacy. Key takeaways: 🔹 The EMA's Concept Paper suggests reconsidering the necessity of confirmatory efficacy studies for biosimilars. 🔹 The agency highlights the importance of relying on scientific rationale and advanced analytical methods. 🔹 This move aligns with global trends towards more streamlined biosimilar approval processes. Read the full article here: https://lnkd.in/gKM7aKhr #Biosimilars #PharmaLex #HealthcareInnovation #RegulatoryAffairs #ClinicalStudies

🚀 Discover the latest advancements in biosimilar development! 🚀 In our latest blog, Christian K. Schneider, M.D., explores the European Medicines Agency's (EMA) new Concept Paper on confirmatory clinical studies for biosimilars. This pivotal document paves the way for more flexible and science-driven approaches to biosimilar development, potentially easing the burden on manufacturers while ensuring safety and efficacy. Key takeaways: 🔹 The EMA's Concept Paper suggests reconsidering the necessity of confirmatory efficacy studies for biosimilars. 🔹 The agency highlights the importance of relying on scientific rationale and advanced analytical methods. 🔹 This move aligns with global trends towards more streamlined biosimilar approval processes. Read the full article here: https://lnkd.in/eGyQiNsu #Biosimilars #PharmaLex #HealthcareInnovation #RegulatoryAffairs #ClinicalStudies

🚀 Discover the latest advancements in biosimilar development! 🚀 In our latest blog, Dr. Christian K Schneider, M.D., explores the European Medicines Agency's (EMA) new Concept Paper on confirmatory clinical studies for biosimilars. This pivotal document paves the way for more flexible and science-driven approaches to biosimilar development, potentially easing the burden on manufacturers while ensuring safety and efficacy. Key takeaways: 🔹 The EMA's Concept Paper suggests reconsidering the necessity of confirmatory efficacy studies for biosimilars. 🔹 The agency highlights the importance of relying on scientific rationale and advanced analytical methods. 🔹 This move aligns with global trends towards more streamlined biosimilar approval processes. Read the full article here: https://lnkd.in/dKPNum4R #Biosimilars #PharmaLex #HealthcareInnovation #RegulatoryAffairs #ClinicalStudies

Market Access teams need to make sure to create and disseminate cross-functional understanding of the evidence needs of payers and HTA bodies, what kind of evidence they are asking for and how they will look and interpret this data. There also needs to be a shared understanding of what the implications are if certain evidence is not available in time so that strategic trade-off decisions can be taken consciously. For further insights on achieving market access excellence through a strategic integrated evidence generation plan, click the link below. https://lnkd.in/dibbv-AA #MarketAccess #BusinessGrowth #Pharma #LifeScience

Leveraging real-world clinical data in novel ways can result in important changes to pharma companies’ ways of working. Our health and life sciences expert Jenna Phillips explains how this can give a competitive advantage for products that are coming to market more quickly, and safely, than ever before in STAT ⬇️

🚀 Discover the latest advancements in biosimilar development! 🚀 In our latest blog, Christian K. Schneider, M.D., explores the European Medicines Agency's (EMA) new Concept Paper on confirmatory clinical studies for biosimilars. This pivotal document paves the way for more flexible and science-driven approaches to biosimilar development, potentially easing the burden on manufacturers while ensuring safety and efficacy. Key takeaways: 🔹 The EMA's Concept Paper suggests reconsidering the necessity of confirmatory efficacy studies for biosimilars. 🔹 The agency highlights the importance of relying on scientific rationale and advanced analytical methods. 🔹 This move aligns with global trends towards more streamlined biosimilar approval processes. Read the full article here: https://lnkd.in/gKM7aKhr #Biosimilars #PharmaLex #HealthcareInnovation #RegulatoryAffairs #ClinicalStudies