Accelsiors CRO’s Post

📊 Clinical Trials Roundup: Tracking the “COVID Effect” on Trial Initiations 📊 Over the last three editions of Citeline's Clinical Trials Roundup, we've closely monitored the impact of the pandemic on clinical trial initiations across all therapeutic areas (TAs). The "COVID effect" brought dramatic fluctuations: 📉 2020: A -4% decline due to the global disruption. 📈 2021: A surprising +22% recovery. 📉 2022: A -6% dip driven by biopharma’s tough economic environment. Now in 2023, the yo-yo has swung back up, showing 13% growth—excluding COVID-19 trials—well above the 7% average growth seen from 2017–2023 for non-COVID trials. Is the industry set for continued recovery, or will we see more cycles of growth and decline? Stay tuned as we continue to track this dynamic landscape! 🔍 #ClinicalTrials #Pharma #Biotech #COVIDEffect #Citeline #HealthcareInnovation #ClinicalResearch #Recovery

The rare disease drug development journey begins with understanding regulatory requirements and pathways and adopting a holistic approach to study design. Don’t miss the roundtable discussion: "Navigating Rare Disease Drug Development" on May 8th at 10am ET/ 3pm GMT/ 4pm CET. Register now: 🔗 https://lnkd.in/gxBX3USa Listen to experts from PharmaLex share their insights into the rare disease development pathway, such as: ➡️ Adopting optimized study design methodologies such as the use of Bayesian statistical approaches ➡️ The importance of early health authority interaction and leveraging expedited pathways ➡️ Understanding how to navigate the HTA, pricing and payor pathways. Panelists: 🎙️ Dr. Christian K Schneider, M.D., Chief Medical Officer, Strategic Product Development Consulting, Biopharma Excellence at Cencora PharmaLex 🎙️ Dennis Earle is Senior Director - Development Consulting & Scientific Affairs at Cencora PharmaLex. 🎙️ Dr. Brad Carlin, Senior Advisor, Data Science and Statistics, for Cencora PharmaLex 🎙️ Erika Wissinger, Ph.D., Senior Director, Market Access and Healthcare Consulting, Cencora #PharmaLex #RareDisease #DrugDevelopment #PharmaceuticalIndustry #BiotechIndustry #HealthcareIndustry #ResearchAndDevelopment

Thoughts on this? >> Boehringer Ingelheim, Zealand’s positive Phase 2 MASH fibrosis data ‘unintentionally’ released >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #productmarketing #pharma #pharmaceutical #healthcare #biotech

Preparing for an IND?   Identifying what in vitro data is required for IND submission and accurately predicting FIH efficacious dose is critical.  Certara’s internationally recognized consulting services can help. Our PK-guided approaches help minimize animal and dose escalation studies where possible, saving months in time and costs.   Learn how we can help optimize your FIH dose selection and streamline your drug development process. https://ow.ly/2hX250SRJCa

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

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

Thoughts on this? >> Boehringer Ingelheim, Zealand tout key fibrosis data from mid-stage MASH trial >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #productmarketing #pharma #pharmaceutical #biotech

Thoughts on this? >> Boehringer Ingelheim, Zealand tout key fibrosis data from mid-stage MASH trial >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #pharmaceutical #productmarketing #biotech #healthcare

We are thrilled to have participated in the Thirteenth London International Cough Symposium (13th LICS)! Our CMO, Peter Small, delivered an insightful talk on continuous cough recording, highlighting both published and ongoing evidence on the value of cough monitoring across various clinical indications. Hyfe’s Digital Health Lead Mindaugas Galvosas, MD and Peter also proudly presented four posters covering: - Validation of our cough monitoring technology - Cough variability in problematic coughers (97 subjects with 30d of monitoring data each) - Tracking treatment response through cough monitoring - The minimal impact of acoustic contamination Additionally, our CoughMonitor Suite was featured in two biopharmaceutical presentations: - Nocion’s Phase IIb RCC study ASPIRE, which uses our CoughMonitor Suite for continuous cough monitoring - SensoryCloud’s (FEND) studies on the impact of airway hydration on cough The importance of continuous cough monitoring was a recurring theme, with multiple presenters emphasizing its potential as a future biomarker in clinical research, routine practice, and drug development. We’re excited to continue leading the way in cough monitoring innovation! #hyfeai #AI #biomarker #coughmonitoring #coughmonitorsuite #coughresearch

Many thanks to the BEAM Alliance for inviting us to join their webinar series! In today’s session, the Swiss Round Table on Antibiotics made the case for why we need both pull and push incentives to bring new antimicrobial technologies to patients. The speakers, Rudolf Blankart, Chantal Morel, and Barbara Polek, discussed topics such as: - The antibiotic challenge: Why is the #antibiotics market far less attractive than the markets for other #pharmaceuticals? -  "Business as usual" is not an option: If we don’t find a solution to solve the major #publichealth challenge posed by #antimicrobialresistance, the costs of non-action will conceivably be enormous. - Implementation of pull incentives is gaining momentum: England and Sweden have been conducting pilot projects to test revenue guarantee models; other countries are planning to do so. In our White Paper "Effective antibiotics for the Swiss health care system: today and in the future" we suggest how a pilot project could be implemented in Switzerland to test a pull incentive-model. You will find the publication on our website: https://lnkd.in/eYVvPy_T #AMR, #globalhealth, #silentpandemic