Caroline Kirwan’s Post

Nearly half of the attendees to our recent Xtalks webinar agreed that infrequent measurements and assessments during clinical studies has had the most significant negative impact on their company’s CNS drug development efforts. The Cumulus Neuroscience Platform was formed in collaboration with leading global pharmaceutical companies to enable the centralized collection of objective, longitudinal real-world data across multiple domains of brain function in clinical studies. Click here to learn more. #CNS #innovation #digitalbiomarkers https://lnkd.in/gmEhx3S4

Biotrial’s CNS Breakfast Series Wrap-Up! We recently hosted three breakfast events focusing on "Translational Strategies for Successful Early CNS Drug Development." These events, led by Florian ADRAOUI and Mathieu Grace, Preclinical and Core Lab experts, gathered industry leaders for insightful discussions on key CNS drug development topics. 👉 Read the full article to learn more and stay updated on upcoming events: https://lnkd.in/egux5gqE #CNS #drugdevelopment #translationalresearch

Novel approaches and targets in #neurodegeneration at the AngloNordic Sceince Conference. Five Big Pharma key projects are in CNS drug discovery. 💡

Optimizing Pharmaceutical Innovation Through AI: A Pathway to Expedited Drug Discovery and Development: Clinical trials are using AI to handle large and complex volumes of data to develop oncology, cardiovascular, and neurologic compounds and to integrate molecular and imaging data. #finance #pharmacy #lifesciences

A message from our Industry Partner, ONO PHARMA USA! ONO PHARMA USA, the U.S. subsidiary of Ono Pharmaceutical Co., Ltd., is developing an investigational S1P5 receptor agonist, for multiple system atrophy (MSA), a rare, degenerative neurological disorder affecting your body's involuntary (autonomic) functions, including blood pressure, and motor control. There is no known cause for MSA, which affects potentially 15,000 to 50,000 Americans each year. ONO PHARMA USA is actively recruiting patients for a double-blind, parallel-group, placebo-controlled, Phase 2 clinical trial of an investigational S1P5 receptor agonist in patients with MSA in the U.S. For more information regarding this clinical trial, please email us at medinfo_us@ono-pharma.com or follow this link: https://lnkd.in/gbaR6ZZA #ClinicalTrial #MSAStudy #ONOPHARMAUSA This statement is an acknowledgment that Mission MSA received a financial contribution from the organization sponsoring this digital communication. Mission MSA has agreed to distribute information about the study, but the safety and scientific validity of the study is the responsibility of the study sponsor and investigators. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.

MEDIcept Minute: Upcoming FDA Webinar - "Regulatory Do’s and Don’ts: Tips from FDA” Exciting news for the industry! Join the FDA and NIH for their latest webinar regarding Regulatory Do’s and Don’ts on September 4, 2024, from 11 AM to 3 PM ET. This event is perfect for early-stage companies and academic spin-offs developing new anticancer therapeutics, devices, and diagnostics. Gain valuable insights into the resources and programs offered by FDA centers (CBER, CDER, CDRH) and learn when to engage with the FDA during preclinical development. Don't miss the Q&A sessions with FDA regulators. Learn more about how you can attend at the link below. https://lnkd.in/eyKhGgC5 For personalized regulatory support, contact MEDIcept Inc. at sales@medicept.com for expert guidance in navigating FDA requirements. #FDA #RegulatoryAffairs #Webinar #MedicalDevices

I am thrilled to announce that my book chapter titled "Kisspeptin-1 Signaling Pathway in Infertility: Exploring the Molecular Pathways and Therapeutic Implications for Reproductive Dysfunction" has been accepted for publication in the edited book titled "Recent Advances in Pharmaceutical Sciences (Volume 13)."

Race for #Keytruda Biosimilars Heats Up! As Merck Group approaches #LossofExclusivity for its blockbuster drug #Keytruda in 2028, multiple biosimilar players are now entering into clinical development phase. On Feb 20, 2024, Samsung Bioepis initiated a Phase 1 trial comparing the safety, efficacy, PK and immunogenicity of SB27 vs US and EU-sourced Keytruda, as adjuvant treatment in Stage II/IIIA NSCLC patients. Additionally, the company has also registered a parallel Phase 3 study in metastatic NSCLC patients (Not yet recruiting). This development positions Samsung Bioepis as the 4th global #biosimilar player to either initiate or publicly register a clinical study for a #Keytruda biosimilar. The other 3 contenders in the race include Sandoz (Parallel Phase 1 and Phase 3), mAbxience (Phase 3) and Biothera Pharmaceuticals, Inc. (Phase 1). Additionally, Formycon AG also recently announced plans to start a clinical study for Keytruda by Q4 2024 or Q1 2025, further intensifying the competition. Furthermore, few other companies are conducting clinical studies for their #Keytruda biosimilar for regional markets. #oncology #biosimilars #keytruda #strategy #pipelineanalysis #loe #competitiveintelligence #datazymes #clinicaltrials

Preclinical ADME prediction remains a significant challenge in drug development. Fowler et al. (2022) underscore the necessity of a multifaceted approach to accurately predict ADME properties for complex therapeutic candidates. Our latest article delves into the complexities of preclinical human ADME profiling, cited in peer-reviewed publications, and explores advanced human-relevant preclinical models that can enhance bioavailability estimations for improving drug safety and efficacy. 👉 Read the full article to learn more: https://lnkd.in/e7iE9Rpz #OrganOnAChip #ADME #DrugDevelopment

💊 𝐒𝐦𝐚𝐥𝐥 𝐦𝐨𝐥𝐞𝐜𝐮𝐥𝐞𝐬 𝐝𝐨𝐦𝐢𝐧𝐚𝐭𝐞 𝐚𝐦𝐨𝐧𝐠 𝐅𝐃𝐀 𝐧𝐨𝐯𝐞𝐥 𝐝𝐫𝐮𝐠 𝐚𝐩𝐩𝐫𝐨𝐯𝐚𝐥𝐬 𝐢𝐧 2023 Among the FDA & CDER 2023 novel drug approvals, oncology and haematology are the dominant therapeutic areas. 2023 brought more diversity in terms of modalities, especially bringing an increase in nucleotide-based therapeutics. According to 𝘕𝘢𝘵𝘶𝘳𝘦 𝘙𝘦𝘷𝘪𝘦𝘸𝘴 𝘋𝘳𝘶𝘨 𝘋𝘪𝘴𝘤𝘰𝘷𝘦𝘳𝘺, the FDA approved in 2023: ⚆ 34 small molecule products ⚆ 17 protein-based products ⚆ 4 oligonucleotides 𝘞𝘩𝘢𝘵 𝘵𝘳𝘦𝘯𝘥𝘴 𝘪𝘯 𝘵𝘦𝘳𝘮𝘴 𝘰𝘧 𝘮𝘰𝘥𝘢𝘭𝘪𝘵𝘪𝘦𝘴 𝘤𝘢𝘯 𝘸𝘦 𝘦𝘹𝘱𝘦𝘤𝘵 𝘪𝘯 2024? Source: https://lnkd.in/eT_j65eT #pharma #drugdevelopment #biotech #innovation #business #clinicaltrials #womeninbusiness #drjojo