Biomere (Biomedical Research Models, Inc.)’s Post

The 4th Annual Psychedelic Therapeutics and Drug Development Conference has officially commenced! As a leader in helping bring psychedelic-assisted therapy to global health authorities for approval, we are hopeful that the discussions over the next 2 days bring forth new collaborations, ideas, and perspectives to a growing segment in the pharmaceutical industry. Don't miss our Regulatory Expert, Ritchie Patton’s session titled 'A Psychedelic Shift: Assessing the Potential for Nonmedical Use in a Changing Regulatory Landscape' on the first day at 4 PM! This session will dive deep into the challenges and nuances of evaluating nonmedical use potential for psychedelic drugs, highlighting the need for a refined regulatory approach. Expect insights into the FDA's requirements for abuse potential summaries and unique considerations for psychedelic therapeutics. For a deeper understanding of the evolving regulatory landscape and its implications, check out our latest blog: "Psychedelics and Regulatory Considerations Part II: A Shift in Lexicon and Implications of 'Nonmedical Use' on Labelling." 📖 Read more here: https://hubs.li/Q02yfjQQ0 #MDMA #Psychedelics #FDA #NewDrugApplication #PTSD #Neuroscience #DrugDevelopment #PsychedelicTherapeutics

Advances in Peptide drug formulations have led to the development of target-specific, longer-lasting treatments for patients. The FDA recently issued draft guidance for the clinical pharmacology considerations for peptide drug products. The guidance outlines the importance of assessing immunogenicity and the impact of hepatic impairment and drug-drug interactions on pharmacokinetic (PK) and pharmacodynamics (PD) parameters. Celerion’s team of clinical and bioanalytical experts provides comprehensive solutions for peptide drug development. FDA draft guidance: https://lnkd.in/gYt_weiM Learn about our approach to peptide drug development: https://lnkd.in/emwydYv #Celerion #FDA #DDI #PKStudy

Neuraxpharm and Minoryx Therapeutics announced today that the companies are seeking a re-examination of #leriglitazone for conditional approval for patients with cerebral adrenoleukodystrophy (cALD), following the negative CHMP opinion.   cALD is characterized by demyelinating brain lesions which can become rapidly progressive, leading to acute neurological decline and death in three to four years. #Neuraxpharm and #Minoryx believe that leriglitazone could be a lifesaving treatment for these patients in a disease without pharmacological treatment options available.   Find out more in the press release here: https://lnkd.in/ddHw2CMf   #CNS #cALD #pharmaceuticals #pharma 

Cardiac liability of new therapeutic agents needs to be thoroughly investigated during a preclinical drug discovery program. Towards this, CRL now offers a comprehensive assessment of cardiac liability for novel compounds using established CiPA Ion channel panel, on Automated Patch Clamp system. For more details contact our client service https://lnkd.in/eGbNJsNC or connect with our specialists Stefano Stabilini and Amit Kumar Chouhan, PhD #drugdevelopment #CharlesRiver #Cardiotoxicity #pharmacology #drugdiscovery #ionchannels Follow us at Discovery | Charles River

Predicting how well a drug clears from the body is critical for the success of drug discovery and development. This recent study reported findings of a physiologically based pharmacokinetic model to accurately predict target concentrations and assess the risk of drug interactions. These strong findings using a humanized mouse model has the promise to accelerate the progress of drug discovery and development. Read the findings here: https://bit.ly/3QnrMpo. #TheJournalofPharmacologyandExperimentalTherapeutics #pharmacology

Continued Emphasis on the Brain Disease Model: Despite its limitations, the brain disease model continues to dominate largely because it supports the development and funding of medical treatments and pharmaceutical interventions, which are concrete, scalable, and economically beneficial for the medical and pharmaceutical industries. Additionally, this model has played a significant role in shaping public policies and research agendas. #Addiction #Recovery

October is #BreastCancerAwarenessMonth. NeoGenomics is passionate about equipping physicians and pharmaceutical partners with the tools to deliver precision medicine to their patients. Below includes national statistics as well as insights derived specifically from NeoGenomics.   #BreastCancer #FastFacts #NeoGenomics #CancerTesting

Our latest review article, "PATHOLOGICAL SIGNALING PATHWAYS AND THERAPEUTIC STRATEGIES FOR CARDIAC FIBROSIS," has now been published in the esteemed *World Journal of Pharmacy and Pharmaceutical Sciences*. We explore cardiac fibrosis, its signaling pathways, and cutting-edge anti-fibrotic therapies. By understanding these pathways, we aim to improve patient outcomes. 🔗 Read the full article here: [Link](https://lnkd.in/debPACsk) Kudos to the entire research team! Let's make a difference in cardiac health together. 💪🫀 #CardiacFibrosis #ResearchPublication #MedicalAdvancements #HeartHealth #ScientificDiscovery

Attention Pharmaceutical Drug Developers- Clinical Research for Liver Disease is about to get easier... with the latest innovations in non-invasive liver imaging from E-Scopics and the #Hepatoscope. We are excited to announce that #Hepatoscope is now being utilized at California Liver Research Institute. E-Scopics is proud to partner with CLRI and Dr. Edward Mena, to support MASH drug studies and accelerate screening #Hepatoscope.

Join Dr. Thorsten Dr. Ruppert from the German Association of Research-Based Pharmaceutical Companies at the ClinBiz Summit 2023 (Fully Online) on October 23-25, 2023. Have your teams attend fully online with the very affordable group ticket options - It is an event you DO NOT want to miss! For the full agenda, speakers and to register visit ( www.clinbizsummit.com ) today. #clinicaloperations #clinicaltrials #clinicalresearch #pharma #oncology #biotech #digitalhealth #investigatorgrants #fairmarketvalue #clinicalstudybudgets #clinicaloutsourcing #clinicalfinancials #clinicalcontracts #decentralizedtrials #decentralizedclinicaltrials  #clinicalbudgets #sitepayments #sitebudgets #virtualtrials #investigatorfees #fmv #clinicalstudy #clinbiz #innovation #studystartup #sitecontracts #siteagreements #clinicaltrialagreements #ClinBiz #cta #clinical #sourcing #ClinBizSummit