Serán BioScience is a leading science-based CDMO that specializes in a variety of drug delivery and formulation approaches suited to optimizing bioavailability. Serán’s experienced formulation team works with customers to identify an appropriate technology and formulation strategy to meet each program’s unique needs with a material-sparing approach. For early discovery and toxicology studies, our scientists utilize a variety of suspension and solution approaches to obtain desired in vivo exposure, especially at high doses. As programs advance to the clinic, Serán's solid dosage form approaches are designed to achieve preferred performance and are engineered for scalability. Learn how Serán's approach to formulation development can gain your molecule the competitive edge. https://hubs.li/Q02vs9zx0 #drugformulation #cdmo #drugdevelopment
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SP-26, Silo’s novel time-released, dosage-controlled formulation of #ketamine, is utilizing Zylö Therapeutics’ Z-pod technology. The drug revealed positive toxicology results in a study that evaluated the feasibility of using a rising dose design or maximum feasibility. “We are advancing our work with our regulatory partners to prepare a Pre-Investigational New Drug (IND) package for SP-26 and intend to pursue the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval, “ said CEO, eric weisblum. Learn more about SP-26 here: https://lnkd.in/g9sv-Cfh #Psychedelics #PsychedelicResearch #Biotechnology #Biopharma #Science
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This week we touch base on the subject which dates to 300 BC, preclinical testing study, where drugs undergo extensive laboratory and animal testing to assess their safety and potential effectiveness. This study gives an understanding of preclinical global CRO market and some of the recent development with US FDA giving a nod to alternative methods of trials such as computer models, cell cultures, organ-on-chip, etc. could bring a paradigm shift in the sector. It will be interesting to see how the sector will shape up with upcoming alternatives and increasing reliance on data driven approach like GAN method. The adoption of advanced alternatives to traditional animal models could reshape the way pharmaceutical companies conduct research and development, fostering a more ethical and efficient approach to drug testing. #drugdiscovery #CRO #preclinical #drugtesting #pharma #pharmainnovation #alternatives #advancement #researchanddevelopment #shift #lifesciencesindustry #GAN #3dbioprinting
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From early safety assessments to predictive modelling and QSARs, the drug development journey comprises of a number of crucial testing stages. Regardless of whether it’s in vivo, in vitro or in silico, all of this testing must be performed to rigorous regulatory standards prior to any drug getting to market for human consumption. This long and complex journey of discovery, development and evaluation is time-consuming and costly, with only around 12% of the drugs that enter clinical trials reaching pharmacy shelves. Find out more about the crucial role toxicology research laboratories play in drug discovery! Read the blog here - https://bit.ly/3YTxnri #preclinical #invivo #drugdiscovery
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Stefanie Johns, PhD is honored to be a part of the panel discussion, Navigating Unknown Compounds in Medical and Combination Device E&L Studies, from a Chemistry, Toxicology and Regulatory Standpoint, on 24 August 2023. Learn more about the webinar panel discussion here: https://lnkd.in/gNTbPFWX #regulatoryaffairs #lifescience
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Talking to and partnering with the experts can save time, money and enhance the prospects of success
From early safety assessments to predictive modelling and QSARs, the drug development journey comprises of a number of crucial testing stages. Regardless of whether it’s in vivo, in vitro or in silico, all of this testing must be performed to rigorous regulatory standards prior to any drug getting to market for human consumption. This long and complex journey of discovery, development and evaluation is time-consuming and costly, with only around 12% of the drugs that enter clinical trials reaching pharmacy shelves. Find out more about the crucial role toxicology research laboratories play in drug discovery! Read the blog here - https://bit.ly/3YTxnri #preclinical #invivo #drugdiscovery
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While working to identify the different methodologies used in drugs of abuse screens, the following has evolved. Would you agree? Or what did i miss? TIA - EMIT, immunoassay - GC, gas chromatography - GC-MS, gas chrom, mass spectrometry - LC-MS, liquid chromatography, mass spectrometry -LC-MS/MS, liquid chromatography, tandem mass spectrometry Does anyone use HPLC routinely in toxicology?
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I’m excited to speak about the current regulatory landscape for developing therapeutic products. I have been fortunate to witness and to help drive the evolution of this landscape as an FDA regulator and consultant. Please register for my in-person presentation at the link below - I’m looking forward to sharing my experiences and insights and engaging the audience in discussions on how to leverage the current regulatory landscape. #Allucent #BringNewTherapiesToLight #RegulatoryAffairs #FDA #DrugDevelopment #DrugDiscovery
Join Marcus Delatte, PhD, Vice President, Regulatory Strategy at Allucent and former Senior Pharmacology and Toxicology Reviewer at the FDA, as he shares his insights acquired over an 18+ year career in drug discovery and development. This informative discussion on "Navigating an Evolving FDA Landscape" will take place with Portal Innovations, LLC in Chicago, IL. Topics will include: - Current therapeutic development landscape - FDA's governance of drug approval - Emerging science policy issues involving the FDA - Strategies for entrepreneurs to leverage these developments This event will take place on Thursday, April 11th from 9:30-11:00 a.m. CT. Register here: https://lnkd.in/gcYHqwwm #Allucent #BringNewTherapiesToLight #RegulatoryAffairs #FDA #DrugDevelopment #DrugDiscovery
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Discover strategies to overcome matrix effects, endogenous interference, and calibration difficulties in our new whitepaper. Utilize high-resolution mass spectrometry (HRMS) for enhanced detail and specificity in any animal matrix, empowering your research endeavors. #highresolution #biotech #immunotherapy #pharma #fda
Read the Whitepaper.
analytical.sannova.net
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Assisting to connect biotech and pharma companies with nonclinical experts to help advance new therapies.
Avoid getting too far into your IND program or toxicology study and realizing you are not prepared for your SEND dataset submission. Join Audrey Walker (Senior Director SEND Practice Lead at Charles River, CDISC SEND Mentoring Lead) on June 14 for a live webinar. Get the latest SEND updates that are impacting nonclinical studies today and in the future. https://lnkd.in/gkTeuNj6 #send #webinar #biotech #biotechnology #pharmaceutical #drugdevelopment