Dana O.’s Post

A Superagonist, A Novel Anti-obesity Agent from a Zebrafish Screen, and More News Highlights From January 2024 | https://lnkd.in/gkBDxXgk Among the small molecule highlights in January’s news were a $100M+ Series A for a PARP1 + PI3Kα focused company, clinical data with an SLC inhibitor for PKU (Jnana Therapeutics), a 5-HT2C superagonist for seizures (Longboard Pharmaceuticals), and a NK1,3 dual antagonist for women’s health (Bayer | Pharmaceuticals, GSK). A novel anti-obesity agent from phenotypic screening also made headlines, and the close of a major acquisition may bring relief to the industry. You can read about these notable scientific highlights and more in our January news roundup. Full Article: https://lnkd.in/gkBDxXgk

Slides from the recent keynote "Biopharma Dealmaking: Time for a Re-Think" I delivered at the Swiss Healthcare Licensing Group meeting in Montreux in May are now available on the Lumanity website. https://lnkd.in/ePi9Vwse This data rich presentation is important viewing for anyone involved with or interested in biotech corp dev strategy but especially for those pre-commercial biotech "sellers" pinning their hopes on a large pharma partnership. The historically unprecedented increase in the number of biotechs reaching or surpassing clinical PoC stage (5 x or greater over past decade) coupled with a limited number of large pharma "buyers" means odds for vast majority of would be sellers are long. Many more of these biotechs should start to see self-commercializing, especially those pursuing advanced therapeutic modalities, such as cell and gene therapy, as more of a "Plan A" than B. And for many of these companies the time to get started is now, not when they are late in P3 or beyond.

Fascinating analysis from Ed Saltzman. In the current environment, it is time for #biotechs to rethink exit strategies and prioritize current resources to derisk commercial #risks, especially for novel/complex modalities. Novel technology platforms should also focus on demonstrating agile #CMC production process to increase incentives for partnering. However, self-commercialization should also be on the table regarding next steps. #drugdevelopment #biotech #investor #partnering #businessdevelopment #riskassessment

Join us on September 30th for an exciting webinar with Bioanalysis Zone: Unlocking the Future of Antibody-Drug Conjugates. Dr Eric Thomas and Dr Eric Bonner will dive into the bioanalysis strategies, innovations and discuss what the future holds for the bioanalysis of ADCs. Please be sure to register. #Bioanalysis #AntibodyDrugConjugates #Webinar #LabCorp #Innovation

Discover the significance of plasmid DNA, updates in regulatory guidelines for your therapeutic projects, and success stories in accelerating ATMP development. Join Dr. Andrew Frazer for a concise 30-minute case study webinar. Watch here: https://okt.to/Oq4ICG #plasmiddna #genet

Don’t miss the upcoming panel discussion on LBA and LC/MS/MS hybrid assays hosted by Bioanalysis Zone. Shashank Gorityala, Associate Director of LC/MS Operations, and a panel of experts will explore whether hybridization assays are the new norm and discuss the pros and cons, including equipment requirements, digestion considerations, multiplexing potential, and future trends. #LCMS #HybridAssays #biotherapeutics #InnovationInScience #bioanalysis #massspectrometry #drugdevelopment https://lnkd.in/gmhUzkzZ

The ICH M12 #DrugInteractions Guideline has been finalized and global regulatory agencies are already adopting it. Are you? The new Guideline replaces the corresponding guidance documents from the US FDA, EMA, and PMDA, among others. Join us on July 23rd to hear DDI expert, Dr. Brian Ogilvie, discuss what’s new and how to plan your drug development strategies: https://hubs.ly/Q02D0PnY0 #DrugDevelopment #ADME #DMPK #Enzymes #DrugTransporters

As the IVD industry continues to evolve, new regulations frequently come into place to better control an innovative and growing industry. Molecular IVDs in particular are experiencing tighter regulations regarding the presence of appropriate controls within the assay. All tests must include both positive and negative controls which are subjected to the whole testing process, including the extraction step. Novel co-extracted exogenous controls are providing cutting edge solutions for monitoring RNA or DNA analysis including the detection of potential inhibition. These controls can be used across a variety of sample types and assays, representing a significant advantage over traditional spike-in controls. Learn more by watching our webinar on “Novel Solutions for Improved Process Control in Your Molecular IVD Assays”. Click here: https://hubs.la/Q02dssbz0

Differentiating human iPSCs into liver cells involves specific stages and media, each with unique growth factors and cytokines. Using iQue®️3 High-Throughput Screening by Cytometry in combination with live-cell analysis and Sartorius Research Use Growth Factors, we've established a straightforward, standardized method for creating mature liver organoids, streamlining the production of functional liver cells from iPSCs for research in drug development and toxicity testing. Learn more in our application note: https://ow.ly/tX4B50Rhsjx #ipscs #organoids #drugdiscovery #cellanalysis #flowcytometry #hts

Join Prof. Johan Gabrielsson and Dr. Bernd Wendt for a new case study analyzing acute and repeated dosing of a monoclonal antibody (mAb) using literature data, followed by an exploration of pharmacologically relevant questions. 🗓️ 𝗗𝗮𝘁𝗲: June 26 🕒 𝗧𝗶𝗺𝗲: 10 AM ET 📚 𝗪𝗲𝗯𝗶𝗻𝗮𝗿 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀: ・Insights from the 6th edition of the standard book "Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications." ・Simulation of new synthetic population data. ・Extended pharmacological reasoning to calculate in vivo potency (IC50), covering binding properties, target turnover, and complex kinetics. ・Demonstration of pivotal pharmacological target properties. 🔍 𝗪𝗵𝘆 𝗔𝘁𝘁𝗲𝗻𝗱? ・Discover how new expressions of in vivo potency offer robust parameters for predicting exposures and doses across different individuals and species. 🔗 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝗡𝗼𝘄: https://ow.ly/WGGp50S904v #Pharmacokinetics #Pharmacodynamics #PKPD