Prelude Therapeutics’ Post

In a recent webinar, my #SmallMolecules colleague David Hall described some of the ongoing trends in small molecule drug development and looked at how the right choice of CDMO can help a company overcome problems as diverse as the complexity of the drug, and the demands of meeting timelines for fast-track designations. Watch here the on-demand version to learn more: https://lnkd.in/eXnAwpt2 #LonzaSM #weworkasone #cmc #cdmo

In a recent webinar, my #SmallMolecules colleague David Hall described some of the ongoing trends in small molecule drug development and looked at how the right choice of CDMO can help a company overcome problems as diverse as the complexity of the drug, and the demands of meeting timelines for fast-track designations. Watch here the on-demand version to learn more: https://lnkd.in/eZPKEnCd #LonzaSM #weworkasone #cmc #cdmo

What inspiring conversations did you have at this year’s JPMorgan Healthcare Conference? We met up with David Bearss Ph.D., Halia Therapeutics, Inc.’ CEO, to talk about his thoughts. This series of video interviews of #BioTech and #Pharma leaders is brought to you by Russo Partners. For more about us, please visit: https://lnkd.in/gqZGjQr #HealthcareConference #BiotechLeadership #JPM24 #JPM2024

Dr. Terri Gaskell, CTO of Rinri Therapeutics, shares her insights on developing and manufacturing a PSC therapeutic at IMAPAC Biomanufacturing 5.0 conference today in London. Her advice? Begin with the end in mind. Don't just focus on what is acceptable in a First-In-Human (FIH) trial, but consider what will likely change to generate a commercial product. Dr. Gaskell emphasizes the importance of collecting everything while developing your manufacturing process. This will facilitate retrospective analysis and help you identify areas for improvement. Additionally, it's crucial to know the sensitivity, robustness, and limitations of your tools. Rely on them only as much as justified. Bank sufficient material to validate your assays if justified in risk assessment. Remember, developing a successful commercial product requires thoughtful planning and attention to detail. Thank you, Terri, for sharing your valuable insights. #productdevelopment #manufacturingprocess #commercialproduct #biotech #advancedtherapies #PSC

Making the right choices is important in today’s R&D environment. Short-term thinking can lead to long term problems. Join this event featuring speakers from Catalent, JLABS and Cardiff Advisory LLC focusing on several key considerations for developing the best small molecule drug product for patients. https://ow.ly/hMat50PKCk8

Making the right choices is important in today’s R&D environment. Short-term thinking can lead to long term problems. Join this event featuring speakers from Catalent, JLABS and Cardiff Advisory LLC focusing on several key considerations for developing the best small molecule drug product for patients. https://ow.ly/hMat50PKCk8

InMed's CEO, Eric A. Adams, presenting TODAY at 1:45pm EDT at the Emerging Growth Conference. Hear about the company's #pharma programs in #Alzheimers, age-related #macular degeneration #AMD and #EB. Eric will go over the data and next steps. Register to watch the presentation: https://ow.ly/ewHW50SfMm6 $INM #investor #conference #emerginggrowth

Making the right choices is important in today’s R&D environment. Short-term thinking can lead to long term problems. Join this event featuring speakers from Catalent, JLABS and Cardiff Advisory LLC focusing on several key considerations for developing the best small molecule drug product for patients. https://ow.ly/hMat50PKCk8

This morning we published an update note on Dimerix Limited. The company's flagship asset, DMX-200, is in a Phase 3 trial for focal segmental glomerulosclerosis (FSGS). It is the only such product to be in Phase 3 for FSGS, and there are no treatments on market already. Earlier this month, the company released results of the first interim analysis and these showed positive results. Dimerix has several near-term milestones awaiting it such as the execution of potential licensing deals for available jurisdictions, (including the US and China), and recruitment and dosing of 144 patients for Part 2 (the second analysis outcome is estimated for mid-CY25). Dimerix is well poised to bring the drug to market with an existing commercial partner for Europe, Canada and ANZ in Advanz Pharma, and potentially more to come in jurisdictions not covered by Advanz Pharma. We update our valuation of Dimerix to A$0.63 per share in a base case scenario and A$0.83 per share in an optimistic case scenario. We have reduced the discount rate in light of the company’s results, but have also the increased the number of shares on issue after the recent capital raising. Please be advised that this report is General Advice only and is a report commissioned by the Company. Please see p.10 for the key risks and the final page for the full General Advice Warning, disclosures and disclaimers. #dimerix #dxb200 #kidneyhealth #kidneydisease #biotech #biotechs #biotechstocks #healthstocks #ASX #equities #equityresearch #researchreport #researchinitiation https://lnkd.in/gbCjh5va

1 week left to register for a free webinar on "Navigating the New Era of Asset Maintenance Management: 4D Molecular Therapeutics’ Transformation". https://lnkd.in/gHFh-dG8 . Attendees will learn how 4D Molecular Therapeutics overhauled their manual maintenance-related processes throughout their facility, unveiling a plethora of improvement opportunities. Dave Porrill from Blue Mountain and Wes Champion from PCI will discuss 4DMT’s journey of implementing a validated Computerized Maintenance Management System (CMMS) and the tangible benefits they reaped. It not only brought about better alignment and structure to their processes, but it also revolutionized their maintenance workflow. Register here to attend: https://lnkd.in/gHFh-dG8 .  #BlueMountainRAM #GMPDigitalMaturtityModel #RegulatoryAssetManager #AdvanceGMPcompliance