Insights On Drug Discovery

  1. Don't Skip Preformulation: Your Blueprint For Drug Development Success 9/22/2023

    Investing in the right preformulation studies and gathering evidence to inform decisions is critical to identify product dead-ends and failure modes without the pain of hindsight.

  2. Recommendations For Successful IND Approval Of RNA-LNP Drugs 8/22/2023

    The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.

  3. Managing Momentum With Rezolute Bio's Nevan Charles Elam, JD 8/16/2023

    Since we last spoke in the Spring of 2021, Nevan Charles Elam, JD has managed to advance both of small-but-mighty Rezolute Bio's candidates onto the next phases of their journey. This year, on the back of a $130 million investment, Rezolute Bio is prepping its RZ358 candidate, a monoclonal antibody for congenital hyperinsulinism, for a pivotal phase 3 trial. On this week's episode of the Business of Biotech, we're settling in for an interrogation of Elam on the management principles of maintaining multi-candidate clinical momentum among highly disparate candidates and raising big dollars as a small biotech.

  4. Optimizing Drug Discovery And Development Collaborations 8/15/2023

    As demand for more precise, tailored CRO services grows, so does the emphasis drug developers place on their partners’ flexibility, agility, and enthusiasm for collaboration.

  5. Apollo, A Unique Cloud-Based Platform, Takes Flight At Charles River 8/14/2023

    The leading-edge system breaking new ground in the contract research space offers real-time access to study data and empowers users with self-serve access to analyze their important data.

  6. Best Practices Under ICH E14/S7B For Non-Clinical, Clinical Strategies 8/14/2023

    Scientific experts discuss how the ICH E14/S7B (Q&As) in vitro hERG and in vivo QT assays will be conducted, interpreted, and reported.

  7. De-Risking Preclinical Candidates With Predictive Immunotoxicology 8/14/2023

    From target engagement and mechanism of action to efficacy and prediction of adverse immune reactions, immunology assays deliver data that reduce your risk of failing later.

  8. Direct CNS Delivery Of Oligonucleotides: Beware Of The Unexpected 8/14/2023

    As we gain more experience in the CNS ASO administration field, we are beginning to see unexpected scenarios arising despite using “well-understood” oligonucleotide backbones.

  9. Digital Pathology And Machine Learning 8/14/2023

    Learn how digital pathology can advance non-clinical pathology workflows and expand opportunities to improve study outcomes with increased speed and flexibility, data quality, and communication pathways.

  10. Challenges And Solutions For Viral Product Development, Manufacturing 8/3/2023

    To execute complex viral product manufacturing, a service provider needs expertise in adherent cell culture capabilities, cell line productivity, and the intricacies associated with these products.