preclinical white papers and articles

  1. Phase I Studies: From First Drug Design To First-In-Human Studies 5/8/2017

    Phase I is often seen as the gateway between scientific research and clinical medicine, and the outcome of the trials have a major impact on the next steps of any prospective drug.

  2. Precision Medicine In Immuno-Oncology 5/4/2017

    The ongoing advances in cancer immunotherapy together with precision medicine may promise a bright future for patients. Learn about the two most common biomarkers in clinical trials that are critical for the drug development process.

  3. On-Site Manufacturing In Early Clinical Drug Development (In Europe) 3/13/2015

    Early drug development requires adherence to Good Manufacturing Practices (GMP) guidelines when manufacturing investigational medicinal products (IMPs) for clinical studies conducted within Europe.

  4. Catching Up With The Consumerization Of Technology In The Clinical Trial World 2/21/2014

    Not too long ago, a clinical operations professional likely enjoyed more powerful technology capabilities at the office than at home. She had a sophisticated email infrastructure, shared calendaring, a high-speed network and maybe a Blackberry.

    At some point during the last 15 years this trend flipped. Suddenly people had better tools in their personal lives and the limitations of their office tools became apparent by comparison – for example, systems that won’t talk to each other, small inbox quotas, file size attachment restrictions, slow email searches and difficult file sharing. Meanwhile, consumer technology rapidly became more sophisticated, available and accessible with collaborative cloud-based tools, personal devices and similar applications to improve the efficiency of everyday tasks.

  5. Toxicometabolomics For Compound Attrition To Reduce Late Stage Failures Due To Safety 4/10/2013

    Many ’omics’ technologies have now become the primary way of discovering new biomarkers, and validation of these biomarkers is a relatively new and evolving concept. By Michael V. Milburn, John A. Ryals, and Lining Guo

  6. How To Leverage Modeling And Simulation In The Candidate Development Stage

    Modeling and simulation provides another way to predict the clinical performance of a molecule, based on a robust and holistic approach, before investing the required time and money.

  7. Impact OF A Pandemic Outbreak On Vaccine Development Approach

    Several challenges with traditional vaccine development methods must be overcome in order to reduce the timeline for vaccine distribution.