preclinical white papers and articles

  1. A Deep Dive Into NASH Physiology And Drug Targets 5/1/2019

    One of the problems with non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) has been a lack of understanding of the basic science. Up until the past few years, the treatment approach outside of changing lifestyle factors (i.e. diet and exercise) has been to repurpose old drugs that were used for metabolic syndrome or type 2 diabetes, since these diseases overlap in many ways. By continuing to study the basic science behind the disease and the drugs designed to treat it so that better, more specific drugs may be developed in the future.

  2. Understanding The Power Of Natural Killer Cells And New Nonradioactive Assay Approaches 9/21/2017

    With proactive planning and validated processes, NK cell functional analysis can support a range of various immunotoxicity endpoints in a study, from discovery and development to the clinic.

  3. 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.

  4. 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.

  5. The Importance Of Stakeholder Research In Rare Disease Drug Development 10/27/2016

    Leading manufacturers increasingly employ stakeholder research early in development to better identify the needs of patients and providers.

  6. Advancing Safety and Efficacy Studies with Novel Surgical Applications 7/8/2016

    Novel therapeutics such as gene and cell therapies, nanoparticles, and combination products requiring targeted delivery,  novel treatments for wound healing, cardiovascular disease, and bone regeneration,  and new medical device technologies call for innovative surgical procedures in preclinical trials to determine safety and efficacy.

  7. Understanding The True Value Of Your Biopharma Product With Earlier Intelligence 6/23/2016

    In the initial stages of drug development, it is natural to focus on a compound’s novel mechanism of action and potential implications in a therapeutic area. Yvonne Spark, Consultant, Covance Market Access Services

  8. 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.

  9. Dermal Toxicology: A Multifaceted Approach To Meet Today's Research Needs 3/3/2015

    Developing a dermal NCE generally follows the same path as other small molecule NCEs administered orally or systemically, except that the dermal route is used in a non-rodent model.

  10. 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.