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. What Does The Chan Zuckerberg Biohub Mean For Clinical Research And EDC?
    4/19/2017

    Medical research has seen a great deal of high-profile philanthropic investment in recent years. Last year, for example, tech billionaire Sean Parker made a $250 million donation to further the development of immunotherapy. More recently, the Chan Zuckerberg Biohub has made headlines by announcing plans to invest $3 billion in new research over the next 10 years. The investment is part of the Biohub’s ambitious goal of curing all disease by the end of the century. It will be directed toward a wide array of medical solutions including new drugs, vaccines, and diagnostic tests - and the first round of grant recipients has already been chosen.

  4. 3 Early Obstacles In Phase I Clinical Trials, And How To Address Them
    2/23/2017

    Anyone with an involvement or interest in clinical research is likely to be aware of the challenges sponsors face in getting their compounds approved by the FDA. The low rates at which drugs make it all the way through the research process is a favorite topic of blogs and journalistic outlets covering clinical research. Many of the drugs that fall by the wayside suffer that fate because of unfavorable efficacy data in the middle and later phases.

  5. Avoiding Headaches In Today’s Complex Phase I Landscape
    1/23/2017

    Statistics suggest that Phase I clinical trials, while by no means free of challenges, are more manageable than later phases. They tend to take less time and cost less money; the drugs they test have a comfortable 70% chance of moving on to the next phase.(1) These figures are a reprieve from some of the realities that make Phase I trials, in some respects, uniquely stressful. The absence of a safety profile for the drug being tested can make subject recruitment particularly challenging. And any errors or delays in Phase I can set the tone for the rest of the drug development process.

  6. Educating Tomorrow’s Clinical Researchers
    10/28/2016

    A drug’s journey from proof of concept to FDA approval is a years-long, far-reaching process in which healthcare, business and government each play important roles. For aspiring clinical researchers hoping to navigate this sprawling field, there’s certainly a lot to learn. We thought we’d take a look at a pair of initiatives educating students in healthcare and pharmacology in the many aspects of clinical research. Driving these initiatives is the understanding that clinical research shouldn’t be a niche skill, that strengthening knowledge of clinical research among all kinds of healthcare providers will strengthen the healthcare industry as a whole.

  7. 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.

  8. Integrated Workflows: The Unsexy Plumbing Of Clinical Trials
    7/29/2016

    There is no doubt that clinical research is critical to the advancement of medicine and public health. But conducting such research is a complex, resource intensive endeavor that relies on a multitude of stakeholders, workflows, processes, and information systems.

  9. 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.

  10. It’s Site Selection, Not a Toss of the Dice
    7/7/2016

    When shooting craps,odds are 17% that the player will role a 7 to start the action, and the odds of actually winning may be even lower. But, the odds of selecting sites that perform well in clinical trials are worse, far worse.