preclinical white papers and articles

  1. Educating Tomorrow’s Clinical Researchers

    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.

  2. The Importance Of Stakeholder Research In Rare Disease Drug Development

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

  3. Integrated Workflows: The Unsexy Plumbing Of Clinical Trials

    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.

  4. Advancing Safety and Efficacy Studies with Novel Surgical Applications

    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.

  5. It’s Site Selection, Not a Toss of the Dice

    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. 

  6. Understanding The True Value Of Your Biopharma Product With Earlier Intelligence

    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

  7. Creating Your Biomarker Strategy From Discovery To Development

    In the effort to reduce attrition rates and improve approval rates of new molecular entities by regulatory agencies, there’s no doubt that biomarkers can make a big impact. But it’s not as simple as tacking on additional studies. Biomarker development requires an insightful strategy and consideration of specific opportunities and needs throughout the drug development pipeline.

  8. Making Sense Of Antisense Oligonucleotide-Based Therapies In Muscular Dystrophies

    Good news for the Duchenne Muscular Dystrophy (DMD) community. On June 8th, BioMarin announced the filing of a Marketing Authorization Application to the European Medicines Agency for Drisapersen, an antisense-mediated exon 51-skipping compound able to target the most prevalent genetic mutations responsible for the lack of production of functional dystrophin. The European filing follows the submission of a New Drug Application to the US FDA for Drisapersen back in April 2015.

  9. On-Site Manufacturing In Early Clinical Drug Development (In Europe)

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

  10. Dermal Toxicology: A Multifaceted Approach To Meet Today’s Research Needs

    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.