Preclinical feature articles

  1. France Tragedy Reminds Us Phase 1 Researchers Must Live With Tragic Results

    The recent clinical research tragedy in France that resulted in the death of one patient and the hospitalization of four others shocked many who work in the clinical research space. The adverse effects experienced by the previously healthy patients, reportedly involving deep brain bleeds, were both rare and disturbing.   

  2. Health Experts Weigh In On Zika Risks And Potential For Future Outbreaks

    With the Zika virus spreading in the Americas, the outbreak and potential for future outbreaks in other areas of the world has many health professionals and organizations concerned. The European Society of Clinical Microbiology and Infectious Diseases (ESCMID), which promotes research, risk assessment, knowledge sharing, and best practices in the fight against infectious diseases, is one of those organizations.

  3. What Went Wrong In France?

    According to news reports, a drug undergoing testing in a French clinic has left one patient dead and four others critically ill, two that may have permanent brain damage. The drug has thus far been unnamed, but it appears to have been produced by the Portuguese company Bial. The French health minister has stated the drug acted on natural receptors found in the body known as endocannibinoids, which regulate mood and appetite.

  4. Quantitative Systems Pharmacology Brings Value To Drug Development

    Quantitative systems pharmacology (QSP) sits at the interface between pharmacometric modeling and simulation, and systems biology. It uses mathematics to describe biological processes. While pharmacokinetics describes what the body does to the drug, pharmacodynamics quantifies what the drug does to the body; the pharmacological response. QSP is a mechanistic modeling approach and an emerging technology, which mathematically integrates pharmacokinetics, pharmacological response and disease progress/modulation.

  5. High Drug Prices: Should We Blame Pharma Or The FDA?

    Last week, the Internet blew up over the greed of pharma companies and the cost of life-improving and life-saving medicines. This time the hatred was focused on Martin Shkreli, CEO of Turing Pharmaceuticals, whose company purchased the generic drug Daraprim and immediately increased the price from $13.60 to $750 per pill. Patients were angry, and politicians were outraged. The uproar even caused one presidential candidate to immediately issue a plan to try and fix the problem. But is the anger being directed at pharma deserved or misplaced?

  6. WIB Profile: CROs Must Have The Ability To Deliver

    Zhaoqing (Ching) Ding has been involved with the sciences for more than 15 years. She earned a B.S. in Microbiology and a M.S. in Immunology, both from the University of California, San Diego. She then earned a Ph.D. in Immunology from the Stanford University School of Medicine before rounding out her education by attending the program in Innovation and Entrepreneurship from the Stanford University Graduate School of Business. She started her career performing research in academia before joining The Janssen Pharmaceutical Companies of Johnson & Johnson as a scientist in 2013. In this WIB profile article she shares her experience in working in academia versus pharma, the challenges of working with CROs, and the future potential of biotherapeutics.

  7. Why Do Most Clinical Trials Fail?

    According to the latest industry research, about 90 percent of drugs that reach clinical stage development never make it to FDA approval and commercialization. At first glance, one could conclude that the reason is the stringent FDA review process designed to ensure that only products that deliver an acceptable efficacy and safety profile ever reach consumers. But a more detailed analysis of the results of many clinical research programs tells a different story.

  8. How Informed Are Patients When They Give Informed Consent?

    The informed consent process and its intent is necessary, but problems can arise when patients try to digest informed consent information that is often spelled out in 20-plus page documents. These documents are essential to properly convey the trial activities, however, they are riddled with medical terminology that is difficult for patients to decipher. Furthermore, protocols are becoming increasingly complicated.

  9. Understanding Key Early Phase Clinical Trial Cost Drivers

    Pharmaceutical companies have been implementing intensive cost–saving efforts in the recent years through mergers, reducing overheads, and trimming down of entire business units for efficiency. These efforts have increased the need to outsource services to external vendors throughout the R&D value chain. The early phase clinical trial market in 2014 saw an approximate outsourcing rate of 56 percent with most of the patient studies being externalized to both global and specialist CROs. As cost efficiency is the main focus for pharma, it is important to understand the cost behavior of outsourcing services.

  10. Signal Management In Drug And Biosimilars Development

    Signal management in drug development has been ongoing, evolving, and improving for many years. For the European Medicines Agency (EMA), Food and Drug Administration (FDA) and other regulatory bodies immunogenicity is a major area of safety concern for biosimilars as well as for peptide, protein, and drug therapeutics, all of which have the potential to trigger some level of antibody response.