It is our belief that intelligently designed clinical development programs and clinical trials, driven by rigorous science, and based on well conceived proof of pharmacology and proof of principle studies are essential for driving a product concept through development and ultimately to regulatory approval.  The recent trend, among small companies in particular, to prematurely initiate phase 3 clinical trials before they understand the pharmacology of their drug is responsible for many of the failed products, programs and companies that litter the landscape.  We advocate beginning many clinical programs seeking to develop new chemical entities (NCEs) with small, and relatively inexpensive,  proof of pharmacology studies that ascertain whether the preclinical observations that support the efficacy of the drug are valid in human beings and in the intended clinical target in particular.  Once the pharmacology is established, it is then important to validate the concept in relatively modest but carefully designed phase 2 proof of principle studies that confirm the likely efficacy of the drug, and narrow the optimal dosing range and regimen.  Once this is established, and it need not take very long if properly planned, then the program may proceed to expensive phase 3 studies with much of the risk reduced.

A rapidly growing disparity distinguishes the remarkable accomplishments of basic science over the past century, with our ability to translate them into practical therapeutics for patients with serious illnesses.  Funding for basic science has increased on average 13% per year over the past 25 years.  This has led to a dramatic improvement in our understanding of cellular and molecular mechanisms of disease, genomics, proteomics, neuroscience, and the identification of hundreds of new drug targets.  Despite these remarkable advances, we face a crisis in our inability to move science from the bench to the clinic.  The number of new innovative drugs has remained constant at about 20 per year over this same period of time.  However, the number of drugs brought prematurely through clinical development, the number of clinical trials being conducted, and the total expenditure on clinical research by the pharmaceutical industry has increased many times.   The vast majority of these programs end in failure.

Parallax Clinical Research has both in-house and network based expertise to guide pharmaceutical companies and biotechnology companies through the process of moving qualified drug candidates into clinical development and through the process towards FDA approval.  We also have the expertise to assist venture capital firms in identifying those programs that are most promising from a scientific and clinical perspective.