Despite years of effort and advances in technology and data mining, bringing a drug from bench to bedside remains a costly, complex and time-consuming process with no guarantee of success. According to a recent report by Pharmaceutical Research and Manufacturers of America, “Biopharmaceutical Research & Development: The Process behind new Medicines,” it takes on average at least 10 years for a drug to make the journey from discovery to the marketplace at an average cost of $2.6 billion. And the likelihood that a drug entering clinical testing will eventually be approved is estimated to be less than 12 percent.
Researchers have begun testing ways to overcome bottlenecks in drug discovery and development, thereby streamlining the process involved in selecting a candidate drug, developing it, getting it into the clinic and then to the public. They’re becoming more proactive about identifying and investigating potential adverse effects before the clinical trial phase; using stem cells and in silico (computer) modeling to gain insights earlier into how a promising compound might react in the human body; and changing how they select and work with animal models, thereby reducing the amount of animal testing required for a new drug approval.
In a recent symposium for pharmaceutical industry thought leaders, “Preclinical Safety Strategies to Impact Early Decision-Making,” experts in pharmacokinetics/pharmacodynamics, safety pharmacology and toxicology explained how these approaches are enabling drug developers to predict sooner and with more accuracy whether a candidate drug has a chance of success.
Read the entire article, which includes a link to the webinar, here: