Elias Zerhouni, president, global R&D, Sanofi, outlined four areas—patient needs, regulations, payer-driven markets, and science—as key challenges for drug research and development during a keynote address at an innovation and funding summit hosted by BioNJ's Diagnostics & Personalized Medicine Initiative.
Understanding patient needs and scientific approaches are closely tied. Early successes in animal models and genomics gave the drug research community a false picture and those findings did not translate to humans, Zerhouni said. He urged a shift in research strategy to one that looks first at the patient population and is based on a better understanding of disease biology.This new approach will require a change in the way drug companies conduct R&D business. Closed R&D campuses are a thing of the past in other industries, but pharma has resisted, Zerhouni said. The industry needs to evolve to an open R&D system.
Traditional business, medical, and personal-health practices also face upheaval; event speakers identified examples in medical diagnostics. New diagnostic devices based on smartphone technology can monitor heart rates, blood pressure, blood sugar, and more. While many of these devices and applications are still unproven, the appeal for lower-cost diagnostic technologies is strong in emerging nations.
US firms are developing technology that the US market does not want to adopt due to existing payer models, entrenched practices, and regulatory hurdles, said G. Steven Burrill, CEO of Burrill & Company at the BioNJ event. These technologies may allow emerging nations to "leap-frog" established countries and implement better healthcare systems, said Frank Prendergast, MD, PhD, professor of Biochemistry & Molecular Biology and Professor of Molecular Pharmacology & Experimental Therapeutics, The Mayo Clinic.
While technology may allow a patient to turn to their smartphone for routine diagnostics, the high cost of medical care may force patients and doctors to use such technology. In 2010, the US spent 17.6% of its gross domestic product on healthcare. The average per-person-cost of $8,233 per year is more than 2.5 times more than most developed nations, and by far the most in the world, according to the Organization for Economic Co-operation and Development. For the medical establishment, including drug companies, the price people will pay for medical care is a deciding factor in how products are produced or if the products are produced at all.
In mid-June, the International Society of Pharmaceutical Engineers (ISPE) released results of a survey on drug shortages, which examined manufacturing and quality issues that contributed to the recent spike in drug shortages. However, the survey did not address economic or business choices that may have had an impact on the shortages. Participants at the ISPE/FDA conference, Ensuring a Reliable Supply of Quality Medicines, where the study was released, noted financial factors often drive corporate decisions about which products should be manufactured.
New drugs are expensive to develop and produce. Some prove too expensive to be consumed. Others are too cheap to be manufactured for a profit. Change to achieve a patient-centered solution that still meets business goals will be difficult, but necessary.
Rita Peters is the editorial director of BioPharm International.