The pharmaceutical and biomedical research industry have had many successes over many years, curing and eradicating diseases, prolonging and enhancing life. Such success has entailed years of testing and trials and millions and even billions of dollars.
Today, however, the development and costs of new drugs have become two of the most difficult – and sometimes controversial – topics in medicine today. The cost of developing even a single drug can run into the billions of dollars; the cost of one life-saving therapy can erase the life savings of a patient. Such conditions have brought the pharmaceutical industry under scrutiny and under fire.
However, even with so many triumphs, says Janet Woodcock, M.D., “the biomedical research enterprise is surprisingly ineffective at improving health and treating disease, given our level of investment in it.”
Dr. Woodcock, Director of the Center for Drug Evaluation and Research at the Food and Drug Administration, shared her thoughts on drug development programs as she delivered the 2016 Shattuck Lecture, Lost in Translation: The Path from Scientific Discover to the Clinic, presented by the MMS Committee on Publications and the NEJM Group as part of the MMS annual meeting today.
She offered her perspectives – and some recommended solutions – to improve scientific discovery based on her 30 years of observing thousands of attempted drug development programs, both commercial and academic, while at the FDA.
Dr. Woodcock was clear and direct in her analysis: “Multiple systemic flaws impede generational knowledge,” she stated. “Medicine must take back ownership of clinical evidence development.”
The shortcomings in the system, she says, are the result of three problems in biomedical research: a lack of reliable basic scientific information to support development program; the absence of a robust translational infrastructure to develop and assess tools and drug candidates; and the inability of clinical medicine to create effective systems to generate evidence.
Despite the flaws, Dr. Woodcock believes opportunity for change and improvement exists. “The system we have successfully operated for many years is under severe stress,” she declares, “and transformative change is needed. New structures and technologies will provide opportunities.”
“Transformation of clinical research would be challenging with many obstacles,” she notes, “but the payoff might be worth it.” Among the benefits would be rapid and efficient generation of clinical evidence, patients as active participants in the clinical research enterprise, the integration of research into healthcare, and more effective and clinically relevant evaluations of new products and other interventions.
For more observations from Dr. Woodcock and a sampling of her recommendations for a better way forward, view her presentation here.