A: R&D productivity in decline is a questionable assumption. Productivity should be measured by the development of investigational new drugs rather than how many get approved. On average, developing a new drug takes 10 to 15 years and costs $2.6 billion. A big contributor to this cost is attrition (i.e., five in 5,000 investigational drugs ever make it to human testing, and only one of those ultimately gets approved). Other contributing factors include the shift in investment priorities from acute to chronic, intractable, and degenerative diseases; increased regulatory burden on authorities; increased need for research to meet payer demands; increased focus on areas where science is difficult and failure rates high; and increased trial complexity.
Improving R&D efficiency requires transforming the clinical trial process by utilizing adaptive clinical trial designs, incorporating Big Data, building strategic alliances, and integrating comprehensive partnerships that include patients, payers, government research agencies, healthcare providers, and contract service organizations.
MITCHELL KATZ, PH.D.
Mitchell has 30 years’ experience in the pharmaceutical and biotechnology industries, including preclinical research, pharmaceutical operations, and regulatory affairs. He is the Head of Clinical Research and Drug Safety Operations at Purdue Pharma L.P.