Drug Manufacturing and the Innovation Deficit: Amgen’s Perlmutter and FDA’s Winkle Discuss Issues

Chemical Engineering Progress just ran an interesting summary of the Society of Biological Engineering's first international conference on accelerating biopharmaceutical development, held in late March in California. Amgen's EVP of R&D, Roger Perlmutter, had a lot to say about the dearth of new drugs.  He mentioned the fact that there are only 16 new molecular entities. "The industry cannot continue down this path."  The environment has changed substantially over the past few decades.  In the past he said there were few interesting targets and strong IP. Today, he noted there are "thousands of new drug targets and rapid generic penetration,"  he said. He pointed the finger at weak preclinical trials, which, he said, provide poor predictive information.  He suggested that the industry focus on serious illnesses such as cancer and not on modest improvements to existing therapies. He also suggested that preclinical and clinical evaluations be integrated. Following his presentation, Dr. Helen Winkle director of the Office of Pharmaceutical Science, FDA's CDER discussed manufacturing's role in the innovation problem, noting that the waste involved in drug manufacturing "can be as high as 50%."  In addition, she emphasized that industry must assume the policing of its internal quality control, rather than leaving that to FDA. "FDA's role is to do an initial verification and subsequent audits," she said. New drivers for industry, she said, are 21st Century GMPs, Critical Path Initiaative, Quality by Design and PAT.