The Reproducibility Crisis in Biomedical Research
New quality practices developed by the ASQ FD&C Division could change the trend in the Reproducibility Crisis in Biomedical Research!
“The productivity of modern drug development has been steadily declining over the last two decades. The total spend on biomedical research has reached about $270 million globally, but the number of new drugs relative to this investment has been going down steadily. There are many reasons for the declining output of drug development, but one of the main reasons is the lack of reproducibility of biomedical research in general. Some people even claim that the majority of biomedical studies cannot be reproduced. There is now mounting evidence that general quality problems are a root cause for this issue. Indeed, there is no commonly accepted quality standard for biomedical research. A working group of the ASQ FD&C has therefore developed new guidelines for “Best quality practices for biomedical research in drug development” which will be discussed in this session.”
Ülo Palm, MD, PhD, MBA, is currently Senior Vice President Branded Drug Development Operations with Actavis Pharmaceuticals. Prior to Actavis, he was the SVP Clinical Operations & Biometrics and Therapeutic Area Head Respiratory Clinical Development with Forest Labs. Before joining Forest, Dr. Palm held the positions of Global Head Laboratory & Preclinical Quality Assurance and Global Head Clinical Operations Oncology with Novartis Pharmaceuticals. Prior to Novartis, Dr. Palm worked with Schering-Plough and Bayer in different operational and medical drug development functions. He has a total of 25 years of experience in the pharmaceutical industry. Dr. Palm is Senior Member of the American Society for Quality (ASQ), he is certified as a Manager of Quality and Organizational Excellence (CMQ/OE). He serves on the Board of Directors of ANAB, the ANSI-ASQ National Accreditation Board. He is also a member of the TransCelerate BioPharma Operations Committee and chair of the Future Initiatives sub-committee, investigating new project opportunities for TransCelerate to improve the efficiency of clinical research.
Wednesday, October 29, 2014
5:30 p.m. at Phenomenex
2341 West 205th Street, Torrance, CA 90501