The use of advanced diagnostics in guiding treatment decisions that are tailored to individual risks and benefits is becoming increasingly acknowledged as the future of healthcare. But what are the opportunities offered by personalized medicine? What forces are holding the healthcare system back from moving more rapidly in this direction? These were the topics discussed during the breakout session "Co-development of Therapies and Diagnostics: Opportunities and Barriers" at the BIO 2009 International Convention in Atlanta.
The session sought to address the challenges in developing companion technologies. Chair Andrew Robertson, McKenna, Long, and Aldridge, LLP, led a discussion of diverse panelists who were able to provide perspectives from various personalized medicine stakeholders, including: molecular diagnostics developers, pharmaceutical companies looking to develop partnerships, payers, and government regulators. I was thrilled to be included in this panel and I tried to provide the perspective of the molecular diagnostic companies for which I work with as Director of BIO’s Research Tools and Molecular Diagnostics (RTMD) Working Group.
The panel first dived into the often tricky issue of defining the clinical utility of companion technologies, and each perspective added a little more to the picture. The conversation turned to the evidentiary standards that are required to get products through the thicket of what is currently an unclear regulatory oversight process. Bob Yocher, Genzyme Corp., is well versed in the FDA’s activity in oversight of companion technologies. Yocher pointed out that the current regulatory framework demonstrates that “one size of evidence does not fit all”. The panel then suggested that the standards of required evidence are somewhat different for payers.
Bryan Dechairo, Medco Health Solutions, Inc., offered that the key to reimbursement of companion tests lies in strong comparative effectiveness research. Dechairo was provocative in suggesting that payers need to be confident that the diagnostic is providing a clear benefit from a cost perspective. Amy Miller, Personalized Medicine Coalition, and myself argued that comparative effectiveness, when done correctly, can be a strong factor in the advancement of personalized medicine, but in all CER studies, the patient has to be the central focus. BIO strongly advocates for clinical comparative effectiveness research that is patient-centered.
When asked what the number one issue is for the advancement of companion technologies development, panelist Cecilia Schott, Astra Zeneca Corp., pointed to strong and effective partnerships between pharmaceutical companies and MDx companies. These partnerships are the key to advancing product development, she said. All of the panelists agreed that no matter from whose perspective; payers, regulators, industry, or researchers, the field revolves around bringing safer, more effective therapies to patients. Healthcare will evolve to include more drug-diagnostic combinations, and patients will benefit.
Just how quickly can we get there? Some on the panel suggested a timeframe of 10-15 years. Others suggested that we can move faster...