Castellani Calls for Collaboration, Continued Hard Work at PMC Annual Luncheon

At yesterday’s Seventh Annual State of Personalized Medicine Luncheon, I couldn’t help but reflect on how far the field of personalized medicine has come. John Castellani, President and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA) delivered the keynote address, and Dr. Werner Verbiest, head of Johnson & Johnson’s Companion Diagnostics Center of Excellence, introduced him. Thinking through the varied and distinguished background of the other speakers at our Annual Luncheon over the years (including Dr. Margaret Hamburg, Commissioner of the Food and Drug Administration; Dr. Denis Cortese, President and CEO of the Mayo Clinic; and Dr. Francis Collins, then Director of the National Human Genome Research Institute, among others), I see strong representation of the collective commitment from the biopharmaceutical industry, government research institutes and agencies, and patient care providers to the advancement and provision of personalized medicine.

While much progress has been made in promoting an understanding of personalized medicine and widening the circle of those working to move it forward, as Mr. Castellani reminded us yesterday, there is still much work to be done. He emphasized that we cannot work alone in our silos, but must come together to “drive the science forward and create an environment that embraces change and opens the door to personalized medicine.”

Mr. Castellani mentioned several policy challenges that must be overcome, and this is an area of particular priority for the PMC. We have recently formed a workgroup that is developing legislative specifications for consideration by Congress in many of the areas Mr. Castellani highlighted, such as:

• Ensuring that policy and regulation provide appropriate incentives for companies engaged in the research and development of personalized medicine;
• Aligning comparative effectiveness research methodology to illuminate differences among patient subpopulations;
• Improving patient access and sustaining innovation through reimbursement and payment policy reforms for treatments targeted to small patient groups;
• Improving the regulatory environment for targeted therapies and companion diagnostics; and
• Working with providers in areas such as physician education, health information technology and clinical decision-support so that caregivers have the information they need to apply evidence-based, personalized medicine at the bedside.

I’d like to thank Mr. Castellani and Dr. Verbiest for their participation in yesterday’s event. Calling to mind the 30^th anniversary of the discovery HIV/AIDS, both speakers underscored how much can be accomplished when research and clinical care come together and are spurred on by the daunting challenges patients face, particularly where there is significant unmet need. In the same way, those of us committed to improving health care quality through personalized medicine and encouraged by our ever-increasing knowledge of the molecular basis of human disease are ultimately inspired by the patients who will benefit from a more targeted, effective approach to medical care.