I recently attended the Conference on Personalized Medicine: Impacting Healthcare, hosted by Harvard Medical School, Partners Healthcare, and Harvard Business School two weeks ago. I’ve been reading a lot about personalized medicine in scientific journals lately, so I thought this would be a great conference to attend. I learned quite a bit, so I thought it might be useful to share some notes from my experience.
Personalized medicine is a model of medical care that emphasizes the use of information about an individual patient to guide clinical decisions regarding therapeutic or preventative care. The Personalized Medicine conference (hosted by the Harvard Medical School, Partners Healthcare’s Center for Personalized Genetic Medicine, and Harvard Business School) brought together high-profile experts on this topic from industry, government, academia, and healthcare. The conference gave a broad perspective on the progress, limitations, and outlook of personalized medicine in this country, as well as internationally. The head of the Center for Personalized Genetic Medicine, Raju Kucherlapati, says that personalized medicine is in a Dickens-ian “best of times and worst of times” because in spite of great progress, it is still over-promised and under-delivered.
According to Dr. Mark Boguski (Harvard Medical School), 70% of clinical decisions are based on lab tests, either from molecular diagnostics, pathology, or radiology. Because of progress in personalized medicine, he thinks this percentage will continue to increase each year. As an example of progress, Harvard’s Laboratory for Molecular Medicine has added 10 new genetic tests this year (see their page for lists of available genetic tests and their prices).
Progress has also been made in the pharmaceutical industry, as the industry leaders are moving away from the “blockbuster drug” research model in which only drugs that can be prescribed to large populations are developed since they are the most financially rewarding projects. Mikael Dolston, president of worldwide research and development at Pfizer, says his company is moving towards a “precision medicine” drug development model. Precision medicine is an approach that lies somewhere between the personalized medicine and blockbuster drug development methodologies. Precision medicine is the genetic targeting of patient segments, rather than individuals (i.e., they select very well molecularly-defined patient populations) to reduce the costs and size of clinical development and to increase commercial benefit since there is a pronounced treatment effect.
The general sentiment among speakers and the audience was that the science of personalized medicine is advancing faster than the healthcare infrastructure to support it. Cost is one of the major limitations. Life Technologies has reduced the cost of genome sequencing to thousands of dollars and is quickly approaching the $1000 genome. They recently acquired a semiconductor company, Ion Torrent, that may bring the cost of sequencing a genome on a chip to about $500. Still, standard gene tests today cost $1k-$2k per patient. Even when new tests come out, they can be slow to reach the clinic simply because it takes too much time to devise a reimbursement scheme with health insurance companies. IT infrastructure is another area for improvement in clinical and research areas. The need for clinical decision systems that collate the latest changes to clinical guidelines and molecular diagnostics was particularly emphasized by different speakers throughout the conference. Lastly, the conference speakers strongly recommended better molecular medicine education for clinicians, as well as better information dissemination to the general public regarding personalized medicine in order for this approach to succeed.
There were several recurring themes in the conference – precision medicine, collaboration, translational projects, and companion diagnostics. Translational projects and collaboration between industry and academia were mentioned in almost every talk, regardless of the speakers’ affiliation. The executive dean for research at Harvard Medical School decried research in isolation, saying “we need more ideas that don’t just sit around, but that are translated.” He and others went as far as to say that we will never make any progress without collaboration between government, industry, academia, regulators, and clinicians. One of the other most commonly discussed topics was companion diagnostics, the idea of developing drugs alongside a diagnostic test (or even post-market) that can be used to select patients for a particular drug. Companion diagnostics are increasingly being developed – 94% of pharma companies say they’re investing in personalized medicine, but only about 10% actually have compounds in late clinical development with companion diagnostics, meaning there will be more to come. FDA representatives said they will thus help companies integrate genomics into clinical development plans, and their companion diagnostics guidance is forthcoming next month.