As sequencing moves out of the lab and into the clinic, a host of players must get involved to make our collective promises of personalized medicine a reality. CEOs, entrepreneurs, researchers, clinicians, regulators and payers need to work together to take on the next challenges in the implementation of personalized medicine. Some of those challenges include:
- Cost vs. Benefit: How do we define and benefit from transformational technologies?
- Form vs. Function: What about the less compelling basics of sampling, preparation and QA?
- Biomarkers & Therapeutic Targets: What is the promise versus the reality?
- Social Networks: Is the immediate feedback connecting patients, scientists and clinicians?
- Best Data Practices: What are the best practices for scientific data validation and dissemination?
- Partnerships: What defines an effective partnership between academia, industry, regulators and payers?
- Addressing the Reimbursement Conundrum: What’s best for patients and industry?
- Ethical & Legal Issues: Which pitfalls are associated with new diagnostic tools and targeted therapies?
The 5th annual Personalized Medicine World Conference (PMWC) 2013, from January 28-29 in Silicon Valley, will provide stakeholders with an opportunity to learn from other experts and engage in dialogue focused on moving innovation forward.
While analyses that were cutting edge several years ago have become routine, new problems have arisen concerning the transmitting, processing and storing of information. We have entered a phase where scaling up to large numbers of patients and correctly assisting them in medical treatment have created a bottleneck. PMWC is dedicating an entire afternoon to discussing “Actionable Data Analysis.”
For example, clinical exome sequencing is not limited by the time or cost of a single analysis. However, roadblocks have occurred in the process of ethically and responsibly communicating results (including incidental findings) to patients while sustainably and securely managing a large amount of data generated by increased testing.
Ethical and privacy concerns have also drawn attention, including a recent Presidential Report on the ethical implications of Whole Genome Sequencing (www.bioethics.gov). There is a wide-spread fear that genomic information represents a poorly understood Pandora’s box for the individual that sequences their own genome. Cross discipline discussions are important for generating a set of well informed best practices that will allow the industry to police itself and avoid reactionary regulation and public backlash. Education and a clear plan forward are necessary to convince patients, payers, and doctors that personal information will be handled safely and responsibly.
In addition, PMWC is honoring Dr Janet Woodcock of the FDA for her role in making two personalized medicines possible. Not only are these drugs currently extending and saving lives, but the process used to bring them into the clinic clarifies and streamlines what have previously seemed like high regulatory hurdles. This achievement has blazed a trail for the future development and approval of targeted therapies.
However, as more drugs move towards approval, previously theoretical discussions of reimbursement have moved to the forefront and reignited questions about cost effectiveness. PMWC will highlight the voices of payers, including Dr. Ira Klein of Aetna, who has pointed out that, “Every good steward of health care resources wants the same thing: the right treatment at the right time for the right patient with the right diagnosis. Payers are no different.”
It is critical for the personalized medicine community to reach a consensus on how to deliver on Dr. Klein’s vision.
To reflect the diversity of the participants PMWC has three tracks. The first is a main stage showcasing major developments and hosting the largest discussions. In addition, two parallel tracks will be dedicated to the advances of established and emerging players.
The outlet dedicated to new technologies is especially important in the field of personalized medicine because, as we’ve seen previously, this year’s cutting edge technique can be next year’s standard practice. This track will also include a “Most Promising Company Competition” judged by industry leaders.
We look forward to sharing the excitement with you by discussing how to deliver on the promise of personalized medicine. For more information, please visit PMWC 2013.