Global Agenda Council on Personalized & Precision Medicine 2012-2013
Personalized medicine involves combining established clinical parameters with emerging molecular information to create preventative, diagnostic and therapeutic solutions that are individually tailored to each patient’s requirements. Personalized approaches will facilitate more precise healthcare delivery based on individual-specific molecular data (i.e. precision medicine).
Precision medicine has the potential to deliver some of the most significant changes on the healthcare horizon: improving diagnosis, treatment and patient prognosis. The arrival of precision medicine is imminent: what was once considered a “blip on the horizon” is now just around the corner. Ensuring its successful and appropriate adoption will be vital.
Precision medicine has the ability to drive deep structural changes in healthcare delivery. As well as improved outcomes for patients, it also has the potential to bring significant efficiency savings, transforming health and saving lives and money.
Recent biotechnological advances have led to a proliferation of disease-relevant molecular information that has brought the promise of personalized medicine within reach. While this is expected to deliver significant healthcare benefits at each step of the patient care continuum, it will also bring a new set of challenges. Ensuring a smooth transition will require frameworks for regulating, compiling and interpreting the influx of information that can keep pace with rapid scientific developments.
- Instead of basing a pharmacotherapeutic dose solely on characteristics like weight and age, doctors will be able to use a patient's genetic profile to determine the best drug and the optimal dose.
- Currently, genetic testing is available for approximately 2,000 clinical conditions; the number of available diagnostic tests is increasing exponentially.
- The cost of obtaining a single human-genome sequence has decreased from US$ 95 million in 2001 to almost US$ 21,000 in January 2011 and is projected to further decrease to US$ 1,000 in a few years.
“I see personalized medicine as very broad. Not just genomic medicine, not just bio-markers, but to take care of the whole patient, in a personalized, individualized way.”
Victor Dzau, President and Chief Executive Officer, Duke University Medical Center and Health System, Duke University, USA; Chair, Global Agenda Council on Personalized & Precision Medicine
“This is absolutely the turning point. Patients will be just as likely to have their genomes sequenced as they will be to get MRIs or CT scans. And sequencing doesn't just tell you where you are; it can tell you the future. You can see whether you are predisposed to disease.”
Jonathan Rothberg, Founder, President, Ion Torrent by Life Technologies, Life Technologies, USA; Member, Global Agenda Council on Personalized & Precision Medicine
8th Annual Personalized Medicine Conference, Harvard Medical School
28-29 November 2012
Boston, MA, USA
Personalized Medicine World Conference
28-29 January 2013
Mountain View, CA, USA
International Conference and Exhibition on Personalized Medicine & Molecular Diagnostics
5-7 August 2013
Las Vegas, NV, USA
The Council has identified six areas for further development. Collaborative efforts will be needed to address these at the national and international levels to ensure the success of precision medicine.
- More incentives for innovation: The challenges, costs and risks associated with modern product development and lengthy approval processes are well established. Appropriate financial incentives and reimbursement schemes are needed to stimulate innovation.
- New disease classification systems that incorporate emerging molecular data: A deeper understanding of the molecular mechanisms that underpin health and disease calls for new models that include this emerging knowledge. Precision medicine will require a new disease classification system.
- More streamlined clinical trial regulation frameworks: Recently published figures show that approval times for clinical trials and financial costs are increasing. These procedures should be more streamlined by taking into account previous experience with the agent being investigated and/or the study population.
- Effective data interpretation and clinical decision support (CDS): The success of precision medicine will require the handling of multi-parametric data and basic proficiency with “–omics” data interpretation and bioinformatics platforms. The development of appropriate health IT systems that incorporate CDS tools presents a significant logistical and financial challenge and warrants urgent attention.
- Stimulation of consumer interest and active participation: Significant public uncertainty on the legal, ethical and privacy issues surrounding open-access data is expected. These will require careful regulation as will the security architecture of future health IT systems. A cultural shift will also be needed to ensure successful public engagement.
- A rational approach to Health Authority regulatory oversight of precision medicine: The global regulatory oversight of precision medicine, which includes both the therapeutic and associated companion diagnostic, must provide an appropriate mechanism to ensure safety and efficacy (effectiveness) as well as timely premarket review and approval.
Research Analyst: Shubhra Saxena Kabra, Knowledge Manager, Global Agenda Councils, email@example.com
Council Manager: Gary Phillips, Director, Head of Healthcare Industry, firstname.lastname@example.org
Forum Lead: Olivier Raynaud, Senior Director, Head of Global Health and Healthcare, email@example.com