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What You Need to Know about the Precision Medicine Initiative

Last month, I was fortunate to be able to represent Certara at the BIO International Conference in Philadelphia, PA. One of the most exciting sessions that I attended was the Personalized Medicine Plenary with Dr. Francis Collins, the director of the NIH. He discussed how the Precision Medicine Initiative (PMI) will revolutionize the approach to improving health and treating disease. In this blog post, I’ll discuss the goals of PMI and how this initiative aligns with our mission to use biosimulation and strategic regulatory writing to bring safer and more effective medications to patients.

What is the Precision Medicine Initiative?

At this year’s State of the Union, President Obama announced a new research program—the Precision Medicine Initiative—that will leverage disease prevention and treatment strategies that account for individual variability in genes, environment, and lifestyle. It will use proteomics, metabolomics, genomics, and bioinformatics methods to characterize patients and better understand the mechanisms of disease. Ultimately, the knowledge gained will inform clinical practice and support the use of optimal therapies for each patient.

“Doctors have always recognized that every patient is unique, and doctors have always tried to tailor their treatments as best they can to individuals. You can match a blood type—that was an important discovery. What if matching a cancer cure to our genetic code was just as easy, just as standard? What if figuring out the right dose of medicine was as simple as taking our temperature?”

—President Obama, January 30, 2015

Near term goals of the initiative

The immediate focus of the initiative will be addressing some of the long standing challenges of cancer medicine—incomplete understanding of the genomic heterogeneity of tumors, insufficient means of monitoring responses to therapies and disease recurrence, and limited knowledge about the use of drug combinations. The National Cancer Institute (NCI) will be leading this initiative and will focus its efforts in three areas:

  • To facilitate collaboration, they will build a cancer knowledge network to store the data resulting from NCI-supported clinical trials and make it accessible to scientists, health care workers, and patients.
  • The NCI-Molecular Analysis for Therapy Choice (NCI-MATCH) program will explore treating patients based on the molecular profiles of their tumors.
  • NCI scientists and clinicians will also be seeking new ways to address the persistent problem of drug resistance to cancer treatments.

Longer term goals of the initiative

The second component of PMI is applying the principles of precision medicine to health care more broadly. This will mean supporting research to enable better assessment of disease risk. The success of the initiative will rely on the active participation of large numbers of citizens to support the assembly of a longitudinal “cohort” over a 1 million or more Americans who have participated in clinical research. The participants will be asked to give consent for extensive characterization of biological samples and behavior data. Knowledge gained from the cohort will help identify new targets for disease treatment and prevention and lay the scientific foundation for precision medicine for many diseases.

How does Certara’s mission align with this approach?

  1. The concept of accounting for individual variability is central to our use of biosimulation technology for drug development. One example of this is the notion of personalized drug dosing. Virtual Twin™ technology will be an important step towards making this vision a reality. The idea is to match the characteristics of a real patient with his or her virtual twin in order to predict individual risk of complex drug-drug interactions (DDIs). This matching will happen at several levels:
    • Age, weight, height, sex, and ethnicity
    • Current drug dosage and co-medications
    • Activity of metabolic enzymes and transporters
    • Level of organ function
  2. An initiative of this scale will require a large number of bright, motivated people working together to make it succeed. Indeed, PMI will support the next generation of scientists in developing new approaches to analyzing large amounts of biomedical information to find the molecular signatures of disease pathophysiology. At Certara, we’re committed to training pharmacometricians who can apply modeling techniques to understanding the pharmacokinetics and pharmacodynamics of new medications. For example, we are providing the University of Maryland’s School of Pharmacy’s Center for Translational Medicine (CTM) with Phoenix software licenses for teaching and research purposes, and also delivering training and workshop assistance. By supporting the CTM, their students will gain valuable practical experience by training on Certara’s state-of-the art biosimulation software and then co-developing novel Phoenix features with our experts.
  3. In his perspective paper in the New England Journal of Medicine, Drs. Collins and Harold Varmus discuss how PMI will “pioneer new models for doing science that emphasize engaged participants and open, responsible data sharing.” Supporting clinical trial transparency and disclosure initiatives has long been part of the mission of Synchrogenix, our regulatory writing consultancy. That’s why we recently partnered with the nonprofit Center for Information and Study of Clinical Research Participation (CISCRP) to help pharmaceutical companies inform and educate clinical trial volunteers by developing lay summaries that explain a clinical trial’s design, objectives, and findings.

Learn more about PMI

PMI is certainly an exciting venture that will usher in a new way of practicing medicine. If you’re interested in learning more about this program, I’ve provided a few resources for you to check out:

Learn more about meeting transparency and disclosure initiatives

Disclosing clinical trial information and creating transparency around the data are key steps toward increasing trust between the public and the industry. Increased transparency regarding data about ongoing research could spur new products or therapeutic approaches and potentially avoid unnecessary trials. Are you struggling to integrate these initiatives into your processes? Please read a white paper that we’ve written on this subject. Let me know what you think in the comments!

About the author

By: Suzanne Minton

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