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Personalized Medicine

Meet Rutgers’ RADICAL Supercomputing Guru; Shantenu Jha Says Computing Is Making The ‘Impossible Possible’ and ‘The Barely Possible Routine’

shantenu-jha-rutgers

Dr. Shantenu Jha

New Brunswick, NJ, September 23, 2016 Shantenu Jha, Ph.D. is a RADICAL man.  The Rutgers professor wants to enhance personalized medicine, global health, science and engineering through high-performance computing.

Dr. Jha and his RADICAL (Rutgers Advanced Distributed Cyberinfrastructure and Applications Laboratory) team operate at the crossroads of computing and science, and their work has benefited research in the molecular sciences, polar sciences and high-energy physics.

Dr. Jha’s expertise earned him a summer invitation to The White House, where he attended a workshop organized by its Office of Science and Technology Policy. Continue reading

FDA Touts 3D Printing’s Potential in Personalized Medicine

3D Printing MedicalWashington, DC, July 15, 2016 — Christine Ayala reports in The Hill that the Food and Drug Administration (FDA) touted the potential of 3D-printed medical devices and drugs Thursday, releasing regulatory science research on devices already cleared and approved by the agency.

The FDA issued draft guidance on 3D-printed devices in May, which is currently open for comment until Aug. 8.

James Coburn, the principal investigator for the FDA’s Center for Devices and Radiological Health, highlighted the potential for advancements in personalized medicine through 3D printing, also called additive manufacturing. Continue reading

PhRMA CEO on the Challenges and Opportunities in an Era of Personalized Medicine

Stephen J. Ubl

Stephen J. Ubl

Washington, DC, May 3Pharmaceutical Research and Manufacturers of America (PhRMA) President and Chief Executive Officer Stephen J. Ubl writes on The Catalyst, PhRMA’s blog, on the challenges and opportunities of personalized medicine.  Mr. Ubl writes:

We are at a pivotal time in health care in America. Biomedical discovery and innovation have the potential to revolutionize the way we diagnose and treat patients.  At the same time, rapidly changing regulatory and market dynamics are shifting the ways we develop and pay for new technologies.

Personalized medicine stands right at the center of this revolution, with the science enabling greater precision that not only can improve the lives of patients, but can also create efficiencies within the health care system by delivering the right treatment to the right patient at the right time. Continue reading

PhRMA: 2015 Was a Banner Year for Personalized Medicine

 Precision Medicine 9 PillWashington DC, January 25, 2016 — According to Pharmaceutical Research and Manufacturers of America (PhRMA), 2015 was a record year for personalized medicine approvals, according to a new analysis from the Personalized Medicine Coalition (PMC).

Writing on PhRMA’s blog The Catalyst, PhRMA’s Emma Van Hook reports that this news confirms the growing role of personalized medicine as an approach to treatment that can improve outcomes for patients and also create important efficiencies in the health care system.

Personalized medicine is an emerging field of medicine that uses diagnostic tools to identify specific biological markers to help assess which medical treatments and procedures will be best for each patient.  Personalized medicine also takes into account patients’ medical history, circumstances and values in developing targeted treatment and prevention plans. Continue reading

The Hill and PhRMA Host Policy Discussion on Personalized Medicine

Precision Medicine 8Washington, DC, October 25, 2015 The Hill reports that in an era of personalization—where music apps filter songs based on listener preferences and online ads populated based on user search history — healthcare is the next frontier.

Scientific advances are transforming healthcare and ushering in a new era of personalized – or precision — medicine.  This approach makes it possible to account for each patient’s genetics, health history and lifestyle as researchers develop and doctors prescribe individualized treatments.

Such data-driven medicine has far-reaching policy implications, from regulations to delivery systems. Continue reading

President’s Precision Medicine Initiative Advances; NIH Unveils Framework

Precision Medicine 4Bethesda, MD, September 18, 2015 ― The National Institutes of Health Advisory Committee to the Director (ACD) yesterday presented to NIH Director Francis S. Collins, M.D., Ph.D., a detailed design framework for building a national research participant group, called a cohort, of 1 million or more Americans to expand our knowledge and practice of precision medicine.

Dr. Collins embraced the design recommendations made by the ACD, noting the need to remain nimble and adaptable as the Initiative progresses.  He also thanked the Committee for their recommendations on policy issues and welcomed the opportunity to review them.

NIH plans to move quickly to build the infrastructure so that participants can begin enrolling in the cohort in 2016, with a goal of enrolling at least 1 million participants in three to four years. Continue reading

NCI-MATCH Trial Will Link Targeted Cancer Drugs to Gene Abnormalities

Bethesda, MD, NJ, June 2, 2015 ― Investigators for the nationwide trial, NCI-MATCH: Molecular Analysis for Therapy Choice (EAY131), announced yesterday at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago that the precision medicine trial will open to patient enrollment in July.

The trial seeks to determine whether targeted therapies for people whose tumors have specific gene mutations will be effective regardless of their cancer type.  NCI-MATCH will incorporate more than 20 different study drugs or drug combinations, each targeting a specific gene mutation, in order to match each patient in the trial with a therapy that targets a molecular abnormality in their tumor. Continue reading

Study: Personalized Medicine Is Gaining Traction, But Faces Multiple Challenges

Boston, MA, May 21, 2015 ― While development of personalized medicines has grown since the human genome was first sequenced in 2001, biopharmaceutical sponsors face a number of hurdles that are impeding more rapid market uptake, according to a recently completed study by the Tufts Center for the Study of Drug Development.

Fourteen years after the human genome was initially sequenced, paving the way for development of personalized medicine, 13 percent of drugs marketed in the United States today post pharmacogenomic information on the label, Tufts CSDD reported.

However, developers continue to encounter challenges relating to basic science, regulatory and reimbursement policies, and, equally critical, clinical adoption, Tufts CSDD added. Continue reading

NYT: President to Request Research Funding for Treatments Tailored to Patients’ DNA

Washington, DC, January 26, 2015 The New York Times’ Robert Pear reports that President Obama will seek hundreds of millions of dollars for a new initiative to develop medical treatments tailored to genetic and other characteristics of individual patients, administration officials say.

The proposal, mentioned briefly in his State of the Union address, will be described in greater detail in his budget in the coming weeks.  The effort is likely to receive support from members of both parties, lawmakers said.

In his address, President Obama called it “precision medicine,” but the terms “personalized medicine” and “individualized medicine” are also widely used to describe the evolving field in which, for example, a doctor prescribes a medication that targets a specific mutation in a patient’s genes. Continue reading