Who We Are

The New Jersey Life Sciences Vendors Alliance (NJLSVA) is a coalition of businesses, individuals and academia who provide goods and services to New Jersey’s life sciences companies.

The NJLSVA was founded to educate suppliers on trends in industry procurement and public policy that affects the life sciences industry.

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.

Building on President Obama’s announcement in his 2015 State of the Union Address in January, the Administration on January 31 unveiled details about the Precision Medicine Initiative, a bold new research effort to revolutionize how we improve health and treat disease.

Launched with a $215 million investment in the President’s 2016 Budget, the Precision Medicine Initiative will pioneer a new model of patient-powered research that promises to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients.

“The biopharmaceutical industry is increasingly committed to translating genomic discoveries into personalized medicines, but it needs to overcome scientific, regulatory, and economic challenges,” said Joshua Cohen, associate professor at Tufts CSDD.  “In particular, the continued development of personalized medicine depends on identifying biomarkers and developing clinically useful diagnostic tests.”

Cohen noted, however, that higher R&D success rates alone may not lead translate into commercial success without physicians increasing the rate at which they prescribe personalized medicines, supported by payer willingness to reimburse users.

These assessments, based on a survey of major drug manufacturers and interviews with leading drug and diagnostics companies, were reported in the May/June Tufts CSDD Impact Report, released today.  Other highlights include the following:

  • Biopharmaceutical firms said they expect investment in personalized medicine to increase 33 percent, and medicines in development to increase 69 percent, over the next five years.
  • Biomarker identification and diagnostic test development rank highest in terms of scientific challenges, followed by regulatory and reimbursement issues.
  • Oncology products continue to rank highest in terms of average share of personalized medicines in development across all phases, followed by neurology and cardiovascular drugs.

According to Tufts CSDD, to date, the U.S. Food and Drug Administration (FDA) has approved 137 drugs with pharmacogenomics information in their labeling, with 20 percent of all FDA approvals in 2014 for personalized medicines.

To purchase a single report or subscription, please visit the reports page.

The Tufts Center for the Study of Drug Development at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums, and publishes Tufts CSDD Impact Reports, a bi-monthly newsletter providing analysis and insight into critical drug development issues.