The biopharma industry is on the precipice of making personalized medicine a reality with access to massive amounts of data, computing power, and artificial intelligence to run in silico clinical trials, says GNS Healthcare CEO. (outsourcing-pharma.com)
Genetic component is complicating clinical trials, esp oncology
Genetics are playing a growing role in clinical trials, as more therapies in development are targeted to the underlying cause of a disease. Nearly half of all therapies in clinical trials, and 73% of oncology trials, are collecting biomarker and genetic data. Adding genetic testing can complicate a study, and the authors recommend that sponsors provide trained genetic counselors as a resource to their investigators. (MedCityNews)
Rep. Rose DeLauro introduces the “Recall Unsafe Drugs Act”
Although the FDA is supposed to intervene when safety concerns arise with an existing pharmaceutical or over-the-counter product, they do not have the authority to require companies to stop marketing unsafe products. This loophole allows companies to refuse FDA’s calls to remove their pharmaceuticals from the market because they are unsafe. Rep. Rose DeLauro (D-CT) introduced the “Recall Unsafe Drugs Act” that will give the FDA mandatory recall authority over drugs and homeopathic products. (Regulatory Focus)
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San Diego Tech Startup, CureMatch, is Revolutionizing Precision Medicine in Oncology
-by Madison Arenchild, special to Clinical Research Currents For medical professionals, making course of treatment decisions for the 1.6 million new cancer diagnoses made each year in the US alone is an extremely difficult undertaking. This decision is further complicated by the heterogeneous nature of tumor make-up and behavior and Read more
Biomarkers triple clinical trial success rate, says report
A recent study of clinical drug development success rates found that biomarker-enabled drug programs are three times more likely to reach approval. (Outsourcing-Pharma.com)
Genomic and Precision Medicine on Coursera
This free online 7-week course aims to educate the health care workforce in the field of genomic and precision medicine. Materials also available through the UCSF website.
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National leaders in precision medicine speak at SDCRN meeting
Advancing Precision Medicine: Genomics, Metabolomics, and Clinical Trials By Dr. Roberta Alexander San Diego, CA. October 12, 2015 The San Diego Clinical Research Network (SDCRN) organized another great event on October 12. It was held in the Alexandria Building of BIOCOM in the Torrey Mesa area. The building and the Read more
Scientists urge national initiative on microbiomes
Scores of leading scientists on Wednesday urged the creation of a major initiative to better understand the microbial communities critical to both human health and every ecosystem. (New York Times online)
Human Longevity appoints head of regulatory affairs and policy
Human Longevity (HLI), the genomics-based, technology-driven company, has announced that Sally Howard, J.D., has been hired as head of regulatory affairs and policy. Howard, who has more than two decades of health policy and regulatory expertise, will lead all efforts related to federal and state regulatory oversight for HLI. (CenterWatch News Online)
Seek 1 million U.S. citizens
The U.S. National Institutes of Health (NIH) will start enrolling 1 million or more U.S. citizens as the first key step to implementing President Obama’s nationwide Precision Medicine Initiative (PMI). Plans for the clinical research cohort were outlined in September by the NIH Advisory committee. ($. Nature Biotechnology)