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Pink Sheet - US FDA Office Of New Drugs Likely To Be Headed By Deputy Director Stein

Executive Summary

Peter Stein is a familiar face within OND and has been working alongside CDER Director Janet Woodcock on the proposed “modernization” of OND. As a previous recruit from outside FDA, Stein has had time to make the key connections and adjustments to working inside government.


The US FDA’s Center for Drug Evaluation & Research is wrapping up its two-year search for a permanent director of the Office of New Drugs, with an official announcement expected in early December.


Pink Sheet - Gene Therapy Guidance From US FDA Likely Needs Updating Sooner Rather Than Later

Executive Summary

CBER Director Peter Marks says the "half-life" for the existing six gene therapy guidances likely is two to three years due to the fast pace of scientific discovery.

Genetic Medicine with dna isolated on white.3d rendering

Gene therapy sponsors should not expect the US FDA's latest guidances to maintain a long useful life.


POLITICO - Trump’s Part B demo getting less pushback than Obama’s

When President Donald Trump rolled out an ambitious pilot program to lower the costs of physician-administered drugs in late October, policy experts expected the same swift condemnation Congress and the health care industry directed at former President Barack Obama’s Part B demonstration plan. But so far, at least, the outrage hasn’t been nearly as loud.

Targeted Oncology - Computer Analysis Determines Best Practices for Use of Tumor Mutational Burden in Patient Care

In an effort to determine best practices and ensure consistent clinical interpretation of tumor mutational burden ( TMB) assessment for cancer patients, a group of diagnostic test partners conducted an in silico analysis and found that panel-derived TMB strongly correlated with whole-exome sequencing (WES) data provided from The Cancer Genome Atlas (TCGA). The group's findings were presented by David Fabrizio, PhD, Cancer Immunotherapy Leader at Foundation Medicine during the 33rd Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2018).


GenomeWeb - Thermo Fisher Liquid Biopsy, Immuno-Oncology Tools Featured in User Reports at AMP

In a group of sponsored presentations at last week's annual meeting of the Association for Molecular Pathology, Thermo Fisher Scientific product users reported on their experiences in a variety of clinical areas, including liquid biopsy, immuno-oncology, and pharmacogenomics.


According to Anagh Vora, head of medical affairs for clinical NGS and oncology at Thermo Fisher is eager to strengthen its longstanding position as a technology supplier while increasing the implementation of its tools in clinical practice.

The ASCO Connection - The Language of Clinical Trials

I am a big proponent of clinical trials. I think everyone should have access to them and any trial that they qualify for should be offered – regardless of whether or not I think they are “appropriate” (however one chooses to define it). It’s not only good medicine, but now some data from SWOG shows that access to trials may help address the disparities in cancer care and outcomes.1


The ASCO Post - Next-Generation Sequencing: New Technology That Requires Further Thought

Next-generation sequencing is used with increasing frequency to provide essential information about a patient’s diagnosis and treatment. In recent months, the U.S. Food and Drug Administration (FDA) has approved several new next-generation sequencing diagnostic tools, and the Centers for Medicare & Medicaid Services (CMS) has issued a positive national coverage decision.


The ASCO Post - Labeling Act to Keep Drug Label Information Up-to-Date Introduced to Senate

Friends of Cancer Research (Friends) recognized Senators Orrin Hatch (R–UT) and Michael Bennet (D–CO) for responding to a recently identified public health issue and proposing a solution to an issue impacting patients and their physicians. Senators Hatch and Bennet jointly introduced the Making Objective Drug Evidence Revisions for New Labeling Act, or MODERN Labeling Act.


The ASCO Post - Friends of Cancer Research Launches Tumor Mutational Burden Harmonization Project

The Friends of Cancer Research (Friends) recently announced the launch of phase II of its tumor mutational burden Harmonization Project, as the research team finalizes data collected from phase I in silico analysis.


Rare Disease Report - How FDA's Breakthrough Therapy Designation Program Changed the Rare Disease Space

On July 9, 2012, officials signed the Food and Drug Administration Safety and Innovation Act (FDASIA) which had a section within it that established a new designation—the Breakthrough Therapy Designation—which allows for expedited development and review of drugs to treat serious or life-threatening diseases if substantial evidence is provided.