HHS Workshop: National Toxicology Program, Converging on Cancer

The Department of Health and Human Services (HHS), National Toxicology Program (NTP), announces a forthcoming workshop titled "Converging on Cancer."

Cancer is a leading cause of mortality worldwide. While the defining feature of cancer is uncontrolled division of abnormal cells, it is a complex disease with varied presentations (i.e., different etiologies and target tissues) that involves dysregulation of multiple interconnected signaling pathways. Diverse environmental factors have been associated with the development and progression of various cancer types. A critical question in the field of environmental health is how to harness what is known about cancer biology and associated environmental exposures to improve public health outcomes.

The Converging on Cancer Workshop is aimed at providing a clear path forward for evaluating the interactions between environmental exposures and cancer biology using the latest tools in toxicology and identifying knowledge gaps that require research attention. Potential applications of this understanding include building a framework for incorporating mechanistic data into cancer risk assessment, developing effective screening tools to detect the carcinogenic potential of environmental chemicals (including mixtures), engineering safer products, and designing more effective multi-target therapeutics. 

This free meeting is open to the public with attendance limited only by the space available. The meeting will consist of plenary sessions which will be webcast, breakout discussion sessions, and a poster session. The plenary sessions will be webcast but the breakout sessions and poster session will not be webcast.

Individuals who plan to attend in person or view the webcast must register on the NTP website. For more information regarding the workshop and attendance, please see this notice.

FDA Workshop: Development of Tissue-Agnostic, Biomarker-Based Indications

The Food and Drug Administration (FDA), in cooperation with the American Society of Clinical Oncology and Friends of Cancer Research, is hosting a workshop titled "Development of Tissue-Agnostic, Biomarker-Based Indications." The workshop aims to identify clinical trial designs and strategies to accelerate drug development based on biomarkers that are agnostic to tissue types. The workshop is intended to explore concepts in research and development that would assist the research community and regulators in understanding how to optimize product development and patient access to safe and effective biomarker-driven therapies that have clinical use across a variety of cancer types. 

Workshop objectives include:

  • Seek feedback from industry, academia, patients and other stakeholders on trial designs and analysis approaches that will aid in understanding the effect of a biomarker and its related diagnostic assay across multiple tissue types;
  • Ensure that cancer patient advocates and the leading experts in clinical research, pharmacology, drug manufacturing, and clinical care have an opportunity to contribute to the discussion about how to demonstrate safety and efficacy of a drug across multiple cancer types and how to communicate that information to the clinical community; and
  • Obtain input from multiple stakeholders on approaches the FDA uses to review applications for drug products that are intended to treat cancers based on the presence of a biomarker, rather than specification of the tissue type.

Members of the public may attend in person or via webinar with advance registration. More information, including the agenda, is available at this FDA website.

A monkey born from frozen testicular tissue offers fertility hope to pediatric cancer survivors

STAT – Cancer treatments like chemotherapy can wipe out sperm production, so men who want to one day have children sometimes freeze some before they undergo treatment. Boys who haven’t gone through puberty don’t have that option. An estimated 30 percent of childhood cancer survivors will be infertile.

FDA labels Duke researchers' device to help extract brain tumors a 'breakthrough'

The Duke Chronicle – A tumor removal tool created at Duke was recently designated a “Breakthrough Device" by the U.S. Food and Drug Administration. This device—called the "Tumor Monorail"—was designed by the Bellamkonda Lab. It works by mimicking the white matter fibers in the brain to trick tumors into moving to locations more accessible by surgeons.

BRCA Exchange aggregates data on thousands of BRCA variants to understand cancer risk

Science Daily – A global resource that includes data on thousands of inherited variants in the BRCA1 and BRCA2 genes is available to the public. The BRCA Exchange was created through the BRCA Challenge, a long-term demonstration project initiated by the Global Alliance for Genomics and Health (GA4GH) to enhance sharing of BRCA1 and BRCA2 data.