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Engaging Innovation

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October 10, 2019

Despite criticism, FDA is doing what is right by rare cancer patients

On October 1, the first-ever Rare Cancer Day, an awareness day highlighting the challenges people living with rare cancers face and emphasizing the importance of early diagnosis, was marked by thousands nationwide. Cancer is not a singular disease but, rather, many diseases, of which several are rare. One in 5...
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The Future Use of Real-World Evidence

  Significant progress has been made in data collection efforts to support use of real-world evidence (RWE) in regulatory settings; however challenges remain, chiefly with combining, organizing, and analyzing data from various information sources. On July 10th, Friends of Cancer Research (Friends) hosted a meeting to present data from a pilot...

Data Driven: Molecular Diagnostic Testing in Lung Cancer

Molecular diagnostics are central to the delivery of personalized cancer care. Without these important tools, physicians would not be able to select the appropriate patients for targeted therapy, negating the advantages conferred by recent advances in genomics. In the past fifteen years, there has been an explosion of new technologies to...

Data Driven: US Regulatory System Leads the World in New Drug Review Times

In the second installment of Data Driven, Friends of Cancer Research explores President Trump's claim that FDA's drug regulation impedes timely access to new medicines. We compared the time the FDA takes to review new cancer drugs with the time it takes European regulators to accomplish the same task.

The Importance of Pediatric Drug Development: A Conversation with Pr. Gilles Vassal, Dr. Gregory Reaman, and Mr. Raymond Rodriguez-Torres

Studying pediatric oncology has proven difficult since pediatric drug development can face unique challenges. Due to this, Friends of Cancer Research held a forum on accelerating pediatric drug development. Ahead of the event, we reached out to a few panelists on the importance of pediatric drug development.

Four Years Later, Breakthrough Continues to Exceed Expectations

In 2012, the Breakthrough Therapy Designation was signed into law. Four years later, Friends of Cancer Research (Friends) continues to steward the program that the organization developed by working closely with FDA and other stakeholders to ensure the program is as efficient and effective as possible. As part of this stewardship, Friends hosted a Senate briefing to discuss the successes so far, lessons learned and future strategies to enhance the program and the FDA at large.

Katie Couric, Mark McClellan, and Ellen Sigal Huffington Post Op-Ed on 21st Century Cures

This is an incredibly exciting time in biomedical research. New discoveries are announced almost every week that bring us closer to managing cancer and other life-threatening diseases.

In Case You Missed It: Highlights from March, April, May & June 2015

It been a busy couple of months for medical policy and drug development. Here are some of the highlights.

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