New Combinations to Fight Cancer

Data from experiments using 5,000 different pairings of approved drugs will be made available.

Researchers at the National Cancer Institute have tested 5,000 different combinations of 100 approved cancer drugs in the hope of finding new pairings that could ultimately provide patients with more effective and safer treatments.

Scientists in the Division of Cancer Treatment and Diagnosis at the National Cancer Institute completed some 300,000 experiments aimed at testing all possible combinations of every currently approved small molecule cancer drug in the United States.

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Updates on Regulatory Developments and Guidances on Drug/Device Combinations and Companion Diagnostics ~ Premarket Considerations

Learn the Regulatory Processes for All Aspects of Product Development and Management Combination Product Premarket Considerations May 21 | 11:00AM-12:30PM ET FDA receives a large number of combination products for review as technological advances continue to merge product types. Because combination products involve components that would normally be regulated under different types of regulatory pathways, and frequently by different FDA Centers, they often raise difficult policy, regulatory, and review management challenges. This 90-minute webinar will cover topics from what kind of product you have, to how it’s assigned, to application development and review, as well as the premarket steps for combination products. Case studies and scenarios will bring these steps together. Presenters: • Kathy Lee, Lead Interdisciplinary Scientist; Division of Therapeutic Proteins/OBP/OPS/CDER, FDA • Hina M. Pinto, Regulatory Advisor, CDRH, FDA Who Should Attend? Pharmaceutical, academic and government senior-level professionals and decision-makers involved in: • Drug Research and Development • Medical Device and Diagnostics • Regulatory Affairs • Clinical Research • Development of Drug/Device Combinations and Companion Diagnostics Overview | Register Online Next Week's Webinar: A Closer Look at FDASIA Provisions to Promote Biomedical Innovation April 30 | 12:30-2:00PM ET The Food and Drug Administration Safety and Innovation Act (FDASIA) includes a number of significant new provisions to promote the development and availability of safe, effective, and innovative therapies. This webinar will discuss these provisions as well as the user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilars. Overview | Register Online May 23 | 10:00AM-12:00PM ET May 30 | 1:00-2:30PM ET Almost Half of the Sites Recruited by Trial Planners End up Enrolling Less than Two Patients Connecting the Right Sites to Promising Trials: The Role of Web-based Feasibility Assessment May 22 | 10:00-11:30AM ET Selection of the right sites for a promising clinical trial is the most relevant step in the planning process for subsequent successful study conduct. A number of obstacles stand in the way of efficient implementation of this process. This webinar will address common weaknesses in the established process of feasibility assessments and site selection, from the point of view of both trial planners and research centers. You will learn relevant key performance indicators (KPIs) and how to address them, global country selection strategies, and better management of site feasibility assessment by improving the efficiency of information exchange between sites and trial planners. Overview | Register Online Stay Up-To-Date with DIA

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