Monique Pond, PhD, Medical Writer and Consultant, at Whitsell Innovations, Inc. will be presenting at the Expedited Review Pathways Conference, Best Practices for Successful Early Launch of Investigational and Unapproved Drugs, being held August 16-17, 2017, at the Embassy Suites by Hilton Alexandria Old Town, in Alexandria, VA.
Dr. Pond will be presenting “Precision Medicine – Best Practices for Leveraging Expedited Approval Programs.” Trial design, companion diagnostics, and patient recruitment considerations will be discussed from the perspective of precision medicine. Recent trends in the use of expedited approval programs among targeted oncology therapies will be highlighted.
“Expedited approval programs can benefit patients by providing them with earlier access to therapies,” says Dr. Pond. “The challenge for life science corporations is determining which expedited program (or programs) best aligns with their unique potential therapy.”
The Expedited Review Pathways Conference will bring together leaders in the pharmaceutical industry to discuss the FDA’s expedited approval programs. This summit is designed to educate potential drug sponsors of novel medications and devices for small populations and emergency health scenarios who are interested in pursuing one or more of FDA’s expedited approval programs.
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