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Scott Gottlieb, MD
Opening Keynote Address
The Food and Drug Administration (FDA)
Janet Woodcock, MD
Keynote Address: The Center for Drug Evaluation and Research in 2017 and the Year Ahead
U.S. Food and Drug Administration (FDA)
Matthew Might, PhD
Keynote Fireside Chat : The Future of Precision Medicine
University of Alabama at Birmingham
Here an update from CDER on current initiatives, challenges and accomplishments of 2017 and what’s in store for the year ahead
Here an update on developments in OND and what is currently in the pipeline for 2018.
Here an update from the director on the latest developments from the office of Surveillance and Epidemiology.
Sit in on a panel discussion in follow up to the morning’s keynotes and updates. What are the current trends and developments affecting the industry, key industry implications of regulatory policies and updates, as well as industry insight on what is anticipated for the year ahead.
Patient reporting has not historically held much sway in FDA considerations, but the tide has been turning. As the FDA more seriously considers including patient-reported outcomes (PRO) as part of its approval processes, examine the potential impact on drug manufacturers as well as what this will mean for the approval process moving forward and current developments and considerations for individual diseases and treatments.
Discuss the latest DC developments, what is coming down the pipeline? Identify and examine current proposals that are circulating the Hill which would impact the Bio/Pharma and healthcare industries.
This session examines best practices and modern approaches to integrating well-designed large group access programs into the drug development process.
Examine the current requirements of all expanded access uses and its evolution, as well as those specifically for investigational drugs and biologics
What are the practical, ethical and legal issues to be considered?
Discuss the drivers of commercial feasibility including cost recovery, regulatory considerations, and pragmatic design.
Sit in on a discussion on the intersection of ethics, innovation and precision medicine, from patient to pill.
Matthew Might, Ph.D., a strategic leader appointed to the White House Precision Medicine Initiative by former President Barack Obama, has been named the inaugural director of the Hugh Kaul Personalized Medicine Institute at the University of Alabama at Birmingham School of Medicine.Might comes to UAB from the University of Utah, where he is a Presidential Scholar and an associate professor in both computer science and pharmaceutical chemistry, and from Harvard Medical School, where he is a visiting professor of biomedical informatics. Might’s research interests focus on the intersection of computation and medicine to advance precision medicine through personalized therapeutics.