Sally Howard, JD, serves as Head of Regulatory Affairs and Policy for HLI. Howard, who has more than two decades of health policy and regulatory expertise, leads all efforts related to federal and state regulatory oversight for HLI. Howard comes to HLI from the United States Food and Drug Administration (FDA) where she served most recently as Senior Advisor and Acting Chief of Staff to the FDA Commissioner. In this role, Howard coordinated the FDA’s response to rapidly emerging issues such as bacteria resistant infections from medical equipment and response to adverse events from compounded drugs.
She also spent two years as FDA Deputy Commissioner for Policy, Planning and Legislation, during which time she directed the team implementing the White House’s Precision Medicine Initiative. She and her team were responsible for developing a standards based approach for ensuring accuracy of genomic tests, and the use of genomic data and databases for clinical and diagnostic use. She was also a key leader on FDA legislative initiatives such as the 21st Century Cures initiative which seeks to modernize the approach to patient centered drug development, and the development of biomarkers.
Prior to her role at the FDA, Howard spent two years as Chief of Staff at the U.S. Department of Health and Human Services (HHS), where she worked directly with the Secretary and senior agency and administration leadership to develop and implement policy priorities including the Affordable Care Act and new standards for Electronic Health Records.
Howard brings extensive legal expertise including from her role as Deputy General Counsel at HHS and Chief Counsel to the Office of then Kansas Governor Kathleen Sebelius. Howard spent ten years in private practice in Kansas, where she litigated a variety of health and medical issues including, medical malpractice, physician licensure issues and risk management efforts.
Creating a Coordinated Path Forward: Biomarkers in Drug Discovery and Clinical Practice
11:20 AM - 12:10 PM