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Sally Howard
Sally Howard
About
Detail
Senior Vice President, Regulatory and Quality
United States
Attorney/Executive with 20 years plus experience in health care law, regulatory and compliance issues, and government relations. I believe in the power and promise of precision medicine, artificial intelligence, and digital health to make better health care available to all. Established Sally Howard Regulatory Resources, LLC. to help companies successfully navigate regulatory, reimbursement, privacy and data use issues.
As Vice President of Regulatory Affairs and Policy for Human Longevity, Inc., developed US and global regulatory strategy for genomic testing and imaging services. Oversaw Quality Department and led CAP accreditation of next generation sequencing lab, and developed strategy for New York State accreditation. Responsible for HIPAA and GDPR compliance and education across organization. Led FDA filing strategy for novel genomic/imaging predictive models.
As Chief of Staff, and as Deputy Commissioner for Policy, Planning, and Legislation at the FDA, was responsible for overseeing policy development across all of FDA, and for shaping legislative initiatives, such as 21st Century Cures, that impact the FDA. Led FDA's participation in President Obama's Precision Medicine Initiative, which led to innovative approaches for regulating next generation sequencing technology. Oversaw FDA regulatory policy across many developing technologies, including digital health, biosimilar products, and cellular therapies.
As former Chief of Staff and Deputy General Counsel at HHS, guided HHS policy development across all major agencies, including CMS, NIH, FDA and CDC. Provided leadership on major white house initiatives, and led responses to major public health challenges.
As Vice President of Regulatory Affairs and Policy for Human Longevity, Inc., developed US and global regulatory strategy for genomic testing and imaging services. Oversaw Quality Department and led CAP accreditation of next generation sequencing lab, and developed strategy for New York State accreditation. Responsible for HIPAA and GDPR compliance and education across organization. Led FDA filing strategy for novel genomic/imaging predictive models.
As Chief of Staff, and as Deputy Commissioner for Policy, Planning, and Legislation at the FDA, was responsible for overseeing policy development across all of FDA, and for shaping legislative initiatives, such as 21st Century Cures, that impact the FDA. Led FDA's participation in President Obama's Precision Medicine Initiative, which led to innovative approaches for regulating next generation sequencing technology. Oversaw FDA regulatory policy across many developing technologies, including digital health, biosimilar products, and cellular therapies.
As former Chief of Staff and Deputy General Counsel at HHS, guided HHS policy development across all major agencies, including CMS, NIH, FDA and CDC. Provided leadership on major white house initiatives, and led responses to major public health challenges.
