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Transforming FDA’s Approach to Digital Health

Remarks by Scott Gottlieb, M.D., Commissioner 
Academy Health’s 2018 Health Datapalooza
Washington, DC, April 26, 2018

Digital health tools have vast potential to

  • Improve ability to accurately diagnose and treat disease
  • Enhance delivery of health care for the individual
  • Make medical care truly patient centric — empowering the individual

Digital Health Innovation Action Plan

  •  New policy  to streamline path for digital health products with several functions
  • Draft of Working Model for precertification pilot program

Launch of Program to Apply Digital Health to Drugs

  • Expand opportunities to use digital health tools as part of drug development
  • Improve safety and effectiveness of drug delivery
  • Mobile devices and software linked to specific drugs for medication compliance
  • Advance policy framework and new guidance

Artificial Intelligence

  • New regulatory framework to support use of AI-based technologies
  • Understand connection between decision-making in traditional health care settings vs. use of advanced technologies
  • Appropriate guardrails for to deliver benefits  and meet safety /effectiveness stds
  • Make drug/device development more predictable, efficient, more reflective of patients’ real-world experience

Launch of a New Premarket Digital Safety Program

  • Launch of Premarket Digital Safety Program with unified data standard for electronic reporting requirements
  • New digital framework can significantly improve efficiency and accuracy of premarket safety submission and review process

Launch of FDA’s New Digital Health Incubator

  • Creation of an internal data science incubator – Information Exchange and Data Transformation (INFORMED)
  • Conduct of regulatory science research in health technology and cancer analytics
  • Collaboration with nonprofit open-access Project Data Sphere, to develop algorithms for classification of tumor dynamics
  •  Joint fellowship program with NCI to design and develop digital biomarkers as drug development tools

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CaptureMission Possible: Moving the Needle Forward to Advance Health Equity

FDA’s Office of Minority Health (OMH) protects, promotes, advances public health of vulnerable and underrepresented populations

  • Conduct and fund research on diseases that disproportionately affect minorities
  • Diversify the public health workforce
  • Help minorities make better informed health decisions
  • Engage with minority-serving institutions of higher learning
  • Serve as a voice for those in need; rural health challenges, need for telemedicine

Partnering with private- and public-sector organizations (including VA, Yale University) to further equity on all fronts

  • Getting culturally sensitive messages out to minority communities
  • Ensuring minority representation in clinical trials

New Journal Article: Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs 

www.fda.gov/minorityhealth

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CaptureInformation Exchange and Data Transformation (INFORMED)

Incubator for collaborative oncology regulatory science research

  • In collaboration with the U.S. Department of Health and Human Services’ Innovation, Design, Entrepreneurship and Action (IDEA) Lab
  • Focused on supporting innovations with expertise of a diverse group of oncologists, data scientists, statisticians, and entrepreneurs-in-residence
  • Big data analytics and modern approaches in evidence generation for regulatory decisions
  • Special emphasis on systems thinking in oncology regulatory science research t

Research portfolio

  • Use of real world data for clinical evidence generation. prospective pragmatic clinical trials
  • Utility of biosensors, IoT to quantify intrinsic and extrinsic factors influencing patient’s experience
  • Opportunities for machine learning and artificial intelligence to improve existing practices
  • Utility of open-access platforms and emerging technologies such as blockchain

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CaptureAdvancing Development of Treatments for Neurological Disorders

Published five guidances for industry related to neurological conditions

Noteworthy aspects

  • Recent explosion of new scientific knowledge about nervous system.
  • Drug developers looking for clear paths to treatment solutions
  • Worked with patient advocacy organizations and scientists to ensure voices were heard
  • Streamlined internal review process  to encourage development of short, concise documents free of unnecessary background information

Stakeholder community engagement

  • Alzheimer’s disease (AD), Duchenne muscular dystrophy (DMD), amyotrophic lateral sclerosis (ALS), migraine, and epilepsy communities
  • Frequent conversations with multiple drug developers about their needs

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Advancing Science of Nanotechnology in Drug Development

Steady increase in approved drug products containing nanomaterials

  • Including investigational new drugs, new drug applications, and abbreviated new drug applications (commonly known as generics)

Uniqueness of drug products containing nanomaterials

  • May take on different chemical, physical, or biological properties
  • May impact quality, safety, or efficacy
  • May follow a different pathway in the body compared to small molecule drug; reach areas typically difficult to reach for a small molecule

Research to Address Challenges Related to Nanotechnology

  • FDA’s Office of Testing and Research (OTR) conducting research on manufacturing and quality issues
  • Identifying critical processes and material properties that can impact quality within context of efficacy and safety
  • Evaluating drug’s performance and release from the nano carriers
  • Encourage use of advanced manufacturing techniques to reduce variations in product quality
  • Characterizing excipients in complex formulations

Draft guidance on Drug Products, including Biological Products, that Contain Nanomaterials

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Biomarkers for Brain Injury Monitoring

FDA Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories, Division of Physics

“We envision a day when soldiers or civilians who have experienced a blast or a head impact will be able to stick a small sensor to their forehead and know if they have sustained a brain injury. Although we may not be the ones who develop such a device, we want to contribute research that can help advance the field.” 

Recent  Scientific Advances

  • Fexible microelectronics that are wearable and conformable for portable electroencephalogram (EEG) technology
  • Use to detect brain injury in victims of traumatic events e.g. accidents, explosions
  • Need scientific knowledge base related to validated brain injury biomarkers and models

Research project on field-deployable devices to rapidly collect and evaluate EEG signals 

  • Detect Traumatic Brain Injury (TBI) rapidly and non-invasively
  • Create “smart sensors”  to for emergency responders to detect EEG signals rapidly
  • But lack of validated biomarkers and models of brain injury
  • This research focuses on developing useful brain injury models, identifying and validating brain injury biomarkers, and studying new EEG technologies

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 Image credit: FDA

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