By Stephanie Baum | MedCity News, April 26, 2018
The pharma industry’s use of digitized healthcare data and digital health tools to support drug development and quantify the impact on patient health has increased bit by bit over the past seven years. At the Health Datapalooza conference in Washington, D.C. this week, U.S. Food and Drug Administration Commissioner Scott Gottlieb rolled out a set of initiatives designed to help the regulator keep up with the increasingly complex world of drug development where data science is playing a bigger role in the path to commercialization.
Gottlieb discussed a new incubator at the FDA for data science projects, initially focused on cancer research, which is intended to come up with standardized practices to review artificial intelligence in healthcare and a new application of digital health tools for the pre-market review of drug safety.
INFORMED incubator launch
The FDA launched an incubator initially focused on health technology and advanced analytics initially related to cancer. The Information Exchange and Data Transformation incubator, or INFORMED was formed in collaboration with the Department of Health and Human Services IDEA Lab. It will also include projects focused on exploring the utility of open-access platforms and technologies such as blockchain to the secure exchange of health data at scale. It’s an interesting development because although HHS has been keen to collaborate with startups internally and externally, FDA has not historically done these kinds of programs.
Gottlieb highlighted a few projects that are already part of the INFORMED incubator:
- Collaborations with Project Data Sphere, a nonprofit open-access cancer data repository, aimed at developing algorithms for classification of tumor dynamics using medical imaging data.
- A joint fellowship program with the National Cancer Institute to design and develop digital biomarkers as drug development tools. This program stems from the need to school radiation oncologists on how they can harness the big data and emerging health technologies, according to the American Society for Radiation Oncology.
- A fellowship program with Harvard’s program in Therapeutic Science on AI and machine learning focused on designing, developing and implementing machine learning and artificial intelligence algorithms for regulatory science applications.
Digitizing pre-market safety report submission
An FDA assessment of its pre-market safety review process found that a big chunk of time, or 16 percent, was being devoted to managing paper-based premarket safety reports, either because they were not in a format that lent itself to being shared electronically or they were sent by fax.
“We found inefficiencies resulting from a disjointed, analog workflow,” Gottlieb said. An internal survey of the FDA’s office of hematology and oncology products revealed that reviewers spend an average of 16 percent of their time managing these paper-based premarket safety reports.
“Medical officers and clinical reviewers must review and track each report individually, reading thousands of narratives to understand the safety profile of investigational new drugs and biologics,” Gottlieb explained.
Digital health and drug development
Gottlieb also indicated a policy framework is coming, once it gets user feedback on how best to regulate that will address how to regulate software that’s designed to be used with prescription drugs, pending public input on the right approach to incorporating software that’s designed to be used with prescription drugs.
He offered a few use cases to make his point. For example, software that can help cancer patients monitor side effects of their treatment with smartphone cameras and facial recognition software to objectively classify pain symptoms and track cognitive performance.
“In some cases, these tools might allow for safety and efficacy claims supported by data collected through software or sensors embedded in smart devices – like increased activity, improved mood, or greater social interactions for patients treated for severe depression,” Gottlieb said.
Pre-Certification program:
Gottlieb also shared a progress report on the Pre-Certification pilot program launched last year. An initial first draft of its working model will be made available along with suggestions on how to expand it. It marks the first, high-level draft of the program.
The goal is to verify the safety, effectiveness, and performance of software as a medical device and reduce the need for unnecessary resubmissions of applications when technology products have initially cleared the clearance process.
“The critical piece we need moving forward is input from developers, patients, providers, and members of the public,” he said
Gottlieb noted that the FDA plans to roll out a first version of the program by the end of 2018 before it is further refined next year.