A new team of Presidential Innovation Fellows (PIF), Robert Goldel and Rana Saad, have begun their work at the Food and Drug Administration (FDA), applying data science approaches to device, drug, and software development, and the associated regulatory decisions.
Project teams at the agency have been exploring ways to incorporate more digital tools into its own processes within the FDA, including the drug approval process. The FDA has also been reviewing how, through the software precertification pilot program, to streamline processes for reviewing digital technology that are medical devices.
“The FDA has committed to being at the forefront of advancing the use of digital tools to empower consumers to take an active role in managing their own health while creating new opportunities for the agency to carry out its public health mission, such as through improved measurement of important endpoints in clinical trials and ensuring patients have access to safe, effective digital health devices,” said Dr. Sean Khozin, Director of FDA’s INFORMED. “We’re also looking at ways to incorporate more advanced digital processes into our regulatory review process, through INFORMED and other efforts. We’re excited to be working with the Presidential Innovation Fellows and to apply their experiences to enhance and scale our digital health strategy and research portfolio.”
From left to right: PIF Rana Saad, FDA’s Dr. Sean Khozin, and PIF Robert Goldel. Photo by Jeff White, GSA.
Robert Goldel will be working closely with Dr. Sean Khozin, the Founding Director of INFORMED on questions of digital biomarkers, artificial intelligence (AI), and machine learning approaches in medicine. Khozin and Goldel will also be coordinating and supporting FDA work groups establishing data science and algorithm / AI regulations, procedures, and programs that have national or international impact.
“I am deeply honored to receive this Presidential Innovation Fellowship,” says Robert Goldel. “As a neuroscientist and data-driven technologist I’m really excited to be joining the FDA to promote and protect public health. I’m humbled to support their digital efforts by drawing from my experiences in neuroscience, biosensors, mobile and cloud software, artificial intelligence, and machine learning.”
Goldel believes the potential to link these technologies with traditional approaches in foods, medical devices, and pharmaceuticals is where personalized medicine is headed. “I’m looking forward to learning from the amazing people and history at the FDA. The future of digital health depends upon their expertise and passion to ensure the regulatory frameworks for software as medicine and the wide diversity of new technologies,” Goldel adds.
Rana Saad will be working closely with Mr. Bakul Patel, Associate Director for Digital Health in the FDA’s Center for Devices and Radiological Health, on standing up the infrastructure and organization needed for the Digital Health Unit at the FDA that is responsible for the software Pre-Certification pilot program (Pre-Cert) – which is going to help develop an innovative regulatory paradigm which will be designed to maximize safety of medical devices while matching the speed of innovation to realize the full potential of digital health technologies. Patel and Saad will also be coordinating and supporting the FDA to build its bench strength to prepare to be digital future ready.
“This is an exciting, pivotal time to join the FDA,” said Saad. “There is tremendous opportunity to positively impact millions of lives through working with the FDA’s staff to develop policies for regulating digital innovations in healthcare in general. It will be wonderful to play a role in helping accelerate the pace of innovation in this important area.”
To apply directly to our program, please visit our website to begin your application process for the Summer 2019 Cohort.