Institute’s Partnership with the FDA Enhances Relationships On Both Sides

Since its inception four years ago, the Fogarty Institute’s FDA Fellowship program has blossomed into a successful, ongoing partnership that is being lauded on both sides for enhancing the understanding, communication and collaboration between entrepreneurs and regulators. To date, the Institute has hosted 41 Fellows in addition to FDA scientists and department heads.

The relationship has proven to be beneficial for both sides: The FDA better understands the challenges inherent in device development, and Fogarty Institute entrepreneurs better appreciate the reasons behind the steps required in the regulatory process.

Over the past several years, the FDA has made significant enhancements to its regulatory process to improve the efficiency of reviews and accelerate the delivery of innovative technologies to patients. “We have been very pleased with the relationship we have forged with the agency,” said Andrew Cleeland, CEO of the Fogarty Institute. “Their passion and dedication to approve new products that advance patient care while at the same time protecting public health is impressive and very much aligned with our goals here at the Institute.”

Fellows Impart Important Lessons

In September, we had the privilege of hosting our 13th class of FDA Fellows. Their busy five-day schedule provided a full perspective of the medical technology ecosystem, including visits with our companies-in-residence, team members from the Fogarty Institute and El Camino Hospital, FII board members, graduates, members of the VC community, reimbursement experts and Stanford Biodesign.

We had the opportunity to hear from the Fellows regarding their background and tips for our entrepreneurs.

Luna Zaritsky, Ph.D., Biologist at FDA

Luna went to graduate school at Johns Hopkins School of Medicine where she received her Ph.D. in biochemistry, cellular and molecular biology. Prior to joining the FDA, she spent four years as a Postdoctoral Research Fellow at the National Institute of Health.

Currently she is as a scientific reviewer in the Division of Microbiology Devices in the Office of In Vitro Diagnostics and Radiological Health, where she reviews molecular assays detecting human papillomavirus, reviews sexually transmitted infection (STI) diagnostics and consults on devices used in cervical cancer screening.

While her area of expertise is in women’s health, Luna had valuable advice for all early-stage entrepreneurs, including the important reminder that we are all on the same team and collaboration is critical to benefit patients. She recommended startups begin discussions and information sharing with the FDA at the earliest possible stage; provide clearly written scientific explanations and high-quality data; and proactively offer solutions when problems are presented. “We are scientists talking about science,” she said.

Jessica Lamb, Ph.D., AI in Radiology at the FDA

Jessica received her Ph.D. in Applied Physics from Cornell University, and she also spent five years at the National Institutes of Health as a Postdoctoral Fellow, following positions as research assistants at Cornell and Dartmouth.

She works in the division of Radiological Health, reviewing relevant devices, including X-ray, CT, mammography and radiation therapy, with a particular focus on software-only devices that utilize AI and machine learning to increase efficiency for physicians and radiologists.

Jessica shared that the nuance of indications is very important; for example, whether the device is helping determine the likelihood of a malignancy, compared with telling the radiologist a person doesn’t need a biopsy. She says AI is an example of a new field where the FDA is working hard to stay informed and determine how to best regulate new devices, which creates the need for greater collaboration with technology developers.

Aneesh Deoras, Electrical Engineer, FDA

Aneesh received his Master of Science in Bioengineering and Biomedical Engineering from the University of Pennsylvania. Similarly to his colleagues, he had prior experience working as a research assistant and engineering intern before joining the FDA.

Aneesh works in the Office of Cardiovascular Devices and Center for Devices and Radiological Health. His review focus is on electrophysiology devices that include ablation and mapping catheter, coronary and intracardiac imaging catheters and novel critical care and diagnostic devices. His department ensures that new devices or systems function properly in the electromagnetic environment – for example, that implantable pacemakers aren’t adversely affected by antitheft systems and metal detectors.

His key takeaways are to understand the purpose of testing, including taking into consideration all potential electromagnetic adversity risks; and maintain control of the testing process, as outsourcing may lead to inefficiencies and poor documentation. In addition, he recommends communicating results and corrective actions during premarket submissions.

Andrea Bell-Vlasov, Ph.D., Scientific Reviewer, FDA

Andrea has a Doctor of Philosophy in Analytical Chemistry from the University of Michigan and went straight into working for the FDA as a scientific reviewer in the Division of Chemistry and Toxicology in the Diabetes Diagnostic Devices branch. She is proud to have reviewed and approved the first Automated Insulin Delivery System, which was a game changer for diabetics.

Approximately 40 to 45 percent of her division’s work is focused on diabetes-related devices, including continuous glucose monitoring systems and automated insulin delivery systems. With the widespread incidence of diabetes, the FDA is working hard to provide viable options for this community and has made a concerted effort to quickly get new solutions to patients by streamlining the process and optimizing interactions with innovative startups to speed up time to market.

Andrea shared that the FDA wants to improve the regulatory process to support innovation and improve access to patients. Therefore, it’s important to establish a relationship early on and interact frequently to explain barriers and work together to solve them collaboratively.

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