Johnson & Johnson Innovation – JLABS Archives

Medical technology innovator Julia Finkel, M.D., principal investigator for the Pain Medicine Initiative of the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital, recently participated in Galen Growth’s 2020 Global Healthtech Summit on a virtual panel featuring resident companies from Johnson & Johnson Innovation – JLABS who are utilizing artificial intelligence (AI) with the aim to create advanced solutions for diagnostics, treatment and clinical trials. The summit, hosted in Singapore, brought the innovators together to discuss their views on their progress, the challenges and opportunities for bringing medtech innovations to market in the current climate, as well as the tools needed to succeed.

Dr. Finkel’s innovation, AlgometRx, is a real-time pain measurement technology that captures a digital image of a patient’s pupillary response to a non-invasive stimulus and applies proprietary algorithms to measure pain type and intensity. AlgometRx, a spin-off of Children’s National, recently received a JLABS @Washington DC Quickfire Children’s Challenge award.

Joining Dr. Finkel on the panel were JLABS resident company leaders Don Crawford, CEO, Analytics 4 Life; Jim Havelka, CEO, Inform AI; and Kim Walpole, CEO, Trials.ai, which leverages AI to help research teams design more effective clinical trials. The 50-minute program, moderated by Kara Bortone, senior director, Portfolio and Sourcing Management, Johnson & Johnson Innovation – JLABS, focused on topics such as how these startups approached the market and regulatory processes as well as the up-and-coming trends in health technology.

A pediatric anesthesiologist, Dr. Finkel explained the significance of achieving real-time, objective pain measurement. “Pain is one word that represents a myriad of conditions,” she says. “Pain from acute post-operative conditions is very different from peripheral neuropathic pain and different from the type of inflammatory pain seen in lupus and rheumatoid arthritis. Being able to discern the drivers of pain, the etiology, is essential to treating it well and to developing better therapeutics in the future.”

Dr. Finkel points out that AlgometRx measures nociception, which is pain fiber activation, and that is also what medications are addressing. “We’re not discounting a patient’s perception of pain, as we recognize that one’s experience of pain is very complex,” she says. “What we aim to measure is the activity being transmitted by the pain nerve and the type of nerve fiber that is doing the transmitting.”

Aiming to identify pain phenotypes is an important part of current AlgometRx development work, says Dr. Finkel, as it could significantly aid clinical decision-making in treating and monitoring patients’ pain. The company’s current regulatory focus is to seek FDA clearance related to its potential use for patients with peripheral neuropathy, which is pain and numbness resulting from damage to the nerves outside of the brain and spinal cord. The company has also identified fibromyalgia cases as a place where the technology could potentially benefit a large number of patients as it considers regulatory clearance targets.

As the COVID-19 pandemic presented many unique challenges to healthcare startups this year, panel participants were asked to discuss the hurdles they faced and how it impacted device development.

Dr. Finkel notes that the pandemic slowed patient enrollment in AlgometRx clinical studies, but also presented some upside. “At first, that had a negative impact, but it wound up being a good thing,” she says. “It gave us a moment to pause, regroup and examine the data we’d already generated. That break gave us improved information and a new, more powerful approach. It changed our trajectory by altering our regulatory path in terms of the order of things in our pipeline, so we’ve been enormously productive.”

As a Johnson & Johnson Innovation Quickfire Children’s Challenge awardee, Dr. Finkel and AlgometRx will be among the first group of startups taking up residence at the new JLABS @ Washington, DC, located on the Children’s National Research & Innovation Campus, when it opens in 2021 at the historic former Walter Reed Army Medical Center site. Along with a one-year residency at the new JLABS @ Washington DC facility,* AlgometRx will receive mentorship from experts at the Johnson & Johnson Family of Companies and grant funding to help support its continued advancement to commercialization.

*Residency at JLABS @ Washington subject to acceptance and execution of a License Agreement with Children’s National.

“Innovation in children’s medical devices consistently lags behind that of adults and we need to change that if we are to confront the challenge to children’s health of COVID-19 and future pandemics,” said Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI.

As medical data increasingly highlights the serious impact of COVID-19 on children’s health, the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces a special pitch competition focused on COVID-19-related pediatric medical devices that support home health monitoring and telehealth, and improve sustainability, resiliency and readiness in diagnosing and treating children during a pandemic.

The “Make Your Medical Device Pitch for Kids!” COVID19 edition is led by NCC-PDI co-founders the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital and the A. James Clark School of Engineering at the University of Maryland and powered by nonprofit accelerator and NCC-PDI member, MedTech Innovator. The finals in the virtual pitch event will be held on July 20, 2020. Winners will each receive a grant award of up to $50,000.

“Despite early reports that COVID-19 posed less of a threat to children, a recent study published by Children’s National shows that considerable numbers of pediatric patients are hospitalized and become critically ill from the disease,” said Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI. “Innovation in children’s medical devices consistently lags behind that of adults and we need to change that if we are to confront the challenge to children’s health of COVID-19 and future pandemics.”

Funding for the competition is made possible by a grant from the Food and Drug Administration (FDA) and a philanthropic gift from Mei Xu, founder of e-commerce platform Yes She May, a site dedicated to women-owned brands.

Along with grant funding, one company from the competition will be selected by Johnson & Johnson Innovation – JLABS to receive a one-year residency at JLABS @ Washington, DC, which will be located on the new Children’s National Research & Innovation Campus currently under construction. In addition to the 2021 JLABS residency, the awardee will have access to the JLABS community and expert mentoring by the Johnson & Johnson family of companies.

Submissions for the competition are being accepted now through Monday, July 6, 2020z at the NCC-PDI website, Innovate4Kids.org, where complete details can be found.

NCC-PDI is one of five members in the FDA’s Pediatric Device Consortia Grant Program created to support the development and commercialization of medical devices for children, which lags significantly behind the progress of adult medical devices. Along with Children’s National, University of Maryland and Medtech Innovator, NCC-PDI members include accelerator BioHealth Innovation and design firm Archimedic.

To date, NCC-PDI has mentored over 100 medical device sponsors to help advance their pediatric innovations, with seven devices having received either their FDA market clearance or CE marking. The consortium hosts a major pediatric pitch competition annually that showcases and awards promising pediatric innovations and provides a first-of-its-kind pediatric-focused accelerator program for finalists.

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Children’s National pain expert and innovator shares global summit spotlight

NCC-PDI launches special pediatric medical device competition focused on covid-19 innovations