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Research & Innovation Campus building entrance

Children’s National Research & Innovation Campus welcomes new resident company, AlgometRx

Research & Innovation Campus building entrance

Located on a nearly 12-acre portion of the former Walter Reed Army Medical Center campus, the Children’s National Research & Innovation Campus is the nation’s first campus dedicated to pediatrics, which formally opens in September 2021.

On April 26, 2021, AlgometRx Inc., a Children’s National spinout company developing a handheld device to objectively measure pain by pupillary response, will relocate to Johnson & Johnson Innovation – JLABS @ Washington, DC on the Children’s National Research & Innovation Campus. The AlgometRx move comes following the company being awarded the JLABS @ Washington, DC Children’s QuickFire Challenge, which includes a one-year residency at the newly opened JLABS @ Washington, DC – a 32,000-square-foot incubator located at the new Children’s National Research & Innovation Campus in northwest Washington, D.C. As an awardee, AlgometRx also receives access to research and development space, capital equipment, mentorship, resources and programming.

Located on a nearly 12-acre portion of the former Walter Reed Army Medical Center campus, the Children’s National Research & Innovation Campus is the nation’s first campus dedicated to pediatrics, which formally opens in September 2021. This campus aims to help address a significant problem: the development of medical and surgical devices for children has long lagged behind that for adults. Over the past decade, only one in four medical devices approved by the Food and Drug Administration (FDA) were indicated for use in children, and the majority were for those ages 12 and up.

By bringing together public and private partners, the campus is a one-of-a-kind innovation ecosystem that aims to accelerate breakthrough discoveries into new treatments and technologies.

AlgometRx was founded by pediatric anesthesiologist Julia C. Finkel, M.D., and originated at the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National.

“Pain is the only vital sign that is not objectively measured,” Finkel said. “The current standard of measuring pain is the 0-10 scale, which is based on observations and subjective assessment. This technique increases the likelihood for inaccuracies, especially for infants and children who cannot clearly communicate their pain.”

Finkel’s research was inspired by a desire to find an objective measurement of pain in nonverbal pediatric patients so physicians can better determine the appropriate pain treatment or the effectiveness of a treatment.

“The Children’s National Research & Innovation Campus enables AlgometRx to focus almost exclusively on collecting data, which is the most crucial step at this time,” Finkel said.

AlgometRx aims to submit a formal application to the FDA in the next 12-18 months, with the next six months dedicated to validating the device through a clinical trial.

“The campus also allows us to take advantage of a vast network of the nation’s most innovative pediatric researchers who can provide mentorship on subjects like clinical trial design, prototyping and grant applications,” Finkel said. “Just outside the campus, our team has proximity to relevant federal agencies, such as the FDA, meaning that to date, we’ve only met with FDA officials in person. This advantageous environment will accelerate our progress and allow us to use this technology to more quickly benefit children in pain.”

After its September grand opening, the Children’s National Research & Innovation Campus aims to expand its role as a biomedical incubator to include about 50 start-up companies, working to translate potential breakthrough discoveries into new treatments and technologies.

Learn more at www.childrensnational.org/innovationinstitute.

Research & Innovation Campus building entrance

Research campus provides opportunities for entrepreneurs and innovators

Research & Innovation Campus building entrance

Artist’s rendering of the entrance to the research building on the Children’s National Research & Innovation Campus.

In 2021, Children’s National Hospital intends to open a one-of-a-kind pediatric research and innovation hub, located on a portion of the former Walter Reed Army Medical Center campus. Called the Children’s National Research & Innovation Campus, this collection of facilities will house both our Research and Rare Disease Institutes. In the 160,000 square foot space, we are excited to pursue breakthrough potential discoveries that aim to quickly translate into new treatments and technologies benefitting our most vulnerable population, children and babies.

The campus also represents an opportunity for entrepreneurs and innovators who share our passion for finding new and better ways to care for children thanks to a collaboration with Johnson & Johnson Innovation called JLABS @ Washington, DC, a facility within the campus.

Strategically located with proximity to leading academic research institutions, medical schools and federal research institutions and agencies, the JLABS @ Washington, DC site will be open to emerging pharmaceutical, medical device, consumer and health technology companies aiming to advance the development of new drugs, medical devices, precision diagnostics and health technologies, including applications in pediatrics.

Johnson & Johnson Innovation – JLABS, in addition to offering emerging life science companies modular lab units, office space, shared core laboratory equipment and business facilities, aims to link the entrepreneurs within the District and across the greater Virginia and Maryland regions with the full breadth of the Johnson & Johnson Innovation model, including opportunities for collaboration, a resource hub, educational events and mentorship from experts from the Johnson & Johnson Family of Companies. AlgometRx, a spin-off company from Children’s National Hospital, will be among the first residents of JLABS @ Washington, DC, which aims to opens in 2021, as an awardee of the JLABS @ Washington, DC Children’s QuickFire Challenge.

AlgometRx’s novel technology was developed by hospital pain medicine expert Julia Finkel, M.D., The non-invasive handheld device aims to objectively measure pain by capturing real-time images of a patient’s pupillary response and applies proprietary algorithms to determine the patient’s pain type and intensity.

Do you have a pharmaceutical, medical device, consumer health or health technology innovation that could benefit from this unique and transformational ecosystem? If so, we invite you to submit an application to be considered for joining us at JLABS @ Washington, DC. Learn more by visiting the JLABS website.

Research & Innovation Campus

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

Research & Innovation Campus

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.

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.

Pitch Competition Winners

7th Annual Pediatric Device Innovation Symposium

 Melinda Richter and Dr. Newman

The event featured an onstage discussion by Melinda Richter, global head of Johnson & Johnson Innovation – JLABS and Dr. Kurt Newman, M.D., president and CEO of Children’s National Hospital, about the power of collaboration to spur innovation.

The 7th Annual Pediatric Device Innovation Symposium, presented by Children’s National Hospital, recently brought together stakeholders from across the clinical, investor, business and regulatory sectors of pediatric device development for a day-long program focused on closing the wide gap that exists between the number of medical devices developed for adults and the significantly smaller number developed for children.

Co-located with AdvaMed’s The MedTech Conference for the third consecutive year, the symposium featured an opening keynote address by Melinda Richter, global head of Johnson & Johnson Innovation – JLABS, who was later joined Kurt Newman, M.D., president and CEO of Children’s National Hospital, for an on-stage discussion about the power of collaboration to spur innovation.

That collaboration was on display as Dr. Newman and Richter shared details of the recently announced JLABS @ Washington, DC, a 32,000 square-foot facility to be located at the new Children’s National Research & Innovation Campus on the former Walter Reed Army Medical Center campus in the nation’s capital.

“We had this idea at Children’s National to develop the first pediatric research and innovation campus in the world to create a sustainable pipeline and ecosystem of everything needed to bring medical devices from concept to market for children. Seeing what Johnson & Johnson has accomplished with JLABS across the world, we knew they were the right partner,” said Dr. Newman.

Richter highlighted the need to take action, “We have made modest progress in pediatric device innovation, but we need to do better. We need to advance solutions that take into account the unique characteristics of our youngest and most vulnerable of patients. Only then will we achieve real progress for children and their families.” Of all the medical devices approved each year, only 25% are approved for children and most of those are approved for patients over the age of 18. Richter encouraged symposium attendees to leverage collaborations and convenings to move pediatric device development forward and lauded innovators focused on babies and children, calling them “super heroes.”

$150K medical device pitch competition

Pitch Competition Winners

Six innovations that address the significant unmet needs of neonatal intensive care unit (NICU) patients were awarded a total of $150K during the medical device pitch competition at the 7th Annual Pediatric Device Innovation Symposium hosted by Children’s National Hospital at Boston Convention & Exhibition Center. From L to R are: Anthony Sandler, M.D., Children’s National Hospital; Neil Ray, Raydiant Oximetry; Julia Finkel, M.D., AlgometRx, Inc.; Eric Chehab, Ph.D., Novonate; Xina Quan, Ph.D., PyrAmes, Inc.; Mark Lehmkuhle, Epitel, Inc.; Adam Zysk, Ph.D., Rhaeos, Inc.; and Kolaleh Eskandanian, Ph.D., Children’s National Hospital.

Six winners were announced in the symposium’s $150,000 “Make Your Medical Device Pitch for Kids!” competition, sponsored by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) and focused on NICU devices, which the FDA identifies as an area of significant need for innovation. Ten finalists presented their innovations for a panel of 25 expert judges. Each winner receives a $25,000 award and an opportunity to participate in a first-of-its-kind pediatric accelerator program led by MedTech Innovator.

The winning pediatric devices and companies are:

  • AlgometRx, Inc., Washington, D.C. – The AlgometRx Rapid Drug Test is used to detect and monitor neonatal abstinence syndrome, allowing for earlier assessment and intervention of opioid withdrawal to reduce physiological stress.
  • Epitel, Salt Lake City, Utah – Epilog is an inexpensive, discrete and disposable EEG machine that provides real-time monitoring to revolutionize the way neonates suspected of hypoxic-ischemic encephalopathy are managed at community hospitals.
  • Novonate, South San Francisco, Calif. – LifeBubble secures and protects the umbilical catheter insertion site for neonates in intensive care, preventing infection from caregivers and parents.
  • PyrAmes Inc., Cupertino, Calif. – Noninvasive and wireless, the Boppli Band allows for risk- and pain-free continuous blood pressure monitoring for neonates.
  • Raydiant Oximetry, Mountain View, Calif. – Raydiant Oximetry Sensing Systems is a novel, non-invasive technology that more accurately detects fetal distress during labor and delivery, reducing medically unnecessary cesarean deliveries and the occurrence of newborns suffering the consequences of metabolic acidosis.
  • Rhaeos, Inc., Evanston, Ill. – FlowSense is a wearable device that enables noninvasive monitoring of ventricular shunt function in patients who have hydrocephalus, obviating the need for imaging and unnecessary hospital visits and admissions.

“Improved neonatal monitoring devices, such as those among our award winners, can make a critical difference in detecting interventions that could positively impact the long-term developmental trajectory of many children, said Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National and principal investigator of NCC-PDI. “We welcome these winning companies into the NCC-PDI network of device startups and entrepreneurs and look forward to helping them accelerate commercialization so that these innovations can benefit children everywhere as soon as possible.”

 Julia Finkel

Children’s National anesthesiologist and innovator Julia Finkel, M.D., delivers a winning pitch for her AlgometRx device for detecting and monitoring neonatal abstinence syndrome.

Award-winner AlgometRx is a spinout company from Children’s National Hospital that was founded by anesthesiologist and pain medicine research chief Julia Finkel, M.D.  A non-invasive, handheld and portable device, AlgometRx captures a digital image of a patient’s pupillary light response and applies a series of propriety algorithms to measure pain type, intensity and drug effects in real time. Designed for use in virtually any clinical setting, Dr. Finkel originally developed this objective pain measurement technology to aid in diagnosing and monitoring non-verbal pediatric patients such as neonates. AlgometRx was also selected earlier this year to join the JLABS location in Philadelphia.

This is the ninth pediatric medical device competition sponsored by NCC-PDI, one of five FDA-funded programs focused on addressing unmet needs for pediatric medical devices. The consortium is led by 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. NCC-PDI recently added new accelerators BioHealth Innovation and MedTech Innovator and design firm partner, Archimedic.

The symposium also featured four multidisciplinary panel discussions that followed the theme “Pediatric Device Clinical Trials: Forging a Better Path.” Solutions uncovered during these panels will be highlighted in an upcoming whitepaper that will be used to suggest FDA guidance on pediatric device trial conduct and best practices to safely validate medical devices for children more efficiently and effectively.

Vasum Peiris, M.D., chief medical officer, Pediatrics and Special Populations, Center for Devices and Radiological Health, FDA, gave the closing address, which outlined FDA initiatives focused on pediatric device development. David L. Wessel, M.D., senior vice president for the Center for Hospital-Based Specialties at Children’s National, provided an insightful overview of why NICU device development is so important and shared some of the NICU innovations currently in development at Children’s National, which ranks #1 nationally in NICU care.

Julia Finkel

Two Children’s National spin-outs join Johnson & Johnson–JLABS

Julia Finkel

AlgometRx, which joins JPOD @ Philadelphia, was founded by Julia Finkel, M.D., pediatric anesthesiologist and director of Pain Medicine and Research at Children’s Sheikh Zayed Institute.

AlgometRx and Adipomics, two companies that spun out of innovations discovered at Children’s National Health System, have been selected by Johnson & Johnson Innovation – JLABS to join JPOD @ Philadelphia and JPOD @ Boston, respectively.

JLABS is a global network of no-strings-attached incubators for innovative companies from across the pharmaceutical, medical device, consumer and health technology sectors. Start-up companies are free to pursue their own research priorities independently, with access to state-of-the-art facilities to develop new drugs, medical devices, precision diagnostics and health technologies for people around the world.

Both companies got their start at the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National. The Institute focuses on research and innovation that can improve health for children everywhere.

AlgometRx, which joins JPOD @ Philadelphia, was founded by Julia Finkel, M.D., pediatric anesthesiologist and director of Pain Medicine and Research at Children’s Sheikh Zayed Institute. The AlgometRx device is a first-of-its-kind platform technology that aims to objectively measure pain intensity, type and drug effects in real time by capturing a digital image of a patient’s pupillary light response and applying a series of proprietary algorithms to various characteristics.

AlgometRx is designed to provide an objective pain measurement that aims to help physicians select the correct analgesic class of drug and dosage. By optimizing pain assessment, drug selection and drug management, AlgometRx aims to impact the opioid epidemic and the monitoring and management of Opioid Use Disorder.

Robert Freishtat and Evan Nadler

Adipomics, which joins JPOD @ Boston, was co-founded by Robert Freishtat, M.D., M.P.H., senior investigator in the Center for Genetic Medicine of the Children’s Research Institute and chief of the Division of Emergency Medicine at Children’s National, and pediatric surgeon Evan P. Nadler, M.D., co-director of the Obesity Program and director of the Bariatric Surgery Program at Children’s National.

Adipomics, which joins JPOD @ Boston, was co-founded by pediatric surgeon Evan P. Nadler, M.D., co-director of the Obesity Program and director of the Bariatric Surgery Program at Children’s National, and Robert Freishtat, M.D., M.P.H., senior investigator in the Center for Genetic Medicine of the Children’s Research Institute and chief of the Division of Emergency Medicine at Children’s National. Adipomics was founded with the aim to address the global epidemic of obesity-related diseases including Type 2 diabetes and cardiovascular diseases. World health experts predict that one billion people worldwide will be obese by 2030.

Drs. Nadler and Freishtat discovered that exosomes released from fat cells (adipocytes) carry genetic material that can mediate various diseases related to obesity. Through their research, they developed a proprietary method that aims to detect how obesity affects an individual patient’s metabolism before the onset of overt disease. Adipomics aims to create the first non-invasive, “anticipatory medicine” diagnostic that detects risk for obesity-related diseases prior to the onset of clinical signs or even biochemical abnormalities. If successful, this predictive methodology would enable treatment much earlier in the disease process, which is likely to improve effectiveness.

A recent news release from Children’s National provides more details on these innovations.

As organizations that share a commitment to improving the pace of healthcare innovation, Children’s National and Johnson & Johnson Innovation – JLABS also recently announced their collaboration to launch JLABS @ Washington, DC,  a 32,000-square foot facility to be located at the new Children’s National Research & Innovation Campus in Washington, D.C. The JLABS @ Washington, DC will have the capacity to house up to 50 pharmaceutical, medical device, consumer and health technology companies that are aiming to advance the development of new drugs, medical devices, precision diagnostics and health technologies, including applications in pediatrics. The campus is located on a 12-acre portion of the former Walter Reed Army Medical Center campus in the nation’s capital and is slated to open in 2020, coinciding with the 150th Anniversary of Children’s National Health System.

Julia Finkel

Novel pupillary response biomarker for BBD discovered

Julia Finkel

“To our knowledge, this unique pupillary signature has not been previously seen or described in other patient populations and we have not seen it in any of our other studies,” says Julia Finkel, M.D. “It may represent a distinctive and readily-identifiable physiologic marker of disease.”

Researchers at Children’s National have discovered a potential biomarker in the pupillary response of some pediatric patients with Bowel and Bladder Dysfunction (BBD) that could improve the speed and accuracy of diagnosis and treatment, according to a recent study published in the Journal of Pediatric Urology.

BBD describes a range of lower urinary tract symptoms accompanied by bowel complaints such as enuresis (bedwetting), urgency and urinary retention, often accompanied by constipation. While these symptoms represent 40% of pediatric urology visits, BBD is considered an underdiagnosed pediatric ailment.

Julia Finkel, M.D., pediatric anesthesiologist and director of Research and Development for Pain Medicine at the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National, led the pilot study to explore whether BBD could be detected from a patient’s pupillary light reflex response. Using a novel application of pupillometry, Dr. Finkel and her research team recorded and analyzed the pupillary light reflex responses of 28 patients with BBD, ages 7 – 21, from the Wetting, Infections and Stooling Help (WISH) clinic at Children’s National Health System. The study included baseline static and dynamic pupillometry assessments obtained from each patient before and after voiding. Pupillary measurements were also taken after five minutes of lying down by the patient, and again after five minutes of standing.

In reviewing the patient’s graphed data, the researchers noted a distinct “notch” shape repeated in the pupillary response graph of 11 of 28 patients with BBD symptoms. In those 11 patients, the graph notch appears to indicate a brief repeat constriction of the patient’s pupil before returning to its resting size.

Considering that bowel and bladder functions are controlled in part by the autonomic nervous system, researchers surmised that the notch on the graph is likely to reflect a characteristic disturbance in the regulation of the autonomic nervous system of those 11 patients, which would indicate a physiological cause for their BBD, either alone or in combination with a behavioral cause.

“To our knowledge, this unique pupillary signature has not been previously seen or described in other patient populations and we have not seen it in any of our other studies,” says Dr. Finkel. “It may represent a distinctive and readily-identifiable physiologic marker of disease.”

Causes of BBD can be physiological, such as anomalies in the synapsis of the nervous system, and can be related to behavioral health issues such as anxiety. Early diagnosis and treatment of BBD is important in avoiding secondary complications that can adversely impact a child’s kidney and bladder function as well as psychosocial well-being.

Dr. Finkel says that, while the results of this study are broadly consistent with other studies that examined the autonomic nervous system activity of BBD patients, this small study is preliminary. She notes that further research is needed and would include assessing abnormalities in pupillary response stemming from the parasympathetic and sympathetic functions of the autonomic nervous system.

Her hope is that further study will lead to more effective diagnostic and monitoring tools for clinicians treating BBD patients.

Dr. Finkel’s research focuses on the diagnostic potential of various pupillary reflexes. She says that pupillometry makes an ideal point-of-care diagnostic tool because it is noninvasive, easy to use, portable and provides real-time data for diagnosis and monitoring of therapeutic effects.

In addition to Dr. Finkel, study co-authors include Kevin G. Jackson, Nadia B. Kalloo, M.D., and Emily Blum, M.D., of Children’s National Health System; and Elizabeth L. Malphrus, MS-III, George Washington University.

AlgometRX

Breakthrough device objectively measures pain type, intensity and drug effects

AlgometRX

Clinical Research Assistant Kevin Jackson uses AlgometRx Platform Technology on Sarah Taylor’s eyes to measure her degree of pain. Children’s National is testing an experimental device that aims to measure pain according to how pupils react to certain stimuli. (AP Photo/Manuel Balce Ceneta)

Pediatric anesthesiologist Julia C. Finkel, M.D., of Children’s National Health System, gazed into the eyes of a newborn patient determined to find a better way to measure the effectiveness of pain treatment on one so tiny and unable to verbalize. Then she realized the answer was staring back at her.

Armed with the knowledge that pain and analgesic drugs produce an involuntary response from the pupil, Dr. Finkel developed AlgometRx, a first-of-its-kind handheld device that measures a patient’s pupillary response and, using proprietary algorithms, provides a diagnostic measurement of pain intensity, pain type and, after treatment is administered, monitors efficacy. Her initial goal was to improve the care of premature infants. She now has a device that can be used with children of any age and adults.

“Pain is very complex and it is currently the only vital sign that is not objectively measured,” says Dr. Finkel, who has more than 25 years of experience as a pain specialist. “The systematic problem we are facing today is that healthcare providers prescribe pain medicine based on subjective self-reporting, which can often be inaccurate, rather than based on an objective measure of pain type and intensity.” To illustrate her point, Dr. Finkel continues, “A clinician would never prescribe blood pressure medicine without first taking a patient’s blood pressure.”

The current standard of care for measuring pain is the 0-to-10 pain scale, which is based on subjective, observational and self-reporting techniques. Patients indicate their level of pain, with zero being no pain and ten being highest or most severe pain. This subjective system increases the likelihood of inaccuracy, with the problem being most acute with pediatric and non-verbal patients. Moreover, Dr. Finkel points out that subjective pain scores cannot be standardized, heightening the potential for misdiagnosis, over-treatment or under-treatment.

Dr. Finkel, who serves as director of Research and Development for Pain Medicine at the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National, says that a key step in addressing the opioid crisis is providing physicians with objective, real-time data on a patient’s pain level and type, to safely prescribe the right drug and dosage or an alternate treatment.,

She notes that opioids are prescribed for patients who report high pain scores and are sometimes prescribed in cases where they are not appropriate. Dr. Finkel points to the example of sciatica, a neuropathic pain sensation felt in the lower back, legs and buttocks. Sciatica pain is carried by touch fibers that do not have opioid receptors, which makes opioids an inappropriate choice for treating that type of pain.

A pain biomarker could rapidly advance both clinical practice and pain research, Dr. Finkel adds. For clinicians, the power to identify the type and magnitude of a patient’s nociception (detection of pain stimuli) would provide a much-needed scientific foundation for approaching pain treatment. Nociception could be monitored through the course of treatment so that dosing is targeted and personalized to ensure patients receive adequate pain relief while reducing side effects.

“A validated measure to show whether or not an opioid is indicated for a given patient could ease the health care system’s transition from overreliance on opioids to a more comprehensive and less harmful approach to pain management,” says Dr. Finkel.

She also notes that objective pain measurement can provide much needed help in validating complementary approaches to pain management, such as acupuncture, physical therapy, virtual reality and other non-pharmacological interventions.

Dr. Finkel’s technology, called AlgometRx, has been selected by the U.S. Food and Drug Administration (FDA) to participate in its “Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder.” She is also the recipient of Small Business Innovation Research (SBIR) grant from the National Institute on Drug Abuse.