Written By Jason Hartman

As a part of our series about business leaders who are shaking things up in their industry, I had the pleasure of interviewing David Happel.

David Happel is the President and CEO of Cognoa, the leading digital diagnostics and therapeutics company developing FDA cleared pediatric behavioral health solutions. Prior to joining Cognoa, Happel served as President, CEO, and Director at Chrono Therapeutics, a biopharmaceutical company focused on the development of treatments for neurologically debilitating conditions. He also previously served in senior management roles at Horizon Therapeutics, Raptor Pharma, Allergen Research Corporation and others. With 30 years’ industry experience, Happel has an extensive track record of improving clinical and commercial outcomes for cutting-edge health-tech companies.

Thank you so much for doing this with us! Before we dig in, our readers would like to get to know you a bit more. Can you tell us a bit about your “backstory”? What led you to this particular career path?

I’ve spent over 30 years in the industry with the goal of helping individuals and families who are living with health conditions. It is my passion and I have been fortunate to have had the opportunity to work with some of the largest pharmaceutical companies that were dedicated to treating very large populations of patients, to working for smaller biotech companies that were committed to helping individuals and families living with rare diseases, some of which occur in only 2,000 individuals globally. While helping all individual families living with an array of health conditions has been extremely rewarding, it has been especially gratifying to work with patients and families living with rare diseases. This is why I am so enamored with Cognoa and what we are on the path to achieving. Although autism is not a rare disease in terms of sheer numbers of individuals living with the condition, it presents very similarly to a rare disease in that the first concerns about a child’s development are expressed between 14 and 18 months of age. Most families are not familiar with what is happening to their child and how to help them. Simply put, it is our goal to help these families find the right solution to improve the likelihood of a better outcome for the child.

Can you tell our readers what it is about the work you’re doing that’s disruptive?

At Cognoa, we are pioneering a new approach to autism diagnosis, harnessing the latest AI technology to introduce a new paradigm of care and bring autism diagnosis into the digital age. The standard of care for autism has remained unchanged for decades. Pediatriciansrefer most children with suspected developmental delays to specialists to diagnose and prescribe treatment, rather than making such diagnoses themselves. This leads to long waiting times for children and families often waitingmonths and even years to see a specialist and/or to receive an initial autism diagnosis. In fact, on average, theoverall delay between first parental concern and a definitive autism diagnosis is approximately 3 years. These excessive wait times prevent children from receiving early intervention during a key window of neurodevelopment which occurs before age six. Early autism-specific intervention has shown to improve lifelong outcomes for children and their families with research demonstrating thatchildren can benefit from cognitive developmental gains, higher IQs, and up to25% of highly functioning autistic children can progress beyond their autism diagnosis altogether.

By empowering pediatricians to accurately diagnose autism, our Autism Diagnostic device will change the autism diagnostic journey. Our Autism Diagnostic device is positioned to be the first FDA cleared digital device designed specifically for pediatricians to aid them in diagnosing autism to accelerate the initiation of appropriate treatment. Cognoa’s AI has also been consciously built to embrace and account for gender, racial, ethnic, and socio-economic origins which enables us to tackle the longstanding issue ofdisparities and inherent biases in autism diagnosis.

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