PEAR: A Pioneer in Prescription Digital Therapeutics- talks reviews from the 9th US-China Health Summit
Speaker: Corey McCann, President and CEO of Pear Therapeutics
Writer: Christiane Zhao
"How many people in here have some knowledge about Prescription Digital Therapeutics or PDTs?" Corey McCann, the President & CEO of Pear Therapeutics, is about to give a presentation at the US-China Health Summit. He is pointing at the FDA approval report on his slides, "PDTs are at an inflection point, and PEAR is the first PDT to receive market authorisation from the FDA to improve disease treatment. " This company just announced its FDA submission for Somryst, a Prescription Digital Therapeutic Treatment for adults with chronic Insomnia and Depression.
“It is the first time that the product work with the patient to develop software from the ground.”, Corney continues to explain, “We post monthly updates based on real-world data. ”Since Sandoz and PEAR officially launched its FDA-approval therapy (reSET-O) for opioid use disorder(OUD) this January, the market believes it is another important signal that PDTs are entering the healthcare mainstream.
"PDT can be view as a combination of Telemedicine, Remote Monitoring, Wearables and Health IT infrastructures," Corey explained, "The use of DPT can enhance drug efficacy, treat the untreatable, and possibly, replace drugs in some circumstances." As a subset of digital health, PDT is evidence-based therapeutic interventions driven by a high-quality software system. It is also commonly employed in cognitive behaviour therapy. The development of PDT software usually required using the machine learning method to analyse real-world data to accelerate patient-faced interventions. Although it means there will be technical challenges like data accuracy and patient privacy, the Prescription Digital Therapeutic Development is still having a much shorter timeline than a traditional pharma product development timeline.
Corey then compared PDT with traditional molecular therapeutics. The main similarities it addressed are, both need prescriptions written by specialist and both reimbursed traditional medical pathway. He also emphasized that the use of PDT is enabling insurance companies to claim processors and patients with eligible questions. However, PDT is much different from the molecular therapeutics in terms of product updates, compliance, ongoing monitoring, data analytics and costs of goods. PDTs require marginal investment, but it can be completed much quicker within weeks or months only. Patient compliance and engagement with the application is tracked in a longitudinal term in real-time, while in the traditional case, the physician is not able to track compliance. Besides, patient-facing assessment can regularly monitor product efficacy and effectiveness. PDT support the shift from none or limited patient data collection to customisable data analysis which targets patient, clinicians, hospital network and payers.
reSet as one of the core products in PEAR, which can be used as an excellent example to explain the implication of PDT. As mentioned above, the company released reSet & reSet-O earlier this year, and it is a 90-days prescribed cognitive behavioural therapy for substance use disorder in an outpatient treatment setting. The service is provided based on a mobile application, and digital treatment is provided based upon on the supervision of clinicians. It is connected with an associated clinical dashboard, which enables care providers to get updated information about the patients' treatment performance and outcome, including the use of the software, lessons completed, patient-reported substance use and else more. These patient-reported data can be integrated and used to compare with in-clinic data input to develop a personalised report. These real-life data will be used to support the update and building of the software. It is intended to provide partial support for the adult user only.
“PDTs are still marked as a very innovative sector in the healthcare industry,” Corey said, “After all, it is just a piece of software, and our job is to help the integration of such software into the clinical workflow.” PDTs also experiencing many challenges like other digital health products, enabling and monitoring changes of both the behaviour of clinicians and patients is one of the obstacles for all PDT products. Also, the healthcare system and its market still need times to digest and distinguish from the health and wellbeing market. Regulator’s involvement is necessary as usual. The active participation and regulatory of the FDA makes the PDTs market became more favourable for investors.
It is just one of the many talks Corey gave since the company established. In the past two years, this pioneer is actively presenting in healthcare-related summits and conferences in the field nearly every month. 2018 seems to be an essential year for the company. The company has successfully raised $134 million in four rounds, two of them announced on Jan 2018 and Jan 2019. In 2nd Jan 2018, PEAR received $50 million from Series B funding as an early-stage venture; followed by that, they received $64 million from nine investment parties including Temasek Holding in Series C just less than 20 days after they received the FDA clearances in December 2018.
"75% of the healthcare cost are lifestyles related, so mobile and digital therapeutic should be involved in this industry. " Joseph Kvedar said, Professor of Havard Medical School. PDT is targetting at conditions that are poorly addressed by the current healthcare system, and it is expected to become one of the steps which can transform the future of healthcare. Today, such kind of advanced technologies have provided many opportunities for companies and organisations to improve the quality of care and system efficiency.
Declaimer: This article is generated based on a talk given at the 9th US-CHina Health Summit in Boston, the United States in 26th September 2019. The views and opinions expressed in this article only reflect the speaker’s opinion and does not necessarily reflect the author’s official policy or position. All rights reserved.