DeciBio Q&A — Unpacking Takeda & Seqster’s New Real-Time, Massively Scaled RWD Partnership by Chris Lew & Fanny Anderson
Our digital health team takes a deep-dive into the cutting-edge of RWD, tangible use cases for pharma, and musings on longer-term trends with Emir Roach, Takeda’s Head of Emerging Technologies, Data and Digital Partnerships, and Ardy Arianpour, CEO & Co-Founder of Seqster. 

So what? The political philosophies underlying Biden-Harris’ anticipated healthcare changes should come as no surprise. While Harris was an early “Medicare for All” champion and Biden a more moderate “public option” proponent, both plans for restructuring America’s coverage will be challenging without a decisive Democratic Senate majority. More myopically, we expect a Biden administration to usher in a decisive, top-down strategy for halting and reversing record-breaking COVID infection rates, and ultimately, implement coordinated federal-state plans for safe re-openings and vaccine rollout. At a high-level, Biden’s administration is expected to contrast the Trump administration’s tone with respect to social determinants of health (SDOH) and equity of healthcare access and outcomes, with expected investments in virtual care and revitalized emphasis on value-based care and alternative payment models via CMMI. While agency deregulation and unique emergency / pandemic-driven authorizations during Trump’s term have seemingly set the stage for a digital health “boom”, we expect the next 4 years under Biden to bring structured investments, industry expertise, and emphasized goals of equity and access that will allow the digital health sector to leverage built momentum and thrive.

TLDR: The program aims to leverage the nearly century-old technology of EEG and advancements in machine learning to discover composite biomarkers for depression, anxiety, and other mental health conditions. While the program’s scope is broad, its initial focus appears to be on development of compound subjective-objective biomarkers (i.e., objective digital biomarkers that complement subjective patient experience and clinician observations) with highest initial uptake for patient monitoring and prognostic applications. 

So what? Project Amber signals a tonal change from “big tech”, which to-date has largely safeguarded in-house development for leading digital biomarkers (e.g., Apple & Google / Fitbit’s Heart studies). While Alphabet will still pursue independent development, this open-source call for collaboration invites leading researchers and digital health experts to leverage Project Amber’s portable EEG hardware design, machine learning techniques, and data visualization and stimulus software to derive their own insights. While EEG biomarkers are largely perceived as non-novel and lab-based (i.e., requiring presentation to a traditional healthcare setting), Alphabet’s prototype adds to a growing cohort of portable EEG devices aimed at virtual / remote use. Outside of EEG, other companies are pursuing smart device-based digital biomarkers for mental health (e.g., Mindstrong Health, Ellipsis Health, BrainCheck, CompanionMx).    

So what? NightWare joins a growing list of FDA approved digital therapeutics in mental health. In PTSD, the commercial DTx landscape is relatively nascent, with Freespira as the key FDA-approved solution and other products still in development (e.g., Pear Therapeutics). Since its FDA approval, Freespira appears to have garnered insurance coverage by some private payers including Highmark and Anthem. Payer coverage of FDA-approved DTx is improving, but remains spotty across payers. Long-term evidence generation around care outcomes and cost appears to be crucial for more robust payer coverage. Pear Therapeutics just released analysis of real-world claims data, suggesting reduced payer spending of ~$2,150 per patient over six months with its reSET-O product for opioid use disorder. Though Pear’s data suggests near-term costs savings, ICER experts call for additional evidence to compare the long-term clinical and economic value of DTx companion therapies, like reSET-O and NightWare, relative to standalone medication.