Akili Interactive (“Akili”), a leading digital medicine company creating prescription treatments for people living with cognitive dysfunction and brain-related conditions, and Shionogi & Co., Ltd. (“Shionogi”), a major research-driven pharmaceutical companyfocused in two therapeutic areas: infectious diseases, and pain/CNS disorders, today announced they have entered into a strategic partnership for the commercialization of Akili’s digital medicines, AKL-T01 and AKL-T02, in Japan and Taiwan. AKL-T01 is currently under review with the U.S. Food and Drug Administration (FDA) as a potential digital treatment for children with attention-deficit/hyperactivity disorder (ADHD); AKL-T02 is currently in late stage development as a potential digital treatment for cognitive dysfunction and related symptoms in children with Autism Spectrum Disorder (ASD). The digital treatments are delivered through immersive action video game experiences.
Nicky Lineaweaver/Business Insider – Digital therapeutics has caught the eye of pharmaceutical companies as a potential balm to a host of the pharma industry’s struggles, according to MedCity News. Digital therapeutics is a category of software — typically in the form of consumer-facing mobile health apps — that replaces or complements the existing treatment of a disease.
Forbes (Greg Licholai) – Quality standards are necessary to help promote adoption of the novel class of interventions called digital therapeutics. This rapidly emerging industry needs to bring together regulators, engineers, practitioners, and companies to agree on definitions that enable innovation, according to product development and regulatory specialists.
As the digital transformation sweeps through healthcare, industry experts say that new classes of medicines and therapeutics present extremely promising opportunities.
Otsuka America, Inc., and Click Therapeutics, Inc., announce today that the companies have signed a collaboration agreement to develop and commercialize a prescription digital therapeutic for treatment of Major Depressive Disorder (MDD), with the intent to address unmet medical needs among this patient population and to improve outcomes.This collaboration will leverage Click’s demonstrated ability to discover and validate a software application and deploy it commercially, with Otsuka’s expertise in developing approved prescription therapies for patients with serious mental illnesses, including Otsuka’s established development and commercialization capabilities. The companies believe digital therapeutics align naturally with psychiatry and have significant potential to transform mental healthcare. Together, the companies aim to bring to market a new offering that will provide a novel treatment for patients with MDD.
PharmaTimes (Jim O’Donoghue) — The future will see the pharma industry change two things: what and how it sells. As payers become more focused on Value Based Contracts (VBCs), the days of pay-per-pill are disappearing. Drugs will remain core but they will be augmented by a portfolio of digital therapies, wrap-around services and data analytics, which providers will pay for according to overall patient outcomes. But what are Digital Therapeutics, and what do they mean for pharma firms?
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As we wrap up the year, we want to take a moment to thank each of you as Members and Advisors. We appreciate all of the time and effort you and your teams have invested in DTA this year. What began as a small alliance of DTx companies in January has grown over the year into a dynamic organization, representing a broad range of perspectives from across the industry.
We are taking a quick look back at what we’ve accomplished this past year.
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This month, we are thrilled to welcome the following companies as DTA members:
We appreciate developing such a strong diversity of perspectives across our membership and we look forward to working with each of your teams in the coming year. Welcome aboard!
This past year DTA welcomed several new members. If you are interested in submitting your DTx company, health system, academic medical center, investment firm, or patient advocacy organization for membership consideration, please visit the DTA membership application.
Digital health interventions have been associated with reduced rescue inhaler use and improved controller medication adherence. This quality improvement project assessed the benefit of these interventions on asthma-related healthcare utilizations, including hospitalizations, emergency department (ED) utilization and outpatient visits. The intervention consisted of electronic medication monitors (EMMs) that tracked rescue and controller inhaler medication use, and a digital health platform that presented medication use information and asthma control status to patients and providers.
ARLINGTON, VA – October 29, 2018 – Digital therapeutics (DTx) – a new category of medical interventions – combine patient-centric technologies with evidence-based medicine to deliver highly personalized care. Digital therapeutics present patients, healthcare providers, and payers with evidence-based technologies that have the ability to elevate medical best practices, address unmet medical needs, expand healthcare access, and improve clinical and health economic outcomes.
Today, the Digital Therapeutics Alliance (DTA) released a comprehensive report that provides an overview of the DTx industry and establishes the definition of a digital therapeutic. Core principles and best practices related to the design, manufacture, clinical validation, and regulatory oversight of these products are also featured. Visit www.dtxalliance.org/dtx-solutions to access the report.
“The integration of digital therapeutics into healthcare is no longer a theoretical conversation. As an Alliance, we are focused on building a strong foundation for this rapidly growing industry,” said Megan Coder, DTA Executive Director. “We are committed to empowering patients, healthcare providers, and payers with engaging and accessible tools that deliver meaningful clinical outcomes across a broad spectrum of physical, mental, and behavioral disorders.”
Digital therapeutics deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease. They incorporate advanced technology best practices and are validated by regulatory bodies as required to support product claims regarding risk, efficacy, and intended use.
Over the coming months, DTA will further develop best practices and frameworks that directly support the design, validation, utilization, and regulatory oversight of digital therapeutics across multiple cultures, languages, and national borders.
The Digital Therapeutics Alliance
The Digital Therapeutics Alliance is a global non-profit trade association with the mission of broadening the understanding, adoption, and integration of clinically-validated digital therapeutics into healthcare through education, advocacy, and research. DTA envisions enabling broad access to high quality, evidence-based digital therapeutics for patients, healthcare providers, and payers in order to improve clinical and health economic outcomes. For more information, please visit: www.dtxalliance.org.