The Digital Therapeutics Alliance (DTA), a global non-profit trade association that represents the healthcare industry’s leading digital therapeutics manufacturers, announces today the expansion of its membership to a diverse group of organizations dedicated to broadening the understanding, adoption, and integration of digital therapeutics into healthcare through education, advocacy, and research.
The Alliance was founded in 2017 through a collaboration of leading DTx companies – Akili Interactive, Propeller Health, Voluntis, and WellDoc. Until today, membership has been limited to founding members.
New Alliance members will gain access to and engage with leading DTx companies, and will guide the development of the evolving digital therapeutics industry. In 2018, DTA will focus on supporting the U.S. Food and Drug Administration’s (FDA) Software Pre-Certification Program and will work to drive clinical, organizational, and financial integration of digital therapeutics into mainstream healthcare.
“DTA members are dedicated to advancing novel digital therapeutics aimed at transforming patient clinical outcomes and adding value to physicians, care teams, and the healthcare system,” said Megan Coder, DTA Executive Director. “Growing our membership allows DTA to receive critical input from a wide array of stakeholders in order to establish a strong foundation for this robust and rapidly growing industry.”
Organizations encouraged to apply for DTA membership include digital therapeutic companies, healthcare provider associations, patient groups, payers, academic institutions, investors, technology and data organizations, and pharmaceutical manufacturers. For more information, visit www.dtxalliance.org/membership.
About DTA
The Digital Therapeutics Alliance represents the healthcare industry’s leading manufacturers of clinically-validated digital therapeutics. DTA members collaborate to enhance patient outcomes through assessing the value and impact of digital therapeutics in clinical practice, constructing industry and regulatory frameworks, and encouraging data-driven integration and utilization of digital therapeutics across the healthcare industry. Learn more at www.dtxalliance.org and follow us on Twitter @dtx_alliance.
About Digital Therapeutics
Digital therapeutics are clinically-validated solutions that may be used as standalone direct treatments or in association with other treatments to improve the overall quality, cohesion, outcomes, and value of healthcare delivery. Digital therapeutics demonstrate safety and efficacy in randomized control trials, receive regulatory clearance when used as a medical device, integrate into clinical practice, and are tailored to patients’ clinical needs, goals, and lifestyles. DTx solutions consist of patient-facing treatments, clinical assessment and outcomes tracking tools, clinician monitoring dashboards, and HIPAA-compliant data storage.
WellDoc®, a leading digital health company, announced today that its clinically proven hemoglobin A1C reductions for users of its BlueStar® digital therapeutic with type 2 diabetes can translate into significant healthcare cost savings.
ARLINGTON, Va., Dec. 18, 2017 /PRNewswire/ — The Digital Therapeutics Alliance (DTA), the pre-eminent industry organization for digital therapeutic approaches, is leading an initiative to support the development of the U.S. Food and Drug Administration’s (FDA) Software Pre-Certification Program. FDA’s program embraces the principle that certain digital technologies provide significant benefits to patients’ lives by helping them manage chronic conditions outside of traditional healthcare settings, as well as supporting providers, healthcare systems, and payers by facilitating disease prevention, diagnosis, and treatment.
The Pre-Certification Program will enable FDA to certify companies that design and manufacture regulated digital health solutions with a demonstrated culture of quality and organizational excellence through a robust certification process suited for the iterative software design, development, validation, and maintenance processes.
As part of DTA’s interaction with the FDA, the industry group will propose a comprehensive overview of how the Pre-Certification Program may be developed, operated, and scaled to achieve its goals. DTA member companies will draw on their collective regulatory and clinical-validation expertise to provide the Agency with an industry-level perspective for establishing the necessary program frameworks, key performance indicators, and benchmark criteria.
“Our Alliance supports FDA’s approach to designing a regulatory framework that accommodates the distinctive nature of digital technology, its clinical value, unique and impactful user interfaces, and our industry’s compressed commercial cycle for introducing new products to market,” said Pierre Leurent, CEO, Voluntis, and DTA Chair. “This collaboration with the FDA is designed to foster and stimulate innovation, while ensuring individuals using digital therapeutics have access to high-quality, safe, and effective options for managing and treating medical conditions.”
Digital therapeutics are clinically-validated solutions that may be used as standalone direct treatments, or in association with other treatments to improve the overall quality, cohesion, outcomes, and value of healthcare delivery. Digital therapeutics demonstrate safety and efficacy in randomized control trials, receive regulatory clearance when used as a medical device, integrate into clinical practice, and are tailored to patients’ clinical needs, goals, and lifestyles.
“We are extremely appreciative of the tremendous interest in participating in the FDA Pre-Certification Pilot Program,” said Bakul Patel, Associate Director for Digital Health in the FDA’s Center for Devices and Radiological Health. “This feedback will be invaluable as we progress through the pilot and onto the next stages of digital health oversight.”
About the Digital Therapeutics Alliance
The Digital Therapeutics Alliance (DTA) represents the healthcare industry’s leading manufacturers of clinically validated digital therapeutic (DTx) solutions. DTA members – including patients, healthcare providers, payers, academic institutions, technology organizations, and pharmaceutical manufacturers – collaborate to enhance patient outcomes through assessing the value and impact of DTx solutions in clinical practice, constructing industry and regulatory frameworks, and encouraging data-driven integration and utilization of DTx solutions across the healthcare industry. Founding members include Akili Interactive, Propeller Health, Voluntis, and WellDoc. Learn more: www.dtxalliance.org
The 10th annual Biotech Showcase™, the largest international biotech investor conference in the world produced by Demy-Colton and EBD Group, will bring together over 3,500 life science decision makers and investors from 50+ countries to collaborate and discuss industry trends through panels, workshops, and fireside chats. Taking place on January 8-10, 2018 at the Hilton San Francisco Union Square, attendees will hear from key biotech investors, leaders, pharma executives, and other industry advisors on topics such as the future of biotech and the public markets, the rapidly advancing digital and medical technologies, and the health of cross-border investments and collaboration in China.
“We’re looking forward to participating in Biotech Showcase, which continues to serve as a home base for the life science community to discuss innovative opportunities and investment partnering during the largest week in healthcare in San Francisco,” said Art Pappas, Managing Partner, Pappas Capital.
Understanding the health of the life sciences and biotech industries involves dissecting the past year’s successes. The January 10th lunch plenary, “Reflecting on 2017 record-breaking venture numbers: What’s behind the surge?”, will be moderated by Ellen Corenswet, Partner, Covington & Burling LLP, and include perspectives from investors and healthcare companies on 2017 financials:
The January 8th lunch plenary, “The future of biotechnology and life sciences sector: Are we at a tipping point?”, will discuss whether the pace of heavy investments and accelerated drug approval in 2017 will continue. The session will be moderated by Sara Radcliffe, President and CEO, California Life Sciences Association, and include panelists:
“I’m looking forward to discussing the promising projections for next year at Biotech Showcase and uncovering with investors and industry decision makers where the biggest growth and investment opportunities are as we move into 2018,” said Asthika Goonewardene, Senior Biotech Analyst, Bloomberg Intelligence, who is leading a January 8th workshop, “The public markets and biotech: What to expect in 2018.” Gabriel Cavazos, Director, Investment Banking, Leerink Partners LLC will also participate in this workshop moderated by Barbara Ryan, Founder, Barbara Ryan Advisors.
The program will include a Digital Medicine & Medtech Showcase, highlighting the companies and partnerships that are making the advancement of digital medicine possible, such as Qualcomm Life and Digital Therapeutics Alliance, among others. “We’re looking forward to diving into conversations with our colleagues on the future of medical technologies and the challenges we are working to overcome as leaders driving change in healthcare through digital medicine,” said Rick Valencia, President, Qualcomm Life.
A January 10th closing panel, “The future of healthcare with the convergence of digital innovations” moderated by Anne Smart, Managing Director, ClearView Healthcare Partners, will elaborate on this topic with panelists from organizations working to drive technological advancements in life sciences:
The list of current speakers can be found on the Biotech Showcase Speaker page here and the Digital Medicine & Medtech Showcase Speaker page here. A concurrent event, China Showcase, will highlight cross-border investment and collaboration opportunities through key sessions, keynotes, and valuable networking opportunities.
For more information or to register for the event, go to BiotechShowcase.com. Credentialed press can apply for free registration online here. Follow Biotech Showcase on Twitter: @EBDGroup and @DemyColton (hashtag: #BTS18).
About Demy-Colton
Since 2008, Demy-Colton has been at the forefront of building networks between leaders from innovative biotech companies and industry stakeholders to examine and address biotech opportunities and challenges and deliver on the promise of transformational science.
We do this through facilitating networking and biotech community development on an international scale. Our investor conferences and CEO Summits expand communities that transcend geographical boundaries establishing ongoing, high-value relationships that contributes greatly to the evolution of the biopharmaceutical ecosystems we cultivate.
We set a unique stage where biotech leaders, investors, and stakeholders can connect to realize significant opportunities for investment, learning, and growth. Our events spur introductions and thoughtful conversations. In turn, inspiration, ideas, and opportunities for investment flow. Demy-Colton’s expanding portfolio of conferences includes:
About EBD Group
EBD Group’s overriding mission is to help collaborations get started across the life science value chain. Our range of partnering conferences has grown to become the largest and most productive conference platform in the industry. Each one of our seven landmark events held in key life science markets around the world is powered by our state-of-the-art partnering software, partneringONE®, that enables delegates to efficiently identify and engage with new opportunities via one-to-one meetings.
Today our events (BIO-Europe®, BIO-Europe Spring®, BioPharm America™, Biotech Showcase™, ChinaBio® Partnering Forum, Cell & Gene Exchange, and BioEquity Europe) annually attract more than 12,000 senior life science executives who engage in over 48,000 one-to-one partnering meetings. These vital one-to-one engagements are the wellspring of deals that drive innovation in our industry.
Tune into EBD Group’s Partnering Insight for timely coverage of news that influences the business strategies of the life science industry. EBD Group is an Informa company. For more information please visit www.ebdgroup.com.
Contacts
EBD Group
Kari Bennett, (760) 930-0500
kbennett@ebdgroup.com
or
CG Life
Nicole Goelz, (858) 457-2436 ext. 2014
ngoelz@cglife.com
STAT News (Stephanie Tilenius) — The next blockbuster therapy is probably already in your pocket or purse.
The FDA recently approved the first prescription digital therapy, Pear’s Reset app and program, which is focused on substance abuse. Others are likely to follow. That means your next trip to the doctor could include a prescription for a mobile app in addition to, or instead of, medicine.
Digital therapy represents a powerful yet provocative new idea in health care. Software brings a precision to therapy and with it an ability to personalize treatment. This gives digital therapy a big role to play as we transition to value-based care.
HuffPost UK (Martin Blinder) — As the digital health sector continues to evolve, a new category of tools and digital services called ‘Digital Therapeutics’ has emerged, and it has the power to revolutionise how people prevent and manage non-communicable diseases (NCDs) and relieve the burden on public health systems across the world.
Company completes large multi-center, randomized, controlled study of novel digital medicine and plans regulatory filing. Akili Interactive, an affiliate of PureTech Health, today announced top-line results from the Company’s STARS-ADHD pivotal study of its lead investigational digital medicine, AKL-T01, in pediatric attention-deficit/hyperactivity disorder (ADHD). In a randomized, controlled trial of 348 children and adolescents diagnosed with ADHD, AKL-T01 showed a statistically significant improvement compared to an active control (p=0.006) on the predefined primary endpoint, a change in the Attention Performance Index (API), a composite score from the Test of Variables of Attention (T.O.V.A.®).
Fast Company (Steven Melendez) — While some have expressed concerns about patient privacy, proponents say new pills that track when you take them could be just the beginning for edible technology.
A “digital pill” approved by the Food and Drug Administration could be the start of a new wave of ingestible technology.
The recently approved medication is a version of Otsuka Pharmaceutical’s Abilify–used to treat schizophrenia, bipolar disorder, and depression–with a safe-for-consumption electronic sensor inside the pill. When someone takes the pill and it reaches the stomach, the sensor sends an electrical signal through the body to a wearable, bandage-like patch. That patch then sends a wireless message to an app on the patient’s phone, recording that the dose was taken.
Voluntis announced that it will be integrating Insulia® into Onduo’s virtual diabetes clinic. Onduo, a new diabetes management company created by Verily (an Alphabet Company) and Sanofi, is developing a virtual platform that integrates hardware, such as wirelessly-connected continuous glucose monitors, software, and personalized support from healthcare experts to help people manage their Type 2 diabetes. Insulia is a digital companion that provides insulin titration recommendations for people with Type 2 diabetes.
Berlin, November 15, 2017 – The newly announced Digital Therapeutics Alliance (DTA) is heralding its European launch by joining forces with Frontiers Health, the premier European health innovation conference being held this November 16th and 17th in Berlin, Germany. Reinforcing the global nature of its mission, DTA leaders Pierre Leurent, Anand Iyer, and Vincent Hennemand will participate in a dedicated keynote presentation and panel discussion called “Software as a drug: The dawn of Digital Therapies”.
Mr. Leurent, CEO of Voluntis, and Chair of the DTA Board of Directors, explains, “digital therapeutics are at the forefront of a new era in healthcare. As the global industry prepares for what’s next, we are excited to represent digital therapeutics in this rapidly evolving environment, working with regulators, patient advocacy groups, providers, payers, pharma and tech companies.”
Joining the DTA leaders on stage for the panel discussion are Frontiers Health conference chair and Healthware CEO Roberto Ascione, conference steering committee member Marc Sluijs who is principal at digitalhealth.network, a global digital health investment advisory, and healthcare investor Steven Yecies, Venture Partner at OrbiMed.
Roberto Ascione says that he and his team at Healthware are honored to support DTA’s mission by partnering on strategic communications activities, with the Frontiers Health conference appearance being the first European communications touchpoint for the Alliance.
The panel discussion will touch on a number of significant developments being seen, in their aggregate, as the “3rd wave of medicine”. Transformational opportunities for healthcare providers and the pharma industry highlight the efforts currently underway to define new protocols of care and measures of clinical effectiveness. The rise of the digital therapeutics industry is highlighted by the fact that more than 150 companies are already working in the space, and a fast-growing number of their solutions are starting to show significant clinical evidence and results on par with traditional clinical practice.
In addition, investment in digital therapeutics companies on the part of Pharma is on the rise, as are partnerships to distribute digital therapeutics through traditional Pharma sales channels.
Marc Sluijs reaffirms his belief that having ways of clinically validating digital therapeutic outcomes is key to usher in continued growth in the digital health industry. To that end, he sees the formation of the DTA as essential in creating a common set of references and guidelines to measure digital clinical results by. The DTA’s announcement and participation at Frontiers is, according to Mr. Sluijs, proof of the digital health’s industry increasing level of maturity, and eventual coming of age.
About the Digital Therapeutics Alliance
The Digital Therapeutics Alliance represents the healthcare industry’s leading manufacturers of clinically validated digital therapeutic (DTx) solutions. DTA’s mission is to broaden the understanding, adoption, and integration of digital therapeutic solutions into mainstream healthcare through education, advocacy, and research. DTA members and partners – including patients, healthcare providers, payers, academic institutions, technology organizations, and pharmaceutical manufacturers – collaborate to enhance patient outcomes through assessing the value and impact of DTx solutions in clinical practice, constructing industry and regulatory frameworks, and encouraging data-driven integration and utilization of DTx solutions across the healthcare industry. For more information visit: www.dtxalliance.org
About Frontiers Health
Frontiers Health is a spin off event of Frontiers Conferences, which designs and produces international conferences about technology and innovation since 2005. The yearly Frontiers Conference in Milan has become Italy’s leading conference for business, design and technology. The company was co-founded by Matteo Penzo, who also founded “Talent Garden”, the biggest co-working space in Milan, and is a technology practice executive at frog, and by Leandro Agro’ – a designer and entrepreneur with more than 20 years’ experience in the field of design and business innovation. Frontiers Health is chaired by Roberto Ascione, CEO of Healthware, the co-host organization of the yearly Frontiers Health conference.
About Healthware
Healthware is a next-generation healthcare consultancy, combining a unique blend of marketing and creative services with innovation and technology capabilities, able to deliver value to existing and emerging healthcare stakeholders. Established twenty years ago in Italy, Healthware is now an independent global company, consistently ranked among the top healthcare agencies worldwide, with offices in London, Milan, New York, Rome and Salerno. Learn more at www.healthwareinternational.com or contact Healthware at info@healthwareinternational.com.