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In the news

The digital therapeutics revolution is happening and Big Pharma is buying in — with caution

Michael Gibney, Senior Editor & Writer

Digital technology that would be considered cutting edge just a decade ago is now widely available — and pharma companies are beginning to embrace the world of digital therapeutics to both understand and better treat patients.

The definition of digital therapeutics is somewhat fragmented. There are several ways to understand how patient data, cognitive behavioral therapy or companion apps can be used either passively or actively to improve patient outcomes and the overall healthcare system. Drugmakers are exploring these options — carefully and methodically — to see in what ways digital therapeutics can fit into the work they already perform.

For much of pharma, one of the driving forces behind the adoption of digital therapeutics is remote patient monitoring, which allows for insights throughout the drug development life cycle, said Jaydev Thakkar, chief operating officer of the digital health company Biofourmis.

“Most pharmas are looking at how they can combine digital therapeutics with drugs, where they have over decades perfected an engine and have a strength and expertise,” Thakkar said.

But even with the promise of technologies like drug companion apps or remote monitoring tools, the digital therapeutics space is still fresh — which, by nature, isn’t pharma’s forte.

“Pharma certainly remains — in many areas and not just digital — a bit more conservative,” Thakkar said. “There is a good reason for that, which is that they have a very different responsibility when they bring innovation, a different bar, and pharma’s acceptance of new things like digital intervention takes quite a bit of internal convincing.”

As more digital therapeutics solutions become part of the core pharma model, the companies bridging the gap are approaching coalitions with a combination of gung-ho enthusiasm and cautious optimism while recognizing the limitations that need to be addressed.

The Big Pharma approach

The biggest pharmaceutical companies in the world now have digital teams exploring the potential of digital therapeutics and where they fit into the more traditional paradigm of making and selling drugs.

“There is a conviction on the pharma side that, yes, this is something that truly can benefit patients and actually effectively combine with a drug strategy,” Thakkar, who spent 14 years at Amgen before coming to Biofourmis, said. “One lesson I recollect learning back at Amgen was building a cross-functional alignment early on was key — ultimately, it’s a win-win when we educate pharma, and it creates pathways for what can or cannot be done when the right expectations are set from the beginning.”

Pharma giants like Novartis are wholeheartedly trying to involve digital solutions to make the most out of the therapies they are already delivering to patients, said Lauren Bataille, head and digital director of the Swiss company’s digital strategy and partnering division.

“Pharma is getting more comfortable with the idea of digital therapeutics as its own wing … but it’s just taking a bit of time.” - Whitney Stewart, Director of clinical trial management, Curebase

“We’re looking to understand how we can take these evidence-based solutions that are digital, work with our partners at different healthcare systems, our (key opinion leaders), to see how we can implement a solution like a clinical decision making tool or a medication adherence app, and how that functions as an add-on to the therapy compared to the standard of care,” Bataille said as part of a panel at the DTx East conference held in Boston at the end of September.

Bataille, who has a background in patient advocacy with the Michael J. Fox Foundation, said that bringing the patient into the solution is a critical part of the process, especially when it comes to a companion app. Novartis was running a mid-stage trial for an injectable drug aimed at kidney transplant patients — the shot would not be administered with the same regularity as the standard-of-care oral pill that patients were used to, so adherence was a concern.

“We wanted to make sure we developed a co-digital solution that provided all the information not only about the trial but targeted information with nudges about when patients needed to take the therapy, because it’s critical,” Bataille said. Unfortunately, she said, “as these things go,” the trial didn’t meet its endpoint, but from this seed of innovation, Novartis developed an infrastructure that’s now being used for other therapies to develop similar tools.

These innovations have become increasingly important as the world changes, particularly during the COVID-19 pandemic when home monitoring became the norm almost overnight, said John Cairns, the global head of digital in the oncology unit of France’s Sanofi.

“What’s important is looking externally, looking at how things have changed and how you need to adapt — the drug life cycle is very long and technology changes very quickly and patients’ needs change very quickly,” Cairns said. “We do tend to replicate what’s happening in other parts of the business and we should all be a little more joined up, in all honesty.”

One of the challenges that many of Big Pharma’s digital heads have pointed to is integrating with the core tenets of their historic institutions. For that, Bataille said there can be a little bit of hand-holding to bring more traditionally minded units up to speed.

“We’re in traditional medicines companies trying to bring digital transformation, and it’s truly a cultural transformation,” Bataille said. “Particularly in the R&D space where you’re working with folks who have been doing clinical trials in the same way for 20 years and that mindset shift is critical.”

Ultimately, though, the adoption of digital therapeutics has potential to help patients receive better care from pharmaceutical companies and the healthcare system, said Josh Raysman, vice president of the Digital Innovation Lab at Pfizer.

“There are lots of challenges, but what we’re most excited about is this idea of patient need and an understanding of patient need at a level that I would argue would never happen before,” Raysman said. “And it’s not just patients but prospective patients — we start at the very beginning of the journey where we can increase (detection) and general awareness in a personalized way and carry that through the patient journey.”

The evidence limitation

Discussing the potential for digital therapeutics to change the patient journey also requires a step back to understand what work is yet to be done. In that respect, many of these digital leaders agree that it comes down to evidence.

In drug development, a proof-of-concept study shows direct measurable results. With digital therapeutics, those signals are harder to display in the same way, said Raysman.

“Most folks are skeptics, and candidly we have an evidence challenge,” Raysman said. “There’s been some great work, especially lately, in generating evidence, but I’m hard-pressed on any given day to bring forward evidence that justifies the vision — I believe it’s there, but the challenge for us is working together to generate that evidence.”

Digital solutions have always suffered from a lack of comparable standards of care, even outside of pharma. For Whitney Stewart, director of clinical trial management at Curebase, which places an emphasis on decentralized trials, this can come down in part to the difficulty of developing a placebo arm for digital therapeutics. Some companies have created “sham” apps that do not contain the therapeutic part of the real digital therapeutic, but these methods have been difficult to repeat, Stewart said.

“Pharma is getting more comfortable with the idea of digital therapeutics as its own wing … but it’s just taking a bit of time,” Stewart said. “There’s hesitation and probably a little bit of nervousness around how digital therapeutics get approved.”

The testing and approval around digital therapeutics is currently not as cut and dry as it would be around drugs, she said.

“With a traditional pharmaceutical, you would create it, and it would be how it is and you don’t have to retest it, and it’s approved — but with digital therapeutics, the product is constantly being iterated on, and you might have to retest in a future version and track that.”

Overall, pharma companies are riding the digital wave to the extent that the evidence allows, and leaders are leaning in to make it part of the business model by working with other departments within their organizations. After all, digital leaders not only have to sell the product — they have to sell their ideas to the people within their own company, said Suhas Krishna, vice president of digital health product management at Bristol Myers Squibb.

“Pharma is very good at making drugs, selling drugs, making money from it — so oftentimes what we’re seeing internally is that we need to show that we’re solving some unmet primary medical need,” Suhas said, adding that understanding the value capture is equally important.

“If we can get a good balance between those critical areas, and there’s a credible story about how this is supporting BMS’s mission, helping patients, helping providers, that sweet spot is what we’re looking for,” Suhas said.

Original Article

The digital therapeutics revolution is happening and Big Pharma is buying in — with caution

Digital technology that would be considered cutting edge just a decade ago is now widely available — and pharma companies are beginning to embrace the world of digital therapeutics to both understand and better treat patients.

The definition of digital therapeutics is somewhat fragmented. There are several ways to understand how patient data, cognitive behavioral therapy or companion apps can be used either passively or actively to improve patient outcomes and the overall healthcare system. Drugmakers are exploring these options — carefully and methodically — to see in what ways digital therapeutics can fit into the work they already perform.

For much of pharma, one of the driving forces behind the adoption of digital therapeutics is remote patient monitoring, which allows for insights throughout the drug development life cycle, said Jaydev Thakkar, chief operating officer of the digital health company Biofourmis.

“Most pharmas are looking at how they can combine digital therapeutics with drugs, where they have over decades perfected an engine and have a strength and expertise,” Thakkar said.

But even with the promise of technologies like drug companion apps or remote monitoring tools, the digital therapeutics space is still fresh — which, by nature, isn’t pharma’s forte.

“Pharma certainly remains — in many areas and not just digital — a bit more conservative,” Thakkar said. “There is a good reason for that, which is that they have a very different responsibility when they bring innovation, a different bar, and pharma’s acceptance of new things like digital intervention takes quite a bit of internal convincing.”

As more digital therapeutics solutions become part of the core pharma model, the companies bridging the gap are approaching coalitions with a combination of gung-ho enthusiasm and cautious optimism while recognizing the limitations that need to be addressed.

The Big Pharma approach

The biggest pharmaceutical companies in the world now have digital teams exploring the potential of digital therapeutics and where they fit into the more traditional paradigm of making and selling drugs.

“There is a conviction on the pharma side that, yes, this is something that truly can benefit patients and actually effectively combine with a drug strategy,” Thakkar, who spent 14 years at Amgen before coming to Biofourmis, said. “One lesson I recollect learning back at Amgen was building a cross-functional alignment early on was key — ultimately, it’s a win-win when we educate pharma, and it creates pathways for what can or cannot be done when the right expectations are set from the beginning.”

Pharma giants like Novartis are wholeheartedly trying to involve digital solutions to make the most out of the therapies they are already delivering to patients, said Lauren Bataille, head and digital director of the Swiss company’s digital strategy and partnering division.

“Pharma is getting more comfortable with the idea of digital therapeutics as its own wing … but it’s just taking a bit of time.” - Whitney Stewart, Director of clinical trial management, Curebase

“We’re looking to understand how we can take these evidence-based solutions that are digital, work with our partners at different healthcare systems, our (key opinion leaders), to see how we can implement a solution like a clinical decision making tool or a medication adherence app, and how that functions as an add-on to the therapy compared to the standard of care,” Bataille said as part of a panel at the DTx East conference held in Boston at the end of September.

Bataille, who has a background in patient advocacy with the Michael J. Fox Foundation, said that bringing the patient into the solution is a critical part of the process, especially when it comes to a companion app. Novartis was running a mid-stage trial for an injectable drug aimed at kidney transplant patients — the shot would not be administered with the same regularity as the standard-of-care oral pill that patients were used to, so adherence was a concern.

“We wanted to make sure we developed a co-digital solution that provided all the information not only about the trial but targeted information with nudges about when patients needed to take the therapy, because it’s critical,” Bataille said. Unfortunately, she said, “as these things go,” the trial didn’t meet its endpoint, but from this seed of innovation, Novartis developed an infrastructure that’s now being used for other therapies to develop similar tools.

These innovations have become increasingly important as the world changes, particularly during the COVID-19 pandemic when home monitoring became the norm almost overnight, said John Cairns, the global head of digital in the oncology unit of France’s Sanofi.

“What’s important is looking externally, looking at how things have changed and how you need to adapt — the drug life cycle is very long and technology changes very quickly and patients’ needs change very quickly,” Cairns said. “We do tend to replicate what’s happening in other parts of the business and we should all be a little more joined up, in all honesty.”

One of the challenges that many of Big Pharma’s digital heads have pointed to is integrating with the core tenets of their historic institutions. For that, Bataille said there can be a little bit of hand-holding to bring more traditionally minded units up to speed.

“We’re in traditional medicines companies trying to bring digital transformation, and it’s truly a cultural transformation,” Bataille said. “Particularly in the R&D space where you’re working with folks who have been doing clinical trials in the same way for 20 years and that mindset shift is critical.”

Ultimately, though, the adoption of digital therapeutics has potential to help patients receive better care from pharmaceutical companies and the healthcare system, said Josh Raysman, vice president of the Digital Innovation Lab at Pfizer.

“There are lots of challenges, but what we’re most excited about is this idea of patient need and an understanding of patient need at a level that I would argue would never happen before,” Raysman said. “And it’s not just patients but prospective patients — we start at the very beginning of the journey where we can increase (detection) and general awareness in a personalized way and carry that through the patient journey.”

The evidence limitation

Discussing the potential for digital therapeutics to change the patient journey also requires a step back to understand what work is yet to be done. In that respect, many of these digital leaders agree that it comes down to evidence.

In drug development, a proof-of-concept study shows direct measurable results. With digital therapeutics, those signals are harder to display in the same way, said Raysman.

“Most folks are skeptics, and candidly we have an evidence challenge,” Raysman said. “There’s been some great work, especially lately, in generating evidence, but I’m hard-pressed on any given day to bring forward evidence that justifies the vision — I believe it’s there, but the challenge for us is working together to generate that evidence.”

Digital solutions have always suffered from a lack of comparable standards of care, even outside of pharma. For Whitney Stewart, director of clinical trial management at Curebase, which places an emphasis on decentralized trials, this can come down in part to the difficulty of developing a placebo arm for digital therapeutics. Some companies have created “sham” apps that do not contain the therapeutic part of the real digital therapeutic, but these methods have been difficult to repeat, Stewart said.

“Pharma is getting more comfortable with the idea of digital therapeutics as its own wing … but it’s just taking a bit of time,” Stewart said. “There’s hesitation and probably a little bit of nervousness around how digital therapeutics get approved.”

The testing and approval around digital therapeutics is currently not as cut and dry as it would be around drugs, she said.

“With a traditional pharmaceutical, you would create it, and it would be how it is and you don’t have to retest it, and it’s approved — but with digital therapeutics, the product is constantly being iterated on, and you might have to retest in a future version and track that.”

Overall, pharma companies are riding the digital wave to the extent that the evidence allows, and leaders are leaning in to make it part of the business model by working with other departments within their organizations. After all, digital leaders not only have to sell the product — they have to sell their ideas to the people within their own company, said Suhas Krishna, vice president of digital health product management at Bristol Myers Squibb.

“Pharma is very good at making drugs, selling drugs, making money from it — so oftentimes what we’re seeing internally is that we need to show that we’re solving some unmet primary medical need,” Suhas said, adding that understanding the value capture is equally important.

“If we can get a good balance between those critical areas, and there’s a credible story about how this is supporting BMS’s mission, helping patients, helping providers, that sweet spot is what we’re looking for,” Suhas said.

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Curebase Hires HR Veteran Andi Seymour as VP of People

Andi Seymour brings over 15 years of progressive and hands-on experience to Curebase as the newly appointed VP of People.

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Curebase, Portamedic Partner to Support Decentralized Clinical Trials with Mobile Phlebotomy Services

Curebase and Portamedic partner to collect patient samples and other tests from participating DCT trial patients' homes throughout the U.S

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Curebase Hires Healthcare Technology Veteran Scott Garcia as Vice President of Finance

Scott Garcia brings 15+ years of experience scaling high-growth companies to Curebase as the new VP of Finance

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Curebase, Flow Neuroscience Announce Joint Clinical Trial  for the use of an at-home tDCS device for treating depression

Curebase and Flow Neuroscience investigate a digital therapeutic for reducing depressive symptoms.

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Curebase Adds Pharma, Clinical Research Veteran to Advisory Board

Lars-Olof "Lollo" Erkisson, Head of Clinical Development at Infant Therapeutics AB, brings cross-continental clinical operations expertise to Curebase Advisory Board

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Curebase Secures $40M Series B

Curebase closes $40M Series B led by Industry Ventures, with strategic investment by Gilead Sciences

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Curebase Named Honorable Mention in Best World Changing Idea NA Category of Fast Company’s 2022 World Changing Ideas Awards

Curebase recognized by Fast Company's 2022 World Changing Ideas Awards for decentralized, patient-centric trial model

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Note to File Podcast - Episode 45: Jane Myles, Decentralized Clinical Trials: Evidence of Impact

Part 2 of Note to File Podcast with Brad Hightower featuring Jane Myles, VP of Clinical Trial Innovation at Curebase

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Curebase Selected to Launch a Clinical Investigation of a Digital Therapeutic for IPF

Curebase and Vicore Pharma partner on IPF mental health digital therapeutic study

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DCTs’ Broader and Multifaceted Implications

Curebase featured as decentralized clinical provider optimizing digital processes for patient safety and scientific advancement

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Decentralized Clinical Trials Help Level the Playing Field for Health Equity

Jane Myles, VP of Innovation at Curebase, discusses how DCTs play a role in improving health equity

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Note to File Podcast - Episode 41: Jane Myles, VP Innovation at Curebase

Jane Myles appears on Note to File Podcast with Bradley Hightower to discuss all things DCT

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Curebase Rapidly Reaches Growth Milestone

Curebase hires its 100th teammate within six months of raising Series A financing

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Curebase and Blue Note Therapeutics Collaborate on Home-based Clinical Trial of Prescription Digital Therapeutics to Help People with Cancer Manage their Health

Curebase and Blue Note Therapeutics partner on a fully virtual study comparing effectiveness of two PDTs on mental and physical health of cancer patients recently/currently undergoing treatment

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Curebase and CoBTek (team from Côte d'Azur) to Collaborate on a European Clinical Trial of Remote Tools Designed to Help Seniors Retain Autonomy

Curebase launching DCT study in Italy and France with a lab from the University of Côte d'Azur to improve the quality of life for elderly people

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Curebase Adds Two Clinical Trial Veterans to Kick-off New Advisory Board

Curebase welcomes Dr. Amir Lahav, leading digital health innovator, and Dr. Aaron Kamauu, leading real-world data expert, to new Advisory Board

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Curebase Joins the SCRS Global Impact Partner Program

Curebase will work closely with Society for Clinical Research Sites to advance trial site engagement and sustainability

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The Growing Case for Digital Therapeutics

Continuous developments in digital health innovations has led to the expansions of the Digital therapeutics dtx clinical trial space

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Creating New Decentralized Clinical Trial Ecosystem Including Bring Your Own Physician Option with Tom Lemberg Curebase

Tom Lemberg, founder and CEO of Curebase, talks all things BYOP (Bring Your Own Physician) on Empowered Patient Podcast

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2022 Predictions for Health Equity

Healthcare IT Today features predictions from Tom Lemberg, founder and CEO of Curebase, on diversity in clinical research

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The Future of Clinical Trials is Here Today

Curebase founder and CEO, Tom Lemberg, discusses the future of patient-centric decentralized clinical trials, including the Bring Your Own Physician (BYOP) model

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Curebase and Persephone Biosciences Partner in Clinical Trial of Colorectal Cancer Among Diverse Populations

Curebase and Persephone, collaborating with Janssen Research & Development, announce study to develop prevention strategies and treatment options for colorectal cancer (CRC) focusing on patient diversity

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Built In Honors Curebase in Its Esteemed 2022 Best Places to Work Awards

Curebase Earns Top 100 on Built In's Best Remote-First Companies to Work for in 2022

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Curebase Joins WCG Avoca Quality Consortium

Decentralized clinical trial company brings expertise in remote studies to large industry group devoted to improving trial quality

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Curebase Technology Key to metaMe Health's FDA Clearance of Regulora

Curebase serves as technology and decentralized trial execution partner for MetaMe Health's digital therapeutic dtx

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Curebase Named to the 2021 CB Insights Digital Health 150 -- List of Most Innovative Digital Health Startups

Curebase recognized for achievements in Clinical Trials Tech

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Curebase CEO, Tom Lemberg, Featured in Drug Discovery and Development's "9 Predictions for Pharma in 2022"

Curebase CEO offers expert insight into the dawn of dynamic clinical trial designs

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Forbes 30 Under 30 Names Curebase CEO Tom Lemberg to it's 2022 List

Founder and CEO of Curebase receives Forbes 30 Under 30 prestigious honor for leading positive, global change in healthcare

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Curebase's Enhanced Telemedicine Feature Expands Patient Access to Edesa Biotech Derm Study

Edesa Biotech uses Curebase's eClinical platform for enhanced telemedicine that allows providers to view, measure, and record patient symptoms via the built-in application

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Curebase, LEVEL Announce Clinical Trial to Determine Whether Cannabinoids Can Help Veterans Sleep Better

Decentralized clinical trials leverages Curebase eclinical software platform, Veterans' advocacy groups

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Curebase, Checkable Medical Announce Joint Clinical Trial to Assess Effectiveness of At-home Strep Test Kit

Curebase and Checkable Medical launch first-ever at-home strep test decentralized clinical trial

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Curebase, Digital Therapeutics Alliance Announce Partnership to Accelerate Adoption of DTx Products

Curebase and DTA partner to develop a joint white paper to provide clinical trial regulatory guidance and best practices for DTx clinical evidence generation

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Curebase Solutions Supports Another InBios FDA Emergency Use Authorization for COVID-19 IgG Antibody Rapid Test

Curebase's decentralized clinical trial approach helps secure FDA Emergency Use Authorization for InBios' new COVID-19 IgG Antibody Rapid Test

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Curebase Hires Katri Langel as Senior Director of Program Development for Europe

Katri Langel, international IT and clinical research expert, joins Curebase as Senior Director of Program Development for Europe

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Curebase Hires Wayne Bowden as Vice President of Business Development

Curebase names clinical trials veteran, Wayne Bowden, as Vice President of Business Development to lead new growth and expansion efforts

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It's a virtual world: Curebase, AppliedVR team up on virtual reality-based, at-home clinical trials

AppliedVR will test its virtual-reality-based digital therapeutics dtx across five studies using the decentralized clinical trials software from Curebase

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Curebase Secures Jane Myles as Vice President of Clinical Trial Innovation

Curebase has named tenured clinical research expert Jane Myles as vice president of clinical trial innovation

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Curebase, Adaptive Biotechnologies Announce Collaboration to Expand Clinical Study Access

Curebase decentralized clinical trial model will be used to study effectiveness in infections disease study

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Introducing ‘BYOP’ Clinical Trials

Curebase is promoting the concept of 'bring-your-own-physician' clinical trials.

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Curebase Names Paul Donnelly as Senior Vice President of Enterprise Strategy

Industry veteran, Paul Donnelly, brings more than two decades of success building healthcare companies to Curebase

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Startups Cash In as Venture Funding for Digital Health Rises

Curebase featured in Wall Street Journal among startups realizing venture capital boom in digital health

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Curebase, InBios Announce Results of Virtual Clinical Trial of InBios COVID-19 Rapid Detection Test Using Curebase Platform

Curebase decentralized trials platform used to study efficacy of diagnostic test

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Curebase Nabs $15M for Siteless Trials that Revolve 'Around the Patient's Lifestyle'

Curebase has raised a $15 million series A for a new approach to decentralized trials that goes beyond the current drop of virtual trial platforms.

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Cofactor Genomics Begins Multi-Site Clinical Trial for Immunotherapy Prediction Assay

Curebase is participating as a CRO partner with Cofactor Genomics in first multicenter clinical trial of its OncoPrism immunotherapy response prediction assay

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Non-Traditional Clinical Trial Sites Powered by the Curebase System Support Emergency Use Authorization of New Rapid COVID-19 Test

Operationalizing drive-through COVID testing locations as clinical research sites provided a safe and convenient way to enroll and consent potential participants in key diagnostic validation study

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CLM Tests Drug Plus Digital Combo for High Blood Pressure

CLM drug and DTx digital therapeutics study with Curebase

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Preliminary Outcomes of a Digital Therapeutic Intervention for Smoking Cessation in Adult Smokers: Randomized Controlled Trial

Digital interventions delivered through smartphones offer a promising alternative to traditional methods, but little is known about their effectiveness.

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Remote Care Powered CURE-19 Platform Enables At Home COVID-19 Clinical Trials

Curebase launches the CURE-19 Platform to provide a resource for researchers seeking to better understand COVID-19 as the pandemic begins

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