Digital therapeutics get first FDA clearance, Novartis focuses on digital after announcing job cuts and other Q4 pharma news

Also: The pharma industry continues to use digital technologies for R&D and diabetes management.
By MobiHealthNews
11:25 am

The pharma industry has become increasingly interested in the digital health space over the last few years, but this quarter numerous projects that have been in the works for years have finally came to fruition. For instance, Pear's reSET, the first digital therapeutic cleared by the FDA, was recently launched to commercial markets. 

But that wasn’t the only advance in the space as pharma continues to use digital health products to further its research and development, often employing artificial intelligence to help sift through and collect valuable information and data sets. Digital tech is also being used to help support patients on traditional medications — notably patients living with diabetes. 

Read on for a recap of pharma news in Q4 2018 and check out the links to Q1, Q2, and Q3 news

Digital therapeutics 

Perhaps the hottest topic in the pharma-digital health intersection is digital therapeutics. 

In November reSET — a substance use disorder treatment that was the first software-only therapeutic cleared by the FDA — is now commercially available for clinicians to prescribe to their patients, according to a release from Pear Therapeutics and Sandoz, a division of Novartis with which Pear partnered back in April.

But while physical prescription drugs are usually handled through a pharmacy, the process is a bit different for the digital therapeutic, Dr. Yuri Maricich, Pear’s chief medical officer and head of clinical development, told MobiHealthNews. Prescribing physicians will write a script that is sent to Pear’s reSET Connect Patient Service Center, which staffs specialists who guide the patient through downloading and using the app.

Not a month later the company announced that the FDA has officially cleared reSET-O — a digital therapeutic to treat opioid use disorder (OUD) jointly developed by Pear Therapeutics and Sandoz, a division of Novartis — a little over a year after it was granted an Expedited Access Pathway designation from the agency. 

This announcement makes reSET-O the first digital therapeutic to treat patients with OUD. Patients will need a valid prescription from their licensed provider in order to access the therapeutic. The therapeutic employs cognitive behavioral therapy (CBT) to help outpatients living with OUD. reSET-O is intended to be used by patients who are currently under the supervision of a clinician along with other outpatient treatments including medication-assisted-treatment, such as transmuscosal bupernorphine.

The precise definition of digital therapeutics has been a hot topic as the new technology category has been discussed and debated in event sessions and articles over the last few years. Now the Digital Therapeutics Alliance, a consortium of industry stakeholders, is hoping to put that to rest with an official definition with the release of a new whitepaper

The alliance specifies that a digital therapeutic must be evidence based, clinically validated and used “independently or in concert with medications, devices or other therapies to optimize patient care and health outcomes.” 


Diabetes management and resources continues to be a major area of interest for big pharma. 

During the quarter, Abbott was granted FDA clearance for FreeStyle LibreLink, a companion mobile app for its 10-to-14-day CGM.

The launch adds a long-awaited feature for US users that’s been available for some time in Europe: users will be able to scan their sensors with an app on their smartphone — and see their latest reading — rather than requiring a separate, proprietary handheld reader (although the reader will still be an option for those that prefer it).

Novo Nordisk also announced the launch of the two connected insulin pens at the beginning of October. The company plans to roll out the devices, dubbed the NovoPen 6 and NovoPen Echo Plus, worldwide, starting in early 2019. 

This was shortly followed by news that Novo Nordisk has struck a deal with Flex Digital Health, part of the IoT logistics company Flex, formerly known as Flextronics. Novo Nordisk will use Flex's BrightInsight platform, which focuses on managing connectivity and compliance for regulated digital health devices, as it rolls out two new connected insulin pens.

But not every diabetes project has been so successful. In November Alphabet’s Verily, along with Novartis subsidiary Alcon, announced plans to shelf its project to create a glucose-sensing contact lens. It will continue to work on two other medical contact lens projects, aimed at presbyopia and cataract surgery recovery.

Research and development

Another key area that the pharma industry has been focusing on is using digital tools for research and development. 

In October Researchably, a young startup incubated at UC Berkeley, announced that it was launching a pilot with Sanofi in China that would use AI to sift through thousands of research studies and surface the most relevant ones to pharma stakeholders.

In a prior three-month pilot, Sanofi found that using the software cut down the time from an average of 13 minutes per paper to less than one second per paper.

Sanofi isn’t the only company looking to team up with international partners. Earlier this month Oxford, UK-based e-therapeutics announced that it is entering a research partnership with Novo Nordisk that will see them use its proprietary Network-Driven Drug Discovery (NDD) platform to identify potentially new biological mechanisms and therapies for a “specific area” of Type 2 diabetes.

The tools are also being used to make clinical trials easier. Biopharmaceutical service Parexel International Corporation is turning its attention to mobile and wearable technology to aid drug development and clinical research. In early October the Boston-based company announced a slew of new products that will be built on its Perceptive Cloud platform. 

One of the new technologies uses Microsoft’s Azure App Services and will be able to send patient data to healthcare teams and first-line clinicians, alerting the them when there is a patient safety threat, according to the company.  

It will also expand its patient sensor's capabilities to connect with more medical devices including DataLabs, Parexel’s electronic data capture technology and ClinPhone, according to a statement. The sensor will also be employing AI to help transfer data and predict patients' adherence in the trials, according to the company. 

Still others are focused on breaking down silos in research. Merck KGaA, Darmstadt, and Silicon Valley-area big data company Palantir Technologies announced a joint venture that will focus on building an analytics and collaborative technology platform for cancer researchers. Called Syntropy, the Boston-based effort will rely on Palantir Foundry to power its data integration platform. Any research data shared across participating groups will be transparent and secure, according to the companies, with the participating institutions maintaining ownership of their data.

Other pharma news 

In November Belgian biopharma company UCB called on customer engagement company Verint Systems to create an app for patients with Parkinson's disease. The app is called PD Coach and includes an AI assistant named April that can communicate with users either by text or speech.

Meanwhile, in the Asia Pacific region, Roche announced the launch of FoundationOne CDx, Foundation Medicine’s comprehensive companion diagnostic test for personalized cancer care in Singapore. According to the official media release, FoundationOne CDx supports clinicians in their decision making by providing a clear, in-depth report that describes the unique genomic profile of a patient’s tumor as well as associated, approved therapies and relevant clinical trials.

Other news from the region includes the announcement that, China's online healthcare platform, will be entering into a strategic partnership with US-based global pharmaceutical leader Pfizer. Both companies will leverage their leadership in their respective fields and successful practices to implement a patient-focused strategy in terms of retail, hospital services and internet healthcare, in addition to co-creating an omni-channel retail system that combines online and offline channels.

The business side of pharma

In October Novartis announced that it would be cutting 2,200 jobs as part of a restructuring of the company focusing on particular priorities. But at that time CEO Vas Narasimham told STAT News that it would be turning to digital technologies as its next strategy. While Novartis has been pursuing digital technologies in various spheres for some time, it’s significant that the CEO went straight to digital in answering the question of why the company made the cuts it did. 

In October Pfizer  detailed a number of C-suite shakeups coming in the wake of its incoming CEO Albert Bourla.

Among the new hires is the appointment of the company's first chief digital and technology officer, Lidia Fonseca. Currently the CIO and SVP at Quest Diagnostics, Fonseca has also held tenure at the Laboratory Corporation of America, Synarc Incorporated and Philips Healthcare.

Dr. Kirsten Lund-Jurgensen, EVP and president of Pfizer Global Supply, as well as Laurie Olson, EVP of strategy and commercial operations, will both be retiring with the new year.

In other hiring news, Dr. Maria Rivas, currently the head of global medical affairs at Merck KGaA, has joined the board of digital clinical research organization Medidata — the first woman to do so as part of the company’s pledge to increase female board positions by 2020.

More regional news

Person in a telemedicine visit at home

(Photo credit: Alistair Berg/Getty Images) 

Piggy Bank

(Photo Credit: Kwanchai Lettanpunyaporn/Getty Images) 



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