Diving deeper into digital, this quarter the pharma giants have continued to implement new tools to enhance clinical trials, support medication management with technology and partner in developing digital therapeutics.
Onc, a foreign entity to this established industry, pharma executives are now becoming better versed in working with digital health companies and sharing the lessons they've learned.
“It’s not partnerships of pharma versus [digital] but a partnership of equals,” Erik Janssen, VP of innovative solutions in neurology at UCB Biopharma, said at HIMSS Europe last month. “It is about collaboration, and it is about learning a different perspective of the complexity of healthcare as well. It is also about improvisation … You must be agile. It is also about sustainability.”
While Janssen and others have encouraged partnerships between the two worlds, others have pointed out the challenges.
“The number one [risk to pharma] is just the complexity of developing these technologies,” Dr. Ameet Nathwani, chief medical officer and chief digital officer at Sanofi, said at BIO 2019 in Philadelphia. “Just imagine, when you develop a biologic drug and you make a slight modification, you have to go through this whole process. Just imagine that in the software world, where software changes over time. What’s the IP of it, can you IP a software? Well, actually, the regulations are not that clear and so there’s software’s copyright, and then what’s the generic version of it?”
Companies are still figuring out where digital fits into their model through partnerships and research, but it’s becoming more evident the new technology is transforming the industry.
Read on for pharma news from Q2.
Pharma companies have been increasingly interested in incorporating digital tools into the clinical trial process.
In May Alphabet’s life science subsidiary Verily announced a series of new strategic partnerships with four global pharmaceutical companies that will bring low-burden digital data collection and analysis tools to clinical research projects.
Alongside Novartis, Otsuka, Pfizer and Sanofi, Verily will employ its Project Baseline platform to increase the number and diversity of study populations by making it easier for participants to enroll and contribute their health data.
“Evidence generation through research is the backbone of improving health outcomes. We need to be inclusive and encourage diversity in research to truly understand health and disease, and to provide meaningful insights about new medicines, medical devices and digital health solutions,” Dr. Jessica Mega, chief medical and scientific officer at Verily, said in a statement. “Novartis, Otsuka, Pfizer and Sanofi have been early adopters of advanced technology and digital tools to improve clinical research operations, and together we’re taking another step towards making research accessible and generating evidence to inform better treatments and care.”
Also looking to real-world evidence, Concerto HealthAI, the maker of a clinical insight generation platform that employs real-world data in its analyses, is racking up the pharma partnerships as of late. Just weeks after the AI company agreed to a multi-year deal with Bristol-Myers Squibb, Concerto announced another similar project with Pfizer that will support the latter’s research on precision oncology treatments.
“This collaboration aims to find and help patients who may benefit from new therapeutic combinations,” Jeff Elton, CEO of Concerto HealthAI, said in a statement. “We are using our definitive real-world data, AI-enabled abstraction, data science expertise and strength in outcomes research to identify new and more precise treatment options; refine study designs; and speed up the completion times for various outcomes studies.”
However, with the potential of digital to be used in clinical trials, there also comes concerns around privacy and data security from industry players.
“You see a lot of things out there that are not even necessarily HIPAA compliant,” Luba Greenwood, who focuses on strategic business development and corporate ventures at Alphabet subsidiary Verily, said during the MassBio forum in May. “There are many wearables and other gadgets that claim to be wearables for clinical trials, but there is a big difference between something that you truly use for clinical trials, to get clinical validation and real-world evidence and other wearables that are there for consumer use.”
However, at during that same panel Matteo Lai, cofounder and CEO of Empatica, stressed that once the regulatory side is sorted, the tools could be key in passively collecting data. In particular he mentioned wearables and voice assistance.
This type of passive collection is already being used in the field. In fact, wearable sensor maker MC10 is teaming up with biopharma company AbbVie on a new set of multiple sclerosis (MS) clinical trials.The pair plan to use MC10’s FDA cleared wearable sensor technology, dubbed the BioStamp nPoint system, to help keep track of a patient’s physiological data and outcomes during the trials.
Pharma is starting to look outside of traditional drugs and increasingly incorporate digital medications into its research. Oftentimes this means partnerships between digital therapeutics companies and pharma. Pear Therapeutics, maker of prescription digital therapeutics, and Novartis have been an example of this type of relationship for years.
In May this partnership continued as the pair kicked off a feasibility study for Pear-006, an in-development treatment for depressive symptoms in those with MS.
Pear Therapeutics has been developing Pear-006 in conjunction with Novartis as per an agreement between the two companies announced early last year (which also applied to the development of another treatment for schizophrenia). The therapeutic is intended to be used alongside others targeting the MS itself, according to the announcement.
“Digital therapies will play an important role in treating patients with MS and are part of our commitment to further strengthening Novartis’ leadership in this area,” Ricardo Dolmetsch, global head of neuroscience at Novartis Institutes for BioMedical Research, said. “Pear-006 has the potential to change how we treat these patients and initiation of this trial is an important first step in this journey.”
While Pear and Novartis may have a long partnership history, other players in the pharma space are still figuring out how it fits into their business model.
“A digital therapeutic can be a friend or a foe, we just have to open our eyes to the fact that competition is coming from new angles that we otherwise would not have considered,” Sanofi's Nathwani said at BIO 2019 in Philadelphia. “Our approach and response should be equal: Let’s embrace it, understand what it can do. If the patients are going to benefit in the end, that’s great for everyone. If we can’t differentiate our drug from a digital therapeutic we have a different problem, because I think digital therapeutics will be faster, they’ll be quicker, they won’t have the same safety burdens that you would encounter with our own drugs.”
However, industry reports warn that there is still a lot of unknowns in this industry. As more and more digital treatments come onto the market, the successes or failures of these partnerships and others will likely play a major role in defining the broader landscape of pharma-backed digital therapeutics, according to a new report from Rock Health and ZS Associates.
“We predict that the visibility, credibility and availability of digital therapeutics will continue to advance incrementally, step by step — not in one fell swoop. In turn, this will drive a progressive shift in the mindset of key influencers, entire organizations, and ultimately the healthcare industry as a whole — from pharma, health plans, health systems, and the government,” market researchers wrote in an excerpt of the report. “We also believe that the execution risks and complexity of forming pharma-[digital therapeutics] alliances will be addressed as new alliances are formed and the industry builds on the lessons learned from early successes.”
While digital therapeutics may be the treatments of the future, pharmacies and pharma companies are already using digital tools to help patients manage their prescription drugs today.
In April, Diplomat Pharmacy released data surrounding its partnership with smart pill bottle maker AdhereTech, as the companies also announced plans to expand that deal.
The data, representative of more than 1,000 patients, showed that on average, patients who used the smart, connected pill bottle technology filled their medication one additional time over the course of the year. Patient retention was 12% higher, and the average patient experienced 19 fewer “gap days” (days of skipped medication because of a delayed refill).
Also looking to medication safety, Medisafe, a digital medication adherence app, is joining forces with Amerisource Bergen’s Lash Group in order to integrate the former’s management app into the latter’s hub services. The partnership seeks to help patients manage their medications and identify patients who need extra support. As part of the deal Lash patients will be able to enroll in the Medisafe platform when medication is prescribed.
Through the deal, Pfizer patients will be offered Popit’s adherence solution, which monitors pill-taking with a smart device and alerts users via an app if they forget to take their medication. The scheme will initially be rolled out to 1,000 people in Finland, Sweden and Norway, with discussions ongoing about eventually expanding to other countries in central Europe.
In addition to the medication safety component, pharma companies are looking at the money. Working with Eli Lilly and Company, chronic disease management company Livongo completed a retrospective analysis of more than 10,000 patients that suggested Livongo's diabetes program can prevent $88 worth of medical spending per person per month.
Citing an average cost to employers of $68 per person per month, including about $30 worth of diabetes management products, this could indicate an ROI of between $20 and $50 per member per month.
Research institutes and pharma alike are starting to turn to the genomics space.
In April, 23andMe announced that it is teaming up with The Michael J. Fox Foundation for Parkinson’s Research on a new data and analytics platform dedicated to Parkinson’s research. The new tool, dubbed Fox Insight Data Exploration Network (Fox DEN) is set to include patient surveys, de-identified genetic data and data exploration tools all aimed studying Parkinson’s. This announcement came after last year GlaxoSmithKline invested $300 million in the company to gain exclusive access to its DNA database.
But this isn’t the only pharma company teaming up with genomics startups. Just a few weeks ago blockchain-enabled genome sequencing startup Nebula Genomics announced its first pharma partnership with Merck KGaA’s EMD Serono. This early partnership will come in the form of a pilot program.
As part of the deal, EMD Serono will be able to use Nebula’s network of anonymized genomic data. This new pilot is specifically zeroing in on lung cancer patients and still looking to recruit new participants. In exchange Nebula is offering participants fitting the criteria germline and tumor whole genome sequencing.