AbbVie quits one of two potential Alzheimer's treatments connected to Alector partnership.
In 2017, AbbVie and Alector joined together to develop and commercialize two therapeutics for Alzheimer’s. After a recent review of AL003, AbbVie has decided to abandon efforts for that drug, but will continue to pursue AL002, which is focused on targeting triggering receptors expressed on myeloid cells 2 (TREM2).
AL002 is an investigational, humanized monoclonal antibody whose role in potentially treating Alzheimer's was first identified in large-scale genome-wide association studies. Researchers found that reducing TREM2's functionality may contribute to AD progression and other types of dementia. By increasing TREM2 in the brain, there may be a way to target multiple pathologies linked to the disorder instead of just focusing on one pathology type.
The role of TREM2 in Alzheimer's treatment has been studied for many years. In 2021, AL002 became the first product candidate to reach Phase 2 clinical development that targets TREM2. Results from the INVOKE-2 Phase II clinical trial, which looked into the safety and efficacy of the drug in slowing disease progression in people living with Alzheimer's were positive.
Alector's novel approach -- immuno-neurology— to treating neurodegenerative diseases focuses on the immune system. In 2018, the company doubled down on this theory by tripling its workforce and expanding its facility, all with the expectation of taking five drugs into clinical trials.
The abandoned drug, AL-003, was designed to treat Alzheimer's using the body's immune system to fight the neurodegeneration. AL003 is a molecule designed to modulate checkpoint receptors on the brain’s immune cells, targeting sialic acid-binding Ig-like lectin 3 (SIGLEC 3, also called CD33).
The monoclonal antibody counteracts the function of Siglec-3, a microglial transmembrane receptor that reportedly interacts with TREM2. The gene encoding Siglec-3, CD33, has been associated with AD risk via a protective variant, expression levels, and alternative splicing.
Lawmakers seek "steep financial fines" for biopharmas not supplying discounted medicines as required by 340B.
Recently, the 340B discount pricing program has created a hornet's nest of pointing fingers and financial opportunities that were never intended to be part of the equation. Created in 1992 to support safety-net clinics (those providing care to uninsured patients) and qualifying hospitals through a discounted medicine program funded by biopharmaceutical manufacturers, the sole purpose was to give vulnerable patients access to necessary medicines.
Due in part to unclear language, lack of oversight, and rules with no enforcement power, parties on all sides – health systems, pharmacies, and biopharma– have been reported as taking advantage of loopholes that enabled them to profit from the program that was set up to help patients in need. The law, as written, does not require patients to benefit directly; absent this distinction, the law fails to outline exactly how the program should work, creating wiggle room for all involved.
It is from this thorny backdrop that the biopharma industry recently came under the 340B scrutiny microscope again. On Friday, July 15, a bipartisan group of the U.S. House of Representatives sent a letter to the Biden administration requesting "steep financial fines" on companies that are refusing to provide the discounted pricing. This is the third letter sent by Reps. Abigail Spanberger (D-Va.) and David McKinley (R-W.V.). Their appeal was sent first in 2020 and in 2021.
Since 2021, 12 more manufacturers have announced policies restricting access to the 340B program, the latest letter states. "These companies’ actions have increased costs for federal grantees and other safety net providers and have reduced patient access to care in vulnerable communities," it reads.
The letter asks the HHS Office of Inspector General (OIG) to conclude its ongoing review (started eight months ago) of seven drug companies that have been referred to it for continued refusals to come into compliance with federal law on 340B discounts. The law authorizes OIG to impose civil monetary penalties of up to more than $6,000 per drug claim on companies that are “knowingly and intentionally” overcharging 340B providers, and the lawmakers said those fines should start taking effect as soon as possible.
Up to 18 biopharma companies have restricted their 340B pricing programs, some stating that the program is growing too large. They are AbbVie, Amgen, AstraZeneca, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Exelixis, Gilead, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Novo Nordisk, Pfizer, Sanofi, UCB, and United Therapeutics. Not participating in the 340B is against federal law, however, over the past couple of years, court cases have both denied and upheld biopharma companies requests to not offer or to limit their 340B program.
Major drug companies such as AstraZeneca and Eli Lilly have no longer provide 340B-discounted products to contract pharmacies. Merck is suing the Biden administration to avoid potential fines for cutting off 340B contract pharmacies from getting discounted products.
Agencies hope for more data before deciding on approval.
It's not uncommon for a neuroscience treatment—like Amylyx's AMX0035 for the treatment of ALS-- to look good in small, early trials and then not stand up in larger, phase 3 trials. That is why the FDA required further review in March before it would approve AMX0035.
That review will happen on Sept. 7, when the FDA Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) will reconvene to discuss the New Drug Application (NDA) for AMX0035, also called Albrioza. The PCNSDAC met on March 30 to discuss the NDA but voted 6-4 to deny approval based on the fact that the available data on the drug's effectiveness didn't meet the criteria for approval. The FDA will announce the scheduling of the PCNSDAC meeting in the Federal Register.
The company's initial submission to the FDA was based on results from its CENTAUR trial, a multicenter Phase 2 clinical trial with 137 participants with ALS encompassing a 6-month randomized placebo-controlled phase and an open-label long-term follow-up phase. Amylyx has already started a larger trial with about 600 patients globally, which is expected to be completed in 2024. According to the company, the initial trial met its primary efficacy endpoint of reducing functional decline as measured by the ALS Functional Rating Scale-Revised.
"Overall, reported rates of adverse events and discontinuations were similar between AMX0035 and placebo groups during the 24-week randomized phase; however, gastrointestinal events occurred with greater frequency (≥2%) in the AMX0035 group," a press release stated.
Detailed data from CENTAUR is published in the New England Journal of Medicine (NEJM) and Muscle and Nerve.
The FDA reports that discussions on September 7 will focus on the additional analyses of data from the company’s clinical studies that the FDA determined to be a major amendment to the NDA.
PCNSDAC members questioned the Amylyx study due to "the small size of the trial, the possibility that patients could tell whether they were receiving the drug or placebo, the high percentage of participants in the drug portion who dropped out and the company’s definition of “death,” which included hospitalizations and tracheotomies in addition to actual deaths," reported Bloomberg in an opinion piece back in March.
The treatment has already been approved in Canada in June, with certain conditions, including release of data from the ongoing global late-stage study. The oral fixed-dose medication is also awaiting approval by the European Medicines Agency. The FDA is expected to make its decision on September 29.
According to the Christopher and Dana Reeves foundation, some of the $200 million raised by the Ice Bucket ALS challenge over the past six years has gone toward research involving AMX0035. The foundation described the drug as "one of the most significant findings in development" for ALS. The CENTAUR trial was also funded, in part, by the ALS ACT grant and supported by The ALS Association, ALS Finding a Cure, the Northeast ALS Consortium, and the Sean M. Healey & AMG Center for ALS at Mass General.
The news of the Sept. 7 meeting shot up shares of the company about 13% to $21.91 earlier this week.
The drug makers are in acquisition talks, but there is no recorded offer yet and no agreement has been made public.
One of the most talked about pharma deals this past week may never actually happen, according to experts.
Merck & Co. is looking to buy Seattle-based Seagen to expand its cancer portfolio, which would represent the biggest deal of the year so far. Seagen’s work in antibody drug conjugates has a market value of over $30 billion, with its shares rising 16% at the news of Merck's interest in the acquisition.
According to the Wall Street Journal and others, Merck is in talks with Seagen, but there is no recorded offer yet and no agreement has been made public. However, the two companies are scheduled to meet this week to further discussions.
The two companies have worked together in the past developing a new breast-cancer treatment. They plan to test the experimental treatment in combination with Keytruda. Two years ago, Merck agreed to pay $600 million upfront to Seagen, while buying five million shares for $1 billion.
With the patent for Keytruda, a $17 billion drug, expiring in 2028, this is a tactical time for Merck to expand its cancer treatment pipeline.
The new acquisition makes strategic sense for both companies, but analysts fear it may be too big to pass the increased regulatory scrutiny stemming from a FTC/DOJ Pharmaceutical Task Force that is suggesting a tougher approach to evaluating mergers.
The FTC/DOJ task force held a workshop in early June, and at that meeting FTC Commissioner Rebecca Kelly Slaughter noted that although the immediate agenda of the task force was complete, the group would continue to work with the FTC "on both specific cases and general approaches, keeping our ideas fresh and reflective of market realities."
"Going forward, our individual enforcement and policy work can inform each other’s agendas," she said in her keynote address. "I have no doubt the knowledge the FTC will gain will help better inform our pharmaceutical merger investigations."
Just two days after the workshop concluded, the Wall Street Journal reported that Merck may be looking to acquire Seagen. According to the same report, however, analysts were doubtful the merger would pass regulatory requirements. Experts predict the two may continue as marketing collaborators.
Seagen was previously known as Seattle Genetics. In April, it announced plans for a manufacturing facility to help provide “greater control and flexibility” over the production of its cancer medicines based in Washington state. Its co-founder Clay Siegall resigned as chief executive and chairman in May as the company was investigating his conduct following an allegation of domestic violence.
If Merck does step up to the plate to buy the biopharma, the merger will be a test of the new FTC attitude towards mergers, as well as a threat to other companies in the oncology space.
ASCO Chief Medical Officer evaluates the rise of the virtual model in cancer clinical trials.
The 2022 ASCO meeting kicked off in the first week in June, inspiring many discussions throughout the following weeks about new and exciting innovations in cancer care and treatment, but two buzzworthy topics included the need for more focus on diversity in cancer clinical trials and how sponsors can use the decentralized model to improve patients access to trials.
HealthLeaders spoke to ASCO Chief Medical Officer Dr. Julie Gralow shortly after the ASCO annual meeting to discuss the value DCTs can bring to oncology research.
According to Gralow, people who work with and around ASCO (including oncologists, clinical trialists, patients, industry, and FDA representatives) would prefer to change the term 'patient-centered trials' rather than DCTs, because the No. 1 goal of using DCTs is to focus on patients and adjust the protocol in ways that make trials more pragmatic and easier for patients to comply.
"The basic goal behind any DCT is simple: make it easy for the patient," Gralow says. "It goes beyond decentralizing."
Clearing Doubt in DCT
The FDA reported just last year that the use of full or hybrid DCT designs was rare in oncology, because of uncertainty surrounding the effect of remote assessments on data quality and outcomes. Gralow believes that is about to change.
"The big concern is will the quality of the clinic visit, the physical exam, the labs, radiology and everything else, be as good when done remotely," says Gralow. "That's why we are collecting data now on the remote trials, so we can identify any problems with them."
FDA has initiated a study to evaluate trial datasets of remote trials against site trials by requesting NDA/BLA applicants to voluntarily add flags to datasets to delineate between remote assessments and trial site assessments.
Challenges
Another challenge is not all patients may have reliable WiFi to support telemedicine. Also post covid, medical licensure will become a problem as waivers for using telemedicine that were in place during Covid have expired. Now patients must be in the physical state where the trial is happening.
However, the overall value of DCTs to improve patient enrollment and retention of oncology trials outweigh the concerns.
"On our taskforce, the majority of the stakeholders involved believe that the benefits outweigh the challenges, and our next step is to make it easy by coming up with good general practices and identifying what's safe and what's not," Gralow says.
Benefits
The FDA research has shown that DCTs bring several benefits including reduced patient and sponsor burden and increased accrual and retention of a more diverse trial population.
"There is also a big equity piece to this," Gralow says. "All of us are committed to having enrollment in cancer trials be more representative of the cancer patient population of the country – and we know we fall behind in that – but DCT is a way to make it easier to enroll patients, they have less days off work, it really helps manage the logistic pieces to make it easier to enroll for populations that are more vulnerable who don't have those resources."
According to a report last year in Journal of the National Cancer Institute, more than half of all cancer patients who are offered a clinical trial will participate, suggesting that the barriers to enrollment are more structural and clinical. For example, patients more than half the patients in the study didn’t have a trial available to them at their institution and nearly 22% were deemed ineligible for an available trial. Therefore, enabling access to trials and broadening eligibility criteria through remote trials can improve patient enrollment.
ASCO is conducting a remote hub and spoke care model in Montana, but it is for cancer care instead of cancer clinical trials, but the trial piece will be added, Gralow says. The Boseman Cancer Center serves as the hub and there is currently one remote site where patients can go for infusions. This is a location with no oncologists but there are health providers who can administer infusions, and this allows cancer patients to get treated closer to home.
Broadening the eligibility criteria in DCTs is another way to increase patient access. While site location can be a hurdle for patients, as can stringent criteria, much of which may not be necessary.
In fact, ASCO and Friends of Cancer Research jointly issued new recommendations to further efforts to broaden eligibility criteria in cancer clinical trials with the goal of making clinical trials more accessible to patients.
"There's been a lot of work between ASCO and Friends of Cancer Research, along with the FDA, and the National Cancer Institute on the acceptability of loosening eligibility criteria," Gralow says. "I've seen more trials being written with the eligibility being much looser to reflect a more real-world population."
Barriers go beyond the site location but also include the practices of creating really narrow windows for visits and scans. For example, site visits are often required to be on a particular day plus or minus one day, and often those dates could have more flexibility. "While there's some things where exact dates are crucial, like the date of an infusion is fairly important and should be a fairly narrow window, but some of the other criteria is not," Gralow says. "Loosening requirements will help more patients participate and not impact the results of the trial."
The FDA's interest in determining if DCT trials are viable is spurring other stakeholders to give serious consideration to DCTs. Its studies have already concluded that DCTs can reduce geographic barriers and minimize financial burden by allowing remote participation.
"Changes in oncology trials are already happening," Gralow says. "We'll continue to see changes in the next couple of years, and the process will be more standardized within five years."
Two breakthroughs in particular have the power to change survival rates.
The American Society of Clinical Oncology (ASCO)'s recent annual meeting has set the stage for pharma players, as studies and posters across multiple therapies were presented and analyzed by the oncology community. As projections were made on the effect of the study results, from big pharma to small biotech, the overall buzz ranged from great innovation to equity in cancer care.
Innovation in Breast Cancer
News that resonated throughout the week included the groundbreaking data from the DESTINY-Breast04 study of Enhertu, which, according to Shanu Modi, MD, medical oncologist at Memorial Sloan Kettering Cancer Center, could impact survival for about half of patients currently diagnosed with metastatic breast cancer. These results, released early this year, are dramatic enough to change the way HER2-low metastatic breast cancer is treated and classified. For the first time, the HER2-directed therapy categorized the patient population of HER2-low, including disease that's hormone receptor-positive and -negative.
"This is the first randomized clinical trial to show that targeting metastatic breast cancer that expresses low levels of HER2 with trastuzumab deruxtecan, which is a HER2-antibody drug conjugate, is a more effective or superior approach versus using standard chemotherapy," Modi says in an ASCO video. "Up until now, our currently available HER2-targeted therapies have really not shown benefit in patients with HER2-low-expressing breast cancers."
In addition, the drug created a statistically significant benefit in median progression free survival (PFS) among all treated patients, increasing the median from approximately five months to approximately 10 months.
Modi further reported that patients treated with trastuzumab deruxtecan experienced an approximate 50% reduction in the risk of disease progression and an almost 40% reduction in the risk of death in comparison to standard chemotherapy. The patient's metastatic disease was under control for twice as long with trastuzumab deruxtecan therapy, and they had longer survival.
CAR-T Advancements
Five years ago, Gilead saw similar ground-breaking when Yescarta became the first CAR-T cell-based gene therapy approved for the treatment of certain blood cancers. This year at ASCO, Gilead presented new data on the use of Yescarta for second-line treatment of large B-cell lymphoma along with real-world outcomes by race and ethnicity for Yescarta. While the results are laudable, as the CAR-T field evolves, the competition for Yescarta gets stronger.
For example, small-cap biotech Arcellx reported a 100% overall response rate and a 70% complete response rate in a small phase 1 clinical trial for multiple myeloma at ASCO, putting the pressure on Legend Biotech/Johnson & Johnson's Carvykti, Bristol Myers Squibb's Abecma, and GlaxoSmithKline's Blenrep.
These remarkable results stemmed from a study that included many difficult-to-treat patients who had already received three or more prior therapies. These 21 patients were described as having poor prognostic factors, including extramedullary disease, which means myeloma cells had formed tumors outside the bone marrow in the soft tissues or organs of the body.
Legend Biotech showcased 28-month follow-up data for Carvykti, already on the market for two years. Its overall response rates remained at 98%, according to ASCO data. Fewer than 10% of patients had severe neurotoxic effects—a prior concern—from Legend's or Arcellx's treatments, which puts their products equal to Abecma in terms of side effects, but above in terms of response rates.
As the theme for this year's 2022 ASCO was Advancing Equitable Cancer Care Through Innovation, these breakthroughs bring to light just two of the many new developments that will change cancer care.
Tune in to virtual sessions June 14–15 to learn how industry merger enforcement may change.
The FTC and DOJ will host public virtual sessions Tuesday and Wednesday, June 14–15, that will reveal what the review group, the Multilateral Pharmaceutical Merger Task Force, has discovered about the current nature of competition in the pharmaceutical industry and its assessment of how existing enforcement approaches reflect present conditions.
The task force was set up in March 2021 to identify actionable steps to review and update the analysis of pharmaceutical mergers. In 2021, global deal-making reached an all-time high of $5.8 trillion, so the review was well-timed. In addition, the guidelines have not been updated for 12 years.
The analysis provided new data to update the FTC investigation process, including fully analyzing and addressing the varied competitive concerns that arise with pharma mergers and acquisitions. Exploring a nuanced layer in M&A, the review explored labor market issues, such as how mergers impact the healthcare labor markets, an element experts say is an important byproduct of continual mergers.
The virtual workshop, called The Future of Pharmaceuticals: Examining the Analysis of Pharmaceutical Mergers, will feature a keynote presentation and panel discussions organized by the task force. The workshop is open to the public, and it will be webcast on the FTC's website, transcribed, and posted online. Registration is not required, and the link to each webcast will be made public on the day of the event.
On the first day of the meeting, FTC Commissioner Rebecca Kelly Slaughter will deliver a keynote address, followed by plenary sessions on market concentration in the pharmaceutical sector and merger remedies. The second day features sessions on the innovation aspects of pharmaceutical mergers and how conduct by pharmaceutical companies affects merger analysis.
Public participation and awareness of the event is crucial to the future of pharmaceutical mergers, says Slaughter in a prepared statement. "Public input is critical to the process of refreshing our approach to pharmaceutical mergers," she says. "In the face of skyrocketing drug prices and ongoing concerns about anticompetitive conduct by pharmaceutical companies, we need to ensure that our investigations fully capture the potential impact on prices, quality, access, drug supply chain resilience, capital market investment, and innovation for new drugs."
Pharma merger and acquisition activity for 2022, according to data and analytics company GlobalData, has totaled 256 deals involving top global pharmaceutical companies in just the first quarter. These include a variety of mashups, including high-profile contract service agreements, licensing agreements, partnerships, mergers, venture financing, equity offerings, asset transactions, debt offerings, acquisitions, and private equity deals. The U.S. pharma market was the most active, with 114 deals, followed by China, with 28 deals.
"Given the high volume of pharmaceutical mergers, it is imperative that we rethink our approach toward pharmaceutical merger review," Slaughter says. "Working hand in hand with international and domestic enforcement partners on this new joint project, we intend to take an aggressive approach to tackling anticompetitive pharmaceutical mergers."
Sanofi and Leaps by Bayer are just two pharmaceutical companies using digital technologies to reach stakeholders more effectively.
This spring ushered in a swell of partnerships between pharma and digital health companies that flag a growing trend in healthcare. This much needed move to digital has been spurred by the increasing number of health consumers who want an Amazon-like experience, combined with the forces of the COVID-19 pandemic that required pharma to rapidly adopt digital technology.
"The pandemic pushed both digital health and telehealth forward by 15 years in a matter of three weeks," says Rick Anderson, president and general manager of North America at DarioHealth.
According to a CBI Insights report of 2021 digital health investment activity, funding grew 79% year over year to reach a record of $57.2 billion. Experts claim these investments will only continue to grow. "There are more and more opportunities for collaboration, and I expect that will accelerate over the next three to five years," Anderson adds. "We're definitely going to see more and more of those kinds of partnerships as people try and leverage those different worlds."
Jurgen Eckhardt, MD, senior vice president and head of Leaps by Bayer, says the company deems digital user–centered products as a relevant and growing area for the organization that will help it be closer to patients and healthcare providers (HCP). "From our point of view, digital user–centered products can become an important link between Bayer's treatments and diagnostics efforts to the daily lives of patients' and HCPs," he says.
Examples of 2022 pharma investments in digital health include partnerships between Biogen Inc. and MedRhythms, who joined up in May to develop and commercialize an investigational prescription digital therapeutic for the potential treatment of gait deficits in multiple sclerosis. Novartis and Evermed also made waves in May with a new Netflix-style approach that entails tailored, education-based videos aimed specifically at rheumatologists. And in March, AstraZeneca sold its disease management platform to Huma Therapeutics and the two companies will collaborate on creating apps targeted at different therapeutic areas.
Partnerships at work
HealthLeaders spoke with leaders from Sanofi and DarioHealth about their recent partnership, as well as Leaps by Bayer and Woebot, and all agree that despite the challenges, the pharma industry is realizing the need to use digital health to bring added value to patients.
Just last month, Sanofi established a $30 million agreement with digital therapeutics company DarioHealth to develop solutions on Dario's platform and expand the commercial reach of its products in the health plan and employer markets.
According to Alex Condoleon, MD, head of digital healthcare for U.S. general medicines at Sanofi, the company made this decision because it thinks digital solutions can transform how it discovers, develops, and delivers therapies. "Collaborating with Dario brings us another step closer in accelerating our mission of reversing the course of chronic diseases through the integration of healthcare and technology to help empower people to improve their health," he says.
Anderson says that Sanofi's approach to digital health is not just a one-off, but rather a complete shift in its business mindset. "What was interesting to us about Sanofi was that many partnerships between digital health companies and pharmaceutical companies consist of using the digital health company's software as an adjunct or an add-on to an existing device or pharmaceutical product. There has not been much in terms of pharma companies looking at digital health and saying, 'Okay, here's where healthcare is going, and we want to be there.'
Sanofi is a visionary because it is seeing that digital therapeutics can be an opportunity to provide care to people as a separate category."
Condoleon says that is true.
"We believe the integration of healthcare and technology can help empower people to improve their health," he says. "That is why Sanofi is a leader in digital partnering to solve critical challenges and pioneer new business models in this rapidly evolving space. Through our collaboration with Dario, we're aiming to enhance the value of digital therapeutic solutions and further our commitment to help people with personalized whole health disease management solutions.
Challenges
The challenge for Sanofi and others, according to Anderson, is how to get from how they currently do business to a more consumer-centric model that adds value. "The only way you get to value-based is to have digital health as a component of it," he says. "This is going to become an integral part of business just like the other pieces."
However, the shift won't be an easy one. It will be daunting for the industry to steer away from using rebates and other structures to capture and hold on to customers. This model generates multiple millions of dollars of revenue on those products. Reversing the thought process to provide more value within a new revenue structure, rather than being rebate-based, will be a difficult transition for many, Anderson says.
"Many will struggle with how to transition to more consumer-focused solutions without cannibalizing existing business, but it's worth it," he says. "You get a one-to-one relationship with people through digital health. And you can collect a lot of data, you can understand how to provide value-based contracting. Theoretically, for every member on a medication or a drug, you can determine the savings related to those people. Another advantage is the ability to conduct real time, real-world evidence studies at a much faster pace and understand how to cycle through that in terms of providing care to people."
This is definitely one of the goals of the partnership with Sanofi. "Working with Dario, we plan to generate evidence relating to the effectiveness of Dario's solutions and platform in improving diabetes management, patient engagement in their self-management of diabetes, and utilization of healthcare resources in a real-world setting," Condoleon says.
Better outcomes for all
Digital health solutions can lead to better relationships and better patient outcomes, says Condoleon, who expects the partnership with Dario to bring both of those elements to the table.
"Through this collaboration, we aim to expand access to Dario solutions for people living with chronic conditions, such as diabetes, hypertension, musculoskeletal pain, and behavior health, through payers and employers," he says. "Our hope is that, by offering patients a range of technology solutions including coaching, education, and digital sensors through this collaboration, we can empower them to manage their chronic conditions and help improve outcomes."
Similarly, Eckhardt, at Leaps by Bayer, says the impact investment arm of Bayer AG is investing in transformative digital technologies to improve its mental health initiatives. The $9.5 million investment in Woebot Health marks Leaps by Bayer's first investment in mental health.
"Regaining mental health is one of the main focus areas of Leaps by Bayer, and we believe that Woebot's technology represents a unique opportunity to support the development of digital behavioral health solutions," he says. "Investing in Woebot displays a unique opportunity for Leaps by Bayer to support brain and mind protection and to transform health with data."
Eckhardt expects to see better patient outcomes via digital health than from prior traditional methods.
"Woebot's approach in combining psychology and technology with AI and clinically proven therapeutic research has the potential to significantly improve patient's well-being by providing 24/7 access to digital behavioral health solutions to help with the unmet need," Eckhardt adds.
We design our digital applications to provide predictive, personalized, and actionable insights, to patients HCPs, and healthcare providers."
Eckhardt says that Bayer understands "that we cannot walk this road alone, that's why we have several avenues in place, such as Leaps by Bayer and the G4A Digital Health Partnerships Program, that help us identify areas of collaboration with high-potential companies to accelerate our digital capabilities and support us in our efforts to bring the right tools to our patients and HCPs."
According to Anderson, this is just the beginning of a growing wave of pharma and digital health partnerships. "Digital health and digital therapeutics will become part of the landscape much like pharmaceuticals and devices are today," he says. "We will continue to see more cross-industry partnering associated with digital health."
