Monsenso has signed an agreement with Awakn Life Sciences, a global biotech company

Monsenso has signed an agreement with Awakn Life Sciences, a global biotech company

Monsenso has signed an agreement with, a global biotech company, to support the company’s medical psychedelic treatments. Awakn Life Sciences is a global biotech company that leads the field of psychedelic medicine for the treatment of addiction. In October 2021 commenced the implementation of the Monsenso Digital Health Solution in Awakn Life Sciences clinical practice as a tool for supporting patients throughout their treatment while capturing real-world patient insights to inform clinical decision-making and personalised treatment.

Mental illness and addiction are some of the biggest public health challenges facing the global community.

Nearly one billion people worldwide suffer from mental illness, for which there are too few effective treatments available beyond coping strategies and treating symptoms. With global spending on mental health estimated to reach $16 trillion by 2030 (as measured by lost economic output)[1], it is critical that effective new treatments are developed to address the current gaps. Psychedelic-assisted therapy has emerged as a potential solution to this treatment vacuum. In the early 20th century, these substances were severely restricted and had a negative connotation. Today, however, a growing body of evidence and urgent unmet patient needs have led clinicians and regulators to consider them as a viable treatment option.

Psychedelic-Assisted Psychotherapy represents a paradigm shift in psychiatric treatment

Psychedelic drugs are substances that alter perception and mood and affect various cognitive processes. When used in conjunction with psychotherapy, they can put patients in a temporary state where they can better process memories, emotions, and past traumas[2], allowing for processing that enables subjects to let go of things that have previously troubled them[3]. For the same reason, psychedelic-assisted psychotherapy has shown effective in treating historically difficult-to-treat illnesses[4] and is today considered a promising game-changer in psychiatric treatment[5,6,7].

While psychedelics have spurred great interest in the life science industry, only a few psychedelic companies are currently treating patients in the clinical setting. Awakn Life Sciences launched the UK’s first psychedelic-assisted clinic in Bristol, followed by London and Manchester, offering evidence-based psychedelic therapies for addiction and other mental health indications, and has also opened a clinic in Oslo, Norway with plans to scale across Europe quickly.

In October 2021, Awakn Life Science commenced implementation of the Monsenso Digital Health Solution in its clinical practice to support patients throughout their treatment journey and to capture real-world data to inform clinicians’ decision making for personalised patient support and management.

“We are excited to work with Awakn Life Science to support new treatment options for people who have experienced insufficient treatment results. We look forward to partnering with Awakn Life Sciences and be part of their growth journey” says CEO of Monsenso, Thomas Lethenborg.

Awakn’s CEO, Anthony Tennyson added “There’s such a critical need to provide solutions and hope to people suffering from mental illnesses and addiction. We’re excited to partner with Monsenso to better engage with clients throughout their treatment, gain insights to help inform clinical decisions and improve health outcomes, and generate insights that inform our research and treatment development programs”.

About Awakn Life Science Awakn Life Sciences is a publicly-traded (NEO: AWKN) (OTCQB: AWKNF) biotechnology company with clinical operations; researching, developing, and delivering psychedelic medicine to better treat Addiction. Awakn’s team consists of worldleading chemists, scientists, psychiatrists, and psychologists who are developing and advancing the next generation of psychedelic drugs, therapies and enabling technologies to treat Addiction.

About Monsenso Monsenso is an innovative technology company offering a digital health solution for mental health and behavioral disorders. Our mission is to help provide better mental health to more people at lower costs. Our solution helps optimise the treatment of mental disorders and gives a detailed overview of an individual’s mental health through the collection of outcome, adherence and behavioural data. It connects individuals, carers and health care providers to enable personalised treatment, remote care and early intervention. Based on continuous research and development, our team is committed to developing solutions that fit seamlessly into the lives of individuals, increase their quality of life and improve the efficacy of mental health treatment. To learn more visit www.monsenso.com

For additional information contact:
Bettina van Wylich-Muxoll
Chief Marketing Officer
marketing@monsenso.com
Monsenso

Sources:

[1] https://www.weforum.org/agenda/2020/10/mental-health-day-covid19-coronavirus-global/

[2] https://www.health.harvard.edu/blog/back-to-the-future-psychedelic-drugs-in-psychiatry-202106222508

[3] Jennifer Mitchell, neuroscientist and professor in the departments of neurology, psychiatry and behavioral sciences at the University of California San Francisco.

[4] Psychedelic-Assisted Psychotherapy: A Paradigm Shift in Psychiatric Research and Development

[5] https://www.health.harvard.edu/blog/back-to-the-future-psychedelic-drugs-in-psychiatry-202106222508

[6] https://www.scientificamerican.com/article/a-renaissance-for-psychedelics-could-fill-a-long-standing-treatment-gap-forpsychiatric-disorders/

[7] Psychedelic-Assisted Psychotherapy: A Paradigm Shift in Psychiatric Research and Development

Patient Voice in RWE: generating evidence that will impact payer and HTA decision-making

Patient Voice in RWE: generating evidence that will impact payer and HTA decision-making

With the rise of patient-centered medicine and accelerated approvals, health technology assessment (HTA) bodies and payers are looking to real-world evidence (RWE) to strengthen evidence packages and reduce uncertainties at the time of launch.

Increasingly, stakeholders are recognizing the importance of RWE that incorporates patients’ real-world experiences in understanding what treatments work, and for whom, in clinical practice.

Real-world evidence is generated through applying data science to real-world data (RWD), or data “relating to patient health status or the delivery of healthcare routinely collected from EHRs, claims, registries, patient-reported outcomes, devices/applications, etc.” Decision-makers are exploring how this evidence can supplement clinical trials and provide additional context on the effectiveness of therapies.

There is some overlap between patient experience data, which provides information about a patient’s experience with a disease or condition, and real-world data (RWD), however, they are not one and the same. For example, patient-reported outcomes (PROs) collected in an electronic health record (EHR) would be considered both RWD and patient experience data, however, lab test results in the medical record would be considered only RWD. As personalized medicine continues to gain traction, decision-makers like ICER, FDA, NPC, EMA, EUNetHTA, and EHDEN are calling for patients’ voices to be included in the drug development and assessment process. Such information – direct input from patients on how they feel and function is often lacking from RWD sources, and FDA and EMA identified such missing data as problematic for interpretation.

We spoke with Ashley Jaksa MPH, Scientific Partnerships Lead, Aetion and Chung Yen Looi, DPhil Partnerships Director, Monsenso, about the evolving landscape of patient experience data and how biopharma organizations can incorporate the patient voice into their RWD and RWE programs.

Q: Ashley, can you tell our readers a little more about what Aetion does? 

AJ: Aetion is a healthcare technology company that uses routinely collected health care data to generate RWE on the safety and effectiveness of medical treatments and technologies. We were founded by Harvard epidemiologists to develop a way to conduct scalable and transparent RWD analyses at the highest level of scientific rigour. Our RWE analytics platform helps biopharma organizations, regulators, HTAs, payers, and other researchers generate RWE to inform decisions on the safety, effectiveness, and value of medical interventions across the product lifecycle. Our platform is data fluent, meaning it can analyze almost any type of RWD, and we often work with our customers and partners to identify the most fit-for-purpose data set for their research question.

Q: Why is the patient experience important for biopharma to understand, and where in the drug development lifecycle is it most important to integrate patients’ voices? 

CL: I think we can all agree that pharma and its stakeholders want to develop safe and effective drugs and bring them to market, to improve patients’ lives. As such, asking patients directly about how a drug impacts their lives is critical. Without the patient voice, we will never know how patients experience therapies in the real world, and how medical interventions could make a meaningful difference to their lives. Capturing and incorporating the patient voice across the product lifecycle can help biopharma companies to better understand the real-world impact of their drug, treatment responders, and meaningful endpoints based on a wider, representative population, in a quick and cost-effective way. 

AJ: Similar to RWE, patient experience data is important in almost all stages of the product lifecycle—not just as a post-marketing exercise. For example, understanding the treatment pathways and patient experiences on first-line therapies can help shape what comparators and outcomes should be captured in future randomized controlled trials to differentiate the drug in the market.

Q: How can incorporating the patient voice improve market access?

CL: Patient voice is a powerful way to demonstrate the impact of a drug on patients’ quality of life to payers and HTA bodies, particularly for cost-effectiveness evaluations. Some biopharma organizations have used PRO measures on daily functioning and health-related quality of life as their primary and secondary endpoints in clinical and real-world studies, while others have directly linked PROs to their drug reimbursement contracts. Patient voice contributions can help biopharma companies differentiate their product from similar drugs for coverage, especially for payers who are tying reimbursement to the value to patients based on outcomes and have longer-term responsibilities for their populations.  Some of the common myths are that “payers don’t care about PRO evidence, PROs only matter if they make it to the label, and that PROs should only be collected in Phase IV.” The facts are that not all payers are alike. Some pay a lot of attention to PRO evidence. Payers will consider all data from pivotal trials, whether or not it is on the package insert, and coverage decisions will be made on pivotal trials, so waiting until Phase IV to collect PROs would be too late.

Q: What are the common barriers in generating high-quality, patient-centric RWE?

AJ: I think the common barriers to generating RWE and patient-centric RWE are very similar; researchers must ensure that the data exists, that the data is capturing the relevant underlying medical concept, and that it is generated in a way that limits bias and confounding. Traditional RWD sources, like claims and EHRs, often have limited patient-centric data. This is a challenge for researchers attempting to incorporate this information into their studies. However, groups like Friends of Cancer Research and data providers like Monsenso are working to ensure this information is being collected. Once it is collected, it is essential to validate that these data and algorithms are actually measuring what we are intending to measure. Finally, researchers must be cognizant of bias and confounding and control for this as much as possible through study design and analytic methods. 

CL: Adding to Ashley’s points, I think data privacy and security, patients’ burden of contributing to research, and standardized methodology to analysis and interpretation are common barriers. It may seem like a no-brainer to ensure that patient data is managed in a secure way, but a recent study showed that almost a third of health apps out there collect patient data without privacy policy, and about one in five data transmissions occurred on insecure communication protocols. Furthermore, as patients are already suffering from their disease or conditions, contributing to research could add to their burden, which is why data capture platforms should be designed in a way that is easy-to-use and that provides valuable insights to patients. Finally, there is a lack of standardization in analysis and interpretation—which is why companies like Aetion are important to ensure that critical questions are answered, data sets are relevant, and standards are followed to derive and present meaningful insights that will inform decision-making.

Q: How can biopharma generate high-quality, patient-centric RWE for decision-makers? 

AJ: In addition to addressing the common barriers mentioned above, we think it is important to follow a principled approach to study design and execution. The main reasons why decision-makers like regulators and HTAs/payers dismiss RWE are due to deficient data selection and insufficient methodology. Following principled epidemiologic methods of selecting fit-for-purpose data, avoiding common methodological mistakes, and ensuring the protocol and results are clearly communicated are essential to ensuring the decision-makers trust the evidence. This planning and execution of RWE studies is not easy; it takes forethought. Biopharma manufacturers should be considering RWE at every stage of the product lifecycle, and proactively planning for how RWE studies will be incorporated into each product’s launch. 

Q. What is the cost-benefit for biopharma of generating patient-centric RWE? 

CL: Relative to the costs of bringing a new drug to market – which could go up to billions of dollars and take over a decade, with limited success ratesthe costs associated with collecting patient-centric RWE is insignificant. In return, patient-centric evidence could provide significant savings and valuable insights as early as possible to ensure that new drugs are truly driven by patients’ unmet needs, that they impact outcomes that matter to patients, and, ultimately, that they have the greatest chance of reaching the market and making a meaningful difference to patients. 

AJ: RWE can provide value for biopharma organizations across the product lifecycle—from eliminating costs typically incurred during clinical trials to accelerating time to market. Using a validated RWE platform can take this a step further, allowing companies to run more efficient, credible studies and reach insights faster than they could with traditional line programming. By ensuring patient-centric outcomes are collected in clinical data sources, then incorporating patient-centric RWE across drug development and commercialization programs, biopharma organizations can unlock insights that deliver value not only for their company but for patients as well. 

Q: Lastly, for our readers who are not familiar with Monsenso, Looi can you kindly tell a little more about what Monsenso does? 

CL: of course, Monsenso is a digital health company that enables patient-centric care and research. We’re a spinout from the IT University of Copenhagen based on the groundbreaking research of Professor Lars Kessing and Dr. Mads Frost on bipolar disorder and depression. We were founded in 2013 and have been listed on Nasdaq First North in Denmark since 2020. Our solution enables pharma companies to collect self-reported and device-generated data directly from patients in a simple, scalable, secure, and cost-effective way. Our cloud-based platform connects patients and investigators via an app and a web portal, respectively, to collect data in real-time across clinical development, post-market studies, and clinical practice to inform decision-making. Our platform can integrate with wearable devices and sensors, and combine with other RWD sources to provide a more holistic view of the impact of a drug on patients’ lives.

Monsenso signs agreement to support global pharmaceutical across Europe

Monsenso signs agreement to support global pharmaceutical across Europe

Following a year-long collaboration, Monsenso signs a three-year +10 mio DKK agreement with a global pharmaceutical company.

Monsenso’s mobile health solution will be used for real-world data collection across two studies in connection with the launch of a new drug for depression treatment. The studies are expected to start in the first half of 2021 and will run over a three-year period, covering up to 2250 patients and 120 clinicians across Belgium, the Netherlands, the United Kingdom, Switzerland, Italy, Spain, Denmark, Sweden and France.

In connection with the two studies, Monsenso’s solution will be used to collect data from patients and their relatives through clinical questionnaires, daily self-assessments and behavioral data from smartphones and wearables.

In addition, the patients will be offered in-app study information and can receive reminders about medication and consultations with their clinician. Monsenso’s unique mobile health solution will in this way help increase the quality of clinical studies with real-time data collection while also facilitating better communication between patients, caregivers and clinicians.

“We are very pleased to expand our collaboration with this global pharmaceutical company and to participate in these projects. Depression is a leading burden of disease for society, and it has severe consequences for patients and their family caregivers, so we are proud to contribute to solving this problem” says Thomas Lethenborg, CEO of Monsenso. “In addition, the project will support our European expansion and our focus on partnering with pharmaceuticals, which is in line with our strategy”. 

The project will not affect Monsenso’s previously communicated plans and guidance for the 2020 financial year.

To read the Danish version, click here.

For additional information contact:
Bettina van Wylich-Muxoll
Chief Marketing Officer
marketing@monsenso.com
Monsenso

Why pharma can benefit from mHealth solutions

Why pharma can benefit from mHealth solutions

Pharma can benefit from mHealth solutions by using them in clinical trials, and by offering them to healthcare providers as part of a comprehensive treatment solution.

Meeting the needs of healthcare providers

The healthcare industry is widely adopting digital technologies. But, today’s healthcare providers are extremely busy between seeing patients and filing paperwork, which limits their time online.

Nowadays, more than 80% of HCPs have a desktop/laptop computer and a smartphone, and 72% own a tablet. [1] Mobile assets are rapidly becoming components in the clinical environment.

Pharma can benefit from mHealth solutions since many healthcare providers would like to find new evidence-based medicine to provide better treatment for their patients, but in many cases, they don’t have time.  In fact, according to a survey conducted by Publicis on Sermo, 81% of clinicians want higher quality pharma representatives capable of having serious discussions of multiple therapeutic options. [2]

Pharma can benefit from mHealth solutions by offering  them to healthcare providers, and  help them satisfy their needs – improving health outcomes, information sharing, and staying updated with the latest treatments.  Providing this type of solution will not only facilitate their customers’ jobs, but they will also open new doors and new opportunities to propose comprehensive treatment solutions.

Pharma should reach out to healthcare providers and offer them digital tools, content, and communities that can help them do their jobs more efficiently.

Improving outcomes in clinical trials

Given the challenges faced during clinical trials, it is only natural that pharma turns to mHealth solutions to help them recruit patients, as well as monitoring and measuring their results.

Subjects are much more likely to participate in a study if they have the possibility to raise their concerns or ask any questions 24/7.

Pharma can benefit from mHealth solutions, since these tools can collect even more data in real-time, improve efficiencies in time and costs, shorten timelines, as well as increase patient satisfaction, retention, and future recruitment.

A key element of success when using mHealth solutions for clinical trials is the ease with which mHealth solutions can collect data, and how that information is integrated into the whole clinical database. These data integrations should be done as closely as possible to real-time, making it easy for clinicians to visualise all the patients’ data.

Conducting clinical studies using mobile devices can help collect and monitor behavioural data and vital signs in patients. These solutions can also work as medication reminders and gather patient feedback – all these improve the decision-making process when developing new medicines.

Monsenso can provide Pharma companies with  a customised, white-label mHealth solution for their clients and to use on clinical trials. If you are interested in learning more about this, click here.

References:

[1]. Publicis Healthcare Communications Group. Publicis Touchpoint Solutions, Inc. (2012). What Physicians Want! http://en.calameo.com/read/00018255192e3ec186674?authid=adzLms3ud6Vf
[2] Manhattan Research. Unknown Author. (2013). Taking the pulse 2013. www.manhattanresearch.com
[3] MHealth in Clinical Research. Denise, Myshko. Pharma Voice. (2016, October) http://www.pharmavoice.com/article/2016-10-mhealth/

How mHealth Solutions can improve the research methodology of clinical trials

How mHealth Solutions can improve the research methodology of clinical trials

Using mHealth solutions for clinical trials as data-collection tools, can potentially revolutionise clinical research. Wearable devices and mobile health solutions can offer pharmaceutical companies access to additional patient data to provide a more comprehensive overview of safety and efficacy.

According to a new report by IMS Institute for Healthcare Informatics, there are now more than 165,000 mobile health apps on the market.

A report released in 2015 by Rock Health revealed that:

  • 4 out of 5 internet connected adults use some kind of digital health technology
  • 52% of consumers strongly agree that they are responsible for their own health
  • 40% of people who made an online search for health information acted on the results of their search in some way
  • 92% of users agree that they should be the one controlling their health data
  • 80% of users would share their health data with their care provider to get better care [1]

The use of mHealth solutions for clinical trials is increasing, and according to industry experts, this trend will dominate the market in the coming years. In a recent SCORR Marketing report, 50% of industry experts surveyed say they use mHealth technology in their clinical trials and protocols, and of those 60% consider mHealth very important or critical to their research. [2]

As of August 29th, a search of clinical trials.gov showed 272 studies that mention the use of mHealth and 186 studies that mention a wearable. [2]

People use their mobile phones every day; it is the first and last thing they see when they wake up in the morning and before they go to bed. This is one of the reasons why the use of smartphones and wearables will continue to increase the use of mHealth solutions in clinical trials and pharmaceutical research.

The patient data obtained from mHealth devices, whether it is sensor or self-reported data, will transform the way patients are being diagnosed, monitored, and treated.

Additionally, the costs of conducting clinical trials are high, and mHealth technology has the necessary means to optimise the resources used and maintain lower costs. Mobile health data provides researchers with access to real-time data and visualisations that enable them to spot situations that otherwise would have been at best an indicator when reported through traditional clinical channels.

Additionally, pharmaceutical companies and researchers can immediately identify if a patient has stopped taking their medication or they present any unusual symptoms in real-time, and take action.

By using mHealth solutions, pharmaceutical companies expect to bring patients closer to the research and obtain better enrolment rates, compliance, and retention.

In addition to receiving information from patients, these devices can also be utilised to send information to the patients such as information about their condition and clinical questionnaires.

In the near future, pharmaceutical companies will be able to gather and visualise even more data in real time using mHealth technology, which will potentially shorten timelines, improve patient satisfaction, and increase future recruitment.

Interested in using mHealth technology for your clinical trial? Click here to learn more.

References:

[1] Rock Health: 80 percent of Internet-connected adults use digital health tools. J. Comstock. MobiHealthNews. (2015, October 19)
http://mobihealthnews.com/47675/rock-health-80-percent-of-internet-connected-adults-use-digital-health-tools

[2] MHealth in Clinical Research. Denise, Myshko. Pharma Voice. (2016, October)
http://www.pharmavoice.com/article/2016-10-mhealth/