Business Development

When working in the biotech industry, it’s easy to keep a sole focus on the discoveries and innovations that could revolutionize whole treatment landscapes. But how well do biotech executives know the needs of patients, caregivers, and physicians? Do innovations meet the actual needs, are there obstacles other than pricing, or are all improvements just welcomed? We asked our colleague Tatiane, a former clinical psychiatrist, about her perspective on some of the most debilitating psychiatric diseases. First out: bipolar disease.

Imagine the average Tuesday morning in a psychiatric emergency room, there’s a new patient called Maria. Maria is a 32-year-old architect that explains that she’s been monitored by the FBI for the last couple of months, and lately, they’ve been sending agents to observe her from the roofs of her neighbors’ houses. When she goes to work every morning, she knows they are sending someone to follow her every movement and send the information to the US government. They also have access to her computer and mobile, and she’s sure they have bugged her house, even though she couldn’t find any devices when she dismantled most of her furniture. She explains that the monitoring started when they found out she could time travel, moving to certain points in the past or the future, as she wishes. All she needed was a quiet place and a bit of concentration. Maria is certain that this power can be a useful tool for the FBI, but she is not sure if they want to recruit her as an agent or use her as a “lab rat” to understand the origin of her power to try to reproduce it in other people. She explained that she was sleeping on average 1-2 hours per night the last week, and while describing her situation she is very agitated.

One of many many patients

Maria was diagnosed with bipolar disorder type 1 five years ago. She went through several months of depression, started taking antidepressants, and after only a few weeks presented an episode of mania. At the time she was full of energy, had no need for sleep, was talkative, and eventually started believing she had time travel powers. Since then, she received the prescription for an effective antipsychotic drug that makes her lose her power, forget about the FBI, and live a relatively ordinary life. Maria felt so well that two times since the diagnosis, she stopped taking her pills because she didn’t feel the need to keep treating a disease that doesn’t exist anymore. Besides, her mouth is always dry, and she had gained weight, and it can only be because of the medicine. The last time she took the pills was three months before the emergency visit.

There are so many Maria-type patients in the daily life of a psychiatrist. It is unthinkable that there aren’t better therapeutic solutions for these patients at this day and age. Although many of today’s drugs are effective in controlling the symptoms, bipolar disorder is still one of the most challenging diseases to maintain long-term stability.

So, despite having a technology that, on paper, could revolutionize the treatment regimen and is proven to work isn’t enough to change the treatment landscape. There are many more aspects to be considered for true success.

Digitizing therapies

Recently, new technologies have been developed focusing on better treatment response, adherence improvement, or complementary therapy solutions.

In 2017, the US FDA approved the first digital medicine that was based on the established antipsychotic drug, Abilify, used mainly for schizophrenia and manic episodes in bipolar disorder type 1. The smart pill, called Abilify MyCite, has an ingestible sensor that transmits information about the if and when of ingestion to a mobile app and a web-based portal. The idea of this smart pill is to solve the common non-adherence issue within psychiatric diseases by giving caregivers and physicians access to the information, so interventions can be made before the patient gets into a risky situation. Abilify MyCite is still available in the US but the company behind the sensor technology, Proteus Digital Health, filed for bankruptcy in 2020. This after raising almost 500 million dollars and having a valuation in the billion range. So, despite having a technology that, on paper, could revolutionize the treatment regimen and is proven to work isn’t enough to change the treatment landscape. There are many more aspects to be considered for true success.

Several other technologies have been developed and tested for mental health monitoring. Smartphones and smartwatches, for instance, have been used to analyze patients’ lives and behavior with the aim to find connections between people’s routine and their mental status. Information about physical activity, sleep quality, and changes in the device usage pattern can be used to identify red flags; as well as camera, keyboard, and audio data can help to identify psychiatric symptoms. An ongoing collaboration between Apple, the University of California, Los Angeles (UCLA), and Biogen has studied data from iPhones and Apple Watch of 20,000 participants to identify links between device usage and cognitive function. Patients with different diagnoses could benefit from this type of monitoring, such as dementia, depression, bipolar disorder, substance addiction, and anxiety disorders. But naturally, those mental health tracking systems are controversial, have raised privacy questions, and typically require the consent of the person being monitored.

What can go wrong?

There are several drawbacks from both a medical and commercial perspective that must be regarded when looking at new technologies in the psychiatric space. The smart pill is expensive to develop, and the drug-sensor combination costs almost three times of what the same branded anti-psychotic in its regular form costs, and several times the generics price. Additionally, the reimbursement landscape can be complex with digital therapies. But most importantly, would it be the best way to address the non-adherence issue for this population?

Patients with schizophrenia and severe cases of bipolar disorder not rarely have a persecutory delusion, the idea of being followed, monitored, or having an unwanted and non-authorized microchip installed in their bodies is many times part of their delusions. How would the idea of ingesting a sensor that transmits information to an app resonate with our patient Maria, for instance?

Terms like digital medicine, software as a treatment, software as a medical device, virtual care, and smart pills, for instance, have emerged in the last years and indicate the industry’s interest in finding solutions to improve the established medical treatments using technology. Several acquisitions, licensing deals, and collaboration agreements involving start-ups and big pharma companies show that the most traditional players have already started focusing on innovative solutions.

What’s next?

The treatments available for bipolar disorder today work well and control the symptoms most of the time, if taken as prescribed. However, the challenge of treatment adherence remains. Bipolar patients often rationalize why they stop following their treatment regime of which the top reasons include:

• the feeling that the medicine is no longer needed,
• experiencing uncomfortable adverse side effects,
• the feeling that they were better (more confident and more powerful) in hypomanic/manic state, or
• the feeling that they are too depressed and hopeless about a long-term solution.

So, how should the issue of treatment adherence be addressed? What would make Maria and so many other bipolar patients adhere to the treatment for long-term stability and a chance at an ordinary life? Technological innovations have a great potential to revolutionize medicine, but a crucial step in the innovation journey is to understand the actual needs of patients, caregivers, and clinicians. Only then can innovations that truly change the treatment landscape succeed and give these patients a chance at a long, stable regular life.

By: Tatiane Abreu Dall’Agnol, Associate at MSC Nordics

Tatiane is a medical doctor and has worked as a clinical psychiatrist in several public and private institutions in Brazil, including outpatients’ consultations, psychosocial center care, psychiatric emergency care, and hospitalization.