The Rise Of Digiceuticals – Can You Afford To Not Get Involved?

By Ed Miseta, Chief Editor, Clinical Leader

When Heather Bell hears the term digiceuticals, she can’t help but think about transformation. “I think that mobile health [the use of smartphones, tablets, and other mobile computing devices to record patient information] has the potential to be profoundly transformative for healthcare,” says Bell, formerly AstraZeneca’s VP of program management in IT/operations and now Sanofi’s VP of corporate strategy and emerging opportunities.

"I believe it will usher in a realm of predictive medicine, complete with what we might call digital biomarkers and digital drugs."

While that may sound futuristic, some of these are already on the market today.” While a lot of the hype in this area is focused on large tech companies, advances in technology will also present opportunities for pharma companies. “Bringing mobile health technology to clinical trials will certainly empower consumers,” says Bell. “Patients have access to more information than ever before, and mobile technologies have also given them greater access to each other. Finally, wearable sensors and the promise of continuous monitoring have given pharma access to new sources of data.”

MOVING FROM REACTIVE TO PROACTIVE
Bell believes we currently live in a medical world based on reactiveness. When patients have a disease exacerbation, they go to the hospital or their physician. But she envisions a different world, one in which we have more thoroughly studied what it is like to live with the disease through the eyes of the patient. What if, through the process of continuous monitoring and mobile technology, we understand how these diseases are experienced and develop new insights into what it is like to live with them?

“We might discover that 10 days prior to a major episode in a depression patient, their emailing, texting, and phone calls drop off dramatically versus a baseline,” says Bell. “We might discover that three days before admission to the hospital, a child with asthma will start wheezing in the middle of the night. If it doesn’t wake them up, the child, their parents, and their physician would never know. But a mobile device sitting on their bedside table would note the event and code changes in their breathing.”

Having that information would enable physicians to take preemptive action, provide medications, and possibly avoid costly and painful hospitalizations. This scenario is not as futuristic as it sounds. Bell references a Medtronic study from 2004 showing data obtained from pacemakers in heart failure patients. The data revealed patients had a dramatic drop in heart rate variability 20 days before required hospitalization. Not every patient has a pacemaker, but continuous monitoring is certainly moving the medical community toward a world of predictive medicine.

FILL IN THE DOTS BETWEEN VISITS
Bell cites Ginger.io as another example of where the industry is heading. The company has expertise in predictive algorithms and the management of Big Data. She references a chart from the company’s website that plots national health measures against time, which she believes illustrates a major challenge that exists in medicine today.

A doctor will see how a patient is doing when that patient visits the clinic. But if a physician wants to know how that subject feels between visits, they have to rely on the patient’s account of what has occurred. While helpful, it generally does not tell the whole story. “Ginger.io is trying to fill that gap with continuous data,” says Bell. “Having that information gives the physician a much richer picture of where the ups and downs are for any patient.”

Ginger.io has built the platform that underpins UCSF’s healthy heart study, a largely digitally powered, epidemiological study of a million people’s heart health. They are also enrolling individuals in studies on neurological disorders. If patients have depression or bipolar disorder, that study is capturing data on how much they email, text, and phone to establish a baseline.

TECHNOLOGY ADVANCES FROM NONTRADITIONAL SOURCES
When discussing advances made in wearable technologies, Bell gives a nod to gaming developers. Quality of life initiatives exist within companies like Nintendo that are attempting to bring better fitness apps to the gaming generation.

“These companies are outstanding at rapid prototyping, creating user-friendly interfaces, and having profound customer insight,” she says. “Samsung is involved in a partnership with UCSF, co-running a lab to validate sensor technology that is expected to lead to better preventive health solutions.”

Bell adds, “I think we can envision a world in which there are companies that know a lot more about diseases pharma is interested in, as well as the drugs we sell. Technology presents opportunities for pharmaceutical companies to reinforce the core drug business and move into new and different spaces.”

USE TECHNOLOGY TO ENGAGE PATIENTS
One aspect of the advances in technology that has Bell most excited is patient recruitment via websites and social media. She references a partnership between Biogen Idec and MyHealthTeams to illustrate her point.

MyHealthTeams is a Silicon Valley-based start-up that provides “mini-Facebooks” for specific disease communities. For example, a patient with breast cancer can become a part of the MyBreastCancerTeam. Similar teams are in place for autism, multiple sclerosis, lupus, and more. The teams are only open to patients who have the disease or, in some cases such as autism, those who are caring for someone with the disease.

The user communities are highly engaged with an interest in clinical trials. The monthly active use rate for most groups is more than 50 percent, and it’s not unusual to get an 85 percent response rate when querying members about relevant clinical trials. This allows sponsors to target their outreach.

Bell notes Biogen Idec approached patients on MyMSTeam with relapsing MS who were in the relevant age demographic and on an existing specified therapy (Beta-Interferon).

“Patients were sent an email asking if they would be interested in the trial and speaking with a screener,” says Bell. “At that time, Biogen Idec’s baseline for trial screening was five patients a week. Within 24 hours of sending the email, 35 patients had been screened. This ability to tap into an incredibly engaged population and get quick responses has been encouraging.”