Over the last year, digital has transformed the caregiver experience, but pharma has also been undergoing a metamorphosis in order to reach patients.

During the pandemic, life science companies were pushed to reconfigure their care in order to meet the needs of some of the most at-risk patients. MobiHealthNews sat down with the leader of pharma giant Otsuka's Global Clinical Development on Nephrology, Dr. Charlotte Jones-Burton, to talk about innovating for rare disease, digital in clinical trials and lessons learned from past tech partnerships.

One of Otsuka's treatment areas focuses on autosomal dominant polycystic kidney disease (ADPKD), a genetic disease that requires substantial monitoring. There have always been challenges for patients living with this disease, which have been exacerbated during the pandemic.

"When you think about a rare disease such as ADPKD – which is one of the diseases we focus on in nephology at Otsuka – because it’s a rare disease, it means there are only a certain number of specialists that are treating that disease," Jones-Burton said.

"So, it makes it even more difficult, because there are only certain areas that you go to see these specialists. We need to think about convenience for these patients, and also how do we ensure that they have access to the experts of the disease? I believe, specifically for patients who have rare diseases, that it is really important we continue to remove any barriers. And I believe digital innovation will help us remove barriers."

These barriers to care became particularly pronounced during the coronavirus pandemic. This put some of the ideas into action.

"We've been focused over the last year … on helping ensure that our patients who are being treated with our medicines and enrolled in our clinical trials too have seamless care in this socially distant world," Jones-Burton said. "What that really means is we want to make sure that they can remain on their medications, receive the monitoring of their medications required, and continue to have the treatments available for them."

One of the biggest hurdles for ADPKD patients during the pandemic is blood monitoring. Patients on medication for the condition need to get their blood drawn on a regular basis.

"We put forth, number one, a mobile phlebotomy collection service, where we had a phlebotomist, which is someone who takes their blood, actually go to their home to take the blood samples that are required to monitor their liver functions," Jones-Burton.

The company's efforts also included setting up a service to help support patients remotely where they can ask clinicians questions in between visits about their condition.

Over the last year the company has also put emphasis on promoting its peer mentor program for patients who have ADPKD.  

"This program, as the name speaks for itself, is really connecting those who have the disease, like similar patients who are also experiencing what they are going through. ADPKD is a rare disease, so it's really helpful for us to be able to do that," she said.

While these have all been tools that have evolved during the coronavirus pandemic, the company is planning on rolling out additional neurology tools down the pipeline.

“Otsuka is currently developing an ADPKD Progression Monitoring Tool to help patients understand the state of their kidney disease. This will help patients, in partnership with their physician and care team, make informed decisions about their treatment,” a spokesperson from the company wrote in an email to MobiHealthNews.

While details about the tool are still forthcoming, it's no secret that Otsuka has been interested in the digital space for some time. Much of its digital efforts have focused on major depressive disorder.

In fact, in February the company teamed up with Click Therapeutics to kick off a decentralized pivotal trial for depression-focused digital therapeutics.

"It’s a remote clinical trial study that uses digital therapeutics as an adjunctive therapy [with] patients who have major depressive disorder," Jones-Burton said. "What is so amazing about this technology is that it's digital and its really to be utilized to help retrain the brain in order to reduce depressive symptoms in patients who have been diagnosed with major depressive disorder who are on antidepressants as monotherapy, but aren't achieving the response to treat the disease."

Jones-Burton said that partnerships are a key part of the digital strategy going forward.

"I think we have seen the power that comes with collaborations and what it's really allowing us to do. … What we are really focused on at Otsuka is [having] the patient at the center of everything we do. It doesn't mean we are going to be the ones to innovate everything.

"So, identifying – starting with that focus of the patient at the center – and then identifying other partners or individuals who are creating solutions that also keep the patient at the center and [bringing] forth partnerships with those individuals will help us continue to meet the needs of the patients."

The world of clinical trials is one place that we are seeing these partnerships bloom. The company collaborated with Alphabet subsidiary Verily on Project Baseline, which is devoted to recruiting a more diverse population for research.

"We want to make sure the populations we are enrolling in our clinical trials really reflect those that have the disease," Jones-Burton said. "In order to do that … we realized we do have to meet patients where they are. That means that offering options to clinical trials, democratizing clinical trials, making sure we have sites that are nontraditional sites and are in locations where the patients are and it doesn't require the patients to take time off from work or long gaps where they are away from their family, is going to be really important. So, we need to leverage digital innovations to really help us do that."

It is important to note that Otsuka has been in the digital health game for some time. However, not all digital bets have paid off. The company has a history with digital pill company Proteus. Together the two received the FDA's green light back in late 2017 for Abilify MyCite, which combined medication designed for schizophrenia with an ingestible pill that can track adherence.

This was followed by an $88 million deal it signed with Otsuka in 2018. However, in subsequent years Proteus struggled financially, and the pair eventually split ways. Last year, Proteus announced bankruptcy. In August of 2020, Otsuka approved the purchase of Proteus' assets by a federal bankruptcy court.

"We are making sure that we are mindful of lessons learned, and continuing to as we move forward and think through products we are working on in development, thinking about how do we leverage the information we've always learned. Things don't always go according to plan, so it's important to make sure that even from our experience, as you mentioned, with other products such as Abilify MyCite that we are refining and learning."

At the end of the day Jones-Burton said the innovation will be driven by patient needs. While we've seen a lot of innovation due to the coronavirus pandemic, she thinks that these advancements will continue even after.

"The main reason I think it's going to stay is if we think about the patient and keep the patient at the center, this will allow us to increase access for those patients who haven't had that access. It will give patients more control of what they can do," Jones-Burton said.