The public health crisis of Covid-19 continues to cast a long shadow on business operations everywhere, including the biopharma industry. It is preventing sales reps from visiting doctors, delaying product launches and making them more complex to execute. It is also impacting clinical trials and underscoring the need for a more digital focused strategy for pharma companies.

Kal Patel, MD

Kal Patel, MD, is the CEO and co-founder of BrightInsight, which developed a digital health platform for medical device and biopharma companies. This regulated digital health platform enables companies to host and maintain their regulated drugs, devices and Software as a Medical Device solutions, and to analyze data to generate insights for the biopharma or medical device companies to optimize their therapies. Among BrightInsight’s customers are global pharma leaders, including Novo Nordisk, Roche, AstraZeneca and, most recently, CSL Behring

In an interview, Patel said the business has seen the virus impact customers in different ways. Four to six-month delays in clinical trials are common, including for oncology treatments. It has also led to a rapid expansion of telemedicine in many facets of healthcare delivery.

“Covid-19 wasn’t a part of anyone’s 2020 business plan. Many recognize that this virus is not going away anytime soon. So, when it comes to long-range planning, biopharma companies are saying, ‘How do we actually prioritize and, in some cases, severely limit investment in certain areas?’ That’s where digital becomes an interesting topic because we’re starting to see folks take a differential view to how they’re thinking about digital investment.” 

There are also many companies focusing on how they can help to be a part of the solution to the coronavirus. The virus is also factoring into their plans for 2021. That’s led to a big shift from an experience and investment perspective, observed Patel.

On the investment front, Patel said the business is seeing biopharma and medical device companies divert investment away from zero to low-value, unregulated apps. These are the kinds of apps that populate “graveyards” of ill-conceived marketing efforts, served as point solutions and offered no insight on the patient experience. Instead the public health crisis is accelerating the move by companies to embrace tools that will have more impact — regulated digital health offerings.

“Most apps are conceived with no product roadmap in mind,” Patel said. “What you really want to know is how many people are still using the app 30 days after they download it? How many are still using it, in cases of a chronic illness, 90 days later? Six months later? What are the features and functionalities they’re actually using? What are the features and functionalities that they’re asking for? What can we add to the next generation of the app? Instead, the historic strategy has been short-term and more along the lines of one and done.”

To illustrate the short sightedness of such a strategy, Patel contrasted this approach with what a technology giant would do: Nobody at a Facebook or Google would develop a product without a plan to collect any of the data on the back end, without knowing anything about how end users interact with it on a mobile device, without a roadmap to think about the next generation version of how their product would continue to improve. That’s why we’re seeing a shift away from these one-off marketing efforts.

“We’re seeing a change around how we get the patient’s permission to collect the data and to really understand what features and functionalities are valued by the user on day one, and how user feedback is treated. We’re seeing companies put in place parameters around these apps for privacy, security, regulatory, and quality.

“Biopharma and medical device companies are beginning to focus on developing Class II Software as a Medical Device or Class III Software as a Medical Device. They’re saying, ‘Let’s consolidate our resources and focus on those value-driving programs that will ultimately be regulated but that can be rolled out globally, similar to the approach they would take if they were developing a drug or a diagnostic.’ We’re seeing that shift of digital being decentralized and independent to focusing on high value tools in a strategy driven from the center.”

Patel noted that the digital evolution at biopharma companies takes on many forms. For instance, a pharma company may have developed an innovative approach to assessing clinical data or electronic patient reported outcomes (ePRO) from clinical trials to produce valuable insights that will have clinical value and could provide great commercial value. But they may not know how to take that insight and those findings and transform them into a commercialized, regulated, digital product. Patel said he is beginning to see small to medium sized pharma companies take action so they can realize the potential of these insights.

One trend Patel is seeing is a shift to personalized interventions across chronic conditions and other diseases. For example, a disease that affects a large number of people but produces a therapeutic approach that supports and facilitates personalization. It could include personalized drug dosing or how to identify patients who will not respond well to certain therapies for their illness. It’s a trend that is partly based on a recognition that the role of digital is going to increase throughout the patient’s journey from diagnosis, through appropriate therapy selection, through personalized treatments.

Another important factor for pharma and medtech companies to succeed with digital transformation is the need for the direction and vision to drive these initiatives to come from the C-suite. Those conversations will lead to a sharper focus on areas where the company believes they can provide compelling solutions with ROI. 

“About 80% to 90% of the companies we interact with recognize that digital is a strategic imperative,” said Patel. “We’re seeing very senior level, top-down engagement. The CEO has to really set the strategy and communicate the strategy because developing regulated digital health products is really complex. 

“The CEO needs to articulate the places where digital will drive the future for the company — on the R&D side, the clinical trial side, and regulated digital product side. If a company makes a short-term decision to, say, cut digital programs that feel like experiments, I think they’ll find that to be a really big mistake. Although their initiatives may need to be revamped, it’s no time to stop investing in digitization. By the time the company comes back to it in a couple of years, not only the money but also the talent you need to be successful in this area won’t be available. I think they will be really behind their competition. We’re not seeing a pullback, really.”

Patel also expects that the pressure to successfully develop and launch regulated digital products on deadline will lead to more partnerships between biopharma and medtech companies and tech companies to co-develop digital tools, rather than try to do it on their own.

“Building a digital infrastructure is much more of a long-term bet because you don’t throw it out and start over. You know that’s going to collect and manage all of your data. If you have more than one device or other data sources, you want to bring in an infrastructure to support them for the long term that can support biopharma and medtech companies as they seek to turn data into insight.”

Image: Who_I_am, Getty Images



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