Big Pharma Cooperation Advances Digital Measures, Drug Development

January 07, 2022 - As big pharma looks to advance its pipelines of innovative drugs and digital measures, industry cooperation is crucial.

In recent years, pharmaceutical companies have embraced a more collaborative way of working to overcome major challenges facing the industry, including research and development agreements, cross-licensing, joint ventures, and mergers/ acquisitions.

Specifically, with digital measures, industry cooperation is critically important.

“Until industry starts to coalesce around the most important and high-value digital measures of health, progress towards a shared understanding of how these new digital endpoints reflect health status will be slow,” “Jennifer Goldsack, co-founder and CEO of the Digital Medicine Society (DiMe) said in an interview with PharmaNewsIntelligence.

“In turn, realizing the full promise of digital measures to speed new therapies that address the most important facets of disease to market for patients will be limited,” Goldsack added.

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DiMe is a global non-profit and professional home for all members of the digital medicine community. Along with its partners, DiMe drives scientific progress and broad acceptance of digital medicine to boost overall public health.

The company’s library of digital endpoints currently includes 225 unique statistical endpoints.

This first crowdsourced library specifically focuses on industry-sponsored studies of new medical products and new applications of existing medical products.

A new paradigm for research and development

A few decades ago, almost all drug discovery took place inside traditional pharmaceutical companies. But today, internal research and development is no longer the primary source of drug innovation or even an important source. Top pharmaceutical and biotech giants willing to come together in this space marks a seed change for digital endpoints in the industry. 

In November, DiMe teamed up with AbbVie, Janssen, Novartis, Pfizer, and UCB to scratch the surface of atopic dermatitis and advance the adoption of digital endpoints in clinical research as a whole.

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Atopic dermatitis can lead to nighttime itching and scratching, severely impacting an individual’s quality of sleep. Recent studies have outlined wearable sensors’ role in digitally tracking and monitoring the condition.

DiMe is positioning this new initiative, and using digital endpoints in general, as a way to help reduce time and cost associated with researching and developing new therapies. 

“Industry learned from past experience that the technology-first approach didn’t work and that it should be changed to a measure-first approach and perhaps, more importantly, a patient-first approach, insisting on developing only measures that matter to patients in addition to seeking improved quality and efficiency in the system to bring effective drugs to market for patients more quickly,” Goldsack explained.

Therefore, industry collaborations like this will speed the development and drive broad acceptance of digital measures as digital endpoints for use in medical product development.

“This initiative is an important precedence with the right focus and the right approach in the pre-competitive environment where each of the parties brings unique expertise to the table in pursuit of a shared goal,” she continued.

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Clinical trial recruitment rates have declined over recent years — nearly half of all clinical trial sites under-enroll. As many as 86 percent of clinical trials do not reach recruitment targets within their specified time periods.

Goldsack noted that participant burden is often high, timelines are long, and research costs continue to increase as technical success rates stagnate.

“Digital endpoints are not a silver bullet but offer the promise of collecting high-resolution data about the aspects of disease that matter most to patients while reducing the burden on participants,” she explained.  

“Cooperation that brings together these internal experts with other players in the ecosystem has the potential to do the important work towards advancement of new and important outcomes that will move the whole field forward.”  

A sea of pharmaceutical changes

Over the past few years, technology has begun to transform pharmaceutical research and development. A 2020 GlobalData survey revealed that over 70 percent of pharma industry respondents anticipate that drug development will be the area most impacted by the implementation of smart technologies. 

For example, digital measures are used to inform decision-making, identify likely responders to new therapies, and diagnose patients earlier in their disease.

Pharmaceutical executives are looking for ways to leverage artificial intelligence (AI) and machine learning within the healthcare and the biotech industry. Reports show an increasing number of entities are realizing current use cases, driving the digital future of the tech in the industry.

But despite the advantages of technology in the pharmaceutical space, there are still notable barriers that hinder full adoption and use of these technologies in a meaningful way.

“Even now, we can see how technology is beginning to transform pharmaceutical research and development, “Goldsack stated.

“We believe that collaborative projects like this will create a blueprint of an approach that can be replicated in the future to improve technology adoption in research and development. The impact the technology can have is immense,” she continued.

Although DiMe’s partnership will advance the digital endpoint for atopic dermatitis, Goldsack explained that this project will be the first to bring together industry stakeholders in collaboration and apply existing guidelines and frameworks to a specific use case to advance development and cross-ecosystem acceptance of a novel digital endpoint.

Overall, it is essential to use frameworks to properly approach future development and deployment of digital endpoints in medical product development.

If done right, many researchers and ecosystem players can follow these steps to bring new digital endpoints to the market.

Pharmaceutical companies may not have welcomed collaborative working in the past, but now it has become a necessity. With new technology for patients, medical staff, and a better understanding of how diseases are becoming more advanced, the pharmaceutical industry has to adapt.

In short, collaboration is the key.