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Transforming Clinical Drug Development: Pharma’s Four Element Technology

Pharmaceutical companies invest considerable time and resources to move drugs through discovery and clinical development (collectively referred to as R&D) and commercialization. To balance cost-effectiveness while bringing life-saving therapies to patients faster, the pharmaceutical industry has prioritized the adoption of cutting-edge technologies in the “end-of-the-book” phases of drug discovery and commercialization.

Over the past 10 years, these bookends have seen a flood of innovation primarily driven by artificial intelligence and machine learning-based solutions. Yet the extraordinarily complex middle phase of pharma, clinical development, remains a veritable technological black hole. I believe that reluctance to innovate and organizational inertia are among the conditions preventing the adoption of technology in clinical development.

INNOVATIVE CLINICAL DEVELOPMENT

Pharma has experienced phenomenal growth over the past 20 years. The total global pharmaceutical market was valued at $1.42 trillion in 2021, up from $390 billion in 2001. Progress has prevailed despite inefficient manual methods, heavy reliance on vendors, and consumer-grade technology solutions. uniquely expensive in clinical development. Yet it is undeniable that many patients still have unmet medical needs for various diseases, and the need for life-changing scientific advances remains.

R&D budgets typically represent 15% to 25% of a pharmaceutical company’s annual revenue, or approximately $215 billion to $355 billion. This equates to approximately 400,000 to 680,000 man-hours per year or 200 to 325 people to complete the current workload. Additional resources are needed to develop additional drugs, study new indications, or study more patients to increase health equity.

How can the pharmaceutical industry use technology during clinical drug development to align profitability with “doing good”?

One method is to reduce drug development costs to reallocate resources; another is to increase profitability by accelerating drug candidates to market.

Optimally, I believe the goals during the seven- to eight-year clinical development phase are for a technology to achieve both methods: shorten the time and reduce the cost from investigational new drug application to approval. regulatory.

WHERE ARE THE TECHNOLOGICAL OPPORTUNITIES FOR EFFICIENCY?

In clinical development, twelve cross-functional business units work to accomplish more than 300 critical and interdependent tasks. Currently, most programs are built around spreadsheets, calendar reminders, and manual data analysis to perform huge volumes of work. Manual processes contain a bottleneck of inefficiencies. Clinical development is ripe for innovation.

Today’s technology solutions provide efficiencies by addressing unique challenges within the process. To date, no comprehensive solution has been adopted to address the complex web of clinical development. Such technology could help streamline the efforts of cross-functional teams and save valuable time and resources.

To truly transform clinical drug development, I believe it is essential to integrate comprehensive technology that incorporates the following four-point wish list:

TRANSFERRING THE “GOOD” WORK FROM HUMANS TO TECHNOLOGY

Technology has taken over from human expertise in patient-centered clinical development, and I believe this is largely due to the lack of trust in technologies as drugs are tested on patients. Although clinical trials remain the most significant task in drug development, trials represent only a part of the cross-functional workload. The complex and interdependent network of drug development is loaded with redundant tasks and analytical needs from large datasets. Although technology excels at this type of work, many tasks remain manual processes.

I think the pharmaceutical industry’s reluctance to innovate can also be attributed to the complicated and intense workflow involved. Further skepticism of technology has arisen when highly touted innovations by tech giants filled high budgets but fell short.

INCREASE COLLABORATION ACROSS SILOS AND DIFFERENT ACCOUNTABILITY

It is common for well-meaning drug development teams to unknowingly duplicate their efforts. It’s the nature of the industry where communication is limited between siled cross-functional teams. Yet layoffs are slowing progress and costing the pharmaceutical industry valuable time and resources.

This “silo effect” dates back to the early 2000s, when industry organizations such as the PhRMA issued guidelines on responsible disclosure, transparency, and data sharing. To follow best practices, the pendulum became too conservative and unity faded among cross-functional pharmaceutical teams.

Often, no single group or individual is responsible for overseeing the entire cross-functional process that brings a drug candidate to market. It is therefore not surprising that clinical development lacks a single holistic technological solution.

REMOVE THE STATUS QUO AND ACCEPT CHANGE

Perhaps the biggest challenge to the clinical development innovation lag involves the pharmaceutical industry’s willingness to change the status quo and embrace validated technology partnerships.

For true innovation to occur, the corporate culture of the pharmaceutical industry must change. Individual functions within development teams that operate according to their own processes, systems, and business goals must become flexible, collaborative, and embrace new ways. Likewise, technology solutions should help the pharmaceutical industry overcome institutional inertia and resolve misaligned business processes.

Following the rapid development of COVID treatments, healthcare and pharmaceutical technology innovators can no longer justify the status quo. Coordinated efforts, shared science, and the deep pressure of a global pandemic have forced the pharmaceutical industry to embrace efficiencies and create solutions faster. The benefits of this efficiency have translated into viable and rapid advances in drug development. It was a watershed moment for the pharmaceutical industry, proving collaboration and technology box accelerate drug development.

Pharmacy should capture the essence of this viable efficiency and create technologies that replicate this process in all diseases. All patients with unmet medical needs deserve the same urgent call to action as those in the global pandemic. Change will take time, but I believe the benefits to patients and industry are paramount.

BUILDING ALLIANCES BETWEEN PHARMA AND TECH

I believe that the successful implementation of meaningful technologies in clinical development requires an alliance between health technology and pharmacy. To build a successful alliance, health technology innovators must be steeped in pharmaceutical knowledge, experience and expertise and implement a pharma-first/tech-second approach. Pharma should return the favor with a willingness to embrace the change management needed to modernize outdated legacy processes. These two factors are essential for technology and pharmacy to solve critical process problems that accelerate drug development.

It can be done! The global pandemic has offered a real-time case study of the seismic shift that has taken place in the clinical development workflow. Adopting these efficient, forward-thinking processes starts with a comprehensive technology that can unite clinical development teams and create a pathway out of the technological black hole of the pharmaceutical industry.


Donna Conroy, MS is the co-founder/CEO of SciMar ONE, Inc.