Pharmaceutical companies invest considerable time and resources moving drugs through discovery and clinical development (collectively known as R&D) and into commercialization. To balance profitability while bringing life-saving therapies to patients faster, pharma has prioritized the adoption of cutting-edge technologies in the “bookend” phases of drug discovery and commercialization.
In the past 10 years, these bookends have seen a flood of innovation primarily led by artificial intelligence and machine-learning-based solutions. Yet pharma’s extraordinarily complex middle phase—clinical development—remains a veritable technological black hole. I believe innovation hesitancy and organizational inertia are among the conditions preventing technology adoption in clinical development.
INNOVATING CLINICAL DEVELOPMENT
Pharma has experienced tremendous growth in the past 20 years. The total global pharmaceutical market was valued at $1.42 trillion in 2021, up from $390 billion in 2001—progress prevailed despite inefficient manual legacy methods, heavy reliance on vendors, and costly single-use technology solutions within clinical development. Yet, it is undeniable that many patients still have unmet medical needs across a variety of diseases, and the need for life-changing scientific advancements 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 roughly 400,000-680,000 person-hours annually or 200-325 people to complete the current workload. Further resources are required to develop additional drugs, investigate 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 the costs of drug development 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 timeline and reduce costs between investigational new drug application and regulatory approval.
WHERE DO TECHNOLOGICAL OPPORTUNITIES FOR EFFICIENCIES RESIDE?
In clinical development, twelve cross-functional business units work to complete more than 300 critical, interdependent tasks. Currently, most programs are built around spreadsheets, calendar reminders, and manual data analytics to complete tremendous volumes of work. Manual processes contain a bottleneck of inefficiencies. Clinical development is ripe for innovation.
Current technological solutions bring some efficiency by addressing single 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 cross-functional team efforts 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-item wish list:
SHIFT THE “RIGHT” WORK FROM HUMANS TO TECHNOLOGY
Technology has taken a backseat to human expertise in patient-centric clinical development, and I believe this is largely due to lack of trust in technologies while drugs are tested on patients. Although clinical trials remain the most meaningful task of drug development, trials represent only a portion of the cross-functional workload. The complicated and interdependent web of drug development is laden with redundant tasks and analytical needs from large data sets. While technology excels with this type of work, many tasks remain manual processes.
I believe pharma’s innovation hesitancy can also be attributed to the complicated and intense workflow involved. Additional skepticism of technology resulted when highly touted innovations by tech giants garnished high budgets but failed to deliver.
INCREASE COLLABORATION ACROSS SILOS AND DISPARATE ACCOUNTABILITY
It is common for good-intentioned drug development teams to unknowingly duplicate efforts. It is the nature of the industry where communication is limited among siloed cross-functional teams. Yet redundancies slow progress and cost pharma valuable time and resources.
This “silo effect” can be traced to the early 2000s when industry organizations such as PhRMA issued guidance for responsible disclosure, transparency, and data sharing. To follow best practices, the pendulum swung to overly conservative, and unity waned among cross-functional pharma teams.
Often, no particular group or person is responsible for overseeing the entire cross-functional process that moves a drug candidate into the market. So, it should be no surprise clinical development lacks a singular holistic technology solution.
REMOVE THE STATUS QUO AND EMBRACE CHANGE
Perhaps the greatest challenge to clinical development’s innovation lag involves pharma’s willingness to change the status quo and embrace validated technology partnerships.
For true innovation to occur, pharma’s corporate culture should change. Individual functions within development teams that operate under their own business processes, systems, and goals should become flexible, collaborative, and embrace new methods. Likewise, technology solutions should help pharma overcome institutional inertia and address misaligned business processes.
Following the rapid development of COVID treatments, healthtech and pharma innovators can no longer justify the status quo. Coordinated efforts, sharing of science, and deep pressure of a global pandemic forced pharma to embrace efficiencies and build solutions faster. The benefits of this efficiency resulted in viable, swift progress within drug development. It was a watershed moment for pharma, proving collaboration and technology can speed drug development.
Pharma should capture the essence of this viable efficiency and build technologies that replicate this process across all diseases. All patients who suffer from 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 both patients and the industry are paramount.
BUILD ALLIANCES BETWEEN PHARMA AND TECH
I believe the successful implementation of meaningful technologies in clinical development requires an alliance between healthtech and pharma. To build a successful alliance, healthtech innovators should be steeped in pharmaceutical knowledge, experience, and expertise and implement a pharma-first/tech-second approach. Pharma should reciprocate with a willingness to adopt the change management needed to modernize outdated legacy processes. These two factors are essential for tech and pharma to solve critical process issues that accelerate drug development.
It can be done! The global pandemic offered a real-time case study into the seismic shift that took place in clinical development’s workflow. Adopting these effective and forward-thinking processes starts with a comprehensive technology that can unite clinical development teams and create a path out of pharma’s technology black hole.
Donna Conroy, M.S. is the Co-Founder/CEO of SciMar ONE, Inc.