Outgrowing the Black Hole of Pharma
Pharma Tech Outlook

Outgrowing the Black Hole of Pharma

Pharma Tech Outlook | Thursday, August 11, 2022

Although technical improvements aid drug discovery and commercialization, clinical development is still a technological black hole in pharmaceuticals.

FREMONT, CA: Before a pharmaceutical business can begin commercialization, the two-step research and development (R&D) process of medication discovery and clinical development can take more than a decade and cost up to $2.8 billion.

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Investing time and resources is a high-risk, long-term plan. As a result, the pharmaceutical industry has an extra incentive to boost efficiency, as decreased time to market offers patients with quicker access to life-changing medications. Incorporating technology that improves profitability by increasing efficiencies is a widely accepted, industry-agnostic method for achieving this goal.

The pharmaceutical industry has streamlined R&D and marketing operations to balance profit and "doing good." As a result, pharma corporations have included innovation teams within their organizations and tasked them with identifying external innovations with the potential to boost productivity. In medication discovery and commercialization, the bookends of the pharmaceutical R&D process, there has been an influx of digital innovations introduced by health tech businesses. Artificial intelligence (AI) and machine learning (ML) technologies have prompted industry-altering advances in both industries.

Clinical development is a complex procedure including many interdependent tasks distributed across multiple cross-functional teams. It is challenging and demanding labor hampered by inefficient, archaic manual procedures. However, the inefficiency bottleneck persists in the pharmaceutical process's middle phase.

Clinical development aims to reduce the time between submitting an investigational new drug application and receiving regulatory approval; thus, why is it the technological black hole of the pharmaceutical industry?

Clinical Development: In clinical development, innovation lags due to numerous complicating issues. During the period of seven to eight years, patient risk is high, and funds are low. In addition, contrary to the prevalent belief that clinical trials are the exclusive activity of clinical development, this process incorporates many business units. More than twelve cross-functional teams, including clinical, medical, early commercial, regulatory, and managed care, work concurrently to accomplish hundreds of interdependent activities in preparation for the commercialization of the product and market.

Collaboration is complex since diverse teams frequently work in segregated contexts. Groups have duplicated work throughout the years, impeding progress and costing businesses significant resources. In addition, most of these cross-functional tasks necessary to get a medicine closer to commercialization rely on clinical data supported by empirical evidence. Few technological solutions address the intricate web of clinical development at present.

Existing clinical development technologies are often limited in scope and offer efficiencies for single functions. Only with comprehensive innovations will significant efficiencies be achieved. How can a system meet the requirements of cross-functional teams that rely on manual processes, various tools, and vendor outsourcing? How might technology contribute to the complex nature of medication development?

It begins by examining the two ends of the research and development process: drug discovery and commercialization.

Drug Discovery: Followed by arduous and repetitious assessments of millions of combinations of multimodal data points, the drug discovery step involves preclinical evaluations of therapeutic candidates. As the stage comprises large data sets, duplicated tasks, and lacks patient participation, the risk-to-benefit ratio is minimal, making it an ideal candidate for ML- and AI-based technologies. Thus, innovation dominates drug discovery. Simplistically, technologies replace time-consuming manual methods for exploring vast databases to uncover prospective compounds, new therapeutic targets, and repurposing current medications.

Without end, innovation is growing in medication discovery. Pharma corporations are signing multi-year contracts with AI-based discovery companies for millions of dollars. These wise investments are in response to a significant worldwide market predicted to be worth $53.3 billion in 2021 and projected to reach $80.2 billion by 2026.

Commercialization: Technological breakthroughs in the production, sales and marketing, and supply chain due to commercialization. The current wave of digital innovation emphasizes the consumerization of healthcare by targeting patients directly throughout their healthcare journey. In the first quarter of 2022, venture capitalists invested $357.6 million in 23 health and wellness technology transactions.

Innovations guide patients to awareness, diagnosis, treatment, or management of side effects and comorbidities by including a call to action inside user-friendly, convenient technologies. These patient-centric technologies require substantial investment because they address a market movement toward value-based and outcome-based healthcare models while addressing issues associated with limited revenue due to patent protection timeframes.

While drug discovery and commercialization benefit from technological advancements, clinical development remains a technological black hole. Individuals working across functions on clinical development teams need investment and expertise in holistic solutions that leverage data, improve collaboration, and simplify a nuanced process.

There are numerous reasons for the lack of innovation in the clinical development stage. Is it because of high patient risk or a dislike of change management? The list of objections is lengthy, but the reasons are unimportant. Accelerating equitable access to life-changing therapies should be the North Star that guides technological innovation away from the clinical development black hole.

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