Moving Closer to Dynamic Drug Development through Automated Solutions

Modernization, collaboration, and innovation are some of the most important concepts in the drug development sector due to how increasingly complex the therapeutic landscape is becoming. Despite high levels of investment being poured into the biopharma industry each year, many challenges that arise from the use of traditional models and processes still exist within drug development. For example, the emergence of artificial intelligence (AI) can find potential new molecules a thousand times faster than existing models, yet patients are not able to access the benefits because of bottlenecks in the development process, such as project management and collecting data (1).

However, hope is on the horizon as novel solutions and improvements aimed at benefitting the drug development process with the right framework are coming to the fore. Focusing on the patient, digital and technology enablement, and advanced analytics are a few ways that research and development have been given a kickstart in transforming traditional approaches; although, this is just the beginning of a long journey toward a more dynamic, beneficial drug development process (2).

According to Robert King, executive director of functional service partnership (FSP) solutions, PPD clinical research business, Thermo Fisher Scientific, there are solutions on the horizon that will help overcome the current bottlenecks and other challenges that are occurring in early drug development, which also have the potential to increase performance levels at an astounding rate.

Bottlenecks in early drug development

PharmTech: Are there any specific hurdles/bottlenecks that pertain to early drug development processes that you could pinpoint?

King (PPD): The increasing number of investigational medicines entering clinical development is driving greater demand for qualified clinical site researchers. As a result, clinical trial sites are now struggling to hire, train, and retain staff, leading to study bottlenecks that are causing significant delays. This delay in delivering clinical trials is likely to continue with clinical research positions expected to show year-over-year growth of more than 10% over the next five years.

Overcoming hurdles in the pipeline

PharmTech: What potential solutions are available/in the pipeline that are helping drug developers to overcome these hurdles?

King (PPD): Lack of staffing availability at the site level is an area of tremendous need and is becoming a rate-limiting factor with some clinical research sites that are accepting new studies and/or executing current studies. Our new site support solution has been developed and deployed to help ease site burden and assist our customers with the tasks associated with study conduct at sites. With both patient-facing and non-patient-facing support available, we can deploy qualified resources to assist with items such as patient visits, consent process, data entry, chart abstraction, startup preparation, and other study coordinator tasks.

AI to advance processes

PharmTech: Automated solutions, such as artificial intelligence, are being widely employed in multiple industries to advance processes and improve efficiencies. Can you explain the value of implementing such technologies into biopharmaceutical drug development?

King (PPD): The introduction of automated solutions such as robotic process automation, artificial intelligence, and machine learning expected to streamline and/or remove expensive, inefficient, and unreliable manual steps. Within clinical data management (CDM) for full-service and functional service provider (FSP) engagements, examples of implementing these technologies are automated clean patient tracking, automated loading of third-party data, and human in the loop smart data querying. This combination of human and machine intelligence means that in the not-too-distant future, CDM operating models will include human managers working with virtual managers to deliver performance levels that currently aren’t achievable.

The future of drug development

PharmTech: Are there any particular approaches, solutions, or technologies that are enabling drug developers to function in a more agile and flexible way? Is there anything that might be introduced in the near future that could provide a paradigm shift within this area perhaps?

King (PPD): Since the advent of COVID-19, the demand for clinical development expertise has significantly exceeded capacity, which has caused sponsors to look to CROs [clinical research organizations] to provide resources where they are unable to obtain them in time or at the appropriate talent level required to meet their project needs. In turn, that situation is driving an acceleration in the growth of the hybrid outsourcing model, where full-service engagements are being augmented with FSP models that help sponsors access additional expertise and resources. Through that approach, CROs can provide the flexibility and nimbleness needed to fill key client capability and resource gaps to ensure the delivery of both internally and externally sourced project goals.

References

1. Conroy, D. Accelerating Drug Development to Keep Pace with Drug Discovery. Forbes Technology Council, Council Post, Mar. 10, 2023. https://www.forbes.com/sites/forbestechcouncil/2023/03/10/accelerating-drug-development-to-keep-pace-with-drug-discovery/?sh=4ca1be21a5da
2. Agrawal, G.; Keane H.; Prabhakaran, M.; Steinmann, M. The Pursuit of Excellence in New-Drug Development. McKinsey & Company, Article, Nov. 1, 2019. https://www.mckinsey.com/industries/life-sciences/our-insights/the-pursuit-of-excellence-in-new-drug-development