Report: R&D Trends in the Pharma and Biotech Industry

Since the pandemic, drug developers have experienced countless disruptions in the clinical trial process. Adoption of new innovations, strategies and technologies offers opportunities to meet these challenges head on and shift approaches going forward.

The PPD clinical research business of Thermo Fisher Scientific surveyed more than 150 drug developers around the globe in spring 2022 to gather insights on trends in pharmaceuticals research and development. Check out the full R&D trends report.

The findings reflect a shifting industry landscape amid the after-effects of the pandemic, growing importance of patient diversity and increasing complexity of trials.

Respondents emphasized the challenges, opportunities and innovations they are pursuing, as well as the related impact of the COVID-19 pandemic over the past two years.

Key Takeaways on Trends and Opportunities in Pharmaceuticals Research and Development

Drug Development

• Survey participants reported slower drug development timelines since the pandemic, along with challenges in patient recruitment and increasing complexity of clinical trials.
• Participants noted several areas of opportunity, including greater use of real-world data (RWD)/real-world evidence (RWE) to complement data from clinical trials and the ability to leverage new drug development technologies and solutions, like decentralized trials.

Decentralized Trials

• Respondents involved with digital and decentralized clinical trials in their organizations shared that there has been an uptick over the past year, and they expect an increase over the next two years.
• Respondents not currently involved with decentralization reported that they expect their organizations to employ this strategy in a quarter of their clinical trials by 2024.

Outsourcing

• Full-service, trial by trial models account for the highest proportion of participants’ outsourced clinical development work, followed by hybrid full-service/functional service partnership (FSP) and in-house models, almost evenly matched.
• Participants also reported clinical laboratory diagnostic services, data management, clinical trial management and biostatistical analyses as the most likely outsourced activities.

The Pandemic: How COVID-19 Disrupted and Created Opportunities for Clinical Trial Sponsors

Over the past few years, there have been incredible shifts within the clinical trials space.

The COVID-19 pandemic created a disruption, which quickly led to opportunities. Pharmaceutical and biotechnology organizations continue to build on these opportunities, looking for ways to accelerate the clinical trial process and improve the patient experience by increasing remote trial activities and lessening the burden on patients. It is safe to say that COVID-19 has underscored the importance of virtualization and decentralization in clinical trials.

Overwhelmingly, survey participants’ responses aligned with the following trends:

• In terms of the need to improve clinical trial speed, nearly half (48%) of survey participants reported that the average timeline to produce a drug moves more slowly than it did two years ago.
• In finding ways to increase speed to market, 49% of respondents said that their organizations are currently identifying areas for process improvements.
• In embracing decentralized trials, 51% of respondents shared that the COVID-19 pandemic has encouraged them to decentralize trials or work with partners that can do so.

There is a widespread belief that these shifts will become permanent and standard operating practice well after the pandemic. As such, clinical trial sponsors are embracing both current solutions (including implementing decentralized approaches, developing guidance to drive greater inclusion and using digital platforms for improved tracking), as well as employing new innovations, strategies and technologies from big data to adaptive trial designs.

Today’s Hurdles for Drug Developers: Patient Recruitment and Increased Clinical Trial Complexity Remain the Biggest Challenges

Drug developers share a common sentiment: Recruiting the planned sample size within a defined time frame remains “the chief bottleneck in the drug development process.”

Survey respondents shared two of their biggest organizational pain points that underscore this concern. The first is challenges with patient recruitment in clinical trials, particularly patient retention and patient population diversity (55% of respondents). Clinical trial populations historically were almost exclusively comprised of white male participants, which exacerbates gaps in knowledge of diseases and conditions, preventive factors, and treatment effectiveness.

The second biggest challenge is the increased complexity of clinical trials (51% of respondents). Clinical trials are getting more complex, especially oncology trials, the fastest growing area of drug development, resulting in more new product approvals. For example, the total number of investigational treatments targeting cancer nearly quadrupled over the past two decades (2000-2020), from 421 to 1,489. Phase II and Phase III oncology trials typically require more investigative sites and countries in comparison to other phase trials for drugs. Overall, since 2013, the total number of trial objectives, endpoints and eligibility criteria has grown across all clinical trial phases.

New Horizons: Real-World Data, Real-World Evidence and New Technologies Offer Greatest Areas of Opportunity

Survey participants conveyed that the greatest opportunity areas in drug development in clinical trials include greater use of real-world data (RWD) and real-world evidence (RWE) to complement data from clinical trials (45% of respondents) and leveraging new technologies in drug development (44% of respondents).

RWD and RWE

There has been an increased need for RWD and RWE regarding a product’s safety, effectiveness and value. Each is necessary to achieve successful market access and product uptake. Robust early development clinical trial programs rely on real-world evidence of benefits and risks.

PPD’s team of experts includes researchers who design and lead the execution of studies to meet payer and regulator evidence requirements through diverse scientific methods and high-quality project and data management expertise.

RWD and RWE can also help solve the challenge of patient diversity in clinical trials. RWD and RWE analysis can provide information on trial site locations where diversity is higher, and when combined with decentralized trials, together they can dramatically improve the representativeness of patient populations.

New technologies in drug development

The emergence of COVID-19 emphasized the need for developers to identify areas for process improvements to increase speed to market. New technologies offer opportunities for areas of improvement.

As an example, the pandemic highlighted the need for vaccines that could:

• Safely protect from severe disease while reducing infection rates in vaccinated populations.
• Elicit long-term memory immune responses.
• Offer the potential for quick and lower-cost manufacturing in extremely large quantities.
• Provide global accessibility.

mRNA vaccines quickly surged to the forefront of COVID-19 vaccine candidates. Using and implementing new technologies, like messenger ribonucleic acid (mRNA) vaccines in drug development, can both accelerate development timelines and reduce costs, as well as improve the quality of clinical data.

Drug discovery platforms, particularly those that apply artificial intelligence (AI) techniques, also offer an opportunity to hasten the drug development process. Through these platforms, developers can identify optimal drug candidates in record time. The wide variety of AI applications currently utilized can help solve the challenge of costly and timely new drug development. Pharmaceutical research companies recognize the potential cost and time savings and the increased overall drug efficacy. As a result, they are building in-house AI teams or are partnering with companies that deliver these capabilities.

Drug Developers Should Continue to Implement Solutions That Provide Them with a Competitive Edge

Although the COVID-19 pandemic created various disruptions, drug developers have adjusted and tackled some of their biggest challenges by embracing new innovations, strategies and technologies. As the industry continues to shift, developers would be wise to remain nimble and continue implementing solutions that provide them with a competitive edge.