Strategies to Accelerate Clinical Research During a Public Health Emergency
Learn strategies to de-risk your clinical pipeline and preserve the development of your assets during a pandemic.
The unprecedented disruptions brought on by the COVID-19 pandemic underscored the global need to establish proactive response policies to minimize the social and economic burden of a future pandemic.
Governing bodies and agencies — including the World Health Organization, the U.S. Department of Health and Human Services, the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, and the European Commission — have implemented pandemic preparedness action plans outlining processes for increased surveillance to protect supply chains and manufacturing.
Just as public health leaders have outlined plans to address gaps during a future global health emergency, pharmaceutical developers must also be prepared to meet potential challenges.
Key Factors to Consider When Choosing a Clinical Research Partner in a Public Health Emergency
During a pandemic or other public health emergency, a dedicated clinical partner that is strategic and forward-looking in its approach and has a track record of working with compressed timelines in a high-stress and rapidly changing environment will be key to success.
Here are three critical factors to consider when choosing a clinical research organization (CRO) in a pandemic scenario:
1. Regulatory affairs expertise: A global network of experts is vital to navigating a rapidly evolving regulatory landscape during a public health crisis. To maintain study continuity, the right CRO partner will quickly gather, maintain and apply regulatory intelligence on the evolving situation, including:
- Emergency measures
- Site restrictions
- Use of digital technologies
- Regulatory contact restrictions
- Safety reporting
2. Digital tools and decentralized trial strategies: A public health emergency can lead to a rapidly evolving clinical landscape, requiring flexibility in protocol design, collection of study data, monitoring strategies and participant follow-up plans. Look for a CRO partner that proactively implements a forward-thinking approach to using technology and decentralized solutions in trial design and implementation.
3. Manufacturing and CMC management: A single partner with extensive experience in bioprocess and pharmaceutical manufacturing under GMP and deep CMC consulting knowledge will ease the regulatory and logistical burden in drug discovery and development from a manufacturing and distribution perspective. The right CRO partner will not only manage the clinical study but also manufacture the pharmaceutical product, streamlining the entire process.
A Proven Pandemic Preparedness and Rapid Response Delivery Model
Bringing medical countermeasures to market is challenging and complex in the middle of a rapidly evolving public health emergency. The key to effectively and quickly developing a clinical pipeline in a high-stakes environment is choosing an experienced CRO partner with an established pandemic preparedness and rapid response delivery model and internal execution plan. A successful plan will compile processes from lessons learned and can be implemented quickly for emergency use authorization (EUA)-eligible drug candidates, rapidly moving these assets through development to market access.
During the COVID-19 pandemic, PPD managed over 240 clinical studies for sponsors looking to develop medical countermeasures against COVID-19 (SARS-CoV-2) and established a track record for offering the highest quality vaccine trial execution in the industry. Incorporating lessons learned while managing EUA products and recognizing the benefit of having critical processes firmly in place during a public health emergency, PPD gathered a cross-functional group of experts and developed a pandemic preparedness and rapid response delivery model and enterprise-wide action plan. This transformative guidebook is an operating model with clearly defined policies and standardized protocols to ensure decreased roadblocks, a streamlined drug discovery and development process, and rapid study execution, even amid a public health emergency.
Proven Clinical Research Expertise in a Pandemic
PPD arose as a global leader during the COVID-19 pandemic and was recognized by Citeline as “Clinical Research Team of the Year” for a partnership with Moderna for the development of Spikevax, a novel mRNA-based COVID-19 vaccine. In addition, PPD was awarded the prestigious Vaccine Industry Excellence (ViE) Award for “Best Vaccine CRO” in both 2021 and 2022.
- The regulatory affairs team at PPD has developed an accurate and vast network for acquiring global regulatory intelligence. Data from this network feeds our in-house, proprietary regulatory intelligence platform, which is queried to ensure study continuity even in a rapidly evolving regulatory environment.
- From a digital and decentralized perspective, PPD has invested in remote tools to assess digital endpoints, remote data capture and flexible points of care, and can consult on regulatory and other overall considerations for digital and decentralized solutions.
- Manufacturing and CMC expertise from Thermo Fisher Scientific allows for streamlined manufacturing processes, rapid development of analytics and quality controls, proactive capacity management, and accurate resource and supply chain projection and management, as well as regulatory/CMC consulting from an experienced team of experts.
Implementing a proactive and streamlined approach to producing medical countermeasures will allow for a more effective response to forthcoming public health emergencies. This forward-thinking approach to the preservation of public health will be vital in addressing a future pandemic.