Since the start of the pandemic, America’s biopharmaceutical companies have worked around the clock to research, develop and manufacture treatments and vaccines to fight COVID-19. We’ve made unprecedented progress with having delivered over 12 billion vaccines globally with another 20 billion expected in 2022.
In a new resource released by PhRMA, here are some key lessons learned from the more than two years of dedicated efforts:
- Partnerships: Public-private partnership and collaboration can be applied to areas beyond the COVID-19 pandemic to ensure a strong supply chain, create efficient manufacturing processes and limit production bottlenecks, all with the ultimate goal of ensuring patients have access to the lifechanging medicines they need when they need it.
- Clinical trials and digital health: These efforts have provided the foundation for potential long-term changes to the clinical trial process that could lead to a more streamlined and accessible approach to developing new medicines. There is now greater experience with and broader acceptance of telemedicine and digital health tools, making remote clinical trials possible.
Further, the integration of cloud-based technologies as part of a comprehensive strategy for data modernization and regulatory processes is key to the FDA’s ability to support a move to a more virtual environment. A properly designed cloud-based system will increase the scalability and performance of the submission and “ingestion” process, while allowing for streamlined analysis and review due to the co-location of all FDA data on hand and potentially reducing security risks. It is critical to maintain momentum for the increased use of digital health technology tools in drug development. For instance, the Prescription Drug User Fee Act (PDUFA VII Goals Letter) includes proposals to advance the use of digital health technologies in decentralized clinical trials, as well as the use of RWD/RWE. The greater application of RWE in regulatory decision-making can ultimately lead to more timely access to innovative, safe and effective medicines for patients.
- Future pandemic preparedness: PhRMA and our members are committed to bolstering pandemic preparedness and health care resiliency to make sure American patients are stronger, healthier and better prepared for the next public health emergency. This is integral to American national security, the health of the American public and future economic stability and growth.
We support efforts to ensure that we are ready for future wide-reaching health threats, such as a superbug caused by drug-resistant bacteria. Data shows the COVID-19 pandemic has been exacerbating antimicrobial resistance (AMR). As more patients are hospitalized due to severe COVID-19 infections, often due to worsening respiratory symptoms requiring ventilation, an increasing number of patients have been acquiring secondary bacterial infections that require treatment with antibiotics — thereby worsening current levels of resistance.
To address this crisis, our industry has proactively created the AMR Action Fund, which aims to bring two to four new antimicrobials to market by 2030, focusing on innovative medicines that address the highest priority public health needs. This industry-driven effort is key, along with the importance of driving comprehensive policy reforms like the PASTEUR ACT, which would incentivize companies to develop new antimicrobial medicines by awarding a partially delinked subscription contract to highly novel candidates.
As we continue to fight COVID-19, it is important to catalog which innovations have been deployed or expanded upon during the global pandemic and the operational, technological and regulatory considerations that pose unique challenges to biopharmaceutical companies.
Additionally, it is important to evaluate the patient impact of these innovations to drive high quality, patient-centric clinical trials moving forward. Biopharmaceutical companies continue to work with stakeholders, including regulators, to assess the extent innovative approaches and durable learnings should be utilized routinely in medical product development in the future. The lessons we’ve learned over the past couple years will have positive implications lasting long beyond our fight with COVID-19.
Learn more about how the biopharmaceutical industry is leveraging lessons learned to meet patient health needs now and in the future.
Topics: Research and Development, PDUFA, Coronavirus, Antimicrobial Resistance