Pharmaceutical and biotechnology companies face major changes this year if the BIOSECURE Act passes into law and are already taking steps to prepare. This bill seeks to mitigate biosecurity risks to the United States by limiting partnerships with specific foreign actors, such as those from China, Russia, North Korea, and Iran.

Although the Act does not penalize companies for working with the Chinese biotechnology service providers referenced in the legislation (BGI Genomics, MGI, Complete Genomics, and WuXi AppTec), it does restrict access to U.S. federal funds for companies connected to these organizations.

This controversial legislation will require the U.S. and European companies to re-think over this impact. So, what can we expect and what role does technology play in helping the industry anticipate the potentially broad-sweeping impact of this new legislation?
 

Transforming the Pharmaceutical Supply Chain 

The law protects impacted companies, like WuXi Apptec, until January 1, 2032, which means biotechnology companies have until then to loosen their ties with these entities and find new providers. WuXi and its subsidiaries hold a strong position in the CDMO market with 10.3% of the biologics market share worldwide. In addition, WuXi is deeply embedded in the global pharmaceutical supply chain, supporting the development and production of key therapeutics like Pfizer’s COVID-19 drug Paxlovid and Eli Lilly’s therapeutic terzepatide used to treat type 2 diabetes (Mounjaro) and obesity (Zepbound).

Pulling out of these long-term partnerships doesn’t happen overnight and can pose challenges as companies seek new partners that not only have the capacity to support their drug development and manufacturing needs but also the know-how and the technology. This restructuring of the global supply chain may lead to increased costs and potential delays for new therapies in development.
 

Adapting to the New Regulatory Landscape 

In addition to reshaping supply chain dynamics, the BIOSECURE Act will bring about more stringent data security and compliance oversight. The biopharmaceutical industry is especially susceptible to data breaches given its reliance on sensitive healthcare data, leading to more rigorous requirements for real-time data reporting.

Pharmaceutical companies will need to work with data management experts to adopt a robust digital infrastructure that ensures traceability and data integrity. Cybersecurity will also be top of mind as the industry implements measures to further protect data security across the entire pharmaceutical supply chain. This evolution of the regulatory landscape will drive industry-wide demand for novel compliance technologies and services, such as AI-powered solutions for data management, monitoring, and risk mitigation. 
 

Leveraging Technology to Mitigate Risk

Technology providers will play an integral role in helping businesses manage sensitive data and mitigate risk. Revvity Signals solutions, such as Signals Synergy for streamlining CRO collaboration, is well positioned to aid the biotechnology sector in its preparations for the eventual enactment of the BIOSECURE Act. Adopting a multimodal cloud software suite breaks down data siloes and accelerates drug discovery, an advantage for biotechnology companies seeking to reevaluate existing CRO (contract research organization) and CDMO (contract development and manufacturing organization) partnerships and engage in new ones. Researchers will benefit from:

1.    Improved efficiency and productivity: Signals Synergy streamlines data sharing and collaboration between teams, allowing for faster decision-making and increasing productivity. The platform speeds up the drug discovery process by simplifying project initiation, user onboarding, and security set-up, while simultaneously strengthening contractor and user administration.

2.    Enhanced data security and compliance: our software suite provides a secure and segregated environment for exchanging sensitive information with contractors. Signals Synergy employs robust security measures, including built-in masking of proprietary codes, properties, and material IDs, to restrict access and prevent unauthorized data leakage.

3.    Advanced analytics and insights: by automatically transforming multi-tabular CRO and CDMO reports into structured columnar data tables, the platform empowers scientists to leverage powerful analytics and visualization tools, such as those within the Signals Research Suite.

4.    Scalability and flexibility: as drug discovery scientists' needs change, the software scales and adapts, enabling quick data access, analysis, faster research, and better decisions.

5.    Collaboration and integration: Signals Synergy facilitates seamless collaboration between internal teams and external partners, such as contract research organizations (CROs). The platform uses scientifically driven Kanban-style project management tools to monitor collaborative progress, giving real-time visibility into project schedules and promoting agile workflows.

The BIOSECURE Act is guaranteed to shake up the industry in a big way if it becomes law, and drug makers will look to technology providers for guidance on best practices for data exchange between sponsors and CROs.  Our team of technology experts is here to facilitate secure and efficient data exchange with your outsourcing partners as you navigate this new legislation.  Learn how Signals Synergy, Signals Notebook, and Signals Research Suite can help you improve efficiency, enhance data security, promote collaboration, and accelerate drug discovery.