BIOSECURE Act: Implications for US-based drug developers

Regulatory-blog-image_100x100.jpgThis blog is part of The Regulatory Navigator series, where we explore the evolving regulatory landscape with actionable insight from Parexel's experts, sharing their experience to maximize success for clinical development and patient access.


For biotech companies who partner with providers throughout their drug development, the BIOSECURE Act may have a significant impact. In this blog, we provide an overview of the proposed legislation and outline ways that US-based developers – particularly those working on newer modalities such as cell and gene therapies – can mitigate associated risks.  

Federally funded medical providers may face restrictions in collaborating with foreign biotech “companies of concern” through the introduction of the BIOSECURE Act1 in the US House of Representatives. The bill, proposed by the US House Select Committee on Strategic Competition, outlines prohibition on contracting with certain biotechnology providers (section 3 of the current version of the bill) and includes provisions that may restrict:  

  • Procuring or obtaining any biotechnology equipment or service produced or provided by a biotechnology company of concern; or  
  • Entering into a contract or extending or renewing a contract with any entity that 
    • Uses biotechnology equipment or services produced or provided by a biotechnology company of concern.  
    • Enters any contract the performance of which will require the direct use of biotechnology equipment, or services produced or provided by a biotechnology company of concern.  

Like all legislation undergoing the drafting process, the above language is likely to change after moving to the US Senate. For example, many legislative commentators believe that it makes sense to grandfather in existing contracts with “companies of concern”, so that the new legislation may apply only to future cases of collaboration. Additional considerations from stakeholders will likely also shape the legislation.  Recently, the Biotechnology Industry Organization (BIO) has asserted that it is taking "important steps" to support U.S. national security, including supporting the BIOSECURE Act.2  

While the bill has several stages to pass, its existence and key stakeholder endorsement raise business risks that US-based drug developers should be aware of.  

Defining biotechnology companies of concern 

A “biotechnology company of concern” is headquartered in or subject to the jurisdiction of a foreign government and poses a threat to national security.1 Consequently, the companies impacted by the bill include contract development and manufacturing organizations (CDMOs) that work with biotech and biopharma companies to provide manufacturing, testing and supply chain support at various stages of biotherapeutics’ development. Within the CDMO industry, there are several local and foreign organizations contracted by US-based companies.   

Risks for US-based drug developers 

For many US-based companies, relying on any CDMO identified as a “company of concern” by the BIOSECURE Act could mean a complete derailment of their drug development plans, especially since the proposed bill prohibits the use of services as well as equipment. As a theoretical example, a US-based company that contracts with a “CDMO of concern” for the supply of clinical trial material (CTM) for their first-in-human trial (FIH) could face delays in the initiation of clinical development due to capacity, raw materials, and equipment constraints. 

Those biotech companies developing newer drug modalities with stringent timelines, such as cell and gene therapies (CGTs), may need to rapidly pivot on their chemistry, manufacturing, and controls (CMC), non-clinical, and clinical plans. Often, these developers heavily depend on external partners due to the typical transition of early CGT development from academia to start-up biotech companies. Limited funding and resources can often preclude the establishment of in-house labs and manufacturing facilities, leading to a reliance on CDMOs.  

Biotech companies can develop effective CMC strategies to mitigate development and supply chain risk, including those associated with working with external partners who may be impacted by the pending BIOSECURE Act.  

The two main attributes of a risk-tolerant CMC strategy are:  

  • Robust contingency plans, including selecting and working with more than one CDMO and/or clinical research organization (CRO) to support the pipeline.  
    • This not only helps de-risk the advancement of one program but can also be an effective strategy to advance the pipeline. For example, the risk of capacity or supply chain issues could be minimized if more than one CDMO is engaged to advance a program from preclinical to clinical stages. Also, a CDMO site may fail a regulatory inspection, causing delays and/or raising some red flags.  
  • Phase-appropriate CMC development and alignment with regulatory guidance. 
    • Since costs and resource requirements for early CMC activities for CGT can be higher than those for biotherapeutics, it is prudent to align activities with regulatory guidance, e.g., method validation can be initiated and finalized after the completion of phase 1 clinical development since CTM used for phase 1 studies is not expected to be released and characterized using validated methods.  
Working with partners to mitigate risk  

With the introduction of “companies of concern” through the BIOSECURE Act, we have identified approaches to manage biotech companies’ risk, specifically as relates to CMC processes. Risk can further be mitigated through identifying the right regulatory consulting partner who can support the increased oversight required to ensure compliance with the Act – and we urge developers to start to prepare now.  

Activities to consider include: 

  • CDMO selection through informed capability assessments and audits – select the most appropriate CDMOs and CROs based on product profile, matching with the right manufacturing and testing partner(s). Parexel SMEs can also facilitate RFP authoring and review, offer in-depth CDMO capability assessments and lead audits. 
  • Supply chain strategy evaluation
  • Review of tech transfer documents and development reports for process and analytical development. 
  • Alignment of CMC strategy with evolving regulatory guidance, including authoring and reviewing dossiers for all stages of development, from pre-IND to BLA. 
  • Phase-appropriate CMC development planning

To discuss how your drug development plans could be impacted by this potential new legislation and explore strategies for risk mitigation, please get in touch. Parexel Regulatory Strategy’s CMC experts are always available for a conversation.   





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