Surviving BIOSECURE: US companies must prepare to avoid disruption

The BIOSECURE Act was introduced to the US House of Representatives after the government found that certain Chinese companies had engaged in unethical actions, including international property (IP) theft and unauthorized data collection. The Act passed through the house last month, and if it also succeeds through the Senate and is signed into law by President Joe Biden, it will restrict named Chinese biopharmaceutical companies – including WuXi AppTec and WuXi Biologics – from doing business in the US.

Although the BIOSECURE Act aims to protect American interests and has garnered bipartisan political support, it is not without controversy. Experts have expressed wariness about the impending burden on the biomanufacturing supply chain with the passage of BIOSECURE, calling for more discussions and a common-sense approach to the issue.

Josh Carpenter, CEO of Southern Research, a nonprofit full-service contract research organization (CRO), is a proponent of the Act. He spoke with BioProcess Insider about how companies can best prepare for its passage. His company, Southern Research, was founded in 1941, and it specializes in drug discovery and development, having discovered 20 drugs during its history, including seven for oncology.

Carpenter identified areas in which BIOSECURE changes the biopharmaceutical landscape in the US. Although he acknowledged the value in gathering human genomic data, he denounced the methods used by organizations such as the Beijing Genomics Institute (BGI), which the US government has accused of harvesting from millions of pregnant women around the world without consent. Carpenter said passage of the Act will encourage appropriate procurement of such data. He said that companies must gather data “in a way that is ethically sound and that assists the patient before it is used in research.”

Southern Research is one of several organizations addressing that need, in its case by using its own Catalyst platform, which enables the creation of a clinical genomic database using clinical record data that in turn assists drug discovery. The Catalyst program has secured $25 million in funding from state and local governments and aims to sequence about 40,000 people initially, with plans to expand to at least 80,000 by 2030.

Companies must also consider how they will develop and manufacture drugs in light of the upcoming changes, which will come into effect in 2032 if BIOSECURE becomes law. 

“COVID made clear that we rely on a number of outsourced providers to provide key aspects of our drugs, whether it’s active pharmaceutical ingredients, or synthesis of various types of drugs,” Carpenter said, adding that several organizations are making strides to meet those needs. “I believe there are places throughout the country that have the capability to deliver and fill the gap once WuXi Biologics and others are removed from the development list.”

He cited organizations across the midwestern US, including Heartland BioWorks in Indiana as some that are preparing for BIOSECURE’s passage.  

But for American companies to weather the manufacturing and supply chain challenges to come, the government must be on board. “We think that the US government needs to continue to invest in places and institutions that can backfill this gap that will be created once BIOSECURE is here,” Carpenter said.

Some initiatives already are in place to enable such strides. The CHIPS and Science Act of 2022 created the regional tech hubs program, allocating a potential $10 billion to technology hubs in specific sectors, including life science. However, according to Carpenter, only $500 million of that money has been fully allocated so far.

Furthermore, companies can seek opportunities through programs such as the Advanced Research Projects Agency for Health (ARPA-H), which Carpenter said enables the government to “take big bets that could stabilize not just supply chains but also lead to healthcare breakthroughs, not just in America but elsewhere.”