Why Is Boston's Biotech Industry Struggling?

 

China is tackling the "valley of death" in biotech by creating government-backed platforms, reforming regulations (like the MAH system and ICH adoption), providing massive financial incentives and subsidies (especially in Shanghai for AI and trials), fostering talent, and leveraging its cost and speed advantages in clinical trials to bridge the gap between research and commercialization, moving from "fast followers" to genuine innovation.

 

The MAH (Marketing Authorization Holder) system is a regulatory framework, common in pharmaceuticals and medical devices (like in the EU, US, Japan, and China), that separates the license to sell a product from the license to manufacture it, making the MAH legally responsible for the product's quality, safety, and efficacy throughout its lifecycle, even if they outsource production to a third-party manufacturer (CDMO). This system promotes innovation by allowing research entities to hold authorizations and streamlines market access by decoupling production from the authorization holder. It reduces barriers for innovative companies (like research institutes) by eliminating the need for them to build their own production facilities, speeding up market entry.

 

ICH (International Council for Harmonisation) guidelines provide global standards for biotech products, covering Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M) aspects, ensuring consistent quality, safety, and effectiveness for easier market access. Key guidelines for biotech focus on manufacturing consistency (Q series), toxicity testing (S series), clinical trial design (E series for novel biologics), stability testing (ICH Q5C for proteins/antibodies), and standardized submission formats (M series like the CTD), streamlining development and regulatory approval worldwide.

 

 

Key Strategies:

 

    Government-Backed Platforms: Establishing pilot testing platforms to connect labs with industry, using AI and IoT to industrialize research, reducing the hurdles to application.

    Regulatory Reforms:

        MAH System (Marketing Authorization Holder): Separating drug production from marketing rights, allowing innovation-focused firms to outsource manufacturing.

        ICH Adoption: Joining the International Council for Harmonisation (ICH) in 2017 to align with global standards, making Chinese drugs more acceptable internationally.

        Breakthrough Therapy Designation (BTD): Implementing programs to speed up approval for life-saving drugs.

    Financial & Infrastructure Support:

        Government Guidance Funds: Leading public investment in biomanufacturing.

        Subsidies & Tax Breaks: Offering significant funding for clinical trials (e.g., Shanghai), free land, and talent incentives.

        Infrastructure: Investing in labs and tech parks, like the Biomanufacturing Innovation Academy in Tianjin.

    Talent Development: Attracting talent through programs like the Thousand Talents Program and fostering industry-academia collaboration.

    Strategic Focus Areas: Prioritizing new chemical drugs, antibodies (ADCs, bispecifics), vaccines, personalized medicine, and medical AI.

 

Outcomes & Challenges:

 

    Speed & Cost Advantages: Faster and cheaper clinical trials attract global investment, accelerating drug development and deals.

    Shift to Innovation: Moving beyond generic "me-too" drugs towards novel therapies in oncology, immunology, and metabolic diseases, though concerns remain about true groundbreaking discovery versus replication.

 

    Global Competition: China's advancements challenge U.S. and European biotech, driving innovation but also raising national security and supply chain concerns.

 

By integrating supportive policies, regulatory alignment, and massive investment, China aims to bridge the "valley of death" and solidify its position as a global biotech powerhouse, focusing on efficient, large-scale development of high-value therapies.

 

Why is it difficult to compete with this? The letter below tries to explain:  

 

 

“Your report "Boston's Biotech Engine Is Sputtering" (U.S. News, Dec. 30) rightly notes that highly trained Ph.D.s are struggling to find work as Boston's biotech sector contracts. But the problem isn't an oversupply of scientists or a temporary venture-capital cycle. It's a deeper structural failure in how the country builds industries.

 

The U.S. excels at funding discovery and celebrating breakthroughs, then neglects the hard work of manufacturing them at scale.

 

When commercialization stalls, capital retreats, companies collapse and top talent is left without a place to apply its skills. We have seen this before in semiconductors, solar energy and nuclear power. Research leadership remained but manufacturing -- and economic strength -- moved elsewhere.

 

Biotechnology faces the same risk. The real bottleneck isn't the lab; it is the lack of domestic biomanufacturing capacity to carry innovations across the "valley of death" from proof-of-concept to commercial reality. That gap is where today's job losses are felt most acutely.

 

Biotechnology's strongest case isn't ideological or aspirational. It is practical. Modern fermentation enables more reliable medicines, higher-performance materials and more secure supply chains. These advantages already exist, but without shared-scale facilities and de-risked first-of-a-kind plants, they can't support sustained employment.

 

If the U.S. wants biotechnology to remain an engine of growth, it needs to treat biomanufacturing as essential infrastructure. Otherwise, we will keep training world-class scientists for jobs that no longer exist here.

 

Mark Warner

 

Liberation Bioindustries” [1]

 

1. Why Is Boston's Biotech Industry Struggling? Wall Street Journal, Eastern edition; New York, N.Y.. 10 Jan 2026: A12.