Dr. Jim Li, President of CMC Solutions at BioDuro recently had the pleasure to sit down with the Pharma Source team to discuss how we build strategic partnerships through our integrated CRDMO Services. Please enjoy this podcast!
“Our goal is to be more than a service provider. We aim to be a strategic partner that grows with our clients from bench to bedside.” – Dr. Jim Li
Dr. Jim Li, brings extensive experience as a chemist and pharmaceutical industry veteran, having held leadership positions at global companies including Pfizer and Henkel before joining BioDuro to build up and manage the company’s CMC business.
In this podcast episode, Jim explains how our integrated CRDMO model creates higher value outcomes for clients while balancing cost considerations with speed to market.
Differentiation in the CDMO Landscape
BioDuro sets itself apart from typical CDMOs by offering fully integrated services spanning the entire drug development lifecycle. As a US-owned company with global operations, they leverage their unique structure to provide clients with efficiency, speed and flexibility.
“We offer full services from drug discovery to development all the way to manufacturing. Typical CMOs or CDMOs only focus on the manufacturing part. By seamlessly integrating from discovery through development and manufacturing, we get contact with clients very early on,” explains Jim.
This integration allows us to build relationships with clients from the earliest stages of development, particularly benefiting startups and biotechs. Being a 100% US-owned company with operations in both the United States and China gives them a global footprint while maintaining compliance with regulatory frameworks like the BioSecure Act.
Their therapeutic expertise spans multiple modalities including small molecules, ADCs, peptides, and oligonucleotides, supported by purpose-built platforms that address the growing demand in these areas.
Managing Client Partnerships for Success
The company’s approach to client partnerships varies depending on the stage of the client’s program, with a focus on maintaining scientific continuity throughout the development and manufacturing process.
“For startups and biotech companies, we often engage them very early, sometimes way before manufacturing even enters the picture. We offer integrated drug discovery and IND programs to these customers and build strong relationships,” Jim notes.
A key differentiator in their client management approach is the continuity of scientific oversight: “Our scientists who did the development stay with the project throughout the manufacturing to solve issues immediately and ensure the quality of our work.”
This scientific continuity helps address challenges that inevitably arise during scale-up, as Jim explains: “During the manufacturing process with different scales, you always see new issues associated with the process of manufacturing. So our scientists can solve these issues immediately.”
Digital Technologies Enhancing Transparency
We have invested significantly in digital technologies to improve project visibility and transparency for sponsors, with tailored approaches for different client types.
“For biotechs and smaller customers, we offer electronic lab notebooks (ELN) that provide real-time tracking. Clients can see day by day what experiments we did, what reagents we used, and what the results were, including NMR and GC spectra. This gives them real-time access to information, enabling efficient communication,” says Jim.
For clients accumulating large compound libraries, they offer digital compound management systems: “Clients can see in real time where their compounds are, how much was shipped elsewhere, and how much remains in inventory, giving them real-time management of their samples stored with us.”
The company has also strengthened its IP protection platform through investments in IT infrastructure, recognizing that intellectual property protection is paramount for clients. Additionally, they’re exploring AI-driven workflows to accelerate molecular design and virtual screening of biological assays.
Capacity Management and Investment Strategy
Backed by Advent International, BioDuro continues to invest in expanding capacity to meet growing demand while maintaining the ability to serve both existing and new clients effectively.
“We have 1,500+ active customers and a team of more than 2,000 experienced scientists across China and the US. We’re still expanding whenever we see future need,” Jim shares.
Their recent expansion includes a new site in Wuxi City outside Shanghai for drug substance commercial manufacturing, featuring a large capacity of 130,000 liters total reactor volume. This proactive approach to capacity management helps them avoid the bottlenecks that often plague the CDMO industry.
Balancing Cost and Speed to Deliver Value
In an increasingly competitive CDMO landscape, we focus on optimizing value for clients through cost management strategies while recognizing that speed often trumps price considerations.
“Solvents and raw material costs are always top of mind. We focus on recovery, recycling, and vendor management to reduce material costs,” notes Jim. “But speed is often more valuable than price.”
Their integrated service model creates efficiencies that deliver value beyond competitive pricing: “Our integrated model streamlines the process among different functional areas, reducing technology transfer and material transfer costs and time. This accelerates program progress, delivering value beyond just pricing.”
Commitment to ESG and Sustainability
We have made significant strides in sustainability and corporate responsibility, earning recognition for their efforts in this increasingly important area for pharmaceutical companies.
“ESG is core to how we operate at BioDuro. We earned a gold EcoVadis rating in 2023, placing us among the top 3% in the industry and recognizing our efforts in sustainability, ethics, and responsible sourcing,” Jim proudly states.
Their approach includes applying green chemistry principles across CMC operations, with a focus on solvent recovery, waste reduction, and efficient process design. These initiatives help clients meet their Scope 3 emission targets while maintaining operational excellence.
The company also demonstrates a strong commitment to diversity and inclusion: “We have more than 50% female scientists and 40% female directors at BioDuro. It’s part of what makes us a collaborative organization aligned with the values of the biotech and pharma partners we support.”
Future Growth and Strategic Direction
Looking ahead, we have a clear roadmap focused on investing in high-demand therapeutic areas, advancing AI capabilities, and expanding their global footprint beyond China.
“We continue to invest in high-demand areas like ADCs, GLP-1s, peptides and oligonucleotides, including chemistry, biology, and DMPK capabilities,” Jim outlines. “We’re also increasing our investment in AI, as we see that trend heavily influencing future chemistry and biological assay demand in the discovery area.”
Geographic expansion forms the third pillar of their strategy: “As a US company with some operations in China, we’ll continue expanding our footprint globally, outside China. We’re actively searching for sites in Europe or North America to become the most trusted, full-service, US-headquartered CRDMO with de-risked global operations.”
This strategic vision positions BioDuro to adapt to the changing needs of pharmaceutical innovation while providing clients with a trusted partner across the entire drug development journey.
Connect with our team at CDMO Live 2025, 7-8th May, Rotterdam. Book a meeting.
PharmaSource article: https://pharmasource.global/content/podcast/bioduro-building-strategic-partnerships-through-integrated-crdmo-services/
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