INSIGHTS

Introduction

Recently, Kevin Li, Chief Marketing Officer of BioDuro-Sundia, sat down with Pharmaceutical Technology at CPHI 2024 in Milan to discuss how integrated CRDMO services can expedite the development of new drugs for biotechnology companies and start-ups.


Kevin Li

Chief Marketing Officer 

Kevin Li, MBA, has more than 15 years of industry experience. Prior to working at BioDuro-Sundia, Kevin led the global marketing and public relations teams across the US and China for the WuXi Chemistry division at WuXi AppTec. Additionally, Kevin led the global marketing efforts for the Oral Dose, Rx, and OTC Softgel business units at Catalent Pharma Solutions. Earlier still, Kevin worked in marketing for ConvaTec and Becton, Dickinson and Company, and held scientist roles at Pfizer (Hospira) and Abbot (AbbVie). Kevin studied chemistry at Northwestern University and business administration at Duke University.

What role does an integrated CRDMO play in the biopharma industry?

BioDuro-Sundia, founded in 1996, offers a comprehensive range of services that span the entire drug development process—from early discovery through to commercial manufacturing. As an integrated CRDMO platform, our services provide multiple layers of integration.

First, we have horizontal integration, which covers every stage from drug discovery to commercial production. Additionally, there’s vertical integration. For example, at the drug discovery stage, we offer fully integrated modules, including medicinal chemistry, biology, and DMPK. At the preclinical phase, we handle everything from raw material sourcing to final product development.

We also have geographical integration advantages. Our sites are designed to support both vertical and horizontal integration. For instance, our Waigaoqiao facility provides comprehensive drug discovery services, while our formulation R&D and manufacturing base in Irvine, California, offers end-to-end support from pre-formulation research to commercial-scale production.

By managing material transfers, information sharing, and quality control within a single facility, we streamline operations and significantly speed up timelines. This allows our API team to consistently supply high-quality raw materials to the formulation team, while our early-stage scientists anticipate later-stage challenges to mitigate risks. This comprehensive approach accelerates the journey from drug development to commercial manufacturing, driving faster innovation for biotech companies.

What other advantages do integrated services provide?

Beyond the speed benefits, integrated services simplify supplier management for our clients. Coordinating with multiple suppliers can be time-consuming and complex, especially for biotech companies and start-ups that may have limited internal resources. Our dedicated project managers and integrated solutions streamline the process, reducing potential disruptions in R&D.

With over 1,500 global customers, more than 500 IND submissions, and successful commercialization of over 20 finished drugs, BioDuro-Sundia has the expertise to help start-ups and early-stage biotech companies navigate potential risks and identify optimal pathways for accelerated drug development. While larger pharmaceutical companies often have extensive internal resources, they frequently collaborate with us in specialized areas due to our deep expertise.

What services does the Compound Management Center offer, and why are they important?

We recently launched a state-of-the-art Compound Management Center in Waigaoqiao, Shanghai. The center provides critical services such as storage, weighing, dissolution, plating, LC-MS analysis, and distribution. It has the capacity to manage over 400,000 solid or liquid compounds, ensuring secure storage, accurate tracking, and real-time updates. This means compounds are always securely stored and readily available for quick distribution, offering our clients peace of mind. Additionally, the center helps streamline drug discovery projects, reducing both costs and timelines.

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