Ben Drucker BS, BA

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Ben Drucker is the President and Principal Consultant at BDBio, Inc., where he specializes in regulatory strategy and CMC (Chemistry, Manufacturing, and Controls) content for biologic and biosimilar products across all development stages. With over 23 years of experience in the biologics industry, Ben brings deep expertise in regulatory affairs, engineering, validation, manufacturing, and documentation to every project.

Ben's comprehensive background spans the entire biologics development lifecycle, from early-stage research through commercial manufacturing. His regulatory expertise includes preparing and reviewing various filing documents for INDs and BLAs, including meeting packages, eCTD Modules 2/3, and amendments/supplements. He has successfully guided multiple biosimilar products through complex FDA interactions and regulatory submissions.

Prior to founding BDBio, Ben served as Senior Director of Regulatory Affairs at Coherus BioSciences, where he led regulatory CMC strategy for late-stage immunology and oncology biosimilars. His leadership included overseeing contract CMC authoring teams and serving as the primary regulatory representative for BLA preparations and FDA meetings.

Ben holds dual bachelor's degrees from Stanford University in Chemical Engineering and Linguistics, reflecting his unique combination of technical expertise and communication skills. He further enhanced his leadership capabilities through an Executive Certificate in Management and Leadership from MIT Sloan School of Management.

Ben's multicultural background includes basic fluency in Mandarin Chinese, moderate proficiency in Spanish, and working knowledge of German, enabling him to effectively collaborate with international partners and navigate global regulatory landscapes.

Known for his impeccable written and oral communication skills at all organizational levels, Ben is committed to delivering strategic regulatory solutions that advance biologic development programs efficiently and effectively. His hands-on experience across manufacturing sciences, process development, and regulatory affairs provides clients with comprehensive insights that bridge technical development and regulatory requirements.

Ben is based in San Francisco, California and Taiwan, and serves clients worldwide in advancing their biologic and biosimilar development programs.

At NexusBio Partners, we specialize in providing expert consulting services for drug development in the biotechnology sector. Our team of experienced professionals offers insights that can help streamline your research processes and enhance your product development timelines. We are committed to guiding you through the complexities of biotech with tailored strategies.