Verified recordBiotechnology Research

Fengju Bai

Director, Development Toxicology, Preclinical Safety at Biogen

Based in Boston, United States

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Seniority

Director

Department

Research & Development

Location

Boston

Industry

Biotechnology Research

Company size

7.5K

Contact information

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Email

1 credit

f•••••••@biogen.com

Phone

5 credits

+1 ••• •••• ••••

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Background

About Fengju Bai

Board-certified toxicologist with 20 years of industry experience. Experienced in non-clinical testing of modalities including small molecules, biologics, ASOs, and gene therapy products. Served as the toxicology expert for development programs. Knowledge of FDA, OECD, and JMHLW GLPs and ICH guidelines. In-depth knowledge and experience in the planning, design, execution, reporting and monitoring of non-clinical studies. Experienced in US and Global filing from IND/CTA to market registration. Specialties: Non clinical research and development Drug safety evaluation Regulatory toxicology GLP IND/CTA/NDA/MAA

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