Alan Wu
Senior Consultant / Acting COO
New Taipei City
Summary
Visionary biotechnology executive with over 20 years in clinical research, regulatory affairs, and business development across Asia-Pacific. Expertise in building CRO operations, leading cross-functional teams, and managing international collaborations for regulatory submissions to FDA and NMPA. Currently serving as Senior Consultant and Acting COO for an AI-driven genetic diagnostics company, focusing on business operations, regulatory strategy, and market expansion.
Overview
2
2
Languages
25
25
years of professional experience
Work History
Senior Consultant / Acting COO
Compass Bioinformatics
10.2023 - Current
- Serve as Senior Consultant and Acting COO for an AI-powered genetic diagnostics company specializing in Software as a Medical Device (SaMD).
- Collaborated with CEO to implement corporate strategy, manage daily operations, enhance regulatory compliance, and expedite commercialization efforts.
- Lead cross-functional teams covering Regulatory Affairs, Quality Management, Product Development, and Business Operations while ensuring compliance with FDA, ISO 13485, and EU MDR requirements.
- Forged strategic partnerships with hospitals, laboratories, and international biotechnology firms to expand market reach and drive growth.
Senior Consultant
Freelance
04.2023 - Current
- Delivered strategic consulting services to biotechnology, pharmaceutical, CRO, and medical device companies across Asia, enhancing their competitive positioning.
- Guided clients in clinical development strategy, regulatory pathways, business expansion, due diligence, licensing opportunities, and international partnerships to achieve project milestones.
- Facilitated global clinical trial planning and regulatory submissions, streamlining project execution and commercialization strategies for successful outcomes.
CEO
Anser CRO
03.2018 - 03.2023
- Founded Anser CRO, establishing one of the earliest multinational clinical trial platforms in Taizhou, China, to enhance access to clinical research.
- Built and led multidisciplinary organization of over 50 professionals across clinical operations, medical writing, data management, biostatistics, regulatory affairs, and quality assurance, driving successful project outcomes.
- Led the organization through seven successful regulatory inspections with full compliance to ICH-GCP and GLP standards.
- Built and led a multidisciplinary organization of more than 50 professionals covering Clinical Operations, Medical Writing, Data Management, Biostatistics, Regulatory Affairs, and Quality Assurance.
- Developed strategic partnerships with pharmaceutical, biotechnology, and medical device companies throughout Asia, increasing collaboration and expanding service offerings.
VP of Business Development
Protech Pharmaservices Corp. (PPC)
10.2001 - 02.2018
- Led business development for bioanalytical laboratory and central laboratory services that supported innovative and generic pharmaceutical companies, driving revenue growth.
- Developed strategic collaborations with pharmaceutical sponsors, CROs, hospitals, and laboratory networks across Taiwan, Japan, China, and the Asia-Pacific region, enhancing market presence.
- Expanded key accounts and established long-term partnerships with multinational pharmaceutical companies, contributing to sustained business growth.
- Served concurrently as an Independent Consultant for GLG (Gerson Lehrman Group), providing expert advisory services in biotechnology, clinical development, and regulatory strategy.
Education
M.D. - Biotechnology
Chinese Culture University
Taipei City, Taiwan 04.2001 -
Skills
Clinical Development Strategy
Clinical Operations Leadership
Clinical trial management
Regulatory affairs
Regulatory Strategy Development
Business development
Market Access Strategy
Operational Excellence
Medical software
Healthcare AI
Strategic leadership
Biomarker Development
Timeline
Senior Consultant / Acting COO
Compass Bioinformatics
10.2023 - Current
Senior Consultant
Freelance
04.2023 - Current
CEO
Anser CRO
03.2018 - 03.2023
VP of Business Development
Protech Pharmaservices Corp. (PPC)
10.2001 - 02.2018
M.D. - Biotechnology
Chinese Culture University
04.2001 -