Pfizer Research and Development, United States
👨🎓Profiles
🏛️ Early Academic Pursuits
Qiang Qu embarked on his academic journey with a strong foundation in biochemistry, earning a B.S. from Nankai University in 1995. He further honed his expertise by obtaining a Master’s degree in Genetics from the Chinese Academy of Sciences, Institute of Genetics in 1998. His academic training provided him with a solid understanding of molecular biology, protein analysis, and genetic mechanisms—knowledge that would later fuel his career in biopharmaceutical research and clinical assay development.
🏢 Professional Endeavors
With over 14 years of experience in the biopharmaceutical industry, Qiang Qu has played pivotal roles in assay development, clinical research, and regulatory strategy. His career began at Pfizer in 2010 as a Senior Scientist in BioMedicine Design-PDM, where he focused on bioanalytical assay development for pharmacokinetics (PK) and immunogenicity assessments. In 2016, he joined EMD Serono as an Associate Director and Lab Head, where he managed a team of scientists, overseeing assay development for large molecule therapeutics. By 2020, he returned to Pfizer as the Biologics & Immunogenicity Clinical Assay Lead, a role in which he continues to make significant contributions to the development and regulatory approval of biologics.
🔬 Contributions and Research Focus
Qiang Qu's research expertise spans PK, anti-drug antibody (ADA), and neutralizing antibody (NAb) assay development, particularly in clinical phases. He has led the development, validation, and transfer of bioanalytical assays using state-of-the-art technologies such as ELISA, MSD, Gyros, and Octet platforms. His contributions have been instrumental in ensuring the robustness, reliability, and regulatory compliance of assays used in drug development.
🌍 Impact and Influence
Through his leadership roles, Qiang Qu has had a direct influence on clinical assay strategies, shaping the scientific direction of bioanalytical projects. His collaborations with CROs (Contract Research Organizations) and regulatory bodies have ensured the successful transfer and validation of critical assays supporting IND/BLA/NDA submissions. He has also mentored and managed teams, fostering the next generation of scientists in assay development.
📚 Academic Citations & Industry Recognition
His work in biologics and immunogenicity assays has been widely recognized within the scientific community. His contributions have been cited in regulatory filings, scientific reports, and industry presentations, strengthening the scientific foundation for immunogenicity risk assessment and bioanalytical methodologies in pharmaceutical research.
🛠️ Technical Skills
Qiang Qu possesses extensive technical expertise in:
- Bioanalytical assay development (PK, ADA, and NAb)
- Method validation and assay transfer under GLP/GCLP compliance
- Technology platforms: ELISA, MSD, Gyros, Octet, and automation tools
- Regulatory compliance and dossier preparation for clinical and regulatory submissions
- CRO management, troubleshooting, and scientific oversight
🎓 Teaching & Mentorship Experience
Throughout his career, Qiang Qu has played a significant role in mentoring junior scientists and contractors, guiding them through assay development and regulatory expectations. His leadership at EMD Serono and Pfizer involved training and supervising 6-8 direct reports, helping them build expertise in bioanalytical methodologies. His mentorship extends beyond the lab, as he frequently participates in scientific discussions, internal knowledge-sharing sessions, and industry conferences.
🔥 Legacy and Future Contributions
Qiang Qu's contributions to bioanalytical sciences and immunogenicity assay development have already left a lasting impact on the field of biologics drug development. His expertise in method validation, regulatory submissions, and clinical strategy continues to shape the future of biopharmaceutical research. Moving forward, he is poised to further enhance assay innovation, improve immunogenicity risk assessment, and contribute to emerging technologies in biologics. His legacy is one of scientific excellence, leadership, and mentorship, ensuring that his influence extends well beyond his immediate projects.