An Song - Senior Director & Senior Scientist, BioAnalytical Sciences – Assay Development & Technology

An Song

Senior Director & Senior Scientist, BioAnalytical Sciences – Assay Development & Technology

"Genentech is such an amazing and rewarding place to work because of its purpose to help patients by driving cutting-edge science. It’s also fun to interact with many incredibly talented and dedicated people and immerse yourself in its challenging yet nurturing culture. I’ve learned so much about how to translate science into medicines and I am still on the learning curve. Genentech also provides opportunities to me and helps me growing into a leader. With all that, I am inspired and excited to come to work every day!"
15
Years at Genentech
25
Publications
7
Awards & Honors

I joined Genentech in 2002 as a Scientist contributing to the development of bioassays/potency assays for development molecules. Soon my responsibilities expanded to all bioanalytical strategies and methods for the evaluation of pharmacokinetics (PK), anti-therapeutic antibodies (ATAs) as well as biomarkers to support biotherapeutic development, regulatory filing and approval. In 2006 I was promoted to Senior Scientist and started to lead a group of 10 people. I was appointed to Associate Director in 2008 and started to lead the department of Assay Development & Technology (ADT) (formerly BioAnalytical Research & Development [BARD]) in 2009. I am currently the Director of ADT overseeing ~60 employees and accountable for bioanalytical assay development, validation, outsourcing, and performance for Genentech Research & Early Development (gRED) biotherapeutic pipeline from ED (including selected LSR projects) to post-marketing.

During my time at Genentech, I also contributed to drug development and approval by leading cross-functional teams as Pharmacology Subteam Leader (PSTL) and Biomarker Subteam Leader (BMSTL). I personally contributed to 10+ IND, BLA and global regulatory filings and participated in global health authority interactions. I am a reviewer of Development Review Committee (DRC), Diagnostic Review Forum (DxRF), Development Sciences Review Group (DSRG), and BAS Review Group (BASRG). I also served as a member of the Development Sciences Promotion and Appointment Committee (DSPAC).

Featured Publication

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity).

Bioanalysis. 2015 Dec;7(24):3107-24.

Amaravadi, L., Song, A., etc.

Strategies to compare clinical antitherapeutic antibody data when changing assay platforms: a case study.

Bioanalysis. 2015;7(14):1775-83.

Qiu, Z., Ying, Y., Lewin-Koh, S-C., Coleman, D., Brignoli, S., Hendricks, R., Siguenza, P., Quarmby, V., Fischer, S. K., and Song, A.,