Guilin Huang, MBA

Guilin Huang oversees the regulatory efforts at AnHeart Therapeutics. She brings over 17 years of experience in global regulatory affairs and drug development focusing on oncology and rare diseases. Prior to AnHeart, Guilin accumulated and enriched her drug development expertise as Head of Global Regulatory Affairs at RelayTx as well as an accomplished regulatory strategist at Takeda, ARIAD, Chugai and Vertex. She contributed to global clinical development of several breakthrough therapies from early stage through global approvals, and she was instrumental to delivering successful global simultaneous filings and regulatory approvals of Kalydeco® (ivacaftor) for cystic fibrosis with gating mutations and R117H mutation, Alunbrig® (brigatinib) for ALK-positive non-small cell lung cancer (NSCLC), and Exkivity™ (mobocertinib) for NSCLC with EGFR exon20 insertion mutations. Additionally, Guilin played a key role to secure successful approvals of companion diagnostics for Alunbrig® and Exkivity™ .

 

Guilin holds a B.S. in Pharmacy and Japanese from Shenyang Pharmaceutical University, and she received her MBA in Health Sector Management from Boston University.  Guilin also graduated from WOMEN Unlimited LEAD Program.