Aastrom Biosciences (ASTM) appoints Dr. LaVonne Lang as Head of Regulatory Affairs
ASTM appointed of Dr. LaVonne Lang as head of regulatory affairs as it prepares for the final stages of regulatory review. Her considerable regulatory experience, including extensive work with the Center for Biologics Evaluation and Research (CBER), will be a critical resource
Most recently, Dr. Lang consulted on various investigational drugs and biologics for United BioSource Corporation. Previously, she was a therapeutic area regulatory lead at Pfizer. She also served as a worldwide regulatory lead for the CAD/PAD gene therapy development program, and was involved with various marketed wound care biologic products while at Parke-Davis.
- Dr. Lang has over 20 years of industry experience and holds BS degrees in psychology and nursing, an MPH in environmental and industrial health with a subspecialty in toxicology, and a doctorate in public health policy from the University of Michigan.
The Bottom Line: With ixmyelocel-T recently advancing into pivotal p3 clinical testing, ASTM is preparing for the final stages of regulatory review. Her considerable regulatory experience, including extensive work with the Center for Biologics Evaluation and Research (CBER), will be a critical resource as ASTM continues to work closely with the FDA and other regulatory agencies to position ixmyelocel-T for review and approval.
