Dr. Ken Chang has over 30 years of experience in biopharmaceutical industry with hands-on expertise in various phases of drug development and approval process that include discovery, product/process/assay/cell line development, protein characterization, fermentation, scale-up production, cGMP compliance, validation, quality control, quality assurance and regulatory submission.
Targeted drug delivery using radioimmunoconjugates, antibody-drug conjugates, enzyme-antibody conjugates, bispecific antibodies, T-cell redirected bispecific antibodies, engineered antibodies, recombinant immunotoxins, CAR-T and CAR-NK cells
Co-inventor and key architecture of the DOCK-AND-LOCK (DNL) platform technology
Oversaw the development of CEA-Scan and LeukoScan, resulting in approval by CPMP and FDA for CEA-Scan in 1996 and by CPMP for LeukoScan in 1997
A member on the 1988 ad hoc committee organized by professor Claude Meares for American Chemical Society, which resulted in recommending the creation of Bioconjugate Chemistry
A member on the International Editorial Advisory Board of Bioconjugate Chemistry from its launch in 1990 to 2016
A reviewer for various NIH study sections (2007-2013)
An invited speaker to present DNL-related topics at meetings organized by Cambridge Healthtech Institute (CHI)
A total of 114 publications in peer-reviewed journal.
To date, more than 21 patents have been issued on the DNL platform technology, among which US 7,521,056, titled “Stably Tethered Structures of Defined Compositions with Multiple Functions or Binding Specificities”; and US 9,315,567, titled “T-cell redirecting bispecific antibodies for treatment of diseases”; have won the 2012 and 2016 Thomas Alva Edison Patent Award in the Biotechnology category, respectively.