Alan Chang

CEO
​Taron Solutions Limited

Dr. Alan Chang obtained his PhD in the department of Chemical and Biomolecular Engineering
from North Carolina State University. Dr. Chang has 20+ years of experience in drug product
formulation, micro to nano sized particle engineering, process development and manufacturing
scale-up, and US FDA and EMA regulatory experience. During his career, he has worked on drugs
in different stages of development cycle. He was part of the process team to successfully launch a
commercial product worldwide with Novartis (USA) and led other early-stage drug products from
pre-clinical to clinical production. Dr. Chang has also worked as the Director of Science and
Technology for iPharma, an inhalation CRO based in San Francisco, that was acquired by Kindeva.
He is currently the co-founder and CEO of Taron Solutions, a CTDMO to accelerate gene therapy
and other biologic drug development and getting effective medicine to the hands of patients by
incorporating better science and regulatory discipline in the drug development and manufacturing
process.
 

Speech title & Synopsis

Trends in CMC design for drug products: What works and what doesn’t

During the lifetime of the drug, once a lead candidate is selected to be move forward with
translational research, other development for future regulatory filing such as CMC (Chemistry
manufacturing and controls) design becomes crucial to the successful advancement of the product
toward human trials. Beyond checking boxes for regulatory guidelines for CMC requirements,
there are other aspects that can derail a project. The team must consistently implement good
project management, sound financial planning, and consider the latest market information for
consideration. In addition, constant adaptation to regulatory landscape and government policies
are equally important to the eventual success of the drug. A technically sound drug candidate with
poor execution of the CMC design or subpar strategic planning that fails to excel in all the areas
mentioned earlier can result in less than desirable outcome for the program. In this presentation,
we will explore different aspects of CMC readiness, where is our field heading, and some specific
examples of considerations that can minimize the risks of failure.