Luk Consulting
"CMC Right the First Time"
Drug Eluting Devices
Drug-Device Combination Product
Pharmaceutical Product Development
Drug Delivery Platform Development
Dear Medical Device and Pharmaceutical Product Developers:
Welcome to Luk Consulting! I am an independent consultant with 15+ years experience in developing controlled release products for proteins/peptides and small molecule drugs, spanning from chronic/systemic delivery to acute/local delivery, with special focus on drug delivery platforms and drug-device combination products. I have worked previously in both large (Fortune 100) and small company setting. My expertise is to drive, lead and streamline advancement of convergent medical technologies, from feasibility to clinical testing to commercialization, within a sound scientific and regulatory framework to address unmet medical needs.
Deliver creative solutions from concept definition to commercialization
My contract services offer clients high-quality and practical solutions to streamline all aspects of technical development strategies and decision makings, from concept selection, study design, risk mitigation, change control and mitigation, regulatory submission, to commercialization. I offer critical analytical thinking and sound recommendations to your complex issues. For drug-eluting device projects, I offer fresh perspectives to integrate sound pharmaceutical development principles with device development requirement from both technical and regulatory perpsectives.
CMC Right the First Time
"Chemistry, Manufacturing and Controls", CMC in short, is a key module in a regulatory submission that includes all key development information demonstrating proper identity, strength, quality, and purity of the medical product seeking regulatory approval. One of my consulting services is to advise clients to achieve "CMC Right the First Time". It is of utmost importance to adopt this philosophy from concept to launch to minimize unnecessary reloops and maximize probability of technical/regulatory success for any projects. Especially with the tighter timelines of developing drug-eluting devices, flawless CMC executions, together with excellent communications with diverse cross-functional experts, including device engineers, are crucial to successful product advancement and launch.
Why wait? Please contact me at asluk6@gmail.com or (510) 332-0203
Sincerely,
Andrew Luk, Ph.D.
(left) Immediate-release dosages give wide fluctuation of drug level in blood often leading to undesirable side effects and sub-optimal efficacy.
(right) Controlled-release dosages offer a consistent drug level in blood, minimizing side effects and frequency of dosage administration, thus increasing overall patient adherance. Most drug-eluting devices utilize such principle to engineer long-term drug release into implantable medical devices.
