I have more than 24 years’ experience working in the pharmaceutical industry. Most of that time was concerned with liquid suspensions of micronized drug substances for delivery to the lung. Though this work included developing aqueous suspensions for nebulization and pressurized liquid carbon dioxide formulations, by far the most experience and expertise is with the metered-dose inhaler dosage form. I was the CMC leader for ADVAIR® HFA MDI Inhalation Aerosol — a major product for GlaxoSmithKline approved and launch in the US in 2006. I was responsible for developing robust components from many suppliers. Weaknesses in the control of the components led to delays to the Phase IIIb development program and I used my experimental investigation skills to lead the efforts to efficiently identify and resolve the issues. At the same time I used those skills to provide key technical insight to resolving issues with another MDI product that had been recently withdrawn from the European market.
|Inhaled products||CMC leader|
|Process development||Method development|
|Life-cycle management||Regulatory documentation|
An important aspect of my work — particularly in resolving root cause analyses — is my ability to design bespoke instruments to quantify properties of the products otherwise unavailable to other traditional off-the-shelf techniques. I led the development of some of these from proof-of-concept to fully validated GMP methods.
The last 5 years of my career with GSK saw my transition from product development to product manufacturing, supply, and life-cycle management. I learned the important difference between the scopes of the two functions including striking an appropriate balance between the need to understand product supply challenges from a data-driven scientific perspective and the pragmatism required to meet the aggressive timescales inherently involved in supplying the market. Through both my late phase development and commercial supply work I have amassed a lot of knowledge regarding efficient use of experimental design, statistics, and analyzing large and/or sparse datasets. These are aligned with industry standard practices such as Quality by Design and ICH guidelines.