How long have you been withAlcami? I joined Alcam in June of 2008.
What is your role? I am a scientist in the pharmaceutical development laboratory at our Durham, North Carolina site. I evaluate, develop, validate test methods, perform abuse deterrence studies, and train analysts in specialized analytical methods often for clinical trial development.
What is the most rewarding part of your job? The most rewarding part of my job is completing and executing a test successfully– be it an evaluation, development, validation, or a special research project– because a successful execution entails a lot of things– company filing a new drug application (NDA) on time; timely manufacture of a drug product; sharing experiences and knowledge of drug product properties; contributing to the site’s goals, and most of all, helping to ensure that a product delivered to the patient is safe, has integrity, and is of high quality.
What are your team’s latest achievements? The Durham team was able to meet a client’s aggressive timeline for an end-of-year submission of weekly and monthly subcutaneous injection therapeutic drug products that will aid in the treatment of the nation’s ongoing drug addiction problem. We were able to develop and validate a wide range of challenging methods within the required time frame, enabling the testing of numerous lots of drug products to occur on time. I was very fortunate to play an integral part in the successful completion of these methodologies; I was involved in the evaluation and later led the validation of challenging, extended-release (over several days) dissolution methods for the products, which utilizes technology for the release of the active ingredient. Thereafter, I planned and organized the dissolution testing of the initial and successive time points of these lots. With the support of dedicated team members, management, and laboratory services, we were able to successfully complete these long dissolution tests.
How do you see those accomplishments affecting the pharmaceutical and biotech industries? Based on the clinical and analytical test results, the FDA has concluded that the different extended-release formulations of the subcutaneous injections have met all the required quality, safety, and efficacy standards necessary for the approval of the drug products. The tentative approval of the extended-release formulations that utilize the client's proprietary drug delivery technology brings promise in the effective treatment of opioid use disorder (OUD). The formulation is designed to maintain therapeutic levels of the active ingredient in the blood for a week or a month, improving treatment retention and patient compliance. Current available oral medications require a daily dose of treatment, so the risk for abuse, exposure, limited treatment, and misuse is high.
The approval of these innovative injection products will also encourage the development of similar therapeutic products that will help in treating opioid addiction as well as the development of better delivery techniques overall.