Wow, can you believe it? Over two years have passed since the pandemic began. In that time, we have had to change so many things about our lives—like having to work from home while, at the same time becoming teachers for our children or caregivers for our aging family. We have also experienced a historic loss of lives due to this pandemic that we have not seen before.
While all this has been very challenging, we also saw some major advancements in our industry. From the rapid approval of multiple vaccines to multiple antibody treatments, and now, specific antiviral small-molecule treatments. This newly found agility and speed of approach, based on a bedrock of sound science and data, cannot be taken for granted and should become our future norm. This is the theme of our upcoming 2022 PDA Quality and Regulations Conference in Amsterdam, The Netherlands, October 5-6.
This will be our first face-to-face meeting in two years. At the conference, we are looking forward to exploring the use of novel technologies to manufacture medicinal products, the regulatory approaches to see data review as an iterative process during the review of an application and remote quality oversight of manufacturing sites. How we use data over the lifecycle of products will become a competitive advantage to any organization that fully embraces and utilizes “Big Data.”
While there have been many conferences on Big Data, this event has the distinction of addressing the use of Big Data from a regulatory and industry perspective in the context of quality and regulatory compliance. How do we use data contained within our quality systems, manufacturing sites and labs to drive continued product and process knowledge and better patient outcomes? We will listen to regulators from various global authorities about how they use data provided by clinical trial sponsors, marketing authorization holders, manufacturers, parallel importers/distributors, post-market complaints and pharmacovigilance to develop quality oversight. Leading industry speakers will discuss how they use data to drive product and process improvements.
We hope to see you there, and we look forward to continuing this important conversation to advance our industry into the future!
About the Author
Patrick Costello, PhD, is Director of Quality Assurance at AbbVie Pharmaceuticals Ireland. Dr. Costello has spent the last 21 years working in the pharmaceutical industry, initially as a regulator with the Health Products Regulatory Authority, followed by four-and-a-half years at the European Medicines Agency. He held various roles at these agencies from assessor and inspector to associated management positions. In his most recent appointment with AbbVie Inc., he manages a team responsible for GxP reporting of significant events to global regulators, management review, quality metrics and data analytics. Costello has been on the PDA Europe Quality and Regulations Planning Committee for the last three years and is co-chair with Vinny Brown for the 2022 PDA conference.
Vinny Browning, III, is currently Executive Director of Quality Assurance, Drug Substance and Site Operations, at Amgen Puerto Rico. Mr. Browning has spent the last 24 years working in the biotechnology industry on more than 75 commercial and clinical products. Browning has worked a range of functions, from bench analyst in quality control to site head in operations in Abingdon, UK to a Global Commercial Attributes Sciences Executive in Process Development, He is now Quality Assurance Lead for two drug substance plants and site operations at Amgen’s manufacturing facilities in Puerto Rico. Browning has been on the PDA Europe Quality and Regulations Planning Committee for the last several years. He was co-chair of the 2021 PDA Europe Quality and Regulations Conference and, with Costello, serves as co-chair for this year’s quality and regulations conference.