Quality Takes Center Stage At ISPE Event
By Trisha Gladd, Editor, Life Science Connect
As part of my summer conference hit list, I will be venturing to Washington, D.C., next month in order to attend the ISPE/FDA/PQRI Quality Manufacturing Conference. This year’s event is scheduled to take place at The Mayflower Renaissance hotel, the longest continuously operating hotel in our nation’s capital (for those of you interested in both upcoming events and hotel trivia).
A location that has survived four ownership changes, bankruptcy during the Great Depression, and is steeped in presidential history, the Mayflower Hotel is the perfect site to host an event focused on surviving and thriving during changing times. As the pharmaceutical landscape continues to change and evolve, it is up to you to not only determine how to raise the bar for innovation but also do so with the utmost focus on quality. And if you take a look at this conference’s agenda, attendees will see this is an opportunity to learn how to accomplish just that.
As with any conference I attend, my first step in preparation was to peruse the schedule and determine what my can’t-miss sessions will be. While I have multiple targets during the June 1-3 event, here are the top three that I am particularly excited about and why. I’ve set the bar high, so I certainly hope they don’t disappoint.
1.A Regulatory Perspective on Continuous Manufacturing of Pharmaceuticals, Dr. Rapti Madurawe, Acting Division Director of the FDA Office of Process and Facilities
CDER Director Janet Woodcock, M.D., referred to continuous manufacturing as “the future” of the industry. However, there are still only a few drugmakers who have made serious commitments to this process by building continuous manufacturing facilities (Novartis, GSK, J&J, Vertex). There are a number of reasons that contribute to this hesitation to commit. One of those being the ability of a continuous process model surviving the rigors of the FDA. After all, the material simultaneously charged and discharged from the process needs to create the exact same perfect drug every time. In this presentation, Dr. Madurawe will discuss key control strategies and regulatory aspects that pharmaceutical manufacturers should consider during the process of developing and implementing a continuous manufacturing setup. With so much focus on this topic, it’ll be interesting to hear the FDA size up this challenge.
2.Supply Chain Risk Management, Andrew Skibo, Head of Global Biologics Operations & Global Engineering, MedImmune/AstraZeneca, USA
The ability to effectively manage your supply chain risk is a key strategy to keeping the total cost of a drug low, as well as protecting it from counterfeiters. As pharma companies expand into the global market, supply chains become more complex and the list of risks expands. With nearly 40 years of experience in the industry, I anticipate Dr. Skibo will have very valuable insight to offer on how to manage risk in the supply chain while balancing the other challenges of drug development.
3.Robust Change Management, Dr. Mary Oates, VP of global quality operations and environmental, health, and safety (EHS) at Pfizer, USA (Panelist)
A vital part of a risk management program includes the ability to understand and control changes in your manufacturing process. Without truly understanding the impact of a change, blindly implementing one can be dangerous to not just the quality of a product but also the safety of the patient. Dr. Oates is a vigorous advocate of the role quality plays in all aspects of drug development and delivery. She has both presented and written on what it takes to establish a “culture of quality,” and it’ll be significant to hear how she was able to successfully do this at Pfizer over the course of 21 years in her current position.
So there you have my top three on a long to do list of sessions to attend, hands to shake, and sights to see, starting with The Presidential Room at the Mayflower.
Okay, so I probably don’t have the credentials for that part, but I certainly intend to hit the rest of the list. If you’re attending the event, drop me a line. I’d love to meet up and discuss the challenges you’re experiencing in your role. If you won’t be there, I hope this gave you a flavor of what to expect from my full report when I return to the office.