Recently, James E Hamilton had the opportunity to assist in the facilitation and to participate on the panel discussion on “Maximizing the ROI in Quality Innovation” at BIO 2014 in San Diego. The September issue of Pharmaceutical Manufacturing, a trade magazine, highlighted several key points of return on investment.
In his article, Steven E. Kuehn, Editor-in-Chief, of Pharmaceutical Manufacturing, zeroed in on three discussion topics:
- “the ROI on quality and innovation,
- where best biopharmaceutical manufacturing might take place and
- what the industry can do with its regulatory partners to achieve quality through compliant manufacturing operations.”
Joan Koerber-Walker, president and CEO of the Arizona Bio Industry Association, introduced the panel participants including James Hamilton, Kurt Brorson an FDA research biologist and Martin VanTrieste, a vice president at Amgen.
Kurt Brorson, updated the current stance of where the FDA is in the effort to strengthen the ties with industry. He pointed out that working more closely with industry fosters best practices, promotes a greater understanding technological gaps and establish over all SOPs ready for a FDA submission.
Martin VanTrieste, opening remarks were based on a Wall Street Journal (2003) critique of the condition of pharmaceutical manufacturing. He pointed out that the industry was far behind in manufacturing modes and that percentages allocated for quality in production and innovation was very low compared to other industries. Near his ending remarks he posed the question what is preventing change in the industry; both in the U.S. and world-wide.
It was consultant James E. Hamilton that turned attention to emerging companies might go for resources to help them in quality by design in manufacturing. He explained that once these companies get to the development stage, they need to incorporate quality by design (QbD) and develop a culture which will continuously examine new technologies in production. He went on to say, “What I run into is the retroactive approach where you have failures. And then you try to find out what caused those failures. What we’re looking at is trying to be more proactive in coming up with the continuous manufacturing process where the processes is actually controlling the ( quality of the] product.”
The entire review of the panel’s discussion is available via the link below.
Finding Pharma Manufacturing’s Innovation ROI
Steven E. Kuehn, Editor-in-Chief
A recent panel discussion at BIO 2014 magnified three topic areas: the ROI on quality and innovation, where best biopharmaceutical manufacturing might take place and what the industry can do with its regulatory partners to achieve quality through compliant manufacturing operations.