Wednesday, February 14, 2007

My conversation with Mr. Inoue

While attending the ISPE meeting last Thursday night, I had the pleasure of meeting Mr. Mikio Inoue. We wound up having a pleasant conversation regarding his involvement with the competition and some other aspects of the pharm/bio industry.

We had both arrived at the meeting early and were waiting for the festivities to begin and I took the opportunity to introduce myself. We were exchanging pleasantries typical of being just introduced at a meeting and discussing the fact that it seemed like it was going to be crowded based on the Baxter FOY presentation.

Look for a review of that presentation coming shortly…

Mr. Inoue mentioned that he had been involved in the FOY competition (website link) and he was attending tonight to provide local representation for the project and his company.

I noticed he had a Facility of the Year sweatshirt on and we began to discuss his involvement with the competition.

It dawned on me that this was going to be a better conversation than the usual “Consultant meets Vendor at an industry function”... you know the type….we’ve all had a million of them…
With his permission I started scrawling some notes…I hope this captures the basics of our conversation, I do not have any actual training as a reporter, so bear with me…

Mr. Inoue had participated in a very successful project for the Daiichi Asubio Pharma Co., Ltd (website link). The project is a multi-product production facility located in Gunma Prefecture, Japan. Descriptions of the five finalist projects are available here at the FOY website (website link).

The project was a finalist in the 2006 Facility of the Year competition, which is how he got the sweatshirt. The competition is sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine.

He was very knowledgeable about the project and had a lot of detailed information regarding building layout, processes, and equipment involved in the project. The facility is capable of multi-product and multi-scale production and launch operations. The major pieces of process equipment were provided from a very geographically diverse set of countries. Mr. Inoue stated that part of the success of the project was having the architect understand the process to be supported by the facility.

Mr. Inoue indicated that the project was reviewed with the FDA in order to align the project with regulatory expectations. We both agreed that a Type C Meeting with the FDA is a very valuable step and allows for valuable input to be provided by the FDA in a more casual setting.

He was very knowledgeable about the project type and had some interesting rules of thumb regarding building size and process valve count. We also discussed the level of automation a project might have based on differences in approach between the level of automation between Japanese and US approaches to plant operation.

Mr. Inoue described the typical Japanese approach of using a high level of automation and centralized DCS systems in order to limit manual interaction of the operators in the production process. This approach also reduces labor costs associated with the plant operators and also addresses the difficulties of staffing a plant with operations personnel.

This approach is in contrast to the equipment specific PLC/ “islands of automation” approach that is often found in plants built here in the US. This results in less centralized control, beyond data gathering, and more manual interactions with the process. We discussed how the US approach may be driven by an operating company’s regulatory history, risk aversion, perceived complexities and costs of validation efforts associated with complex automation and control systems.

Both approaches are driven by the need to respond to the expense and availability of operator labor. While these are not hard and fast approaches, it represents a philosophical difference in each countries typical approach to the industry.

Mr. Inoue holds a PhD and is the General Manager of the Pharmaceutical & Biotechnology Project Division for the Fujikin of America Inc.

Mr. Inoue has recently moved to the US and is living and working in New Jersey. When asked how he found living in NJ, he replied “tough…” When I heard his response, my first thought was “well, it is New Jersey…” home of the Sopranos, the Jersey Turnpike, and the Attitude Capital of the World

Mr. Inoue indicated he is very involved in the ISPE New Jersey Chapter activities. He had attended the Holiday Cruise party and would also be going to the Nets- Spurs game coming up on date.

Mr. Inoue can be contacted by phone at (201) 641-1119 or via e-mail at minoue AT (substitute the "@" symbol for e-mail address...)

I guess I should try to introduce myself to more people more often when I go to ISPE meetings.
A lot of highly qualified and experienced people attend and I would probably be able to have a lot of interesting conversations.

I consider myself lucky to have met Mr. Inoue and to have had such an interesting conversation.

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