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Member Spotlight: James Agalloco, 40-Year ISPE Member

ember Spotlight: James Agalloco

As ISPE celebrates the 40th anniversary of its establishment, we would like to recognize those members that have been with ISPE throughout its journey. Let’s begin with James Agalloco, who joined ISPE in October 1980. We talked with James to learn about his many years with ISPE, his experiences and accomplishments, and his thoughts on ISPE as we move forward in the future.

You have been with ISPE for 40 years – WOW! Can you give me a brief summary of your involvement with ISPE and share some of the more interesting experiences and successes you’ve had with the Society during your lengthy tenure?

I became a member because I felt that the discipline of engineering was underrepresented in much of what the industry does. I think bringing that to greater prominence was perhaps the most significant achievement that ISPE has achieved. In the past, the importance of facilities and equipment was neglected by many, and ISPE helped change that. Increasingly, we are seeing innovation beginning in engineering, and that's essential if we are going to advance technologies further.

How did you come to dedicate your career to the pharma industry?

I was looking for my first job after two years in the military and I wasn't focused on any specific industry. The job market was tight, and after interviews in the petroleum and other industries I landed a position at Merck in Rahway, NJ, in a tech service role working with active pharmaceutical ingredients. The ability to work on something that would help society was appealing. My early assignments involved production of vitamins, antifungals, and different heart medications, all of which convinced me this was a worthy career path.

What are your thoughts on the state of the pharmaceutical industry today as opposed to how it was in 1980?

In the 1980's (and I began my career nearly a decade earlier) the equipment we employed was extremely primitive by today's standards. When I look back, I am amazed we accomplished as much as we did with the limited tools available to us. Respect that back then cell phones, PCs, the internet, and so much more were not available. We have experienced a wealth of change and the rate of change continues to rapidly increase. It is important that everyone in this industry embraces lifetime learning if we are to continue to improve.

What do you, as one of the original Members of ISPE, hope to see happen with the organization in the coming years?

I hope that we can find a way to advance technology more easily than we have in recent years. Regulatory agencies need to emphasize a ‘what to’ mentality and avoid the prescriptive ‘how to’ so we can continue to innovate without the burden of outdated expectations. ISPE needs to lead the advance to make our processes as robust as possible. Years ago, we would hear about the ‘art of drug manufacturing,' which has evolved into increasingly sophisticated and vigorous processes. Engineering is at the very core of that transition and ISPE needs to further advance our capabilities with the continuation of supportive guides, standards. publications, and educational materials.

Anything else you would like to share with the ISPE Community?

We are stronger together. Our employers may compete for market share, but as employees (and at some point, patients) it is important that we share our skills, insights, and learnings with each other. Making the world’s medications has never been more important, and the open exchange of ideas fostered by ISPE members is essential to increased availability and improved patient outcomes.