In 2006, the PDA Letter ran a series of articles highlighting past leaders as part of PDA’s 60th Anniversary celebrations. Over the next few months, we will republish those articles as part of this year's 75th Anniversary. Look for video Past Leader Spotlights of more recent leaders to post soon, as well.
This month, the “Past Leader Spotlight” features Nathan Kirsch, and the interview was conducted by Past Chair and President Bob Myers.
To celebrate our 60th anniversary in 2006, each issue of the PDA Letter will feature a “Past Leader Spotlight,” an opportunity for PDA to connect our current generation of leaders with their predecessors. Below is the first in this series.
I chose to conduct the first interview with Nathan Kirsch, PDA’s President from 1965-66. I worked for Nathan at Schering-Plough in the 1970’s, and he helped me get involved with sterile products, sterilization and validation. He also encouraged me to join PDA.
For the interview, I met Nathan at his residence in New York and asked him to explain why he got involved in PDA during the Association’s early years, how the organization grew during his time, and where he thinks we are headed. I found his answers resonated with me and my belief that PDA plays a valuable role in advancing science in a constructive way, and that we help bring greater understanding between the industry and health authorities.
Myers: How did you get involved with PDA?
Kirsch: I got involved with the industry it seems as a matter of luck. I completed graduate school at the [University of] Illinois in 1942 and was looking for a job, when I saw an advertisement in an endocrinology magazine for a position at Schering, which had just been brought under the control of the Alien Property Custodian law. I interviewed with the company’s Executive VP and VP of Research. I was one of the first persons selected and was needed at the company for my microbiology background. I was hired as head of production for sterile products.
I soon learned that the people actually making the product were not scientifically trained and did not know exactly what they were doing. With a background in food processing from Illinois, I believed the same science should be applied to the manufacture of sterile pharmaceuticals. In fact, at an early pharmaceutical meeting on quality control, I recall asking Schering’s Chairman, following a long discussion on sterility testing, if the pharmaceutical industry should adopt the same science as the food industry and test only a very few units following sterilization. Once the mechanical settings are known then the product can be assured of sterility and the batch released by what has become known as “parametric release.” His answer was, “you must be an engineer, since no microbiologist would agree to that for pharmaceuticals.”
Bill Bucke [PDA President, 1958-1959] nominated me to the Board of Directors of PDA. At first I had to decline because, at that time, we at Schering were not allowed to join organizations such as PDA. Bucke called our CEO, Francis Brown, who then called me. Francis told me that I would run for the Board of Directors of PDA, and, if elected, I would always remember Schering was a first class operation when I opened my mouth, and I would have his full support.
Myers: What do you see as PDA’s largest contribution to the industry?
Kirsch: That’s almost like asking which of my kids I like best. PDA has made many contributions to the industry in the area of better pharmaceutical science, especially in the area of sterility assurance. In the 50’s and 60’s, the pharmaceutical industry was using techniques for sterilization that just didn’t work. One technique was called tindyalization, which called for raising the temperature of a solution to 50-60°C for one hour and then cooling it. This was repeated three times, and the material was supposed to be sterilized. This, of course, does not sterilize.
This brings me to my most significant contribution to the industry. This was to get Irving Pflug [University of Minnesota] to put the sterilization course together. I told him that the industry needed a progressive sterilization program with a good validation approach. That goes back 30 years, and believe it or not, the PDA Board at the time was not 100% behind the idea, since some of the members thought we already knew enough about sterilization. I had several other discussions with Irving and convinced him of the need, and, of course, PDA has used his material ever since. After doing the training at Schering, it was offered by PDA, and we were overwhelmed with participants. He originally felt it would be a one-time effort in the mid-70’s, but we always have new people coming into the industry, and the course is still needed and essential today. It is a good lesson for PDA—focus on the need of the industry, not what people want to talk about.
Myers: What direction do you see PDA going in the future?
Kirsch: I had a lot of involvement with the U.S. FDA while a member of PDA. We had a close relationship with FDA to the extent we moved to a new sterile facility at Schering, and they were comfortable using the facility for training their people. They came to Schering a couple of times a year to get a better understanding of sterile manufacturing.
You need a positive relationship between FDA and industry. We (Schering) had a significant issue with gentamicin in Puerto Rico in the early 70’s. I ended up going to Washington to discuss the issue in person. As a result of the good relationship with FDA, and being given the opportunity to explain our position scientifically, we were able to resolve the issue during the meeting. I asked to wait for the letter agreeing to our position from FDA, and I was able to leave with the problem resolved in writing. It took years to gain the trust to be able to reach an understanding.
One of the most important aspects of PDA is the Association’s interest in trying to get people to talk in meetings about issues. The ability to ask speakers questions at meetings has been one of the great things about PDA. In the past, these questions and answers were published in our journal. Those discussions were generally better than the presentation.
Myers: At Schering, you were my mentor of sorts, encouraging me to work with Irving Plfug to develop the company’s sterilization validation program as the first validation engineer. You then asked me to make a presentation on the subject at the 1978 PDA meeting in Chicago and later nominated me to run for the PDA Board in 1984. What do you think of a mentoring program for PDA to get our newer members involved in our many activities?
Kirsch: My oldest grandson, who will be 24 in January, worked as an intern at a production company during the last years of high school and the first year in college. At 19, he was given the opportunity to direct and produce a golf program for television. His boss had developed the confidence to allow him to be completely responsible for the entire program, and there it was on television. Jeffrey was listed as the director and producer. What a great experience for him, and it was to the credit of his mentor. Today, our leaders in America are not usually able to allow their subordinates to add creativity. There are ways to coach subordinates to allow for them to input their creativity, and in that sense, I support the concept of mentoring.
This Past Leader Spotlight originally appeared in the following issue:
January 2006 PDA Letter