ABSTRACT
Introduction A few years later, I was asked to attend a meeting in Hilton Head,
South Carolina, where bioequivalence was one of the topics of discussion. There were presentations by several statisticians from the FDA, academia, and industry on the topic. I regarded this as somewhat of a pain - there was a lot of work to do, I had a date that weekend, and I could not see where flying off to Hilton Head was going to be helpful to anyone at all. My boss, however, vetoed my not going. It was expected that I would
attend (and eventually participate in) such conferences as a matter of professional development, representing the company and the discipline of statistics (etc., etc.). Also, she did not have time to go. So I dutifully packed my bags and headed down. One of the reasons I had gone to work was that I was tired of sitting through lectures, but I left secure in the knowledge that at least maybe I could possibly play golf while down there. When the conference was over, I came back and reported on the upcom-
ing new FDA proposals about assessing bioequivalence (to be discussed later in this chapter). I was still pretty new to the company and industry at this point, so how bioequivalence testing was done did not really bother me one way or the other. As long as I knew what to do with the data and how to design the studies, I was holding up my end. The FDA was planning to issue a draft guidance on the topic later that year. The reaction I received was kind of like the reaction one gets when
accidently knocking over a bees’ nest - the bees are very surprised, kind of annoyed, do not like it, and may be less than friendly. My boss was very surprised by the information I brought back, and to be blunt, did not believe me. I argued about it with her for a while, showed her my notes, and pointed out that if she did not like the message, it was her fault as she was the one who had made me go. That was not helpful in resolving the argument. In the end, I had her invite one of the local academic statisticians who had given a talk at the meeting to come to ‘the Unit’ to discuss the upcoming FDA proposals. If she did not believe me, I figured she would believe him. Either way, it
was fine by me. I had work to do, and it was windy and rained the whole time, so I had not gotten to play golf. My going to the conference had been a disappointment to everyone as far as I could tell, and I resolved to do so as little as possible in future (little did I know....). It is amazing how often this type of thing happens in industry (not the
arguments - that happens every day - the inviting of external people to make a point). I have had to do this type of thing several times since then. You may know exactly what is going on for a particular issue, but very often people at the company want to hear it themselves from someone else external to the company before they will believe that they really have to do anything about it. It has been pointed out that we have to pay these people to come talk to us (i.e., this approach is not really cost-effective), but that is how business is often done. After the external academician came in and spoke with us, my boss
believed me, and there was a great deal of discussion at the company about the possible implications of this proposal (nobody knew) and when it would come into effect (no one knew that either). In the end, my boss asked that I go down to Washington, DC, with her the following winter after the draft guidance was issued [122] for a special FDA Advisory Board meeting on the topic. These are meetings of experts (external to the FDA) on a particular topic who advise the FDA on how to protect public health. In the end, this resulted in my spending the next approximately five
years working on this area of bioequivalence, doing extensive research and presenting at various meetings here, there, and everywhere on the topic and its implications for public health. It was important and also interesting research, and I saw most of the airports in North America (and beyond). The lesson of this experience is:
1. Conference attendance is actually important. It keeps one on the cutting edge at work.
