From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories 40
After teaching a one-semester graduate regulatory course at a major university, I
followed the usual routine of asking students to fill out an evaluation form. Much to my
dismay, several students commented on my poor teaching methods, saying the course
was of little value in terms of their current jobs. Many of the students were employed
by pharmaceutical companies, and the course was devoted to medical device law.
Surprisingly, one student resented the opening remarks of each lecture where I discussed
and recommended books I felt should be part of a personal professional library. The
student unabashedly wrote that she was able to select her own books or would read only
those recommended by a supervisor. Obviously, even though I prepared my lectures
carefully, I did not convey my philosophy of learning to every member of the class.
I also was unable to persuade the majority of the class to keep up with current lit-
erature, or convince them that knowing about the derivation of food and drug law is one
factor that distinguishes an excellent employee from an average one.
Another student objected to a lecture on “21 Ways to Stop Procrastinating.”
Admittedly, the lecture was rather simplistic, but it addressed an issue that continues to
trouble me. It has taken me years to understand how and why I tend to delay what is most
difficult, fail to prioritize my tasks and do the easy things first. Just preparing that lecture
helped me. Perhaps, by continuing my focus on excellence, I belabored the point empha-
sizing that a regulatory career is a process that requires a commitment to continuous
improvement. I wanted the students to appreciate the fact that knowing about the Code of
Federal Regulations, the Medical Device Directive, standards and FDA guidance documents is
just one facet of the overall profession.
During the often exhausting and interminable lecture period (classes were Sundays,
8 am–4 pm), I stressed the need to develop a broad knowledge base including speak-
ing, negotiating and writing skills, and suggested that joining such organizations as
Toastmasters and the American Medical Writers Association helps hone those skills.
(According to Rudyard Kipling, “words” are the most powerful drug used by mankind.)
I did not overemphasize the fact that fastidious proofreading, hard work and comprehen-
sive research and practice are required to produce an accurate, complete, well-written,
organized and scientifically sound submission. Agency officials have often criticized
industry for submitting incomplete or poor-quality documents.
Several students resented the time devoted to negotiating skills, even though they
often are instrumental in attaining product approvals or dealing with compliance issues.
Negotiation requires solid planning, preparation, careful listening and attending to the
other party’s signals.
I mentioned the value of learning more about clinical research and quality assur-
ance to those aspiring to advance their regulatory careers, an important factor because
higher-level positions often include these disciplines. This was one reason for recommend-
ing books dealing with medical language, scientific writing and practical approaches to
clinical trials and statistical methods. For the latter, I believe regulatory personnel should
know the difference between the “Frequentist” technique (the null hypothesis approach)
and Bayesian analysis. While we cannot all be statisticians, it is important to become
familiar with significance levels, power, Type I and II errors and confidence intervals—
terms common to clinical and test protocols. Six Sigma programs also require a broad
understanding of statistics.
My teaching methods may be archaic and sometimes ineloquent, but I still believe in
them. Years spent working in industry and as a consultant have taught me a number of
lessons. Among them are:
• Never be complacent—learn as much as you can. Make a commitment to con-
tinuing education throughout your life.
• Change yourself and your job will improve.
• Be silent when you have nothing relevant to say and learn to listen.
After teaching a one-semester graduate regulatory course at a major university, I
followed the usual routine of asking students to fill out an evaluation form. Much to my
dismay, several students commented on my poor teaching methods, saying the course
was of little value in terms of their current jobs. Many of the students were employed
by pharmaceutical companies, and the course was devoted to medical device law.
Surprisingly, one student resented the opening remarks of each lecture where I discussed
and recommended books I felt should be part of a personal professional library. The
student unabashedly wrote that she was able to select her own books or would read only
those recommended by a supervisor. Obviously, even though I prepared my lectures
carefully, I did not convey my philosophy of learning to every member of the class.
I also was unable to persuade the majority of the class to keep up with current lit-
erature, or convince them that knowing about the derivation of food and drug law is one
factor that distinguishes an excellent employee from an average one.
Another student objected to a lecture on “21 Ways to Stop Procrastinating.”
Admittedly, the lecture was rather simplistic, but it addressed an issue that continues to
trouble me. It has taken me years to understand how and why I tend to delay what is most
difficult, fail to prioritize my tasks and do the easy things first. Just preparing that lecture
helped me. Perhaps, by continuing my focus on excellence, I belabored the point empha-
sizing that a regulatory career is a process that requires a commitment to continuous
improvement. I wanted the students to appreciate the fact that knowing about the Code of
Federal Regulations, the Medical Device Directive, standards and FDA guidance documents is
just one facet of the overall profession.
During the often exhausting and interminable lecture period (classes were Sundays,
8 am–4 pm), I stressed the need to develop a broad knowledge base including speak-
ing, negotiating and writing skills, and suggested that joining such organizations as
Toastmasters and the American Medical Writers Association helps hone those skills.
(According to Rudyard Kipling, “words” are the most powerful drug used by mankind.)
I did not overemphasize the fact that fastidious proofreading, hard work and comprehen-
sive research and practice are required to produce an accurate, complete, well-written,
organized and scientifically sound submission. Agency officials have often criticized
industry for submitting incomplete or poor-quality documents.
Several students resented the time devoted to negotiating skills, even though they
often are instrumental in attaining product approvals or dealing with compliance issues.
Negotiation requires solid planning, preparation, careful listening and attending to the
other party’s signals.
I mentioned the value of learning more about clinical research and quality assur-
ance to those aspiring to advance their regulatory careers, an important factor because
higher-level positions often include these disciplines. This was one reason for recommend-
ing books dealing with medical language, scientific writing and practical approaches to
clinical trials and statistical methods. For the latter, I believe regulatory personnel should
know the difference between the “Frequentist” technique (the null hypothesis approach)
and Bayesian analysis. While we cannot all be statisticians, it is important to become
familiar with significance levels, power, Type I and II errors and confidence intervals—
terms common to clinical and test protocols. Six Sigma programs also require a broad
understanding of statistics.
My teaching methods may be archaic and sometimes ineloquent, but I still believe in
them. Years spent working in industry and as a consultant have taught me a number of
lessons. Among them are:
• Never be complacent—learn as much as you can. Make a commitment to con-
tinuing education throughout your life.
• Change yourself and your job will improve.
• Be silent when you have nothing relevant to say and learn to listen.