The pharma and biopharma industries spend billions of dollars every year in their pursuit to discover and develop new drugs. These companies employ brilliant scientists who analyze vast quantities of scientific data in the hope of finding the next blockbuster drug. Discovering a promising new drug is certainly an accomplishment, but navigating it through the development process and ultimately getting approval from the appropriate regulatory agency is a long, expensive journey. For some of these companies, their very existence will depend on their success at getting a drug approved and marketed. Money, scientific expertise, addressing regulatory hurdles, and having convincing data that shows that a new drug actually works all contribute to getting a new drug to market. As a potential new drug proceeds through the gauntlet of the drug development process, it is tested in a series of nonclinical toxicology studies. Data from these studies are used to support subsequent human clinical studies and ultimately are included in regulatory submissions for drug approval.

To summarize, billions of dollars are spent on drug development; brilliant scientists are hired to discover and develop drugs; and in the U.S., the FDA devotes significant time, money, and resources to review new drugs to ensure public safety. So, in the pharma, biopharma, or CRO companies where nonclinical toxicology studies are conducted, guess who generates the data that is the foundation of this complex drug development process? The answer is “kids”! The aforementioned brilliant scientists analyze these data but they don’t generate it. There are exceptions, but in many research components, the data from toxicology studies that are the basis for FDA new drug approval or non-approval decisions is ultimately generated by lower paid, less trained, twenty-somethings. In this column, we’ll examine the effectiveness of training for one of the most critical roles in drug development.

After that introduction, it is probably best for me to explain my perspective. First, I mean no disrespect. I have worked in the drug development industry for more than 30 years, so just about everyone that I encounter in the research environment today is younger than me. Some of these individuals seem really young, hence my use of the term, “kids.” It has to be that they are just getting younger and not that I’m getting older, right? I am sure that I seem like an old fuddy-duddy to them.

Second, many times but not always, the individuals who generate data on toxicology studies are among the most dedicated and passionate workers in the industry. At the same time, I believe that many research organizations have squandered the opportunity to achieve technical and operational excellence by not focusing more on the development of their front-line technical staff. Any scientist will tell you that the quality of the conclusions that are derived from an experiment is only as good as the quality of the data that is used to form those conclusions. This same premise applies to the conduct of tox studies. Thirdly, I won’t waste time reflecting on the extensive in-house training programs that existed when I started in the industry, because economic times are different now and I prefer to look forward rather than backward.

The FDA’s Good Laboratory Practices (GLP) indicates that it is the responsibility of the test facility management to “assure that personnel clearly understand the functions that they are to perform.” This directive assumes that management also clearly understands the functions that personnel are to perform. Sadly, that is not always the case; the criteria for promotion in some organizations seems to be based more on popularity than competence (that debate isn’t exclusive to this industry). That aside, the regulations define the desired endpoint for training, but the “how” is left up to the interpretation of the management team. It is here that philosophical differences in training programs can profoundly influence organizational performance.

Many training programs are developed from industry standards that may include classroom, computer, and/or on-the-job instruction. In some organizations, it almost seems like the credibility of the technical staff is based on the size of their training folders, while in other organizations, the most talented technicians may have relatively small training files. It is one thing to have an impressive-looking training program, but that doesn’t necessarily mean that the program is effective. There is a significant difference between participating in training sessions and being recognized as “trained.”
On a personal note, all of the Six Sigma and human resources awareness training-of-the-month classes mean nothing to me if a technician screws up a study because he lacked sufficient operational training or because he had to hurry to attend one of these training sessions. The seeds of mediocrity are sown when organizations can’t prioritize important activities.

In the U.S., many of the technicians that are hired conduct tox studies often possess two- or four-year college degrees, although there are also outstanding technicians in the industry that are high school graduates. Educational requirements are established by each individual preclinical research organization and may vary somewhat across the industry. I have known highly educated individuals who were less than optimal technicians and I’ve known individuals with no scientific background who were among the best technicians that I have encountered during my career. I have also experienced the opposite of these extremes.

I don’t know any research organization that wouldn’t want an educated workforce, but in some companies, the operational economics may influence staffing decisions. It is pretty simple; non-degreed staff can generally be hired cheaper than those with college degrees. Some operational managers in the industry believe that hiring less educated staff will ultimately improve employee retention. The argument to this philosophy is that hiring more educated technical staff may result in more effective technical operations and a higher quality of toxicology study data. The challenge with this approach is that it may be more difficult to maintain operational stability if the technical staff constantly aspires to higher levels of responsibility in or outside of the company. When the retention of the technical staff is an issue, many individuals do not reside in their jobs long enough to be trained effectively despite their level of education.

Technician training in CROs seems to be subject to changes in the economy. When customer demand is high, revenue growth becomes dependent on available facility space and an appropriately-sized technical staff. As new technicians are hired, there is extraordinary pressure for them to quickly progress to actually conduct of toxicology studies. Although new technicians may go through an accelerated training program, checking off boxes on the appropriate forms does not equate to operational competence. Just because an individual allegedly reads 20 or more standard operating procedures on her first or second day of employment, that doesn’t necessarily mean that she understands or remembers the specific details of each task.

This issue is further magnified during times of sustained high customer demand.
Suddenly, the technician who never really mastered preclinical operations gets inserted into a supervisory role due to the rapidly growing workforce. What may seem like a good employee retention tactic will actually accentuate this growing operational problem. Lesser-trained staff will now oversee poorly trained staff and everyone will be too busy, too afraid, or too ignorant of the problem to raise the concern. It comes as no great surprise that quality and compliance issues seem to occur more frequently during times of increased customer demand. Accordingly, it would seem then that times of slower customer demand would present an ideal time for technical staffs to focus on training. Unfortunately, the recent slow economic times were marked by layoffs across the drug development industry, so this opportunity may have disappeared as remaining employees needed to cover for their departed colleagues.

It has been my experience that the most effective training for technical staff — as well as scientists and managers — comes from the guidance and mentorship by more experienced employees. Some don’t like this on-the-job training because it is not standardized or predictable. I have often used the term “industry veterans” in many of my articles. Many nonclinical research organizations employ industry veterans who are highly experienced technicians. These individuals are walking encyclopedias when it comes to research operations. They’ve had experiences that you won’t find in any book or SOP. In my opinion, the research operations that are best situated for operational success have highly experienced technicians who are willing to mentor combined with less experienced technicians who are willing to listen. I hasten to add that having highly experienced technicians who think they know everything is almost as dangerous to a research operation as having an undertrained technical staff. Truly savvy, experienced technicians understand that they don’t know everything. Mentoring is a powerful training tool and, when used with the appropriate combination of more accepted training programs, it can elevate organizational performance from average to excellent. It comes then as no surprise that one of the most effective marketing tools for a CRO is to acknowledge its highly experienced technical staff. For sponsors unsure about which CRO to select to conduct their nonclinical studies, the experience level of the technical staff can be the deciding factor.

Effective employee training is an investment in a research organization. It is also clear that training programs will suffer when resources are limited or when there are budgetary pressures. Training needs to go beyond regulatory compliance. Effective organizational training requires effective leadership. I have seen highly experienced organizational trainers who failed to understand research operations; their efforts only resulted in a resource tug-of-war with the staff. That said, we have seen that there is more to a training program than checking boxes on a form. Effective training requires time, prioritization, and an overarching understanding of research operations. Effective leadership is required to make a commitment to training. Leadership is also necessary to determine the difference between effective training methods and those that look good on paper but provide little value for the employee. An effective training program should be intertwined with an employee hiring and retention strategy. An employee retention strategy would suggest that some type of career development planning is in place. I favor and would urge research operations to seriously consider minimum time requirements for many of their positions. Yes, I’ve heard that we are dealing with different generations who are less inclined to stay in a job for a period of time. The last time I checked, the drug development industry was still a business. Hiring individuals and allowing them to move to different areas in the company after less than a year or two on the job will result in operational mediocrity and instability. That isn’t a good business practice. Businesses are not democracies. If you are a hiring manager, get a backbone! Set minimum time in the upfront job requirements and stick with them. You will be helping your company and you’ll win the respect of your existing employees. Your company can’t be productive if you are hiring and training staff all of the time. A truly effective employee training program is a comprehensive part of an effective business strategy. 

Finally, I would like to send kudos out to Laura, Lisa, and Christine who work at different CROs across the industry. Each of these primary technicians just recently finished conducting a carcinogenicity study. I had the rare opportunity to work with these individuals for the entire two-year duration of these studies. Conducting these studies is not terribly stimulating, so their commitment is admirable. In addition to their mastery of the study status, I especially appreciated the leadership that each one exhibited so that no less trained technician would mess up “their” study.

Training and Leadership. Leadership and Training. Do it well and you’ll have satisfied customers. And by the way, a little recognition along the way goes a long way. 

Steve Snyder is a consultant with more than 25 years of experience in preclinical toxicology as an outsourcing customer and provider. He can be contacted at info@outsource-support.com.