By Wendy Meyeroff
We take pride in hiring top-tier individuals,” says Robert Sexton, associate director/learning program leader at Novartis Pharmaceutical’s Oncology Global Development Education Office. Well, of course. Doesn’t everyone?
And because everyone in biopharma hires such “top-tier individuals,” there’s no real reason to worry much about training them, right?
Voiced aloud, the question probably sounds ridiculous. Yet, as we explored this topic we heard regularly that not all biopharma executives see any need for formal training of their personnel. Instead, most managers have to cull training dollars out of the overall budget of their specific departments — if they even look for the money.
Where Training Is Needed
There is actually an astonishing array of issues in which biopharma personnel need training. Some are clinical, such as meeting lab cleaning compliance issues, understanding and meeting FDA requirements for product safety, and understanding specifics on coping with EU regs. Others are more business-oriented, such as managing your lab, writing effective SOPs and procedural documents, and applying good manufacturing practices (GMPs). Understanding the latter, experts agree, is a major factor in receiving approval for any biopharma product brought to market.
Despite all these needs, many companies only come (often reluctantly) to training in response to outside regulatory pressures. Other times, courses are sought or established through corporate insight, as was Sexton’s situation. His job, in a department created only about a year ago, involves ascertaining the best training method for whatever needs to be taught to his group and providing it.
Why even create such a learning department? “It was determined that we needed organizational agility that promoted rapid deployment of new techniques, new knowledge in anything. It could be in computer use, new management skills, or new methods of clinical development,” says Sexton. “As those changes come about, we want to ensure our people have the information they need to implement them expeditiously.”
Definite Cost Concerns
“Upper management often sees training as an unnecessary expense on the bottom line,” says Bill Beyer, director of marketing at the Center for Professional Innovation and Education (CfPIE). CfPIE supplies training and certification in biotech/pharmaceuticals, medical devices, and skin/cosmetics products.
The expense of training was a concern even before the recession, but it’s been exacerbated over the last few years. Two- or three-day training sessions can cost from $1,800 to over $2,500 per person — and that’s just the class fee. When a class is off-site, there are additional expenses such as transportation, meals, and housing.
Leslie Orischak understands the financial pinch of training even more acutely than many larger companies. That’s because she is the VP/general manager of Puresyn, a nine-person company in Malvern, PA, that provides proprietary polymer technology for the separation and purification of nucleic acids and other biological molecules. “We don’t have budgeted training money, so we obtain state grants for training,” she says.
There are also less tangible costs to training, such as those Sexton faces when choosing options for high-level personnel such as clinical trial managers, outsourcing managers, and doctors (e.g. M.D.s) who are program leaders.
Feedback from these people indicated a need for a course on managing interactions with their clinical research organizations. Sexton could have turned to Novartis’ own experts to teach the class internally, but he determined that wasn’t the most productive solution. “The people who would have had to teach it are fairly high up and didn’t have two days to devote to training,” he says, pointing out their time was better spent elsewhere. Instead his experts provided CfPIE with input as to what the class needed, and then CfPIE developed and taught the class.
Although Sexton’s work involves responding to issues his managers raise, external pressures are often the impetus for biopharma training. “FDA and other global industry regulations tend to mandate training. Companies now realize that training is part of compliance,” says Beyer. “And it’s not just taking the training; it’s proving it’s been completed. Most federal regulations reference the need for documented training.”
In the United States, the FDA has several offices of compliance that set standards for various industries, including medical devices; vaccines, blood and biologics; or materials relating to the veterinary field. “In our training, we studied 21 CFR [Code of Federal Regulations], the regulations particularly pertaining to pharmaceuticals. Thanks to that, we know to go back to the CFR on the FDA website, so we can stay current and handle any regulatory changes and updates ourselves,” says Katharine Fuellhart, manager of technical writing at a major biopharma company.
Some of the classes biopharma companies seek involve creating and maintaining precise documentation. One such class is understanding and utilizing batch records, the documentation of how a specific batch (e.g. pharmaceutical) of something’s been processed. When negative reactions to a drug or vaccines occur, the ability to track back to a specific batch can be crucial.
Orischak says although they’ve always provided such records, training gave them new insights. “It showed why our customers ask for such a record. We saw that even when the customer doesn’t ask for the batch record, the FDA does.” Now Puresyn has one manager overseeing documentation. As new procedures arise or old ones need to be modified, says Orischak, “Changes are reviewed at a staff meeting, and everyone has to sign off that they’ve learned and understood it.”
In Fuellhart’s company, electronic sign-offs occur. Now not only is there limited access to forms to begin with, but if you do try to open an outdated file, “There’s a prompt telling you that you’re not working in the current version,” she says.
These may sound like relatively small details for bringing a product to market, but proper training in them can impact a company’s success when they’re audited. Instituting such procedures also reinforces a company’s emphasis on precision.
Online Vs. Live Instructors
There are a wide variety of training options available, especially now with online webinars generally available. These types of webinars offer a lot of convenience, such as allowing individuals to move at their own speed and have the ability to take a class anywhere they want, even when on the road. It’s also sometimes less expensive, though this depends on the class. For example, the FDA Office of Regulatory Affairs touts ORAU, its online “university,” where classes are free. But there are other considerations. “Online training is great and can be very effective, but it depends on the course. For example, learning team building is hard to do effectively when online alone,” says Orischak.
Besides, ORAU doesn’t seem to teach much specific to biopharma. Your staff might get an understanding of microbiology in ORAU’s class on Food Microbiology, but is it as relative to your work as something like CfPIE’s class on cleanroom microbiology for the nonmicrobiologist? Also, ORAU’s classes are only 60 to 90 minutes, so it’s unlikely your people will get as much depth of information as they can in certified providers’ classes, which often last one to three full days.
Trainers On- or Off-Site?
“When the FDA sees live instruction, they say [unofficially] the firm has a higher commitment to compliance and is seen more favorably,” says Beyer. “Also, classroom interaction keeps participants focused and interested.”
Then, the question becomes whether to hold the event in-house or off-site at one of the trainer’s offices. The latter incurs a more nebulous cost: the price of losing key personnel’s time when they train off-site. So what makes it worthwhile?
“This kind of course content is highly technical, so there should be no distractions,” says Beyer. Kelly Morello agrees. “If your people are away, the home office thinks twice about interrupting. If they’re learning on-site, there are calls, emails, and other distractions,” says Morello, senior director of programs and workforce development at Pennsylvania Bio, a trade association dedicated to ensuring that Pennsylvania and the mid-Atlantic area is a leader in bioscience industry. (It’s the group that helped Orischak fund her team’s training.)
With off-site training, employees also have the chance to interact with other attendees. “Sitting next to me at a recent training session was someone from Pfizer and someone from Merck,” says Fuellhart. “You’re hearing from other document coordinators, and you get to see that they have the same problems you do, as well as some you haven’t anticipated. Even if you’ve solved the problem being discussed, you may find a new approach to use.”
If you are training on-site, it’s essential you make a commitment to keeping your staff focused on their class. Orischak made that kind of commitment. “We wanted everyone in the lab to be cross-trained. That way someone can take a vacation or be out sick, and we’re not suddenly desperate. So the CfPIE instructor came here and trained all of us together over a two-day period,” she says. It wasn’t easy, she notes, especially having to adjust everyone’s schedule, factoring in deadlines, and making sure they were present.
Specialization can be critical, and it’s one of the characteristics Morello encourages companies to look for in their training provider. “Look for a company that has a good reputation, understands the industry, and has made a commitment to it,” says Morello. (You don’t want a provider that’s teaching execs in biopharma one day and hotel execs the next.) “Find out how long this provider has been in business. What are their references?” she adds.
Beyond what they teach, look for how classes are taught. Are the instructors experts in their fields? Are the teachers monitored for providing quality content? Are class sizes limited to a number that allows students to learn anecdotally from each other as well as the course directors? Also, make sure the provider is willing to customize or tweak its program to best fit the needs of your staff.
The executives interviewed for this article repeatedly stressed the consequences of not having proper training. Enough failures in getting approvals — or other hassles — can cause key personnel to leave and join companies they respect more.
In short, training lets you stay on top of your game. “You might have learned a new technique which, brought in-house, could have saved you production dollars down the road, or you might have had a higher profit margin on your product with it,” says Morello.
Having improperly trained personnel can have a major impact on getting products to market. “If it’s discovered someone had used an outdated procedure, that would have ramifications on how the product is packaged or processed, delaying FDA approval. So there you are, getting ready to ship, and now you can’t,” says Fuellhart.
“Time is critical,” says Sexton. “The development pace in oncology is very fast. You want the drug out quickly, and the patient doesn’t have a lot of time; a one-day difference can be crucial.” Ultimately, all of the experts interviewed emphasized that delays in biopharma due to poor training are not just about money — they can cost people’s lives.