By Paul Thomas, Managing Editor
In step with FDA’s 21st Century GMPs, more drug manufacturers are working to better understand and control their processes. Biotechnology, and concepts such as process analytical technology (PAT), continuous processing and more advanced control promise to change the way that drugs are made.
As it considers whether to embrace this brave new world, the pharmaceutical industry also faces a critical question: Can the existing workforce handle the changes taking place? Will it be up to the challenges in store for it?
Experts within industry, the FDA and academia aren’t so sure. The industry just doesn’t yet have the right people, with the necessary skill sets, to move drug manufacturing to the “Desired State” where scientific principles define quality, they say.
“Manufacturers will need professionals with multidisciplinary skill sets combining process knowledge, process control, industrial IT, process analysis, multivariate analysis and Design of Experiments,” says Ingrid Maes, an Antwerp-based consultant for Siemens. “There are probably only 30 people alive who fit that description,” she says. “This is the real reason why PAT has not yet been fully adopted by the industry.”
Drug manufacturing professionals today do their jobs well and products released are of high quality, but industry expectations are rapidly changing. What was okay 10 years ago “is just not good enough anymore,” says Ray Scherzer, SVP of engineering, technology and capital management at GlaxoSmithKline. “Our manufacturing professionals will need to continue to expand their technical skills and gain even more expertise in the fundamental sciences that govern our manufacturing processes.”
“It’s like turning a battleship.
If they’re not to stifle progress, drug manufacturers will need to reorient their workforces, and to find new, innovative ways to train, reward and recognize employees (see Training with Some New Twists, below). Academia will also have to change the way it teaches its students — both on the university level and on the “gold-collar” paraprofessional track (see Get Them While They’re Young, below).
What is needed, experts agree, is nothing short of a drug manufacturing workforce revolution. Can it happen?
Yes, but it will take some time, Scherzer says. Most industry watchers expect it to take five to seven years, as training and degree programs are updated and upgraded, and students and professionals complete them. In addition, the industry will need to attract a different type of professional. Drug companies already have pharmacists, chemists and microbiologists, Scherzer says. Now they need more chemical engineers, as well as physical chemists, statisticians and rheologists. FDA has already moved in this direction by hiring more modeling experts. Industry will need to follow suit.
To date, the most comprehensive effort to tackle the workforce training issue is ISPE’s (Tampa, Fla.) “Pharmaceutical Manufacturing Professional of the Future” initiative. The program’s goal is to identify the knowledge areas and skill sets that will be critical to the industry’s future. “We need to ensure that the people coming into the industry have the right skill sets to hit the ground running,” says Jon Tomson, a past ISPE chair who is leading efforts. Contributors from ISPE, FDA, manufacturers and academia are now just beginning to articulate those needs. Once that is done, the group will “take it on the road” and sell the objectives to manufacturers and universities, Tomson says.
The training issue
The concept behind the initiative already resonates with many regulators and manufacturers, who note a serious disconnect between what manufacturing professionals can do, and what they will have to do from now on. “Right now, [during the manufacturing process], the guy on the shop floor doesn’t know whether what he’s making is the right quality of product or not,” says Ali Afnan, Ph.D., of FDA’s Office of Pharmaceutical Science. “He needs to understand what is special about his processes and how to manage them.” That means more exposure to engineering principles and some familiarity with skills such as multivariate analysis, process analysis and process control. It also presupposes an appreciation and understanding of other functions within the organization.
Pharma’s tendency to “compartmentalize” is one of the major obstacles that training programs face. “Honestly, it will be extremely hard for companies to [adequately] retrain existing employees,” says Siemens’ Maes. “They’re used to a silo organization and it’s quite hard to change this [mentality].”
But the silos must go. “The luxury of doing one thing doesn’t exist any more,” says Gail Sherman, VP of education for PDA (the Parenteral Drug Association; Baltimore, Md.). This is true for everyone in manufacturing. Courses at PDA’s Training and Research Institute were once populated by plant-floor operators, but they’re now also attracting supervisors, managers and QA/QC professionals, Sherman says.