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Agnes Shanley is senior editor of Pharmaceutical Technology.
This month marks the death of a pragmatic, original thinker who helped make PAT and QbD a reality at more pharmaceutical facilities throughout the world.
This month, the pharmaceutical industry has lost one of its most zealous advocates for modern quality and process improvement, with the death of chemist Pedro Hernandez Abad, an expert in the implementation of process analytical technology (PAT) and pharmaceutical quality by design (QbD). Born in Puerto Rico, where he obtained his undergraduate degree in chemistry, Mr. Hernandez received his PhD in organic chemistry from the University of Pennsylvania and studied at Oxford University, where he did post-doctorate research in carbohydrate chemistry. Early this year, he had set up his own independent consulting business, after working as director of QbD at Merck-Serono in Switzerland.
Prior to that, he had led quality and bioanalytical efforts for Frontage Labs in China, and oversaw PAT efforts at Wyeth, where he managed Wyeth’s “PAT Factory,” a model for many companies launching PAT programs.
Mr. Hernandez established the company’s PAT team in Pearl River, whose many achievements include obtaining real-time release product approval from FDA. Former colleagues have praised his dedication, with Jack Carroll calling him “One of the foremost effectors of PAT and QbD in the working pharmaceutical environment,” and Saly Romero-Torres noting that he always put the interests of his reports and the company above his own, and that he encouraged and promoted an environment conducive to new ways of thinking.
As his LinkedIn profile notes, Mr. Hernandez' career followed the path of a drug product, moving from discovery, at companies that include SmithKline Beecham and Johnson Matthey, to scaleup, and manufacturing. He had worked on both the API and finished drug product sides of the industry. He had authored numerous peer-reviewed papers and held 13 global patents. He had also taught at the University of Puerto Rico.
Mr. Hernandez was anything but one dimensional, with varied interests, a sharp, ironic wit and a pleasant way with people of all backgrounds. Never one to suffer fools gladly, he wasn’t above getting involved in “unorthodox” editorial projects from time to time, including this “letter to Santa Claus” on behalf of the industry.
Informally, some of his colleagues within the PAT and QbD expert communities have been discussing programming a brief tribute to him at the next IFPAC conference in January, 2016.
Many of the advances that we see within the industry and within FDA, and the dawning interest in robust quality standards in China and other developing nations, stem directly from the efforts of Mr. Hernandez and thinkers like him, who recognized the transformative power of PAT and QbD. His example might serve as an inspiration for any scientist who struggles to get senior management support for a new, better way of doing things.
Mr. Hernandez will be missed by many. Below are some comments that he had on the progress of PAT, five years ago. We do not have any more details, beyond confirmation of his death, at this time, but wanted to let the community know. If anyone would like to share recollections of Mr. Hernandez, please leave a comment after this post.
Question: What is Holding PAT Back?
There is a fear of change and loss of control. When quality moves from lab to the manufacturing line, there’s a learning curve, and of course, there are issues of cost, and fear of the unknown, so there’s a big cultural component to implementing QbD that needs to be addressed in the transformation.
There has been a lot of discussion about mandates and incentives. The problem with those, which stems mainly from the industry’s global nature, is that the Agency can only provide a target or a goal, not a map. There are too many specific processes and particular products, and there is so much variability in terms of unit processes and products, that efforts must be left to each organizations.
One approach might be to do some benchmarking studies using “success stories” from pilot programs, but the secretive nature of the industry has made such data sharing difficult. This approach could be dangerous too, because we could create silos for different groups within the same company, for different companies and the same group of inspectors and then end up with slightly different requirements for different companies, within the same company, or within the same regulatory agency, if we’re not all on the same page.
There’s a need for champions. QbD and PAT cannot be done part time. You need to have champions who can drive the effort... The big question is ‘How much is it going to cost?’
The roadmap issue is very specific to the process. If I put $500,000 into equipment and training, I need the money back by the end of the year. An exact number is not always possible to predict. More and more companies are moving toward doing real financial viability studies for PAT. In the current environment that’s understandable.
Then there’s the lack of understanding, the question of “What’s in it for me?” But if you don’t put product quality as the object of your organization, and think of good product quality and good patient outcomes as the target, there’s no financial argument that can be made. You have to first believe in these goals and then manage risk wisely, invest properly and innovate.
Part of the problem is that we’ve stopped doing innovation. We validate, and then the learning stops there. After that, we just put out fires. There has to be a real change in the way we think….and an understanding that quality means continual improvement.
For some organizations, it’s a question of the support systems. It’s not just an instrument on the line, but the issues such as IT infrastructure and meaningful sampling strategies. Then there’s the question of which metrics will be most meaningful”