Our fellow QbD evangelist – passed away this month. He will be missed by many of us. My friend, Mehtap Saydam suggested we reflect on Pedro’s contribution as a community with Pedro’s family at this time.
Pedro presenting at a conference
Urn of Pedro with his family at home
Process Understanding with the Right Tools
Many know Pedro for his contribution to the QbD and PAT. Pedro was relentless in preaching “Process Understanding with the Right Tools”.
Pedro emphasized the tools in PAT and QbD should be only implemented if only they help to improve process understanding – as evidenced in his publications and presentations (at the end of this article).
I was grateful and honored that Pedro supported Lean QbD software when it first came out.
Memories of Pedro:
Pedro E. Hernández grew up in Puerto Rico. His family was gracious to share his personal photos.
Pedro Hernandez and Birthday
Pedro Hernandez growing up
Young Pedro Hernandez in Puerto Rico
After finishing BS in chemistry at University of Puerto Rico, Pedro E. Hernández obtained his Ph.D. degree in organic chemistry/natural products synthesis at the University of Pennsylvania with Prof. K.C. Nicolaou. Below is Pedro’s dissertation from 1986.
Then he continued his post-doctoral work at the University of Oxford in the UK focused on carbohydrate chemistry. He worked in drug discovery or scale up with Smith Kline Beecham, Johnson Matthey Biomedical Research, Zynaxis, and Albany Molecular Research.
In February 2004, Pedro joined Wyeth in Guayama Puerto Rico as a Sr. Technology Transfer Scientist II where he was involved in the registration, validation and commercial launch of Lybrel and Pristiq. In 2005 he moved on to lead the PAT group within the Technology Department.
In 2008, he became the Associate Director of QbD/PAT at Wyeth (Pfizer) in NY. He was part of the project team responsible for QbD/PAT implementation that obtained real time release approval from the FDA.
Most of his notable publications (Scroll down) are from this era of work.
Over the course of his career, areas of work have expanded from API to finished drug product manufacturing and packaging finished drug product process. Naturally, he worked closely with regulatory agencies (FDA, EMEA, IMB) and ICH in implementing QbD and PAT.
He later became the Senior Director of Quality in overseeing CMC, Clinical and Bioanalytical areas for Frontage in China. Afterwards, He was the Director of Quality by Design at Merck Serono in Switzerland.
Below are some photos from the many conferences he attended:
Here is a recollection of Pedro Hernandez from Mehtap:
“He is not only a well educated scientist, but also an inherent instructor and mentor. He is such a honest QbD&PAT evangelist, that he can say,
“Stop PAT investment if it is not useful for improving your process understanding.”
“No, this is not real PAT unless can make measurement real time, even it is expensive and high technology”.
As such an insightful QbD and PAT evangelist, sometimes unconventional, he could examine HPLC results with his FT-IR, and disclose the mistakes on HPLC methods.
As a tireless QbD and PAT evangelist, when asked, “Should we renew the PAT model when we change the API vendor?” he would come back without reservation:
“Of course you have to renew the mode!”
He was inventing, implementing and expanding fit-for-purpose technology.
At a conference, someone asked him. “What would it be like without QbD – in one word?”
Pedro said, “We would be exploded! ” (He was referring to PAT and RTR in API synthesis)
He is top of the influencers who wants to improve current pharmaceutical quality system. His priceless experiences will always be an inspiration for our community. Maybe he will smooth our RAMAN spectrums, or correlate our results with an unexpected harmony, maybe like in one of his poems “I will become a ray of light, and with the morning sun I will come through your window”. If not by the hand, in the soul…”
Contributed by Mehtap Saydam
Pedro and Family
Pedro and Family
As Ajaz S. Hussain, Ph.D recollects,
“Through the many presentations and writings of Pedro Hernandez it is abundantly clear that he understood what it takes to achieve quality by design in the pharmaceutical sector.
When some in the sector were inadvertently driving a wedge between the “PAT and QbD” he was one of the few who emphasized the value of an integrated, systems approach, to quality. Pedro was a true champion for ‘process understanding’.
In his passing we have lost a dedicated champion for process understanding. Pedro was a genuine leader – not a searcher for consensus but a molder of consensus (Martin Luther King, Jr.). His teachings and legacy will live on.”
We’ll always remember our friend Pedro and his mission of implementing “Process Understanding with the Right Tools.”
The torchlight has been passed to us.
We shall continue to make QbD and PAT a reality together as a community.
Publications and Presentations co-authored by Pedro Hernandez
- A PAT Approach to Improve Process Understanding of High Shear Wet Granulation Through In-Line Particle Measurement Using FBRM C35
- A PAT Approach to Enhance Process Understanding of Fluid Bed Granulation Using In-line Particle Size Characterization and Multivariate Analysis
- In-line Particle Characterization of Fluid Bed Granulation By Parsum HKI-272 Oct 2009 Campaign at Excella
- QbD/PAT Implementation: The Road to RTR From Science to Compliance Quality by Design China 2013 April 17-18, 2013 Shanghai, China
Pedro Hernandez on PAT – in his Voice:
Photos are resources are from Mehtap and Hernandez family.
If you’d like to add your words to remember Pedro, please comment below.