Warren Casey Ph.D. This is Me

Education

 Web References

1. 1. Making Dollars and Sense of Rapid Microbiolog

   www.pharmaquality.com/makedols - [Cached]

   Published on: 6/8/2002   Last Visited: 6/8/2002

   "Most of the new methods I've seen are labor intensive and you need to get skilled at the technique to get the high throughput," says Warren Casey, Ph.D., Manager of Pharmaceutical Development Microbiology with Glaxo Wellcome in Research Triangle Park, NC. "There are often additional preparation steps, so while you're getting faster results it takes more work. With culture the procedures are relatively simple and standardized, they're just not as fast. You have to set your samples aside and wait."
   
   Some note that looking at rapid microbiology strictly for high-volume QC applications represents a narrow usage of the systems.
   ...
   "The relatively low-tech stuff that is mechanically straightforward is the easiest to validate," Casey says. "Data security and traceability is almost non-existent for some systems. It's nearly impossible to establish an audit trail."
   
   Unfortunately, computer validation was not being intensely scrutinized by FDA years ago when many systems were developed and introduced; it has since emerged as a key focus and point of inquiry. Some manufacturers are finding themselves having to reassess and reengineer some of their systems to be validatable to industry standards. "It's a bit of bad luck really, but manufacturers are definitely aware of this and are working to fix the situation," Casey says.
   
   ...
   "For me, molecular testing is the holy grail," Casey says. "It's so reliable, and the tools are getting cheaper because the technology is being fueled by the big sequencing projects. It's very fast, too: you can get an identification from a colony now in three to four hours, and certainly rule out classes of organisms in an hour. We're working on some method improvements now, and in three or four years I think we're going to be able to get a positive identification in an hour using nucleic acid testing."
   
   Dedicated Evaluators
   
   ...
   Casey is among a relatively new breed of corporate microbiologists who are being tasked specifically with evaluating new methodologies, and implementing them where appropriate.
   ...
   "I figure out which methods have real potential use for us, then blend them in with our existing procedures and eventually implement them worldwide to improve our efficiencies," Casey says. "We have to be able to meet the needs of regulatory authorities throughout the world because we don't want to implement methods piecemeal or in isolated locations."
   
   In looking to increase efficiencies, one should not neglect to look for opportunities for improvements in existing methods, Casey says. For microbial limits testing, for example, sample and growth medium are incubated two to three days, then sample is streaked to selective media, and after another incubation period, the microbiologist examines the plate for growth. "You don't need an $80,000 instrument to give you a yes or no answer at that level," he says. "If there is some cloudiness or turbidity then you would need more than an analyst's judgment call, but a clear plate is a clear plate."
   
   Casey and his staff evaluate new systems and methods by looking for weaknesses. "All systems have an Achilles' heel, so you want to look for this first." Provided further assessment is warranted, "we bring the technology in house and evaluate it for a period of time, running our samples or conducting experiments that have more direct relevance to our needs," he says. "After we evaluate the scientific merits, we then have the QA group check the methods to see if validatable."
   
   Many pharmaceutical companies have indeed validated rapid and automated microbiological methods, and use them routinely in a number of applications. The uptake of these methods will only increase, albeit at a cautious pace, particularly as finalized guidance documents are handed down from authorities such as PDA and USP. But careful evaluation is in order, of both method performance and financial impact, areas in which alternative technologies have largely been able to demonstrate their worth. But as the practice of microbiology steps farther away from its roots, especially as nucleic-acid probe and other molecular techniques come into wider usage, observers remind that the discipline still requires human acceptance and cogitation, and that these will be the primary governors to the pace of change.

2. 2. Making Dollars and Sense of Rapid Microbiolog

   www.pharmaquality.com/makedols - [Cached]

   Published on: 3/11/2001   Last Visited: 3/11/2001

   Most of the new methods I've seen are labor intensive and you need to get skilled at the technique to get the high throughput , says Warren Casey , Ph.D. , Manager of Pharmaceutical Development Microbiology with Glaxo Wellcome in Research Triangle Park , NC. There are often additional preparation steps , so while you're getting faster results it takes more work. With culture the procedures are relatively simple and standardized , they're just not as fast. You have to set your samples aside and wait..
   
   Some note that looking at rapid microbiology strictly for high-volume QC applications represents a narrow usage of the systems.
   ...
   Casey is among a relatively new breed of corporate microbiologists who are being tasked specifically with evaluating new methodologies , and implementing them where appropriate. Johnson & Johnson's Hauschild fulfills a similar role for his company. It takes a lot of effort to validate a method and show equivalence , and a bit of a different approach and skill set , Hauschild says. What we're seeing now is that special groups are being established to investigate microbiological methods. People working in routine QC testing labs don't have the time or resources to focus on feasibility studies and method development issues..
   
   I figure out which methods have real potential use for us , then blend them in with our existing procedures and eventually implement them worldwide to improve our efficiencies , Casey says. We have to be able to meet the needs of regulatory authorities throughout the world because we don't want to implement methods piecemeal or in isolated locations..
   ...
   In looking to increase efficiencies , one should not neglect to look for opportunities for improvements in existing methods , Casey says. For microbial limits testing , for example , sample and growth medium are incubated two to three days , then sample is streaked to selective media , and after another incubation period , the microbiologist examines the plate for growth. You don't need an $ 80 , 000 instrument to give you a yes or no answer at that level , he says. If there is some cloudiness or turbidity then you would need more than an analyst's judgment call , but a clear plate is a clear plate..
   
   Casey and his staff evaluate new systems and methods by looking for weaknesses. All systems have an Achilles' heel , so you want to look for this first. Provided further assessment is warranted , we bring the technology in house and evaluate it for a period of time , running our samples or conducting experiments that have more direct relevance to our needs , he says. After we evaluate the scientific merits , we then have the QA group check the methods to see if validatable..
   
   Many pharmaceutical companies have indeed validated rapid and automated microbiological methods , and use them routinely in a number of applications. The uptake of these methods will only increase , albeit at a cautious pace , particularly as finalized guidance documents are handed down from authorities such as PDA and USP. But careful evaluation is in order , of both method performance and financial impact , areas in which alternative technologies have largely been able to demonstrate their worth. But as the practice of microbiology steps farther away from its roots , especially as nucleic-acid probe and other molecular techniques come into wider usage , observers remind that the discipline still requires human acceptance and cogitation , and that these will be the primary governors to the pace of change.

3. 3. PMFLIST archives -- March 1998 (#111)

   www.microbiol.org/cgi-bin/wa.e - [Cached]

   Published on: 3/31/1998   Last Visited: 8/3/2001

   Warren Casey , Ph.D.
   
   Glaxo Wellcome
   
   > -----Original Message----- > From : NLMora1 [ SMTP : NLMora1@AOL.COM ] > Sent : Tuesday , March 31 , 1998 9 : 41 AM > To :
   
   PMFLIST@MICROBIOL.ORG > Subject :
   
   Re : [ PMFLIST ] Open Conference - Pathogens > > Warren : > > The way I read your post , you are proposing the famous two tier approach > or a > variation of it.