Saturday, 24 October 2015

10th Parenteral Drug Association (PDA) pharmaceutical microbiology conference report

Near Washington D.C., pharmaceutical microbiologists recently gathered to discuss drug safety concerns together with the latest technologies. Here we report from the 10th Parenteral Drug Association (PDA) pharmaceutical microbiology conference.


The PDA Global Microbiology Conference is the largest gathering of microbiologists, together with other scientific disciplines, engineers and quality personnel, related to pharmaceuticals and healthcare products in the world. This year the conference took place at the Bethesda North Marriott Hotel and Conference Center. The vent was aimed at industry, academic, and regulatory professionals.
Bethesda North Marriott Hotel and Conference Center; a view of the hotel exterior.
Bethesda North Marriott Hotel and Conference Center; a view of the hotel exterior.
The conference spans three days, often with two streams running concurrently together with plenary sessions. Days begin at 7 a.m. with work groups and run onto 6 p.m., resulting in plenty of discussion, debate and activity. The conference program was put together by a PDA organizing committee and co-chaired by Amy McDaniel, PhD of Pfizer, Inc. and Kalavati Suvarna, PhD, of the U.S. FDA.
Day one of the conference opened with two key note speakers on Ebola. The first was from Michael Kurilla, MD, Director, Office of BioDefense Research Affairs, National Institute of Allergy and Infectious Diseases (NIAID), which is part of the U.S. National Institutes of Health (NIH) and Luciana Borio, MD, Assistant Commissioner, Counterterrorism Policy and Acting Deputy Chief Scientist, Office of Counterterrorism and Emerging Threats at the U.S. Food and Drug Administration (FDA.)
Dr. Kurilla presented on the reasons why the current Ebola crisis in West Africa has been so devastating. This related to infrastructure, controls, customs, and new information about the undiscoverability of the virus itself. Digital Journal carries a full review of Dr. Kurilla's presentation here.
Dr. Borio explained the FDA's role in the Ebola situation, especially in relation to the safety assessment and approval of new drugs. Here Dr. Borio explained why the process of assessment is sometimes seen as slow, which she puts down to the importance of safety assessments. Here she drew a contrast with European authorities who have been more willing to release Ebola drugs with less efficacy data. Digital Journal has an in-depth review of Dr. Borio's presentation here.
Following these presentations the conference divided into different streams. One was chaired by Michael Miller, PhD, President, Microbiology Consultants, LLC. This focused on rapid microbiological methods, a subject for which Dr. Miller is one of the world's leading authorities. These are methods designed either to give a faster time-to-result, so that medicines can be released faster in relation to an assessment about microbiological contamination, or where methods are more accurate.
Program for the PDA 10th Annual Global Conference on Pharmaceutical Microbiology  where Ebola resear...
Program for the PDA 10th Annual Global Conference on Pharmaceutical Microbiology, where Ebola research was featured.
The second stream looked at microbial contamination control case studies. This was chaired by Marsha Stabler Hardiman, Senior Consultant at ValSource, LLC. This session included a presentation delivered by Jeanne Moldenhauer, who is Vice President at Excellent Pharma Consulting, Inc. Jeanne spoke about how microbiologists need to focus on preventing contamination incidences from occurring rather than continually gearing themselves up to investigate incidents when they occur. To do this, she emphasized, required a new paradigm.
The first stream of the afternoon was chaired by Dr. Amy McDaniel, looking at innovative technologies. Running in parallel Dr. Kalavati Suvarna chaired a session on risk assessment. This contained a good presentation by Jim Polarine on strategies for fungal contamination.
These sessions led into a plenary session chaired by Dr. Richard Levy on myths relating to microbiology. The three speakers were Dr. David Hussong, who covered common misinterpretations about pharmaceutical drug manufacturing; Dr. Tim Sandle, who addressed common laboratory myths; and Captain Sharon Thoma, who looked at inspections by regulatory authorities.
Access all areas - Tim Sandle s PDA conference badge
Access all areas - Tim Sandle's PDA conference badge
The key note speaker on day two was delivered by Andrew Gewirtz, PhD, Professor, Center for Inflammation Immunity and Infection, Georgia State University. Dr. Gewirtz raised some interesting issues pertaining to processed foods and the effect they have gut microorganisms and a potential role in disease. These issues are explored further in an in-depth Digital Journal feature.

Parenteral Drug Association logo. The PDA was founded in 1946 and it a non-profit making science soc...
Parenteral Drug Association logo. The PDA was founded in 1946 and it a non-profit making science society.
The conference then divided into two streams. One was led by senior FDA reviewer Dr. Vinayak Pawar, on biofilms and endotoxin, with a strong focus on how water systems become contaminated and how contamination can be addressed. The second was moderated by Osama (Sam) Elrashidy, looking at quality issues. This stream included an important presentation by Dennis Guilfoyle, PhD, Senior Director, Microbiology and Analytical Regulatory Compliance, Johnson & Johnson, about the quality issues surrounding several compounding pharmacies and the spate of recalls over the past three years.
Two further streams followed. One was on biotechnology, moderated by Kim Sobien; the second looked at how regulatory agencies and pharmacopeia bodies can work more closely together, led by Julie Barlasov.
Delegates in between sessions at the PDA 10th Annual Global Conference on Pharmaceutical Microbiolog...
Delegates in between sessions at the PDA 10th Annual Global Conference on Pharmaceutical Microbiology.
The final plenary of the day allowed younger scientists the opportunity to present their thoughts and research in a series of fifteen minute presentations. Many of these were extremely good. The presenters were: Jarett Scalzo, QC Microbiologist Supervisor, Agensys, Inc. (on risk assessment); Ayako Hasegawa, PhD, Senior Scientist Applied Microbiology, Allergan, Inc. (on aseptic processing); Susan Hatley, Scientist I, Pfizer, Inc. (on processing contamination) and Lia Jeffrey, PhD, Senior Manager, Genentech, Inc. (on developing a laboratory test method for anaerobic bacteria.)
During a gala dinner later that evening, a life time achievement award was presented to Dr. Tony Cundell. Among his many achievements, Dr. Cundell is currently co-chair of the PDA task force on the exclusion of objectionable microorganisms from pharmaceutical drug products, medical devices, consumer health products and cosmetics.
Dr. Tony Cundell receiving the distinguished service award from the PDA.
Dr. Tony Cundell receiving the distinguished service award from the PDA.
Day three had a regulatory focus. Dr. David Hussong discussed developments and future work for the United States Pharmacopeia and Karen McCullough discussed endotoxin. These were followed by a review of the recent FDA re-organization delivered by Lynne Ensor.
The final feature of the conference was a two hour "ask the experts" panel where international experts in pharmaceutical microbiology fielded questions from the audience. The panel included Dr. Lynne Ensor; Dr. Tim Sandle; Captain Sharon Thoma; and Dr. Patricia Hughes.
A pillar listing the organizing committee of the 10th annual PDA microbiology conference.
A pillar listing the organizing committee of the 10th annual PDA microbiology conference.
What is especially good about the conference is the opportunity to meet and mingle with the U.S. Food and Drug Association (FDA), where reviewers and inspectors are present along with senior staff. There is no other conference that I am aware of where the so-called 'regulatory divide' is temporarily suspended.
There was a sad note at the conference with the passing away of Dr. Scott Sutton. Scott was one of the pioneers of 'modern' pharmaceutical microbiology and he had been instrumental in the development of techniques relating to antimicrobial effectiveness testing and with the neutralization of disinfectants (something necessary to avoid 'false negatives' and to enhance the accuracy of microbial counts.) I had spoken with Scott on the afternoon of Sunday 18 October and exchanged pleasantries. Later it was announced that he died later in the evening in his hotel room. He was an inspirational figure to me, as a microbiologist, and I would frequently reference his writings. I hope that some future award or conference theme is named in his honor.

Posted by Tim Sandle