Chair Lynne Ensor speaks about coronvirus
SMi Reports: Lynne Ensor, Vice President, Technical, Parexel International discussed the latest development in the field, her thoughts on the developing regulatory environment and more.
The 3rd Annual Pharmaceutical Microbiology East Coast Conference will convene in Boston on April 29th and 30th, 2020 to address the unique needs of pharmaceutical microbiologists and interdisciplinary scientists involved in manufacturing. It will also provide excellent opportunities to network, interact, exchange, as well as learn from industry experts and professionals from around the world.
SMi Group caught up with the conference chair Lynne Ensor, Vice President, Technical, Parexel International, to find out more about her expertise and role in the industry, what she’s looking forward to at this year’s Microbiology East Coast Conference, what vital topic she’ll be addressing in her presentation, and much more.
In particular, Lynne provided a thorough overview of significant developments within the field from over the past year, including a discussion on the new Corona Virus.
Here is a snapshot of what was discussed:
The pharmaceutical microbiology market has matured greatly over recent years, what significant developments have you noticed in the last year within the field?
“With the most recent media headlines dominating our news feeds, the coronavirus outbreak is an excellent starting point. Since the question posed specifically asks about recent maturity of pharmaceutical microbiology, this outbreak highlights the utilization of recent pharmaceutical microbiology advances. Some of these advances allowed the organism to be identified quickly to determine if it was in fact a novel organism (as mentioned below), may assist in the determination of its origin, and allow for development of diagnostics for earlier detection. Areas where improvements are still needed and could be addressed with future advances in pharmaceutical microbiology have also been highlighted by COVID-19 and similar outbreaks, such as understanding ‘super spreaders’ of the virus.”
What are your thoughts on the developing regulatory environment in sterile and non-sterile manufacturing and how is this currently impacting your role?
“Having recently departed from the FDA and having the opportunity to be involved in the development of countless regulations and guidance’s, the publication of the Agency’s guidance for microbiological consideration for non-sterile pharmaceutical manufacture is overdue and highly anticipated. The appropriate level of control and risk management within a manufacturing environment is critical.”
The full interview can be downloaded and read from: www.microbiologyeastcoast.com/pr4
Lynne will be presenting “Microbiological Quality Considerations in Non-Sterile Pharmaceutical Manufacture and Control of BCC” on day one of the conference, which will cover:
• Introduction of the FDA’s impending guidance on this topic
• Regulatory Expectations for microbial control of non-sterile drugs
• Case studies of microbiological contamination of non-sterile drug products to demonstrate the impact on product quality and the manufacturing process
Interested parties can register for the event at: www.microbiologyeastcoast.com/pr4, and can save US$200, expires on February 28th, 2020.
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Pharmaceutical Microbiology East Coast 2020
Conference: April 29th – 30th, 2020
Workshops: May 1st, 2020
Sheraton Boston Hotel, Boston, USA
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