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Broughton research facility gathers pace with series of appointments and investments


November 19, 2019

Published by Andrew Mooney

News, Nicotine Services, E-cigarettes, ENDS, PMTA, FDA, US Market

We are delighted to announce that Broughton has made a series of major business transactions to meet the demands of our growing portfolio.

Our Contract Research Organization (CRO) has made three senior appointments and completed investments totalling over £10m into people, facilities, equipment, software development and quality standard certification, establishing us as the leading force in the industry to achieving a smoke-free future.

High profile additions to the team include Dr Fozia Saleem, who joins Broughton as Director of Scientific Affairs and Program Management. Fozia will be responsible for leading pre-market tobacco applications (PMTA) for e-cigarette companies seeking regulatory approval for their products in the US, EU and wider global market.

We also welcome toxicology expert, Louise Neilson, who has over 7 years’ toxicological experience specifically within the e-cigarette sector. Louise has been appointed as a Principal Scientist and will lead the non-clinical elements of regulatory applications for our clients in US and UK markets.

Meanwhile, Leon Birch, our new Head of Scientific Development, brings with him 12 years’ experience in a Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) certified environment focusing on extractables and leachable. He will lead a team of development scientists and analytical experts focused exclusively on advancing scientific methodologies for the analysis of ENDS.

 

Fozia Saleem                    Louise Neilson                 Leon Birch

Left to right: Dr Fozia Saleem, Louise Neilson & Leon Birch.                                                                                                          

Having opened a brand new CRO facility at our Lancashire (UK) headquarters in January 2019, in March Broughton achieved GLP certification for the site. The certification defines a set of quality standards for study conduct, data collection, and results reporting, providing reassurance to our clients that studies conducted can be completed for PMTA and Medicinal Product (MA) submissions.

In response to announcements in July that the US Food and Drug Administration (FDA) would be implementing changes to ENDS testing requirements for the PMTA regulatory process, Broughton also developed and validated innovative HPHC testing methods, adhering to ISO 17025 standards and in line with the low limit of detection/limit of quantification (LOD/LOQ) levels required for precise toxicology assessments of the new FDA list of 33 analytes.

Finally, we have also made a duo of investments into high quality equipment and services for the new facility. First, into our bespoke LIMS software system, LabHQ Link, which has been deployed to enable direct capture of test data from analytical equipment, reinforcing data integrity for all Broughton’s clients. And second, into high specification analytical equipment for use in our specialist laboratories.

Broughton Chief Executive, Dr Paul Moran, is keen to continue this momentum of growth and investment, with plans in place to further harness Broughton’s expertise to support its clients in revolutionizing the ENDS industry.

Paul said: “We have seen rapid change over recent months within the reduced-risk nicotine products market, and we are committed to supporting this evolving industry towards creating a smoke-free future.

“Fozia, Louise and Leon will be great additions to the Broughton team as we continue to pursue new innovations and scientific advancements to help clients achieve success and remain at the forefront of ENDS regulatory compliance.’’

 

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