Shane Smith

B.Sc. (Hons), CChem, MRSC

Managing Director and Lead Consultant of ExtLe Solutions Limited

Shane has over 35 years experience in industrial analytical chemistry, with around three quarters of that time spent in the pharmaceutical sector. As well as being an expert in designing strategies for dealing with extractables and leachables, he is a specialist in trace analysis and chromatographic techniques, with over 30 years experience in HPLC & GC method development and validation.

He also has a wealth of experience in training, having run the chromatography training department for Chrompack UK, providing bespoke training courses for organisations across Europe, Asia and Africa.

From 2004, he worked for GlaxoSmithKline’s world class E&L team at Stevenage in the UK, managing E&L projects for global cross-site project teams. He was responsible for the E&L content of regulatory files submitted to regulatory agencies in North America, Europe and other territories, for a range of products including Eperzan/Tanzeum and Avamys/Flonase Sensimist, and for post approval material changes for Flixonase/Flonase and Beconase.

Shane left GlaxoSmithKline in early 2016 to pursue a career as an Independent Consultant, and set up ExtLe Solutions Limited.

His 35+ years of experience, plus the time spent in managing extractables and leachables projects for a variety of products, provide him with skills in various areas of the product development process including:

• Project Management, including Resource and Budgetary Forecasting
• Analytical Method Development and Validation
• Stability Study Design and Management
• Outsourcing
• Training

Graham Wilson

B.Sc. (Hons), MRSC

Senior Associate Consultant

Graham has 28 years of experience as an Extractables and Leachables specialist within the Pharmaceutical Industry and its supply chain.

Graham has worked throughout his career as an E&L specialist for GlaxoSmithKline, Mylan and Bespak. He has provided the development and execution of strategies to fulfil the extractable and leachable requirements for global registration of many products, both generic and brand named. Particularly, Graham has extensive knowledge of the strategic, tactical and regulatory aspects of successful E&L work programs for inhaled products.

Until recently Graham worked for Mylan for 4 years as their Extractable and Leachable specialist, providing oversite and guidance to CDMO’s and internal project teams on the delivery of E&L support to a growing portfolio of inhaled and biosimilar products through development, registration and into commercialization. During this time, his responsibilities included oversight of the E&L effort for the successful registration of Wixela Inhub DPI and Yupelri Inhalation Solution.

Prior to Mylan, Graham worked for GlaxoSmithKline for 16 years as an E&L subject matter expert, holding positions of increasing seniority, ultimately managing a group of E&L specialists supporting global R&D and Manufacturing organizations. He was responsible for the E&L aspects of GSK's inhaled MDI & DPI portfolio including the E&L strategy for GSK's Ellipta products, Relvar/Breo, Anoro, Incruse and Trelegy.

Before joining GSK, Graham worked for 7 years at Bespak as an analytical chemist focused on supporting extractable and leachable control strategies for a range of pharmaceutical customers inhaled products.

Beverley K Atkins

B.Sc. (Hons),MRSB, MRQA, SRPharmS, PCQI

Senior Associate Consultant

Beverley has a diverse range of experience across the pharmaceutical and education industries. The decades she has spent at SK&F, GSK, Intertek and other institution’s has given her an invaluable perspective of regulatory compliance and requirements.

A pharmaceutical scientist and quality professional that conducts all work to regulated standards, including study plans, interim and final project reports, compliance checks and supply chain assessments.

An excellent communicator and an accomplished Study Director. Beverley has worked and trained to meet the GLP and GMP standards expected of all Pharmaceutical and Analytical Laboratories for decades. A very pro-active well-organised worker who has a track record in designing work/studies and carrying them to completion. All works completed were peer reviewed and have been audited by agencies such as the Medicines and Healthcare Products Regulatory Agency.