Throughout this process we have sought to take all reasonable steps to ensure the safety and efficacy of the generic products we have identified. Yesterday we shared a blog from Dr Wilbert Bannenberg outlining his work with us and his assessment of the regulatory safeguards relevant to Gador and their generic version of ivacaftor-lumacaftor (Orkambi®).
Today we are very happy to share further information on another step we have taken to ensure safety. We had independent tests done at a leading London university lab to confirm that the active pharmaceutical ingredients in the generic product are directly comparable to those found in the Vertex product.
As a further step, Paul Coombes, the brother of one of the parents involved in the Buyers Club, Christina Walker, agreed to review and provide an independent assessment of the test methodology and findings.
Paul is Director of Advanced British Instruments Ltd, an independent Consultancy for Pharmaceutical clients and law firms specialising in FDA compliance matters. (See his profile here: https://www.linkedin.com/in/paul-coombes-7b02a36/)
He is one of a handful of non-US citizens accepted by the US FDA Office of Compliance as a ‘qualified independent consultant’ and his job involves reporting (in writing and personal testimony) on aspects of Good Manufacturing Practice and Data Integrity. Paul has more than 40 years’ experience in the Pharmaceutical industry and has been a Head of Chromatography at a major pharmaceutical firm and held senior global positions at Agilent and PerkinElmer.
Paul is extremely knowledgeable in analytical chemistry and the strict scientific and legal regulations in the pharmaceutical sector (e.g. FDA, ISO, WHO, MHRA). He wrote the industry textbook “Laboratory Systems Validation Testing & Practice”. Dec 2002 ISBN 1930114486.
Because of his knowledge of laboratory instrumentation (e.g. chromatography, spectroscopy, etc) he was the ideal person to provide an independent scientific assessment of the testing that we commissioned from an NHS University laboratory.
Paul provided his services pro bono and his report can be accessed and used for Buyers Club member’s purposes.