About Us > Our People
GxP Consulting has extensive experience that captures the full lifecycle of biopharma processes from pre-clinical studies and concept design through to de-commissioning and technology transfer. The diversity of projects includes hospitals, government facilities, start-up biotech companies and the world’s leading bio-manufacturing organisations. This experience has been gathered from a variety of perspectives, including as senior directors of operating companies, project directors, principal technical consultants and even as expert witness for legal cases.
Our consultants are highly skilled and experienced in identifying, communicating, managing and delivering your business objectives and regulatory compliance requirements. By understanding your product, your process and your intended markets, we can advise on what you need to comply with and how to achieve this.
Dr Neil Rotherham
Neil Rotherham has over 20 years’ experience in the medical and pharmaceutical industries. Neil co-founded ClinPhone in 1993, recognizing the opportunity to improve the clinical trials process through the implementation of telephone and web-based solutions. The services initially developed by Neil at ClinPhone are now a well recognised part if best practice for managing clinical trials.
Neil led the ClinPhone business from conception to a 500+ person company with offices in Europe and the US, only stepping down from the ClinPhone board in 2006 after introducing a management team to take the company public. Neil leads the clinical technology consulting group and has successfully completed a number of engagements with large biopharma organisations and CROs
Dr Anthony Gasson
Tony is qualified and experienced both as a Microbiologist and an Analytical Chemist. He has acted as a Qualified Person since its inception in the 1970's, releasing products for world markets under BP, EP, and FDA or WHO requirements. His experience includes acting as Technical Director of GeneMedix plc., and as Managing Director of a Biotech factory in Shanghai for three years. Tony qualified in Physiology with Chemistry, and joined the Wellcome Research Laboratories as a Research Scientist working on Diagnostics. He became a Senior Scientist involved in development, production and control of vaccines for medical and veterinary use. Later he managed Microbiological Laboratories controlling all Wellcome Products worldwide.
He joined the Public Health Laboratory Service in 1989 as Director/Head of Quality Assurance and Regulatory Affairs. He introduced Quality Standards to the Headquarters at Colindale and the Centre for Applied Microbiology and Research, Porton Down, obtaining new licences for vaccine products in the UK and USA. Since 1995 he has worked as a Principle Consultant, advising on Regulatory Compliance and Pharmaceutical Engineering for the design, construction and validation of new facilities for the Pharmaceutical and Biotechnology Industries. He has trained client's staff in a number of countries.
Jim Stracey
Jim has a wide experience gained over 40 years within the pharmaceutical industry, covering production/general management within the manufacturing sector, plant engineering and project engineering and management in the contracting and consultancy area. Recent experience includes new-product industrialisation, pharmaceutical development and clinical trials supply facilities, high-containment facilities, and multi-purpose API production and pilot plants for major pharmaceutical companies. He has specialist knowledge and experience in high-potency materials operations and the industrialization of new products.
During an industrial career with GSK/Beecham Pharmaceuticals, he became site director of the Crawley factory after working in primary plant engineering and production management followed by secondary production management. Subsequently Jim spent a period overseas in pharmaceutical project planning, design and management, followed by the establishment and operation of an international project consultancy business and several other companies serving the pharmaceutical industry. From 1993 to 2006, he worked with AMEC Group as a Pharmaceutical Consultant working on a range of projects including product development, clinical trial manufacture and commercial production.
Dr Steve Collins
Steve has an MA in Natural Sciences and a PhD in Biochemistry from Cambridge University. He is a registered QP (Italian Health Ministry accreditation as “Direttore Technico”) and has over 30 years experience in the biotech and pharmaceutical sector. This includes working with recombinant proteins, monoclonal antibodies, bacterial products, vaccines, cell culture therapies and radiochemicals. Steve has senior level management experience, has directed R&D programmes, technology transfer and scale-up to industrial production. He has designed and developed industrial fermentation and down-stream processes, as well as devising analytical methods and support for a variety of microbial fermentation and mammalian cell culture systems in the UK and elsewhere in Europe.
Keith Williams
Keith has been working within the biopharmaceutical sector since 1989. During this time he has been involved with engineering design, project management, commissioning, validation, strategic planning and high-level consultancy. He has managed a recombinant protein facility production facility, worked on the process engineering and validation: 4 vaccine processes at GSK Biologics in Rixensart, 3 processes for Novartis Vaccines in Italy and was part of the Project Management Group training the directorate at Wyeth BioPharma in Grange Castle, Dublin.
Dr Tom Dine
Tom has been involved with regulatory compliance, validation, project management, product development and QC analysis of pharmaceutical, biopharmaceutical and cosmetic manufacturing operations for over 25 years. He has worked with many of the world’s leading pharmaceutical and biopharmaceutical manufacturers. Tom has worked across a broad range of business areas incorporating research, development, pilot plant and commercial manufacturing facilities.
Mark Stevens
Mark has been responsible for the successful delivery of projects within the Biopharmaceutical and Pharmaceutical industries in a variety of business areas. During this time he has been involved with engineering design, project management, commissioning, validation, strategic planning and high-level consultancy. Key projects have included the development and implementation of corporate project management methodologies, quality systems and GCP compliance improvement projects, retrospective validation projects and directing multiple projects during shut-down periods.
Dr Keith J Williams
Keith has 28 years experience in drug development and coordination of development programs, in all stages from research to product launch and life cycle management. He has led a number of global clinical trials including studies within cystic fibrosis, meningitis, haematology, oncology, rheumatoid arthritis, urinary incontinence and cardiovascular drugs, along with paediatric studies and patent exclusivity. Keith is experienced in leading multi-functional global teams during pre-clinical development and clinical phases. During recent projects he has led risk management, drug developments strategy and training in multi-functional team development
Mark Wright
Mark Wright is a highly experienced consultant within the regulatory requirements of data management and computer systems validation for GMP, GCP and GLP applications. He has held senior Quality Assurance and Regulatory Compliance positions within CRO, GCP and GLP environments.
His experience includes the development and implementation of a number of quality management systems, management of CSV projects, QA auditing and ensuring the regulatory compliance requirements of all computer systems applications were adhered to. He is an experienced trainer and is able to address the specific needs of different job functions and business areas.
