CAMBRIDGE, UK, October 13, 2016 – Coalesce Product Development Limited, a technology company focused on design and development of drug delivery devices and products, today announced the opening of its new drug delivery development centre in Cambridge. The company also revealed the appointments of several well-known drug delivery experts to the management team to support increased demand for its Concept to Clinic® service.
In addition to a design office and engineering development suite, the new 375 square metre facility at St John’s Innovation Park includes an analytical laboratory designed for drug product characterisation and an ISO Class 7 cleanroom for assembly of devices for human factors studies and early clinical trials.
“Adding analytical and assembly capabilities to our established expertise in engineering, industrial design, project management, and regulatory affairs gives us more control over the development process and, critically, over the timescales”, commented Dave Ahern, Founder and CEO of Coalesce. “Having the experts and facilities in-house allows us to fast-track complex drug delivery programmes so that our partners can achieve early clinical proof of principle and proceed to manufacturing scale-up with complete confidence in the design.”
In order to support the expansion, Coalesce has enhanced its management team with the appointments of Dr Colin Dalton as Chairman of the Board and Director, Mr James Tibbatts as Head of Business Development, and Mrs Samantha Shelley as Quality Manager.
Dr Dalton brings over 30 years of experience in the pharmaceutical, vaccine, biotech and medtech industries, having held senior positions at PA Consulting, Quadrant Holdings Cambridge Limited, GSK Biologicals S.A., Innovata PLC, and Vectura Group plc. He is currently Company Director of UK-based consulting company Margarite Limited, a non-executive director of Imcyse SA, a Belgian immunotherapeutics company, and a member of the Supervisory Board of the Centre for Drug Design and Discovery (CD3) in Leuven, Belgium.
Mr Tibbatts is a renowned expert in computational fluid dynamics and inhaler optimisation. An experienced programme manager, he has worked in all aspects of inhalation product development from inception through to clinical trial manufacture, including quality, regulatory, particle engineering, formulation, manufacturing and analytical. His previous experience includes positions at Fluent Europe and at inhaler development consultancy firm Concept Flow Ltd., which he founded in 2007.
Mrs Shelley has held various positions in quality systems management, compliance and regulatory affairs, with a wide range of medical device manufacturers and sub-contract manufacturers. She has worked with a diverse range of devices including metered dose inhalers, orthopaedic implants, breast implants and lasers.
Dr Dalton commented: “This is an exciting time to be joining the Board of Coalesce. The move to the new development centre represents a significant expansion in our capabilities, and we have assembled a very special team to provide a comprehensive development service in response to growing demand.”
About Coalesce Product Development Limited
Coalesce provides first class medical and drug delivery device development services to the pharmaceutical industry, with a focus on inhalation and injectable products. Coalesce’s experienced team includes experts in mechanical engineering, electronics, analytical science, industrial design, human factors, project management, regulatory affairs and quality assurance. The team operates from a unique facility in Cambridge, UK, equipped with a state-of-the-art design centre, an analytical science laboratory, an ISO Class 7 cleanroom and an advanced engineering development and testing suite.
Coalesce holds ISO 13485 certification for the design and development of medical devices.
For additional information, contact James Tibbatts or visit coalesce.co.uk.
+44 (0)1223 421855