Atmps

Allogeneic MSC for tissue engineering

Added: 14th November 2016

CellData Services is developing a long-standing collaboration with a UK-based regenerative medicine company, providing regulatory affairs support and expert guidance on a long-term basis. The compa.... View Details

"I would and have (!) recommended Alison to other Companies as a result of her excellent support for Azellon and we have worked together on other projects, notably the set-up and conduct of a Phase I/IIa patient trial using a combination drug-device (another area of expertise for Alison)."

Helen Delahaye - Chief Operations Officer - Azellon Ltd, UK

EMA Scientific Advice for US-based somatic cell therapy

Added: 13th December 2015

CellData Services was asked to provide a detailed assessment of the data available on a US-based somatic cell therapy for neurological disorders. As this product was at a quite advan.... View Details

"CellData Services is our default regulatory expert for cell-based therapies in Europe. They bring an uncommonly found knowledge of the science behind our products and they use this knowledge to ask extremely relevant questions that are essential in formulating our responses and approach to the EMA. CellData Services have consistently provided us with actionable guidance and support in a timely fashion. In short, they are an essential component of our European development strategy."

- Chief Medical Officer & Head of ResearchSanBio Inc, USA

Regulatory Workshop for Universities

Added: 13th December 2015

We were approached to develop a workshop to introduce a large group of PhD students and university researchers from several UK universities to the regulatory environment for development o.... View Details

"Alison Wilson helped us put together a successful two day workshop intended for PhD students working in regenerative medicine.  The workshop was entitled “The Regulatory Route to the Clinic” and our aim was to show PhD students the guiding principles behind the regulatory environment and then help them apply these to some examples that they were interested in based on their own research.  The feedback on the workshop was excellent.  People found Alison approachable and helpful and that her common sense approach to tackling translational challenges was exactly what was needed. I can thoroughly recommend Alison as a consultant. She helps take the fear out of the regulatory environment and has great people skills. "

Sheila MacNeil - Professor of Tissue Engineering - University of Sheffield

Tissue engineering with autologous stem cells

Added: 12th August 2015

Working with a client from initial spin-out from a UK university, we guided development to gain first-in-man clinical trial approval for a novel tissue engineering prod.... View Details

"CellData Services has worked with us since 2007 on the development of our stem cell technology for meniscus repair. Alison has played a vitally important role in identifying and managing regulatory issues and developed the regulatory strategy that led to successful progression to our first-in-man clinical trial. She combines an abundance of expert regulatory knowledge with hands-on practical experience of working within the pharmaceutical industry to help optimise progression of the development programme. Throughout our time working together CellData has been pro-active in supporting our ongoing development programme with clear and detailed input, providing understandable and relevant regulatory guidance at each step. Alison is a delight to work with and we are very happy to continue with her providing expert support for our project."

- Chief Scientific Officer - Azellon Ltd, UK