Case Studies

Below is a selection of our most recent case studies which we hope will provide you with an idea of the range and quality of work that we can supply.

Clinical Development of A Drug-Device Combination

Added: 14th November 2016

A US-based client wished to conduct a first-in-human clinical trial of a novel drug-device combination product in the UK. Both the medicinal substance and the medical device were well-known and app.... View Details

" With over 10 years of experience of using consultants and other suppliers for all sorts of activities, I can truly say that Alison Wilson is a rare find.  Alison was our UK regulatory consultant for a first in human clinical trial for a combination product.  Our internal project team did not have previous experience with combination products, clinical trials, and let alone the first human clinical trial outside the US.  Alison was critical to our success from the very beginning to the very end of that trial.  What I found to be so commendable about Alison is not just her technical skill and experience that we were hiring her for, but her clear communication style and personal commitment to the project team and overall project success.  Alison on several occasions, made herself available outside business hours to accommodate the time difference between the UK & US and support hitting deadlines.  She took the time to dig into details and truly understand technical data in order to write a strong submission.  She also took the time to not just check the boxes and tell us what to do from a regulatory perspective, but to educate us on the benefits of different strategic approaches and background of the MHRA's potential interpretation.  "

Christine Kearney - Principal Engineer - CareFusion Inc, USA

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

Biomaterials for soft tissue repair

Added: 13th December 2015

A research group from the University of Manchester asked for regulatory advice during the development of a novel biomaterial for guided repair of soft tissue. The use of scaffolds is a key approach.... View Details

"After confirming the right regulatory classification, Alison provided thorough and understandable guidance to help the development of our novel regenerative medicine scaffold. Systematic and timely explanations of the data needed and options at each stage have led to an optimised pathway to first clinical trial in man."

Adam Reid MBChB FRCS (Plast) PhD - NIHR Clinical Lecturer - University of Manchester

Classification Challenge

Added: 6th October 2015

A client asked us to assist with classification of a complex novel biomaterial consisting of elements of a medical device, medicinal products and human blood-derived pr.... View Details

"CellData Services did a superb job in helping us to determine the regulatory classification of a complex regenerative medical device. A number of other conflicting opinions had been given which served to confuse the issue. CellData Services worked through the available information to come to a logical and sound conclusion."

Mark Wickham - Principal - Alacrita LLP

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

A biomaterials approach to regenerative medicine

Added: 11th August 2015

The use of novel biomaterials to guide and stimulate tissue repair is a major approach in regenerative medicine, allowing the developer to engineer desirable characteristics into a material. In par.... View Details

"I have had the pleasure of working with Alison Wilson for the last few years and will continue to do so. Alison has been instrumental in providing valuable regulatory advice to our translational clinical project. Her significant expertise along with her proficient ability to rapidly comprehend the products we are delivering has led us to successes in our project. Alison is professional and able to concisely communicate with people from a wide range of disciplines and areas."

Sarah Cartmell PhD - Professor of Bioengineering - University of Manchester