Clinical pipeline

The step process of taking basic research to the clinic.

Clinic – intro

When research reaches the point where translation can be considered, the need to comprehend the regulatory structure of a clinical trial is essential, especially when translating research that qualifies as an Advanced Therapy Medicinal Product (AMTP).  ATMPs include cell or gene therapies and tissue engineered products, that can contain novel bio-materials. In order to assist with the efficient planning of an application, we have created this page to address pre-application concerns.

Pre-application Tools

If the correct regulatory questions are not addressed prior making a clinical trial application, significant delays will be encountered, which may effect the success of your application; this is particularly pertinent for the translation of cell/gene therapies and novel bio-materials, where the regulatory environment is constantly evolving.  In order to address these pre-application requirements, we have created this page, which is intended to be used a as the first port of call when academics, or clinicians begin to consider moving their research towards an ATMP-based clinical trial.

The regulatory framework surrounding clinical trials is formidable and for those unfamiliar with the requirements, it can be daunting.  However, the process of preparing an for an application will involve three to four primary steps, which are outlined below.  These steps are based on the experience of Giulio Cossu, initiating a first in man PhI/IIa cell/gene therapy trial for Duchenne Muscular Dystrophy; Adam Reid, initiating a first in man PhI/IIa trial for a novel polymer nerve scaffold; and Brian Bigger, who has conducted gene therapy trials to treat Mucopolysaccharidosis.

The process has been divided into a linear, stepwise framework and this page provides points of contact for each step.  The individuals listed below can explain regulatory requirements and the application process, in addition to supporting applications through approval to execution.  However, the single most important step when considering such work is to know who the study sponsor will be and to engage with them as you soon as you consider moving forward with a trial. Mohammed Zubair, should be your first contact for this information, if it is not known.

Once you have contacted the appropriate individuals we recommend that you proceed to the MAHSC Clinical Trial Route Map, which will provide you information on how to execute a clinical trial once the pre-application concerns have been addressed.

Cell, gene or tissue engineered therapies

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Application support

Bridge to clinic – Cell therapy – Application support

After ethical and regulatory issues have been addressed, assistance with potential funding and the appropriate application process should be obtained.  The University of Manchester provides support for researchers seeking funding for basic or clinical research. Application support will initially be strategic, focused on determining the correct funding stream and secondly administrative, focussing on correct costings.

Faculty of Life Sciences

Strategic Application Support:

Research and Business Support Services:

There are four Research Support Managers (RSMs) for FLS; if you do not know who your RMS is please contact Dr. Darian Rozentals, Head of Research and Business Support Services, who will know which is assigned to you.

Dr Darien Rozentals
Head of Research and Business Support Services
1.21 Simon Building
Oxford Road
Manchester M13 9PL
0161 275 1407
Darien.Rozentals@manchester.ac.uk

Financial Administration Application Support:

Faculty Research Finance Office:

Once the correct funding stream has been determined the application will require costing. Within FLS there are five Research Finance Officers (RFOs); please contact Alison Bate, the Head of Faculty Research Finance, to learn which RFO is assigned to you.

Mrs. Alison Bate
Head of Faculty Research Finance
C.2274 Michael Smith Building
Oxford Road
Manchester
M13 9PT
0161 275 5464
alison.bate@manchester.ac.uk

Faculty of Medical and Human Sciences

Within FMHS strategic and administrative support provided by the same body, but split based on the value of the application:

Research Support Services

For projects under 1m£ support is provided by RSMs or a RSM/RSO pair.  Please contact Shirley Hanna, the Research Support Services Team Manger for assistance with which RMS is assigned to you.

Mrs. Shirley Hanna
Faculty RSS Delivery Team Manager
Faculty of Medical and Human Sciences
Room 3.53, Simon Building
University of Manchester
Brunswick Street
Manchester, M13 9PL
+44 (0)161 275 5106
Shirley.Hannan@manchester.ac.uk 

FHMS Research Deanery

For projects over 1m£ application planting and support is provided by the FMHS Research Deanery; please contact Graham Cadwallader for further information.

Dr Graham Cadwallader
Director of the Research Deanery
Faculty of Medical and Human Sciences
Simon Building 3.64
University of Manchester
Manchester M13 9PL
0161 275 5157
graham.cadwallader@manchester.ac.uk

Faculty of Engineering and Physical Sciences

FEPS application support is divided into four major subject areas and further subdivided into RMSs for strategic support and RSO for administrative support.  The general contact details for the four major subject areas are listed below:

CEAS and Materials:

Room E36/37, Jackson Mill
Opening Hours for Visits: 10:00-16:00
researchsupportCEAS_Materials@manchester.ac.uk

Lead RSM:
David Blundell
0161 306 3068
David.Blundell@manchester.ac.uk

Computer Science and Mathematics

First Floor, Room 1.135, Alan Turing Building Opening
Hours for Visits: 9:00-17:00
researchsupportCSM@manchester.ac.uk

Lead RSM:
Vinod Verghese
0161 306 3274
Vinod.Verghese@manchester.ac.uk

EEE and MACE

Sackville building, Room B6
Opening Hours for Visits: 9:00-17:00
researchsupport-eee-mace@manchester.ac.uk

Lead RSM:
Katya Tarasova
0161 306 4699
e.tarasova@manchester.ac.uk

Chemistry, Physics & Astronomy, and SEAES

Chemistry Building, Room 4.20
Opening Hours for Visits: 9:00-17:00
researchsupport_cpe@manchester.ac.uk

Lead RSM:
Charlotte Jackson
0161 275 1323
Charlotte.Jackson@manchester.ac.uk

Ethics and governance

Bridge to clinic – Cell, Gene of Tissue Engineered therapy – Ethics and governance

Gene therapy, cell therapy or tissue engineered products intended for human use are defined as Advanced Therapy Medicinal Products, or ATMPs, by Article 2(1) of Regulation 1394/2007 of the European Medical Agency, Committee for Advanced Therapies (CAT).

The translation of cell/gene therapy and/or tissue engineered products will involve preclinical and clinical stages.  The preclinical work is likely to use human tissue in protocols which are more complex or high risk than standard academic uses of human tissue, and therefore require more stringent regulation.  To assure your application adequately addresses these concerns, please ensure that you have contacted the relevant individual in a timely manner.  Experience demonstrates that not all projects are the same and some require greater input from the sponsor at the pre-funding/application stage.

Preclinical Use and Collection of Human Tissue:

For complex or high risk studies involving human tissue please contact:

Dr Diane Escott
Research Governance, Integrity and Ethics Officer for Human Tissue
Research Governance and Integrity Team
Directorate of Research and Business Engagement Support Service
0161 275 7583
diane.escott@manchester.ac.uk

Testing ATMPs in Humans:

The regulatory path for approval of an ATMP is dependent on how that specific ATMP is derived;  whether it is derived from hESCs, an adult allogeneic donor or they are genetically modified autologous somatic cells, all have differing regulatory requirements. The figure below illustrates where each cell type enters the pathway and the regulatory bodies involved in granting approval.

Regulatiory Pregression

For guidance thorough this ATMP regulatory pathway please contact:

Dr Mohammed Zubair
Research Governance, Integrity and Ethics Officer for Clinical Trials
Research Governance and Integrity Team
Directorate of Research and Business Engagement Support Service
0161 275 2725
mohammed.zubair@manchester.ac.uk

For Additional Regulatory Information Please Utilise the Links Below:

HRA Regenerative Medicine Resources
UK Stem Cell Tool Kit
MRC Experimental Medicine Tool Kit
Clinical Trials Tool Kit

Clinical research

Bridge to clinic – Cell therapy – Clinical Trial Planning

Once the ethical and regulatory aspects of a trial application are complete the next step will be to plan the trial itself.  There are two key agencies within Manchester to assist with this, please contact both agencies to determine which is appropriate for your proposed trial.

Manchester Clinical Research Facility (MCRF)

Ian Mackay
Operations Research Manager
The National Institute for Health Research
Wellcome Trust Clinical Research Facility
0161 906 7517
ian.mackay@wtcrf.nhs.uk

MAHSC Clinical Trials Unit

In order for the UoM to consider sponsorship of a clinical trial, this would require the MAHSC-clinical trials unit to manage the trial.

Philip J Barley
Associate Director, MAHSC-CTU
0161 918 7454
07825 282636
philip.barley@christie.nhs.uk

Dr. Svetozar Mihaylov
Research Project Team Manager, MAHSC-CTU
0161 918 2141
svetozar.mihaylov@christie.nhs.uk

Biomaterials

 

Application support

Bridge to clinic – Biomaterials – Application support

Awaiting content.

Ethics & governance

Bridge to clinic – Biomaterials – Ethics and governance

Awaiting content.

Manufacture and packaging

Bridge to clinic – Biomaterials – Manufacture and packaging

Awaiting content.

Clinical research execution/support

Bridge to clinic – Biomaterials – Clinical research execution/support

Awaiting content.