ࡱ> monq` CdbjbjqPqP 0::[qXXXXXXXl8L4,l$ll4y${${${${${${$$%h($X$XX$666XXXy$6y$66r"TXXe#` ^ qX%#5$D$0$3#2(N(e#(Xe#`6\$$X$lllDllllllXXXXXX NPDG (UK) Research Strategy. Update 2. Introduction The original paper was produced in December 2005 as a document for discussion by the Board of Trustees and to set out the background, aspirations and constraints of a small charity attempting to make a difference to families affected by rare disease. In particular the problems associated with attempting to pursue medical science research were identified. This document is re-issued from time to time to provide an outline report on activities undertaken as proposed under the Way Ahead heading and to identify other points of significance that have arisen. Background The Niemann-Pick Disease Group (UK) became an independent charity in 1996 and has operated since then in accordance with its Constitution document which was approved by the Charity Commission. The group is small and represents less than a hundred families afflicted by the Niemann-Pick diseases (NPD). The diseases are acquired through autosomal recessive inheritance and have a frequency variously estimated between 1:150,000 and 1:1,000,000. Depending on how a disease is defined, there are two types of Niemann-Pick disease, namely:- Type A/B (NPA/B). This is a deficiency of the lysosomal enzyme, acid sphingomyelinase (ASM) and is highly variable in age of onset and severity. Type A is at one end of the disease spectrum and is a severe neurovisceral cellular storage disease resulting in death in infancy. At the other end of the spectrum, type B has little or no neurological involvement. Affected persons may go on to lead a near normal life although growth is delayed and liver and spleen are often swollen. Type C1 & C2. Type C (NPC) disease is also a condition exhibiting highly variable age of onset, rate of progression and severity. Death may result neonatally or at any time through childhood to adulthood. Type C1 is the major complementation group affecting over 95% of those with the disease. The cellular and clinical phenotypes are very similar leading to the suggestion that the respective proteins act in the same pathway. The C2 protein has been shown to have a lysosomal location and has the capability to bind cholesterol. The function of C1 has yet to be elucidated. The diseases, which are a result of mutations in cellular genomic DNA are pan ethnic and pan species and have been detected in life forms ranging from yeast to humans. At the time of preparing this research strategy there are no surviving cases of Type A, 15 Type B and 75 Type C in the UK. Disease incidence appears to be broadly proportional to population. Aims of NPDG (UK) Charity activities are governed by a hierarchy of documentation which has been written to support the aims of relieving the suffering of families affected by the disease. The exact wording of Clause 3 of the Constitution reads as follows:- The Charitys objects (the objects) are to relieve sickness amongst families afflicted by Niemann-Pick Disease and any distress which may arise therefrom and to advance the education of such families, interested professionals and the general public in all matters concerning the disease as the committee may determine. This general high level statement is translated into a Development Plan which describes the means of achieving the objects. The Development Plan is reviewed annually and, amended as necessary to reflect emerging opportunities that developments in science and social welfare may provide for the enhancement of the service given by the Charity to its members. The Development Plan is further translated into an Action Plan (or Work Programme) which provides detailed activities for the year to come, together with an estimate of resources and timescales for the activities to be undertaken. The plan is updated on a continuing basis throughout the year, and issued for review by the trustees on a quarterly basis. The hierarchy ensures that each specific task is traceable to the Charity objects and that future development is coherent. Pursuance of the Work Programme has become more effective in recent years following the decision of the Board to employ staff. Although the employment is at a modest level, it has been possible to progress activities more quickly and to expand the scope of tasks addressed. There is a financial cost associated with this but it is believed that this decision will produce the greater benefits to the Charity in the longer term. In addition, and perhaps more importantly, carrying out the day to day management and administration had become untenable for the founding members and another route to maintaining Charity viability needed to be found. Constraints and Priorities The NPDG (UK) is a small charity and raises funding to support the continuation of the Charity and its services to the families. After basic annual support services, staff and management costs have been covered, surpluses amount to perhaps a few tens of thousands of pounds. This is insufficient to fund much of the research needed to find effective treatments but is useful in funding data gathering for clinical research or making a contribution to a partnership funded project. This may be with other national or international charities, universities or government funded organisations. The Board has recognised the general limitation in relation to funding research and has determined that the provision of care and information services to families should take priority and, be protected for the foreseeable future. This does not mean that research is viewed as unimportant and the measures described above are pursued continuously by Trustees and staff. The identification of funding sources for both core activities and research has now been formalised with reports made to the Board for discussion at committee meetings. Achievements to Date From the earliest stage the Group has been able to provide family support and educational services to families and professionals associated with the families. These services include telephone help lines, Newsletters, explanatory disease leaflets, co-ordinated clinic days and the services of a specialist nurse to assist families in coping with the affects of the disease symptoms and to provide genetic counselling. In addition an international network of Niemann-Pick disease family groups and a network of research scientists has been established such that families can exchange experiences and see for themselves, the research taking place into the disease. The knowledge base accumulated and being built upon, provides existing families with the information they need and, provides newly diagnosed families with the option of participating in the engagement and learning process that they will require in coming to terms with their plight. The charity has engaged in research work and was awarded a grant by the Lottery Fund in 2000 on submission of a proposal for a gene therapy investigation. The proposal was produced in partnership with the University of Cambridge and was subject to peer review in accordance with the Association of Medical Research Charities (AMRC) guidelines. Funding has also been allocated to a project studying similarities between cystic fibrosis and Niemann-Pick type C. This was in collaboration with our USA sister charity, the National Niemann-Pick Disease Foundation (NNPDF) and was on the recommendation of their scientific advisory board (SAB) which consists of scientists and clinicians at the forefront of research into the disease. Research Definition In order to define a research strategy there is a need to understand what is meant by research and, how it is defined in the context of this strategy. Medical scientific research is today a complex of specialist topics ranging from genetic studies to the application of prosthesis; from pharmacology to surgery. The Niemann-Pick diseases arise as a result of inborn errors of the metabolism traceable to a group of genetic mutations. Affected individuals may require surgical procedures, drug therapy, and other forms of intervention. Many of these activities are newly discovered and may all be considered as subjects for research. The scope of interest, therefore, is very wide. Research into genetic disorders has historically followed a pathway which started from a clinical description of the disorder, followed by microscopic examination of tissue and cellular content to identify abnormalities. The growth of biological knowledge and associated technology over recent decades has provided for greater insight into the molecular cause of particular diseases and has added to the spectrum of specialist knowledge needed to identify, understand and treat a disease. Although a written description of a disease clinical presentation and microscopy examination remain essential for diagnosis, other studies are often required to confirm diagnosis and indicate options for therapy. These include genetic, cytological and pathological investigations to determine the genetic error, the affects on cellular function and response of the immune system. In summary and for the purpose of providing guidelines, research may be considered under the following general headings:- Genetic studies typically relating to mutation analysis, genotype/phenotype correlation and genetic variation in the population. Cytology studies including protein biogenesis, trafficking, protein/protein interactions, signalling pathways, apoptosis, alterations in gene expression relating to NP defects. Therapeutic studies including gene, protein, small molecule (eg substrate reduction, chaperones), stem cell, blood/brain barrier and vector delivery techniques. Clinical studies aimed at collection of clinical data relating to the natural history of the disease, baseline studies for conducting trials or other data as may be required by regulatory/licensing authorities. Prevention studies aimed at preventing or reducing the risk of disease incidence in the population and families known to be at risk. In addition, it is recognised that medical science and the understanding of rare genetic disease is a fast developing field. The Trustees will consider novel proposals from areas not specifically covered by the outlines given above, but which are aimed at progressing the understanding of the disease and its treatment. Healthcare in the UK The vast majority of fundamental research into the Niemann-Pick diseases is taking place in, or is funded from, the USA. The Charity is aware of one academic researcher working in this field within the UK and a similar situation applies to other countries within the EU. These researchers are also part funded by US charities or agencies. It has not been possible to identify a focal point within the Department of Health, the NHS, or other government agencies that have responsibility for the investigation and management of rare genetic diseases at the fundamental level. This situation is unsatisfactory but unlikely to change in the short term although some progress is now being made as a result of the European Commission report into the need for member states to formulate a national plan for rare genetic diseases and the establishment of Rare Diseases UK, a body funded by the pharmaceutical industry partnering with the Genetic Interest Group. Provision of clinical services is available at a few specialist units within the UK. These are the recently formed NCG centres and services include limited genetic testing, monitoring of disease progression and advice on palliative care. The Charity provides much needed assistance to these groups from the Manchester unit (previously the Willink Clinic) and, have entered into an agreement with the Hospital Trust to fund a Nurse Specialist specifically for assistance to families affected by Niemann-Pick disease. The significance of genetics and, more generally, biomedical science within the healthcare system has been recognised by the Government and is part of the DoH/NHS strategy for future development. A White Paper entitled Our Inheritance, Our Future Realising the potential of genetics in the NHS was published in June 2003 and describes the Governments strategy for maximising the potential of genetics in the NHS such that those affected can benefit from advances in disease prevention, diagnosis and treatment. What progress has been made in the implementation of this strategy is not clear and, this is recognised by the charity as an area where dialogue is required and attempts made to raise the profile of Niemann-Pick disease. Research Identification The Charity, having neither a large amount of funds nor the necessary medical and scientific knowledge, is not in a position to dictate research agenda or influence the healthcare programmes of the Nation. There are however, a number of areas of enquiry, both nationally and internationally, where the Charity has previously, and continues to, explore in order to remain in contact with progress on research into the disease. These are as follows:- The USA National Institutes of Health (NIH) where Type C disease was identified in humans and the NPC1 gene was cloned. Although work continues there the profile is much reduced but the very valuable resource of the PubMed database is regularly updated and provides a listing of scientific abstracts of papers published on all types of NPD. The Charity is not able to access the full papers on-line but these may be obtained via the British Library Services. A charge is imposed for this service. The Ara Parseghian Medical Research Foundation (APMRF) is probably the biggest funder of research into NPD and is a private foundation set up as a result of the family being affected by NPC. The Foundations website contains lists of current and previously funded studies and acts as a library, allowing researchers rapid access to work completed or in hand. In addition the Foundation hosts an annual conference in Arizona, where scientists report on their work and exchange information in an informal setting. The Foundation elicits proposals into NPD through advertisements in various medical and scientific journals and these are assessed by the Foundations Scientific Advisory Board. National Niemann-Pick Disease Foundation (NNPDF) is a charity for families and is well supported throughout the US. A primary emphasis of this Foundation is in the care of families and the provision of support for clinical activities. The Foundation also undertakes research and has its own Scientific Advisory Board (SAB). The APMRF and the NNPDF collaborate in funding studies. NPDG (UK) works closely with the NNPDF and has representation on its Management Board and at SAB meetings. There is also collaboration with the Niemann-Pick charities within Europe, especially for clinical activities. It is part of the Charity Development Plan to widen the scope of this collaboration. It has been recognised that a number of single gene disorders have a great deal in common especially with regard to therapeutic applications being developed. A development topic for the Charity is to explore how the charity bodies representing each of these rare diseases could be more effective by working together to fund research into the areas of commonality. These disorders include Gauchers, Tay-Sachs, GM1 Gangliosidosis, Fabrys, Sandhoff and perhaps others. It is notable that the providers of healthcare within the UK do not appear to have any priority for rare genetic diseases and, do not even have a programme for understanding the extent to which they affect the society. It is a Charity development item to pursue changes to the healthcare agenda in line with the 2003 genetic White Paper. Research into disease cause, pathology, potential therapies, and prevention will form part of any dialogue that may be established. Research Elicitation Assessment and Approval Due to the Charitys funding availability and priorities, elicitation of research proposals has not been seen as a practical proposition to date. It has however; been possible to engage in research activity on an ad hoc opportunist basis, where the Charity is able to act as a mediator of funding between the grant giving organisations and the research establishments, provide funds in collaboration with other groups, approve funding directly where this is within the expertise of the Board. A list of research related activities is provided in Appendix 1: Way Ahead In order to influence research into NPD in the short and longer terms, it is intended to pursue the initiatives outlined in this document by the development of existing partnerships and the formation of new ones. It is clear that rare genetic disease is an area of research neglected by the providers of healthcare within the UK. This applies both to fundamental research and to clinical research. The numbers in each rare disease category appear to be too low for the authorities to take an interest and yet these diseases are almost without exception, severe and ultimately costly to deal with within the society. It is important that these diseases should be introduced onto the healthcare agenda and it may be that this will only be achieved by a much greater collaboration between the rare disease patient representative groups. Representation must be made to the health authorities and if that does not yield results, then recourse must be made to the political regulators and governors of the nation. Our voices, our cries for help, must be heard. Progress in 2007 Report at January 08 A number of activities have been undertaken including contacts with the UKGTN, MPs including the Minister for the Third Sector, attendance at meetings on the future of the NHS, rare diseases conferences and issues of treatment and contacts made with the Department of Health. The main result of this work is to confirm the understanding of the lack of priority of rare genetic diseases in the healthcare system. Visit reports have been produced for these activities and circulated to Board members and staff. My main work has been in looking at the possibility of disease prevention and following some investigatory work I produced a paper for consultation with a wide group of interested parties from charity members to professionals. A presentation of the work covered by the paper was presented at the Family Conference in June 2006. Again there has been little response to the ideas raised, although I have received favourable comments from professionals. Towards the end of 2007 we received information from the rare disease umbrella charity, Eurordis on a consultation document issued by the European Commission on rare diseases. We are in the process of responding to this. It is difficult to understand that this important initiative in the EU has, apparently gone unnoticed in the UK as none of the officials I have spoken to mentioned it. Perhaps we can pursue our healthcare system with this knowledge and find out who in the UK, is involved. I understand that Leslie Greene from CLIMB was on the Eurordis committee promoting action on rare diseases in the EU and I believe she will be our first point of contact. I propose to continue with the various contacts made through 2008 and to strengthen the breadth of contact by joining the consultation group of the Human Genetics Commission. Progress during 2008/9 I have yet to bring this up to date but a great deal has happened during this period including the formation of Rare Diseases UK and I have attended the first meeting in the Family Care and Support group. I am also enrolled on the HGC Consultative Committee and have attended their annual conference in addition to responding to the HGC study areas. These activities are contained in my reports to the Trustees and discussed ay our committee meetings. Copies of my reports to the Board are available from the NPDG (UK) Central Office. Appendix 1 List of Research Activities undertaken by NPDG (UK) 1. 2000 2004. The Charity mediated a gene therapy project funded by the National Lottery and conducted by the University of Cambridge. A full peer review was carried out on the Cambridge proposal by the Charity using independent experts. In addition, a Research Advisory Group was set up to monitor the project throughout its life cycle. The Charitys medical and scientific advisers were recruited to this group. Whilst the results were disappointing, a great deal was learnt and new scientists were recruited to the Niemann-Pick cause. A legacy has been the NPC mouse colony which is available and has been used in the UK. 2. Funding has been allocated to a US based researcher at CASE Western University, Cleveland, Ohio investigating signalling similarities between NPC and cystic fibrosis. In this instance the proposal assessment was conducted by the SAB of the NNPDF who recommended that the study be funded. On this recommendation funding was approved by the NPDG (UK) Board of Trustees. This funding allowed CASE time to apply for additional, larger grants in the USA. 3. 2006. Discussions with the Charitys Nurse Specialist identified a need for collection and analysis of clinical information relating to patients affected by NPD. The Charity participated and led the work required to prepare a job description and a the full supporting paperwork required to recruit a Research Nurse and conducted the negotiations with the Hospital Trust where the nurse will be based for the duration of the work. An appointment was made in summer 2006. This important work would not be undertaken without direct intervention by the Charity but it is needed to provide data for defining the natural history of the disease, which in turn, is needed by regulatory authorities when authorising therapeutic trials. In this instance approval to conduct the work was obtained by the Hospital Trust and the Charitys Trustees. The Trustees also approved the funding. In 2008 the Trustees agreed to extend the period of employment for a further 2 years, and in 2009, a further three year extension has been agreed. 4. 2006 2007. The Charity was approached by a scientist from the University of Oxford (UO) for assistance to continue a study on research into therapeutic monitoring of patients with glycosphingolipid storage disease receiving substrate reduction therapy. The requirement was for short term funding until a longer term alternative could be identified. A peer reviewed research proposal was available and support for the work was given from the Charitys Medical Adviser. A number of approaches were made to various grant giving bodies but without success. Time was critical because key staff would be lost to the project. NPDG (UK) agreed an interim grant for 3 months and appealed to NNPDF for further funding. This was granted allowing work to continue for a further year by which time the main grant from Action Medical Research was approved. 5. September 08/June 09. We have again been approached by UO for support for a study on Purkinje cells which are very important in NPC. The Trustees agreed to provide the interim funding requested and an application to the NNPDF for The Peter Pentchev Fellowship was subsequently successful. This secures a valued researcher for a further two years and other applications to further the Purkinje studies are in progress with the MRC.     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