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1 100,000 Genome Project NHS Genomic Medicine Centre Selection Prospectus July 2014

2 NHS England INFORMATION READER BOX Directorate Medical Operations Patients and Information Nursing Policy Commissioning Development Finance Human Resources Publications Gateway Reference: Document Purpose Document Name Author Publication Date Target Audience Additional Circulation List Description Cross Reference Superseded Docs (if applicable) Action Required Timing / Deadlines (if applicable) Contact Details for further information Resources NHS Genomic Medicine Centres' Prospectus NHS England 03 July 2014 Foundation Trust CEs, Medical Directors, Directors of Nursing, NHS Trust Board Chairs, NHS Trust CEs #VALUE! The 100,000 Genome Project is a significant priority for NHS England. The Prospectus is a document of strategic intent and provides general information to any prospective applicant on the process NHS England is undertaking to put in place NHS Genome Medical Centres to support delivery of the project. 0 0 To note the content of the Prospectus and consider applying for NHS Genomic Medicine Centre status By 00 January Genomics Central Coordinating Team/Medical Directorate Quarry House Quarry Hill LS2 7UE Document Status This is a controlled document. Whilst this document may be printed, the electronic version posted on the intranet is the controlled copy. Any printed copies of this document are not controlled. As a controlled document, this document should not be saved onto local or network drives but should always be accessed from the intranet 2

3 Document Title 100,000 Genome Project NHS Genomic Medicine Centre Selection Prospectus Version number: First published: Updated: (only if this is applicable) Prepared by: 3

4 CONTENTS INTRODUCTION Background page 7 Delivery Partners page 8 NHS GENOMIC MEDICINE CENTRE SELECTION Information page 9 Disease Selection page 9 Standing Operating Procedure page 11 DNA Extraction page 11 Working in Partnership page 12 Funding page 12 Workforce Development page 13 Potential Provider Information Days page 13 Invitation to Tender page 13 Selection Timetable for Wave 1 NHS Genomic Medicine Centres page 14 ANNEX 1 - NHS GENOMIC MEDICINE CENTRE SELECTION Preliminary Application Information page 15 Approach Timeline and Process page 18 Assessment page 18 Site Visits page 18 Contract Award page 18 Contract Award and Agreement page 19 4

5 INTRODUCTION On 10 th December 2012, the Prime Minister announced that the Government intended to achieve a paradigm shift in the way that genomics is used across the NHS. To provide the catalyst for this change and to accelerate the benefits to NHS patients stemming from innovations in genomics, the Government committed to sequencing 100,000 whole human genomes by the end of Successful delivery of the 100,000 Genome Project will position the NHS as world leaders in realising a new era of personalised medicine for the benefit of patients, and will build upon the excellent work the NHS and its academic partners have already delivered in the field of molecular medicine, molecular genetics and cytogenetics. The research opportunities and mainstream use of genomic medicine that will flow from this project also stand to make a major contribution toward economic growth in this country through establishing the UK as the leading international base for genomics science and industry. There are two main ambitions for the 100,000 Genome Project: Firstly, by the end of 2015 to establish the UK as: o the home of a unique world leading programme already delivering genomics to improve the lives of patients with rare/inherited disease and cancer; o a pioneer in the global genomics industry. Secondly, by the end of 2017 for the UK to: o be the first country in the world to sequence 100,000 whole human genomes for the treatment of patients with rare/inherited diseases or common cancers; o have high consent rates from patients and public support for genomics; o have established world leading genomics services within the NHS; o have educated and trained health professionals within the NHS in genomics and its applications for improved patient care and treatment, raising broad awareness and understanding of the advantages genomic medicine offers to patient care in the NHS; o be the home of world-leading genomics companies which will work in partnership with the NHS and its academic research partners; o have stimulated the development of diagnostics, devices, medicines and treatments based on a new understanding of the genetic and molecular basis of disease. Some patients participating in the 100,000 Genome Project will benefit because a conclusive diagnosis can be reached for a rare/inherited disease or because a stratified cancer treatment can be chosen that is most suitable to their individual cancer. For most, the benefit will be in knowing that they will be helping people with similar diseases in the future through research on the genome and associated clinical data they generously allow to be studied. Their involvement in the project will allow 5

6 an infrastructure to be developed, which in the future will support genomic services to be applied more widely to patient care in the NHS and across many clinical specialities. However, it is not just patients and the NHS that stand to benefit from the 100,000 Genome Project. Whilst the principal aim is to improve the lives of patients, there are potentially many economic benefits for the nation and the UK tax-payer. Some may be unexpected, built on new, as yet undiscovered technologies that will emerge. Such benefits may be in the realm of improved diagnostic tests, better tailored treatments and development of new treatments and medicines. As the major delivery partners for the 100,000 Genome Project, NHS England needs to put in place arrangements with participating providers to: enable participation of patients and relatives; achieve acquisition of adequate numbers of samples; and, capture clinical phenotype information. NHS England is therefore embarking on a process of selecting NHS Genomic Medicine Centres. Successful providers will enter into an agreement with NHS England to regulate the delivery of these three elements required for the successful delivery of the 100,000 Genome Project. In order to ensure a high degree of confidence in the ability of the selected NHS Genomic Medicine Centres to achieve delivery in a timely manner for selected rare/inherited diseases and certain cancers, NHS England has developed a specification of needs and requirements. Providers may apply to support the Project for rare/inherited diseases or cancers, or both. NHS England envisages a phasing of selecting NHS Genomic Medicine Centres with 3 to 5 identified in the first instance to commence enrolment of cases in January The table below summarises the key points in the competition timetable: Activity Date Potential Provider Days 21 st & 22 nd July 2014 Wave 1 ITT Launch w/c 21 st July Application submission deadline 5 pm, 29 th August 2014 Site Visits (ratification of mobilisation for September st January 2015) Announcement of Likely Wave 1 Sites w/c 6 th October 2014 Wave 1 Site Contract Negotiations October December 2014 The 100,000 Genome Project provides an exciting opportunity for the UK to become world-leading in translating genomics research into the wide use of genomics in NHS patient care, which in turn, will contribute towards delivering high quality care for all, now and for future generations. 6

7 BACKGROUND 1. The 100,000 Genome Project is focused on sequencing the whole genome of patients with rare/inherited diseases and certain common cancers and will further enhance our understanding of the genetic basis underlying these conditions, together with how they are expressed within an individual (phenotype). This cutting edge programme has the potential to drive transformational change in service delivery and workforce, from obtaining informed consent from patients, to obtaining, processing and archiving of biosamples yielding high-quality DNA, to the application of whole genome sequencing and its analysis and confirmation of clinically relevant DNA variants. 2. The analysis requires the application of new skills and expertise in specialist areas such as bioinformatics and computational biology. In addition, the different clinical specialities of the NHS workforce will need to gain an improved understanding of the value of genomics to clinical care and how to communicate findings with patients and their close relatives. 3. The 100,000 Genome Project is a hugely ambitious programme and builds on preceding initiatives such as the 1000 Genomes, UK10K, Deciphering Developmental Disorders (DDD) and National Institute for Health Research (NIHR) BioResource projects. The NHS, supported by its academic partners, has been at the forefront of early implementation of scientific breakthroughs in service delivery. The NHS, in close partnership with its academic partners and companies in the private sector, is ideally placed to be at the forefront of translating genomics into improved patient care. Through the 100,000 Genome Project, the NHS in England will be the first mainstream health service in the world to offer genomic medicine, initially for some rare/inherited diseases and cancer, but increasingly in other domains of care delivery. 4. Results from genomic sequencing and other genomic variant testing may be complemented with other results generated from studying the whole functional genomics pathway, and the use of other omic technologies, which enables an understanding of the genome in the form of proteins (proteomics) or products and biomarkers (metabolomics). The application of all of these omic technologies to routine care for NHS patients will lead to increasingly personalised treatment plans, leading to a precision medicine approach. 5. The 100,000 Genome Project is designed to leave a lasting legacy for patients and to pioneer new models of delivering precision health care. This is set out in the following diagram: 7

8 DELIVERY PARTNERS 6. Genomics England Limited, a company wholly funded and owned by the Department of Health (with the Secretary of State for Health as the sole shareholder) was set up as the main delivery organisation in July 2013 to lead on delivering the 100,000 Genome Project, 7. For the 100,000 Genome Project to succeed, it requires the collaboration of a number of key delivery partners namely: Genomics England, NHS England, partners within academia, Health Education England, Public Health England and the National Institute for Health Research; as well as the support of numerous external organisations; and, most-importantly, from patients and their close relatives. 8. Genomics England will complete in July 2014 its tendering process to purchase whole genome sequencing capacity and clinical annotation service at scale. NHS England and more specifically the NHS is responsible from January 2015 for the: identification of cases; consent, enrolment and case registration; the collection and processing of samples and the associated data from clinical and laboratory records. 8

9 9. Following initial procurement and the enabling of 100,000 Genome Project between now and 2017, the expectation is that NHS England will, in the longer term, ensure system-wide sustainability of Whole Genome Sequencing, validation of gene variants and their annotation and clinical interpretation. NHS GENOMIC MEDICINE CENTRE SELECTION INFORMATION 10. As the major delivery partner for the project, NHS England needs to put in place sufficient arrangements with participating providers to enable sample acquisition and preparation to start from January NHS England is therefore embarking on a process to select NHS Genomic Medicine Centres. Providers successful in this selection process will enter into an agreement with NHS England to deliver: identification of cases; consent, enrolment and case registration; the collection of samples and the associated data from clinical and laboratory records. Each NHS Genomic Medicine Centre will agree with NHS England on the number of patients to be enrolled for selected rare/inherited diseases and/or common cancers 11. In order to ensure a high degree of confidence in the ability of the selected NHS Genomic Medicine Centres to supply the services to enrol a sufficient case load and to provide evidence-based clinical treatment, NHS England is developing a specification of requirements to underpin the selection process. Providers may apply to enrol patients with either rare/inherited diseases or certain common cancers, or both. A track record of providing similar services and/or activities that the 100,000 Genome Project requires will be essential. DISEASES SELECTION 12. Diseases in scope for inclusion in the 100,000 Genome Project will be determined by Genomics England in partnership with NHS England. Those included will be informed by scientific consideration as well as the clinical and other evidence supporting both inherited/rare disease categories and cancers. In the case of cancers it is recognised that the availability of sufficient tissue for processing and extraction purposes may be a limitation. 13. This approach enables participating organisations to maximise their capability for sample collection whilst allowing organisations where appropriate to include additional disease areas or patients that may have an underlying genetic abnormality that Whole Genome Sequencing could unmask. 14. NHS England and Genomics England will continue to look at the evidence to underpin the sample supply chain in each of the potential diseases in scope for the lifetime of the 100,000 Genome Project and to compare these to the sequencing pipeline requirements. 15. Below is an indicative list of potential diseases that could be considered during the lifetime of the 100,000 Genome Project. It has been developed on the basis of current scientific advice and clinical evidence. This list will evolve over time, but provides interested applicants an opportunity to consider their capability and 9

10 capacity in these areas. Potential diseases for inclusion in the 100,000 Genome Project could include but are not restricted to: Rare and Inherited Disorders (these include conditions for which there is no known genetic abnormality identified) Inherited cardiac disease, including structural cardiac abnormalities, arrhythmias, cardiomyopathies and conduction defects; Inherited renal disease, including structural abnormalities, cystic disease, tubular disorders, reflux and early onset renal stones; Inherited neurological conditions, including structural brain abnormalities (e.g. microcephaly), myopathies, epilepsy, ataxias, muscular dystrophy and other progressive disorders, plus familial examples of degenerative or psychiatric conditions such as dementia, schizophrenia, bipolar disorders and autism; Unexplained intellectual disability (moderate to severe); Connective tissue disorders (including Ehlers Danlos syndromes) and skeletal dysplasias; Inherited rare cancer syndromes, including individuals with multiple primary cancers; Dysmorphic syndromes; Undiagnosed conditions associated with multiple congenital abnormalities; Undiagnosed inherited haematological conditions, including primary immunodeficiencies; Inborn errors of metabolism, including mitochondrial disorders; Inherited endocrine disorders; Congenital disorders of growth, including overgrowth and severe failure to thrive; Undiagnosed familial, serious skin conditions; Inherited eye conditions; Congenital deafness (profound/severe); Ciliopathies, including non-cf bronchiectasis. Cancers (in some of these cancers the availability of sufficient tissue for processing and extraction purposes may be limited) Breast; Colorectal; Ovary; Lung; Prostate; Kidney; All haematological cancers, including Lymphoma; Paediatric cancers - as there is expectation that many of these are due to an inherited predisposition to cancer. 10

11 STANDARD OPERATING PROCEDURES 16. Selected NHS Genomic Medicine Centres will be expected to work to standard operating procedures (SOPs) developed and continuously improved by NHS England and Genomics England. Centres will be subject to ongoing monitoring of performance against these. This will cover: ethics and consent; provision of clinical phenotype data to a nationally agreed minimal dataset; integrated Information Governance and Research and Development frameworks; acquisition of samples from patients falling into the clinically defined groups of rare/inherited diseases or cancers that the 100,000 Genome Project will focus on initially; automated preparation and extraction of DNA from blood (for both rare/inherited diseases and cancer patients) and from Formalin Fixed Paraffin Embedded prepared tumour tissue blocks [NOTE: There remains uncertainty about whether fresh frozen tumour samples may need to be used to ensure the quality of DNA extracted for sequencing purposes. NHS Genomic Medicine Centres and therefore all applying centres will need to demonstrate their ability to respond over time to changes in SOPs in this area]; sample transport logistics; and the validation of sequence findings. 17. There will also be an NHS England requirement on the NHS Genomic Medicine Centre to demonstrate its ability to undertake additional clinical and laboratory investigations to more precisely define the clinical phenotype and to deliver the effective clinical care treatment plan, where relevant informed by the results of the Whole Genome Sequencing. DNA EXTRACTION 18. NHS England and Genomics England are developing evidence for the best approach to Whole Genome Sequencing, including a benefits analysis of local and central sample preparation, although this may change with experience over the life of the project. NHS England will ask all interested applicants to detail their DNA extraction methods to understand the potential for this. In doing this they should also demonstrate how they could work with the current NHS commissioned regional genetic centres (and the subsequent infrastructure following the pending re-procurement of regional genetic centres) and access their knowledge, skill and expertise in DNA extraction from blood and tissue and in the interpretation of sequence and genetic variant data and its further investigation or clinical relevance. 19. Successful providers selected as NHS Genomic Medicine Centres will need to demonstrate the robustness of local informational technology systems and the ability to integrate and upload patients phenotypic and genomic data. NHS England and the Department of Health have agreed a Capital Investment Fund (approximately 10m in total) to be made available to a number of selected provider Trusts to further enhance the development of such information systems. 11

12 The informatics system will need to capture clinical management data and patient-specific clinical, laboratory, imaging, etc. data compliant with NHS national data standards. This data need to be combined with the variant results obtained by Whole Genome Sequencing and presented to Clinical Care teams in a clinically-relevant manner. WORKING IN PARTNERSHIP 20. As part of the application process, interested providers should also demonstrate how they are working in partnership with their academic partners, especially with the NIHR-supported Biomedical Research Centres and Units, NIHR/Wellcome Trust funded Clinical Research Facilities, and to have processes in place to process samples to the required standards. 21. NHS England welcomes partnership applications from providers working with their local and national academic partners, other relevant stakeholders within and outside of the NHS to provide a more comprehensive coverage of the diseases and the related activity flows that could be offered. 22. The NHS in England is the first country in the world to establish universal coverage of Academic Health Science Networks (AHSNs). The work programmes of AHSNs are broad and complex and include a range of clinical and cross-cutting projects. They are predicated on a new model of partnership working and collaboration between the NHS, academia, the private sector and a range of other external partners. 23. As system integrators linking all parts of the health ecosystem, they are demonstrating their contribution to the High Quality Care for All mission of NHS England by transforming and improving patient outcomes whilst simultaneously driving productivity, economic growth and wealth creation. It is a pivotal role of AHSNs to create collaborations or partnerships between members and stakeholders who control resources many times those of AHSNs. 24. NHS England would expect organisations participating in the 100,000 Genome Project to demonstrate how they are working with their local AHSN in order to improve patient enrolment and share the best practice, opportunities and lessons learned from the programme with all partners in the AHSN. FUNDING 25. NHS England will meet an amount of the additional revenue costs of providers in delivering their activity contributions to the 100,000 Genome Project. The methodology applied to distribution of any additional revenue costs will be published as part of the Invitation to Tender (ITT) documentation. It is possible that the additional revenue costs may be met in the form of an allocation equivalent to a minimum and maximum of full time equivalent staffing costs set against an agreed pay banding. Providers will need to disclose their additional costs with sufficient breakdown between pay bandings and non-staff expenses. Any cost elements covered by existing tariffs must be excluded. Depreciation 12

13 costs and other revenue consequences of capital investments must also be excluded. 26. Capital funding is available via the Department of Health Capital Investment Fund. The application process and criteria will be notified shortly. Capital Investment Fund applications are conditional upon providers meeting the annual revenue consequences, including depreciation expenses. WORKFORCE DEVELOPMENT 27. Health Education England is developing and providing education and training resources to support the associated workforce development as part of their national genomics programme. POTENTIAL PROVIDER INFORMATION DAYS 28. NHS England will hold two consecutive Potential Provider Information Days on 21 st and 22nd July, between 10am and 4pm. These will enable potential providers to consider how they may prepare their application to be assessed by a joint NHS England/Genomics England/DH assessment panel in September. Representatives of the assessment panel will be present at the Potential Providers Information Days and there will be an opportunity to discuss how the provider considers its future application in light of the Prospectus requirements and in advance of NHS England issuing a formal Invitation to Tender. If potential providers would like to collaborate with partners and have a collective conversation with NHS England, Genomics England and the Department of Health this can be accommodated. 29. In order to book an appointment for your organisation to participate in the Potential Providers Information Days please england.genomics@nhs.net requesting a first and second preference date and time. Please your attendance request by 5pm on Friday 11 th July The meetings will be conducted face-to-face at the following venue: Richmond House Room Whitehall London SW1A 2NS INVITATION TO TENDER 30. The ITT document for Wave 1 will be published during the week commencing 21 st July This will set out the full application criteria. Providers with an interest in applying for NHS Genomic Medicine Centre status will be required to complete the application form and submit it to: england.genomics@nhs.net by 5pm on the 29 August Non-application or non-selection for Wave 1 does not preclude organisations from applying to be NHS Genomic Medicine Centres during the lifetime of the project. Annex 1 of this Prospectus sets out some of the preliminary application information that NHS England will expect applicants to address. This early thinking has been published in order to ensure all potential 13

14 applicants have the opportunity to consider the suitability of their organisation for participation in the 100,000 Genome Project. SELECTION TIMETABLE FOR WAVE 1 NHS GENOMIC MEDICINE CENTRES 31. The table below sets out the timetable for the selection of Wave 1 providers who will be expected to be operational in January Activity Date Potential Provider Information Days 21 st & 22 nd July 2014 Wave 1 ITT Launch w/c 21 st July 2014 Application submission deadline 5 pm, 29 th August 2014 Site Visits (ratification of mobilisation for September st January 2015) Announcement of Likely Wave 1 Sites w/c 6 th October 2014 Wave 1 Sites Contract Negotiations October December

15 ANNEX 1 100,000 GENOME PROJECT NHS GENOMIC MEDICINE CENTRE SELECTION PRELIMINARY APPLICATION INFORMATION The 100,000 Genome Project will operate in phases of activity with the maximum levels of sample accrual likely during the financial year 2016/17. This is a groundbreaking and new process for the NHS and for it to be successful participant organisations will operate in a cycle of continuous learning and improvement. Because of this NHS England will adopt an ongoing and incremental process for designating successful applicants and awarding contracts during the lifetime of the project. The information in this Annex sets out the preliminary and current areas that are likely to be included in the ITT document and that NHS England is likely to expect applicants to address. This information is contained in the Prospectus, and offers all interested applicants the maximum opportunities to consider if they have sufficient capability and capacity for application for Wave 1. The full ITT document for Wave 1 will be published during the week commencing 21 st July This will set out the full application criteria. Providers with an interest in applying for NHS Genomic Medicine Centre status will be required to complete the application form and submit it to: england.genomics@nhs.net by 5pm on the 29 August Non-application or non-selection for Wave 1 does not preclude organisations from applying to be NHS Genome Medicine Centres during the lifetime of the project. All applications will be required to be signed by both the provider CEO, COO and the CIO as well as a representative of key academic partners. Additionally all applicants will need to demonstrate they will have in place a project coordinator, a nominated lead medical professional and a lead non medical statutory regulated Clinical Scientist. The table below illustrates some of the key questions, evidence and practice that applicants may wish to consider when identifying if their organisation has sufficient capability, capacity and experience to participate in the 100,000 Genome Project. NHS Genomic Medicine Centre Preliminary Application Information Questions for Information to consider when providing evidence to consideration answer questions Project Governance Consider your rationale for stating that you are experienced and have the capability and capacity to participate in the 100,000 Genome Project. Consider other research or clinical trial activity in rare disease or cancer that may support or conflict with the 100,000 Genome Project. 15

16 Identify a single senior and a single operational contact for each of the following: rare disease recruitment; cancer recruitment; DNA extraction for blood; DNA extraction for tissue; quality validation; data acquisition. If selected as an NHS Genomic Medicine Centre, from the point of contract award, how quickly can you mobilise to become fully operational? Are you considering becoming operational for Wave 1 in January 2015 or later in the lifetime of the 100,000 Genome Project? Patient Enrolment Consider the number of index patients with Inherited/Rare Diseases - which do you anticipate your organisation will be able to enrol per financial quarter from Q onwards and which fraction of patients you will be able to provide samples from the index case and their biological parents? Please provide evidence supporting these statements including at a minimum incidence, prevalence, clinical appointments, and historic recruitment for each rare/inherited disease included in the Programme. Consent Please consider the cancer types from the indicative list under consideration by Genomics England and identify the number of patients you anticipate enrolling by financial quarter from Q onwards. Provide evidence to support these assumptions. Consider the existing arrangements you have in place for ethics and consent for sample acquisition. If no arrangements are in place, how would you obtain them? DNA Extraction, Quality Control and Storage Consider your process for seeing patients and getting consent and samples separately for inherited/rare diseases and cancers. Would this be in routine or specialist clinics or visiting known (e.g. rare/inherited diseases patients at home)? Please provide details of your experience of extracting DNA, Quality Control of the DNA and storage methods. Please describe what technique you use for DNA extraction. 16

17 In the case of cancer samples consider the types of cancer samples from enrolled patients (e.g. resection, biopsy, fresh frozen, FFPE and any alternative fixation methods used). Provide detailed information about whether you already routinely store extracted DNA alongside serum/plasma from the same patient. Consider the evidence available to supporting these statements. Standard Operating Procedures Successful applicants could work with regional genetic labs to ensure quality of DNA extraction. Consider who you would partner with. Consider your willingness and capability to adopt Genomics England and NHS England Standard Operating Procedures for: enrolment of participants according to Genomics England electronic informed consent; sample acquisition; capture of clinical phenotype information using Genomics England/NHS England phenotype acquisition tools and in compliance with NHS national data standards; supply clinical management information and the NHS number for each enrolled patient. Consider your approach to programme governance and your approach to the introduction of new SOPS over the lifetime of the Project. Consider the SOPs you use for sample processing, for DNA extraction and analysis including those in place for Quality Assurance and validation processes. Data and Informatics Clinical Feedback and Care Management Confirm accreditation with UKAS/CPA and regulated with CQC and participate in EQA schemes? Consider your plan for handling data - patient data for phenotypic data, handling and validating the clinical feedback reports that result from the sequence data and directing any subsequent investigations. This may involve other genetic testing and markers as the test performance of whole genome sequencing is not expected to enable definitive diagnosis in all cases. Consider your approach to the follow up of patients to discuss results and agree treatment and their follow up if treatment changes as a result of genomic profile. The care management information you provide also needs to demonstrate you treat according to evidence 17

18 Financial Investment. Working in Partnership based guidelines. Consider your planned investment and costs (revenue, capital and human resource) to support delivery of potential obligations if selected as an NHS Genomic Medicine Centre. Specify how you intend to allocate resources across each appropriate department of your organisation? Consider any existing partnership arrangements with neighbouring provider organisations that could increase enrolment and confirm their willingness numbers and diseases you can supply APPLICATION TIMELINE AND PROCESS The overall application and evaluation process comprises four main stages as illustrated below: Prospectus ITT Application Site Visit Award & Agreement Receive Funds ASSESSMENT Applicants will receive an within 24 hours of submitting their application confirming receipt and advising of their unique application reference number. If a provider submits an application but does not receive this confirmation please contact england.genomics@nhs.net Applications will then be assessed, using the assessment criteria that will be published alongside the ITT documentation during the week commencing 21 st July Those applicants that score highly enough will be asked to arrange a site visit. SITE VISITS In September, applicants shortlisted for consideration in Wave 1 will receive onsite visits from the assessment panel to validate their ability for mobilisation from point of contract, and their capability and capacity for volume of samples claimed in application. Successful applicants for Wave 1 are expected to mobilise to be operational in January 2015 and we will begin contract negotiation in October CONTRACT AWARD In the week beginning 6 th October: NHS England will announce Wave 1 successful applicants expecting to begin sample acquisition in January It may be that at the time NHS England announces the successful applicants of the first round of selection, as well as announcing a longer list of providers as potential NHS Genome Medicine Centres to begin enrolment during the lifetime of the Programme - between 18

19 2015 and These may be pending further ratification of their application. Nonapplication or non-selection for Wave 1 does not preclude organisations from applying to be NHS Genome Medicine Centres in future Waves of the project. CONTRACT AWARD AND AGREEMENT NHS England will issue each selected applicant with an agreement for the supply of sample acquisition. Successful applicants will be required to sign an agreement setting out a series of obligations on behalf of the receiving organisation. Applicants will be able to access funding once the agreement is signed and returned. Obligations will include: delivery of the total number of samples as specified; tracking and reporting on benefits arising from the programme; publication of programme-related achievements on the organisation s public website; identifying a board member or senior officer as local programme sponsor and champion (if not already in place); regular programme reporting and data collection; providing details of what the capital investment was spent on and suppliers/ procurement frameworks used (if applicable); participating in media activities if requested; complying with the Public Sector Equality Duty; Commercial, IP and publication rights. Underlying these obligations is a commitment to sharing learning across NHS organisations, Genomics England, Health Education England, NHS England, the Department of Health and other interested parties. 19