Therapeutic area

Lung cancer

  • Preparation of 3 existing manuscripts on lung cancer for submission
  • Literature search and analysis of phase 2 vs phase 3 lung cancer studies
  • Literature and reimbursement review of intravenous versus subcutaneous therapies in lung cancer
  • Development of a pan-lung oncology treatment model
  • Landscape analysis for ablation in lung cancer
  • Patient interviews in lung cancer
  • Analyses of endpoints in oncology: Statistical analyses in lung cancer
  • Analyses of endpoints in oncology: Country-specific EQ-5D utilities in lung cancer
  • Analytical evidence for improvement in symptoms and quality of life in lung cancer patients on a specified treatment
  • Analytical evidence for improvement in symptoms and quality of life in pre and post-randomisation lung cancer patients (by age groups)
  • Strategic consulting, research and measurement in solid tumours
  • Strategic communications planning in lung cancer
  • Consulting for an FDA submission in lung cancer
  • Summary presentation of a workstream in lung cancer

Non-small cell lung cancer (NSCLC)

  • Global value dossier and e-v@luate platform in NSCLC
  • Global value dossier and e-v@luate platform in non-squamous NSCLC
  • Global value dossier and e-v@luate platform in advanced squamous NSCLC
  • Global value dossier for a treatment in metastatic NSCLC
  • Payer value deck and response to payer questions update in 1st line NSCLC
  • Updated payer value dossier deck and FAQs deck for 1st line NSCLC
  • Updated burden of disease decks, payer value dossier decks and FAQs decks for 1st line and 2nd line NSCLC
  • Societal costs, health-related quality of life systematic literature review and publications plan for NSCLC in Europe
  • Literature review of overall survival and bone metastases in NSCLC
  • Literature review to inform global market access materials in NSCLC
  • Structured literature review in advanced 1st line NSCLC
  • Systematic review and mixed treatment comparison in advanced NSCLC
  • Development of technical documentation and manuscript on NSCLC
  • Two manuscripts on the indirect comparison of the efficacy of two different therapies for NSCLC
  • Development of a manuscript on the cost-effectiveness of a treatment in NSCLC in Italy
  • Manuscript on the efficacy of three different drugs for the treatment of NSCLC
  • Model review of a drug used in the treatment of NSCLC
  • Multi-indication budget impact model in NSCLC
  • Adaptation of a multi-indication value-based pricing model in NSCLC to China
  • Value-based model in NSCLC
  • Standardisation of economic models in NSCLC
  • Global model update and country adaptations for a multi-indication value-based pricing (VBP) model on NSCLC
  • Burden of disease decks in advanced 1st line and 2nd line NSCLC
  • Burden of disease deck update in 1st line NSCLC
  • Integrated research plan in advanced melanoma and NSCLC
  • Value slide deck for treatment in NSCLC
  • Guidance documents for affiliates in treatment for NSCLC
  • Situational analysis report of epidermal growth factor receptor (EGFR) predictive testing in NSCLC
  • Communication toolkit for a lung cancer supplement
  • Companion diagnostics biomarker FAQs compilation deck in NSCLC
  • FAQs update in advanced 1st line NSCLC
  • FAQs deck update in 2nd line NSCLC
  • Payer slide decks and objection handler in NSCLC
  • Payer tools implementation guide in NSCLC
  • Payer value proposition deck update in 2nd line NSCLC
  • Payer value deck update in advanced 1st line NSCLC
  • Payer value deck and response to payer questions update in 1st line NSCLC
  • HTA submission support in epidermal growth factor receptor positive (EGFR+) and non-small cell lung cancer (NSCLC)
  • Numerous abstracts and conference posters on NSCLC, advanced NSCLC and related treatments
  • Several abstracts and conference posters relating to the cost and cost effectiveness of a first-line treatment option for patients with NSCLC
  • Abstract and poster on progression-free survival and overall survival in patients with NSCLC
  • Literature review of outcomes and costs during treatment for advanced NSCLC
  • Literature review and consultancy on NSCLC
  • Manuscript on stage IIIb and IV NSCLC
  • Development of a measurement dossier in advanced NSCLC for the EMA
  • Meta-analysis and manuscript on stage IIIb and IV NSCLC
  • Statistical analyses of clinical trial data (safety study) in NSCLC
  • Statistical analyses of clinical trial data (observational study) in NSCLC
  • Clinical trial analyses to support health-related quality of life in first-line NSCLC
  • Qualitative study on the needs and preferences of patients with advanced NSCLC for maintenance therapy
  • Development of an analysis plan in NSCLC for the USA and Europe
  • Analysis of PRO data in NSCLC
  • Qualitative interviews to understand the impact of NSCLC on quality of life and on caregivers and family members
  • EQ-5D review for an EMA measurement dossier in advanced NSCLC
  • Exploratory qualitative interviews in NSCLC patients to assess progression-free survival
  • Comparative effectiveness of two treatments for the treatment of NSCLC
  • Feasibility network meta-analysis comparison of two treatments for NSCLC
  • Exploratory analysis of the Visual Symptom Assessment Questionnaire (VSAQ) in patients who have undergone treatment for NSCLC
  • Utilities analyses to support economic modelling in NSCLC
  • Clinical trial analyses to support health-related quality of life in NSCLC
  • Impact of whole brain radiation therapy in patients with NSCLC with brain metastases

Small cell lung cancer (SCLC)

  • Global value dossier and upload to e-v@luate platform in SCLC
  • AMCP dossier in SCLC
  • Systematic literature reviews for the societal and health-related quality of life burden of SCLC
  • Systematic literature review and manuscript on real-world effectiveness and tolerability of treatments in SCLC
  • Literature review on real-world effectiveness and tolerability of treatment in SCLC
  • Utility study in SCLC
  • Development of a budget impact model in SCLC
  • Budget impact model in 1st line SCLC
  • Development of a disease conceptual model and endpoint recommendation for SCLC
  • Phase IV clinical trial analysis of two drugs used in the treatment of SCLC
  • Analysis of symptoms for a drug used to treat SCLC
  • Full text reports on the longitudinal analyses of a drug used to treat SCLC for EU submission
  • Literature and PRO strategy for SCLC
  • Clinical trial analyses to support health-related quality of life in SCLC
  • Literature review and consultancy on SCLC

Melanoma

  • Adaptation of a multi-indication value-based pricing model in melanoma to China
  • Literature review in metastatic melanoma treatment patterns
  • Scientific communication of a systematic literature review on caregiver burden in advanced metastatic melanoma
  • Global value dossier for a treatment in melanoma
  • Development of global market access materials (disease burden slide deck, payer value story and FAQs) in metastatic melanoma to support local access teams
  • Payer slide decks and objection handler update in metastatic melanoma
  • Implementation guide in metastatic melanoma
  • Burden of disease deck update in ipi refractory and ipi naïve advanced melanoma
  • Payer value proposition deck update in ipi refractory advanced melanoma
  • Payer value proposition deck update in ipi naïve advanced melanoma
  • Updated implementation guide in melanoma
  • Frequently asked questions deck in ipi refractory and ipi naïve advanced melanoma
  • Updated burden of disease deck, payer value dossier decks and obstacle handler in a treatment for refractory & naïve melanoma
  • Development of a budget impact model for adjuvant melanoma
  • KOL interviews and primary research into treatment patterns in adjuvant melanoma
  • Payer value deck and response to payer questions in adjuvant melanoma
  • Payer value deck and response to payer questions update in advanced melanoma
  • Burden of disease deck in adjuvant melanoma
  • Burden of disease and payer value deck in adjuvant and advanced melanoma
  • Standardization of economic models in melanoma
  • Value-based model in melanoma
  • Multi-indication budget impact model in melanoma
  • Global model update and country adaptations for a multi-indication value-based pricing (VBP) model on melanoma
  • Adaptation of a value-based pricing (VBP) multi-indication global model in oncology to Greece
  • Strategic communications planning in melanoma
  • Summary presentation of a workstream in melanoma
  • Caregiver burden in advanced melanoma
  • Caregiver burden in melanoma in the EU
  • Evidence synthesis on the comparative effectiveness of systemic therapies for unresectable stage IIIc and stage IV melanoma
  • Pilot patient interviews in melanoma
  • Exploratory analyses of endpoints in oncology: Statistical analyses in melanoma
  • Analyses of endpoints in oncology: Statistical analyses in first-line melanoma
  • Clinical trial analyses to support the relationship between adverse events and health-related quality of life, health status and work productivity in melanoma
  • Clinical trial analyses to support health-related quality of life in melanoma: AMNOG analyses for combination arm therapy
  • Network meta-analysis on the efficacy of first line treatment for unresectable stage IIIC/IV melanoma
  • AMNOG analyses to support health-related quality of life in melanoma

Colorectal cancer

  • Adaptation of a multi-indication value-based pricing model in colorectal cancer in China
  • Project management of a mixed treatment analysis on colorectal cancer
  • Update to a payer value slide deck in metastatic colorectal cancer
  • Value-based model in colorectal cancer
  • Payer communications strategy and tools in colorectal cancer
  • Reimbursement dossiers in subgroups of colorectal cancer
  • Mini literature review in metastatic colorectal cancer
  • Literature review and payer communication tools in metastatic colorectal cancer
  • Translation to support development of a value dossier and budget impact model in capsule endoscopy for colonoscopy
  • Global model update and country adaptations for a multi-indication value-based pricing (VBP) model on colorectal cancer
  • PRO assessment on the neurotoxicity of a treatment for advanced colorectal cancer
  • Clinical trial analyses to support HRQoL in recurrent and metastatic microsatellite instability high colorectal cancer
  • White Paper on continuous infusion in colorectal cancer
  • Development of cost arguments and brochure development in colorectal cancer
  • Network meta-analysis on the efficacy of treatment for metastatic colorectal cancer
  • Recommendations on the economic impact of a treatment for metastatic colorectal cancer
  • Network meta-analysis of a treatment versus other biologics for metastatic colorectal cancer in 1st line, 2nd line and multiple line settings
  • Web-based survey to understand patient-preference and satisfaction in advanced colorectal cancer

Head and neck cancer

  • Adaptation of a multi-indication value-based pricing model in head and neck cancer to China
  • Health economic advisory board on a treatment for head and neck cancer
  • Payer tools implementation guide in head & neck cancer
  • Payer value proposition deck in 2nd line head & neck cancer
  • Payer communications strategy and tools in head and neck cancer
  • Payer communication tool and summary in SCCHN
  • Burden of disease deck, payer value dossier deck and frequently asked questions deck in 2nd line head and neck cancer
  • One-pager on HPV in head and neck cancer
  • Market access and pricing tools to support a value proposition in squamous cell carcinoma of the head and neck (SCCHN)
  • Market access payer value tool in head and neck cancer
  • Economic value story in SCCHN
  • Standardization of economic models in head and neck cancer
  • Value-based model in head and neck cancer
  • Multi-indication budget impact model in head and neck cancer
  • Cost-effectiveness model in head and neck cancer
  • Global model update and country adaptations for a multi-indication value-based pricing (VBP) model on head and neck cancer
  • Dossier for a chemotherapy drug for head and neck cancer
  • Reimbursement dossiers in subgroups of head and neck cancer
  • Mini literature review in SCCHN
  • Literature review and payer communication tools in SCCHN
  • Clinical trial analyses to support health-related quality of life in head and neck cancer
  • Qualitative interviews to assess equivalence of paper and electronically administered questionnaires in head and neck cancer
  • SMC submission of a chemotherapy drug in head and neck cancer
  • Two manuscripts and one mini report for the head and neck cancer models for the UK
  • US costing for a head and neck cancer model
  • Health-related quality of life analyses to support a treatment for head and neck cancer: a Q-TWiST analysis
  • AMNOG and ad hoc analyses to support health-related quality of life in SCCHN

Upper tract urothelial carcinoma

  • HEOR and market access activities in upper tract urothelial carcinoma (UTUC)
  • Strategic consultancy for market access support in upper tract urothelial carcinoma (UTUC)

Other haematology experience

  • Preparation of three core European value dossiers (for use by affiliates and targeted to regional/local decision makers in key markets) and three value stories in haematology
  • Manuscript on a budget impact model for a biosimilar in haematology
  • Revisions to the Lymphoedema Quality of Life Questionnaire (LYMQOL)
  • EMEA training on PROs in haematology

Other genetic disorders

  • Health economic analysis for SMC resubmission in homocystinuria
  • Conference poster on the utility of oral versus subcutaneous iron chelation therapy for beta thalassaemia
  • Real-world evidence toolkit in Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP)
  • Market access and HEOR consultancy in genetic disorders

Diabetes-related conditions/complications

Diabetic neuropathy

  • Linguistic validation of the Norfolk Quality of Life (QoL) questionnaire in diabetic neuropathy
  • Competitive analysis and burden of illness in diabetic peripheral neuropathy
  • Literature review of PROs and endpoints of pain in peripheral diabetic neuropathy
  • PRO assessment in diabetic peripheral neuropathy
  • Validation study of the modified version of the Brief Pain Inventory – Short Form (mBPI-SF), MOS-S and 3 single item questions in diabetic peripheral neuropathy
  • Gap analysis and strategic recommendation for PRO and market access studies in diabetic peripheral neuropathy
  • Consultancy on the validity of the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale for use in painful diabetic neuropathy patients
  • Interview study to understand the experience of walking pain among patients with diabetic peripheral neuropathy
  • Analysis of diabetic neuropathy

Retinopathy

  • Value messages and objection handlers for anti-vascular endothelial growth factor therapy (anti-VEGF) treatment in diabetic retinopathy and retinopathy of prematurity

Hypoglycaemia

  • Scientific communication on the prevalence and cost of severe hypoglycaemic events in Denmark
  • Slide deck on hypoglycaemia in diabetes
  • Study poster on Hypoglycaemia in Insulin Treated (HIT) patients
  • Manuscripts reporting the findings of the HIT Study on hypoglycaemia in diabetes
  • Manuscript reporting hypoglycaemia data for the HIT survey in the Netherlands
  • Three manuscripts for treatment of hypoglycaemia
  • Interactive slide deck presentation of hypoglycaemia study results
  • Abstract and manuscript reporting analyses from a hypoglycaemia study in the UK
  • Two manuscripts reporting specific country analyses from a hypoglycaemia study (Austrian and Finnish)
  • Manuscript reporting specific country analyses from a hypoglycaemia study (Denmark)
  • Scientific communication and presentation of data from the cross EU HIT study in hypoglycaemia

Diabetic macular edema

  • Rapid payer research to inform investment decisions in diabetic macular edema
  • Cost-effectiveness model to inform investment decisions in diabetic macular edema
  • Content validation of a visual function questionnaire in diabetic macular edema and retinal vein occlusion
  • FDA claim strategy and endpoint review for a visual function questionnaire in diabetic macular edema (DME) and retinal vein occlusion (RVO)
  • Review of PRO measures in diabetic macular edema
  • Interviews with patients with diabetes-induced edema in the USA

Diabetic foot infections

  • Diabetic foot ulcer support for FDA meetings
  • Psychometric validation of the Diabetic Foot Ulcer Scale (and Short Form) and the Short Form Health Survey (SF-36)
  • Cost effectiveness analysis model for Portugal on a treatment for bacterial diabetic foot infections
  • PRO strategy of a HRQoL claim for diabetic foot ulcers in vascular endothelial growth factor (VEGF)

Gastroparesis

  • Review of protocol on a phase II study of subjects with severe gastroparesis due to diabetes mellitus
  • Cognitive debriefing of a symptom measure of gastroparesis in diabetics and standalone validation study

Psoriasis

  • Development of a payer value proposition and materials in psoriasis
  • NICE submissions for a new biologic for the treatment of moderate to severe psoriasis in the UK
  • Systematic literature review of quality of life in psoriasis
  • Manuscript on a literature review of quality of life in psoriasis
  • Literature review and stakeholder interviews on payer decision drivers in psoriasis
  • Update a to core value dossier in psoriasis
  • UK value story for a new treatment in psoriasis vulgaris
  • Competitor review deck and objection handler in psoriasis
  • Mini competitor review for a value proposition in psoriasis
  • Budget impact model for a new treatment in psoriasis vulgaris
  • Systematic literature review and network meta-analysis update in psoriasis
  • Indirect treatment comparison for a 2nd round response to PBAC for a psoriasis treatment
  • Supplementary analyses and reporting for the psoriasis network meta-analysis
  • Payer evidence dossier for a new psoriasis treatment
  • Payer dossier for paediatric psoriasis
  • Mini value dossier on paediatric psoriasis
  • Repurposing a slide deck for a payer value proposition in paediatric psoriasis
  • Core value dossier/payer value deck updates and competitor value differentiation slide sets on psoriasis
  • Core value dossier, payer value proposition and objection handler in psoriasis
  • Update to a value proposition slide deck for a treatment in psoriasis
  • Core value dossier update in psoriasis
  • Systematic literature review and network analysis in psoriasis
  • Early global value dossiers for a new monoclonal antibody in psoriasis
  • Total Brand FAQ deck and Total Brand Workshop in psoriasis
  • Global value dossiers and budget impact models for biosimilars in psoriasis
  • Systematic literature review in psoriasis – update for Poland
  • Targeted literature review in psoriatic arthritis patients with concomitant moderate to severe psoriasis
  • Country adaptation of a European payer dossier in psoriasis to Latin America and Spain
  • Core value dossier, value deck, literature review and objection handler in psoriasis
  • Psychometric testing of self-assessment of a psoriasis symptoms questionnaire
  • Psychometric validation of a psoriasis tool
  • Analysis and Abstract Development on a cumulative life course impairment (CLCI) in psoriasis
  • CLCI marketing and clinical data analysis of a psoriasis tool
  • Development of a PRO to assess sexual dysfunction in psoriasis
  • Development of a poster to describe the development of a PRO to assess the impacts of psoriasis
  • Scientific communications on the development of a PRO to assess sexual dysfunction in psoriasis
  • Development of psoriasis symptoms and treatment satisfaction measures
  • Patient preference study in plaque psoriasis
  • Strategic PRO review in psoriasis
  • Interviews with patient focus groups in psoriasis
  • Database analysis and publications in psoriasis treatment
  • Review of PROs and preparation and writing of a PRO briefing document for the FDA on the treatment of psoriasis
  • Review of a briefing document prepared for submission to the FDA in support of labelling claims in psoriasis
  • Briefing book support and psychometric evaluation of the Self-Assessment for Psoriasis Symptoms (SAPS)
  • International economic evaluation of a treatment for moderate to severe chronic plaque psoriasis
  • Measurement strategy in chronic plaque psoriasis
  • Support in development and analyses of a patient support programme in plaque psoriasis
  • Manuscript on Self-Assessment for Psoriasis Symptoms (SAPS) psychometric publications

Arthritis

  • Manuscript and analysis on an anti-inflammatory treatment for arthritis
  • PRO literature review for two different anti-inflammatory drugs for the treatment of arthritis

Ankylosing spondylitis

  • Interactive cost-effectiveness model for a selective inhibitor treatment used for ankylosing spondylitis
  • Manuscript cost-effectiveness analysis of a treatment for ankylosing spondylitis in Norway
  • Workshop and FAQ development in immunology in ankylosing spondylitis
  • Development of a payer value deck in immunology in ankylosing spondylitis
  • Competitor review deck in ankylosing spondylitis
  • Total Brand FAQ deck and Total Brand Workshop in ankylosing spondylitis
  • Global value dossier and budget impact model for a biosimilar in ankylosing spondylitis
  • Competitor value story slide deck in ankylosing spondylitis
  • Payer slide kit in non-radiographic axial spondyloarthritis
  • GI tolerability endpoint white paper including literature and instrument reviews on ankylosing spondylitis

Juvenile idiopathic arthritis

  • Workshop and FAQ development in immunology in juvenile idiopathic arthritis
  • Development of a payer value deck in immunology in juvenile idiopathic arthritis
  • Frequently asked questions deck in juvenile idiopathic arthritis

Osteoarthritis

  • Global value dossier and budget impact model for a biosimilar in osteoarthritis
  • Literature review of PROs and endpoints of pain in osteoarthritis
  • Literature review to support the use of COA measures in osteoarthritis
  • Competitive assessment and burden of illness study in osteoarthritis
  • Review of endpoints for clinical trials in osteoarthritis
  • Instrument review and assessment strategy in osteoarthritis
  • Mixed treatment comparison of two treatments for osteoarthritis of the knee
  • Mode of administration validation study for an electronic diary in back pain for osteoarthritis patients
  • Development and cognitive debriefing on a patient global response to a treatment measure in osteoarthritis pain
  • Translation and validation of the revised Hopkins Verbal Learning Test for osteoarthritis
  • Translation and validation of an osteoarthritis diary
  • Development of a measure of disease flare in osteoarthritis patients
  • Patient interviews to capture disease burden and unmet treatment needs in hand osteoarthritis
  • Mode of administration equivalency and usability testing of COA instruments in osteoarthritis
  • GI tolerability endpoint white paper including literature and instrument reviews on osteoarthritis
  • Consulting on PRO analysis and study design of trials in osteoarthritis
  • Top up literature review of PROs in osteoarthritis
  • Gap analysis and review of PRO measures in osteoarthritis
  • Qualitative exit interviews to assess the patient experience of treatment and clinical trial participation among patients with osteoarthritis

Psoriatic arthritis

  • Payer dossier update in psoriatic arthritis
  • Support for a manuscript on a network meta-analysis in psoriatic arthritis
  • Systematic literature review and network analysis in psoriasis and psoriatic arthritis
  • Targeted literature review in psoriatic arthritis patients with concomitant moderate to severe psoriasis
  • Workshop and FAQ development in immunology in psoriatic arthritis
  • Development of a payer value deck in immunology in psoriatic arthritis
  • Competitor review decks in psoriatic arthritis
  • Competitor value story slide deck in psoriatic arthritis
  • Data checks and DEF amendments in psoriatic arthritis
  • HTA support regarding psoriatic arthritis submissions in Canada, Spain and the UK
  • Regulatory support on SMC questions on psoriatic arthritis work
  • Development and Drug Development Tools (DDT) qualification of a PRO measure to assess the symptoms of psoriatic arthritis

Rheumatoid arthritis

  • Literature search, data extraction and report on rheumatoid arthritis
  • Cost-consequences manuscript on rheumatoid arthritis
  • Generating evidence to support the unmet need in rheumatoid arthritis
  • Measuring indirect and societal costs of morning stiffness in patients with rheumatoid arthritis
  • Manuscript on a treatment in rheumatoid arthritis
  • Review of an economic model to assess utility requirements for a treatment in rheumatoid arthritis
  • Utility study and economic model in rheumatoid arthritis
  • Review of European HTA requirements for treatment in rheumatoid arthritis
  • Adaptation of an economic model on treatment of rheumatoid arthritis for the USA
  • Value message testing for a biosimilar in rheumatoid arthritis
  • Objection handler in rheumatoid arthritis
  • Economic model on a treatment for rheumatoid arthritis
  • Budget impact model for a biosimilar in rheumatoid arthritis
  • Competitor review in rheumatoid arthritis
  • Competitor review of two JAK inhibitors in rheumatoid arthritis
  • Payer focused value communication on rheumatoid arthritis
  • Payer value proposition update in rheumatoid arthritis
  • Frequently asked questions on an immunology biosimilar for rheumatoid arthritis
  • Literature review of unmet need in rheumatoid arthritis
  • Literature review and recommendations for rheumatoid arthritis
  • Utility study in rheumatoid arthritis
  • Competitor value story in rheumatoid arthritis
  • Competitor value stories for two treatments of rheumatoid arthritis
  • Manuscript on a budget impact model for a cross-indication biosimilar in conditions including rheumatoid arthritis
  • Core value dossier, value deck and objection handler in rheumatoid arthritis
  • Update to an AMCP dossier for a rheumatoid arthritis biosimilar
  • Global value dossier and budget impact model for a biosimilar in rheumatoid arthritis
  • Workshop and FAQ development in immunology in rheumatoid arthritis
  • Development of a payer value deck in immunology in rheumatoid arthritis
  • Total Brand FAQ deck and Total Brand Workshop in rheumatoid arthritis
  • Review of PROs and preparation and writing of a PRO briefing document for the FDA on the treatment of rheumatoid arthritis
  • Generation of evidence to support the unmet need in rheumatoid arthritis
  • Modified Delphi Panel to gain consensus in rheumatology (rheumatoid arthritis)
  • Development of a PRO strategy in rheumatoid arthritis
  • Qualitative research in rheumatoid arthritis
  • Poster and manuscript on an indirect comparison of biologic treatments for TNF-IR rheumatoid arthritis patients
  • Systematic review to explore minimal important differences in PROs for rheumatoid arthritis
  • Meta-analysis of joint structural deterioration over time in minimally treated rheumatoid arthritis patients with inadequate response to disease-modifying anti-rheumatic drugs (DMARD-IR)
  • Mixed treatment comparison of efficacy and safety of an immunosuppressant drug versus a TNF inhibitor drug in rheumatoid arthritis patients with DMARD-IR
  • Mixed treatment comparison of an oral drug used in the treatment of rheumatoid arthritis
  • Characterising and predicting treatment response to rheumatoid arthritis biologic therapy
  • Literature review of unmet need in rheumatoid arthritis
  • Mixed treatment comparison of a treatment for rheumatoid arthritis populations – DMARD-IR and MTX-naive patients
  • Q&A and mixed treatment comparison on a treatment for rheumatoid arthritis
  • Indirect comparison of a monotherapy treatment for rheumatoid arthritis patients with DMARD-IR
  • Face and content validity testing of a tiredness item in a sample of rheumatoid arthritis patients
  • Development and Drug Development Tools (DDT) qualification of a PRO measure to assess the symptoms of rheumatoid arthritis
  • Psychometric evaluation of a PRO in rheumatoid arthritis
  • Evaluation of fatigue in rheumatoid arthritis using a PRO instrument
  • Patient interviews on rheumatoid arthritis
  • Patient interviews to capture disease burden and unmet treatment needs in rheumatoid arthritis
  • Support in development and analyses of a patient support programme in indications including rheumatoid arthritis
  • GI tolerability endpoint white paper including literature and instrument reviews on rheumatoid arthritis
  • Top up literature review of PROs in rheumatoid arthritis
  • Development and Drug Development Tools (DDT) qualification of a PRO measure to assess the symptoms of rheumatoid arthritis

Human papillomavirus (HPV)

  • Value cards for human papillomavirus (HPV)
  • Payer value deck and frequently asked questions for HPV and HPV-related diseases
  • Value pack for a HPV vaccine
  • Brief adaptation of a Markov model for a HPV vaccine
  • Update of a budget impact model for a HPV vaccine
  • Cost-effectiveness analysis of a HPV vaccine for Spain
  • HTA submission for a HPV vaccine
  • Manuscript on the German cost-effectiveness analysis of a HPV vaccine
  • Manuscript on the Spanish cost-effectiveness analysis of a HPV vaccine
  • Systematic literature review on the indirect protection from the HPV vaccination
  • Value demonstration and implementation plan for a new HPV test
  • Training sales reps on an interactive model for a HPV vaccine
  • Analysis and reporting on the budget impact of a HPV vaccine
  • One-pager communication tool on cross-protection in HPV
  • One-pager on HPV in head and neck cancer
  • Revision of one-pagers in HPV vaccines
  • Literature review of epidemiology and economic data in HPV
  • Update to European one-pager value communication tools for HPV and for a nine-valent HPV vaccine
  • e-v@luate platform for HPV vaccines
  • Update to a payer value deck in HPV infection
  • Evidence package (literature review and value messages) for HPV vaccination
  • Adaptation of a Markov model on a HPV vaccine to Belgium
  • Development of a rationale for the need for a HPV vaccine
  • Development of a PRO strategy in cervical cancer and HPV
  • Summary report, top-up literature review, meta-analysis, editorial board and manuscripts on HPV infection and cervical cancer

Other project experience

  • Development of a payer discussion guide for new in-license opportunities
  • Review of payer advisory board toolkit materials
  • Consultation on the difference between QoL and QoLIES and their usefulness in regulatory submissions and reimbursements
  • Review of evidence requirements for reimbursement submissions in northern and central Europe
  • Advice on ethical issues in health economics
  • Evaluation of the effectiveness of a referral management intervention on GP-referred outpatient planned care
  • Evaluation of the economic section for the Full Applications to a Personalized Medicine Contest
  • Questionnaire design and data analyses for cost of illness in Germany and the UK
  • Cost of illness review for 54 different diseases
  • Training session on health economics and outcomes research (HEOR)
  • Introductory training and slides on a Health Survey
  • Value strategy training on access to medical devices
  • Provision of support materials for the client’s health care sales meeting and training on material usage
  • Stakeholder interviews (KOLs and payers) in Algeria, Costa Rica, Ecuador, Morocco, Panama and Romania
  • Strategic HE advice on early HTA process
  • EU market access training workshop
  • HEOR strategic consulting
  • Landscape assessment of real-world data sources and impact on reimbursement decisions
  • PRO strategy for observational studies
  • Development of a white paper on PROs in labelling and promotion
  • General consulting in PROs
  • Educational programme in productivity and other PROs
  • Statistical educational series for PROs
  • Support for Advisory Board meeting for Patient-Reported Outcome Excellence Project
  • Analysis, reporting and literature research on the influence of PROs in regulatory approval in China and Japan
  • Understanding the regulators perspectives for a successful submission of PRO data
  • Internal lecture on the use of PRO and HE in the development and commercialisation of drugs
  • Generic quality of life questionnaire, protocol review and providing initial feedback
  • Panel and presentation on PRO research on medical devices
  • Literature review of newly developed PROs in 5 specific disease areas
  • Presentation of a paediatric PRO training workshop
  • Consultancy and training in all aspects of PROs
  • Training on the importance of PROs and a slide deck detailing operational issues in PRO assessments
  • Development of a decision algorithm for incorporating PROs into clinical trials
  • PRO training and presentation
  • Training course on PROs in clinical research and regulatory submission
  • Workshop on draft PRO guidance for the FDA
  • PRO guidance presentation to health authorities
  • Development of a patient acceptability questionnaire for oral paediatric drugs
  • Consultancy on the protocol to compare the responsive reaction of patients between a traditional paper-administered questionnaire and an electronic touch screen device
  • Questionnaire development and testing for the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program
  • Training in productivity measurement
  • Workshop to provide methods and strategic insights into linguistic validation of clinical outcomes assessments
  • Interviews and development of a patient acceptability questionnaire for oral paediatric drugs
  • Systematic review workshop
  • FDA advisory panel
  • Workshop on the Final Guidance to Industry
  • Development and presentation of an internal webinar on tolerability
  • Lecture on quality of life
  • Workshops at the Worldwide Outcomes Research Forum
  • Lecture on the use of the placebo effect in drug development
  • Mixed methods training session including Rasch and Item Response Theory Methodology
  • Development of a market access toolkit for China, South Korea and Taiwan
  • Analysis of market access knowledge gaps in Asia
  • Critical review of a systematic review report written in NICE submission style
  • Evaluation of the Japan Medical Data Center Database and comparison to medical data vision for combination use
  • Literature review, instrument review and database evaluation in 5 pathologies

Chronic obstructive pulmonary disease (COPD)

  • Value proposition for a new metered dose inhaler to treat chronic obstructive pulmonary disease (COPD)
  • External expert assessment of a drug for COPD
  • Development of a global market access value pack to support regional/local access teams and HTA submissions in COPD
  • Value pack (objection handler and budget impact/cost minimisation model) in COPD
  • Conference abstract and poster development on COPD
  • Manuscript on the budget impact of a new treatment in COPD
  • Updates to critical handling error manuscript in chronic obstructive pulmonary disease (COPD)
  • Structured literature review and qualitative interviews with payers/HCPs on a device for COPD
  • Value messaging and HE training support in COPD
  • Protocol development support for a conjoint patient preference study in COPD
  • PRO strategy support for an inhaler treatment for COPD
  • Literature review, FDA briefing document and FDA meeting related to the development of an ePRO for well controlled days in COPD
  • Targeted literature review of PRO measures in frequently exacerbating COPD patients
  • Literature review and research around treatment experiences of patients with COPD
  • Exit interviews to explore patient disease burden, treatment satisfaction and clinical trial participation in muscle wasting associated with COPD
  • Development and delivery of a manuscript on the results from a trial in COPD
  • Translation and validation of the chronic obstructive pulmonary disease population screener (COPD-PS) in Japan
  • Poster presentation on the validation of the COPD-PS in Japan
  • Manuscript on the validation of the COPD-PS in Japan
  • Poster on the development of the Cough and Sputum Assessment Questionnaire (CASA-Q) in COPD
  • Development of a user manual for the cough and sputum assessment questionnaire
  • Validation of the CASA-Q trial
  • Cross-team review of a CASA-Q PRO dossier in COPD for submission to the FDA
  • FDA support for the CASA-Q in COPD
  • Support at investigator meetings for the CASA-Q
  • Psychometric validation of the Shortness of Breath Questionnaire in COPD
  • Validation of a questionnaire for assessing control status of patients with COPD
  • Development of a dyspnoea scale in COPD
  • Development and validation of a satisfaction questionnaire in COPD
  • Development of a symptom diary in COPD
  • Validation of a patient diary to assess symptoms of COPD
  • Development of a poster and validation of a questionnaire in COPD
  • Development and validation of an ePRO in COPD
  • Mixed treatment comparison between competing interventions for COPD
  • Association between exacerbations, a respiratory questionnaire and the use of rescue medication in COPD
  • Network meta-analysis of two treatments for COPD
  • Network meta-analysis of one drug versus fixed dose combinations in COPD
  • Network meta-analysis of competing interventions in the management of COPD
  • Conference presentation on a network meta-analysis of a treatment for COPD
  • Development of a preference-based instrument specific to COPD
  • Validation of a patient diary for evaluating acute exacerbation of chronic obstructive pulmonary disease (AECOPD)

Other ophthalmology experience

  • Slides to outline the intravitreal injection process in the UK
  • Value messages and objection handlers for anti-vascular endothelial growth factor therapy (anti-VEGF) treatment in diabetic retinopathy and retinopathy of prematurity
  • Exploratory analysis of phase II clinical trial data for acute optic neuritis
  • Manuscript on health-related quality of life trial results of a new lens
  • Analysis of focus group results in post-Lasik corneal sensitivity
  • Development and validation of a pterygium instrument
  • Development of a briefing document on a visual function questionnaire
  • PRO review of the subjective eyelid swelling scale for patients with eyelid swelling upon awakening in the morning
  • Analysis and reporting on completed interviews about eyelid swelling
  • Literature review of retinopathy of prematurity
  • Review of PRO measures in diabetic macular edema
  • Development of a PRO measure to assess impacts of full eye rejuvenation