Experience

Adelphi Values has an experienced global team of qualitative researchers, health economists, statisticians, creative scientists, clinicians and strategists with industry experience, who truly understand the need to develop evidence and communicate value throughout the product lifecycle.

Below is a selection of our projects, presented according to therapeutic or strategic/methodological area. It is not exhaustive, and we would be happy to provide further information on request.

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 antibiotic / bacterial infection experience

  • Cost-effectiveness model of a treatment for bacterial infections
  • Cost-effectiveness analysis model for Portugal on a treatment for bacterial infections
  • Cost-effectiveness analysis of a treatment of intra-abdominal infections in the USA
  • Assessment of the commercial and economic value for the development of new diagnostic tests for respiratory infections
  • HEOR team capabilities audit and training plan in infectious diseases
  • Literature review and development of a suite of dossiers in anti-infectives (antibacterial resistance)
  • Literature review of antibiotic resistance
  • Demonstrating the value of antibiotic resistance testing software
  • Development of a manuscript and consulting on economic evaluations alongside a clinical trial in intra-abdominal infections
  • Pharmacoeconomic and PRO design and analysis for an immunoglobulin product
  • Analysis in an EU study in primary immunodeficiency

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

HPV vaccines

  • Value pack for a HPV vaccine
  • Payer value deck update for HPV
  • Literature review of epidemiology and economic data in HPV
  • Systematic literature review on the indirect protection from the HPV vaccination
  • HTA submission for a HPV vaccine
  • Cost-effectiveness analysis of a HPV vaccine for Spain
  • Manuscripts on the German and Spanish cost-effectiveness analysis of a HPV vaccine
  • Brief adaptation of a Markov model for a HPV vaccine
  • Update of a budget impact model for a HPV vaccine
  • Analysis and reporting on the budget impact of a HPV vaccine
  • Training sales reps on an interactive model for a HPV vaccine
  • Update to European one-pager value communication tool for a nine-valent HPV vaccine
  • One-pager communication tool on cross-protection in HPV
  • Revision of one-pagers in HPV vaccines
  • e-v@luate platform for HPV vaccines
  • e-v@luate EVIDENCE platform for HPV vaccines
  • Evidence package (literature review and value messages) for HPV vaccination
  • Development of a rationale for the need for a HPV vaccine

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