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.

Glioblastoma

  • Development of a global value dossier in the treatment of glioblastoma
  • AMCP dossier in glioblastoma multiforme
  • Early global value dossier in newly diagnosed glioblastoma
  • Clinical trial analyses to support health-related quality of life (HRQoL) in glioblastoma
  • Review of instruments for a glioblastoma trial and recommendation of a strategy
  • PRO dossier on glioblastomas for the EMA
  • Literature review on overall survival and progression-free survival in glioblastomas
  • Poster on the association of HRQoL and NCF with progression-free survival (PFS) and PD in glioblastoma
  • Indirect comparison of two treatments in 2nd line glioblastoma
  • Training slide deck for COAs in glioblastoma

Insomnia and sleep disorders

  • Survey of the impact of allergy on sleep (including literature review and HCP interviews)
  • Advisory panel in insomnia
  • Review of PROs in insomnia
  • Cognitive debriefing of the daytime insomnia symptom scale and FDA support
  • Strategic consulting in insomnia
  • Validation of a primary insomnia functioning questionnaire
  • PRO strategy in insomnia
  • Manuscripts on the development and validation of the Sleep Impact Scale (SIS) in insomnia
  • Support on translation of the SIS in insomnia
  • Communications on the SIS in insomnia
  • Support on the adaptation of the SIS into three languages
  • Support on linguistic validation of the SIS in insomnia
  • Investigator meeting, review and presentation of slides on the Functional Outcomes of Sleep Questionnaire (FOSQ) and Work Limitation Questionnaire (WLQ)
  • Validation of the FOSQ in insomnia
  • Development of a conceptual framework and endpoint model in insomnia, plus qualitative patient interviews to confirm the validity of the conceptual framework and the psychometric validation of the final conceptual framework
  • Consultation on study design and interpretation of data on insomnia
  • Advisory panel in sleep disorders
  • Quality of life questionnaire in sleep disorders
  • Modification to the Sleep Impact Questionnaire following FDA review
  • Validation and linguistic adaptation of a sleep questionnaire
  • Linguistic validation of the Fatigue Impact Scale (FIS) into Argentinean Spanish, Austrian German, South African English, Norwegian and Afrikaans
  • Evaluation of the potential for a satisfaction claim for sleep disorders
  • Development of a PRO instrument for measuring mood swings and sleep problems resulting from vasomotor symptoms during the menopause
  • Evaluation of existing documentation and recommendations for psychometrically validating the modified Daytime Insomnia Symptom Scale (mDISS)
  • Scenario model in sleep disorders
  • Development of a sleep measure in different conditions
  • Report of sleep problems in fibromyalgia
  • Content validation of the modified Daytime Insomnia Symptom Scale (DISS) and the Sleep Impact Questionnaire event log
  • Manuscript on validation and efficacy results in insomnia

Other allergic conditions

  • Structured literature review for allergy immunotherapy, including medication adherence compared to other treatments
  • Systematic literature review in allergy immunotherapy products
  • Survey of the impact of allergy on sleep (including literature review and HCP interviews)
  • Portfolio value proposition and literature review on allergy immunotherapy
  • Abstracts and posters for allergy immunotherapy compliance in allergic rhinitis
  • Cost effectiveness analysis of allergy immunotherapy products
  • Internal value communication deck on real world studies in allergic reactions
  • Analysis of phase II symptom data in a study of lactose intolerance
  • Development of a COA strategy to measure treatment side effects for peanut allergy treatments

Immunology

  • Biosimilar payer communications in dermatology, gastroenterology and immunology
  • Development of a payer value deck in immunology in ankylosing spondylitis, juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis
  • Payer value slides for a varicella vaccine
  • Payer value slides for immunology biosimilars
  • Payer value slide deck in muscle relaxation management
  • Payer value deck for an MMR and varicella vaccine
  • Payer focused value communication on rheumatoid arthritis
  • Payer material development for vaccines in hepatitis A, rotavirus gastroenteritis (RVGE), shingles, varicella and pneumococcal disease
  • Payer evidence dossier for a new psoriasis treatment
  • Payer value proposition update in rheumatoid arthritis
  • Communications package in hereditary angioedema
  • Patient support programme, payer communication tool and briefing pack in immunology
  • Frequently asked questions deck in juvenile idiopathic arthritis
  • Frequently asked questions to support the introduction of a new biosimilar in immunology
  • Frequently asked questions for biosimilar policy in immunology
  • Frequently asked questions on an immunology biosimilar for rheumatoid arthritis
  • Workshop and FAQ development in immunology in ankylosing spondylitis, juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis
  • Literature and content searches for global value dossiers in dermatology and immunology
  • Structured literature review for allergy immunotherapy, including medication adherence compared to other treatments
  • Strategic literature review and gap analysis in systemic lupus erythematosus and lupus nephritis
  • Communication of a literature review on systemic lupus erythematosus and lupus nephritis
  • Literature review of unmet need in rheumatoid arthritis
  • Literature review and update to budget impact model in an immunology biosimilar
  • Targeted literature review in psoriatic arthritis patients with concomitant moderate to severe psoriasis
  • Health economics training and model training in immunology
  • Interactive model in immunology
  • Economic workshop in immunology
  • Economic evaluation of a workplace influenza vaccination in Russia
  • Total Brand FAQ deck and Total Brand Workshop in rheumatoid arthritis, prostate-specific antigen (PsA), psoriasis, ulcerative colitis, Crohn’s disease and ankylosing spondylitis
  • Updates to a US budget impact model for an immunology biosimilar
  • AMCP dossier, budget impact model and global value dossier development in immunology
  • Update for a core value dossier in uveitis
  • Early global value dossiers for a new monoclonal antibody in Crohn’s disease and psoriasis
  • Global value dossiers and budget impact models for biosimilars in ankylosing spondylitis, Crohn’s disease, inflammatory bowel disease, osteoarthritis, psoriasis and rheumatoid arthritis
  • Update to an AMCP dossier for an immunology biosimilar
  • Updates to a global value dossier, AMCP dossier and budget impact model on a rheumatoid arthritis biosimilar
  • Two competitor review decks in psoriatic arthritis and ankylosing spondylitis
  • Two competitor reviews in psoriatic arthritis
  • Competitor value story in rheumatoid arthritis
  • Competitor value story in psoriatic arthritis
  • Competitor review of two JAK inhibitors in rheumatoid arthritis
  • Cross-therapy area value proposition alignment in immunology
  • Originator vs. biosimilar value proposition update in immunology
  • Regulatory support on SMC questions on psoriatic arthritis work
  • Identification of PRO measures suitable for implementation in phase III oncology and immunotherapy trials
  • Analysis of a PRO and resource utilization in systemic lupus erythematosus
  • Critical review of PRO instruments in systemic lupus erythematosus and fatigue and pain in rheumatic disease
  • Review of PROs in systemic sclerosis/scleroderma
  • Development of posters on the analysis of a PRO and resource utilization in systemic lupus erythematosus
  • Patient focused outcomes in amyloidosis: Exit interviews to capture the patient experience of systemic amyloidosis, treatment and clinical trial participation
  • Translation and linguistic validation of clinician assessments in ACEI-Angioedema
  • Communications on clinician assessments in ACEI-Angioedema
  • Measurement strategy to demonstrate efficacy of medical devices in patients with pigmented villonodular synovitis (PVNS) or tenosynovial giant cell tumour (dTGCT)
  • Strategic consultancy on physician attitudes and preferences regarding adult vaccinations
  • Regulatory support for the validation of a questionnaire for influenza vaccination
  • Demonstrating the value of antibiotic resistance testing software
  • Modification of the Eosinophilic Esophagitis Activity Index (EEsAI)

Other endocrinology and metabolic experience

  • Total Brand FAQ deck and Total Brand Workshop in prostate-specific antigen (PsA)
  • Structured literature reviews on the burden of disease of nonalcoholic steatohepatitis (NASH), and development of two publications
  • Assessment framework of external presentation and a strategic communication plan in metabolic disorders
  • Preparation for and support at FDA meetings on the validation of PROs in a chronic haemodialysis population
  • Questionnaire in halitosis
  • Classification and Regression Tree Analysis in endocrinology
  • Consultation on a protocol and analysis plan in endocrinology
  • Development of PRO strategies in metabolic disorders

Myelodysplastic syndrome

  • Value dossier and e-v@luate platform in a treatment for low-risk myelodysplastic syndrome
  • Value dossier and e-v@luate platform in a treatment for high-risk myelodysplastic syndrome
  • Resource utilisation in myelodysplastic syndromes
  • Quality of life analysis for a treatment in myelodysplastic syndrome
  • Patient survey of the indirect costs and quality of life impacts in myelodysplastic syndromes
  • Qualitative interviews with patients with myelodysplastic syndrome
  • In-trial analyses of treatments in myelodysplastic syndrome (TASTE-PRO)
  • Manuscript support in myelodysplastic syndrome (TASTE-PRO)

Eczema

  • Literature review to identify the chronic hand eczema population in the US
  • Regulatory support in chronic hand eczema
  • Development of a manuscript to communicate the patient experience of chronic hand eczema
  • Two abstracts to communicate the development of a conceptual model in chronic hand eczema

Biosimilars

Endocrinology

  • Payer value slide deck for a biosimilar in diabetes
  • Budget impact models for a biosimilar in type 1 and type 2 diabetes mellitus
  • Global value dossier, AMCP and accompanying slide sets for an insulin biosimilar

Immunology

  • Payer value slides for immunology biosimilars
  • Frequently asked questions to support the introduction of a new biosimilar in immunology
  • Frequently asked questions for biosimilar policy in immunology
  • Frequently asked questions on an immunology biosimilar for rheumatoid arthritis
  • Budget impact model for a biosimilar
  • Literature review and update to budget impact model in an immunology biosimilar
  • Updates to a US budget impact model for an immunology biosimilar
  • Update to an AMCP dossier for an immunology biosimilar
  • Originator vs. biosimilar value proposition update in immunology
  • Updates to a global value dossier, AMCP dossier and budget impact model on a rheumatoid arthritis biosimilar

Musculoskeletal diseases

  • Value message testing for a biosimilar in rheumatoid arthritis
  • Budget impact model for a biosimilar in autoimmune disease

Oncology

  • Burden of disease deck and frequently asked questions deck in breast cancer biosimilars
  • Development of a cost-calculator for a biosimilar for breast and gastric cancer
  • One-pager communication in a breast cancer biosimilar
  • Payer value deck update for a breast cancer biosimilar
  • Response to payer questions update for a breast cancer biosimilar
  • Budget impact model for a biosimilar in HER2 breast cancer

Women’s health

  • Development of a value dossier, health economic model and literature review in an infertility biosimilar to support pricing and reimbursement submissions in 15 EU countries
  • Pricing updates in Europe for a biosimilar hormone treatment for female infertility

Other

  • Global value and reimbursement dossier for a biosimilar in autoimmune disease
  • Biosimilar payer communications in dermatology, gastroenterology and immunology
  • Global value dossiers and budget impact models for biosimilars in ankylosing spondylitis, Crohn’s disease, inflammatory bowel disease (IBD), osteoarthritis, psoriasis and rheumatoid arthritis
  • Manuscript on a budget impact model for a biosimilar in haematology and rheumatology

Asthma

  • Systematic literature review on treatment patterns and burden of illness in asthma
  • Literature review, analysis and communications for asthma costs
  • Literature review of critical handling errors in asthma
  • Real-world evidence literature review in asthma
  • Landscape analysis in asthma and model assessment to support positioning paper
  • Structured literature reviews for paediatric wheeze detection
  • Rapid structured literature review of nebulisation inhalation efficiency in paediatric asthma and other respiratory conditions
  • Competitor literature review for real world evidence in asthma
  • Advisory board meeting on a literature review in asthma
  • Simple cost-utility model and targeted literature review for the treatment of asthma
  • Budget impact model and manuscript on asthma
  • Consultancy on exploratory economic modelling in severe asthma
  • Update to the pilot inference model for an inhaler used in the treatment of asthma
  • Health economic model in asthma
  • Economic model of asthma therapies for NICE
  • Economic model of combination asthma therapies for NICE
  • Resource use costing in asthma and communicating product value to a local payer audience
  • Global value dossier update on paediatric asthma
  • Global value dossier update and e-v@luate upload for an asthma device
  • Development of a mini global value dossier for an asthma device
  • e-v@luate platform development for paediatric asthma
  • Updates to critical handling error manuscript in asthma
  • Development of a manuscript in mild persistent asthma in specific geographies
  • Update to a critical handling errors manuscript in asthma
  • Preparation of a submission dossier for NICE on paediatric inhaled corticosteroid (ICS) drug use in asthma
  • Several conference posters on asthma, an asthma model, and economic analysis for the treatment of asthma
  • Advisory panel in asthma
  • Regulatory strategy consultancy in asthma
  • Consultancy on obtaining FDA approval of a treatment satisfaction claim for a new asthma treatment
  • Confirmation of an endpoint model for patients with asthma currently receiving treatment
  • PRO consulting on an asthma program for labelling
  • Cognitive debriefing to confirm the face and content validity of secondary endpoint questions in asthma
  • Database analysis and manuscript assessing death rate and hospitalisation rate in asthmatics
  • Development of a conceptual model and conceptual framework for the measurement of asthma control
  • Testing of a conceptual model of asthma in adolescents
  • Development of a symptom-based PRO instrument for adults and adolescents with asthma
  • Exit interviews to provide additional evidence of content validity for a quantitative study in asthma
  • Exit interviews on a connected inhaler system for asthma
  • Cognitive debriefing interviews in asthma
  • Validation of the Asthma Control Questionnaire (ACQ) using trial data
  • Manuscript on the psychometric validation of the ACQ report
  • Analyses of the ACQ
  • Conference poster reporting a ROC analysis performed to define cutpoints for the ACQ
  • Development of a questionnaire to assess control in children with paediatric asthma
  • Longitudinal validation of the Childhood Asthma Control Test (C-ACT)
  • Analysis and abstract on the longitudinal validation of the C-ACT
  • Validity assessment of the C-ACT in Japanese children
  • Validity assessment of the C-ACT in Hong Kong Chinese children
  • Complementary analyses on the C-ACT
  • Minimal clinically important differences for the C-ACT and symptom-free days/rescue medication–free days in paediatric asthma populations
  • Consulting on the linguistic validation of the C-ACT
  • Translation of the C-ACT
  • Equivalency testing of the modified Childhood Asthma Control Test (C-ACT) in children with mild to severe asthma
  • Cognitive debriefing of the Asthma Symptom and Control Diary (ASCD)
  • Linguistic validation of the Inhaled Corticosteroid Questionnaire (ICQ) into US English
  • Exit interviews and evaluation of the psychometric properties of the Asthma Daily Symptom Diary (ADSD) in severe asthma
  • Quantitative study to confirm the content validity of the ADSD
  • Development of a preference-based instrument specific to asthma

Phenylketonuria

  • Value dossier update for a treatment in phenylketonuria (PKU)
  • Updating of a cost manuscript for PKU
  • Value strategy, landscape analysis, health economic model and value dossier development for PKU
  • Development of a poster on a Delphi Panel in PKU
  • Measurement strategy consulting for endpoint hierarchy development in PKU
  • FDA briefing document to support a client’s phase III study measurement strategy in PKU
  • Outcomes interviews in PKU, resource use and impact on patients

Varicella

  • Update to payer value slide deck for varicella
  • Payer value deck for a varicella vaccine
  • Payer material development for vaccines in varicella
  • Response to payer questions deck in varicella
  • e-v@luate platform on vaccines for varicella

Pneumococcal vaccines

  • Manuscripts on the health economics of a pneumococcal vaccine
  • Manuscripts on a vaccine for pneumococcal disease
  • Payer communications on a vaccine for pneumococcal disease
  • Responses to payer questions update on a pneumococcal disease vaccine
  • Payer value deck update for a pneumococcal disease vaccine
  • Payer material development on a pneumococcal disease vaccine
  • Update to a one-page value proposition on a pneumococcal disease vaccine
  • e-v@luate platform on a pneumococcal disease vaccine

Pneumococcal disease

  • Manuscripts on the health economics of a pneumococcal vaccine
  • Manuscript on cost-effectiveness analysis in pneumococcal disease
  • Manuscripts on a vaccine for pneumococcal disease
  • Payer value deck for pneumococcal disease
  • Payer value deck update for a pneumococcal disease vaccine
  • Payer communications on pneumococcal disease
  • Payer communications on a vaccine for pneumococcal disease
  • Payer material development for vaccines in pneumococcal disease
  • Responses to payer questions update on a pneumococcal disease vaccine
  • Update to a one-page value proposition on a pneumococcal disease vaccine
  • e-v@luate platform on vaccines for pneumococcal disease

Literature reviews

We have a dedicated team of experts with vast experience in literature reviews and research, able to address client challenges and steer your product towards market access success. Our experience of systematic and structured literature reviews covers a wide range of therapeutic indications and topics including:

Structured literature reviews

  • Acne
  • Acromegaly
  • Actinic keratosis
  • Acute bacterial skin and skin structure infections (ABSSSI)
  • Acute myocardial infarction
  • Alcohol dependency
  • Allergic rhinitis
  • Allergies
  • Alzheimer’s disease
  • Ankylosing spondylitis
  • Arthritis
  • Atypical haemolytic uremic syndrome (aHUS)
  • Asthma
  • Asthma COPD Overlap Syndrome (ACOS)
  • Benign prostatic hyperplasia
  • Breast cancer
  • Cervical cancer
  • Chronic obstructive pulmonary disease (COPD)
  • Colorectal cancer
  • Constipation (and chronic constipation)
  • Cough and cold
  • Crohn’s disease
  • Dementia
  • Depression
  • Diabetes (type 2)
  • Diptheria
  • Down’s syndrome
  • Dry eye
  • Dystrophic epidermolysis bullosa
  • Epilepsy
  • Fabry disease
  • Fibromyalgia
  • Fragile X syndrome
  • Gastric cancer
  • Gastric reflux
  • Glioblastoma
  • Glucose transporter type 1 deficiency syndrome
  • Group B streptococcus
  • Growth hormone deficiency
  • Haemophilia A and B
  • Hand eczema
  • Head and neck cancer
  • Heart disease
  • Hepatitis A and C
  • Herpes zoster/shingles
  • Hidradenitis suppurativa
  • HIV and AIDS
  • HPV
  • HRT outcomes in the menopause
  • Hypoparathyroidism
  • Idiopathic pulmonary fibrosis
  • Immune thrombocytopenia
  • Infertility
  • Influenza
  • Interstitial cystitis
  • Interstitial lung disease in systemic sclerosis (SSc-ILD)
  • Irritable bowel syndrome
  • Kidney cancer
  • Kidney disease / kidney failure
  • Leukaemia
  • Lipid modification
  • Liver cancer
  • Lower limb spasticity
  • Lung cancer (small cell and non-small cell)
  • Lupus (systemic lupus erythematosus and lupus nephritis)
  • Lymphomas
  • Macular degeneration
  • Melanoma
  • Migraine
  • Mucopolysaccharidosis I (MPS I)
  • Myocardial infarction
  • Neural tube defects
  • Nonalcoholic steatohepatitis (NASH)
  • Osteoarthritis
  • Osteomyelitis
  • Ovarian cancer
  • Pain (including chronic pain and trauma pain)
  • Parkinson’s disease
  • Peripheral artery disease
  • Peripheral diabetic neuropathy
  • Pertussis
  • Phenylketonuria
  • Polio
  • Post-herpetic neuralgia
  • Post-operative ileus
  • Prostate cancer
  • Psoriasis
  • Rabies
  • Retinitis pigmentosa
  • Retinopathy of prematurity
  • Rheumatoid arthritis
  • Schizophrenia
  • Sjögren’s syndrome
  • Smoking cessation
  • Stroke
  • Tetanus
  • Typhoid
  • Ulcerative colitis
  • Wheezing
  • Yellow fever

Systematic literature reviews

  • Asthma
  • Bipolar disorder
  • Chemotherapy-induced anaemia
  • Epilepsy
  • Hepatitis B
  • Herpes zoster/shingles
  • HPV
  • Leukaemia
  • Lung cancer (small cell and non-small cell)
  • Lymphomas
  • Melanoma
  • Post-herpetic neuralgia
  • Psoriasis
  • Psoriatic arthritis
  • Pulmonary arterial hypertension
  • Renal cell carcinoma

Meta-analyses, indirect comparisons and mixed treatment comparisons

  • Breast cancer
  • Cataracts
  • Cervical cancer
  • Chronic obstructive pulmonary disease (COPD)
  • Colorectal cancer
  • Epilepsy
  • Heart failure
  • HIV
  • HPV
  • Irritable bowel syndrome with constipation
  • Kidney disease
  • Leukaemia
  • Lung cancer (non-small cell)
  • Melanoma
  • Miscarriage
  • Multiple myeloma
  • Posterior cacular opacification
  • Psoriasis
  • Psoriatic arthritis
  • Pulmonary arterial hypertension
  • Rheumatoid arthritis
  • Stroke
  • Wet age-related macular degeneration

Other women’s health experience

  • Visual aid and flyer for a drug in pelvic organ prolapse
  • Value demonstration and communication of UK burden of nausea and vomiting during pregnancy
  • Report on the humanistic burden and psychometric validation of the breast pain and vaginal bleeding e-diaries, the breast sensations and vaginal bleeding impact questionnaires and the treatment satisfaction questionnaire
  • FDA meeting on a functioning claim for cyclical mastalgia
  • Psychometric analysis of quality of life questionnaires in women’s health
  • Data entry and analysis of SMILE data received from a clinical trial in women’s health
  • Generation of utility measures in women’s health and rescoring of the Women’s Health Questionnaire (WHQ)
  • Patient preference and utility study for an injectable hormone treatment
  • EVAPIL-R communications and strategic advice regarding the modification of existing PRO measures in women’s health
  • Development of a PRO best practices document – interactions with international regulatory and HTA agencies in women’s health

Other vaccines

  • One-pager value communication tool for the measles, mumps and rubella (MMR) vaccine
  • Development of an e-v@luate EVIDENCE platform for a vaccines portfolio
  • Payer material development for vaccines in hepatitis A, rotavirus gastroenteritis (RVGE), shingles and varicella
  • Payer value slides for a varicella vaccine
  • Payer value deck for an MMR and varicella vaccine
  • Payer communications on a herpes zoster vaccine
  • e-v@luate platform on vaccines for HPV, varicella, MMR, shingles, hepatitis A and rotavirus
  • Strategic consultancy on physician attitudes and preferences regarding adult vaccinations

Other urology and urogenital experience

  • Worldwide advisory board on a treatment for lower urinary tract symptoms (LUTS)
  • Content validation of a neurogenic detrusor overactivity (NDO) diary in paediatric spina bifida patients
  • Analysis of urology and gynaecology in patient waiting lists
  • Systematic review of lithotripters for ureterolithiasis
  • Presentation of a PRO in urology
  • PRO training in urology

Other respiratory experience

  • Literature search and slide deck for a lung surfactant treatment
  • Cost calculator model for lung surfactant
  • Assessment of the commercial and economic value for the development of new diagnostic tests for respiratory infections
  • Review of existing respiratory compromise safety data
  • Respiratory manuscript editing and submission
  • Reimbursement pathway review in respiratory disease
  • Development and validation of a preference questionnaire in a respiratory disease