Special interest

Acromegaly

  • Payer value proposition, payer value dossier and cost effectiveness model in acromegaly
  • Landscape analysis of acromegaly patient registries
  • Adequacy of the Acromegaly Quality of Life Questionnaire (AcroQoL) as an endpoint in acromegaly: endpoint review & strategic recommendations
  • Analysis of PRO data to support clinical trial dissemination activities in acromegaly
  • Consultancy to review acromegaly protocol
  • Exploratory analyses in acromegaly

Anaesthesiology

  • Economic analysis and trial design in hip replacement
  • Health economic endpoints for a locally-acting treatment to provide pain relief after surgery
  • Powerpoint storyboard to support and demonstrate an economic modelling tool in anaesthesiology
  • Preparation of a data collection questionnaire in anaesthesiology for local markets
  • Pricing and reimbursement guidelines on anaesthesia and analgesia for Europe, Canada and Australia
  • Evaluation of the cost of operating time in Japan in relation to anaesthesiology
  • Stakeholder needs analysis in anaesthesiology
  • Recommendation for the use of a PRO in a phase IIIb trial in anaesthesia and face/content validity testing
  • Feasibility of developing a composite endpoint to assess patients’ quality of recovery after surgery requiring anaesthesia and the use of a reversal agent
  • Advisory board on anaesthesia and analgesia
  • Productivity workshop on anaesthesia and analgesia
  • Consultation on PRO assessments and analysis on anaesthesia and analgesia
  • Strategy for FDA translation validity checklist in anaesthesia and analgesia
  • Development of a conceptual framework and SAP for a treatment for neuromuscular block
  • Feasibility study for the surgeon satisfaction questionnaire with quality of surgery related to neuromuscular block
  • Translation of the Bridion Operating Room Study into Japanese
  • Treatment effect analyses based on a Quality of Recovery questionnaire (QoR-40) and Reversal Agent Satisfaction Questionnaire (RASQ) in neuromuscular block
  • Development of a surgeon satisfaction questionnaire for anaesthetic block
  • Endpoint review and gap analysis in bone healing

Animal health

Canines

  • Qualitative activities to support validity and feasibility of the canine quality of life and treatment satisfaction measure administered via a cell phone application
  • Development of a user manual for canine dermatitis quality of life and treatment satisfaction
  • Psychometric evaluation of a revised canine dermatitis quality of life questionnaire
  • Clinical trial analysis and ad-hoc consultancy for a canine quality of life questionnaire
  • Exploration of canine-owner burden in various conditions and provision of recommendations for measurement
  • Psychometric evaluation and analysis of a revised canine dermatitis quality of life questionnaire

Felines

  • Building of a feline QoL tool for cats with GI lymphoma
  • Development and validation of an instrument to measure quality of life in cats
  • Development of a user manual for a feline quality of life tool

Barth syndrome

  • Concept elicitation interviews in Barth syndrome patients
  • Concept selection meeting for a PRO in Barth syndrome
  • Cognitive debriefing for Barth syndrome PROs
  • Qualitative concept elicitation and case studies documenting the disease progression of Barth Syndrome

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

Clostridium difficile

  • Pre-budget impact analysis and economic advice for personalized medicine: approaches to diagnose and control clostridium difficile infections

Dengue disease

  • Finalization and validation of a PRO instrument for measurement of burden in Dengue disease

Diptheria

  • Burden of disease literature review on diptheria in the UK and Ireland

Ear infections and acute otitis media

  • Diary of a caregiver validation for ear infection using the standard methodology
  • Training and manuscripts on the acute otitis media caregiver diary
  • Quality of life impact of otitis media and associated productivity loss in Malaysia and South Korea

Eosinophilic gastroenteritis

  • Evaluation of COA tools in eosinophilic gastroenteritis (EGE) and eosinophilic gastritis (EG) with additional longitudinal data collection

Fabry’s disease

  • Global value dossier in the treatment of Fabry’s disease
  • Strategic literature review in Fabry’s disease
  • Development of a PRO questionnaire to assess gastrointestinal symptoms of Fabry’s disease
  • Survey administration in an observational study to evaluate gastrointestinal symptoms of Fabry’s disease
  • Strategic consultancy on a protocol for Fabry’s disease
  • Consulting agreement and communication in Fabry’s disease
  • Strategic consultancy in gastrointestinal symptoms of Fabry’s disease
  • Cognitive debriefing of the Gastrointestinal Symptom Rating Scale Diarrhoea Domain in patients with Fabry disease

Fragile X syndrome

  • Consultancy support for clinical trials in Fragile X syndrome
  • Literature review to develop a conceptual model for individuals with Fragile X syndrome (aged 5-12 years old)

Gaucher’s disease

  • Payer research to understand evidence requirements for reimbursement in Gaucher’s disease
  • HTA recommendations analysis in Gaucher’s disease
  • Development and validation of a questionnaire in Gaucher’s disease

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

Glucose transporter type 1 deficiency syndrome

  • Qualitative research to explore and support the assessment of the patient experience and impact of functioning of movement disorders in glucose transporter type 1 deficiency syndrome, and literature review in absence seizures