Therapeutic Expertise

Addictions can seriously damage a person’slife, health, finances and relationships, and can have a serious knock-on effect on those around them. They can fundamentally affect someone’s physical and mental well-being, but with the right support they are treatable conditions.

Our experience includes performing extensive literature reviewing and qualitative research to explore the content validity of a Clinician-Reported Outcome measure of opioid withdrawal symptoms, research that involved interviewingindividuals with experience of opioid addiction and also expert clinicians experienced in treating those individuals.

Our work in this area includes a range of addictions and related side effects, including:

Alcohol dependence, including defining the population, understanding the diagnosis, management and referral procedures of alcoholism, and related obsessive-compulsive disorder

Heroin addiction including maintenance therapy and oral morphine therapy

Smoking including readiness to quit

Opioid addiction including withdrawal symptoms, cravings, and defining clinical trial endpoints

As one of the most common chronic health conditions in the world, allergies can affect anyone, and immune responses can range from mild symptoms to potentially very serious.  They can significantly affect quality of life and interfere with day-to-day activities.  Our varied experience in this area has focused on adults, adolescents, children and caregivers, including in conditions such as:

Food allergies including peanut allergies and lactose intolerance

Intolerance to specified medications

Atopic dermatitis and other allergy-related conditions in animals

Allergic rhinitis, atopic dermatitis/eczema, eosinophilic disorders and other conditions that can be triggered by allergies

Allergy immunotherapy and side effects of allergy treatments such as the impact on sleep

Value in animal health can be measured by many characteristics and attributes similar to human health, and they can be imperative for pet owners and veterinary decision-making. Adopting approach methods that consider owner preferences, costs, and health risks can aid decision-making by veterinary practitioners and animal health professionals to optimize treatment selection. 

Our experience covers a variety of therapeutic areas within animal health, targeting key concepts of importance in veterinary medicine and incorporating a range of key stakeholder perspectives.  Additionally we have contributed to advances in outcomes research, targeting and addressing the emerging needs in animal health and demonstrating the value of our clients’ products to the patient, the owner and the healthcare providers.

Our work in this area includes a range of indications including:

Canine health, including quality of life, studies on wearable devices, treatment satisfaction, clinical trial analysis, willingness to pay, pain studies, and the burden on owners

Feline health, including willingness to pay, quality of life, regulatory support, pet owner preference and ease of use studies

Cardiovascular diseases are one of the leading causes of death and disability. An understanding of risk factors and preventative lifestyle choices is important.  Some indications lead to associated damage to other organs, and some other diseases can lead to development of a secondary cardiovascular disease.

Our team has extensive experience working in cardiovascular diseases, including but not limited to:

Heart disease, heart failure, pericarditis, and other problems with the heart muscle

Arterial conditions and high cholesterol

Blood clots, blood pressure and associated conditions, including strokes and heart attacks

Heart devices (such as stents and valves) and adverse events

Central nervous system (CNS) and neurological indications often have their own unique challenges. As experts in the field, we have worked across a wide range of degenerative, chronic, and genetic CNS/neurology conditions, which by their nature also present some hugely debilitating mental and physical side effects in patients.

Our work in this area includes a wide range of diseases and related morbidities, including but not limited to:

Mental health and psychological disorders, including the burden of negative symptoms

Damage to the nervous system or the protective membrane in the brain and spinal cord

Neurological/brain function conditions,including preventing cognition loss

Chronic, acute and trauma pain, including in an emergency setting

The burden of disease in dermatology is often underestimated; chronic skin diseases such as psoriasis can not only cause physical discomfort, but lead to a significantly reduced quality of life, impact upon social engagement and relationships and may increase the risk of other metabolic, cardiovascular and psychological disorders.

A patient-centered approach is important in treatment decision-making to help address the burden of disease, improve adherence and optimise treatment benefits. A greater focus on patient-reported outcomes adds to the complexity of value demonstration for new products and introduces further payer expectations. A crowded landscape means that early planning by Pharma companies is paramount to differentiate their products and demonstrate how they address a genuine unmet need.

Our work in this area includes a wide range of diseases and related morbidities, including but not limited to:

Inflammatory immune system conditions such as acne vulgaris, including evaluation of symptoms, treatment response, and related disease impact (e.g. sexual dysfunction and pain)

Skin infections (and infection prevention), including antiseptics and surgical, fungal and bacterial infections

Other itchy skin conditions and those secondary to a primary disease, including assessment of symptoms, disease burden, related sleep disturbance, and studies of the patient experience

Rare skin conditions such as systemic sclerosis and epidermolysis bullosa

Diseases of the endocrine and metabolic systems come in all forms, from diabetes to eating disorders.  Such conditions come with a wide range of impacts, such as susceptibility to infection and kidney failure, and these impacts can create a major decline in health-related quality of life and costs to the healthcare system.

Our work in this area includes a wide range of diseases and related morbidities, including but not limited to:

Diabetes (types 1 and 2) including insulin delivery and monitoring devices, burden of disease and resulting behaviours, and related complications

Hormonal disorders (including rare disorders) such as issues with growth hormone, enzymes, cortisol or the thyroid gland

Weight issues, obesity and eating disorders, including resultant fat reduction/cosmetic surgery, nutrition studies, and lipid imbalance

Our experience in gastroenterology covers a variety of indications and product types including personalised medicine, biomarkers, biosimilars, vaccines and therapy devices. Symptoms can vary from the mild to the debilitating and can cause great discomfort or burden.

Specifically, our work includes a wide range of diseases and related morbidities, including but not limited to:

Bowel-related indications, including inflammatory bowel diseases, irritable bowel syndrome, and short bowel syndrome with intestinal failure

Medical procedures including colonoscopy, and post-surgery complications including post-operative ileus and complications from a stoma

Gastrointestinal symptoms and problems including constipation, diarrhoea, and heartburn

Gastrointestinal infections including rotavirus and clostridium difficile

With 99% of genetic diseases also being classed as rare, there are multiple challenges associated with research in genetic conditions. Some may be evident at birth while others occur later in life, but they can have a great burden on the patient and their caregivers.

Our work in this area includes a wide range of diseases and related morbidities, including but not limited to:

Genetic conditions affecting the nervous system, muscles, brain, and eyes

Genetic metabolic disorders, and the inability of the body to process, break down or transport substances

Genetic blood disorders 

Hormonal and protein deficiencies

We understand the challenges of hematology research from patient-centered and market access perspectives. With our varied experience in hematological disorders and our flexible approach, we pride ourselves on generating and communicating evidence in the most effective way possible.

Our work in this area includes a wide range of diseases and related morbidities, including but not limited to:

Blood disorders and indications that can lead to imbalances in red blood cells, white blood cells, iron levels and/or platelets’

Disorders that cause blood clots, and conditions that affect the blood’s ability to clot such as haemophilia A and B

Blood-related cancers including leukaemia and myelodysplastic syndrome

We have knowledge and expertise of the specific challenges and considerations in hepatology, including the contributing factors of a patient’s lifestyle, the spread of some of the indications, and the seriousness of side effects. Our experience includes conducting patient-centered research and informing clinical outcome measurement strategies, such as ensuring representation across liver fibrosis stages to align with the target population, the importance of confirmation of diagnosis using specific diagnostic criteria and exploring the potential conceptual overlap with similar symptoms, along with conducting value communications, landscape analyses and HEOR research strategies.

Our work in this area includes a wide range of diseases and related morbidities, including but not limited to:

Liver diseases and liver transplant

Cancersof the liver, biliary tract and pancreas, and related fatigue

Hormonal problems such as pancreatic exocrine insufficiency

With extensive experience and a dedication to innovation, we at Adelphi Values understand the challenges and approaches to market access in immunology and the importance of reducing the burden on those suffering from autoimmune diseases. Our experience in immune conditions is particularly strong in terms of PRO development and qualitative content validity testing research (in Crohn’s disease, ulcerative colitis, rheumatoid arthritis, lupus and atopic dermatitis) and also in health utility state elicitation in similar conditions.

Our work in this area includes a wide range of diseases and related morbidities, including but not limited to:

Autoimmune conditions of the musculoskeletal system, including all types of arthritis, and indications that cause inflammation across various parts of the body

Endocrinological conditions including diabetes, and neurological conditions including multiple sclerosis

Skin conditions including psoriasis, atopic dermatitis, hidradenitis suppurativa and scleroderma

Gastroenterological diseases and issues affecting the bowel and colon, including extensive PRO development research in Crohn’s disease and ulcerative colitis

Other autoimmune conditions that cause pain e.g. fibromyalgia and lupus

We understand the specific considerations and challenges associated with conducting research in infectious diseases, including seasonal variability, rates of transmission, obtaining confirmation of diagnosis, managing hospitalizations, the influence of socioeconomic factors on risk and access to therapies, and the perceived stigma associated with some conditions.

Our work in this area includes a wide range of diseases and related morbidities (mild, serious and life-threatening), including but not limited to:

Bacterial infections including infections of the skin, bowel, brain/spinal cord and bloodstream, along with gram-negative infections

Antiobiotic resistance

Viral infections including common diseases (such as COVID-19, cytomegalovirus and influenza) and conditions that cause organ inflammation

Tropical diseases (e.g. dengue fever) and diseases caught from animals (e.g. rabies and yellow fever)

Vaccine-preventable diseases

Fungal infections

Childhood illnesses e.g. whooping cough, chicken pox and acute otitis media

We understand the complexities of medical devices. As a growing field, payers are recognising that they need increased levels of evidence to support the introduction of new medical technologies, however the approach to evidence generation and the requirements differ from pharmaceutical products. We understand the unique considerations of these products and what it takes to gain reimbursement, as well as the importance of understanding the perspective of patients using such devices.

Our wide-ranging experience in this area includes:

Respiratory devices such as inhalers and ophthalmology devices such as lenses

Contraceptive devices, diabetes monitoring devices and injection pens

Wound dressings and other devices for bleeding including those for haemophilia or post-partum haemorrhage

Ostomy medical devices such as ileostomy, colostomy, and urostomy bags

Cardiovascular devices such as stents and valves

ePRO and actigraphy devices to evaluate disease symptoms and quality of life

We have experience conducting research into diseases and related morbidities that only or mainly affect men. We understand the sensitivities, barriers and unique considerations (e.g. social stigma and health-seeking behaviours) for conducting research within these populations.

Our work in this area includes a wide range of diseases and related morbidities, including but not limited to:

Male hypogonadism

Prostate cancer, including castration-resistant and hormone-naïve variants (and related pain), and other prostate-related diseases

Male infertility

Rare or genetic diseases affecting mainly males, including hemophilia, Hunter syndrome, Duchenne muscular dystrophy, and Leber hereditary optic neuropathy

Erectile dysfunction/premature ejaculation

We have worked extensively in conditions affecting the musculoskeletal system and understand the burden that pain and functional limitations associated with these conditions can have on peoples’ lives.

Our work in this area includes a wide range of diseases and related morbidities, including but not limited to:

Arthritis, including rheumatoid arthritis, osteoarthritis and juvenile idiopathic arthritis

Bone health and degenerative bone conditions

Musculoskeletal surgeries, including hip replacement

Genetic and rare musculoskeletal disorders, including Duchenne muscular dystrophy and GNE myopathy

Musculoskeletal pain, including lower back pain and fibromyalgia, and treatments such as muscle relaxation

We have an in-depth understanding of the challenges and approaches to conducting patient-centered research and facilitating market access for products in nephrological conditions where underlying disease and treatment are often associated with high symptom burden and reduced health-related quality of life. Incorporating the patient voice into drug development and utilizing standardized outcomes in conditions such as chronic kidney disease is increasingly important to ensure outcomes are relevant to patients and can demonstrate treatment benefit and alleviation of burden.

Our work in this area includes a wide range of diseases and related morbidities, including but not limited to:

Kidney cancers

Kidney transplant

Kidney diseases, including chronic, end-stage, Berger’s disease, and kidney failure

Other conditions caused by kidney problems, e.g. secondary hyperparathyroidism

The oncology market is a rapidly evolving space with the last few years bringing exciting developments and opportunities. Several new immunotherapy treatments and combination regimens have recently been developed or approved across different cancer indications and the global pipeline of oncology treatments has expanded dramatically. Emerging therapies have the potential to disrupt the current treatment landscapes and the growing number of drug classes brings new levels of competition. Paired with continued debates over drug costs and growing emphasis on patient reported outcomes, commercial engagement and strategic and timely value demonstration to payers, providers and patients is critical for Pharma companies to position their products in the evolving treatment landscape.

As a key therapy area for Adelphi Values, our wide-ranging work in oncology has spanned the globe and includes a vast number of indications, cancer types and product types. This experience includes but is not limited to:

Liquid and solid tumours

Rare cancers

1st and 2nd line treatments

Complications and side effects including cancer-related pain and fatigue, breakthrough cancer pain, chemotherapy-induced anaemia, febrile neutropenia, and tumour-induced osteomalacia

Immuno-oncology and the use of immune-response modifiers, along with biologics, combination treatments and biosimilars

We have extensive experience of supporting medical product development across a range of ophthalmological conditions. We understand the significant humanistic and economic burden on those living with these diseases, the unmet need for treatments and the challenges of treatment evaluation in these populations. 

Our work in this area includes a wide range of diseases and related morbidities, including but not limited to:

Age-related degenerative conditions and inherited eye disorders

Blindness and other damage to the optic nerve, lens, and retina

Inflammatory eye conditions, including rare diseases

Eye misalignment and bulging eyeballs

Conditions resulting from problems with the tear ducts

Pediatric care comes with its own unique challenges, and as such there is currently a substantial gap in the clinical evaluation of medicines compared to the adult population (leading to significant off-label use). Gaining approval in this vulnerable group requires specialist testing and validation, and the challenge of conducting clinical trials leads to more limited clinical evidence, particularly long-term data. Communicating benefit can also be challenged by high upfront costs and deferred health gains, with economic and health evaluation affected by non-standardization and potentially unreliable data. As many conditions that affect pediatric patients are rare, these issues are further confounded. When considering the pediatric population there is an important need to consider the often overlooked wider picture, along with the impact on caregivers and family members (both from a humanistic and economic standing) and their involvement in decision-making.

Our work in this area covers a variety of therapy areas and topics, with our experience including:

Pediatric burden of disease (and the burden of undergoing treatments) on patients and their families, along with impact on quality of life

Qualitative research studies with children, adolescents, and caregivers, to better understand the patient experience of a health condition and/or its treatment

Development of PRO, ClinRO, and ObsRO instruments to evaluate signs, symptoms, impacts, and treatment acceptability for paediatric health conditions

Advisory boards, strategic recommendations, training workshops, and studies on paediatric immunisation programmes

We recognize the challenges of drug development for rare diseases, the regulatory landscape, the nuances, and the varying requirements across different markets. Meeting rigorous evidence and data requirements can be difficult – we understand the ways to address these challenges and we can provide the tools needed to understand disease progression, how it’s managed by clinicians and the unmet need that exists. With extensive experience in rare diseases and a deep knowledge of regulatory and HTA requirements, we have the technical expertise and ability to adapt standard methods for the specific challenges of rare diseases and orphan drugs.

Our work in this area includes a wide range of diseases and related morbidities, including but not limited to:

Rare cancers

Rare haematological and hormonal disorders

Rare genetic, acquired, or progressive diseases

Rare autoimmune diseases

Respiratory diseases are a leading cause of morbidity and mortality worldwide. We have extensive experience of conducting research designed to understand and evaluate the clinical, humanistic, and economic impact of such diseases throughout all stages of life and with respect to diversity and health disparities between patient groups.

Our work in this area includes a wide range of diseases and related morbidities, including but not limited to:

Chronic inflammatory lung diseases such as asthma and chronic obstructive pulmonary disease (COPD)

Respiratory viruses such as RSV

Lung damage that results in breathing difficulties such as idiopathic pulmonary fibrosis

Mild respiratory indications such as cough, and lung surfactant studies

We understand the wide range of complications associated with surgery, anesthesiology and wound care, including physical symptoms (e.g. pain or skin complications) and the impact on health-related quality of life (e.g. compromised mobility or impact on body image). We have supported sponsors in the evaluation of these complex outcomes from both a patient and societal perspective.

Our work in this area includes a wide range of diseases and related morbidities, including but not limited to:

Surgical procedures including transplants, grafts, hip replacements, and bariatric surgery

Wound care treatment/pain management and anesthesiology

Medical devices for surgery

Surgical infection prevention

Post-operative care/post-operative pain and surgical recovery

We have extensive experience in urological conditions and urogenital diseases. This includes the development, qualitative content validity testing and psychometric validation of both a screening tool and a PRO measure of symptoms and HRQoL in interstitial cystitis. From a market access perspective we have performed reviews of the clinical, economic and humanistic burden of illness and also cost utility modelling in male hypogonadism. We have also conducted literature reviews and qualitative research in herpes simplex virus (HSV), which is characterized by genital symptoms. 

Our work in this area includes a wide range of diseases and related morbidities, including but not limited to:

Hormonal problems with the sex glands

Prostate enlargement that causes problems with the bladder or urinary tract

Urinary problems, including painful bladder syndrome/interstitial cystitis, incontinence and sudden urges to urinate

Kidney diseases affecting urination

With vaccination programmes facing some scepticism and hesitancy, demonstrating the value of a vaccine and expanding coverage rates is increasingly important.  Along with preventing up to 3 million deaths every year, vaccines are responsible for vastly reducing the prevalence of their diseases when public uptake is strong.

We understand how to demonstrate and communicate the clinical, humanistic and economic benefits of vaccines. We have worked with numerous sponsors to demonstrate the value, health economic and market access potential of their products.

Our work in this area includes a wide range of vaccines and related work, including:

The use and effects of vaccines, e.g. the injection process and needle pain

Viral and bacterial indications (and related mobordities), including mass vaccination programmes such as COVID-19 and MMR

Safety studies, vaccination programmes, return on investment, and epidemiology studies

Single, quadrivalent, nonavalent and hexavalent vaccines

The burden, prevalence and impact of vaccine-preventable diseases, along with caregiver and HCP attitudes to vaccination

We have knowledge and experience across a wide range of conditions and related morbidities that only or mainly affect women, or which disproportionally affect or may impact women in different ways than men. Treatments in areas such as female infertility can be complex, time-consuming and costly, with potentially substantial negative physical and emotional impacts, and access to affordable treatments can vary greatly by location.

Our research includes, but is not limited to, the following areas:

Female infertility

Pelvic organ prolapse

Urogenital diseases
e.g. endometriosis and uterine fibroids

Menopause and related treatments
e.g. HRT

Contraception, antenatal care, post-natal care, and symptoms of pregnancy

Cancers affecting mainly or only females, including breast cancer, ovarian cancer, vulval cancer and cervical cancer