Clarion’s recent experience in cardiology includes the following conditions:

• Acute myocardial infarction
• Antithrombosis
• Heart failure
• Hypertension
• Hypercholesterolemia

Clarion has been deeply involved across many CNS disorders—both in setting strategies at the franchise level as well as with products and opportunities specific to singular CNS disorders:

Psychiatric

• Attention-deficit/hyperactivity disorder (ADHD)
• Schizophrenia
• Substance abuse disorder
• Major depressive disorder
• Anxiety
• Bipolar disorder
• Post-traumatic stress disorder (PTSD)
• Sleep disorders
• Devices
• Digital therapeutics

Neurology

• Epilepsy
• Multiple sclerosis
• Parkinson’s disease
• Dementia
• Stroke
• Muscular dystrophies and neuromuscular disorders
• Pain
• Neurodegenerative diseases
• Rare/Ultra-Rare neuro disorders

A rapidly emerging therapeutic category, digital therapeutics are on the cusp of offering new solutions to patients across a range of mental health disorders. Clarion has worked with product innovators in this space to help tackle topics requiring new thinking and perspectives.

• Business development support for advanced digital therapeutic – support for board-level negotiation
• Demand estimation and revenue model for advanced digital therapeutic in Phase III

Clarion has developed a deep expertise in dermatology based on a unique and broad range of projects and client types in medical dermatology and aesthetics, including topicals, orals and injectables. Clarion has strong knowledge of the market dynamics and key considerations in dermatology from pre-approval through LCM. Clarion’s recent experience in dermatology includes the following conditions:

• Acne
• Atopic dermatitis
• Psoriasis
• Autoimmune disorders
• Basal cell carcinomas
• Aesthetics

Clarion has deep and broad expertise in endocrine and metabolic disorders leading to engagements that extend across all stages of product development, commercialization and beyond. Clarion’s recent work in endocrine and metabolic disorders includes the following conditions:

• Diabetes
• Complications of diabetes
• Diabetes prevention
• Obesity / insulin resistance
• Metabolic syndrome
• Cachexia
• Growth disorders
• Rare metabolic disorders

Clarion has significant experience partnering with biopharma in GI & hepatology across a broad range of diseases. Ongoing efforts to monitor developments in a rapidly evolving landscape combined with the opportunity to leverage our medical director’s background and expertise in GI/hepatology have uniquely positioned Clarion to support projects in this space. Our efforts in GI/hepatology include:

• Indication prioritization to guide therapeutic area strategy aligned with broader organizational vision
• Financial valuation to support go/no-go decisions for internal development or for external BD&L opportunities
• Strategic support for organizational development and launch, including developing strategic approaches to patient segmentation, product profile, and trial design
• Market sizing and buying process research, particularly for conditions with complex diagnostic/treatment paradigms and challenging socioeconomic dynamics
• Projects in GI, liver, and pancreatic diseases spanning orphan, genetic, infectious, fibrotic, I&I, pediatric, multi-system, & oncology
• Most recently, as NASH has emerged as an area with critical unmet need for patients and significant opportunity for biopharma, Clarion has contributed to industry-wide discussions, both by leading an expert panel discussion in collaboration with MassBio and by participating as a workshop partner at the 2018 NASH Summit

Rapid advancements in knowledge of the immune system and its relationship to a broad range of disorders has resulted in the emergence of a wide variety of therapeutic approaches aimed at treating diseases from atopic dermatitis to cancer. However, the complexity of the immune system continues to stand as a barrier to the tremendous potential to better treatments and cures.

Clarion has both the disease area expertise as well as the scientific knowledge depth pertaining to key technology platforms (gene-editing/alteration) that enable it to be an excellent partner as biopharma companies navigate this promising but perilous field.

Prematurity is a complex condition which can result in death or long-term disability. Clarion has built significant expertise in this area via work on overall entry strategies into neonatology, as well as work supporting specific disorders across various markets including US, EU, Japan, China, and Brazil. Specific areas of work include:

• Retinopathy of prematurity
• Bronchopulmonary dysplasia
• Hyperbilirubinemia

We live in an era of unprecedented innovation and growth in cancer therapy. Although exciting, the profusion of approvals and pipeline regimens mean that new products have never faced more competition, and differentiation has never been more challenging. Clarion tackles the challenges with an oncology team with broad and deep expertise that enables us to provide a holistic perspective, anticipate future needs of early products, and draw lessons from a broad set of analogs. Clarion’s strategy experiences in oncology span a diverse set of:

• Therapy types: Immunotherapy, engineered cell therapy, targeted therapy, novel chemotherapy
• Functional areas: Marketing, Medical affairs, Market access, New Products, BD
• Stakeholders: Oncologists, Pathologists/Lab directors, Payers, Patients, Nurses, and others
• Cancer types: Solid and hematologic, common and rare, mutation-defined subsets, and others
• Project types across the value chain

Clarion has a long-term interest in the highly specialized ophthalmology area where we combine our managing director’s in-depth knowledge of ophthalmic markets with the team’s scientific expertise in eye, retinal formation and next-generation technologies which are often first used in the eye. Over the years, we have successfully completed a broad range of projects in ophthalmology, including mass market ophthalmic products, devices and treatment for inherited retinal disorders. Recent areas of work include:

• Dry eye
• Wet age-related macular degeneration
• Diabetic macular edema
• Rare retinal disorders
• Glaucoma
• Therapeutic devices
• Drug delivery devices

With over 7,000 rare diseases catalogued, the rare disease space is a complicated landscape consisting of a diverse set of disorders, many of which have profound impact on patients’ lives. Clarion has been focused on this space for the last 7+ years – and has assembled an internal team that maintains a consistent focus on the market, technologies, and emerging business strategies for rare disease consulting in the Boston area. Clarion’s consulting experiences in this space include:

• Deep understanding of disorder and product requirements for success
• Role of rare/genetic diseases in broader franchise contexts
• Valuation of novel products/ technologies
• Depth in multiple rare therapeutic areas including muscular dystrophies, movement disorders, neuromuscular disorders, neurodegenerative disorders, neuroimmunology, immunology, ophthalmology, hepatology, nephrology, dermatology and pulmonology
• Advanced therapeutics, including gene therapy, antisense oligonucleotides, RNAi, cell therapies

Clarion has a long history in the respiratory space, including multiple product launches and portfolio strategy projects in the area. Fields of expertise include:

• Asthma
• Allergies
• Chronic obstructive pulmonary disease (COPD)
• Rare respiratory disorders
• Lung transplantation

Transplant is a complex area where severely ill patients undergo procedures in which physicians and nurses have to balance multiple risks over long periods of time as they guide patients back to health. Clarion’s transplant group has built significant expertise in the area via 350+ hrs of interviews with key stakeholders, largely in renal transplantation and hematopoietic stem cell transplantation as we sought to understand this market at an overall franchise level and a product/disorder level. Recent projects have focused on:

• Rejection and the prevention of rejection
• Graft vs host disease
• Stem cell mobilization
• Opportunistic infections