Recent Data Suggests that even up to 10% of Population May Suffer from Autoimmune Diseases
Autoimmune diseases have been on the rise; recent data suggests that even up to 10% of population may suffer from autoimmune diseases, and this number is continuously increasing. Researchers have identified 80-100 different autoimmune disorders and suspect at least 40 additional diseases of having an autoimmune basis. These diseases are chronic and can be life threatening. A large number of autoimmune diseases cause skin, joints and systemic complaints – among them Rheumatoid Arthritis (RA) and Systemic Lupus Erythematosus (SLE), Psoriasis and Psoriatic Arthritis, Atopic Dermatitis, Ankylosing Spondylitis, Axial Spondyloarthropathy, Myositis (Dermatomyositis and Polymyositis), Juvenile Idiopathic Arthritis (JIA), Sjögren’s Syndrome, Vasculitis and Systemic Sclerosis.
With improvements in understanding of the immune system and molecules that mediate inflammation, new therapies continue to be developed for multiple autoimmune indications. Studies in autoimmune indications often share similar clinical and operational considerations, challenges and risks so it is valuable to work with a research partner that has experience across multiple therapy areas.
ICON provides a fully-integrated approach to the development of therapies in immunology indications - strategic direction as well as hands-on services through all phases of drug development. As a full-service contract research organization, we anticipate the challenges ahead and rely on proven mitigation strategies to ensure efficient operations, patient safety and a strong evidence package. ICON has a dedicated group of individuals who with considerable experience in biologics and biosimilar development. This ICON team of core professionals is organized within Dermatology and Rheumatology Center of Excellence (CoE) who supports programs with knowledge and experience gained from past projects. Four board certified rheumatologists are part of the CoE.
ICON Autoimmune experience in the last five years
Our dermatology study experience ranges from consulting on pre-investigational new drug (IND) briefing packages to preparing multiphase product development plans (including pediatrics) and from assembling new drug applications (NDAs) to providing biostatistical analyses.
ICON has been involved in various types of trials from small Phase I studies involving healthy volunteers to large, global, multicenter Phase III trials.
ICON possesses global dermatology clinical research experience in a variety of areas including:
- Atopic dermatitis
- Cutaneus lupus erythematosus (CLE)
- Prurigo Nodularis
- Uremic Pruritus
- Open wounds
- Skin infections
- Glabellar lines
ICON holds global clinical trial experience in a variety of immunology areas including:
- Rheumatoid Arthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis
- Systemic Lupus Erythematosus (SLE)
- Lupus Nephritis
Our integrated services include
- Early-phase Research: Staff dedicated exclusively to conducting early-phase research, from First-in-Human (FIH) through Proof of Concept (POC)
- Site Selection and Engagement: Close relationships with thousands of investigators and Key Opinion Leaders (KOLs), Electronic Medical Records on 100 million patients, and technology solutions for training and engaging sites
- Expedited Study Start Up: Smart processes and specialized teams to support your race to market
- Patient Recruitment and Engagement: A focused approach that includes patient-centric services, site support services, and an online learning management system - FIRECREST
- An expert Clinical Outcomes Assessments group with experience in dermatology and rheumatology PRO and Clinical assessment instruments creation and validation
- Medical Imaging: Over 200 imaging specialists providing photo services, centralized assessment and adjudication of study endpoints
- Independent DMC Management and Endpoint Adjudication IDEA with experience in Inflammation and Autoimmunity endpoints
- Central Laboratory Services: A global network of wholly-owned laboratories that can receive samples within 48 hours
- Biostatistical Analysis: A dedicated team to help in developing your protocol and perform PK modeling calculations
- Commercialization and Outcomes: Professional services to establish and communicate your product’s unique clinical and economic value
- Data Analytics: ICONIK decision-support platform provides a single view of study data to manage data quality, support a risk-based approach via analysis and visualization of trends, ensure compliance with assessment schedules, assess site performance, analyze and manage quality of rating scales and scoring tools