White Papers

At Symbio Proinnovera, our experience with clinical trials runs deep and so do our insights. We’ve experienced a lot over the decades about what it takes to manage clinical trials and we’ve compiled these learnings to share with you.

Urticaria Overview and Clinical Research Considerations

Urticaria is a highly prevalent inflammatory skin disorder, typically presenting as itchy wheals of various sizes, accompanied by erythema of the surrounding skin. There are two currently known drivers of CSU pathogenesis: autoallergy with IgE autoantibody involvement, and autoimmunity with IgG autoantibody involvement. For all chronic urticaria, the standard first-line treatments are second generation H1 antihistamines.

From a pathological standpoint, the different subtypes of CU are inadequately defined and lack reliable diagnostic biomarkers, making the design of more targeted therapeutic agents difficult. Improved efforts in pathology research and drug development are needed to meet the needs of CU patients across the world. This white paper discusses how to overcome common challenges in clinical research for Urticaria therapies.

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Industry and Clinical Trends in Dermal Fillers

Dermal fillers are aesthetic devices that can be injected permanently or non-permanently to restore volume and aesthetic appearance to a particular area of the body. They have become increasingly popular because they are effective and non-invasive options for facial rejuvenation. Increased demand for filler treatments in the coming years will provide considerable financial incentive for the development of safer, cheaper, and better products.

Dermal fillers are high-risk medical devices that must undergo pivotal clinical investigations, with a design and scope similar to that of Phase III studies for drug/medicinal product approval. Safety concerns and complicated approval regulations in the US and Europe must be considered and addressed. This paper discusses types of dermal fillers, common complications and side effects, and nuances of the regulatory approval process.

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Atopic Dermatitis: Considerations for Clinical Trials

Atopic dermatitis (AD), often called eczema, is a common and often debilitating skin condition whose root cause remains unknown but is likely to be related to allergies and immune dysregulation. No curative treatment exists for this condition and management usually consists of topical corticosteroids. In more severe cases, topical calcineurin inhibitors, biologics or immunosuppressants may be necessary. Unless remission occurs, AD is a chronic disease and needs to be suppressed through medication and vigorous hygiene practices. 

AD’s prevalence, lack of cure, and impact on life quality have driven continuous research and investment into novel therapies. Unless an extremely tolerable and efficacious treatment becomes available, this trend is likely to continue. This paper explores the clinical research challenges involved in AD trials including lack of standardized rating scales, the need to enroll children and young people, and the impact of time of year and geographic region.

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The Clinical State of Psoriasis

Psoriasis is a common and often debilitating skin disease that affects millions of Americans each year. In the last few decades a variety of different pharmaceutical interventions have been brought to market with the intention of alleviating the suffering this ailment inflicts. These efforts have coalesced into two main classes of drugs: Topical medications and systemic treatments. These systemic, biologic treatments generally come from a newer class of drugs known as monoclonal antibodies, or MABs. 

As the psoriasis market expands to include new systemic agents, clinical trials and their enrollment become increasingly complex. Due to the rise of treatment options such as biologics, topical psoriasis drugs have seen slow enrollment over the last decade. This paper aims to explain why biologics have become so popular and why their introduction has been so disruptive to classic topical drug studies. 

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