Bioskin GmbH: A Skilled Partner for Dermatological Drug Development
Dr Walter Wigger-Alberti, CEO and Clinical Advisor Dermatology
Consider this. A pharmaceutical company has a proof of concept of their new topical drug test that would require more than one product to be applied on the same patient. Since dermatological clinical trials are a niche, the pharma company would prefer to bring onboard a CRO that has in-house dermatologists. Such expertise is required as the test would have to consider the effects of the unique formulation, understand the type of formulation, the delivery of the active ingredient out of the formulation and into the skin, and the overall effect of the formulation itself.
The pharma company would approach a CRO, and they will have a host of factors to consider: what is the experience the CRO is bringing to the table, how innovative they have been in their approach, do they have the appropriate infrastructure, and will there be multiple points of contact even to get a response. “We were awarded the CRO Leadership Award in 2018 in the categories expertise, capabilities, quality and reliability,” says Dr Walter Wigger-Alberti, CEO and Clinical Advisor Dermatology, bioskin GmbH. The Hamburg based full-service CRO was established in 1992 and has been growing consistently since then, helping their clients develop a proper protocol, and even help attend scientific advice meetings with authorities. These meetings are particularly useful for small-sized clients for the development of new protocols for their new drugs. Since 1992, bioskin has constantly grown and nowadays organizes also late phase, multicenter, multinational trials.
Our research center participated in more than 150 clinical trials in the past 10 years
Having in-house dermatologists and its Research Center in Hamburg, bioskin is adept at handling new topical drug tests. Take an example of their unique psoriasis plaque test. It allows proof of the efficacy of a new compound in only a small number of patients. The test also integrates biophysical measurements giving an advantage of having proven efficacy before the pharma company progresses to more extensive trials. The inclusion of biophysical measurements to measure various skin properties like atrophy, the thickness of the skin and standardised imaging is exemplary of the expertise that bioskin has gained over 28 years of its existence. “Our research center participated in more than 150 clinical trials in the past 10 years,” adds Dr Wigger-Alberti.
In addition to the psoriasis plaque test, bioskin also offers various models for atopicdermatitis, UV induced erythema models for anti-inflammatories, a successful and robust superficial wound healing model by using an abrasion and Vasoconstrictor assays for topical corticosteroids. The network of key opinion leaders in the dermatology domain helps bioskin stand apart from its competitors. Coupled with a low turnover rate, short internal ways of communication, and project teams with backup solutions have enabled bioskin in timely delivery of the reports. The pharma company will be talking to the same people even if the project has been running for two years or more. “In addition we established an account management. If our clients have three different project managers in three studies, they will have one key account manager responsible as a direct contact with the sponsor overseeing the budget for all three studies,” says Dr Wigger-Alberti.
Moreover, as Hamburg is the second biggest city of Germany, bioskin has good recruitment capabilities from the metropolitan region. A case in point is when a pharmaceutical major from North America was facing difficulty in finding patients for a rare disease in the US, bioskin was able to close the recruitment in just a few months in Europe.