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- A Multinational Company requested a non-clinical overview for a topical pharmaceutical. The Consultant completed the final 44 page document within the very tight deadline by working long hours. The Client was delighted with the high quality expert overview.
- A multinational client required pre-clinical efficacy data to support their ongoing development of a proteinase sequestering biomaterial device for the treatment of chronic wounds. The consultant advised on possible experimental alternatives, and collaborated with the clients' R&D team in selection of the most appropriate delayed wound healing model. The protocol was finalised within 4 weeks, the study was initiated 2 weeks later and the final report obtained within 4 months. The data generated by this study formed part of a successful regulatory submission. The device in question is currently achieving worldwide sales of >$10 million p.a.
- The consultant supported an SME investigating a new indication for an existing product, reviewing the existing data and devising a preclinical programme to cover the data gaps. The consultant placed and monitored the required studies, compiling the regulatory documentation in parallel - ultimately leading to a successful application.
- A small company with an exciting potential therapy for Metabolic Syndrome needed a clear development pathway to achieve proof of principle for their intellectual property and also required further funding for the development phase. The consultant managed a vital early review meeting with FDA that defined critical elements of the pathway to clinical proof of concept and then achieved a successful hand over to the team managing the development work. In addition, support was provided in a financial due diligence review conducted by a major London investment bank. This resulted in the offering of investment banking at a marked reduction in premium.
- An established UK biotech company and a USA start-up sought to co-develop a gene therapy product for autosomal lung disease using a virus vector with targeted delivery to the bronchus.The Consultant advised on the preclinical programme to support Phase I clinical administration and placed safety evaluation and scintigraphy deposition studies at a specialist USA CRO, leading to successful completion of the programme.
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