Regulatory assessment of a generic anti-diabetic peptide drug

Challenge: A biotech client had developed a generic version of a major anti-diabetic peptide drug, and wanted a clearer understanding of the product's registrability, as well as support with defining...
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Due diligence of a plasma protein manufacturer for a PE investor

Challenge: A private equity investor was considering a transaction in a company supplying therapeutic proteins derived from biological sources for the treatment of numerous diseases in the...
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Supporting a CTA submission for the oral form of an approved biologic drug

Challenge: Our client was developing an oral form of an approved biologic drug which appeared to have excellent properties in terms of a rapid time to maximum concentration in the blood. A Phase II...
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Technical & commercial review of anti-inflammatory peptide

Challenge: A university research group had discovered a new pathway for regulation of T cell trafficking in the inflammatory response.  The group had also identified an anti-inflammatory peptide and...
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CMC consulting for a company developing a peptide

Challenge A small biotech company was developing a peptide and needed support in taking the compound to first-in-man studies and Phase II clinical trials. This was the first time the company had...
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Clinical strategies for a novel peptide-based cancer vaccine

Challenge A US-based cancer vaccine company developing a peptide-based product was in clinical trials in its lead indication. Recent laboratory research had revealed the target antigens were also...
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