OUTCOMES Preclinical work and IND submitted within challenging investor-driven timelines: involved complex program management with vendors, client representatives and external consultants. n Alignment of Celerion and client enabled the senior management to focus on investors n Successful initiation of the opening IND healthy normal food effect study n Successful initial study allowed for Phase II program initiation in patients NEED Virtual US Biotech Company developing a central nervous system (CNS) – targeted compound completed an initial Single Ascending Dose (SAD) study in the EU with limited preclinical data package and single dose patient study in Asia. Client required integrated program management of outsourced program to address regulatory gaps required

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