CASE STUDY 1:
Advancement of an Early Development Candidate to Phase IIb Trials
Business Need
A virtual biopharmaceutical company licensed an early development candidate, and a Phase I study had been completed for the drug, which was delivered intravenously.
Some preliminary oral delivery work had been completed by the organization from which they had licensed the compound, including development of limited analytical methods, a tablet formulation, and some in vivo data.
The virtual company needed to design the Phase I/IIa clinical program and intended to fill in the gaps to complement the work that had already been completed.
The virtual company manufactured a batch of drug product according to the processes provided, at which time they determined that few of the methods were reproducible, and in fact, some had significant liabilities.
Rather than try to improve on the existing, questionable methods, the virtual company decided to develop their own oral formulations and ADME profiles.
Technical Approach
Wolfe Laboratories already had an established relationship with the principals in the virtual company, having successfully provided R&D support for this same team at their previous company.
The team collaborated with Wolfe Laboratories to design a development program and then Wolfe Laboratories executed on portions of it.
Wolfe Laboratories developed analytical methods for drug substance and drug products, degradant and impurity characterization, physicochemical characterization, salt screening and selection, preclinical and clinical oral liquid formulation development, bioanalytical methods development and validation for the quantitation of parent drug and metabolites in plasma and tissues, metabolite identification, elucidation of complex intrinsic clearance pathways, PK profiling, training of compounding pharmacists at clinical trial sites, and dose confirmation analysis.
The results were provided as detailed reports which were directly inserted into regulatory filings. Many aspects of the program had especially aggressive timelines, and Wolfe Laboratories worked with the client company to ensure that the programs were designed to yield the results in the requisite timeframe.
Results
The virtual company achieved significant milestones as a result of its R&D partnership with Wolfe Laboratories.
Preclinical studies were completed ahead of schedule and the Phase I/IIa trials demonstrated safe, effective and well-tolerated doses for the formulation.
Based on these encouraging findings, the virtual company is designing its Phase IIb program.
