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Case Study
Regulatory Affairs/Drug Development Support to a Virtual Company for a 505(b)2 Combination Product

Client Need

The Gnomon Group (TGG) was retained by a small biopharmaceutical company to provide regulatory affairs and drug development support to an investigational project to evaluate a fixed combination product for the relief of pain and other symptoms of osteoarthritis. The Company was virtual with one employee, the CEO, and with all other development functions planned to be outsourced to vendors or contractors, as necessary. The Company was developing a marketed drug combination product for an important new indication and planned a pre-IND meeting to discuss a 505(b)(2) application approach with the FDA (and European Authorities). The Company’s needs included:
  • CMC, preclinical, and clinical development support
  • Regulatory strategy (nonclinical, clinical, and chemistry, manufacturing and controls)
  • Submission support, including creation, organization, assembly and submission
  • FDA meeting liaison (meetings and teleconferences with FDA)
  • Medical writing (protocol, Investigator’s Brochure, Informed Consent)
  • Project management
  • Data management and statistical analysis
  • Participant on safety review team

Services Provided by the Gnomon Group

Lacking any internal resources for drug development support, The Gnomon Group assembled the drug development and regulatory affairs team for the client. The project team included regulatory affairs, project management, toxicology, data management, statistical analysis, and medical writing. TGG provided regulatory advice and contributed to the drug development strategy for the investigational compound under development. TGG helped prepare the pre-IND meeting request, briefing package and sponsor questions, and coordinated the pre-IND teleconference with the FDA. Based on FDA comments, the sponsor elected to conduct a non-IND proof of concept study. TGG wrote the study protocol (double-blind, placebo controlled study), prepared the statistical analysis plan, developed case report forms, and helped with site selection and initiation. TGG obtained IRB approval, monitored the sites, performed study close out visits, managed and analyzed the data, and prepared a study report. TGG is currently helping plan the IND documentation, including CMC, preclinical, and clinical reports and summaries.

Benefit to Client

Client gained access to an experienced regulatory affairs and drug development CMC, preclinical and clinical support team without the necessity of adding permanent staff to the organization. TGG had the ability to provide advice, guidance and support on a full range of drug development issues to the client in an efficient and cost effective manner. Our flexible organization and consultant arrangements allowed the client access to several specialists in different functional areas while working through a single point of contact. The Gnomon Group’s submission preparation capabilities also alleviated the need to develop or maintain those resources internally.

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