Situation:
A virtual company was in the process of acquiring an IP and an active IND from a well -known academic hospital. The IND was on clinical hold for a variety of issues. The investment by the venture capital syndicate was dependent upon the ability of the virtual company to prosecute clinical development with the goal of commercialization.
Solutions:
- Halloran defined a set of requirements and infrastructure necessary to acquire the IND.
- Negotiated release of the clinical hold.
- Created and managed an early development plan.
- A minimum set of procedures, systems and personnel were defined by a team of Halloran Consultants which allowed the smooth transfer of the IND and the IP.
- Subsequently, the client asked Halloran to continue the effort and build a clinical development and overall development plan for the acquired compound.
Value:
Investments were made and the company completed Phase 1 development. Data is scheduled to be released this year.