On-Demand Development Team
A completely virtual biotech company initially needed a partner to advise them on the drug development process and development planning. The relationship continued to expand as development progressed.
- Clinical Development Plan created.
- Regulatory Plan created.
- Successful pre-IND Meeting conducted with FDA.
- IND Filed.
- Aggressive plan in place to bring maximum value to sponsor.
- Quality system created.
- FIH dosing achieved- phase 1 SAD study completed on time and within budget.
- Patient dosing achieved- phase 1 MAD study completed on time and within budget.
- Lead all program management, clinical, regulatory, and statistical aspects of the program.
- Participate in sponsor Board of Director and Investor meetings.
- Participate in diligence meetings.
Halloran originally partnered with the CEO to provide advice on the drug development process. We then created and implemented clinical and regulatory development plans. We now drive the program forward by serving as the sponsor team members covering program management, clinical, regulatory, data management, statistics, and medical writing. We are responsible for both the strategic and the operational work on the program and are on track to hit 100% of the planned milestones for the program, which is resulting in a high interest from potential partners and investors.