Johnston McGregor specializes is translational medicine and bringing new drugs from the lab bench to proof of concept. Unlike a CRO we tailor the development plan to your needs and specifically gear the drug development to meeting regulatory requirements while maximizing its attractiveness to large or small investors. We also understand important investment milestones and work with you to achieve these efficiently. We have over 20 years of drug development experience, including frequent contact with regulatory agencies around the world.
Over 20 years of drug development experience in phases I-IV
Experience establishing companies
Experience growing small companies
Appropriate publication and information planning
Conducted clinical trials throughout the world
Established relationships with data providers and key physicians
At Johnson McGregor we follow these key essential principles.
Establish a drug development plan to highlight features of the new drug so investors can make critical decisions.
Organize the key, essential pharmacology and toxicology experiment to maximize success in filing and IND (Investigational New Drug Application) with the FDA and other regulatory authorities.
Provide estimates of costs.
Protect copyright and patent interests.
Educate FDA about cutting-edge science.
Incorporating too many scales and scores into early protocols.
- Dilutes efficacy: over 70% of trials fail.
Not accurately estimating the dose resulting in inadequate safety information.
Inadequate safety reporting.
In complete drug product information (CMC).
Failure to test toxicology adequately.
Not estimating time lines correctly.
Not choosing correct sites to conduct trials.
Inadequate understanding of controls and drug supply (CMC).
Insufficient toxicology design.
Phase III design in phase I and II protocols interfere with interpretation.
Inadequate safety measurements and reporting.
- VENTURE INVESTORS
Our staff has set up or gown nearly 20 small companies.
Select appropriate CRO vendors and designed trials to minimize cost with minimal company structure.
Design overall development plans to capture key proof-of-concept data to allow an attractive platform for partnering or sale.
Key milestones set up to reveal data at strategic intervals to aid in investment decisions.
Establish appropriate relationships with key opinion leaders.
Not selecting appropriate teams at CROs.
Clinical development plan NOT designed to show key proof of concept.
Scientific considerations not properly balanced or aligned with business needs.