Our Services
Preclinical Development
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Clinical Development
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Immuno-oncology Development & Strategy
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Clinical Pharmacology Strategy & Development
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FDA & Global Regulatory
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Strategic Due Diligence
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Pharmacometrics
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Pharmacokinetics
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Project Optimus Services
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Focus on Immuno-Oncology Development & Strategy
Immuno-oncology is truly one of the most exciting, while in the same time very challenging areas of oncology research and development. Immuno-oncology development attempts to utilize the full power of one’s immune system to be able to fight the cancer. These molecules are developed to stimulate the immune system to recognize and to attack the cancerous cells.
Our Drug Development Experience
Preclinical Development
- Early Research and Pharmacology, Designs and Interpretation of results
- Toxicology Study designs, data analysis and reporting
Clinical Development
- Translational Medicine
- Preclinical efficacy/safety interpretation, Starting dose rationale
- Early and Late development
- Study designs, protocol writing and building, CRO collaboration
Immuno-oncology development
- Translational Medicine, Starting dose setting
- Early and Late development
- Early Research and Pharmacology, Designs and Interpretation of results
- Toxicology Study designs, data analysis and reporting
- Translational Medicine
- Preclinical efficacy/safety interpretation, Starting dose rationale
- Study designs, protocol building, CRO collaboration
- HA interactions
Global Regulatory Agencies Engagement and Interactions
- HA meeting preparations and interactions
- Evaluate and provide guidance on all aspects of regulatory strategy for compound development
Clinical Pharmacology Development and Strategy Focus
- Phase I, Phase II, comparability studies with manufacturing changes to materials/CMC assessment.
Strategic Due Diligence
- Early and Late development program risk assessment