Phase 1 Entry
At this stage of development, a company is gearing activities toward filing an IND in order to conduct a first in human clinical trial.
For drugs and biologics, you might have completed a Pre-IND meeting with FDA and have some initial feedback to use in planning your IND submission. Most likely, you have in vitro and in vivo efficacy data, and a plan for GLP and non-GLP studies in animal models to support a dose ranging and toxicity evaluation. It is likely that an assay has been developed to detect biological activity, although you may or may not have initiated Phase 1 manufacturing. In addition, you are likely to have a clinical protocol synopsis and may be creating new IP and/or strengthening existing IP. Also, you may have developed the initial product profile and your initial business plan.
The Atheln team can assist you in advancing your program efficiently, and cost effectively by providing support in multiple areas, including:
- Intellectual Property
- Quality
- Regulatory
- Clinical
- CMC (including process optimization, analytical method development/qualification, stability study design, setting release specifications, etc.)
- Business Development and Licensing
- Preclinical
- Commercial Support
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Detailed offerings are found in the attached PDF.