This is the section of the drug pipeline with the highest risk to industry. For every 1,000 discovered ‘candidate’ compounds, only one will make it to the next stage – a human clinical trial. It is also when a U.S. patent application must be filed; this starts the clock on any eventual “profit pipeline” and makes speed of development critical. The patent situation for drugs is complex, and international patent concerns must be carefully analyzed and handled. Most major research universities have technology transfer offices and Intellectual Property (IP) attorneys. However, these offices are concerned with a wide variety of inventions and need expert advice on the intricacies of drug patenting in particular. In most private research entities, the need for IP protection is greater due to more modest in-house capabilities and limited funding for outside counsel. The same is true for animal modeling – major research institutions have the needed facilities and/or are sometimes willing to construct them when needed. An example of Tiger Team functioning might be to recognize very early the looming need for testing HIV vaccines on primates, and to make the arrangements well in advance, since such animal facilities are rare, expensive, and overbooked.
- Assessment of animal modeling efforts
- Development of a network of pharmaceutical patent attorneys
- Qualification of vivaria
- Matching research efforts with vivaria around the world
- Evaluation of pre-clinical programs and guideline compliance