Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
There are numerous reasons why drugs get stuck in development. Certainly, problems with efficacy or problems with safety are main reasons but there are many other ‘derailers’ as well. For instance regulatory issues or manufacturing, difficulties can stop a program. Occasionally, a suboptimal dose was chosen because of (1) incomplete Continue reading Why Some Did Not Make It
When antibiotics change hands, it can be a good thing. Small companies are often desperate to attract a partner with ‘deep pockets’ to help them finance an expensive late phase development but often have to give up control once the honeymoon period is over. Such transitions can bring delays because new Continue reading The Circuitous Route to Phase 3: Another Chapter in the Fitful Development of PTK-0796
Preclinical and early clinical development is expensive enough already for VC companies but it gets really expensive in Phase 3. Hence, not surprisingly, few small companies tackle Phase 3 programs on their own. Unless an ‘angel investor’ with deep pockets commits to the compound and assures continuity of development, the Continue reading The Difficult Transition Into Phase 3