Commentary Trials & tribulations

As industry watchers have no doubt noticed by now, this fall and beyond could be a critical juncture for the sector, as clinical milestones practically pile on top of one another.

Clearly some drugs will work and others won't, but as the results begin to come out, intense scrutiny will focus on clinical trial strategies and thinking.

From the corporate point of view, the shortage of experienced clinical tacticians and designers makes it an opportune moment to learn from everyone else's experiences.

From the investor's viewpoint, the key issue is sifting through the information to see if any value actually has been created by accomplishing a milestone.

Behind the raw data, each milestone has implications for what actions a company takes next. Particularly important is the transition from Phase II to Phase III trials. Companies need to be able to demonstrate to investors that they have not simply met a milestone - i.e., finished a Phase II trial - but that they have gained enough information and insight to design an approvable pivotal study.

The complexity of the issues that need to be successfully addressed is illustrated by the following discussions with ImmuLogic Pharmaceutical Corp., Cortech Inc. and Matrix Pharmaceutical Inc., three companies that recently reported positive Phase II data (MATX also announced positive Phase III data). They now have to move on to the design of Phase III studies that can replicate those results - a task that has sometimes seemed beyond the capabilities of Tier Two and Three biotech companies.

ImmuLogic's Allervax Cat program

ImmuLogic is one of a growing handful of companies running a comprehensive Phase II program. President and CEO Robert Gerety said his philosophy of running pivotal studies is very simple: "We think that you don't do anything new in a Phase III."