We asked Dr Brian Henry, Executive Director, Pharmaceutical R&D, Pfizer some questions regarding the current challenges his organisation is facing.
What challenges does your organisation face in implementing new approaches for increasing productivity of drug development?
The increased understanding of the genetic basis for disease has opened up the opportunity to develop more specific and effective treatments for smaller patient populations. This opens up many new challenges for the drug inventor, as traditional approaches to drug development does not scale down easily and it is still too expensive and takes too long to deliver new therapies to these patients. So how can we design smaller, shorter and more specific clinical programs to reduce development time for these targeted patient populations, yet not compromise on safety and efficacy of the treatment?
What issues do you face in selecting phase I trial designs that best suits the development of the agent under study?
The key issue is still trying to identify key predictive markers for positive clinical outcomes, that can be measures in small PhI volunteer studies. The cost of drug development increases dramatically as we move from PhI through PhIII and the attrition rate due to poor clinical outcome in PhII is still too high.
What difficulties does your department face in selecting dose and schedule of exploratory treatments?
The Pharmaceutical Sciences departments are the first group in development who need to know PhI/II dose predictions with confidence. We are often working up to a year ahead of the clinical program designing and making drug supplies. During this phase, we are still learning much about the safety and efficacy of the new therapy and the dose predictions will often change once we have committed to a drug supply strategy. Improved translation of Preclinical models for efficacy and better use of PK/PD models could offer a solution to improve our range of dose predictions for early clinical programs.
Dr Henry is speaking more on this topic at the Exploratory Clinical Development World Europe 2012 conference.