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Aug 1, 2009 (Vol. 29, No. 14)

Overcoming Phase II Attrition Problem

Success Here Should Help Pharma Industry Boost Its R&D Productivity

  • Conclusion

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    Figure 2. If you have adopted a translational medicine program, has it been helping you to accelerate movement of promising drug candidates into mid-stage clinical trials and to weed out unpromising candidates?

    Translational medicine programs have been widely adopted in the pharmaceutical industry, and most drug development experts believe that these programs are the best approach to reducing attrition and thus to reducing costs and improving productivity of drug development.

    Most of these experts believe that it is too early to tell whether current translational medicine programs are useful in accelerating the movement of good drug candidates into mid-to-late stage development and weeding out poor ones. The survey respondents agree with this assessment (Figure 2).

    “I think that the Phase II survival data that comes out of industry over the next two to five years will be critical,” explained Dr. Littman. “It’s going to indicate whether or not the changes made by experimental medicine and translational medicine groups within these companies are really going to impact Phase II survival rates.”

    The ability of researchers to successfully identify and validate biomarkers and to design and carry out POC clinical trials depends to a large extent on an understanding of disease biology and disease pathways. Thus biology-driven strategies of drug discovery carry over into the new paradigm of early drug development.

    Although researchers’ limited understanding of the biology of complex diseases has been hampering drug development, researchers over the course of the past several decades have elucidated areas of disease biology that have enabled pharmaceutical and biotechnology companies to develop new breakthrough drugs.

    The majority of these discoveries in disease biology were made in academic laboratories.
    It therefore seems reasonable that increased collaborations between industry and academia might also catalyze improvements in translational medicine.

    Nearly 80% of the surveyed respondents said that their companies work with academic laboratories to improve aspects of their translational medicine programs, which indicates that these companies realize the importance of this collaboration.

    Collaboration between industry and academia in translational medicine can be challenging. For example, academia is mainly focused on basic research, not translational studies. Forging more effective industry-academic collaborations in translational medicine therefore remains an important task for industry, academia, and governmental agencies.

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