Barriers to Closing the Alzheimer Pharmaceutical Gap 2

·         Barriers in biotechnology [i] AD drug discovery and development is considered high risk and attracting capital for early high-risk projects is very difficult,  especially when the return on investment is questionable or long-term. The cost of conducting clinical trials is also another major barrier to small companies: risks are high and the probabilities of scientific success low. Therefore, external funding is important. EUROPA, the European commission group to improve innovation proposes that a small business innovation research programme (SBIR) mechanism-like that employed in public funding in the US, be introduced into the FP6-through integrated projects. This will speed up the creation of new companies and provide capital for small-to-medium sized enterprises. In the US SBIR mechanisms amounts to US 1.3 billion dollars.[ii]

·         Regulatory barriers. Another barrier that affects both the pharmaceutical and biotech industry is the lack of international harmonization of clinical trials and regulatory requirements. Designing trials that meet individual requirements is costly and timely. A further barrier to drug development is the definition of therapeutic effectiveness of AD medicines. The FDA requires that medicines show superiority to placebo on a performance-based test and a measure of global clinical function. Outcome measures are still unspecific and need to be established by the medical community. Other outcome efficacy measures that affect AD function are needed to guide drug development, and registration.

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[i] Alstiel L.D. Barriers to Alzheimer Disease Drug Discovery and Development in the Biotechnology Industry. Alzheimer Disease and Associated Disorders. 2002; 16: suppl 1: s29-s32.

[ii] http://europa.eu.int/comm/research/eurab/pdf/recommendations2.pdf. Improving Innovation European Union Research Advisory Board. Last accessed May 30, 2004.