At this past weekend’s Association of Health Care Journalists (AHCJ) conference in Philadelphia, Ed Silverman from Pharmalot moderated a panel on “efforts to revive the drug delivery pipeline.” He drew the attention of the audience to FDA data, published earlier this year, on the number of applications/approvals for new molecular entities (NME).
FDA CDER NME Applications Approvals Is there a crisis in the drug development pipeline?Source: redrawn from FDA Center for Drug Evaluation and Research (CDER) presentation.  The data in my opinion is a little ambiguous as to the true state of the Pharma industry.  While the number of applications declined last year to a five year low of 23, from a previous 5 year high in 2009 of 37, the number of NME approvals at 21 was only just below the 5 year average of 22.

What I took from this data (see chart), was the fact that in 2010 the number of approvals as a percentage of applications was the highest in 5 years (91%) as compared to 70% in 2009.  It is too early to tell from this data whether companies are presenting better applications to FDA, or if this data reflects the fact that new products are being terminated if the phase III trial results are not promising.

For the biotechnology industry, the challenge remains that bringing a new product to market is an expensive and risky proposition.  However, it is clear that there are some factors that are likely to be key factors for success, including:

  • Improved understanding of the biology of disease
  • Better clinical trial design
  • More rigorous patient selection criteria
  • Increased time in the phase II stage

As big Pharma scales back R&D funding in favor of shareholder value and baby biotechnology companies struggle with the challenges of whether to grow or sell out, it will be interesting to see how the FDA application/approval data evolves.

 Is there a crisis in the drug development pipeline?

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