I recently attended the Association of Health Care Journalists (AHCJ) annual meeting in Philadelphia. “Health Journalism 2011” offered the opportunity to hear speakers on a wide range of topics.
One presentation that by chance I attended was on what we can learn from Massachusetts, where a law was passed two years ago requiring individual healthcare insurance. Many of the features of the MA law were incorporated into the Affordable Care Act that will impact everyone in the United States.
I have used Storify to aggregate some of the live Tweets from the session, and I hope this captures the essence of what the panel presented.
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).
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.