Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘Drug Development Pipeline’

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.

As those of you who have been following my conference schedule already know, I will be at Health Journalism 2011 in Philadelphia later this week.  The annual meeting of the Association of Health Care Journalists (AHCJ) runs from April 14-17.

It’s my first time at an AHCJ conference, and in my first video blog post I have shared why I am going and what I hope to obtain from the meeting.

Some of the expert sessions that I am particularly looking forward to are on:

Spotting fraud in scientific research (moderated by Ivan Oransky, M.D. executive editor, Reuters Health; blogger, Retraction Watch and Embargo Watch)

Efforts to revive the drug delivery pipeline (moderated by Ed Silverman, editor-at-large, Med Ad News and R&D Directions)

Understanding nanotechnology’s role in fighting cancer (moderated by Eric Rosenthal, special correspondent, Oncology Times)

Best practices in blogging and social media (moderated by Scott Hensley, health blog writer and editor, National Public Radio)

As William Heisel states in an excellent blog post on Reporting on Health, the journalism stars have come out for ACHJ Health Journalism conference in Philadelphia. I am looking forward to an exciting and informative meeting. Hope to see you there.


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