Biotech Strategy Blog

Commentary on Science, Innovation & New Products

Posts tagged ‘Time to Market’

Using Social Media to recruit for Cancer Clinical Trials

Richard Schilsky in Science Translational Medicine describes the challenges of enrolling patients into ever more complex cancer clinical trials. It is estimated that only 3-5% of cancer patients participate in clinical trials. Can social media be used to overcome barriers to enrollment?

There are many barriers to enrollment such as a lack of incentive by the physician if they can prescribe the drug off-label and obtain reimbursement, the additional legal liability, time required for research documentation and the need to follow human protection requirements such as informed consent and obtain Institutional Review Board (IRB) approval.

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Is there a crisis in the 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).
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.

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How will innovation change the clinical trials process?

The theme for the biotech strategy blog this week is innovation in bringing new drugs and devices to market.  Innovation is the lifeblood of the biotechnology industry and what drives the acquisition of companies for their pipeline by large pharma companies.

Tomorrow I will be at the Innovation in Healthcare Symposium at MIT in Cambridge, MA. See my earlier blog post for further information. I look forward to writing about the Symposium later this week.

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