Biotech Strategy Blog

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

Posts tagged ‘Time to Market’

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.

There’s also the issue of equipoise, the uncertainty as to whether a new treatment will be beneficial or not and the need to discuss with a patient their willingness to accept the risk that a new treatment may offer less benefit than the current standard of care. This topic is beyond the scope of this post.

Schilsky notes in his commentary that:

“trial start-up times have lengthened to an average of 2 years or longer, up to 40% of cooperative group phase III trials have failed to complete accrual and closed without achieving study endpoints, wasting the contribution of those patients willing to enroll in the trial.”

Time to market is key to the success of biotechnology and pharmaceutical industry, with product life governed by patent years. Delays in time to market have a real ROI impact, and may lead to promising products being discontinued prematurely.

One of the barriers to enrollment noted in Schilsky’s highlights is “insufficient patient awareness/demand.” Can social media play a role in overcoming this?

To look at what is happening currently, I used Storify, a new tool that allows you to create stories using social media:

http://storify.com/3nt/using-social-media-to-recruit-for-cancer-clinical-

Reference

ResearchBlogging.orgSchilsky, R. (2011). Accrual to Cancer Clinical Trials in the Era of Molecular Medicine Science Translational Medicine, 3 (75), 75-75 DOI: 10.1126/scitranslmed.3001712

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.

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.

One experienced industry professional recently told me that he believed the Ipad would revolutionize the clinical trials process.  Do you agree? On reflection, I think the IPad and similar tablets will make the clinical trials process more efficient, but is this an innovative breakthrough that will revolutionize the model? I am not so sure.

At this year’s Consumer Electronics Show in Las Vegas, analysts talked about the 80-100 new tablet computers that were on show, and the fact that an estimated 50 million e-books and tablets will be sold in 2011.  Companies have clearly innovated in bringing new technology to market, that we now have a desire for and want to use.

Health Professionals have embraced the IPad, it’s ease of use, portability and potential for a range of uses from data entry, to the viewing of medical images and access to online reference databases.  In the hospital environment, it can easily be integrated into the IT infrastructure and made HIPAA compliant if no data is stored on it.

For clinical trials, it is already being as an electronic data capture (EDC) interface for case report form (CRF) data entry, although I am not sure whether it will become the primary interface. My expectation is that IPads and similar tablets will increasingly be used as a portal for accessing study resources, the ordering of supplies, recording of adverse events and even the signing of patient informed consents.

I also expect we will see IPads being given to patients for clinical trial diary and journal entries. What’s more by using these devices with 3G wireless capability, study coordinators will be able to interact in real-time with patients, remind them of study visits and monitor medication compliance. Mobile health is set to be a real growth area.

On the medical imaging side, results from a clinical trial published at the Radiological Society of North America (RSNA) annual meeting last December showed that radiologists viewed the IPad imaging quality as equal or superior to standard LCD displays when viewing X-rays. (Erik Ridley wrote up a good post about this on AuntMinnie.com).

Reviewing X-rays to screen for TB is a lot different from diagnostic imaging in clinical trials, so I remain unconvinced that the IPad will take over for primary diagnosis, and central review of images is still going to be the gold standard.

What I think the IPad and other tablet computers will do is allow the easy sharing of images between the central review laboratory, investigators and study coordinators. This will make it easier to monitor patient inclusion, study progress and report imaging results.

So looking at the above, while I think the IPad is an innovation, I don’t necessarily think it will revolutionize clinical trials and bring products to market faster.  It will be interesting to see what industry professionals have to say at the Drug Information Association (DIA) annual meeting later this year.

What are your thoughts on how innovation will change the clinical trials process in the biotechnology industry? How can we bring products to market faster?

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