Biotech Strategy Blog

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

Posts tagged ‘Biotech New Product Development’

The fourteenth annual BIO CEO & Investor Conference takes place next week (February 13-14, 2012) in New York at the Waldorf-Astoria hotel. I will be commuting from New Jersey so will not be experiencing at first hand the charm of staying at this iconic hotel.

BIO-Investor-CEO-Conference-New-York-2012-Waldof-AstoriaThe focus of the meeting is on publicly-traded biotechnology companies, and provides an opportunity for investors, analysts and industry executives to hear company presentations, undertaken one-on-one partnering discussions and listen to pharmaceutical industry leaders present their vision of the future.

Wifi permitting I will be live tweeting from the sessions I attend (@3NT).  I expect others at the conference such as @adamfeurestein to be sharing news and insights.  You can follow the twitter conversation using the (rather long) hashtag #BIOCEO2012.

My focus at the meeting will be on some of the workshops, rather than the company presentations which typically are shared on investor relations websites of publicly traded companies,.  A few that caught my attention include:

Secrets of Oncology Success – Lessons and Trends in Phase II Clinical Trial Outomes

In my opinion, too many companies rush phase II drug development, particularly in oncology.  I recently saw a company go to phase III on the basis of a 14 patient trial.   I will be interested to see what insights the panel offer on what trial designs they liked and which they didn’t and what lessons others can learn from this for new product development.

Speakers in this session include Mohammad Azab, CMO of Astex Pharmaceuticals and Michael Morrissey, CEO of Exelixis.

Neurology: “Alz” Well that Ends Well – Settling the Beta-Amyloid Debate

I doubt very much that this program will settle the debate over the amyloid hypothesis of Alzheimer’s disease, and whether this presents a “real” drug development target.  The challenge in this area is that by the time amyloid deposits can be imaged in the brain, the damage has already been done.

The amyloid load seen in the brain is also only loosely related to cognitive decline, suggesting that even if a therapeutic were able to remove plaque from the brain, it might not alleviate the symptoms of cognitive decline.

Drugs may need to target earlier stages of the disease such as synaptic decline, before beta-amyloid buildup is suggested.  Synaptic proteins have been suggested as a target.

I look forward to hearing the panels views on the current state of Alzheimer’s drug development and what the emerging targets may be.

The 2012 BIO CEO & Investor conference looks to be an interesting meeting in New York next week. If you are attending do let me know as it would be good to meet up if the opportunity presents.

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

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