Understanding the biology of colorectal cancer will lead to more rational drug development

Cancer drug development is becoming more targeted and focused as a result of scientific advances.  The understanding of ALK gene rearrangements in lung cancer led to the development of crizotinib (Xalkori) for the subset of patients who are ALK-positive.

Sally Church, Ph.D on Pharma Strategy Blog has reviewed some of the recent advances in our understanding of colororectal cancer (CRC).

Resistance to chemotherapy in colon cancer

The transcription factor AP-2 epsilon (TFAP2E-DKK4) appears to be responsible for some of the resistance to chemotherapy that occurs during colon cancer.

As Sally noted, “the presence of the TFAP2E-DKK4 mutation may explain why some patients with colorectal cancer do better with chemotherapy than others.

Inflammation linked to the early development of colon cancer

Researchers from MD Anderson Cancer Center have identified the role of inflammation and silencing of tumor suppressor genes in early colorectal cancer.

Understanding the biology of the disease could lead to the ability to identify those at high risk of developing colon cancer. Chemopreventative drugs could then be given to this subset of high risk patients to delay the onset of cancer.  An exciting prospect!

Understanding the role of CIMP in early colorectal cancer

CpG island methylator phenotype (CIMP) can occur in 30% of colorectal cancer patients and has been shown to be an independent predictor of survival with 5FU in early or adjuvant CRC.   CIMP may play an important role in tumor development. Expect to hear more on the link between inflammation, DNA methylation and early development of CRC.

Identifying subsets of patients will support rational drug development

Researchers have now shown that BRAF(V600E) mutations occur in 8-10% of colon cancers. The ability to identify this subset of patients could allow therapeutic options to be specifically targeted at them, in the same way that ALK+ lung cancer patients now receive crizotinib.  Previously though, we didn’t know why vemurafenib was showing lack of efficacy in this group. New research has now given us some pointers.

As Sally noted on Pharma Strategy Blog, “a combination of vemurafenib and and an EGFR inhibitor such as as erlotinib, cetuximab or gefitinib, might be a useful clinical approach to try therapeutically in patients with colon cancer harboring the BRAFV600E mutation.”

As we learn more about the biology and early development of colorectal cancer, the ability to undertake rational drug development will increase.  This is good news both for patients and for biotechnology and pharmaceutical companies who want to successfully bring new products to market.

Pharma Conference Coverage Strategy

We live in a world of data that threatens to overwhelm our work and personal lives.  Part of the reason for this is the price of data storage continues to fall dramatically.

Today, an external hard drive offers a 1TB capacity; a few years ago the same product offered 100GB.  A 10x increase in storage capacity for the same money in the space of a few years.

Data is now available from online posters, abstracts, webcasts and presentations. We also have Facebook, Twitter, Linkedin and other social media competing for our time.

ASCO 2011 Conference Chicago 300x225 Pharma Conference Coverage StrategyASCO 2011: “the never ending walk”

What this means is that if you plan to attend a major medical or scientific meeting such as the annual meeting of the American Society of Clinical Oncology (ASCO), which offers a lot of data, you need to have a conference coverage strategy.

Here are a few tips we suggest you consider:

Don’t go for a “Data Dump”

Too often we see a “fear of missing out” (FOMO) mentality drive a “we must capture everything” policy.  All this results in is a mass of data that somebody has to analyze after the meeting.  Too often a 300+ page data dump report (when it finally is produced) ends up sitting on the metaphorical shelf.

Focus on Key Questions

Prior to a major medical or scientific meeting it’s important to develop a list of the key questions that a brand, commercial or new products team need answered.  The questions could be on competitor activity, developments in a pathway or impact of clinical data on the standard of care.  Data collection can then be focusoned on answering those key questions.

Insights cost more

Recently, staff at a top 20 pharma company told us they were paying $X for a conference “data dump” but only had 10% of $X available for strategic insights.  In Twitter speak, they had #LostThePlot as it should be the other way round since insights are more valuable than raw data.

As management consultants, we might produce a Powerpoint slide with a table or chart based on data from 20 posters. In order to select those 20 key posters, we could have reviewed perhaps 200 posters originally.  Which would you rather have, one slide with insights and analysis or 200 Powerpoint slides with data? Our philosophy is “less is more.” 

Insights cost more because it takes in-depth therapeutic area knowledge and expertise to condense data into a meaningful story and make strategic recommendations.

What is your conference coverage strategy for this year? Please contact us if you would like to learn more about our capabilities.

BOLERO-2 clinical trial of Everolimus in Advanced Breast Cancer

SABCS 2011 San Antonio river walk by night 300x225 BOLERO 2 clinical trial of Everolimus in Advanced Breast CancerUpdated results from the BOLERO-2 (breast cancer trials of oral everolimus) were presented at the recent San Antonio Breast Cancer Symposium (SABCS).

José Baselga had previously presented the impressive results at ECCO/ESMO 2011 in Stockholm.

As Sally Church noted on Pharma Strategy Blog in her second update on “what’s hot at SABCS”:

“The trial data presented by Dr Gabriel Hortobagyi (MDACC) confirmed that the responses continue to be durable, with an improvement in PFS with the combination arm now up to 11.0 months, up from 10.6 months at ECCO. The results for the exemestane control arm remained at 4.1 months.”

The extra 6.9 months of survival benefit shown with exemestane plus the mTOR inhibitor everolimus is good news for advanced breast cancer patients.

One of the problems associated with aromatase inhibitor (AI) therapy in breast cancer is that patients develop resistance over time.  As Sally notes,

“The rationale behind this trial is that mTOR is a known cause of resistance to AI therapy, so the combination targets both the estrogen receptor and mTOR adaptive resistance pathway.”

You can read more on Pharma Strategy Blog about the BOLERO-2 trial presented at the San Antonio Breast Cancer Symposium and why this was a rationally designed study based on solid science.

Memories of 9/11

Sally Church Kite Flying Liberty Park WTC in Background 225x300 Memories of 9/11Those of us who lived around New York City ten years ago will never forget the sight of the World Trade Center towers coming down. It is forever indelibly etched in our minds.

Many of us had dined at “Windows on the World” or been to the Observation Deck and watched light aircraft flying along the Hudson, below us. Many knew people who did not make it out.

It is a trauma that we will never forget, and Sept 11 is a day of remembrance. However, life is a journey and we must look forwards not back.

Icarus Consultants closed on Labor Day

Bidston Hill Windmill © Pieter Droppert 225x300 Icarus Consultants closed on Labor DayAfter all the “excitement” of hurricane Irene last week in the New Jersey/New York metro area, this weekend offers the Labor Day holiday. It is to many the last hurrah of summer.

According to the United States Department of Labor, the public holiday on the first Monday in September pays tribute to the American worker, “creator of so much of the nation’s strength, freedom, and leadership.”

Economic prosperity and access to healthcare are very much linked with employment in the United States, so it is sad to see the recent poor job creation results.

Icarus Consultants will be closed on Monday, September 5 and will reopen for business on Tuesday. We wish all our current and prospective pharma and biotech consulting clients an enjoyable weekend.

Is the current model of cancer drug development sustainable?

hi CC221 150x150 Is the current model of cancer drug development sustainable?Source: NIH

Sally Church on Pharma Strategy Blog has published a thought-provoking piece that discusses why targeted and focused new therapies will lead to higher rather than lower costs of drug development.

Cost drivers include the need to develop biomarkers, undertake more translational medicine and the potential use of combination therapies.

Sally highlights the cost of recently approved drugs such as Yervoy, Adcetris and Zelboraf as examples of how costs are increasing, not decreasing.

Contrary to the opinion of Harpal Kumar, CEO of Cancer Research UK, Sally believes that:

“specialized treatment based on the underlying biology will ultimately cost more, not less, in the long run in terms of research and development, diagnostics/biomarkers and treatment costs of every smaller subsets.”

Is this sustainable in the long-run? Industry, government and payors have yet to tackle this issue.  It’s a problem that is not going away.

You should read Sally’s thought provoking op-ed on “the spiraling costs of cancer research and treatment” on Pharma Strategy Blog.

Boston – Cambridge, Massachusetts is the leading East Coast Biotech Region

Pieter Droppert recently spent a few days in Boston and Cambridge, MA. On Biotech Strategy Blog, he outlines three factors that make these two cities stand out as a biotechnology region.

Icarus Consultants is frequently in Boston/Cambridge visiting clients and undertaking business development, so do contact us if you are interested in meeting up.

Pieter has produced a short 2 minute video based on his “Letter from Boston” blog post, that you can watch below:

Regenerative Medicine – what does the future hold?

At Icarus Consultants we are often asked to look at emerging new products, companies and identify market trends.  Innovation and new product development is driven by the application of basic scientific research.

Regenerative medicine is in its infancy but a marketspace worth watching.

Pieter Droppert on Biotech Strategy Blog has looked at some of the latest developments associated with regenerative medicine and tissue engineering:

Can we rebuild the $6M man?  This post highlights work from the laboratory of D. Kacy Cullen at the University of Pennsylvania.  Dr Cullen’s lab is researching the ability to repair damaged nerves and interface the electrical controls of a prosthetic limb with the human nervous system.

Tissue Engineered Human Trachea Transplant.  This post discusses the announcement last week of a tracheal transplant using a nanomaterial covered with the patient’s own stem cells (to avoid rejection).

Whether we will be able to completely rebuild our bodies as we get older remains to be seen but there is a lot of exciting research that suggest we will be able to replace or repair a lot of body parts.

The potential healthcare savings and improvement in quality of life are enormous.  We expect to see emerging commercial opportunities in regenerative medicine and tissue engineering.

Impact of Video on Pharma Marketing Strategy

Have you noticed that when you search for something on the web, the results now frequently contain videos to watch?

We at Icarus Consultants believe this trend towards video based information is set to continue.

It is perhaps not surprising given that anyone can easily shoot video on a home computer or iphone. Storytelling using video and audio is simply more engaging than just reading.

I don’t think it will be too long before we see more pharma/biotech companies with their own channels on YouTube and other social media platforms. The advantage of video is that once it has been uploaded to YouTube or Vimeo, it can easily be embedded or shared on other sites such as Facebook.

As Sally Church noted on Pharma Strategy Blog when discussing Antibody Drug Conjugates, video lends itself well to physician education and discussing complex mechanisms of action.  However, she notes that pharma and biotech companies still “have a long way to go yet in terms of how they can help improve learning about the science behind new cancer treatments.”

To enhance our video capabilities, Pieter Droppert recently spent 5 days on the Columbia Journalism School Digital Media Boot Camp.

He wrote a daily report about his experiences on Biotech Strategy Blog.

The boot camp took participants through the production of a video project from camera technique, composition, framing, lighting to shooting video and editing in Final Cut Pro.

You can watch Pieter’s course project on the smoking ban in New York City parks below:

Pieter Droppert quoted in LA Times Story on US Supreme Court Pharma Marketing & Data Mining case

LA Times Pieter Droppert quoted in LA Times Story on US Supreme Court Pharma Marketing & Data Mining caseIt is always a pleasure to be recognized by others. Pieter Droppert’s writing on Biotech Strategy Blog was recently quoted by the Los Angeles Times, alongside Pharmalot’s Ed Silverman, in a story about the Sorrell v. IMS Health case heard by the United States Supreme Court earlier this week.

Pieter is a 2005 graduate of Rutgers School of Law-Newark and recalls that the constitutional theory class he did was one of the most demanding! His post on Biotech Strategy Blog earlier this year, “US Supreme Court to decide whether Vermont can control the use of prescribing data by IMS Health and Pharma companies” was also linked to by the Cornell University Law School Legal Information Institute.

The attempt by the State of Vermont to regulate the use of pharmacy prescribing data and restrict its use for pharmaceutical marketing and sales is something that Pieter has followed on Biotech Strategy Blog.  Earlier this week he wrote a preview on the Supreme Court oral argument in Sorrell v. IMS Health and what he thought the Justices would focus on.

His analysis of Tuesday’s oral argument that focused on First Amendment rights and commercial free speech, is that Vermont appear unlikely to prevail and that the law restricting access by data mining companies such as IMS Health will not be upheld.

This is good news for the U.S. pharmaceutical industry that is facing increasing challenges in obtaining access to physicians for sales and marketing.