Biotech Strategy Blog

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

Posts tagged ‘BIO 2011’

Biotech Strategy Blog is 1 today!  I can’t believe that a year has gone by so quickly!  Before moving on to year 2, I thought a brief review might be interesting.

What have been the top posts on Biotech Strategy Blog this past year?

In terms of total visitors per post:

  1. Results from NEJM Lucentis v Avastin AMD CATT clinical trial
  2. AUA Results from PIVOT study show no benefit from radical prostatectomy in low risk early stage patients
  3. ASCO 2011 Cabozantinib (XL184) may be an exciting new prostate cancer drug
  4. Merck’s capthepsin-K inhibitor odanacatib in osteoporosis
  5. Update from AACR on new prostate cancer drugs to watch

For those who like metrics:

  • Highest number of reads per month was in May (19,927)
  • Year to date there have been 79,179 visitors
  • Most visited day was September 22, 2011 (2136 reads)

What have been some of the other posts that I enjoyed writing about?

My top 5 (not in rank order) would be:

  1. Alpharadin will be new treatment option for prostate cancer
  2. Patient advocacy session at European Hematology Assocation EHA Congress shows impact of drug adherence on outcome
  3. How nanotechnology may revolutionize the detection of traumatic brain injury using a sensor that changes color
  4. Innovation in Nanotechnology will lead to improved drug delivery, diagnostics & imaging
  5. Insights of the decade

Finally, I have produced 4 videos that you can watch on the biotechstrategy channel on YouTube.

It’s been a busy but enjoyable year. Biotech Strategy Blog is still a work in progress.  If you have enjoyed a particular series of posts or would like me explore a topic or theme in the future, do email me or post a comment.

What is innovation? Like “strategy” and “leadership” it’s a term we frequently use, something we all seek in the biotech/pharma industry, yet it’s hard to define, even harder to develop or predict.

What is the future for innovative medicines in our industry’s pipeline? was the title of a session that I attended yesterday afternoon at BIO 2011, the annual meeting of the Biotechnology Industry Association (BIO) in Washington DC.

BIO 2011 Innovation Pipeline SessionModerated by John Mendlein, the panel contained some R&D heavy weights:

  • Tom Daniel, President of Research & Early Development, Celgene
  • Charles Homcy, Venture Partner, Third Rock Ventures
  • Moncef Slaoui, Chairman R&D, GlaxoSmithKline
  • Doug Williams, Executive VP, R&D, Biogen Idec

Several people in the audience live tweeted the key messages of the speakers, and I encourage you to review them, if interested.  The take homes that I took from this session were:

Innovation can be incremental or major breakthroughs

Many people think of innovation as a major breakthrough. Well worn clichés such as “ground breaking”, “game changing” come to mind.  In pharma, I’d cite imatinib (Glivec®/Gleevec®) in CML as an example.  In the consumer world, the Dyson vacuum cleaner jumps out to me.  Something completely redesigned and made better = innovation.

However, incremental change can also be innovation if it has an impact.  Take a new drug formulation that instead of daily dosing moves it to monthly doses and in the process improves patient compliance and adherence.  That’s incremental innovation.

“Incremental versus major breakthrough” reminds me of scientific research.  Most published papers are incremental, only rarely is there a major paradigm shift and landmark study.  Only a few PhD students undertake truly novel research, instead the majority pursue incremental avenues associated with their supervisor’s interests. An oversimplification perhaps but there’s some truth to it.

Understanding science enables Innovation

Companies should focus their energies on disease mechanisms where the basic science has reached an inflection point of knowledge i.e. there is enough information for us to apply. This is why the work of research organizations such as the National Institutes of Health (NIH) is so important. In an area where there is the disease knowledge emerging, you can then put together a team of people who understand the science and biology of the disease.  This does not guarantee innovation, but allows the identification of opportunities and in my view “enables innovation.”

Innovation will come from focus on molecular pathology of disease

Drug development is no longer focused on treating symptoms but on the underlying mechanism of a disease.  Medicine itself is moving in this direction with personalized medicine and drugs that target specific mutations of genes e.g crizotinib in lung cancer.  In a complex world of overlapping pathways (cancer and inflammation was the example cited), drug development innovation is going to come from understanding the molecular pathology of a disease. The terms “translational medicine” was not used in the session, but this is what comes to mind.  Understanding science is key to success.

What is the future for innovative medicines in our industry’s pipeline? The panelists didn’t actually answer this question directly, but my view is that it is promising.

Everyone at BIO 2011, the annual international convention of the Biotechnology Industry Organization (BIO) is into networking.  Sit next to someone on one of the shuttle buses, in a coffee line or in a meeting hall and a conversation will soon be struck up and business cards exchanged.  Business development, partnering and making connections is what this meeting is really about.

BIO 2011 Networking Delaware BoatWith this in mind, there’s a series of receptions, parties and events that take place around BIO. Yesterday late afternoon, I attended a reception on the Kalmar Nyckel, AKA the Delaware Boat. It is a replica of the tall ship that sailed from Sweden to the New World in 1638, and landed 24 settlers in the Delaware Valley, in what is today Wilmington, DE. Today’s replica serves as Delaware’s goodwill ambassador.  Hosting a reception on a boat made a change from the standard hotel ballroom.

BIO 2011 Reception NewseumIn the evening the official BIO reception took place at the Newseum.  Plenty of food, drinks and music, plus the opportunity to mix, mingle and explore the Newseum. I enjoyed it! You could even try your hand at being a newscaster at one of the interactive exhibits.

This evening I will be at the New Zealand and Italian Embassies for receptions. BIO 2011 – network till you drop!

BIO 2011 Tweetup Old Dominion BrewhouseThe most enjoyable part of Day 1 of BIO 2011 for me was the unofficial tweetup at the Old Dominion Brewhouse.  Who are the people I have been interacting with on Twitter? Some have twitter handles close to their name, others like me are more cryptic. So at a tweetup it’s common to introduce yourself through the language of twitter, “I’m @3NT.”

Meeting up with someone you have had twitter conversations is like meeting up with a penpal (for those who can remember the days when we still wrote letters and didn’t have email, twitter or facebook). In many ways you already know each other and have common interests, so the conversation is easy.  Putting a name to a face is fun.

At the BIO 2011 tweetup yesterday, it was great to meet up with @IAmBiotech, @LacertaBio, @ldtimmerman, @FierceBiotech, @JKureczka, @corytromblee, @christianetrue, @InVivoBlogChris, @lisamjarvis, @jacquimiller (apologies to anyone I missed who was at the tweetup but I didn’t manage to meet).

If you want to plug into biotech social media and hear what the conversation is at BIO 2011, then the Icarus Consultants website is aggregating the hastag #BIO2011 tweets.

I look forward to following on Twitter what’s happening at BIO 2011 today, especially as there are several parallel sessions that I will not be able to attend.


White House Washington DC BIO 2011 Convention © Pieter DroppertOne of the sessions at BIO 2011 in Washington DC that I hope to make if my travel plans permit, is the Monday afternoon session on “What is the Future for Innovative Medicines in Our Industry’s Pipeline?”

The June issue of Nature Reviews “Drug Discovery” attempts to answer this question by looking back at what happened to the R&D projects involving 28,000 compounds investigated since 1990.

Fabio Pammolli and colleagues analyzed the Pharmaceutical Industry Database (PhID) maintained by the IMT (Institutions, Markets, Technologies) in Lucca, Italy.

In their Drug Discovery article entitled “The productivity crisis in pharmaceutical R&D,” they reach a number of conclusions, some of which are:

  • Output of new drugs has not matched investment in R&D
  • Therapeutic innovation has become more challenging and complex
  • Decline in R&D productivity is associated with investments in R&D areas where risk of failure is high
  • There is no evidence of any R&D productivity differences between United States and Europe.

The authors analyzed R&D investment decisions by looking at the potential pay-off for an R&D project (probability of market launch multiplied by potential market value) and the expected Probability of Success (POS) in reaching the market based on the average success rate of compounds with the same pathology.

What I found interesting in their paper was the fact that many of the therapeutic areas with the highest percentage of R&D projects had the lowest average POS e.g. cancer drugs (antineoplastic and immunomodulating agents) had the lowest POS (1.8%) and the highest share of total projects (21.77% from 1990 to 1999, increasing to 29.77% from 2000-2007).  The 1.8% average probability of success can be contrasted with 4.19% for musculoskeletal system drugs and 6.64% for dermatologicals.

The authors argue that the data shows a shift towards therapeutic markets with a lower POS. What are the reasons for this? Possible explanations include:

  • Orphan drug development incentives: legislation that provides incentives to undertake drug development for rare diseases (orphan drugs) has led to a shift towards these targets, which by definition have smaller markets.
  • Development of drugs for chronic diseases e.g. Alzheimer’s disease: Collectively these have a POS of 6.88% compared to the acute disease average POS of 8.77%.  85.80% of R&D projects from 2000-2007 were within this category.
  • More research targeting lethal diseases such as cancer and infectious disease, which have an average POS of 5.54% compared to non-lethal diseases, average POS of 9.72%.

The authors conclude from this research that:

“R&D investments tend to focus on new therapeutic targets, which are characterized by high uncertainty and difficulty, but lower post-launch competition.”

This article offers some interesting retrospective analysis, but I am concerned that they may have underestimated the market potential for many rare disease areas where market size cannot properly be quantified.

As Novartis showed with imatinib (Gleevec®/Glivec®), it is possible to build a blockbuster out of a very small, rare market (only 4,500 – 5,000 new diagnoses of CML per year in the United States), creating a new market segment and moving the leukemia from a certain death sentence to a chronic disease that can be easily managed with targeted therapy.

The focus of many biotechnology and biopharmaceutical companies on orphan drug development has been shown to be a valid strategy by Genzyme and others.  Proving you can bring a product to market and obtain some revenue is likely to stimulate more company investment rather than less.

In the run up to BIO 2011 several companies have highlighted their orphan drug strategy, including Oklahoma City based Selexys Pharmaceuticals who announced news about SelG1 in Sickle Cell Disease and Lamellar Biomedical from Glasgow with LMS-611 for Cystic Fibrosis.

I am looking forward to learning more at BIO on how industry experts view the future for innovation within the sector.  Also whether the orphan drug strategy that many biotech companies are now following will pay off given the lower probability of success in rare indications.

All in all, the 2011 BIO international convention is set to be an interesting and informative meeting.  Business cards, comfortable shoes and camera/video – I’m ready!

ResearchBlogging.orgPammolli, F., Magazzini, L., & Riccaboni, M. (2011). The productivity crisis in pharmaceutical R&D Nature Reviews Drug Discovery, 10 (6), 428-438 DOI: 10.1038/nrd3405

One of the “Super Sessions” at the forthcoming 2011 Biotechnology Industry Organization (BIO) international convention is a presentation of the highlights of Ernst & Young’s 25th Annual Biotechnology Industry Report.

The 97 page report, available online, offers a useful summary of metrics around financing, deals and sector performance.

As the report notes, one of the key issues that biotech companies continue to face is access to funding in order to sustain innovation.  Many biotechnology executives I spoke to at the recent American Society of Clinical Oncology (ASCO) meeting in Chicago confirmed how difficult access to capital remained.

The E&Y report confirms this anecdotal evidence. In their report they note that the 80/20 rule that we are all familiar with applied to biotechnology funding in 2010, with 20% of US companies obtaining 82.6% of the capital!

Given this ratio, it’s not hard to see why so many small biotech companies have struggled for funds.  However, what would have been more interesting to learn about is what were the characteristics of the 20% that led them to successfully obtain more than 80% of the funding? In other words what are the learnings for emerging biotech companies seeking capital?

The report also notes that biotech’s share of available VC funding fell from 18% in 2009 to 12.2% in 2010, as VC’s invested in other market segments such as media and technology.  One only has to look at the recent market interest in LinkedIn to see that investing in web 2.0 companies is back in fashion again, although with the subsequent share price drop it might be considered to be a little akin to Tulip mania.

Another key funding point that the E&Y report picks up on, is that many VC’s now invest in tranches with milestone or contingency based payments.  The result of this “risk sharing” is a lowering of available working capital.  The consequence for biotech companies is that less upfront R&D investments can be made. Instead they may be forced to go after fewer indications and not pursue all available opportunities.

Ernst & Young also interviewed several biotech CEOs about how they planned to sustain innovation, and two strategies emerged:

  • Prove that what you are doing benefits patient outcome
  • Do more with less i.e. improve efficiency

They are not mutually exclusive, and as the report points out, these are the challenges faced by all life science companies.

It will be interesting to see at BIO 2011 how industry executives view the current state of the biotechnology industry and how innovation can be sustained.


I am excited to be attending, for the first time, the Biotechnology Industry Organization (BIO) international convention that takes place in Washington DC in just over a week’s time from Monday June 27 to Thursday, June 30th.

This meeting has something for everyone interested in the biotechnology industry whether it be deal making, partnering, licensing, drug discovery or personalized medicine. There are 16 specialized tracks where industry experts provide insight and best practices.

In addition, there are numerous networking and social events plus an exhibit hall that showcases the world’s biotech regions and how they are promoting innovation.

At meetings where there are parallel sessions, I apply “the law of two feet” (thanks to Podcamp for this) that says if you are not getting what you want from the session, it’s OK to walk out and go to another one.

My top 10 sessions at BIO reflect my personal interests in innovation, science and new product development:

Tuesday June 28

  • How will we afford Personalized Medicines?
  • The Biomarkers Consortium: Facilitating the Development and Qualification of Biological Markers
  • Personalized Oncology: The emergence of Personalized Medicine Strategies in Oncology Clinical Development and Deal Making
  • Navigating the New Law on Licensing Biosimilars

Wednesday June 29

  • Lessons from a Mature Public-Private Partnership. The Alzheimer’s Disease Neuroimaging Initiative
  • Emerging Markets. The Future of Growth for Biologics?
  • The Role of Imaging Biomarkers in Early Phase CNS Drug Development
  • The Promise of MicroRNA-based Therapeutics in Cancer

Thursday Jun 30

  • After the Fall. Venture Capital and the Biotech Funding Landscape
  • Regulatory Issues for Tissue Engineered Products

If you have plans to be at BIO 2011 do say hello after one of the sessions or receptions. You can reach me at the meeting via twitter (@3NT).  See you in DC!

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