Biotech Strategy Blog

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

Posts from the ‘VC & Financing’ category

San Francisco JPM16 Day 2It’s Tuesday at the 2016 JP Morgan Healthcare conference in San Francisco (Twitter #JPM16).

Each day of #JPM16 we’re doing a rolling blog post which we’re updating throughout the day with commentary and insights on the company presentations we’re covering.

While we’re not giving a blow-by-blow account, many companies have the slides readily available, we will be commenting on noteworthy news, and what we learn about corporate strategy going into 2016.

For those of you who like to catch up with the final summary of each day’s highlights, you can read yesterday’s Day 1 synopsis here and our interview with Seattle Genetics CEO, Clay Siegall here.

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San Francisco JPM16 Day 1It’s Day 1 of the annual pilgrimage to San Francisco for the JP Morgan Healthcare conference. In light of the success of the daily rolling blogs we’ve done around the conferences we cover, for the first time we’re doing a rolling blog for each day of #JPM16.

Throughout the day (schedule permitting) we’ll be updating the post with commentary around noteworthy news.

Company presentations mentioned in this post include: $PBYI, $CELG, $GILD, $INCY, $SGEN, $MDVN. There’s also commentary on several of the deals announced by Roche, Juno, Novartis, Sanofi, AstraZeneca & Merck.

If you want to follow along yourself, here’s the link to the JPM16 webcasts & conference agenda.

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BIO-CEO-2012-New-York-CityThe 2012 BIO CEO & Investor conference starts today in New York.

The meeting from February 13-14 is being held at the landmark Waldorf-Astoria hotel.

I’m looking forward to seeing some of the iconic hotel features such as the 1893 lobby clock originally produced for the Chicago World Fair.

With Wall Street analysts and investors in mind, the main focus of the 14th annual conference is on publicly traded biotechnology companies.

I expect that a number of the corporate presentations will be webcast, but if you are unable to be in NYC, you can follow the #BIOCEO2012 twitter conversation below:

 

As always, part of the attraction of these events is the opportunity for networking.

Rodman & Renshaw are hosting a party at the Rockefeller Center’s sunken plaza restaurant.

I hope to see you there or at one of the BIO CEO 2012 receptions.

 

Update Waldorf-Astoria Hotel 8.13 am February 13, 2012
I was all set-up with my trusty Zi8 flip camera to record a few clips of Moncef Slaoui’s fireside chat to share with blog readers, but was publicly told off by BIO staff that I could not shoot any video, despite a media registration. The head of media relations for BIO was not readily available when I asked to speak with her about this.

I’m sorry BIO but you’ve lost the plot. There’s no unpublished scientific data at this meeting, no information that is not publicly available, being webcast or being tweeted. If I’m not welcome, I do have other things to do with my time than attend your meeting, write blog posts about, do a video report & tweet about it. #fail

Update Waldorf-Astoria Hotel 8.58 am  February 13, 2012

Waldorf-Astoria-Hotel-Lobby-ClockAfter 20 minutes I have given up waiting for a BIO media rep to talk to about the “no video” policy for this meeting.

If organizations have a specific photo/video policy for a conference they should take the trouble to communicate this beforehand, at registration or prior to a session starts. Nobody bothered to do that at BIO CEO 2012 today. That’s inept organization.

What BIO did communicate by email to those who registered for BIO CEO 2012 in advance was that:

“By registering for this meeting, attendees authorize BIO to use any photographs taken during the Conference, which may be included in promotion materials.” 

BIO could at the same time clearly have indicated any photography/video policy for media or attendees.  They didn’t.

In the absence of any specific instruction otherwise and the fact that all attendees had consented to be photographed, I had no reason to believe that video or photography was prohibited.

What’s more, I shot a video report at BIO 2011 that I am sure the folk at BIO were aware of. I received no complaints about it, and if I shot a video report before it would not be a leap of imagination to expect I might shoot another video report.

Nobody likes to be publicly humiliated or told they can’t do something in a public forum after a session has started.  I certainly didn’t enjoy that happening to me today.

As a result of my experiences at BIO CEO 2012, Biotech Strategy Blog will not be providing any publicity, promotion or coverage of any future BIO event.

I am sorry if this inconveniences any blog readers. However, on reflection, I don’t think it’s a great loss given that there’s no breaking science or clinical trial data presented at any BIO meeting and company presentations are usually webcast or otherwise publicly available.

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.

BioPharm America 2011 Banner

A conference I regretably will not be at, but would have like to have attended is BioPharm America 2011 – 4th International Biotechnology Partnering Conference that is taking place in Boston from today until this Friday, September 9th.

The program overview suggests that it will be an interesting meeting with sessions on personalized medicine, business development and strategy and partnering. On friday there’s a briefing on Regenerative Medicine and Cell Therapy: The Road to Commercialization. If like me, you are unable to attend, you can follow the conversation on twitter using the hashtag #BPA11 (nice and short!).  I noticed there’s already some excellent live tweeting from the event. I’ve added an aggregator below to make it easier to follow or catch up on the news. Just click on the play button to see the tweets:  

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.

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.

BIO-2011-Interational-Convention-Washington-DC

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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Today and tomorrow, Northern California’s Life Science organization BayBio has their annual meeting.  Entitled ‘Powering Global Innovation” it’s a meeting that covers a lot of ground from deal making to partnering, emerging markets and company presentations.

According to their website, they plan to be live streaming to their website.  However, if you are interested in following the Twitter discussion (hashtag #baybio2011), you can do so using the aggregator below – just click on the play button to see the tweets:

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