Biotech Strategy Blog

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

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Like the Battle of Britain, the cancer immunotherapy landscape is a dynamic one where tactical decisions can make the difference between “winning” and “losing.”

As Bristol Myers recently found out in first-line NSCLC, if you choose the wrong trial design or adopt an overly-aggressive strategy, you can end up losing badly (see post: Detailed thoughts on BMS CheckMate 026 1L trial in NSCLC)

A recent trip to the operations bunker at former RAF Uxbridge, from where the fighters of 11 Group were directed, shows how close we came to losing the Battle of Britain.  Had the German Luftwaffe continued to target RAF airfields instead of diverting their efforts on London, the outcome of the war is likely to have been quite different.

History provides a valuable lesson that strategy and tactics can and do matter; in R&D the targets you choose and how effectively you execute on a plan can make a big difference to outcome.

Battle of Britain Bunker Plot

Pictured: the RAF 11 Group Operations plot as it looked on September 15, 1940.

In Part 2 of the BSB interview with PsiOxus Therapeutics CEO Dr John Beadle, we discuss corporate strategy, and some of the challenges faced by an emerging Biotech company, many of which are likely to be shared by other small companies in the field.

Subscribers can login to read more or you can purchase access.

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 Yonhap news agency announced today that the South Korean equivalent of the FDA had approved Il-Yang pharmaceuticals radotinib (brand name Supect) for chronic myeloid leukemia (CML).  Radotinib is a tyrosine kinase inhibitor, also known by its development code of IY5511.

I briefly mentioned radotinib in my CML update from the ASH 2011 annual meeting.

The Yonhap release quotes an official at the Korean Centers for Disease Control and Prevention (KCDC) as saying that:

“It will be used on patients who have become resistant to existing drugs such as Gleevec, Tasigna and Sprycel.”

While its use in Korea appears to be in second or third line & non-responding patients, the Yonhap release states that “Il-Yang have started additional clinical trials in South Korea, India, Thailand and Indonesia,” and the intention in those countries appears to be directed to front line use.

No mention is made of China or Brazil, but the fact that Il-Yang are focusing on the emerging markets of Asia, does not rule out that this drug might finder wider use outside of the countries where clinical trials have taken place.  I could certainly see generic companies interested in potential licensing opportunities.

Details of the price of Supect (not a name I particularly like, I have to say – suggests “Suspect” but I am sure the name translates better in other languages) are unknown. Il-Yang are quoted in the Yonhap release as saying that it will be priced cheaper than existing CML drugs.

Could Supect be a competitor to Ariad’s ponatinib? I am sure there will be more information released as to which mutations it targets, but it’s a product that has largely flown under the radar.  I have not seen any presentations at recent EHA or ASH annual meetings.  Even if it is more closer to imatinib than ponatinib in terms of efficacy, its launch may have an impact on the future ponatinib pricing strategy.

Will Novartis and BMS compete on price in Korea and other Asian markets? It will be interesting to watch whether they see Supect as serious competition.  With the prospect of generic imatinib in a few years time, radotinib may have just made it to market in time.

Although I had to leave BIO 2011 early due to illness, I did shoot some video during the time I was at the meeting, and have now put this together into a short 2 minute video that you can watch below.

This post wraps up my coverage of the 2011 BIO international convention in Washington DC. Next week, I’ll be writing more about innovative science and new products in the pipeline that have caught my attention.

A happy holiday weekend to everyone in North America.

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-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:

I wrote last week about Second Sight’s European Marketing Approval for the Argus II “artificial retina”.  What this news also stands for is the success of collaboration as a route to innovation.

The Artificial Retina Project (“Restoring Sight through Science”) through which Argus II was developed is a collaborative effort between six United States Department of Energy (DOE) research institutions, 4 universities and private industry.

Each offers unique scientific knowledge and specialist expertise, without which it is unlikely the project (that is continuing with the development of a more advanced Argus III artificial retina) would have been successful.

I’ve listed the collaborators below and as recorded on the DOE website, what they bring to the Artificial Retina Project.

DOE National Labs:

  • Argonne National Laboratory – Performs packaging and hermetic-seal research to protect the prosthetic device from the salty eye environment, using their R&D 100 award-winning ultrananocrystalline diamond technology.
  • Lawrence Livermore National Laboratory (LLNL) – Uses microfabrication technology to develop thin, flexible neural electrode arrays that conform to the retina’s curved shape. LLNL also uses advanced packaging technology and system-level integration to interconnect the electronics package and the thin-film electrode array.
  • Oak Ridge National Laboratory – Measures the effect of increasing the number of electrodes on the quality of the electrical signals used to stimulate the surviving neural cells in the retina.
  • Sandia National Laboratories – Develops microelectromechanical (MEMS) devices and high-voltage subsystems for advanced implant designs. These include microtools, electronics packaging, and application-specific integrated circuits (ASICs) to allow high-density interconnects and electrode arrays.
  • Brookhaven National Laboratory – Performs neuroscience imaging studies of the Model 1 retinal prosthesis.

Universities:

  • Doheny Eye Institute at the University of Southern California – Provides medical direction and performs preclinical and clinical testing of the electrode array implants. Leads the Artificial Retina Project.
  • University of California, Santa Cruz – Performs bidirectional telemetry for wireless communication and chip design for stimulating the electrode array.
  • North Carolina State University – Performs electromagnetic and thermal modeling of the device to help determine how much energy can be used to stimulate the remaining nondiseased cells.
  • California Institute of Technology – Performs real-time image processing of miniature camera output and provides optimization of visual perception.

In October 2004, Second Sight Medical Products and the DOE signed a Co-Operative Research and Development Agreement (CRADA) in which the above institutions agreed to share intellectual property and royalties from their research, with Second Sight chosen to be the commercial partner.  As part of the CRADA, Second Sight obtained a limited, exclusive license to the inventions developed during the DOE Retinal Prosthesis Project.

You can find more information about the history of this fascinating project on the Artificial Retina Project website, that also has links to several patient stories from around the world.

The Artificial Retina Project is a case study on the success of collaboration.  Whether such an ambitious project that was funded by the US Government would ever have taken place in the private sector is the question that comes to my mind?  Would a private company have been able to harness the intellectual power of 10 research institutions in this way?

If not, then do governments have a role to play in biomedical innovation by drawing partners together so that advances in basic research can be applied to new products, whether they be new drugs or novel devices?

And if you agree that governments do have a role to play what should be the extent of government funding?  In the case of artificial retina, the DOE has funded this since 1999, with its contribution rising from $500K to $7M per year. Those numbers may also be direct costs, and not reflect the cost of investments in buildings, research facilities etc.

I’d be interested in any thoughts you would like to share on this.

I was recently in San Francisco so thought I would continue my theme of writing about biotechnology regions that I visit around the United States.

Growing up in England, I remember listening to the radio broadcasts of the late Alistair Cooke, who from 1946 to 2004 shared his “Letter from America“; the longest running radio programme ever produced.  In the pre-internet era his mixture of anecdotes, insights and reflections reminds me of modern day blogs.

San Francisco remains a favorite city of mine. Fueled by access to venture capital and proximity to major research universities such as Stanford, University of California at Davis, Berkelely & San Francisco, start-up companies continue to thrive in the Bay area. BayBio, Northern California’s Life Science Association runs many excellent events. Their annual conference in April is focused on “Powering Global Innovation.”

The anchor tenant in the San Francisco biotech mall remains Genentech, and no other company in the area has had the same growth trajectory.  What catapults a company forward is a combination of a breakthrough product and ability to capture its value. The licensing deals and acquisitions we see today in the biotechnology industry, to some degree limit the ability of emerging biotech companies to repeat Genentech’s model. Risk sharing, partnering and the desire of venture capitalists for an early return on investment, all limit the ability of a biotech company to make it to the major leagues. In the end, even Genentech ended up being acquired by Roche.

What’s the future in San Francisco? It remains a high cost place to live but with a pool of talent in the entrepreneurial culture of the West Coast. There is also the uncertainty about the California economy and the cost of doing business, which is most likely set to increase.  In some way, my impression is that San Francisco has not quite taken off as a biotechnology city in the same way that Boston and Cambridge has. Feel free to comment if you disagree or have an opinion otherwise.

Earlier this month the Michael J Fox Foundation (MJFF) announced that Vancouver based Allon Therapeutics had been able to improve motor function and brain pathology in a mouse model of Parkinson’s disease (PD).

MJFF funded this research with Allon Therapeutics. The preclinical study results are published in the Journal of Molecular and Cellular Neuroscience.

What makes this data interesting is that it adds further support to the potential efficacy of the company’s lead product, davunetide, in a wide range of neurodegenerative disorders.

Davunetide (AL-108) is a microtubule-interacting peptide based on an eight amino acid sequence, Asn-Ala-Pro-Val-Ser-Ile-Pro-Gln, single letter code NAPVSIPQ (NAP) derived from activity-dependent neuroprotective protein (ADNP). It has been shown to have neuroprotective properties.

Davunetide can be administered by IV or intranasally and crosses the blood/brain barrier. It is effective at promoting neurite growth, restoring transmission between nerve cells and untangling some of the damage seen in neurodegenerative disorders such as Alzheimer’s disease. References to the scientific publications and mechanism of action can be found on the Allon Therapeutics website.

Currently it is being developed for Alzheimer’s disease (AD), schizophrenia cognitive impairment and frontotemporal dementia (FTD). Davunetide is in a phase 3 clinical trial for progressive supranuclear palsy (PSP), a subtype of FTD.

The company’s strategy is to pursue a fast-track to market in a small indication such as PSP. This is makes a lot of sense for a small biotechnology company with limited funding.  Successful approval in PSP will significantly increase the value of the company and improve the terms of any future licensing/partnering deals.

The hope for davunetide is that it will prevent disease progression in disorders such as AD and provide neuroprotective prophylaxisis prior to surgery that carries a high risk of memory loss e.g. heart bypass and coronary artery graft surgery (CABG).

While davunetide may not be a cure for AD, being able to slow down disease progression is something that has considerable value.  Given that new imaging biomarkers are likely to provide the opportunity to detect AD much earlier, the market opportunity for early treatment is set to increase.

Many families and caregivers would welcome a drug that delays further cognitive decline and memory loss in their loved ones.

On the basis of the promising preclinical results, I think we can expect to see further clinical research on davenutide in Parkinson’s Disease.

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