Biotech Strategy Blog

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

Posts from the ‘Imaging’ category

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.

http://youtu.be/nDvY7opm3Fs

http://youtu.be/_oAJ1fU0PT4

http://youtu.be/hM_wmjaqDyc

http://youtu.be/i5GNBmuISqQ
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.

I will be flying to Stockholm next week for the European Multidisciplinary Cancer Congress (twitter #EMCC2011), more commonly known as ECCO or ESMO 2011.

What are the sessions that look interesting at the meeting? I previously wrote about the phase III ALSYMPCA trial data for Alpharadin that will be presented as a late breaking abstract.

In addition, the best abstract at ECCO 2011 is on vismodegib in basal cell carcinoma.  Sally Church on Pharma Strategy Blog has written extensively about the hedgehog pathway and role of smoothend inhibition in the treatment of cancer.

What else has attracted my attention at ECCO 2011 in Stockholm? In looking at the preliminary program I was struck by the large number of scientific symposia throughout the meeting. However, many occur at the same time! On Saturday 24th two in particular caught my attention:

Molecular Imaging of Hypoxia

Nanotechnologies for Targeted Drug Delivery

Having written about hypoxia and nanotechnology on this blog, I will probably go to one of those two sessions.

Later in the conference, there is another block of scientific symposia on Monday 26th, again all at the same time! Several that look particularly interesting include:

  • How to understand and to Reverse Drug Resistance in Metastatic Breast Cancer
  • From New Targets to New Drugs in Prostate Cancer
  • Tailoring Personalized Medicine for the Future
  • The Role of IGFs/IGF-1R Pathway in Paediatric Malignancies

And in case one still hasn’t had enough science, there’s another group of scientific symposia on the final day of the conference on Tuesday, 27 September including:

  • Unravelling Ras PI3 Kinases Targets 
  • PARP inhibiting strategies: from Molecular Mechanisms to Rational Clinical Applications

I expect Stockholm to be expensive, they jokingly say you can buy a brewery in America for the price of a beer in the city, but it looks like there’ll be some interesting news and scientific data from the meeting. Hopefully I’ll have a few hours sometime to see something of what looks like a stunningly beautiful city.

If you plan to be in Stockholm do let me know. I can be reached via twitter (@3NT).

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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The highlight of the recent Association of Health Care Journalists (AHCJ) annual meeting in Philadelphia (Health Journalism 2011) for me was the presentation by Kacy Cullen from the Center for Brain Injury and Repair in the Department of Neurosurgery at the University of Pennsylvania.

© Kacy Cullen, University of Pennsylvania

Dr Cullen presented his research on blast-induced traumatic brain injury (bTBI) and the development of a nanomaterial containing photonic crystals that change color upon exposure to blast pressure.

In the same way that a radiation dosimeter badge records exposure to cumulative radiation for a hospital worker, so a helmet-mounted color badge would change color based on a soldier’s exposure to blast pressure; a common occurrence with improvised explosive devices (IED).

In a paper published in NeuroImage, Cullen and colleagues describe in detail a blast-injury dosimeter (BID) made from photosensitive polymers that is like a colored sticker.  This nanomaterial contains microscopic, diamond-like photonic crystals, whose ability to refract light is damaged in a precise way by the pressure from explosive blasts.

The result is a change in color that is related to the degree of pressure and blast intensity. What’s more because the photonic crystals are structurally damaged by the blast, further exposure leads to more widespread microstructural alterations and a further change in color.  In essence, the crystals have a memory for cumulative blast exposure.

Why is this important?

Many soldiers are exposed to blasts, but show no overt symptoms of traumatic brain injury.  Research has shown that repeated hits to the helmet of a football player can lead to brain injury without the obvious signs of a concussion.  Traumatic brain injury as a result of repeated exposure to blasts may also lead to mild cognitive impairment and the possibility of increased risk for dementia, Alzheimer’s disease later in life.  This has been seen in NFL players.

The research by Cullen and colleagues is still in the early stages of development.  In their paper they acknowledge some of the next steps such as calibrating the color changes to levels of blast exposure, and correlating these with traumatic brain injury.  Any blast injury dosimeter will also need to be field tested.

However, this work is promising and an example of how nanotechnology may impact the detection and diagnosis of those soldiers at risk of traumatic brain injury.

War related scientific research often leads to civilian applications. In the future, I could see nanotechnology stickers that change color with cumulative impact on the helmets of NFL, college or high school football players.

You can read more about this innovative research on how color changing photonic crystals detect blast exposure in the journal NeuroImage.

Update June 30, 2011

If you are interested in the exciting and innovative research being undertaken by Kacy Cullen and his team, there is now a website for The Cullen Laboratory and their work on Neural Engineering in Neurotrauma.

ResearchBlogging.orgCullen, D., Xu, Y., Reneer, D., Browne, K., Geddes, J., Yang, S., & Smith, D. (2011). Color changing photonic crystals detect blast exposure NeuroImage, 54 DOI: 10.1016/j.neuroimage.2010.10.076

Changes in brain structure, function and molecular processes occur several years before clinical symptoms of Alzheimer’s disease (AD) become apparent.

The big question then, is can you detect patients who are cognitively normal, but will go on to develop AD before they show symptoms, i.e. pre-symptomatic patients?  The answer is “Yes” according to results published in the April 19, 2011 issue of Neurology by Brad Dickerson and colleagues.

In this small study, the team of researchers from two centers (Massachusetts General Hospital and Rush University in Chicago) followed a small sample of cognitively normal (CN) subjects over time with magnetic resonance imaging (MRI) and then sought to identify what structural changes had taken place in those subjects who were initially cognitively normal, but went on to develop AD, on average 11.1 years later.

The researchers found that changes in brain cortical thickness were associated with AD:

AD-signature cortical thinning in CN-AD converters in both samples was remarkably similar, about 0.2 mm (p < 0.05)

They concluded that:

By focusing on cortical regions known to be affected in AD dementia, subtle but reliable atrophy is identifiable in asymptomatic individuals nearly a decade before dementia, making this measure a potentially important imaging biomarker of early neurodegeneration.

Some of the limitations of this research and questions that come to mind are:

  • Small sample size: only 8 individuals who developed AD and 25 in the cognitively normal control group.
  • Reproducibility: the 0.2mm difference seen is small and the extent to which other centers may be able to reproduce this measurement is uncertain
  • Accuracy of detection: in any screening tool the issue of false positives and negatives arises i.e. in a larger sample size will there be a margin for error that results in some people being included in the pre-symptomatic AD group, when they may be normal?  Also will the proposed measurement remain valid in a large population of patients with other disease symptoms and chronic illnesses?
  • Validity of biomarker: are the changes in cortical thickness causally linked to AD or just an incidental correlation i.e. is this a valid biomarker?

Brad Dickerson in the excellent Neurology podcast available with this publication clearly sees this currently as a research tool, especially given the requirement for considerable computer power to make these types of cortical measurements in the brain.  The podcast interview is well worth listening to.

The MRI biomarker proposed by Dickerson is therefore not something that is really applicable to screen the general population at the moment.

However, the promise from this and other biomarker research is that at some point in the not too distant future we will be able to detect those at risk of developing AD. Those patients could then be given neuroprotective drugs that may delay the onset of the clinical symptoms of AD such as memory loss and cognitive impairment.

Biomarkers that identify those at risk of developing AD will also be useful as inclusion and screening tools for clinical trials of drugs aimed at slowing disease progression in pre-symptomatic patients.

Alzheimer’s disease has been called “The challenge of the Second Century,” we still have a long way to go before this is overcome.

Story Source:  BBC Health

ResearchBlogging.orgDickerson, B., Stoub, T., Shah, R., Sperling, R., Killiany, R., Albert, M., Hyman, B., Blacker, D., & deToledo-Morrell, L. (2011). Alzheimer-signature MRI biomarker predicts AD dementia in cognitively normal adults Neurology, 76 (16), 1395-1402 DOI: 10.1212/WNL.0b013e3182166e96

It’s a busy day of science at the 102nd American Association for Cancer Research (AACR) annual meeting in Orlando, You can follow what’s happening on twitter, #AACR.  Pharma Strategy Blog has an excellent “Cover it Live” widget that shows everyone’s #AACR tweets. It allows you to go back in time, so you can see what happened earlier.  AACR also has some excellent webcasts and podcasts from the meeting.

However, what caught my attention this morning was the launch of a new journal, Cancer Discovery; preview copies were handed out to attendees at the plenary session this morning.

In a world where we are already overwhelmed by data, publications and sources of information, why is this journal both important and worth reading?

Firstly, this team has a distinguished group of editors, Lewis Cantley, PhD and José Baselga MD PhD are Editors-in-Chief.  However, what attracted me was the way this journal, in a highly readable way, covers a wide range of topics from news, updates on current research to mini reviews and research articles.

In the news section, the journal picked up on nanodiamonds for drug delivery (a topic previously mentioned on this blog), and discussed the Gilead acquisition of Calistoga from perspective of bringing PI3K delta inhibitors to market.

I liked the selected highlights of recent articles of exceptional significance from the cancer literature.  The mini review on the “stumbling blocks on the path to personalized medicine in Breast Cancer” summarized the challenges in the clinical development of PARP inhibitors. The research articles reminded me of those I’ve read in other journals such as Science, with high quality figures and tables.

If AACR and the editors can keep up the high standard of the April 2011 preview copy they have published, Cancer Discovery will definitely be on the reading list of those involved with cancer research, new product development and translational medicine.

You can find out more about Cancer Discovery and read online articles on the AACR website.

Yesterday, I posted the first part of my interview with Dr Todd Sherer, Chief Program Officer at the Michael J Fox Foundation.

Next week, I will be posting the second part of the interview that discusses the significant research the foundation is funding on biomarkers that can help the diagnosis of the disease and monitor its progression.

If you are interested in learning more about the latest developments around Parkinson’s disease biomarkers, then you may wish to consider the April 27, 2011 webinar from the American Association for the Advancement of Science (AAAS) on the “Early Detection of Parkinson’s Disease: The Challenges and Potential of New Biomarkers.”

Moderated by Dr Todd Sherer, the webinar will discuss the only FDA approved biomarker, DaTscan that provides for imaging of dopamine transporters at dopaminergic nerve terminals in the nigrostriatal pathway.  It will also discuss the Parkinson’s Progression Markers Initiative (PPMI) that the foundation is funding.

Today is the deadline to take advantage of the early bird discounts on offer for this webinar.

Innovation in drug delivery presents opportunities for biotechnology companies, and is an area I expect we will see major leaps forward through nanotechnology.

Nanotechnology is the application of science and engineering to materials that are between 1 and 100 nanometers (nm) in size.  The Environment Protection Agency (EPA) defines nanotechnology as “the creation and use of structures, devices, and systems that have novel properties and functions because of their small size.”

1nm is one-billionth of a meter.  To put this in context, 1nm is one seven-thousandth of the width of a red blood cell or one eighty-thousandth of the width of a human hair. These are unimaginably small materials that are engineered to operate at the molecular and atomic level.

What’s more, there are now more than 1000+ consumer products on the market that utilize nanotechnology from the titanium particles in sunscreens to the silver contained in advanced first aid strips/plasters.  Nanotechnology will impact more than $2.5 trillion of manufactured goods by 2015.

Lux Research predicts that by 2014, 16% of manufactured goods in healthcare and life sciences will include nanomaterials.

To date, the United States leads the way in the fast evolving field of nanotechnology.  Between 2001 and 2010, the U.S. Government invested $12.4 billion in nanoscale science, engineering and technology through the U.S. National Nanotechnology Initiative (NNI).

The National Cancer Institute’s “NCI Alliance for Nanotechnology in Cancer” has an excellent website that outlines the potential impact of nanotechnology.

Some of the promising new cancer diagnostics and therapies based on nanotechnology include:

  • Positron Emission Tomography (PET) imaging agents that can be used to assess the responsiveness of tumors to chemotherapy
  • Chemically engineered adenovirus nanoparticle that stimulates the immune system. This is in phase 1 trials for chronic lymphocytic leukemia (CLL).
  • Cyclodextrin-based nanoparticle that encapsulates a small-interfering RNA (siRNA) agent that shuts down a key enzyme in cancer cells
  • CRLX101, a cyclodextrin-based polymer conjugated to camptothecin is in clinical trials with solid tumor patients
  • A nanoparticle based magnetic resonance imaging (MRI) contrast agent that binds to αvβ3-intregrin, a protein found on newly developed blood vessels associated with tumor development. This is in early clinical trials
  • Technology for the detection of cancer biomarkers such as prostate specific antigen (PSA)
  • Use of carbon nanotubes to improve colorectal cancer imaging.

Emerging companies such as Bind Biosciences are focusing on targeting cancer, inflammatory, cardiovascular diseases and infectious diseases with therapeutic nanoparticles.  Their lead product BIND-014 is currently in phase 1 development.

Innovations in nanotechnology will continue to present new product opportunities for biotechnology, pharmaceutical, medical imaging and diagnostics companies, and should be on everyone’s radar.

 

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I would like to thank Victor Pikov, a neurophysiologist and biomedical engineer at Huntington Medical Research Institutes (HMRI) for drawing my attention to his NeurotechZone Blog that has a really fascinating post on the manufacturing of the next generation of artificial retina, the Argus™ 111, by the Lawrence Livermore National Laboratory (LLNL).

If you have an interest in this area, then Victor is also co-chair of 3rd International Conference on Neuroprosthetic Devices (ICNPD-2011) to be held in Sydney from November 25-26, 2011. Further information can be found on NeuroTechZone.

Second Sight Medical Products recently obtained a CE mark and European Market Approval for the Argus™ II system that incorporates 60 electrodes into the retinal prosthesis.

However the next generation of artificial retina, the Argus™ III is already in development.  It has 200 electrodes – a quantum leap forwards.  It’s hard not believe that an array that is four times as densely packed with sensors, will not provide improved vision.

Second Sight will no doubt be planning clinical trials for Argus™ III and it sounds like it will provide a further leap forward in the technology to restore some sense of vision to patients who have lost their sight through age-related macular degeneration (AMD) or retinitis pigmentosa (RP).

I have taken the liberty of embedding below, the excellent YouTube video that Lawrence Livermore National Laboratory (LLNL) have produced about their manufacturing of the Argus™ III artificial retina. It is well worth watching!

 

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.

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