The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Monthly Archives: December 2009

Biotech Trends of 2009: Three Biggest Losers

When we started the blog almost a year ago, we identified what we thought would be key trends for biotech investors and companies to watch.  Most panned out, but a few turned out to be… not so trendy.  You can call them premature (if you’re feeling generous) or call them dumb (if you’re feeling mean); but you can definitely call them losers, since they clearly failed their appointed purpose (making us look smart informing you, the reader).

Without further ado, 2009’s three biotech trends that weren’t:

  • Genetically engineered animals.  Way back in February, the FDA released final guidance on GE animal approvals and approved ATryn (a drug produced in the milk of GE goats).  We thought 2009 would be a year of approvals and other successes in this area, but we’ve hardly herd (sic, sorry) from anyone since.  We’ll keep an eye out for ewe, but this is one trend that probably won’t be baaaaack.
  • Commercialization by Foundations.  Despite a late-breaking story on this front about creative approaches in ALS and Diabetes communities, this “trend” has been another loser.  When we kicked things off, we identified two driving forces behind this trend, and each has taught us a lesson: (1) never use the words “availability heuristic” in a blog post about biotech; and (2) a sinking tide sinks all boats.  The crappy economic environment in 2009 was really no better for foundations than for anyone else, but we look forward to more creativity and private enterprise in this area next year.
  • Patent Reform.  It huffed, and it puffed, but with S.610 still in committee, patent reform carries over to another year.  Maybe now that health care reform is almost done using up all the reform oxygen, the patent system will get another turn. Don’t hold your breath, though.

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Top Four Biotech Trends of 2009

These may not all be consensus picks (and don’t miss the IVB’s year-end deal-centric fun) but I’m sticking with these four trends as the ones that have really shaped the year that was:

  1. Follow-on Biologics. Call them what you want (we like “biosimilars”, but we’re internationalist like that), there’s no denying that biosimilars were a major force in the industry and in politics this year.  Some in the press are calling the 12-year exclusivity period a done deal, but I say don’t count your chickens ’til the fat lady sings.
  2. Comparative Effectiveness and Personalized Medicine (not a two-fer, a trend of convergence). How much of comparative effectiveness variation will turn out to be an artifact of genetic sub-populations (each with binary responses to the drugs in question)?  Nobody knows, but as money pours into both fields, the truth will set us (and drug pricing) free.
  3. Shifting IP Constituencies. What do you get when you cross generics-hungry pharma companies with innovation-hungry Asian countries?  A whole new world of collaboration that will ultimately change the face of TRIPS and pharma R&D.
  4. Electronic Medical Records. Not really biotech (if you want to be picky), but it will have a massive impact on the way physicians, patients and payors interact with each other and with drug companies over the coming years.  Plus, with billions allocated to electronic medical records in Canada and the U.S., the pace of innovation and implementation really took off.

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This Week in the Twitterverse

This week was not so quiet in the world of biotech, despite my mostly successful attempts at vacation.  Here are some highlights from our Twitter stream @crossborderbio for you to catch up on:

Monday Biotech Deal Review: Gone Fishin’

The Monday Deal Review is on vacation this week.

Keep an eye on the Twitter stream (over to your right in the sidebar of this page or @crossborderbio), and check back next week for a double dose of Canadian biotech deals. 

All the best to everyone for a happy, successful 2010!

Trends Update — Social Media: Upopolis Keeps SickKids’ Patients Connected

One of the fantastic uses for social media in healthcare (a trend we will be following this coming year) is to connect communities of patients to each other and to their friends and families when those connections would be difficult to make or maintain IRL (in real life). 

The Hospital for Sick Children (SickKids) in Toronto started up an initiative to do just that, with the added twist that it’s built entirely for young patients.  It offers  personal profiles, personal blogs, instant chat and child-friendly games, and as spokesperson/nephrotic syndrome patient Zachary Starkman says:

“When I’m here for long periods and I’m not able to get to Marnie’s Lounge (the patient recreation room at SickKids) and chat with my friends, I feel isolated, lonely… This will really help me feel connected with everyone.”

The SickKids network is called/run by Upopolis.  It was founded by Christina Papaevangelou, who watched the struggles of her friend Katy McDonald when she was treated for cancer in 2002.  The network was developed by Kids’ Health Links Foundation, in partnership with TELUS and McMaster Children’s Hospital and runs as a SaaS solution hosted by TELUS.

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Monday Biotech Deal Review: December 21, 2009

This week’s deal review shows no signs of a holiday showdown.  In Canada, BioMS’ deal with Spectral Diagnostics was interesting as a possible indicator of more to come and internationally, 5 new pharma deals were announced this morning including a $430 million deal that OncoGenex landed from Teva joining new links between Athersys and Pfizer, Lilly and Incyte, sanofi-aventis and Chattem and Seattle Genetics and GSK.  Check out the past week’s Canadian deal-making (and breaking) after the jump…

This Week in the Twitterverse

Things to read this weekend if you aren’t following us on Twitter @crossborderbio

Friday Science Review: December 18, 2009

Advancing Cell Research with Proteomic Tools: Advances in technology – particularly in proteomics – are allowing scientists to perform research in more complex systems, a complexity that more closely reflects the situation inside the body.  In the latest trend, researchers can label two different populations of cells with different modified amino acids and use mass spectrometry to distinguish proteins derived from one population versus the other.  This strategy was recently applied to study the EphB2 receptor protein, which plays an important role in a cell’s communication with an adjacent cell expressing ephrin-B1 protein.  Differential labeling allowed the researchers to determine the unique (and similar) molecular signaling network in each cell population as they coordinate their self-organizational activity.  It’s a powerful tool that can be adapted to investigate various systems that cannot be studied in isolation.  The research was performed in Dr. Anthony Pawson’s group at the Samuel Lunenfeld Research Institute and is published in the journal Science.

New Member in the Protein Synthesis Club: After decades of studying and trying to fully understand the mRNA translational machinery for protein synthesis, new components in this complex process continue to be discovered.  The latest is a protein called DHX29, a helicase enzyme that helps to untangle the nucleic acid during the initiation phase of translation.  Down-regulating the enzyme holds up protein synthesis and presents a possible target point to block cancer cells from growing.  Indeed, when the researchers blocked DHX29 in cancer cells, tumour growth was significantly reduced.  Dr. Nahum Sonenberg was the lead author of the study reported in the early online edition of the Proceedings of the National Academy of Sciences.

PS.  Congratulations to Dr. Sonenberg in becoming the 2009 Researcher of the Year for Biomedical and Clinical Research presented by CIHR.

Low Oxygen Response in Cancer Cells:  Within a large tumour, there may be areas of hypoxic microenvironments – regions that are under low oxygen conditions.  Cells in this environment undergo a stress response to try to adapt by carrying out a process called autophagy.  The consequence of this is that the cancer cells ‘get tough’ and subsequently become resistant to radiation therapy.  This recent study investigated one of the possible cell adaptation methods through activation of the unfolded protein response (UPR) pathway.  Induction of two key proteins, MAP1LC3B and PERK, were required for autophagy.  They also demonstrated that inhibition of autophagy resulted in the cells becoming sensitive to hypoxia and irradiation.  Thus, the molecular players involved in autophagy may be good therapeutic targets.  Dr. Bradly Wouters at the Ontario Cancer Institute led the research and reports the findings in the Journal of Clinical Investigation.

Teasing out the Role of E2f Transcription Factors: Members of the E2f family of transcription factors are key regulators that commit cells through the cell division process.  Information in the literature is somewhat perplexing regarding whether they are essential for this process and different studies will support one argument or the other.  New research settles this debate – at least for the E2f1-3 isoform.  Through a series of expression and deletion studies and looking at the different molecular players involved, it was concluded that E2fs are not absolutely required for normal cell division.  The surprise finding is that E2f1-3 is necessary for cell survival in development and its function switches from ‘activator’ in progenitor cells to ‘repressor’ mode in differentiating cells.  The research was conducted at Toronto Western Research Institute by Dr. Rod Bremner’s team and appears in this week’s Nature journal.  The story is corroborated in another similar study in the same issue.

Possible Risk for Diabetes or Heart Disease: A large genome-wide study revealed an association between a polymorphism in the ARL15 gene (ADP-ribosylation factor-like 15) with lower levels adiponectin.  Adiponectin is a fat cell protein and its circulating level is inversely associated with type 2 diabetes and coronary heart disease.  Accordingly, the polymorphism is also associated to some degree with higher risk of heart disease, diabetes and other metabolic related traits.  Surely this requires a more in depth molecular study but this is a good example of how you can sift through large amounts of data from various genome-wide studies and fish out an important finding.  Dr. Brent Richards, now at McGill University, is the corresponding author of the study published in PLoS Genetics.

Genetic Mutation in Intellectual Disability: Approximately 50% of intellectual disability cases are not related to other syndromes.  In these cases, an explanation for the intellectual disability may lie in the gene called TRAPPC9, where a mutation in the gene causes a truncated form of the protein and renders it inactive.  The research team led by Dr. John Vincent at the Centre for Addiction and Mental Health used microarrays to screen a family that had seven members with non-syndromic intellectual disability to map the TRAPPC9 gene.  Additional families with mutations affecting the same gene validated the importance of TRAPPC9, which encodes proteins involved in the NF-κB signaling pathway.  With this new knowledge, researchers can screen patients or family members to track the mutation and also dig deeper into the mechanisms in the brain that affects cognitive development.  The study appears in the American Journal of Human Genetics.

BioMS’ New Directions — Buys 48% of Spectral Diagnostics, Still Has Dry Powder

BioMS (TSE: MS), which like the kids in Glee* was in need of some re-invention, has entered a new phase.  BioMS announced that it is investing $11.7 million in Spectral Diagnostics (TSE: SDI), which will use the funds to advance its lead product Toraymyxin, a treatment for severe sepsis.  Spectral will pay BioMS $3 million over the next 3 years for clinical, regulatory and capital markets consulting services.

Is this a one-time deal, or the beginning of a shopping spree? Shares of BioMS, which had about $53 million in cash left at the end of September, were up about 7% today.

If you’re done with the idle speculation and ready for the terms of the financing, (which is subject to TSX and Spectral shareholder approval) Read more of this post

Trends Update — Electronic Medical Records: Importance of Telemedicine, Implementation and Data Security

Since the Canadian and U.S. stimuli directed fuding towards electronic medical records (EMR), we’ve been following developments in the area as part of our Biotech Trends series here on the blog and have noted successes and failures.  A few recent stories highlight risks and benefits:

A recent Scientific American story (H/T @mikesgene) turned an analytical eye on the University of Pittsburgh Medical Center‘s implementation, the current iteration of which started in 2004.  Case studies have been an important part of the EMR narrative, and many so far have focused on Kaiser Permanente’s implementation, which is the world’s largest civilian system, so it’s nice to see an in-depth analysis of a different experience.  The article closes with a quote from  National Institute of Standards and Technology (NIST) Director Patrick Gallagher, who says the stimulus effort

“is about using technology to bring health care information together to reduce medical error, reduce the need for testing, put information in front of patients, and put information in front of researchers.”

A FierceHealthIT story reported on an initiative by the American Telemedicine Association, which is running a demonstration program with DocTalker Family Medicine.  DocTalker, founded by Dr. Alan Dappen (partnered with @drval) is providing remote health services to Association members and employees.  It’s being pitched as an employee benefit that can promote worker health and productivity by reducing the need for office visits and providing round-the-clock responsiveness. 

Telemedicine’s role in EMR also features in this story about a pacemaker developed by St. Jude Medical that allows patients and doctors at the Montreal Heart Institute to get data and alerts from the device, which also transmits cumulative data to the doctors in advance of patients’ follow-up visits.

With all of these electronic data floating around, security is key, but it remains an elusive target.  Dan Vorhaus tweeted about a ModernHealthCare.com article that highlights numerous security breaches this Fall.  Microsoft’s purchase this week of Sentillion, which focuses on EMR security, was for an undisclosed sum but you can bet it’s key to Microsoft’s EMR strategy.

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Monday Biotech Deal Review: December 14, 2009

In this week’s biotech deal review, some stimulus money finds its way to biotech, some M&A finds its way to shareholders’ votes, the NRC-BRI finds its way to two deals, and Patheon finds itself entering a new fiscal year a bit less burdened.  Even some securities may find their way into the market…

Read more of this post

This Week in the Twitterverse

A busy week for @crossborderbio on Twitter.  Here’s what you may have missed:

Friday Science Review: December 11, 2009

WOW!  A busy week in the bioscience world…

Pull Down Your ‘SOCS’ and Grow Some Nerves: A long standing question is how to get mature neurons, which stop growing at around the age of two, to start growing again after sustaining nerve damage.  The answer may lie in a protein called SOCS3 (suppressor of cytokine signaling 3).  SOCS3 controls neuronal growth in adults but when it is absent (in a knockout mouse model), axons can regenerate after nerve injury.  This process may be enhanced by supplying a cocktail of neurotrophic growth factors that the researchers also identified in their study.  This is a very important discovery that will push regenerative medicine to new therapeutic strategies.  Dr. Patrice Smith started the research as a postdoctoral fellow at Harvard University and now runs her own lab at Carleton University.  The study is published in the latest edition of Neuron.  There is also an inspirational story about Dr. Smith in the Globe and Mail.

Protecting your Brain after a Stroke: Following a stroke, neurons are at risk of permanent damage caused by overactivation of NMDARs (N-methyl-D-aspartate glutamate receptors).  A key molecular step leading to this excitotoxic neuronal death was discovered in this recent study.  The trauma causes degradation of Insig-1 (insulin-induced gene-1), which triggers the activation of the transcription factor SREBP-1 (sterol regulatory element binding protein-1).  However, when they blocked the activation of SREBP-1 they were successful in reducing the neuronal damage.  This is a promising target for generating therapeutic drugs aimed at minimizing the detrimental effects of strokes and brain trauma.  The research team was guided by Dr. Yu Tian Wang at the University of British Columbia and the study is reported in the latest Nature Medicine.

Breakthrough in Children’s Brain Cancer Research: A rare pediatric brain tumour called Central Nervous System-Primitive Neuroectodermal Tumours (CNS-PNET) offers a very poor prognosis for young patients.  In this gene expression study, a cluster of microRNAs called C19MC was found to be amplified in the diseased tissue in about 25% of the patients. This cluster acts as an oncogene that enhances cell growth and affects differentiation of neural stem cells.   The new discovery will advance opportunities to study this rare pediatric cancer and possibly use C19MC as a diagnostic marker and/or therapeutic target.  The international study was led by Dr. Annie Huang at SickKids Hospital and is reported in the current issue of Cancer Cell.

Genomics Study on Pathogenic Factors: In a large scale study of bacterial genomes, it was proven broadly across microbial species that many of the bacterial virulence factors are contained within genomic islands or clusters of genes.  The virulence factors are proteins that have more “offensive” functions such as toxins that help the bacteria invade the host.  Another significant outcome of this research is the discovery of potentially new pathogen-associated genes that are present pre-dominantly in pathogenic bacteria but less frequently in the non-pathogenic bacteria.  These factors require a closer look as they may represent novel targets for anti-microbial drug development, a critical area of research to combat the increasing prevalence of drug resistant bacteria.   Dr. Fiona Brinkman’s team at Simon Fraser University conducted the research and is detailed in PLoS One.

Dabigatran vs. Warfarin (round 2): Following up on a study that I mentioned here earlier this year, new research further supports the use of Dabigatran over Warfarin.  Patients with a common clotting disorder called venous thromboembolism (VTE) can benefit from Dabigatran as an equally effective and safe blood thinning treatment but without the complications associated with using Warfarin, which requires frequent visits to the clinic for blood monitoring and dosage adjustments.  The study was conducted by Dr. Sam Schulman at McMaster University and appears in this week’s The New England Journal of Medicine.

Research on Congenital Myopathy in Mice:  University of Toronto scientists have generated a mouse model to study a specific type of skeletal muscle disorder.  The mice express a mutant form of the RyR1 protein (type 1 ryanodine receptor/Ca2+ release channel), which causes a severe form of central core disease (CCD). Symptoms in mice that mimic the human condition include progressive congenital myopathy, respiratory stress, skeletal muscle weakness and impaired mobility.  Their study offers insight and future potential to unravel the mechanism behind the disorder.  Dr. David MacLennan’s research is published in The Proceedings of the National Academy of Sciences.

Here is a list of many more important research reports this week from across the country:

Cofactor-activated phosphorylation is required for inhibition of cortical neuron differentiation by Groucho/TLE1. (Dr. Stefano Stifani, McGill University)

Dlx5 Is a cell autonomous regulator of chondrocyte hypertrophy in mice and functionally substitutes for Dlx6 during endochondral ossification. (Dr. Andrew Bendall, University of Guelph)

Pluripotent transcription factors possess distinct roles in normal versus transformed human stem cells. (Dr. Mickie Bhatia, McMaster University)

Nfil3/E4bp4 is required for the development and maturation of NK cells in vivo. (Dr. Tak Mak, The Campbell Family Institute for Breast Cancer Research and University of Toronto).

A novel enediynyl peptide inhibitor of furin that blocks processing of proPDGF-A, B and proVEGF-C. (Dr. Amik Basak, University of Ottawa)

The specificity of the FOXL2 c.402C>G Somatic mutation: a survey of solid tumors. (Dr. David Huntsman, University of British Columbia)

Nuclear function of Smad7 promotes myogenesis. (Dr. John McDermott, York University)

Asf1-like structure of the conserved Yaf9 YEATS domain and role in H2A.Z deposition and acetylation. (Dr. Michael Kobor, University of British Columbia)

Biotech Trends in 2010: Top Three Reasons Why Biotech Companies Should Use Social Media

Tech startups use social media avidly [rabidly?], but biotech companies? Not so much.  Biotech companies should be blogging, tweeting and linking in like mad, though.  Here’s why:

  1. Your customers (pharma companies) do it.  More and more pharma companies are active in social media. Take a look at this article in the December issue of Life Science Leader (h/t @FiercePharma) or read the Dose of Digital blog any day of the week and you’ll be directed to interesting information about how products are being developed, tested and marketed. These are things you need to keep in mind as you move through your own product development process. Also, lots of pharma folks are on LinkedIn, so if you are as well, you’ll maximize your ability to reach out through personal connections when you’re building a constituency for your partnering deals.  Here’s my Twitter list of BioPharma news and analysis.
  2. Your investors do it.  Check out this Twitter List of Canadian VCs, Angel investors and other funders.  Look at what they’re talking about, and you’ll see you don’t have to tell people what you ate for lunch (or disclose your latest lab results) to convey that you’re doing something interesting that other people are interested in.  Check out the CVCA’s blog, Capital Rants or the Maple Leaf Angels blog.  In Toronto? Stop in at the MaRS blog or the R.I.C. blog to see where investors will be and what they’re thinking about.
  3. Your peers (other startups) do it.  If you’re not participating in online conversations, you’re missing a world of good advice and perspectives.  Click over to Rick Segal’s blog or  StartupCFO, Mark MacLeod’s Blog. It doesn’t really matter that these guys aren’t involved in biotech. Lots of startups are facing similar issues to yours — funding, staffing, etc. and getting out of the biotech bubble from time to time can be a good thing.  Plus, being at a startup is isolating, particularly in biotech with its strong incentives to run a virtual company, so go online to find peers, mentors and other resources.

If this all sounds reasonable, but you’re still skeptical, or not interested, then find someone in your organization who’s excited about it, regardless of their actual job, and set him/her loose.  [Not totally loose, of course. Common sense is critical online because it’s hard to hit “undo” on the web, and appropriate confidentiality remains key to biotech ventures.  But all your people have common sense and discretion, right?]

We’ll be keeping an eye out for biotechs and other bioscience companies that are making good use of social media as part of our Biotech Trends series this coming year.  Other suggestions for 2010 biotech trends?  Let us know

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Canadian Science Policy Conference Video: Bruce Alberts, Preston Manning and Other Luminaries

The first Canadian Science Policy Conference was held at the end of October this year, and video and audio of the event is now available at the conference website.  I’d encourage you to check out the whole thing, but definite highlights include:

  • Preston Manning and Bruce Alberts (links to conference videos), who both called for greater involvement of scientists in politics at all levels.  I discussed Bruce Alberts’ proposals in a blog post at the time. Also,
  • On the third day of the conference, there was a great panel on science journalism, media, and communication (audio only), which was moderated by Paul Wells (senior columnist for Maclean’s) and included Mark Henderson (managing editor of Research Money), Nicola Jones (commissioning editor of Nature), Chantal Barriault (co-director of the science communication graduate program at Science North) and Peter Calamai (a science reporter from the Toronto Star whose remarks were read by Mr. Wells). Each had very interesting things to say about science journalism and scientists’ communications to the public.

I also had the privelege of moderating a panel that included Tom Brzustowski, Ronald Dyck, Jorge Niosi and Mark Romoff, who presented a range of approaches to commercialization strategy.  There’s no video of our panel, but you can listen to it here, and I have located a visual aid…

If you look closely, I believe you can see Ron Dyck praying that I’m almost done talking.  I’m not sure when the picture was taken, exactly, but it is statistically unlikely that his prayer was granted.

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Monday Biotech Deal Review: December 7, 2009

This was a fairly busy week for Canadian biotech deals, including a new brain-y collaboration for MaRS; peace at Patheon; some overallotment and some underallotment; some diversification by Canadian pharma (even if not on quite the scale of Pfizer’s deal with Protalix); and some trans-Atlantic acquisitiveness of a Canadian company’s own devicing [sic., sorry].  Don’t stop now… Read more of this post

This Week in the Twitterverse

For those who don’t follow us on Twitter @crossborderbio, here are this week’s short, but notable, developments:

Friday Science Review: December 4, 2009

Universal Cancer Signalling Pathway: This is an interesting new twist on cancer signalling that may make scientists rethink how to tackle the disease.  It is thought that there is no single cure for cancer as the hetergenous disease may arise from mutations in a number of different pathways.  In this report, however, researchers demonstrate that many of the cancers converge on HIF-2a, part of the oxygen-sensing system that is required for tumours to grow.  By inhibiting HIF-2a, they could attenuate the growth of a diverse number of aggressive cancers including glioblastomas, colorectal tumours, and non-small cell lung carcinomas.  This universal cancer axis converging on HIF-2a could turn out to be a silver-bullet for cancer therapy.   Dr. Stephen Lee at the University of Ottawa led the team and describes the research in the online edition of the Proceedings of the National Academy of Sciences.

SKP’ing Stem Cells: A special type of cell called SKPs (skin-derived precursors) may be the elusive adult dermal stem cell involved in regenerating skin, wound-healing, and keeping hair healthy and growing.  In the study, researchers characterized the specialized population of cells and determined that SKPs can self-renew, maintain their ability to transform into other cells types, and regenerate hair follicles or other dermal cell types when grafted.  These properties are suggestive that SKPs are indeed THE dermal stem cells and may have important future applications such as in hair restoration and wound-healing.  Dr. Jeffrey Biernaskie completed the research in the lab of Dr. Freda Miller at Sickkids Hospital and recently started his own group at the University of Calgary.  The report appears in this latest edition of Cell Stem Cell.

Comparative Genomics Links Autism and Schizophrenia: A new study comparing the genomes of autistic patients and schizophrenic patients proved the connection between the two disorders that were previously thought to share behavioural similarities.  Both illnesses are associated with anomalies in the same region of the genome but differ substantially in the nature of the genetic changes.  Part of the genomic region is missing in autistic patients whereas extra copies of the genome are present in schizophrenic patients.  The affected genes appear to control head size and brain growth with overdevelopment of the brain in autistic patients and underdevelopment in schizophrenics.  By knowing that the two disorders are genetically linked, research on one disorder immediately provides clues for the other and will aid in advancing treatment options for both.  The study was conducted by Dr. Bernard Crespi’s group at Simon Fraser University and is reported in the Proceedings of the National Academy of Sciences.

Signalling Links in Neurological Disorders: Perturbations in either Dopamine or BDNF (brain-derived nerutrophic factor) pathways are implicated in neurological disorders.  Researchers have now defined the molecular relationship linking the two pathways to similar disorders.  The calcium signalling cascade is the key intermediate between dopamine receptor activation and BDNF production leading to neuronal growth.  With this new understanding of the pathways associated with schizophrenia, depression, and drug addiction, additional molecular targets are available for potential therapeutic intervention.  The study was led by Dr. Susan George at the Centre for Addiction and Mental Health (Toronto) and is reported in the early online edition of the Proceedings of the National Academy of Sciences.

Small Molecule Pathway Database: SMPDB (www.smpdb.ca) is an interactive, visual database containing more than 350 small-molecule pathways found in humans.  It is designed to support drug discovery research and pathway elucidation by employing clinical metabolomics, transcriptomics, proteomics and systems biology information.  The pathways describe relevant organs, organelles, subcellular compartments, protein cofactors, protein locations, metabolite locations, chemical structures and protein quaternary structures.  SMPBP is a very useful tool that was put together by Dr. David Wishart’s group at the University of Alberta and is described in detail in Nucleic Acids Research.

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No Preemption No Problem: State Courts Step Up

For anyone following the U.S. Supreme Court’s emerging case law on FDA approval and preemption (as we have been here, here, here, and here), it looks like the next frontier is going to be state law. With the Supreme Court’s ruling that drug manufacturers are subject to state tort claims even if they have undergone a full FDA review, liability depends on individual decisions by state legislatures and courts, which still have the power to exempt FDA approved drugs and 510(k) medical devices from tort liability in their states.

A recent decision by the Supreme Court of Arkansas has done just that. In DePriest v. AstraZeneca, the court dismissed claims brought under Arkansas’ Deceptive Trade Practices Act, holding that the Act contains a safe harbor that:

“specifically permits drug manufacturers to promote their drugs to consumers in a manner that is consistent with and supported by the labelling approved by the Food and Drug Administration.”

The court also dismissed the common law claims against the manufacturer on the grounds that FDA approval was sufficient to show that the manufacturer’s statements were not false or misleading.

Read the full opinion here (pdf).

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Biotech Trends Update — Commercialization by Foundations: New Initiatives from ALS Organizations, Juvenile Diabetes Research Foundation

As part of our Biotech Trends series, we’ve been following the increasing commercialization activity shown by non-profits (although they’ve been having as hard a time succeeding as everyone else).  Two recent stories highlight the important role foundations are playing in this market environment.

  1. JDRF Canada – FedDev Ontario Clinical Research CollaborationThe Juvenile Diabetes Research Foundation (JDRF) Canada is partnering with the Federal Economic Development Agency of Southern Ontario (FedDev Ontario) to fund a clinical trial network for diabetes research. FedDev Ontario is committing $20 million and JDRF is committing $10 million. JDRF will collaborate with Southern Ontario universities and research institutions to work on:
    • Speeding advances in cures and therapies for diabetes and its complications;
    • Positioning Southern Ontario as an international hub for translational research; and
    • Attracting the best international scientists and institutions to Ontario.
  2. ALS Foundations-Academia-Industry Project. Three philanthropic organizations (The Angel Fund, The ALS Therapy Alliance and Project ALS) are financing a new collaboration between Dr. Robert Brown and RXi Pharmaceuticals Corporation (NASDAQ: RXII). Dr. Brown will study the use of RXi’s self-delivering rxRNA™ (sd-rxRNA™) compounds as a potential treatment for ALS in a SOD1-overexpressing mouse model.

Each takes a novel approach:

  • JDRF Canada, by collaborating directly with the government and by focusing on clinical activity; and
  • the ALS project by allowing each party to perform in its specialty — academics on research, corporations on commercialization and the philanthropies on fundraising.

My bottom line:

In a stubbornly difficult financing environment, funding sources other than VCs step up because they derive non-financial (or at least indirect financial) benefits from their investments: corporate VCs get access to future partnership prospects; governments stimulate job growth; and charitable foundations are committed to finding cures and treatments.  These two projects are perfect examples of the work-arounds that committed participants can produce.

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