Transgenic plants and animalscontinue to generate some of the most fascinating new science and technology and continue to generate considerable controversy. Canadian expertise contributed to the AcquaVantage salmon and the Enviropig; but the regulatory and legal environment lags behind the science in this area, and things in the U.S. are getting worse instead of better.

Biosimilars are also growing in importance, with FDA guidance pending and even biotech stalwarts Amgen and Biogen-Idec entering the category. Still, the U.S. made the data exclusivity period so long, it drove at least one manufacturer to treat a biosimilar as a brand new drug and submit to the full FDA approval process.

That's it for this week's review of highlights and trends. Stay tuned to the The Cross-Border Biotech Blog and @crossborderbio on Twitter to see how it all shakes out

Social media in biotech and healthcare continues to grow in importance to the industry. At this week's JP Morgan conference, there are live blogs and Twitterati galore. And when even the government gets in on the game… well, the FDA hasn't issued social media guidelines for regulated companies, but it's using the web and Twitter frequently and well, so companies had better be listening.

Every drug company is talking about getting "the right medicine to the right patient at the right time." As personalized medicine (the "right patient" part) is entering the mainstream, it is making room for the central idea of comarative effectiveness: that some medicines may work better than others (the "right medicine" part). Comparative effectiveness and personalized medicine, together at last.

The Canadian Cystic Fibrosis Foundation ended 2010 with one of the year's more interesting collaborations between nonprofit organizations and commercial drug developers. CCFF is helping to fund a new approach at the Centre for Drug Research and Development — a Centre of Excellence at UBC — that will try to "create new medicines" for CF.

Even the capital markets are excited about the new year — the lead-up to 2011 was 2010's best quarter by a wide margin. Stay tuned to the The Cross-Border Biotech Blog and @crossborderbio on Twitter to see how it all shakes out.

1. Canada's 2010 Federal Budget had some juicy bits for biotech, venture capital and innovation, including the elimination of Section 116, which was long held up as an example of an unnecessary barrier to foreign investment.
2. The top three reasons why biotech companies should use social media — their customers, investors and peers all do.
3. Personalized medicine continues to attract tons of attention, not least because people expect it to be a huge market; but there are significant challenges to widespread adoption of the technology.
4. UNC's new "Express License" is a great example of a technology transfer office that is transforming its mandate to focus on more startups instead of higher royalties; and this post explains why that strategy makes perfect sense.
5. This post examining the FDA's 2009 approval statistics also has staying power – as this year's numbers are released and discussed, the analysis continues to be relevant.

Next week, I'll look ahead to 2011 to highlight industry trends that will be featured on The Cross-Border Biotech Blog and @crossborderbio on Twitter.

Two Toronto scientists studied over two million tweets to assess the social network's value as a public health surveillance tool and came away impressed. Even though social networks open some completely new avenues to gathering data and interacting, for the most part they are just valuable tools for use in traditional processes according to a recent Deloitte report. and many Pharma companies remain reluctant to engage.

MaRS CEO Ilse Treurnicht, doing a bit of surveillance of her own on some publication surveillance data, noted that China is now second in publication of biomedical research articles globally, having recently surpassed Japan, the UK, Germany and Canada, among others. If you look at how often China's scientists (as a whole) are cited by other scientists (a proxy for qualify or value), science in China still has a long way to go, though they have improved rapidly in "quality" as well.

At The Cross-Border Biotech Blog and @crossborderbio on Twitter we are surveilling some beaches this week and will return in full force around the New Year. Happy holidays, everyone!

There have been three obesity drugs presented to the FDA for approval this year. The agency has very stringent criteria for obesity drugs because while they could see wide application (sic), the condition they treat is not generally life-threatening. So any signs of dangerous side effects can doom candidates' applications. The third and final drug, however, Orexigen's "Contrave" product, won a positive panel vote this week.

The Indian Drug Manufacturers’ Association is lobbying heavily to slim down the free trade agreement being negotiated between India and the EU. They want to accomplish this by keeping "data protection" and other innovator-friendly IP provisions out. So far, generics makers have been the heavyweights (sic) of the Indian industry, but with increasing amounts of innovative activity, India's official views on IP policy are likely to continue to shift.

For more zero-calorie, highly nutritious biotech news, stop by The Cross-Border Biotech Blog or check out @crossborderbio on Twitter.

The UK's National Institute for Health and Clinical Excellence (NICE), which provides guidance on use of new drugs and medical technologies, showed yet again that price is a key consideration, backing an Amgen drug only after being offered rebates by the manufacturer. This is one example of the general trend that regulatory approval is necessary, but not sufficient, for a successful product – payer adoption and approval is the real finish line.

Medicago, a Canadian company, made a big move south this week because the US Department of Defense is paying $21-million towards a new 90,000 sq ft state-of-the art production facility in North Carolina. Meanwhile, BIOTECanada's push to expand the federal flow-through share program to biotech showed up in an article in the Financial Post this week, hopefully encouraging the payers at Revenue Canada to give the request a serious look.

Finally, a review of this year's Canadian biotech and pharma licensing trends shows that even facing a patent cliff, pharmas (as licensing payers) still wield a fair amount of bargaining power.

Luckily, access to all the latest news and trends is still 100% free at The Cross-Border Biotech Blog and @crossborderbio on Twitter.

The crowd comprising Canada’s Natural Resources Committee, including Conservative MPs, say Canada should consider a new reactor to replace the Chalk River facility in order to maintain our domestic capability to produce isotopes for medical imaging and treatment.

The crowd of VenGrowth investors spoke clearly in favour of the funds' deal with Covington, approving the transaction by a wide margin on 4 of the 5 votes, according to the Financial Post.

The crowd of recent biotech IPOs, however, is telling us that we are still in a challenging environment for the public markets. Anacor, Zealand and Zogenix all faced tough IPO headwinds, lowering their prices, or offering sizes, or both. Everyone in biotech knows in their heart that they are the exception to the rule, though, so this week's bad news didn't stop a series of filings for new IPOs by Clarus, Tranzyme and Acelrys, according to biotech IR maven Lilian Stern.

Stay tuned for the wisdom of our crowd of writers at The Cross-Border Biotech Blog and for the latest news @crossborderbio on Twitter.

In venture capital, GrowthWorks was stepping on Covington's Blue Suede Shoes by soliciting votes against Convington's planned acquisition of the VenGrowth funds, saying it wants time to make its own offer. The CPPIB handed a Big Hunk O' Love to NorthLeaf Capital, turning over management of its $438 million portfolio of venture capital investments including Celtic, Edgestone, Lumira/MDS, Skypoint and Ventures West.

Meanwhile, Dr. Mick Bhatia's group at the Stem Cell and Cancer Research Institute at McMaster University found a way to make human skin cells sing "Any Way You Want Me," turning directly into blood cells without a pluripotent cell step in between.

The FDA, always a Hard Headed Woman when it comes to new regulatory regimes, held two days of hearings on biosmilars, aiming to answer some key questions about bringing this important class of pharmaceuticals to market.

Closer to (my) home, Ogilvy "I Want You, I Need You, I Love You" Renault and Norton Rose are merging, bringing Ogilvy's domestic life sciences expertise to a new global "headlight" for Norton Rose. So, stay tuned for biotech news with a continued international focus, and a new design, at The Cross-Border Biotech Blog and @crossborderbio on Twitter.

The Ontario Network of Excellence (ONE) got two new members this week and Minister of Research and Innovation Glen Murray (or @Glen4TC as he's know to his tweeps) travelled to St. Catharines and Hamilton. ONE is what we're now calling the network of organizations across Ontario that help innovators commercialize ideas.

The U.S. deployed its $1 billion Therapeutic Discovery Project tax credit/grant stimulus program this week, which was launched just 7 months ago as part of the health reform bill. Interestingly, the list of recipients includes a “foreign” section and sure enough, Canada’s Enobia Pharma, Germany’s mtm laboratories, and Israel’s Pluristem Therapeutics all receive TDP cash. Canadian biotechs with U.S. affiliates also reported receiving grants on the domestic U.S. side.

Meanwhile, other Canadian biotechs sauntered on. Equicom's report on Q3 201o suggests that bounceback from the 2008 financial crisis may have masked 2009 weakness, making this year look even worse.

Stay tuned for news from 2010's suspenseful end fourth quarter at The Cross-Border Biotech Blog and @crossborderbio on Twitter.

Universities' technology transfer offices (TTOs) lie at the interface between university researchers and industry, often with the mandate to monetize the University's innovations and technological assets. A new study looked at series of in-depth interviews with 20 senior technology transfer personnel at six Canadian universities and two research hospitals and discovered a disconnect between the social and financial goals of tech transfer. One example of a recent success in this area comes from MaRS Innovation, which announced two transactions this week: an outsourcing and a spin-out. Although financial terms were not disclosed, the licensee notes MaRS Innovation's transactional savvy.

Just in time for what appears to be spin-out season, I gave a talk as part of Ogilvy’s How to Draft a Patent seminar at MaRS this week in which I outlined ten business law tips for startups. There are lots of collections of tips for startups that have excellent business advice on building your team, hitting product milestones, pitching to VCs, etc.; but not that many that give a corporate lawyer’s perspective. Hopefully this list will be a good reference for tech entrepreneurs.

For the latest on tech transfer and tech startups, stay tuned to The Cross-Border Biotech Blog and @crossborderbio on Twitter.

The 2nd Canadian Science Policy Conference took place in Montreal this week. As with last year, the conference this year was full of well-reasoned and compelling ideas. In some areas, like genetically-modified food, Canada is a world leader. In others, like "Encouraging Investment in Science and Innovation", we are not world leaders. I had the privilege of moderating the latter panel, where one of the few points of unanimity was that biotech entrepreneurship in Canada still faces a cultural hurdle. Programs like those at MaRS and UTM help, but we have to teach, encourage and reward entrepreneurship at every level.

The importance of global competitiveness in this area was driven home (sic) by news that Pfizer had struck a deal with India's Biocon that will see the latter develop biosimilar insulin drugs. As the Economist put it, “…to remind the world that new ideas don’t all come from America, it is the Indian firm that will design and manufacture the original drugs; Pfizer will only market them.” It would be great to see "Canadian" in that kind of sentence more often.

For the latest on Canadian biotech innovation and entrepreneurship, stay tuned to The Cross-Border Biotech Blog and @crossborderbio on Twitter.

Canadian VC funding saw a big leap for tech and cleantech funding, but only a marginal increase for biotech. This news roughly coincided with the purchase of the VenGrowth funds by Covington Capital this week, which seems like a big leap, but will probably end up only being a minor step in the reshaping of the industry in Ontario.

Both the United States and Europe took small steps toward increasing the availability of biosimilars ("generic" versions of complex biologic drugs) this week. The EMA introduced guidelines for antibody biosimilars and the FDA formally announced a meeting that has been in the works for some time to implement the U.S. biosimilars legislation that passed as part of health reform.

Public thinking about personalized medicine took a small step forward with the release of a "personalized health manifesto," which read more as "white paper" than as "call to arms" but that nevertheless pointed in some interesting directions.

Stay tuned to The Cross-Border Biotech Blog and @crossborderbio on Twitter to keep an eye on all of the industry's baby steps, strides, leaps and paradigm shifts.

Health Canada is taking a “relaxed approach" to direct-to-consumer genetics tests, saying that personal test kits are “neither prohibited by law, nor subject to federal regulation.” This is in contrast to the U.S., where regulators have been inclined to treat the tests as regulated medical devices.

Endo Pharmaceuticals bought generics company Qualitest this week, demonstrating just how chill they are with mixing generics and innovative products. The blurring of lines between innovators and generics is part of a general re-alignment of constiuencies in the pharma industry that will impact how products are developed and protected.

Even the Ontario Emerging Technologies Fund settled into a groove this week, making an investment in NeurAxon that marks its second biotech deal and shows the fund is distributing nvestments among its three technology areas as intended.

Last but not least, everything's cool at The Cross-Border Biotech Blog, with regular features back to making regular appearances. The Monday Biotech Deal Review is being written by my colleague Jake Cawker and the Friday Science Review is under Mark Curtis' wing. For the latest updates in the word of biotech, stay tuned to @crossborderbio on Twitter.

A report on a so-called "Express License" for university technology transfer led me to call for new priorities at tech transfer offices and led to some debate in the comments. Universities often take in 10-fold more money from industry-sponsored research as they do from licensing royalties, so the Express License makes sense for those willing to sacrifice a bit of royalty income to encourage more sponsored research.

The Business Development Bank of Canada released its 2010 financial statements, and they showed a 38% drop in investments in venture capital funds compared to 2009. BDC says this was due to a lack of available co-investors, but commentators are eager to see BDC take the lead next year instead of waiting for others.

Despite vigorous advocacy on both sides of the issue, the FDA committee that met this week declined to make a recommendation on whether to approve AquaBounty's genetically-modified salmon.

If you, like the FDA, need more information to reach a decision, stay tuned to The Cross-Border Biotech Blog and @crossborderbio on Twitter.

In the lead-up to National Biotechnology Week, Saskatchewan hosted the Agricultural Biotechnology International Conference. ABIC provided an opportunity for Canada to showcase its strengths in agricultural biotechnology, for me to showcase my strengths in agricultural puns, and for Premier Brad Wall to showcase a new $5 million funding program.

One of this year’s big policy initiatives for National Biotechnology Week is to expand Canada’s Flow-Through Shares program from mining and wind power to include biotech and other cleantech companies. Flow-Through Shares have the potential to seriously boost capital influx into Canada’s biotech industry.

As the week kicked off, new Ontario Minister of Research and Innovation Glen Murray spoke at the Ontario launch (video); and the FDA opened public hearings on AquaBounty salmon (developed in Prince Edward Island). Click on through — neither should be hard to swallow.

To see how things turn out for sterile salmon and flow-through advocates, stay tuned to The Cross-Border Biotech Blog and @crossborderbio on Twitter.

The Federal Economic Development Agency for Southern Ontario (FedDev Ontario), which gave BDC $50 million for Ontario tech investments last year, has allocated $45 million this year to the NRC’s Industrial Research Assistance Program (IRAP). The NRC-IRAP program has been active in funding life science companies, so this money seems likely to provide a boost to the sector.

The Ontario Emerging Technologies Fund — which has met with some criticism for the onerous disclosure required to qualify as an investor and for restrictions on investees' deployment of invested funds – showed this week that it can nevertheless fund life science companies and qualify biotech investors.

Stay tuned to The Cross-Border Biotech Blog and @crossborderbio on Twitter to see how and when these funding announcements pay off for the industry and for Canadians.

Twin diagnostics projects were born this week as Warnex, the Montreal Heart Institute & CEPMED announced a project to develop a new test for cardiovascular and metabolic diseases; and CIHR and Genome Canada are funding applications of next-generation DNA sequencing technologies to combat childhood diseases.

Vancouver-based Forbes Medi-Tech found itself with twin suitors, as Pharmachem expressed interest in topping a prior bid by MHT.

Finally, the Canadian industry as a whole got a mediocre second fiscal quarter to match 2010's first mediocre quarter, though Wayne Schnarr found some optimism in recent regulatory successes.

Stay tuned for this week's multitude of developments at The Cross-Border Biotech Blog and @crossborderbio on Twitter.

One interesting feature of this year's report (pdf) was the uniformity of trends among different countries. No matter where you were in the world, a few things were true:

• Revenue was up;
• R&D spending was down;
• There were lots of licensing deals; and
• By the end of 2009, companies had returned to their normal levels of cash reserves and operating runway.

More data is coming to The Cross-Border Biotech Blog this week including VC investment data and a wrap-up of Q2 in Canada. Keep an eye out there and @crossborderbio on Twitter for the latest.

Even deals that looked traditional, such as Aquinox's $25 million raise, included corporate venture capital funds (in this case J&J and Pfizer). These pharma-backed venture funds continue to play a big role in supplementing traditional VCs' coffers.

In B.C., the government put money towards research on personalized medicine and medical isotopes, while the Ontario government's OETF isn't attracting qualified investors as quickly as some would like.

Other government agencies disbursed some funds as well, with Alberta's Climate Change and Emissions Management Corporation joining FONDACTION, Innovati0n PEI, the U.S. Navy and USAID in supporting Canadian commercial projects this week.

For more diverse sources of excitement, stay tuned to The Cross-Border Biotech Blog and @crossborderbio on Twitter.

On the plus side, the FDA approved two new drugs this past week, including one — prostate cancer drug Jevtana — months ahead of the FDA's deadline.

The FDA also moved this week to regulate LDTs (laboratory developed tests) more closely. Most direct-to-consumer (DTC) genetic tests fall into this category, and a series of letters from the FDA to DTC manufacturers last week is evolving into broader action.

Health Canada also took action this week, with the goal of soliciting reports of adverse drug reactions directly from patients. Unfortunately, the benefits of this approach will be hard to realize unless they develop a consumer-friendly form to go along with the new policy.

For more regulatory news, deal news and news of anyone running amok in biotech, stay tuned to The Cross-Border Biotech Blog and @crossborderbio on Twitter.

The generally poor performance of most recent biotech IPOs has indirectly boosted M&A activity. Only 1 of 8 U.S. biotech IPOs in 2010 is currently trading above its IPO price. IMRIS was the last Canadian biotech IPO, completed in November 2007 at $6.00, and it is currently trading at $5.50. M&A exits are healthy, though, with two recent sales at decent prices.

As we pass the 10-year anniversary of the sequencing of the first human genome, some say we have little to show for it. Part of the reason the genome has not immediately translated to clinical results is the large number of indirect ways the genome is regulated. Environmental cues lead to "epigenetic" effects — changes in genetic behaviour that are not driven by changes in genes, as a Canadian-authored editorial in this week's Nature points out.

Even these weekly updates are indirect — for the latest, stay tuned to The Cross-Border Biotech Blog and @crossborderbio.

Orexigen's obesity drug, Contrave, was accepted for FDA review. Contrave joins weight-loss medicines from Arena and Vivus in the FDA hopper. Interestingly, all three are still seeking marketing partners, but there is a very real possibility that there will be an FDA-approved weight loss drug on the market soon.

Patients aren't the only ones dropping weight. Amorfix dropped its vCJD program this week, and its CEO and 5 others are out as well. The company founder is back, along with the ProMIS rational drug design program.

Only The Cross-Border Biotech Blog is putting on weight. A new contributor, Wayne Schnarr, joined this week, bringing 30 years of industry experience and a fourth Ph.D. to the blog.

The recent introduction of generic Lipitor in Canada is one example of the challenges facing pharma companies as current blockbusters come off patent and face generic competition. A lot of commenters have been expecting that challenge to turn into more money spent by pharma companies on biotech; but the Abbott-Piramal transaction emphasized that there's more than one way for pharma companies to replace the lost revenue. Pharma companies facing generics competition will not save biotech companies.

Of course, by-and-large, blogging will not save biotech companies either; so I was out of pocket most of last week working on this deal. Now that I'm closer to my home again, stay tuned to The Cross-Border Biotech Blog and @crossborderbio for more updates.

• Grand Challenges Canada was launched this week to spend $225 million of the Canadian government's money on 5 "grand challenges" over a 5-year period. The first task — a grand challenge indeed — is to create a new class of point-of-care (POC) diagnostics. Along with the X-Prize's ventures into healthcare, we are seeing an interesting experiment in the ability of prizes to drive innovation.
• In a sign of progress being made globally against basic health challenges, this week the WHO reported good progress on health-related Millennium Development Goals with fewer children are dying as malnutrition, HIV and TB all fall.
• In North America, the challenges were different: Pathway Genetics faced a challenge from the FDA when it tried to sell its genetic testing kit on the shelves at Walgreens' drug stores in the U.S., and in British Columbia, a parent complained to the province’s privacy commission about the practice of retaining heel-prick blood samples from newborns, challenging the data collection as a breach of privacy.

Obviously, no-one here at Slaw is afraid of a challenge. Congratulations to Simon and the rest of the crew on the 5th anniversary and a brand new redesign. Back next week with more from The Cross-Border Biotech Blog and @crossborderbio.

Highlights were:

• Consulting company Battelle collaborated with BIO to release a report on biotech employment and government initiativeson a state-by-state level across the U.S. The data covers an interesting time period (2001-2008) and showed flat job numbers in pharma even before the 2008 recession and industry consolidation;
• A session on partnering with nonprofits was full of insight on why these collaborations are good for companies, nonprofits and patients; and
• A session on comparative effectiveness research ended up boosting personalized medicine and social media.

Presidents Clinton and Bush and Vice President Gore also spoke, but except for the first 5 minutes of Gore's speech, all media was banned from the addresses. Alas, I was forced to attend productive meetings instead.

Stay tuned to The Cross-Border Biotech Blog and on Twitter @crossborderbio as coverage returns to Canada this week.

The Ministry of Research and Innovation released a new Life Sciences Commercialization Strategy, which explains where at least part of their recent budget increase will be going. We'll see how it's received at BIO over the next few days.

At least some of the biotech trends we've been following at the Cross-Border Biotech Blog will receive a warm reception at BIO this week: the conference features sessions on commercialization by non-profit foundations, comparative effectiveness and personalized medicine, follow-on biologics and IP constituencies and global innovation, among other topic that pass for fun in this crowd.

One new initiative that isn't going to BIO, but that will receive a warm reception among Canadian attendees (and likely here at Slaw as well): PubMed Central Canada is now open for business, providing free online access to life sciences journals. All publications by CIHR-funded researchers should hit the site within 6 months after journal publication.

Stay tuned for updates from the conference at the Cross-Border Biotech Blog; but if you want to do what I do when I can't make it to a conference but I wish I was there, click here to see the Twitter stream tagged #BIO2010.

The Leukemia & Lymphoma Society is trying to find a way through to new treatments, and has created a whole funding program to do so. This week they pumped $3.2 million into a clinical program at Avila Therapeutics; and three other companies last year were able to start clinical trials with LLS funding. These biotech-foundation collaborations are win-win arrangements that you can expect to see more of.

Canadian Flax growers are trying to find a way through to use Roundup-resistant varieties without alienating the European Union (their biggest customer). Cibus Global has a technology that may develop the desired traits with a technique that's more like "traditional" breeding than genetic modification and falls outside the EU's GM-food regulations.

Generic drug makers are always trying to find a way through to market their products before patents expire. Statistics from Health Canada show that although only 1% of products get the consent of the patent-holder, 67% of the generics that decide to challenge patents record a win.

At The Cross-Border Biotech Blog and on Twitter @crossborderbio, we'll be trying to find a way through the crowds at the annual BIO conference next week. Last year, highlights included global biotechnology rankings, the Premier's breakfast, and a high-profile panel on heath care reform.

I took a look at the reasons why biotech companies aren't using social media very much, even though they should. Biotech companies seem to fall in the "late majority" of social media adopters, so those who are online now are the "early adopters" among biotechs, and without many online peers, the value is low. Critical mass is building, though.

Another kind of network — this one of expat Canadians — was spawned recently. C100 is "a select group of Canadians based primarily in Silicon Valley" who are "dedicated to supporting Canadian technology entrepreneurship and investment." Look forward to seeing some "bio" with that "tech," folks.

On a third kind of network, The Colbert Report weighed in on the gene patenting debate, defending Myriad as well as his own (NSFW) biologic. (U.S. visitors, try this link.)

Stay tuned to The Cross-Border Biotech Blog and on Twitter @crossborderbio for the latest industry news, trends and networking.

The Gairdner Awards announced its 51st set of winners, highlighting the usual range of amazing advances in molecular biology and honouring local biotech maven Dr. Cal Stiller for "outstanding leadership in medicine and medical science."

BIOTECanada also announced awards. This year's Gold Leaf Awards for companies went to OncoGenex , iCo Therapeutics and CO2 Solution. The presentation will be at the BIO conference in May.

Many companies were victorious in the marketplace too. Regulatory milestones brought significant share price jumps as Allon and Æterna Zentaris had products receive "fast track" status from the FDA. 

Even the Cross-Border Biotech Blog scored a victory this week. A trend we have championed since the inception of the blog was validated virtually verbatim by none other than NIH chief Francis Collins. Stay tuned for more prescient prognostication.

U.S. District Court Judge Robert Sweet issued a summary judgment ruling (pdf) that Myriad Genetics' patents on the BRCA1 and BRCA2 genes were invalid, as were the patents on Myriad's tests using those genes. Meh. The commentary (including here at Slaw) has been interesting and the public airing of patent policy is much needed and generally productive; but I don't think the ruling is that big a deal.

In a case of superior serendipity, last week also marked the ten-year anniversary of the first draft of the human genome. The journal Nature marked the occassion with a special issue that contains looks back, looks forward, futurism, skepticism, at least one good mystery and lots of good data.

Stay tuned to The Cross-Border Biotech Blog and on Twitter @crossborderbio for news from this week's BioFinance conference in Toronto and other industry developments.

Health Canada kicked off the week with a novel thought: caffeine guidelines for 4-year-olds. To be fair, it was in the context of expanding the types of soft drinks that can have added caffeine; so I suppose that some 4-year-olds who have been guzzling 7-UP might have to moderate their intake (or at least watch the label). The guidelines for adults are (I hope) more relevant and are worth reviewing.

The FDA had a new idea too: scolding drug developers for deficient applications. In one instance this week, the agency's oncology panel called Australian cancer drug developer ChemGenex out for “fairly sloppy drug development.” It was an instructive moment for personalized medicine, as well as for ChemGenex, because it emphasized that the FDA is very concerned about the accuracy of the diagnoses underlying treatment decisions.

Capstone Therapeutics' new idea was to give its shareholders direct control over a key corporate decision — if its clinical trials failed, should the company dissolve, returning funds to shareholders, or try to rebuild value through other products or strategies? It created a new shareholders' right that could be implemented next month's annual meeting, more than a year in advance of finding out the trial results.

Only the Ontario government found itself without new ideas this week. The 2010 Budget provided a funding boost for the Ministry of Research and Innovation, but needed program changes are still pending.

Stay tuned to The Cross-Border Biotech Blog to see what Ontario cooks up, or check out @crossborderbio for speedy, if unleavened, updates.

First, the bill includes a 12-year exclusivity period for new biologic drugs. The EU and Canada have chosen to provide only 6 years' protection, as discussed in a post on Health Canada's finalized Guidance Document this week. Because these drugs are complex to begin with, there is a high technical barrier to entry. Add to this a long data exclusivity period and you have a potentially huge boost for those few companies that successfully develop, finance and win approval for innovative drugs. 

Second, the bill funds Comparative Effectiveness research (CER). The idea of trying to identify some treatments as provably better than others is apparently one of the scary things to come out of Obama's plan. If you look more closely, though, I think the CER funding in the new legislation continues down the road of personalizing treatments. The CER bill says it's seeking to determine "what works best," sure; but what works best "for which patient under what circumstances.” A promising pronouncement for personalized medicine.

Meanwhile, a different legislative process is stirring closer to home: keep an eye on The Cross-Border Biotech Blog this Thursday for reporting on Ontario's 2010 budget.

• The budget was fairly popular among the science and innovation crowd — though reaction to the budget followed faithfully the degree to which each constituency's requests were funded.
• The full list of relevant line items is here; but this post is a good starting point to focus on the top budget items for biotech and other knowledge-based industries, including an increase in basic research funding, a new innovation commercialization program and…
• The demise of Section 116! Section 116 had created an onerous tax filing obligation that generated zero tax revenue, and has been accused of being a major barrier to an influx of U.S. venture capital investments in Canadian companies. If Section 116 was the barrier it has been made out to be, we'll see a new influx of capital. It would be great to be able to look back and definitively assess the impact of this change, so if anyone can think of a comparator group for a good empirical assessment, please let me know in the comments.

Meanwhile, the rest of the biotech world did not stand still. Canadian biotech deals and new scientific developments continued apace, and India continued its hot-and-cold approach to innovation. Catch up on these developments at The Cross-Border Biotech Blog or follow us on Twitter @crossborderbio.

That's just the tip of the iceberg:

Foundations work together: foundations formed by the families of patients can be the most ardent advocates for getting drugs to market, but that is an expensive process. One solution is for multiple foundations to pitch in to fund the same project. That was the story with CureDuchenne and the Foundation to Eradicate Duchenne each awarded grants of $250,000 to Nasdaq-listed AVI BioPharma to advance its drug development program.

Genes and the environment work together: the more we learn about genetics, and the more genomes we sequence, the harder it is to remember that our health is not fully predetermined. Studies in prominent journals recently have shown that for heart disease and type 2 diabetes, genetic markers aren't as good for predicting risk as some had hoped. Particularly for complex traits and diseases, how you are raised and the choices you make will continue to be at least as important as what you inherit.

Canadians and Americans work together: hard as it may be to remember today, we collaborate all the time with our neighbo(u)rs to the South. This past week saw a great success in that mold when Ception Therapeutics was bought by Cephalon, sending some portion of the money North to Ception investors Lumira Capital. McMaster University also benefitted along the way, having performed some of the clinical work on Ception's products that piqued Cephalon's interest.

This coming week should be exciting as well, with the federal budget showing up on Twitter. Keep an eye on the Cross-Border Biotech Blog and @crossborderbio for an analysis of this year's government-sponsored crop of innovation initiatives.

Citius:Matthew Herper at Forbes called for faster communication to investors when companies deviate from their agreed clinical trial plan with the FDA. Herper suggested that the FDA should disclose the actual agreements with the companies; but I argued that as with any other material information, it is the company's job to communicate with its investors.

Altius: This week certainly saw higher than normal deal volume, with over $100 million of Canadian deals. Labopharm and ProMetric announced headline securities deals, MDS announced its final divestiture, and Biovail and Bioniche both made licensing announcements.

Fortius: Changes to Canadian insolvency legislation created stronger protection for intellectual property licensees. The U.S. has long provided protection against termination of some license rights in insolvency, and Canadian amendments now provide the right to continued use o intellectual property even if the licensor becomes insolvent, though the right is conditional upon the licensee’s continued performance of its obligations under the license agreement.

Remember, you can check your haemoglobin levelscatch up on the latest biotech news any time at the Cross-Border Biotech Blog and on Twitter @crossborderbio. Good luck to all the athletes competing in the Vancouver games!

Pharmacy Benefits Managers (PBMs), pharmaceutical companies and government payors have all expressed a shared goal: getting “the right treatment, to the right patient, the first time.” Doing so would improve care (personalized medicine) and decrease costs (c0mparative effectiveness). However, as industry players try to connect their employees, patients and customers with personalized treatments, they will sometimes be intercepted by the Genetic Information Nondiscrimation Act, other privacy legislation, or plain old public mistrust.

The EU has an established pathway for approving "biosimilars" — generic versions of complex biologic drugs, but with health reform stalled in the U.S., the biotech industry doesn't know what will become of the biosimilars pathway that was set to be included in that legislation. 

But, as the week went by (despite being reuinted with my old router), I realized that for every Peyton Manning there is a Tracy Porter:

PBM giant Medco aims to overcome misunderstanding and mistrust with its purchase of DNA Direct this week. DNA Direct uses its research on 2,000 available tests to help physicians, health insurance companies and patients understand how to use personalized medicine. 

Teva is a winner even with health reform stalled, since it filed a full biologics license application (BLA) for Neupoval last year. The BLA asks the FDA to ignore the fact that Neupoval is a copy of Amgen's already-approved drug Neupogen and treat Neupoval as if it was an entirely new drug. This week, the FDA accepted Teva's filing for review, allowing the company to proceed without needing new legislation (though Teva is still a long way from the plane of the goal line).

The moral of this week's story is: "politically fragile biosimilars pathways are best ignored"… or "education is the key to personalized effectiveness"… or maybe "every cloud has a silver lining." Yep, that's it. So, stay tuned to the Cross-Border Biotech Blog for regular packets of optimism (even though they still mosey along at 54Mbps).

This year has started with some new, and better, data. Equicom's year-end review shows that although several Canadian biotechs did go under, the surviving companies overall outperformed market indices. BIOTECanada updated the July survey recently as well, showing that the numbers have flipped: now only 30% of Canadian biotech companies have under 6 months' cash.

Still, this week brought news that Jubilant (based in India) succeeded in several research collaborations with academics and big pharma, one of many reminders that these high value jobs are highly competitive. 

Kudos to the Ontario Institute for Cancer Research* (OICR), then, which lured two executives with extensive industry experience to its commercialization program.

Even with successful recruitment, there is more that needs to be doneto keep Canada's biotech industry competitive. In Ontario, a group of biotech CEOs formed a new group called the Ontario Bioscience Industry Organization** (OBIO). OBIO consulted with CEOs province-wide and generated 5 recommendations for changes to existing provincial programs that would help these SMEs.

Implementing these recommendations would be a great step forward.

Disclosure notes:
* An Ogilvy Renault client.
**I serve as the Corporate Secretary on the Board of OBIO.

In Florida, a report assessing the state's progress in attracting high value life science jobs showed that in the first six years of its efforts, legislators have spent about $1.4 million for each of the 1,100 jobs created. In the year we've been tracking similar data, this is the highest per-job spending we've seen.

The Florida report recommended more spending to assist with early-stage capital, which is exactly what Ontario is attempting with its Emerging Technologies Fund. The OETF invests alongside private-sector qualified investors to help Ontario companies get the most from their capital raising efforts. This week the OETF closed its first two deals- an IT company and a cleantech company. Biotech is the third prong of the OETF mandate, and there appear be more deals already in the OETF pipeline, so expect to see some benefits for biotech soon as well.

Also this week, an article on venture capital trends in 2010 emphasized the importance of molecular diagnostics– tests that determine how individual patients will respond to a specific medication. The VCs predict these tests will be critical to improving the efficiency of healthcare spending. AstraZeneca is the most recent example of a company that agrees. It announced a collaboration with a molecular diagnostics company this week that aims to ensure that AstraZeneca is "giving the right treatment, to the right patient, the first time."

Regardless of the fate of health reform in the U.S., cost containment will continue to be vital to maximizing the value of our public spending. Companies, investors and governments that keep this foremost in mind will emerge as the most successful this century. Keep an eye on the Cross-Border Biotech Blog where we continue to keep an eye on these efforts.

Line drawn: Since 2004, there have been increasing numbers of instances where pharma companies have compensated generics manufacturers in settlements of patent litigation initiated by the pharmas. The U.S. Federal Trade Commission (FTC, tasked alongside DOJ with enforcing antitrust law) in general, and its current Competition Bureau Director in particular, does not like these settlements. This week, the FTC published a report that claims that these settlements result in substantial extra delay in getting generic products into the market; and the European Commission requested information on the deals from several major pharma companies.

Line blurred: On the other hand, it's not entirely clear who is who anymore. Pfizer sells about 600 generic medicines, including at least 40 that it made a deal for this week that it will sell in the United States; and Teva now reportedly gets about 30% of its revenue from branded drugs.

Line blurred: The Juvenile Diabetes Research Foundation stepped up its artificial pancreas program, collaborating with two industry players to bring a device to market and to bring to fruition the lab research it has funded for the last 4 years. This is the second project by the JDRF recently that has the foundation taking a direct hand in commercial development.

Though more lines were blurred than drawn, one thing was clear: 2010 is looking much better for biotech than 2009 did. Keep an eye on the Cross-Border Biotech Blog and @crossborderbio on Twitter for the latest.

Oh, and one other thing that's clear: Peter Carrescia's new blog, Tech Disruptions, is one to keep an eye on. The first few posts are (not surprisingly) more tech than biotech; but Peter says he's interested broadly in change vs. status quo and in predicting change, and that is an engaging subject for IT people and biotech people and anyone else at the cutting edge.

• New federal-level initiatives in the U.S. and China and state-level initiatives in North Carolina, Missouri, Arizona and Indiana (not to mention Québec's new Biopharmaceutical Strategy) mean that Ontario has to up the ante if it wants to improve its ability to grow and attract top biotech talent.
• Policy makers and commenters need to look farther into the future to effectively regulate the coming revolution in reproductive genomics — "designer babies" are already possible and the technology will only become more sophisticated.
• The number of biotech drugs approved by the FDA increased to seven this year from four last year, but the available analysis needs to improve in order to tell whether this is a meaningful increase or a statistical blip.
• Personalized medicine, according to a PwC report, has the potential to be a huge market, but those who want to profit from it will have to make an unprecedented investment in educational and regulatory changes if they want doctors and patients to start using the technology.

Truth be told, there are plenty of things on my own list when I'm done deflecting; so I'll head back to the Cross-Border Biotech Blog to see how I can top a pretty good 2009.

Several trends were key to business planning in biotech in 2009, but four stood out as the highlights because of reader interest and news volume: follow-on biologics; comparative effectiveness and personalized medicine; shifting IP constituencies and electronic medical records.

Not all was sunshine and roses though. Some of the things I expected to be trendy were, shockingly, not trendy. Maybe they will be next year or ten years from now; but if you can't wait that long, check out the year's three biotech trends that weren’t.

However, if you're an empiricist like me, feel free to ignore the subjective summaries above and head straight for the statistically valid and apparently obligatory top 10 posts post. The In Vivo Blog has a good top 10 list as well.

That's all for now. Happy 2010!

*Avatar was cool, but a teeny bit less so if you've seen UP, which is also spectacular 3D and has a better plot.

In a post on recent developments in electronic medical records, two items highlighted a role for remote access: a pilot program by the American Telemedicine Association that is using phone, email and videoconferencing to resolve over 55% of issues without an office visit; and a new pacemaker that transmits data to the doctor and the patient to allow proactive monitoring and planning.

Another phenomenon one step removed — BioMS, having had to abandon its own clinical programs, has decided to invest time and expertise in another development-stage company, Spectral Diagnostics. BioMS is putting about $12 million in, and is getting $3 million back for "clinical, regulatory and capital markets consulting services." With more money in the bank, this may become BioMS' new gig.

Even President Obama was dependent on others this week, getting a boost from the Congressional Budget Office to put health care reform over the top. The CBO estimated this week that the Senate health care reform bill would reduce the deficit by $132 billion over the first 10 years.

Still, over at the Cross-Border Biotech Blog, we're trying to get you all the news a Canadian biotech company needs as directly as possible. And, in the spirit of being direct — Happy Holidays!

It may not have been "a battle outside," but the Canadian Science Policy Conference did shake some windows and rattle some walls in October; and as of this week, you can check out the audio and video recorded there including Bruce Alberts and Preston Manning.

Dylan's verse for "writers and critics" said "don't speak too soon," but for biotech founders toiling away at startups, my advice is don't wait too long either. Check out the top three reasons for biotech companies to use social media.

You couldn't ask for a better sign of changing times than the closing of three new funds this past week. In Canada, there's a new $2 million fund to lend to growing companies with SR&ED credits as collateral and a new $300 million tech fund that Tandem closed, including money from Teralys (working quickly!). And in the U.S., 5am Ventures closed a $200 million fund for early-stage life science investments.

Bringing It All Back Home: keep on top of all the changing times in biotech by staying tuned to The Cross-Border Biotech Blog and @crossborderbio on Twitter.

I kicked things off with a post on three need-to-know Canadian patent decisions that impact pharma, biotech and generics companies, pulling together three Ogilvy Renault bulletins into one executive-summary-level overview of key recent developments.

Audrey picked up the legal theme with a post noting oral arguments at the U.S. Supreme Court for a case under the False Claims Act (FCA) in which amici curiae PhRMA and BIO are urging the Supreme Court to limit whistleblower suits.

A second post by Audrey highlighted a recent decision by the Supreme Court of Arkansas that dismissed state tort claims against AstraZeneca. Following the U.S. Supreme Court's decision in Wyeth v. Levine that FDA approval does not preempt state tort liability for drug makers, state court decisions like this one will be an important battle ground in pharmaceutical companies' product liability litigation.

Other posts this week spanned the blog's usual bench-to-bedside range, with the Friday Science Review by science writer Richard Chan picking up no less than five cool developments from Canadian labs (ranging from stem cells to informatics) and a Biotech Trends post noting novel approaches to commercialization taken by some non-profit foundations. If that's not enough to satisfy, keep an eye on the Twitter stream @crossborderbio for up-to-the-minute Canadian biotech news.

Proponents of personalized medicine were thankful for several developments that show this trend is picking up speed: CVS followed Medco's example in expanding pharmacogenomic testing, while biotech and pharma companies, as well as the National Cancer Institute, stepped up their investment in the field.

I am thankful to be following a new trend for 2010: synthetic biology, i.e. attempts to create novel organisms. This week, I weighed in on the search for the smallest genome that could constitute a living organism, noting that the most popular candidate seems to be proving itself to be a red herring.

Finally, I am thankful for Richard Chan, our science writer, who has taken over responsibility for the Friday Science Review, and for Jacob Cawker, who provides research support for the Monday Biotech Deal Review. Thanks guys – I couldn't do it without you!

The FDA, famous for restrictive rules on communications, is having a hard time adjusting to current internet trends, leading to some controversial decisions about Google search ads. Trying to do better, FDA held a two-day hearing about the use of the internet and social media for online drug marketing so it can calibrate its decisions for a new era. Rule-making will follow at the old era pace, though.

Simon Fodden and Slaw, already famous, got further exposure in an article in Lexpert Magazine that explored the use of social media by law firms and lawyers. Yours truly was also cited on using social networking to facilitate real-life connections.

Also achieving fame were the winners of the CIHR’s Canadian Health Research Awards and the winners of the Prix Galien Canada. Awardees ran the gamut from basic to applied research and from molecular to population-based approaches. Congrats!

Fame is great, but funding is better. The Ontario Genomics Institute's Pre-commercialization Business Development Fund, which makes investments to fund proof-of-principle programs, is calling for applications for 2010.

Finally, for those hoping for fame or other great things from their offspring, I tweeted @crossborderbio about a cool post by my wife (and editor of the Cross-Border Biotech Blog) about evolutionary advantages for sensitive kids.

The U.S. stimulus funding to promote adoption of electronic medical records bounced across the border to Ontario, where a new program was implemented through the Ontario Medical Association. The Ontario program provides an amount of cash per physician comparable to the U.S. funding, plus it offers consulting help and provides funding for upgrades.

Novartis bounced $1 billion of its R&D efforts to China, and in the same breath called India's upcoming decision on a Novartis patent a "turning point" for India's R&D industry. It's not surprising to see an innovative company like Novartis seek out a friendly IP (intellectual property) environment. It is a bit surprising to see Novartis make the assessment that China provides that environment.

The Venture Capital industry bounced from excited to depressed. While the Q2 numbers had a silver lining that showed renewed biotech strength (at least in the U.S.), the Q3 numbers were miserable all around. Canada's venture capital industry had its worst quarter in 14 years, and even the New York Times suggested the VC crowd was in for a shake up.

Still, deal activity is picking up again and the terms are looking a bit more favourable for companies, so keep an eye on The Cross-Border Biotech Blog and at @crossborderbio for the latest. See you next week. For now … gotta bounce.

In Canada (and presumably elsewhere as well) Merck put out a country-specific press release announcing the closing of its merger with Schering-Plough. Merck calls Canada "an integral part of the company’s expanded global presence."

In the U.S., Congress decided that the shutdown of (Canada's) Chalk River reactor was a warning, and passed a bill to stimulate domestic production of medical isotopes. About 60% of the U.S. supply had been coming from the AECL facility.

In China, all signs point to the country joining the ranks of countries advocating strong IP rights. This week, a study showed China's research output doubling since 2004 and a Forbes article noted a copyright enforcement action by Chinese authors. Not a coincidence.

As always, there's lots more detail at the Cross-Border Biotech Blog and on the twitter stream @crossborderbio.

• Bruce Alberts, the Editor-in-Chief of the journal Science, served for 12 years as the head of the U.S. National Academy for Science, an independent voice for science in policy decision-making. Dr. Alberts is actually in favour of a voice for science in everything, and he advocates for placing scientists into every career and country. He strongly recommends a National Academies-type science fellowship program for Canada.
• David Baltimore, Phillip Sharp and Corey Goodman have three Gairdner awards and two Nobel prizes among them in addition to truly impressive corporate expertise. They had a wide-ranging discussion about the biotech business model and pharma pipelines, and Corey Goodman suggested later that Canada needs to repatriate its expats gained VCs entrepreneurship experience in the U.S.

Also notable this week: the Cross-Border Biotech Blog's science writer, Richard Chan, was thinking big in the Friday Science Review. It has all the usual coverage of cool Canadian publications, plus Richard has branched out into science reporting, noting a Canada-California research collaboration and an international ranking of the best places to work in academia that includes Dalhousie and the University of Toronto.

REMS: The FDA has, increasingly often, been imposing Risk Evaluation and Mitigation Strategies when it approves new drugs. REMS restrict the way new drugs can be distributed, administered and/or promoted. When the program was first introduced, common wisdom said that REMS were to be avoided at all costs, but lately some advantages have become apparent:

• Way back in June, we noted that REMS are expensive for drug companies, but that REMS make life expensive for generic copies as well, meaning that REMS provide a sort of price protection for pharmas even after patent and data exclusivity expire.
• This week, we saw that for some products that are mediocre performers, REMS requirements can keep the product viable by providing a perfect reason not to over-spend on product promotion; and we also saw BOTOX maker Allergan claim that REMS required them to make otherwise forbidden overtures to physicians using the drug off-label (outside of FDA-approved indications).

Comparative Effectiveness: CER is a hot topic, and it inspires controversy because of fears that a beneficial treatment will be denied because of cost considerations. Nevertheless, it has the potential to help patients avoid ineffective or harmful treatments by making head-to-head comparisons of competing treatment options. This week, we saw that sometimes the financial interests of a CER study sponsor can impact study design (cynics delight!), which to me emphasizes the importance of neutral government support for these types of studies.

Swine Flu! No matter how many other interesting ideas were floating around, a lot of people are focused on Influenza A-H1N1 (aka swine flu, aka grippe porcine) this week. At the Cross-Border Biotech Blog, we are your one stop swine flu shop™. This week, we gathered some recent Ontario data and since the summer we have been aggregating swine flu news in the widgets column on the right of the blog. Come for the flu, stay for the fun!