The Cross-Border Biotech Blog

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

Boosting Canadian Commercialization at the Ontario Institute of Cancer Research

Alex Philippidis ran a great story at GenomeWeb last week on the OICR’s plans for 2010, which include hiring 40 more staff, growing informatics capabilities and providing additional support for its Intellectual Property Development and Commercialization program.

On the commercialization front, the news is particularly exciting.  OICR has already been willing to participate in novel initiatives like POP-CURE, and has now hired two executives with extensive industry experience:

Franklin Stonebanks, the new chief commercial officer, “founded global life-science advisory firm Blackcomb Advisors; served as president and CEO of Cynvec; and held managerial positions in the venture funds of Johnson & Johnson and IBM, where he also led its healthcare and life science mergers-and-acquisitions effort.”

Nicole Onetto, the new deputy director, was “senior VP and chief medical officer of ZymoGenetics, and earlier served as executive VP and chief medical officer of OSI Pharmaceuticals. She was international project leader for Taxol, and led the clinical development of Tarceva (erlotinib) for non-small cell lung cancer and pancreatic cancer in collaboration with the National Cancer Institute of Canada.”

The OICR team has already invested over $5 million in 12 startups, three of which have since been acquired.  The funded projects include imaging technologies, biomarkers and new therapeutics.  These two should be great additions, and together with Rafi Hofstein, are raising the international profile of Canadian innovation.

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Jeremy Grushcow Featured in a Globe & Mail Story About Lawyers & Social Media

None other than our very own Jeremy Grushcow is featured in the Law Pages of the Globe & Mail today in a story about lawyers and social media. Go look for yourself – it’s really true. The story was also picked up by @stevematthews on Twitter and by the à l’avant garde blog at

Congrats to Jeremy and David Fraser of the Canadian Privacy Law Blog and all the other bloggers out there who are bringing the wonderful world of social media into the legal mainstream!

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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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Supreme Court Hears Oral Arguments in False Claims Act Whistleblower Case

The United States Supreme Court heard oral arguments today in a case we noted in June in which amici curiae PhRMA and BIO urged the Supreme Court to limit whistleblower suits under the False Claims Act (FCA). Feel like you were really there by reading the full transcript of the oral argument (pdf). Out loud. In your best Supreme Court Justice Voice.

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Jeremy Grushcow Quoted by Lexpert on Social Media

Lexpert Magazine article that came out yesterday quotes our illustrious Jeremy Grushcow. The article about law firms and social media cites Jeremy’s experience using social media to facilitate real life connections between people in his network. Also featured were blawging expert Simon Fodden and his co-operative Canadian legal blog Slaw, where Jeremy contributes weekly posts on biotech highlights.

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Jeremy Grushcow Discusses Comparative Effectiveness and Personalized Medicine in Counsel to Counsel Magazine’s Life Sciences Feature

Labo(u)r Day — Monday Deal Review Returns With a Double Edition Next Week

This Week in the Twitterverse

Some interesting items you may have missed if you weren’t following the Twitter stream this week:

  1. RT: @chrisarsenault Good news always welcomed! RT @markrmcqueen: RBC: Canada unexpectedly adds 27,100 jobs … Expectation was -15,0009:23 AM Sep 4th from TwitterBerry
  2. Changing of the guard at Akela Pharma $AKL following Nventa merger PM Sep 2nd from TweetDeck
  3. $50m to BDC for Southern Ontario. $35m direct, $15m for VCs. Will “collaborate” with OVCF via @startupnorth @markmcqueen5:46 PM Sep 2nd from TweetDeck
  4. Requiem for BioMS-Lilly… Agreement terminated following halted trials in July PM Sep 2nd from TweetDeck
  5. RT @IAmBiotech: Building a biotech hub – the keys to North Carolina’s success #biotech8:28 PM Sep 1st from TweetDeck
  6. RT @drval @ahier I still think the Lone Ranger is on the way health reform is not dead yet <–Nice summary of gang of 6.8:18 PM Sep 1st from TweetDeck
  7. Interesting from Nature News on gene-synthesis and bio-security PM Aug 31st from TweetDeck
  8. Extreme capital efficiency at a medical device startup via the WSJ’s VC Blog PM Aug 31st from TweetDeck

Welcome to Richard Chan!

The Cross-Border Biotech Blog welcomes Richard Chan as a regular contributor and our new Science Writer.  Richard has a Ph.D. in molecular biology and biotechnology and has done postdoctoral research on cancer signaling and proteomics at Beth Israel Deaconess Medical Center/Harvard Medical School in Boston and at the Ontario Cancer Institute in Toronto.  He currently works as a science consultant at R&D Funding Management.  Among his other duties as our Science Writer, Richard will be taking over the Friday Science Review.  Check out his first one here.

Nice to have you on board Richard!

Corporate Liability Journal Article on Wyeth v. Levine, Reigel v. Medtronic and Medtronic v. Lohr

Check out Jeremy’s latest article, published in the current issue of Corporate Liability Journal.

In The Changing Landscape of U.S. State Tort Liability for FDA-Approved Drugs and Medical Devices (pdf), Jeremy and his co-author, Alison Varga, take a more detailed look at this year’s U.S. Supreme Court decisions in Wyeth v. Levine and Reigel v. Medtronic, which Jeremy has been following on the blog.

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PhRMA and BIO in the U.S. Supreme Court: False Claims Act Whistleblowers Beware

As PhRMA and BIO hoped it would, the U.S. Supreme Court has agreed to hear the appeal of a False Claims Act (FCA) case that could determine how easy it is to bring a whistleblower suit under the statute.  Noting the prevalence of healthcare fraud cases brought under the FCA, PhRMA and BIO filed a brief as amici curiae, urging the Supreme Court to take the case and to limit whistleblower suits.

Whistleblowers can’t sue under the FCA if their suit is based on information in publicly disclosed federal reports or audits (see 31 U.S.C. §3730(e)(4)(A) if you’re so inclined) since the federal government has access to that information without a whistleblower’s help.  The Fourth Circuit case that’s being appealed holds that only federal reports and audits operate to bar a whistleblower suit, not state or local government reports or audits.  This decision puts the Fourth Circuit in line with the Third Circuit, but at odds with the Eighth, Ninth, and Eleventh Circuits.

In their amicus brief, PhRMA and BIO argued that allowing whistleblower suits based on allegations in state and local reports or audits would open a floodgate of opportunistic FCA litigation aimed at their members, increasing the costs to pharma and biotech companies and diverting resources from R&D efforts.

We will continue to follow the case (Graham County Soil & Water Conservation District v. United States ex rel. Wilson, 08-304).  Stay tuned…

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Jeremy Grushcow Quoted in Nature Biotechnology


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