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	<title>BioWorld &#187; Mari Serebrov</title>
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		<title>What Would Albus Do? And What Should We?</title>
		<link>http://bioworld.blogs.bioworld.com/2012/02/13/what-would-albus-do-and-what-should-we/</link>
		<comments>http://bioworld.blogs.bioworld.com/2012/02/13/what-would-albus-do-and-what-should-we/#comments</comments>
		<pubDate>Mon, 13 Feb 2012 15:27:40 +0000</pubDate>
		<dc:creator>Anette Breindl</dc:creator>
				<category><![CDATA[Biotechnology]]></category>
		<category><![CDATA[Cancer]]></category>
		<category><![CDATA[Clinical Trial]]></category>
		<category><![CDATA[Albus Dumbledore]]></category>
		<category><![CDATA[Harry Potter]]></category>
		<category><![CDATA[Mari Serebrov]]></category>

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There’s a story, sometimes used to illustrate the difference between counseling and research psychology, about a man who pulls out one, then a second, then a third drowning person out of a river. When he sees a fourth, he starts...]]></description>
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			<content:encoded><![CDATA[<p><a href="http://bioworld.blogs.bioworld.com/files/2012/02/DC12-16-11.jpg" rel="shadowbox[sbpost-775];player=img;"><img class="alignleft size-thumbnail wp-image-776" src="http://bioworld.blogs.bioworld.com/files/2012/02/DC12-16-11-150x150.jpg" alt="" width="150" height="150" /></a>There’s a story, sometimes used to illustrate the difference between counseling and research psychology, about a man who pulls out one, then a second, then a third drowning person out of a river. When he sees a fourth, he starts walking upstream, prompting a bystander to ask “Aren’t you going to pull that one out, too?” Our hero answers “No, I’m going upstream to figure out what’s pushing all these people in.”</p>
<p><span id="more-775"></span></p>
<p>In the Harry Potter books, Hogwarts headmaster Albus Dumbledore reacts the opposite way to a similar conflict as he comes to care for Harry Potter in ways that are hard to square with the responsibility to the larger wizarding world which is also his duty. He speaks to Harry of wanting to “save you more pain than you had already suffered. What did I care if numbers of nameless and faceless people and creatures were slaughtered in the vague future, if in the here and now you were alive, well and happy?”</p>
<p>Clinical trials and their individual patients can face the same tensions. Treating patients according to the best evidence that is available now affects the evidence of the future.</p>
<p>One example is crossover designs, where patients in the control group have the chance to get the experimental treatment.</p>
<p>The scientific problem with this approach is not hard to see. If the control group is also receiving the active agent, and the active agent affects overall survival, then survival time in the control group will be lengthened by the investigational agent, and the difference between the two groups will be less pronounced.</p>
<p>Even where survival effects are strong enough to be visible at interim analyses, crossover effects will affect the final survival benefit. And that’s not just an academic concern. Taking crossover benefits into account, the survival time for <a href="http://www.provenge.com/" target="_blank">Provenge</a> almost doubles. <a href="http://www.bioworld.com/content/cetuximab-results-illustrate-trials-tribulations-clinic?c2VhcmNoX3dvcmQ9YToxOntpOjA7czo1OiJzdG9pYyI7fQ==" target="_blank">Other trials</a> seem to have missed their endpoints altogether due to crossover effects.</p>
<p>I’m not here to defend sky-high drug prices. As my colleague <a href="http://www.bioworld.com/content/our-experts" target="_blank">Mari Serebrov</a> has movingly written about on this <a href="http://bioworld.blogs.bioworld.com/2011/08/30/unless-it%e2%80%99s-affordable-curing-cancer-is-just-a-dream/">blog post</a>, a cure that no one can afford is no cure at all. And I rather suspect that even after you take the high price of drug discovery into account, the profit margins on a number of drugs would raise eyebrows.</p>
<p>But just as we can’t lose sight of the needs of the individual patient of today, we need to remember that unless the numbers add up – unless companies can survive, unless trials are set up to be able to demonstrate benefits of the drugs they test – we can also end up doing a disservice to the patients of tomorrow.</p>
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		<title>The Biotech Toddler Argument: “Chilling Effect on Innovation” Overplayed?</title>
		<link>http://bioworld.blogs.bioworld.com/2011/11/18/the-biotech-toddler-argument-%e2%80%9cchilling-effect-on-innovation%e2%80%9d-overplayed/</link>
		<comments>http://bioworld.blogs.bioworld.com/2011/11/18/the-biotech-toddler-argument-%e2%80%9cchilling-effect-on-innovation%e2%80%9d-overplayed/#comments</comments>
		<pubDate>Fri, 18 Nov 2011 17:24:59 +0000</pubDate>
		<dc:creator>Trista Morrison</dc:creator>
				<category><![CDATA[FDA]]></category>
		<category><![CDATA[Patents]]></category>
		<category><![CDATA[Mari Serebrov]]></category>
		<category><![CDATA[Mary Webster]]></category>
		<category><![CDATA[Nixon Peabody]]></category>

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In last week’s issue of BioWorld Insight, our esteemed Washington editor Mari Serebrov wrote an article titled, “Shorter Exclusivity Could Carry a Hefty Price Tag.” In it, she quoted sources who are very concerned that reducing the current 12-year exclusivity...]]></description>
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			<content:encoded><![CDATA[<p><a href="http://bioworld.blogs.bioworld.com/files/2011/11/perspectives-Nov-18-2.jpg" rel="shadowbox[sbpost-642];player=img;"><img class="alignleft size-thumbnail wp-image-649" src="http://bioworld.blogs.bioworld.com/files/2011/11/perspectives-Nov-18-2-150x147.jpg" alt="" width="150" height="147" /></a>In last week’s issue of <em>BioWorld Insight</em>, our esteemed Washington editor Mari Serebrov wrote an article titled, “<a href="http://www.bioworld.com/content/shorter-exclusivity-could-carry-hefty-price-tag" target="_blank">Shorter Exclusivity Could Carry a Hefty Price Tag</a>.” In it, she quoted sources who are very concerned that reducing the current 12-year exclusivity for innovator biologics to seven years, as the president and a number of lawmakers have proposed, would be bad news for patients, payers and drug makers.</p>
<p><span id="more-642"></span></p>
<p>In the article, Mary Webster, a patent attorney with Nixon Peabody, said: &#8220;If you can&#8217;t corner your market and recoup your costs, are you going to do it?&#8221;</p>
<p>And suddenly I had a flashback to negotiating with my three-year-old:</p>
<p>Me: “No you can’t have a cookie for dinner.”</p>
<p>Toddler: [crossing arms and stamping foot] “Fine, then I’m not going to eat anything for dinner.”</p>
<p>This scene has replayed itself in my head several times recently as I’ve written about biotech news – i.e. when gene patents are questioned, or reimbursement policies are debated, or drug importation gains traction, or the FDA shifts its stance on something. Each time, the industry’s response is to threaten that these moves will result in a “chilling effect on innovation” (translation: mess with us and we’ll stop making drugs).</p>
<p>Don’t get me wrong, I think the biotechnology industry deserves every advantage. But if biologics end up with seven years of exclusivity, do we really think companies will stop making them? Really? When biologics account for many of the top-selling drugs, each raking in multi-billions of dollars annually?</p>
<p>I worry that biopharma firms aren’t winning any points in the court of public opinion by stamping their feet and threatening to stop innovating every time something they don’t like gets put on the table. This approach certainly hasn’t worked for my toddler: When he threatens that he’s not going to eat dinner, I say, “fine, don’t eat” – and within minutes he’s seated at the table, munching away on his veggies.</p>
<p>You know what did work, though? When he said, “What if I eat a good dinner? Then can I have a cookie?” Negotiation is a fact of life – everybody has to give and take. My three-year old figured it out. Maybe it’s time for the industry to follow suit.</p>
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		<title>Biotech Dating, Marriage, Divorce . . . and the New Alternatives</title>
		<link>http://bioworld.blogs.bioworld.com/2011/04/14/biotech-dating-marriage-divorce-and-the-new-alternatives/</link>
		<comments>http://bioworld.blogs.bioworld.com/2011/04/14/biotech-dating-marriage-divorce-and-the-new-alternatives/#comments</comments>
		<pubDate>Thu, 14 Apr 2011 20:32:43 +0000</pubDate>
		<dc:creator>Lynn Yoffee</dc:creator>
				<category><![CDATA[Biotechnology]]></category>
		<category><![CDATA[Bill Gates]]></category>
		<category><![CDATA[Mari Serebrov]]></category>
		<category><![CDATA[Seattle Genetics]]></category>

		<guid isPermaLink="false">http://bioworld.blogs.thompson.com/?p=43</guid>
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Marriage is both heaven and hell. So it goes with people and so it goes with biotech firms racing to bring new drugs to market. Faced with up to $1 billion to bring a drug from idea to patient, funding...]]></description>
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			<content:encoded><![CDATA[<p><a href="http://bioworld.blogs.bioworld.com/files/2011/04/25582WDSRGB1.jpg" rel="shadowbox[sbpost-43];player=img;"><img class="alignnone size-medium wp-image-50" src="http://bioworld.blogs.bioworld.com/files/2011/04/25582WDSRGB1-219x300.jpg" alt="" width="219" height="300" /></a>Marriage is both heaven and hell. So it goes with people and so it goes with biotech firms racing to bring new drugs to market. Faced with up to $1 billion to bring a drug from idea to patient, funding more than a decade of work is a complicated affair, especially amid these weak market conditions.</p>
<p><span id="more-43"></span></p>
<p>Just as people enter courtships and marriages with different hopes and long-term game plans, biotechs hope for long honeymoons, but are smacked with real-life challenges.</p>
<p>BioWorld Today relays news of countless deals gone sour, mostly when drugs don’t pass muster. But sometimes it’s because the deal wasn’t properly vetted. Our Washington editor, Mari Serebrov, recently wrote an article for BioWorld Insight on the horror stories of how firms spend millions and billions of dollars only to find out that their new partner didn’t have clear ownership of the intellectual property. “The problem is too many companies aren’t learning that lesson before they walk down the aisle,” Serebrov wrote. “Pressed by competition from other suitors, the bottom line and the fast pace of dealmaking, they forget that beauty, even in business deals, may be only skin deep.”</p>
<p>Fearful of matrimony (or just unable to land a date), some biotechs go solo. But faced with a lack of traditional financing options these days, these biotech bachelors and bachelorettes increasingly are turning to an “alternative financing bag of tricks,” as BioWorld Assistant Managing Editor Jennifer Boggs wrote recently in BioWorld Insight. These range from rights offerings and selling royalty streams to grants and at-the-market offerings. But none of these options draw enough money to fund costly R&amp;D programs for long, with a series of fundraisings that must ensue over and over again.</p>
<p>Little start-up Nimbus Discovery LLC (with a computational drug discovery model that attracted heavyweight investor Bill Gates, of Microsoft fame) however, might be on to one of the best new models to stay funded . . . multiple partners. That may not be so Kosher among many cultures for people (shades of Big Love or Sister Wives?), but it could be the true answer for savvy biotechs. Rather than banking successive investments from various sources on a decade-long hope for a successful exit, Nimbus is placing its three programs each into separate units, gambling that it will have a better chance of being able to monetize each one as a standalone.</p>
<p>What’s different about the Nimbus strategy? In fact, a lot of firms have multiple partners –Seattle Genetics has a dozen deals involving its platform technologies and other firms have multiple deals for a single product across different regional areas. Nimbus’ strategy is focused on M&amp;A. By operating as a holding company, they’re hoping to attract a big pharma to buy those single-asset entities. That way, Nimbus gets to divest a product early   after Phase I or so   without having to convince big pharma to buy the whole shebang.</p>
<p>Divide and conquer? Don’t put all your eggs in one basket? Can I think of one more lame saying? You get the idea. We’ll see how it goes for Nimbus over the long haul. Diversification makes sense for personal investments – why not fledgling biotechs too? Most people, however, might not be so amenable to plural marriage, despite the drama and reality shows of late.</p>
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