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	<title>BioWorld &#187; China</title>
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		<title>Mamma Mia! It’s Biopharma Season!</title>
		<link>http://bioworld.blogs.bioworld.com/2012/06/11/mamma-mia-its-biopharma-season/</link>
		<comments>http://bioworld.blogs.bioworld.com/2012/06/11/mamma-mia-its-biopharma-season/#comments</comments>
		<pubDate>Mon, 11 Jun 2012 18:48:50 +0000</pubDate>
		<dc:creator>Michael Harris</dc:creator>
				<category><![CDATA[Big pharma]]></category>
		<category><![CDATA[Biosimilar]]></category>
		<category><![CDATA[Biotech conferences]]></category>
		<category><![CDATA[Biotechnology]]></category>
		<category><![CDATA[China]]></category>
		<category><![CDATA[Orphan disease]]></category>
		<category><![CDATA[Reimbursement]]></category>
		<category><![CDATA[BRIC]]></category>
		<category><![CDATA[HSGI]]></category>
		<category><![CDATA[Side Story]]></category>
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“Hey kids, let’s put on a show!” That was a famous line from the 1937 Broadway musical, Babes in Arms, shouted to exhort the old gang to take action to save the orphanage. As the theater market just put on...]]></description>
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			<content:encoded><![CDATA[<p><a href="http://bioworld.blogs.bioworld.com/files/2012/06/blog-June-11-20123.jpg" rel="shadowbox[sbpost-973];player=img;"><img class="alignleft size-thumbnail wp-image-983" src="http://bioworld.blogs.bioworld.com/files/2012/06/blog-June-11-20123-150x150.jpg" alt="" width="150" height="150" /></a>“Hey kids, let’s put on a show!” That was a famous line from the 1937 Broadway musical, <a href="http://www.broadwaymusicalhome.com/shows/babes.htm" target="_blank">Babes in Arms</a>, shouted to exhort the old gang to take action to save the orphanage. As the theater market just put on its <a href="http://www.tonyawards.com/en_US/index.html" target="_blank">Tony Awards</a> to assess the state of its industry, June is also the most active event season for biopharma, as the industry puts on its own long-running show, with the <a href="http://chicago2012.asco.org/" target="_blank">ASCO</a> and <a href="http://convention.bio.org/" target="_blank">BIO</a> events taking center stage this month. Only this time, it’s not the orphanage that’s in need, but the orphan drugs – as well as the biosimilars, the early stage projects, the expiries, the patients and the rest of the cast of thousands that perform on biopharma’s market stage.</p>
<p><span id="more-973"></span></p>
<p>The musical’s stars are two enterprising performers who collaborate to navigate the pratfalls of show business, while performing an altruistic mission; whereas pharma and biotech are two enterprising industries that work in partnership to . . . well, you get the analogy. If not, try these Broadway-to-biopharma correlations on for size:</p>
<p>Death of a Salesman is called to mind, considering the demise of pharma sales reps clutching on to the clinical value proposition, rather than the reimbursement value proposition.</p>
<p>The biggest pharma, aka “The Lion King,” <a href="http://www.pfizer.com/home/" target="_blank">Pfizer Inc</a>. is pulling out all the stops with its Lipitor extended run playbill that employs stage tricks such as co-pays, rebates, discounts and mailing direct to customers. If successful – patent cliff be damned (Yankees) – the New York-based pharma could keep Lipitor running in revival longer than “A Streetcar Named Desire.”</p>
<p>China is leading a BRIC ensemble staging of “How to Succeed in Business Without Really Trying,” as there is no shortage of Western producers willing to supply the talent and innovation to create biopharma’s next round of wicked blockbusters.</p>
<p>The curtain is going up on a real-life “West (coast) Side Story,” as “A Chorus Line” of pharmas are gearing up to fight like the Sharks and the Jets over San Diego-based <a href="http://www.amylin.com/" target="_blank">Amylin Pharmaceuticals Inc</a>. And <a href="http://www.hgsi.com/" target="_blank">Human Genome Sciences Inc</a>. (HSGI) isn’t falling for the song and dance that <a href="http://www.gsk.com/" target="_blank">GlaxoSmithKline plc</a> is putting on either, as the biotech has put itself on the marquee for sale, hoping to secure an M&amp;A exit-stage-left by drawing more than the $13 per share offer that HSGI is offering.</p>
<p>It seems that anything goes in biopharma, including the possibility that the White House – and regulatory edicts – could fall under the auspices of the “Book of Mormon” in November, but whatever happens, count on BioWorld to deliver the newsies.</p>
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		<title>The Good, the Bad and . . . the Huh? A 2011 Biotech Recap</title>
		<link>http://bioworld.blogs.bioworld.com/2011/12/28/the-good-the-bad-and-the-huh-a-2011-biotech-recap/</link>
		<comments>http://bioworld.blogs.bioworld.com/2011/12/28/the-good-the-bad-and-the-huh-a-2011-biotech-recap/#comments</comments>
		<pubDate>Wed, 28 Dec 2011 22:11:41 +0000</pubDate>
		<dc:creator>Jennifer Boggs</dc:creator>
				<category><![CDATA[Accelerated approval]]></category>
		<category><![CDATA[Antibody]]></category>
		<category><![CDATA[Big pharma]]></category>
		<category><![CDATA[Biologic]]></category>
		<category><![CDATA[Biosimilar]]></category>
		<category><![CDATA[Biotech conferences]]></category>
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		<category><![CDATA[Financing]]></category>
		<category><![CDATA[Gene Therapy]]></category>
		<category><![CDATA[Genomics]]></category>
		<category><![CDATA[Healthcare reform]]></category>
		<category><![CDATA[immunotherapy]]></category>
		<category><![CDATA[IND]]></category>
		<category><![CDATA[Investigational New Drug Application]]></category>
		<category><![CDATA[IPO]]></category>
		<category><![CDATA[NDA]]></category>
		<category><![CDATA[New Drug Application]]></category>
		<category><![CDATA[Orphan disease]]></category>
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The past year brought the biotech sector a mixed bag of news. Some of it was positive &#8211; for instance, the FDA picked up its drug approval pace in 2011 and, in some cases, even surprised the most hardened biotech...]]></description>
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			<content:encoded><![CDATA[<p><a href="http://bioworld.blogs.bioworld.com/files/2011/12/blog-Dec-29-20111.jpg" rel="shadowbox[sbpost-713];player=img;"><img alt="" class="alignleft size-thumbnail wp-image-714" height="150" src="http://bioworld.blogs.bioworld.com/files/2011/12/blog-Dec-29-20111-150x150.jpg" width="150" /></a></p>
<p><span id="more-713"></span></p>
<p>The past year brought the biotech sector a mixed bag of news. Some of it was positive &ndash; for instance, the <a href="http://www.fda.gov/" target="_blank">FDA</a> picked up its drug approval pace in 2011 and, in some cases, even surprised the most hardened biotech investors by granting approval of some drugs <a href="http://www.bioworld.com/content/plexxikons-speedy-zelboraf-work-helped-diagnostic?c2VhcmNoX3dvcmQ9YToxOntpOjA7czo4OiJaZWxib3JhZiI7fQ==" target="_blank">a month or two</a> before their PDUFA dates &ndash; while other headlines hailed discouraging trends such as the failure of <a href="http://www.prospectventures.com/" target="_blank">Prospect Ventures</a> to close its latest round, confirming predictions of a venture capital contraction.</p>
<p>As we get ready to head into 2012 (and possibly an apocalyptic count-down, if those <a href="http://en.wikipedia.org/wiki/2012_phenomenon" target="_blank">Mayans</a> are to be believed), let&rsquo;s take a look back at some of the highs and lows of the biotech industry in 2011.</p>
<p>&nbsp;</p>
<p><strong>&lsquo;Me-First&rsquo; Instead of &lsquo;Me-Too&rsquo;</strong></p>
<p>Biotech execs always talk about tackling unmet medical needs. So it was exciting to see in 2011 the flurry of breakthrough drugs hitting the market. An informal <a href="http://www.bioworld.com/" target="_blank">BioWorld</a> poll tagged <a href="http://www.seagen.com/" target="_blank">Seattle Genetics Inc.</a>&rsquo;s lymphoma drug <a href="http://www.adcetris.com/" target="_blank">Adcetris</a> (brentuximab vedotin), the first approved antibody-drug conjugate, as the biggest drug approval of the year, tied with HCV game-changers <a href="http://www.incivek.com/" target="_blank">Incivek</a> (telaprevir) from <a href="http://www.vrtx.com/" target="_blank">Vertex Pharmaceuticals Inc.</a> and <a href="http://www.victrelis.com/" target="_blank">Victrelis</a> (boceprevir) from <a href="http://www.merck.com/" target="_blank">Merck &amp; Co. Inc</a>. But other notable approvals included <a href="http://www.hgsi.com/" target="_blank">Human Genome Sciences Inc.</a>&rsquo;s <a href="http://www.benlysta.com/" target="_blank">Benlysta</a> (belimumab), the first lupus drug approved in 50-plus years, and <a href="http://www.yervoy.com/" target="_blank">Yervoy</a> (ipilimumab) from <a href="http://www.bms.com/" target="_blank">Bristol-Myers Squibb Co.</a> and <a href="http://www.zelboraf.com/" target="_blank">Zelboraf</a> (vemurafenib) from <a href="http://www.roche.com/" target="_blank">Roche AG</a> and <span class="highlight">Daiichi</span> Sankyo Co. Ltd. as the first two drugs approved for melanoma that actually improved overall survival in clinical testing. And, late in the year, <a href="http://www.incyte.com/" target="_blank">Incyte Corp.</a> scored a win with <a href="http://www.jakafi.com/" target="_blank">Jakafi</a> (ruxolitinib), the first approved JAK inhibitor and the first drug for myelofibrosis.</p>
<p>Let&rsquo;s all hope that trend of &ldquo;firsts&rdquo; continues in 2012.</p>
<p>&nbsp;</p>
<p><strong>A &lsquo;Nobel&rsquo; Death</strong></p>
<p>In a bit of irony (in an <a href="http://en.wikipedia.org/wiki/Ironic_%28song%29" target="_blank">Alanis Morissette</a> kind of way), the Nobel committee awarded one-half of the 2011 Nobel prize in physiology or medicine to <a href="http://www.nobelprize.org/nobel_prizes/medicine/laureates/2011/steinman.html" target="_blank">Ralph Steinman</a>, unaware that the Rockefeller University professor had died of pancreatic cancer three days earlier. Posthumous Nobels are unusual but, after brief debate, the committee wisely decided to allow Steinman to remain a Nobelist. And I&rsquo;m glad. He certainly earned the title for his discovery of the dendritic cell and its role in adaptive immunity. Plus, according to BioWorld&rsquo;s science editor, <a href="http://bioworld.blogs.bioworld.com/2011/10/03/ralph-steinman-remembered-a-glimpse-of-humility/">Anette Breindl</a>, who heard Steinman speak in 2007, he was a pretty nice guy.</p>
<p>&nbsp;</p>
<p><strong>Best Bang for the Buck?</strong></p>
<p>The biggest M&amp;A deal in 2011 was easily <a href="http://www.sanofi.us/" target="_blank">Sanofi SA</a>&rsquo;s $20-billion-plus-contingent value rights <a href="http://www.bioworld.com/content/sanofi-uses-212b-cash-cvr-win-grande-dame-genzyme" target="_blank">buyout</a> of Genzyme Corp., which followed nine months of often less-than-friendly negotiations. But it wasn&rsquo;t the best deal for biotech investors. Genzyme shareholders already have lost out on the $1 CVR connected to manufacturing capacity for enzyme replacement therapies <a href="http://www.cerezyme.com/" target="_blank">Cerezyme</a> and <a href="http://www.fabrazyme.com/" target="_blank">Fabrazyme</a>. Whether they will be able to earn the remaining $13 linked to multiple sclerosis drug Lemtrada (alemtuzumab) is up for debate, and, for the most part, analysts are not optimistic.</p>
<p>If I were to choose, I&rsquo;d say that <a href="http://www.dsi.com/" target="_blank">Daiichi Sankyo Co. Ltd.</a>&rsquo;s bid for <a href="http://www.bioworld.com/content/daiichi-sankyo-bolsters-pipe-935m-plexxikon-buy-0" target="_blank">Plexxikon Inc.</a> and <a href="http://www.shire.com/" target="_blank">Shire plc</a>&rsquo;s buyout of <a href="http://www.bioworld.com/content/shire-acquires-advanced-biohealing-750m" target="_blank">Advanced BioHealing Inc.</a> were far more successful M&amp;A deals. Daiichi&rsquo;s hefty $935 million payment for Plexxikon &ndash; a move validated when Zelboraf gained approval in August &ndash; came despite only getting U.S. co-promotion rights to the melanoma drug under Plexxikon&rsquo;s existing partnership with Roche AG. The Shire/ABH deal, meanwhile, showcased the kind of investor returns rarely seen these days. The big pharma firm shelled out $750 million for ABH, a whopping 15x return for ABH&rsquo;s largest shareholder.</p>
<p>&nbsp;</p>
<p><strong>&lsquo;Weighed&rsquo; Down by Safety</strong></p>
<p>Despite health experts clamoring for new ways to treat the so-called <a href="http://www.obesityepidemic.org/" target="_blank">obesity epidemic</a>, drugs aimed at helping people lose weight have not had an easy time of it at the FDA. Industry observers had expected 2011 to usher in not one, but three obesity therapies; instead, all three were rejected by the FDA. <a href="http://www.orexigen.com/" target="_blank">Orexigen Inc.</a>&rsquo;s Contrave got stalled on cardiovascular concerns, while <a href="http://www.vivus.com/" target="_blank">Vivus Inc.</a>&rsquo;s Qnexa raised worries of birth defects related to one of its generic components and <a href="http://www.arenapharm.com/" target="_blank">Arena Pharmaceuticals Inc.</a>&rsquo;s Lorquess bumped up against carcinogenicity concerns. Contrave is set to start a large cardiovascular outcomes study, which would delay its approval until 2014. But Qnexa and Lorquess could have a shot at getting approved in 2012. That&rsquo;s assuming that no additional safety issues crop up. Given the <a href="http://www.bioworld.com/content/some-clarity-predicting-obesity-drugs-fate-still-hard" target="_blank">track record</a> in the obesity space, that&rsquo;s definitely no guarantee.</p>
<p>&nbsp;</p>
<p><strong>The Rough Side of Town</strong></p>
<p>While 2011 had its much-lauded drug approvals (as noted above), the year was not without its disappointments. Two promising areas of research suffered blows &ndash; Roche pulled out of the <a href="http://www.macalester.edu/%7Emontgomery/rnai.html" target="_blank">RNAi</a> space, <a href="http://www.bioworld.com/content/alnylam-ceo-big-pharma-still-confident-potential-rnai" target="_blank">dumping a high-dollar collaboration</a> with RNAi powerhouse <a href="http://www.alnylam.com/" target="_blank">Alnylam Inc.</a>, while <a href="http://www.geron.com/" target="_blank">Geron Inc.</a> abandoned its position as <a href="http://www.bioworld.com/content/hesc-therapy-pioneer-geron-abandons-stem-cell-rd-1" target="_blank">embryonic stem cell pioneer</a> to focus on a less-risky cancer drug. But the biggest disappointment of the year &ndash; as chosen by 41 percent of respondents to a <a href="http://www.bioworld.com/" target="_blank">BioWorld</a> poll &ndash; was the slow sales of <a href="http://www.dendreon.com/" target="_blank">Dendreon Corp.</a>&rsquo;s prostate cancer vaccine <a href="http://www.provenge.com/" target="_blank">Provenge</a> (sipuleucel-T). Sales fell way below estimates, and, over the course of the year, Dendreon&rsquo;s shares have lost about 80 percent of their value. The Seattle-based company has since retrenched and is hoping European approval, now pending, will help accelerate revenue growth. We&rsquo;ll be watching in 2012.</p>
<p>&nbsp;</p>
<p><strong>And the Strange Bedfellows Award Goes to . . .</strong></p>
<p>Probably one of the most bizarre deals ever in biotech was 2011&rsquo;s short-lived <a href="http://www.bioworld.com/content/amag-allos-claim-synergies-costs-drug-sales-merger" target="_blank">merger agreement</a> between <a href="http://www.allos.com/" target="_blank">Allos Therapeutics Inc.</a> and <a href="http://www.amag.com/" target="_blank">AMAG Pharmaceuticals Inc.</a> Having in common only commercially underperforming products &ndash; Allos&rsquo; <a href="http://www.folotyn.com/" target="_blank">Folotyn</a> (pralatrexate) for peripheral T-cell lymphoma and AMAG&#039;s iron deficiency drug <a href="http://www.feraheme.com/" target="_blank">Feraheme</a> (ferumoxytol) &ndash; execs from both firms tried hard to convince investors and analysts of the logic in combining the companies by pointing out a handful of &ldquo;cost synergies.&rdquo; But the merger was met with opposition from the get-go and even prompted hedge fund MSMB Capital Management to make an unsolicited bid for AMAG. Unsurprisingly, the deal was voted down by AMAG shareholders. Seriously, what were they thinking?</p>
<p>Well, that&rsquo;s my list of headline-grabbing biotech news in 2011. But it&rsquo;s hard to remember a whole year, and I&rsquo;m sure I&rsquo;ve forgotten something. What do you think were the biggest events in biotech in 2011?</p>
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		<title>China: An Image Adjustment</title>
		<link>http://bioworld.blogs.bioworld.com/2011/06/17/china-an-image-adjustment/</link>
		<comments>http://bioworld.blogs.bioworld.com/2011/06/17/china-an-image-adjustment/#comments</comments>
		<pubDate>Fri, 17 Jun 2011 20:37:31 +0000</pubDate>
		<dc:creator>Tom Wall</dc:creator>
				<category><![CDATA[Big pharma]]></category>
		<category><![CDATA[Biotechnology]]></category>
		<category><![CDATA[China]]></category>
		<category><![CDATA[Beijing]]></category>
		<category><![CDATA[MBA]]></category>
		<category><![CDATA[Red Guards]]></category>

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I’m an American baby boomer. For me – and I suspect many others of my generation – China’s image has not been the best. In my mental collage, fascination with Chinese culture and invention is offset by wariness of China’s...]]></description>
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			<content:encoded><![CDATA[<p>I’m an American baby boomer. For me – and I suspect many others of my generation – China’s image has not been the best. In my mental collage, fascination with Chinese culture and invention is offset by wariness of China’s political system and potential power.</p>
<p><span id="more-215"></span></p>
<p>Some parts of the collage: as a boy, listening to stories told by a Korean War vet uncle and neighbors about hand-to-hand fighting with young Chinese soldiers wearing tennis shoes on their frozen feet at Chosin Reservoir; as a teen, accounts of Mao Zedong’s chaotic Cultural Revolution, its purges and Red Guards; in middle age, the visual of a man standing in front of a column of tanks the morning after protestors were cleared from Tiananmen Square.</p>
<p>As recently as a decade ago, my wife and daughter returned from a week visiting friends in Shanghai and Beijing with tales of wonder (cosmopolitan Shanghai, the Forbidden City, the Great Wall) and tales of caution (poor air, bad water, strange food.) Interesting place to visit, maybe; but wouldn’t want to live there.</p>
<p>But, as the overnight adoption of the Internet should have taught me, things can change really fast these days. And so it is with my image of China.</p>
<p>As I did research and interviews recently for a BioWorld Today series on the state of China’s biotech industry called Biotech’s Emerging Giant, I was intrigued by the “sea turtle” phenomenon – thousands of Chinese scientists with advanced education and experience in the West returning home to teach and advance high-value enterprises, among them biotechnology. I wondered why anyone with advanced degrees from some of America’s best universities, good jobs with U.S. pharmas and biotechs, and prospects for a comfortable life, would willingly swap life in the U.S. for China?</p>
<p>People like sea turtle George Chen – an MD who has an MBA from University of Pennsylvania’s Wharton School, post-grad medical training at New York Medical College and a tour with Eli Lilly and Co. and was recently named chief medical officer for Beijing-based biotech start-up BeiGene Ltd. ‑ had the answer: opportunity.</p>
<p>Chen’s opportunity list: China has huge unmet medical needs coupled with a rapidly expanding elderly population; it needs effective, affordable medicines for diseases prevalent or unique to China; government-mandated healthcare reform and investment are creating life-sciences opportunities; rapid urbanization and industrialization are fueling economic expansion; there is rapid growth in the life-science talent pool, R&amp;D funding and enabling infrastructure; there are favorable government policies and financial support; and, multinational pharmas are externalizing therapeutics R&amp;D.</p>
<p>Some estimate that there are as many as 80,000 sea turtle scientists like Chen, give or take an advanced degree. Those I interviewed said that returning to China was a chance to do better work, faster work, fulfill a dream and take advantage of an opportunity.</p>
<p>The fact that the sea turtles view China, and not the U.S., as their preferred land of opportunity, is not lost on U.S. biotech executives like Acorda Therapeutics Inc. founder and CEO Ron Cohen and Vertex Pharmaceuticals Inc. founder and director Joshua Boger, who have visited China this year and, in Boger’s case, has a business partnership there.</p>
<p>Both were struck by the investment, optimism, speed, quality, creativity and commitment they saw – in biotech and in general – while there. Cohen said his impression was “shock and awe,” adding that the contrast with a U.S. grappling with economic, educational and infrastructure challenges was scary.</p>
<p>So, I’ve adjusted my image of China, as other Americans undoubtedly have.</p>
<p>But maybe America’s image of China will be less important, going forward, than China’s image of America.</p>
<p>By Tom Wall, BioWorld Today Staff Writer</p>
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		<title>Biotech’s Emerging Giant</title>
		<link>http://bioworld.blogs.bioworld.com/2011/05/24/biotech%e2%80%99s-emerging-giant/</link>
		<comments>http://bioworld.blogs.bioworld.com/2011/05/24/biotech%e2%80%99s-emerging-giant/#comments</comments>
		<pubDate>Tue, 24 May 2011 20:08:20 +0000</pubDate>
		<dc:creator>Lynn Yoffee</dc:creator>
				<category><![CDATA[Big pharma]]></category>
		<category><![CDATA[Biotechnology]]></category>
		<category><![CDATA[China]]></category>
		<category><![CDATA[Collaboration]]></category>
		<category><![CDATA[Deals]]></category>
		<category><![CDATA[New Drug Application]]></category>
		<category><![CDATA[Orphan disease]]></category>
		<category><![CDATA[Pharmaceutical]]></category>
		<category><![CDATA[Pipeline]]></category>
		<category><![CDATA[BIO]]></category>
		<category><![CDATA[Joshua Boger]]></category>
		<category><![CDATA[Tom Wall]]></category>

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			<content:encoded><![CDATA[<p>While attending the China track at this year’s J.P. Morgan conference in January I sat next to a gentleman who was smiling as he scanned the jam-packed penthouse meeting room. Shooting him a questioning glance, he responded with “last year I attended there were five people here.” While I find it hard to believe a session on China was poorly attended, even a year ago, biotech and pharma executives were noticeably shoulder to shoulder, jockeying for position just a few months ago. Intensity over the Chinese market has certainly ramped up, to say the least.</p>
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<p>As company after Chinese company pitched and presented, the Q&amp;A at the end of each session seemed to steer away from the usual grilling about the companies’ worth and pipes. Instead, questions were focused on how to get a toehold in China. Where to start? How to deal with the government? Should we go it alone or partner with existing Chinese companies?</p>
<p>A few weeks ago a contingent of U.S. executives, led by the Biotechnology Industry Organization’s President and CEO Jim Greenwood, visited China. It was a sort of pregame show in advance of BIO’s first China International Partnering Conference in October in Shanghai. The execs came home awestruck. BioWorld Today’s Tom Wall wrote about their impressions from that visit in a new series dubbed Biotech’s Emerging Giant, with the first article found here: http://bit.ly/k8kcJ2</p>
<p>Joshua Boger, founder of Vertex Pharmaceuticals Inc., of Cambridge, Mass. visited a manufacturing site for starting materials for the company’s just-approved hepatitis C drug Incivek (telaprevir), and declared the facility to be so immaculate and well prepared that “You can eat off the floor. Everything over there is so much better coordinated.”</p>
<p>In part II of the series published today, Wall interviews executives who are advising slow comers to light a fire under their China strategies . . . if a company expects to be around in the next five to 10 years.</p>
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