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	<title>Pharma Exec Blog &#187; Global</title>
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	<description>The Business of Pharmaceuticals</description>
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		<copyright>&#xA9;Advanstar Communications </copyright>
		<managingEditor>gkoroneos@advanstar.com (Advanstar Communications)</managingEditor>
		<webMaster>gkoroneos@advanstar.com(Advanstar Communications)</webMaster>
		<category>Pharmceuticals</category>
		<ttl>1440</ttl>
		<itunes:keywords>pharma, pharmaceuticals, life science, business, news, pharmexec, unplugged</itunes:keywords>
		<itunes:subtitle></itunes:subtitle>
		<itunes:summary>The Business of Pharmaceuticals</itunes:summary>
		<itunes:author>Advanstar Communications</itunes:author>
		<itunes:category text="Science &amp; Medicine">
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			<itunes:name>Advanstar Communications</itunes:name>
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		<item>
		<title>Fighting Tropical Disease&#58; It&#039;s Now a Common Cause</title>
		<link>http://blog.pharmexec.com/2012/02/08/partnership-key-to-combating-neglected-tropical-diseases/</link>
		<comments>http://blog.pharmexec.com/2012/02/08/partnership-key-to-combating-neglected-tropical-diseases/#comments</comments>
		<pubDate>Wed, 08 Feb 2012 10:55:30 +0000</pubDate>
		<dc:creator>Guest Blogger</dc:creator>
				<category><![CDATA[Global]]></category>
		<category><![CDATA[Guest Blog]]></category>
		<category><![CDATA[R&D]]></category>
		<category><![CDATA[healthcare]]></category>
		<category><![CDATA[DfID. WHO]]></category>
		<category><![CDATA[Neglected Tropical Diseases]]></category>
		<category><![CDATA[USAID]]></category>
		<category><![CDATA[World Health Organization]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=3495</guid>
		<description><![CDATA[David Torstensson, Senior Consultant, Pugatch Consilium, considers what the London Declaration on Neglected Tropical Diseases reveals about research and development efforts into neglected and tropical diseases.
Last week, the Gates Foundation, several government aid agencies, the World Health Organization [WHO], and a host of  biopharm companies including GSK, Merck, Eisai, J&#38;J, Sanofi, Novartis, Bayer and Abbott, [...]]]></description>
			<content:encoded><![CDATA[<p><em>David Torstensson, Senior Consultant, Pugatch Consilium, considers what the London Declaration on Neglected Tropical Diseases reveals about research and development efforts into neglected and tropical diseases.</em></p>
<p>Last week, the Gates Foundation, several government aid agencies, the World Health Organization [WHO], and a host of  biopharm companies including GSK, Merck, Eisai, J&amp;J, Sanofi, Novartis, Bayer and Abbott, committed to control and eradicate a number of neglected and tropical diseases (NTDs).  Together, the group approved a “London Declaration on Neglected Tropical Diseases.”  This new framework protocol speaks volumes about a signal change taking place in the way big pharma manages R&amp;D:   when it comes to tackling difficult diseases and conditions, cast a wide net. <span id="more-3495"></span></p>
<p>NTDs are diseases for which there is no significant market in developed nations and that disproportionately affect poor and marginalized populations, often in low and middle income countries.  The WHO estimates that one billion people are afflicted by these diseases.</p>
<p>Despite the scale of the problem, relatively small amounts of biopharmaceutical R&amp;D have gone into the development of new drugs and treatments for NTDs.  One of the most frequently cited studies found that out of a total of 1,393 new chemical entities marketed in the period 1975-1999 only 16 were for NTDs.</p>
<p>Findings like this prompted a number of new initiatives and international programs aimed at increasing drug development and available medicines. Scholars, researchers, international organizations, drug companies and policymakers have all tried to understand how to best incentivize new R&amp;D into NTDs and a host of new R&amp;D models have all been put forward including patent pools, research prizes, advanced purchase commitments, R&amp;D tax credits and product development partnerships (PDPs).</p>
<p><strong>A new R&amp;D model?</strong><br />
Since 2000 R&amp;D in NTDs has increased substantially. Research by the Tufts Center for the Study of Drug Development shows that between 2000 and May 2009, 26 products for neglected diseases<br />
were marketed with a total of 26 indications. Out of these almost half of approvals occurred in malaria with 11 new drugs being marketed. New partnerships between industry, governments and philanthropic groups have increased the funding for neglected diseases substantially. The Global Funding of Innovation for Neglected Diseases (GFINDER) survey finds that in 2009 $3.2billion was allocated for research relating to neglected diseases – a significant increase from a decade or two before.</p>
<p>While many of these new R&amp;D initiatives are yet unproven, there is growing evidence that many PDPs are having some success in developing new drugs and treatments for NTDs and other diseases which disproportionately affect poor populations, including HIV/AIDS, malaria and tuberculosis. For example, the percentage of approved NTD products sponsored by public-private partnerships increased from 15% in the time period 1975-1999 to 46% in the decade 2000-2009. Significantly, one of the largest PDPs is the Drugs for Neglected Diseases initiative (DNDi), once a fringe group but now a key partner to industry – and a signatory of the London Declaration.</p>
<p><strong>London Declaration: A Bold Group Consensus </strong><br />
The stated purpose of the Declaration is to mobilize and coordinate the development and dissemination of drugs and treatments for a number of NTDs. Specifically, the declaration seeks to eliminate five NTDs (Guinea worm, Leprosy, Lymphatic filariasis, Blinding trachoma and Sleeping sickness) and control 5 others (Schistosomiasis, River blindness, Soil-Transmitted Helminthes, Chagas and Visceral Leishmaniasis) by 2020. There are three main measures or methods that will be used to achieve these goals:</p>
<ul>
<li>Greater quantities of drugs donated by international manufacturers – examples include Eisai’s donation of 2.2 billion DEC tablets for the treatment of Lymphatic Filariasis and Merck’s commitment to continue unlimited supplies of ivermectin for the treatment of river blindness for an unlimited period.</li>
<li>Research partnerships between DNDi and manufacturers – examples include partnerships with Eisai to develop ravuconazole for the treatment of Visceral Leishmaniasis; agreement with 11 companies to allow DNDi access to their compound libraries, including data and knowledge about the compounds; and clinical and preclinical partnerships with Abbott, Johnson &amp; Johnson and Pfizer to repurpose flubendazole as a potential macrofilaricide used in the treatment of Lymphatic Filariasis and River Blindness.</li>
<li>Technical support and implementation – examples include the World Bank continuing to play a crucial role in funding and overseeing local health systems’ efforts against NTDs; also USAID will continue to support integrated NTD programs in low and middle income countries.</li>
</ul>
<p>The London Declaration in many ways confirms that the partnership route between industry, public sector, nonprofits and philanthropic organizations is a key component in the future arsenal of R&amp;D.  It also joins like never before the art of discovery and development with the crucial issue of building access to existing treatments targeting NTDs.  Progress of the pact clearly bears watching over the next few years, with the key question yet to be answered: can cooperation on a large scale produce lasting gains in global public health?</p>
<p><a href="davidt@pugatch-consilium.com">davidt@pugatch-consilium.com</a></p>
<p><!--more--></p>
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		<title>ePharma Summit&#58; Less Proselytizing, More Results</title>
		<link>http://blog.pharmexec.com/2012/02/07/epharma-summit-less-proselytizing-more-results/</link>
		<comments>http://blog.pharmexec.com/2012/02/07/epharma-summit-less-proselytizing-more-results/#comments</comments>
		<pubDate>Tue, 07 Feb 2012 23:15:36 +0000</pubDate>
		<dc:creator>Ben Comer</dc:creator>
				<category><![CDATA[Advertising]]></category>
		<category><![CDATA[E-Media]]></category>
		<category><![CDATA[Events]]></category>
		<category><![CDATA[Global]]></category>
		<category><![CDATA[Marketing]]></category>
		<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[Strategy]]></category>
		<category><![CDATA[patient education]]></category>
		<category><![CDATA[social media]]></category>
		<category><![CDATA[ePharma Summit]]></category>
		<category><![CDATA[Facebook]]></category>
		<category><![CDATA[J&J]]></category>
		<category><![CDATA[Janssen]]></category>
		<category><![CDATA[Sanofi]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=3488</guid>
		<description><![CDATA[At the digital marketing-focused ePharma Summit in New York this week, many of the problems and frustrations related to the “big three” – Facebook, Twitter and YouTube – were hashed out for umpteenth time.
Those issues (adverse events, off-label discussions, fair balance presentation, no meaningful FDA guidance) hardly need rehashing here, and despite the barriers, progress [...]]]></description>
			<content:encoded><![CDATA[<p>At the digital marketing-focused ePharma Summit in New York this week, many of the problems and frustrations related to the “big three” – Facebook, Twitter and YouTube – were hashed out for umpteenth time.</p>
<p><span id="more-3488"></span>Those issues (adverse events, off-label discussions, fair balance presentation, no meaningful FDA guidance) hardly need rehashing here, and despite the barriers, progress has been made on the digital front, as evidenced by – if nothing else – pharma’s willingness to invest in smaller-scale social media efforts not directly tied to product sales. In the digital sphere, ROI means “hitting the primary endpoint,” and that endpoint could be data collection, engagement with widgets or functionalities on a page or within an app, or the number of visitors (or likes) on a Facebook page. “The ROI of social media is that your business will still exist in five years,” a quote from <em>Socialnomics</em> author Erik Qualman that surfaced in one of the presentations, speaks to the accepted necessity &#8211; in some quarters &#8211; of social media participation and customer engagement.</p>
<p>“Advertising has already largely shifted to what people say about your brand,” as opposed to the magazine, television and radio ads that people consume, said Martin Husar, customer strategy and innovation at Sanofi Canada. In Canada, DTC isn’t allowed, but last October Sanofi tapped the Toronto-based agency MediResource for an interactive Facebook campaign around atrial fibrillation (A-fib). The business objective, said Husar, was to “own the primary venues for Canadian patients and caregivers to learn about AFib.” By his measure, the company’s Afib at Heart | La fibrillation auriculaire à coeur Facebook campaign has been a success – one need not “like” the page to access the content, and thousands have clicked on tabs like “Ask the Expert,” or “Don’t Skip a Beat,” a Simon-inspired memory game.</p>
<p>A Janssen Canada educational campaign around psoriasis goes a step further, offering a list of available treatments, and a dermatology locator that returns only those dermatologists who “agree that they will use biologics” – Janssen markets Stelara, an immunomodulating biologic – and who have voluntarily signed up to be listed on Janssen’s Living Well With Psoriasis website, according to Spilios Asimakopoulos, director of marketing technology, Janssen Pharmaceuticals Canada. The site also offers a shareable psoriasis “severity calculator,” which is available online or as an app for download.</p>
<p>South of the Canadian border, others agree that the educational/disease awareness space is a good place for experimentation. John Patten, a sales rep for Facebook, told ePharma attendees that “Facebook makes sense in terms of initial support groups [for rare diseases], and locating others with the disease.” He also singled out Bayer’s Walk for Hemophilia and Sanofi Pasteur’s Voices of Meningitis as good examples of Facebook educational campaigns. “Pharma is more powerful in the unbranded, open wall pages” on Facebook, said Patten. Whitelisted brand pages, or pages with the comments function disabled, will be “de-prioritized in the news feed,” and they go against Facebook’s model, which Patten defined as “a distribution platform that promotes authentic sharing.” Perhaps as an added nudge to discourage whitelisted pages, Patten announced that by the end of February, “admins can drill down into individual commenters, and message them directly,” to help deal with “your drug turned my arm blue” adverse events comments.</p>
<p>A couple of hours before Patten’s presentation, however, a regulatory affairs director from a major pharmaceutical company was on a panel griping about the fact that while Facebook allows blocking of comments on the wall, “we can’t turn off sharing or commenting” on the actual brand image. Asked whether the company responds to such comments on the branded Facebook page, the panelist said no: “once you do that, where do you stop?”</p>
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		<title>Unmet Need in the Migraine Space?</title>
		<link>http://blog.pharmexec.com/2012/02/03/unmet-need-in-the-migraine-space/</link>
		<comments>http://blog.pharmexec.com/2012/02/03/unmet-need-in-the-migraine-space/#comments</comments>
		<pubDate>Fri, 03 Feb 2012 23:11:54 +0000</pubDate>
		<dc:creator>Ben Comer</dc:creator>
				<category><![CDATA[FDA]]></category>
		<category><![CDATA[Global]]></category>
		<category><![CDATA[Marketing]]></category>
		<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[Strategy]]></category>
		<category><![CDATA[Technology]]></category>
		<category><![CDATA[Allergan]]></category>
		<category><![CDATA[CEOs]]></category>
		<category><![CDATA[MAP Pharmaceuticals]]></category>
		<category><![CDATA[Migraine]]></category>
		<category><![CDATA[PDUFA]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=3472</guid>
		<description><![CDATA[Allergan CEO David Pyott is bullish on Botox’s potential as a salve for  chronic migraine. He’s also betting on a next-gen dihydroergotamine  (DHE) – Levadex – from MAP Pharmaceuticals.

It’s hard to know whether migraine sufferers will get behind Botox as a  treatment; migraine patients are notoriously allergic to doctor visits,  and [...]]]></description>
			<content:encoded><![CDATA[<div id="attachment_3474" class="wp-caption alignright" style="width: 195px"><img class="size-full wp-image-3474 " title="David Pyott" src="http://blog.pharmexec.com/wp-content/uploads/2012/02/Screen-shot-2012-02-03-at-6.00.30-PM.png" alt="David Pyott" width="185" height="144" /><p class="wp-caption-text">Allergan CEO David Pyott</p></div>
<p>Allergan CEO David Pyott is bullish on Botox’s potential as a salve for  chronic migraine. He’s also betting on a next-gen dihydroergotamine  (DHE) – Levadex – from MAP Pharmaceuticals.</p>
<p><span id="more-3472"></span></p>
<p>It’s hard to know whether migraine sufferers will get behind Botox as a  treatment; migraine patients are notoriously allergic to doctor visits,  and many go undiagnosed. But for the worst kinds of migraines,  particularly those that don’t respond to triptans or currently marketed  DHEs, patients will probably be willing to try just about anything.  Allergan CEO David Pyott, and MAP Pharmaceuticals CEO Tim Nelson, see  headroom for growth in the category.</p>
<p>In 2009, the migraine market slipped into a steady decline after Imitrex, the go-to member of the triptan class, lost its patent (and blockbuster sales). Many of Imitrex’s classmates – Maxalt, Amerge, Zomig, and others – will face generic competition this year, if they aren’t facing it already. That makes Botox for migraine a difficult sell – it&#8217;s for chronic migraine, firstly, and it costs exponentially more than generic Imitrex – but during a 4Q earnings call yesterday Pyott said the migraine indication is performing “better than planned.” Around 4,600 physicians have been trained to give the injection, to date, said Pyott. “The vast majority of neurologists will inject for as long as three injection cycles,” even if they’re skeptical about the drug’s efficacy for migraine,” he Pyott. He&#8217;s hoping they&#8217;ll be convinced after that.</p>
<p>Branded print ads for Botox migraine will launch in women’s magazines this month, and an unbranded disease awareness campaign on television “has worked – the click-through on the website is positive,” said Pyott, adding that Allergan&#8217;s internal consumer surveys have shown “a high level of satisfaction” among patients.</p>
<p>After an upfront payment of $60 million last February, MAP Pharmaceuticals scored a $20 million milestone payment last August, when it filed Levadex with FDA. The company could receive up to $97 million more from Allergan if all goes well with the regulatory process; the PDUFA date on Levadex is March 26. Levadex, like Valeant Pharmaceuticals’ Migranal, is a DHE, but Migranal is a nasal spray, while Levadex is inhaled. The benefit with inhalation means that the drug sidesteps first pass metabolism en route to the brain – it avoids the GI tract, and potential dilution. At JP Morgan’s 30<sup>th</sup> Annual Healthcare Conference in January, MAP CEO Tim Nelson said that Levadex “works faster, and has fewer side effects, than the triptans.” He added that 29 million scripts for migraine were written in 2008, and close to half of them were written off-label. After triptan, “41 percent of the scripts were for opioids, and 28 percent were anti-depressants,” said Nelson. MAP will hire 50 specialty sales reps if Levadex gets the FDA go-ahead, and will expand the drug into pediatrics and other neurological conditions later on, he said.</p>
<p>Levadex won’t compete directly with Botox for migraine; the former is for acute migraine, the latter for chronic migraine. Nelson said Allergan’s expertise in managed care, reimbursement and experience with FDA, makes it a good partner for Levadex. MAP is also looking for “a partner in Asia, and in ex-US in general,” said Nelson.</p>
<p>At $40 to $80, with a ceiling at $100 per dose, though, Levadex may be as tough a sell as Botox. But then again, migraine sufferers only want one thing when the pain sets in: for it to be gone.</p>
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		<title>Roche Ups the Stakes on Personalized Medicine</title>
		<link>http://blog.pharmexec.com/2012/02/01/roche-ups-the-stakes-on-personalized-medicine/</link>
		<comments>http://blog.pharmexec.com/2012/02/01/roche-ups-the-stakes-on-personalized-medicine/#comments</comments>
		<pubDate>Wed, 01 Feb 2012 13:59:08 +0000</pubDate>
		<dc:creator>Guest Blogger</dc:creator>
				<category><![CDATA[Biotech]]></category>
		<category><![CDATA[Europe]]></category>
		<category><![CDATA[Global]]></category>
		<category><![CDATA[Guest Blog]]></category>
		<category><![CDATA[diagnostics]]></category>
		<category><![CDATA[Personalized medicine]]></category>
		<category><![CDATA[Roche]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=3439</guid>
		<description><![CDATA[By Patricia Van Arnum, Pharmaceutical Technology.
Personalized medicine, which targets individualized treatment and care based on personal and genetic variations, holds much promise for the pharmaceutical industry. Several pharmaceutical majors continue to invest in this emerging field as evident by Roche’s $5.7-billion bid last week for Illumina, a provider of gene-sequencing tools and related analytics.
Roche, perhaps, [...]]]></description>
			<content:encoded><![CDATA[<p><em>By Patricia Van Arnum, Pharmaceutical Technology.</em></p>
<p>Personalized medicine, which targets individualized treatment and care based on personal and genetic variations, holds much promise for the pharmaceutical industry. Several pharmaceutical majors continue to invest in this emerging field as evident by Roche’s $5.7-billion bid last week for Illumina, a provider of gene-sequencing tools and related analytics.<span id="more-3439"></span></p>
<p>Roche, perhaps, more than any other pharmaceutical company, is banking heavily on the combination of diagnostics and drug development to drive pharmaceutical innovation. In reporting its 2010 results in February 2011, Roche reported that it had 12 new molecular entities in late-stage development, of which six were potential personalized healthcare medicines with planned companion diagnostic tests, which included Zelboraf (vemurafenib) and its companion diagnostic for BRAF mutation-positive metastatic melanoma. FDA approved Zelboraf for treating BRAF V600E mutation-positive, inoperable, or metastatic melanoma and the cobas 4800 BRAF V600 Mutation Test, a diagnostic test developed by Roche, in August 2011.</p>
<p>Earlier this month, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended that Zelboraf be granted full marketing authorization as a monotherapy for treating adult patients with BRAF V600 mutation-positive unresectable or metastatic melanom. The corresponding European Commission decision on the marketing authorization of Zelboraf is expected in February 2012. Marketing authorization submissions for Zelboraf also are under review by health authorities in Australia, New Zealand, Brazil, India, Mexico, Canada, and other countries worldwide.</p>
<p>Roche also is using its diagnostic strategy to support new indications for existing drugs. Last month, it reported that the cobas EGFR Mutation Test was CE-marked, an indicator of a product’s conformity with EU requirements, and is now commercially availabile in Europe and other countries that recognize the CE mark. The cobas EGFR Mutation Test is a companion diagnostic to identify patients with non-small-cell lung cancer (NSCLC) who harbor mutations in the EGFR (epidermal growth factor receptor) gene and who may benefit from treatment with anti-EGFR tyrosine kinase inhibitors, such as Roche’ Tarceva (erlotinib). Tarceva, an oral EGFR inhibitor, was first approved in September 2004 to treat locally advanced or metastatic NSCLC after failure of at least one other chemotherapy treatment. It later was approved by the European Commission in September 2011 as a first-line monotherapy in people with locally advanced or metastatic NSCLC with EGFR-activating mutations.</p>
<p>Other companies also are reporting success with certain personalized medicines. In August 2011, FDA approved Pfizer’s Xalkori (crizotinib) for treating locally advanced or metastatic NSCLC that expresses the abnormal anaplastic lymphoma kinase (ALK) as detected by an FDA-approved test. The agency approved the drug along with a diagnostic test for the ALK gene abnormality, Abbott Molecular’s Vysis ALK Break Apart FISH Probe Kit. Up to 7% of those patients with NSCLC, typically patients without a history of smoking, have the gene abnormality.</p>
<p>Although personalized medicines will likely hold only a small part of the overall pharmaceutical market by value and volume in the near term, these successes portend of a changing paradigm in drug development.</p>
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		<title>Pharma&#58; Get Ready for the New  Supply Chains</title>
		<link>http://blog.pharmexec.com/2012/01/30/pharma-get-ready-for-the-new-supply-chains/</link>
		<comments>http://blog.pharmexec.com/2012/01/30/pharma-get-ready-for-the-new-supply-chains/#comments</comments>
		<pubDate>Mon, 30 Jan 2012 12:35:20 +0000</pubDate>
		<dc:creator>Guest Blogger</dc:creator>
				<category><![CDATA[Global]]></category>
		<category><![CDATA[Guest Blog]]></category>
		<category><![CDATA[Safety]]></category>
		<category><![CDATA[Supply Chain]]></category>
		<category><![CDATA[chill chain]]></category>
		<category><![CDATA[supply chain management]]></category>
		<category><![CDATA[traceability]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=3431</guid>
		<description><![CDATA[New pharma supply chains, where chill control and traceability challenges will be far more critical, will emerge over the next decade, So it’s time, argues Julian Mosquera, for the industry to upgrade its capabilities.


The pharmaceuticals industry is undergoing major disruption and every comparative benchmark indicates that the sector needs to make a step change in [...]]]></description>
			<content:encoded><![CDATA[<p><em>New pharma supply chains, where chill control and traceability challenges will be far more critical, will emerge over the next decade, So it’s time, <em>argues</em></em><em><em> Julian Mosquera,</em><em> for the industry to upgrade its capabilities.</em></em></p>
<p><em></p>
<div class="wp-caption alignright" style="width: 186px"><img title="Julian Mosquera" src="http://farm8.staticflickr.com/7028/6789564771_b7689831d0_m.jpg" alt="Julian Mosquera" width="176" height="176" /><p class="wp-caption-text">Julian Mosquera</p></div>
<p></em></p>
<p>The pharmaceuticals industry is undergoing major disruption and every compar<img src="file:///Users/jupton/Desktop/Julian-Mosquera.jpg" alt="" />ative benchmark indicates that the sector needs to make a step change in asset performance, with working capital targeted for direct improvement. All players are planning major reconfigurations of their supply and distribution operations, from end to end, in a bid to improve cost and service efficiency. This challenge is all the more prescient with a large number of blockbusters coming off patent over the next five years, opening the door to generic producers, who are actively “forging strategic alliances” to secure the rights to produce cheaper copies, according to researchers at Frost &amp; Sullivan. While expenditure on new medicine has risen dramatically over the past decade, regulatory approval for new drugs has declined. Where big pharma could turn to blockbusters in the past, they are now looking to smarter portfolio management for competitive advantage.</p>
<p>Historical margins meant pharma paid little attention to their supply chains. However, over the last decade such complacency has become unacceptable to boards. Directors in the current environment are looking to their COOs and supply chain directors to build resilience into supply chain networks, to protect against market volatility and to drive real cost reduction. <span id="more-3431"></span></p>
<p>The industry’s manufacturing footprint is increasingly challenged by significant overcapacity. Efficiency, agility and flexibility are priorities, with slow moving/low volume production calling for a different supply approach. Now, more than ever, companies should look to increase product speed through the supply chain, challenging inventory touch and holding points in every market in which they operate.<br />
Managing the chill chain is producing real challenges for the sector. As part of a much wider traceability issue, the sector has been slow to adopt the necessary technology and levels of control that may be expected of such a high-value, sensitive product line. Reliance on third parties to introduce such capabilities has had limited success. It is time for the sector to upgrade its capabilities as the new pharma supply chains emerge over the next decade, where chill control and traceability challenges will be far more critical.</p>
<p>There is an opportunity for companies to better leverage scale through structural change, working towards best practices, and most notably by improving and integrating sales and operations planning &#8212; something that is commonplace in other industries such as FMCG. Competition is becoming fierce, putting emphasis onto accurate forecasting and supply chain visibility.</p>
<p>Supply chain cost management is now a priority. Having leveraged scale and rationalised productive capacity businesses are looking for further cost-savings. The global nature of distribution has given rise to over-complex and under-managed supply chains, which are now recognised as a source of major cost reductions. Without a clear framework for delivering these savings, businesses are at risk of compromising service and the integrity of supply.</p>
<p>In this context, it is alarming how few pharma businesses know with any accuracy their ‘Cost to Serve’. Which products, distribution channels, customers or regions need more attention, and which need less? How should stock holding policies be tuned to these different groups? Where can lead times or touch points be reduced? Cost to Serve allows companies to calculate the true cost of servicing any combination of customer, product or market and takes a truly end-to-end approach (materials sourcing, manufacturing, logistics, distribution and consumption). By establishing clear policies for customer-product groupings, alongside disciplined, systematic control, it is possible to realise dramatic and permanent cost reductions.</p>
<p><em><br />
Julian Mosquera is a Director at <a href="http://www.lcpconsulting.com/">LCP Consulting</a>, a specialist in customer-driven supply chain management.</em></p>
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		<title>Arise Sir Andrew &#40;Witty&#41;</title>
		<link>http://blog.pharmexec.com/2012/01/04/arise-sir-andrew-witty/</link>
		<comments>http://blog.pharmexec.com/2012/01/04/arise-sir-andrew-witty/#comments</comments>
		<pubDate>Wed, 04 Jan 2012 10:38:03 +0000</pubDate>
		<dc:creator>Guest Blogger</dc:creator>
				<category><![CDATA[Global]]></category>
		<category><![CDATA[Op-Ed]]></category>
		<category><![CDATA[leadership]]></category>
		<category><![CDATA[Andrew Witty]]></category>
		<category><![CDATA[GSK]]></category>
		<category><![CDATA[New Year Honours]]></category>
		<category><![CDATA[UK pharma]]></category>

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		<description><![CDATA[Big Pharma received a nod in the UK’s New Year’s Honours List this week when a knighthood was duly bestowed upon GSK’s Andrew Witty — making him ‘Sir Andrew’ to you and me. For once, though, receiving such an honor did not exactly place him in totally exalted company.
This year’s list has attracted criticism for [...]]]></description>
			<content:encoded><![CDATA[<p>Big Pharma received a nod in the UK’s New Year’s Honours List this week when a knighthood was duly bestowed upon GSK’s Andrew Witty — making him ‘Sir Andrew’ to you and me. For once, though, receiving such an honor did not exactly place him in totally exalted company.</p>
<p><span id="more-3364"></span>This year’s list has attracted criticism for its inclusion of controversial characters such as Paul Ruddock — whose hedge fund management company Landsdowne Associates made £100 million ($156 million) betting on the collapse of Northern Rock — and Gerald Ronson, who was sent to jail for six months and fined £5 million in 1990 for his part in the Guinness share-trading scandal (but has since redeemed himself with much philanthropic fundraising). There was also a measure of hostile reaction to the knighting of Paul Bazalgette, a TV executive responsible for bringing the egregious <em>Big Brother</em> to British TV screens.</p>
<p>Still, none of this is bad for pharma’s reputation — in such company Witty really does seem something of the ‘knight in shining armour’, rewarded as he is for services to the economy rather than donating vast amounts to the Conservative Party (which some would suggest is the reason for Ruddock’s recognition). And Witty is not the only pharma industry representative to be honored. Richard Barker, former Director-General of the Association of the British Pharmaceutical Industry, was also handed an OBE (Order of the British Empire).</p>
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		<title>Lilly&#039;s Decentralized Global Launch Strategy</title>
		<link>http://blog.pharmexec.com/2011/12/07/lillys-decentralized-global-launch-strategy/</link>
		<comments>http://blog.pharmexec.com/2011/12/07/lillys-decentralized-global-launch-strategy/#comments</comments>
		<pubDate>Wed, 07 Dec 2011 21:09:53 +0000</pubDate>
		<dc:creator>Ben Comer</dc:creator>
				<category><![CDATA[Global]]></category>
		<category><![CDATA[Market Access]]></category>
		<category><![CDATA[Strategy]]></category>
		<category><![CDATA[leadership]]></category>
		<category><![CDATA[Eli Lilly]]></category>
		<category><![CDATA[Launch]]></category>

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		<description><![CDATA[Global headquarters may get the strategic ball rolling for a new drug launch, but Lilly&#8217;s affiliates are responsible for bringing home the bacon, according to a Lilly global brand director.

The decentralized approach to product commercialization, which puts global headquarters in the role of “coach for the affiliate,” represents a corporate rethinking, although the pendulum tends [...]]]></description>
			<content:encoded><![CDATA[<p>Global headquarters may get the strategic ball rolling for a new drug launch, but Lilly&#8217;s affiliates are responsible for bringing home the bacon, according to a Lilly global brand director.</p>
<p><span id="more-3324"></span></p>
<p>The decentralized approach to product commercialization, which puts global headquarters in the role of “coach for the affiliate,” represents a corporate rethinking, although the pendulum tends to swing from centralized to decentralized (and back) over time, said S. Michael Harrill, Lilly’s global brand director, neuroscience, during a presentation yesterday. “We’re now in decentralized mode, which is a big difference from five years ago,” said Harrill.</p>
<p>As such, global headquarters and affiliates do their own market research prior to launch; the former does not necessarily guide the latter. Prior to a global launch, companies are understandably “working with incomplete data,” although Harrill says Lilly is “investing heavily in market research, and will do even more” in the future. But it’s important for affiliates to conduct their own research, rather than cribbing exclusively from headquarters’ intel, “so it’s not supposition on top of supposition,” said Harrill. Allowing affiliates a degree of independence lets them adapt to the situation more quickly, he said.</p>
<p>In pre-launch, Harrill emphasized the importance of ‘PRA,’ or pricing, reimbursement and access issues, and anticipating payers’ needs. “Ten years ago, we were creating a pricing value and access notebook too late, around phase 3, but now that happens much earlier,” he said. Other pre-launch activities include an understanding of the patient journey – a “new moniker” at Lilly – as well as key player segmentation, competitive activities assessment, tracking and influencing environmental issues (SWOT analyses, for example), creation of HCP and patient education materials and brand certification training.</p>
<p>In the peri-launch phase, Harrill said key roles include tracking and influencing an affiliate’s operating expenses, coordinating global manufacturing supplies, insuring PR and patient advocacy plans are in place, conducting launch preparedness assessments, and updating the global brand strategy.</p>
<p>In the post-launch phase, the old rule of thumb – at eight months, it’s possible to get a pretty good idea of a product’s trajectory – isn’t appropriate anymore, said Harrill. “Delays in access, REMS, and other issues have lengthened the front end of uptake…there are often six or 12-month delays in access.” Building on that thought, Harrill said the sales rep to PRA personnel ratio is “out of balance.” He cited the fact that Lilly has only four PRA managers in Italy, in neuroscience. “When you think about the number of accounts in Italy, that’s mind-boggling,” said Harrill. In Italy, marketers could end up “sitting there twiddling their thumbs while four PRAs get access in the 12 provinces you’re counting on.” Harrill also acknowledged rising commercialization costs and shorter net exclusivity periods, and faster uptake of generic products upon expiry, to underscore the need for organizations to “look for what the payer wants, early.”</p>
<p>Harrill’s comments were delivered at <a href="http://www.cbinet.com/conference/pc11121">CBI’s 2<sup>nd</sup> Annual Commercialization and Market Access Congress</a>, in Philadelphia, on December 6. CBI is a subsidiary of Advanstar, publisher of <em>PharmExec</em>.</p>
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		<title>GSK&#039;s Andrew Witty&#58; Further Concerns for Europe</title>
		<link>http://blog.pharmexec.com/2011/11/30/gsks-andrew-witty-further-concerns-for-europe/</link>
		<comments>http://blog.pharmexec.com/2011/11/30/gsks-andrew-witty-further-concerns-for-europe/#comments</comments>
		<pubDate>Wed, 30 Nov 2011 14:16:47 +0000</pubDate>
		<dc:creator>Julian Upton</dc:creator>
				<category><![CDATA[Europe]]></category>
		<category><![CDATA[Global]]></category>
		<category><![CDATA[People]]></category>
		<category><![CDATA[pricing]]></category>
		<category><![CDATA[Barclay's Bank]]></category>
		<category><![CDATA[debt crisis]]></category>
		<category><![CDATA[GSK]]></category>
		<category><![CDATA[High Pay Commission]]></category>
		<category><![CDATA[trust]]></category>

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		<description><![CDATA[GSK’s Andrew Witty underlined his growing concerns with the business climate in Europe with his comments to the UK’s High Pay Commission last week. The Commission, set up by left-wing pressure group Compass, reported on the ‘corrosive’ effects of ‘boardroom excess’ and called for greater transparency in the setting of executive pay. The pay of [...]]]></description>
			<content:encoded><![CDATA[<p>GSK’s Andrew Witty underlined his growing concerns with the business climate in Europe with his comments to the <a href="http://www.guardian.co.uk/business/2011/nov/22/glaxosmithkline-business-executive-pay-bonuses">UK’s High Pay Commission last week</a>. The Commission, set up by left-wing pressure group Compass, reported on the ‘corrosive’ effects of ‘boardroom excess’ and called for greater transparency in the setting of executive pay. The pay of the head of Barclay’s bank, the report revealed, rose by nearly 5,000% in 30 years, from £87,323 ($136,224) a year in 1979 to £4,365,636 ($6,810,392) a year in 2010. The figures stirred anger and dismay among left-leaning politicians but, rather more surprisingly, several newspaper reports led with Witty’s comments that trust in business “has clearly eroded and needs to be reconstructed.” He went on: “It&#8217;s very dangerous if a country doesn&#8217;t trust the private sector.&#8221;<span id="more-3307"></span></p>
<p>This announcement came just a couple of weeks after Witty — in his capacity as President of EFPIA — <a href="http://www.reuters.com/article/2011/11/10/us-pharmaceuticals-europe-idUSTRE7A93C220111110">outlined the industry’s “significant concern”</a> to EC Health Commissioner John Dalli over the debt crisis in Europe, particularly in Greece, Italy, Ireland, Portugal and Spain, where, he pointed out, pharma has been obliged to take price cuts and discounts of more than €7 billion ($9.3 billion) during 2010 and 2011. &#8220;The pressures on innovation are now immense,” Witty wrote. “I believe it is time to review current pricing and reimbursement practices&#8230;” Last month <a href="http://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/8851599/GlaxoSmithKline-chief-Andrew-Witty-an-extreme-bull-on-emerging-markets.html"><em>The Telegraph</em></a> reported that the European price-cut toll has seen GSK’s revenue fall by 4% in the region during the third quarter. Witty predicted that the ongoing crisis (along with the effects of US healthcare reform) will cost GSK about £325m ($507 million) this year.</p>
<p>GSK’s lifeline, of course, is now coming from the emerging markets — outside America and Europe, the company’s Q3 sales grew by 17% — which now represents 38% of its total turnover. But with pharma particularly vulnerable to issues of trust and pricing, Witty’s stance suggests that standing firm and stoically weathering the blows is no longer going to be enough to ride out Europe’s economic storm.</p>
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		<title>Tiered Pricing Not Always a Win-Win</title>
		<link>http://blog.pharmexec.com/2011/11/22/tiered-pricing-not-always-a-win-win/</link>
		<comments>http://blog.pharmexec.com/2011/11/22/tiered-pricing-not-always-a-win-win/#comments</comments>
		<pubDate>Tue, 22 Nov 2011 18:40:58 +0000</pubDate>
		<dc:creator>Ben Comer</dc:creator>
				<category><![CDATA[Corporate Responsibility]]></category>
		<category><![CDATA[Emerging Markets]]></category>
		<category><![CDATA[Global]]></category>
		<category><![CDATA[IP]]></category>
		<category><![CDATA[Manufacturing]]></category>
		<category><![CDATA[Market Access]]></category>
		<category><![CDATA[R&D]]></category>
		<category><![CDATA[Strategy]]></category>
		<category><![CDATA[pricing]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=3301</guid>
		<description><![CDATA[Tiered pricing, or selling critical medicines to developing countries at a standardized discount price, can improve access in the short term, but arbitrary demographic groupings and misaligned incentives often stack the deck in favor of manufacturers, not patients.

At first blush, a system whereby countries or geographic areas are carved out along socioeconomic lines maximizes profit: [...]]]></description>
			<content:encoded><![CDATA[<p>Tiered pricing, or selling critical medicines to developing countries at a standardized discount price, can improve access in the short term, but arbitrary demographic groupings and misaligned incentives often stack the deck in favor of manufacturers, not patients.</p>
<p><span id="more-3301"></span></p>
<p>At first blush, a system whereby countries or geographic areas are carved out along socioeconomic lines maximizes profit: prices are set according to consumers’ “willingness or ability to pay,” which can bring previously unaffordable treatments into use. However, a tiered price can work against local competition in a given area, which tends to deliver a lower sustainable price over the long term, according to a critical analysis of tiered pricing done by authors from Medecins Sans Frontieres and Harvard School of Public Health.</p>
<p>Of the case studies examined in the report, Abbott’s price for the HIV treatment lopinavir and ritonavir (LPV/r) remained at $500 in African countries and other “least developed countries” from 2002 to 2007, or until the Clinton HIV/AIDS Initiative announced a generic LPV/r for $470. Abbott then reduced its price to $440, suggesting that manufacturers “do not have strong incentives to reduce tiered prices in the absence of competition, nor are tiered prices immune to competition when it does arise,” according to the <a href="http://www.globalizationandhealth.com/content/7/1/39">report</a>.</p>
<p>In the case of Bristol-Myers Squibb’s antiretroviral (ARV) treatment for HIV, the company created a Category 1 tier including 57 primarily low-income and African countries, but excluding southern African countries, which were lumped into a higher income Category 2. Southern Africa has the highest HIV-prevalence rates in the world, and the impact of a Category 2 placement means that BMS “prices its important second-line drug atazanavir 25% higher, at $547, in southern Africa, compared with $412 in other [Category 1] countries where HIV prevalence is lower, and in a few cases, income is higher,” the report found.</p>
<p>In the case of Lilly’s drug-resistant TB products capreomycin and cycloserine, however, tiered pricing did work to create lower prices than competitive production, but there were special circumstances. For example, TB endemic countries participating in the “preferential price” scheme facilitated by the WHO Green Light Committee beginning in 2002 – a program that also transferred technology to local generics manufacturers in support of local production – did not see a cheaper generic reach the market. In the case of capreomycin, no generic products were WHO pre-qualified for use as of September 2011, and cycloserine had gone up in price by a multiple of four, after Lilly stopped producing the drug. Lilly’s tiered pricing did in fact keep prices at the lowest rates, although demand was low and production capacity was limited.</p>
<p>“Tiered pricing does not necessarily result in the lowest sustainable prices, nor does it reliably lead to price reductions over time,” the report’s authors conclude. “In comparison, when markets are sufficiently large and multiple sources of production exist, robust competition has consistently proven across different therapeutic areas to result in lower prices.” Tiered pricing also leaves “too little decision-making power to governments, which are accountable to their populations under international law for insuring access to medicines.”</p>
<p>Countries that aren’t strong negotiators, and can’t convincingly threaten compulsory licensing, for example, get the short end of the stick with tiered pricing. In 2006, Honduras purchased LPV/r for about six times more than Brazil paid, despite the fact that HIV rates are equivalent in both countries, and Honduras per capita gross national income is roughly 25% of Brazil’s. To create a truly “win-win” situation for manufacturers and patients, governments and manufacturers will need to consider new models that “de-link” medicine prices from R&amp;D costs. How countries contribute to R&amp;D financing as a global public good will influence the new models that help to bring new medicines to the most needy.</p>
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		<title>The Seven-Billion Society: What&amp;#39s In It For Pharma?</title>
		<link>http://blog.pharmexec.com/2011/11/02/the-seven-billion-society-what39s-in-it-for-pharma/</link>
		<comments>http://blog.pharmexec.com/2011/11/02/the-seven-billion-society-what39s-in-it-for-pharma/#comments</comments>
		<pubDate>Wed, 02 Nov 2011 12:41:11 +0000</pubDate>
		<dc:creator>William Looney</dc:creator>
				<category><![CDATA[Global]]></category>
		<category><![CDATA[Op-Ed]]></category>
		<category><![CDATA[healthcare]]></category>
		<category><![CDATA[Big Pharma]]></category>
		<category><![CDATA[innovation]]></category>
		<category><![CDATA[population]]></category>
		<category><![CDATA[UN]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=3261</guid>
		<description><![CDATA[On Monday, the world’s population hit the 7 billion mark, repeating a pattern of largely unrestrained growth that has endured for the last century: the world is now adding roughly one billion people every 12 years. The UN Population Fund (UNPF) estimates that, barring some unforeseen demographic or environmental/development shifts, the figure will reach just [...]]]></description>
			<content:encoded><![CDATA[<p>On Monday, the world’s population hit the 7 billion mark, repeating a pattern of largely unrestrained growth that has endured for the last century: the world is now adding roughly one billion people every 12 years. The UN Population Fund (UNPF) estimates that, barring some unforeseen demographic or environmental/development shifts, the figure will reach just under 10 billion by 2050.</p>
<p><span id="more-3261"></span>More interesting than the numbers themselves are the implications of this growth. The addition of another billion people over slightly more than a decade requires a 40 percent expansion in the global food chain, another 40 percent spurt in the availability of fresh water, and 50 percent more energy—all just to keep pace with the status quo.  Equally important is the skewed distribution of this new population profile. The sub-Saharan Africa and South Asia regions account for most of the increase, while in the northern climes population totals are set to decline, with key economies like Germany, Italy, Japan, and Russia slated to actually have fewer people in 2025 than today. And many of them will be elderly and female—not additive to the resource mix.  The rise is also disproportionately more urban than rural.  Whereas today there are 10 cities around the globe with a population of 10 million plus people, the UNPF projects that there will be upwards of 21 such cities by 2025.</p>
<p>What do the new numbers really mean for the business model and strategic focus in health care and pharma? Several points come to mind.</p>
<p>First, more people has a hidden upside—it’s called human capital. Leveraging the energy of more young people and women can yield rich dividends in economic growth. Good health is a pre-condition for achieving compensating gains in productivity to alleviate the burden of population on resources.  The health dividend also works in addressing the claims of aging populations, a cohort no longer limited to the “mature” industrialized markets. Poor countries are growing older too.</p>
<p>Second, that “bottom billion” of the customer base that underpins Big Pharma’s new commercial model for developing and emerging markets is going to get larger.  Cracking the “reverse innovation” nut for products and processes in a way that addresses their needs will add significantly to the industry’s success ratio in regions with the most substantial prospects for long-term revenue growth.</p>
<p>Third, accelerated urbanization will create new opportunities for more efficient drug distribution and to link drug therapy more closely to the provision of basic health services. The trend offers the ability to demonstrate how access to essential medicines can drive improvements in primary care and overall health outcomes. This is particularly true in maternal and child health as well as the prevention and management of chronic disease.</p>
<p>Fourth, it follows that drug-makers should devote time and attention to contributing to health system reform, focused on understanding how medicines can more efficiently find their way to all patients who need them, not just the affluent 10 percent at the top.  Applying “cheapening technologies” at the root of the supply chain and learning more about basic consumer preferences is central to this.</p>
<p>Fifth, the relationship between health, disease and the degradation of resources and the environment is likely to see more scrutiny. Interventions, tools, and technologies that help mitigate these effects represent a strong potential growth area for companies active in the health space. Quite simply, it argues for a widening of the product franchise for pharma in the years ahead. Cancer prevention and diagnostics along with nutrition management, food supplements, and control of obesity are research targets that come immediately to mind.</p>
<p>Finally, consider the reputational assets to be found here. One of the most prominent statistics cited by the UNPF in recording Monday’s transition to the seven billion society:  a baby born in the US today has a 50 percent chance of living to the age of 100. It’s the best argument I have heard for awhile of the value from investing in medicines innovation.</p>
<p style="text-align: right;"><em>William Looney, Editor-in-Chief</em></p>
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