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	<title>Pharma Exec Blog &#187; People</title>
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		<copyright>&#xA9;Advanstar Communications </copyright>
		<managingEditor>gkoroneos@advanstar.com (Advanstar Communications)</managingEditor>
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		<category>Pharmceuticals</category>
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		<itunes:summary>The Business of Pharmaceuticals</itunes:summary>
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			<title>Pharma Exec Blog</title>
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		<item>
		<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>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=3307</guid>
		<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>Evaluating Expanded Access Programs</title>
		<link>http://blog.pharmexec.com/2011/09/19/david-vance-on-expanded-access-programs/</link>
		<comments>http://blog.pharmexec.com/2011/09/19/david-vance-on-expanded-access-programs/#comments</comments>
		<pubDate>Mon, 19 Sep 2011 17:39:11 +0000</pubDate>
		<dc:creator>Jennifer Ringler</dc:creator>
				<category><![CDATA[Events]]></category>
		<category><![CDATA[People]]></category>
		<category><![CDATA[CBI]]></category>
		<category><![CDATA[David Vance]]></category>
		<category><![CDATA[Expanded Access Programs]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=3108</guid>
		<description><![CDATA[Pharmaceutical Executive recently spoke with David Vance, Senior Director of the Compliance Counsel at Noven Pharmaceuticals, about the birth of Expanded Access Programs and the role patient advocacy groups can play in shaping those programs.

PE: How did patient advocacy groups first take on a role in shaping Expanded Access Programs (EAPs)?
DV: I was working at [...]]]></description>
			<content:encoded><![CDATA[<p><em>Pharmaceutical Executive</em> recently spoke with David Vance, Senior Director of the Compliance Counsel at Noven Pharmaceuticals, about the birth of Expanded Access Programs and the role patient advocacy groups can play in shaping those programs.</p>
<p><span id="more-3108"></span></p>
<p>PE: How did patient advocacy groups first take on a role in shaping Expanded Access Programs (EAPs)?</p>
<p>DV: I was working at Burroughs Wellcome back in 1986. In fact, September 19 was the 25<sup>th</sup> anniversary of the first AIDS drug, and I was there at Wellcome when we did that. It was the FDA’s recognition that people were dying, sometimes in only six months, of AIDS. And when we announced that we had a drug that could extend lives, FDA knew we had to figure out a way of getting the drug to people before it was approved, because those patients just didn’t have that much time to wait. So the whole idea of expanded access or early access actually began in large part with AZT. Burroughs Wellcome began working a lot with patients, particularly the AIDS activists who were so persistent and were pushing for FDA to do things quickly, and for companies to do things quicker and cheaper.</p>
<p>PE: What is the relationship today between patients groups and pharma when it comes to setting up these programs?</p>
<p>I think it’s wise for the companies to work with the activists to make sure that there is a proper expectation of what the drug may or may not be able to do, make sure that the company is aware of the needs of the patients, and make sure that the materials that are being developed for the EAP are developed with the activists groups—so that if anyone questions whether the materials were clear enough, the pharma company would be in a far better product liability position. Although generally I don’t think that there’s been a great product liability risk with these programs, if they’re done responsibly. We’ve all got to be careful, because of the distrust of the pharmaceutical industry, to make sure that we are transparent.</p>
<p>Another area where the patients groups have played a key role at times is when a pharma company has a life-saving drug and just can’t make enough of it. And sometimes getting patient groups involved, if they’re willing to be the people who help run the lottery, is a big help. They can explain to their membership—the good news is that we’ve got something here, but the bad news is that it can’t be ramped up fast enough to treat everybody.</p>
<p>PE: What stipulations govern which patients will gain access to these EAP medications?</p>
<p>EAPs are for serious or life-threatening diseases. Serious is defined as a disease that, without treatment, would result in a major, irreversible adverse event or condition that would lead to hospitalization or significant impairment of life.</p>
<p>Generally you’re going to start off asking, what were the original criteria for taking patients into the clinical trial? It may be, in the clinical trial—as so often happens—perhaps you’re excluding the sickest of the patients, because they’re so unlikely to make it that their deaths could destroy the drug for everybody, when you could possibly help people who are earlier in the disease state. Depending upon the toxicity of the drug itself, FDA often will allow you to treat a broader range of people in the EAP than were treated in the clinical study if it looks like it’s medically reasonable. And it is a standard that there is no other reasonable alternative for these patients.</p>
<p>PE: Is liability a concern for pharma when setting up EAPs?</p>
<p>DV: EAPs are still considered clinical studies. So anybody that wants to administer a drug through an EAP has to register as a clinical investigator. They get the full clinical investigator’s brochure of all the background and the information that is known to date on the drug. And the patients who enter have to sign an informed consent as a patient in a clinical study. So again it is very important to let patients know what legitimate expectations are, because the drug still is not approved. They’ve always had to have the informed consents and to make very clear that this drug is promising, but it has not been approved and things can still go wrong.</p>
<p>At Burroughs Wellcome I think we felt, to a degree, that with EAPs—particularly for life-threatening diseases or those that are causing severe handicaps—that people were just so grateful to get help, that there’s less of a liability risk in reality.</p>
<p>PE: What kinds of incentive does pharma have to participate in these EAPs?</p>
<p>I think it’s kind of a win-win, if you’re saving lives. And you’re also hopefully getting the drug out early, and getting the data back in a hopefully a little bit more controlled fashion. It also allows you to get a little bit more safety issues data. I’ve often said it might be an opportunity to add other kinds of patients in, in a sub-study. Potentially, if the EAP program goes well, you’re going to actually pull your whole adoption curve forward, you’re going to save some patients, and hopefully give them a free drug. And by the time the drug gets approved, the day it’s approved, you’re going to already have a certain number of patients on the drug.</p>
<p>PE: What work is still left to be done to leverage relationships between pharma and patient groups on these issues?</p>
<p>I think it’s making sure that we continue to build and maximize credibility together and that we recognize the minefields. We need to use the opportunities of transparency, of good clinical trial reporting, to make sure that we can hopefully reestablish the vanished credibility of the pharmaceutical industry with patient groups. We want to help remind people that there are companies out there that are trying. We win when we help patients. That is our goal. We’re not looking to sell drugs for indications that don’t work, because that hurts us in the long run.</p>
<p>David Vance will be part of a panel discussion moderated by William Looney on “The Challenges and Importance of Expanded Access Programs in the Context of the Current Industry Landscape” at the upcoming Center for Business Intelligence (CBI) conference: <a href="http://www.cbinet.com/eaps">Expanded Access Programs—Develop Compliant Strategies to Manage Global Patient Access to Investigational Drugs</a>, October 5-6 in Philadelphia. For more information about the conference and to register, visit <a href="http://www.cbinet.com/eaps">www.cbinet.com/eaps<img class="aligncenter size-full wp-image-3109" title="cbi-logo" src="http://blog.pharmexec.com/wp-content/uploads/2011/09/cbi-logo.jpg" alt="cbi-logo" /></a></p>
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		<title>Leniency and Flexibility&#58; The Optimum Conditions for Innovation</title>
		<link>http://blog.pharmexec.com/2011/07/14/leniency-and-flexibility-the-optimum-conditions-for-innovation/</link>
		<comments>http://blog.pharmexec.com/2011/07/14/leniency-and-flexibility-the-optimum-conditions-for-innovation/#comments</comments>
		<pubDate>Thu, 14 Jul 2011 15:39:12 +0000</pubDate>
		<dc:creator>Guest Blogger</dc:creator>
				<category><![CDATA[Global]]></category>
		<category><![CDATA[Guest Blog]]></category>
		<category><![CDATA[People]]></category>
		<category><![CDATA[R&D]]></category>
		<category><![CDATA[Strategy]]></category>
		<category><![CDATA[Economist Intelligence Unit. innovation]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=2895</guid>
		<description><![CDATA[Leniency and staff reward/recognition are key to improving R&#38;D and product innovation, according to the first of three new Economist Intelligence Unit reports. Innovation Imperative in Biopharma focuses on the how to curb wasteful R&#38;D spending and how to strengthen innovation abilities. The study is based on a survey of 282 senior executives, each of [...]]]></description>
			<content:encoded><![CDATA[<p>Leniency and staff reward/recognition are key to improving R&amp;D and product innovation, according to the first of three new Economist Intelligence Unit reports. <a href="http://www.businessresearch.eiu.com/innovation-imperative-biopharma.html"><em>Innovation Imperative in Biopharma</em></a> focuses on the how to curb wasteful R&amp;D spending and how to strengthen innovation abilities. The study is based on a survey of 282 senior executives, each of whom rated their firm&#8217;s R&amp;D and innovation strategies and explained how they are encouraging innovative thinking in R&amp;D. <span id="more-2895"></span></p>
<p>The report shows that many pharma companies are currently unsure of the quality of their current innovation strategies. Less than half of respondents believe their R&amp;D strategy adequately meets the firm&#8217;s requirements, and 49% claimed their R&amp;D programme is, at most, only moderately successful. However, one in five firms described their innovation strategies as &#8220;very effective&#8221;. These companies typically concentrated on boosting employee motivation, esteem and morale, creating the correct work environment, identifying and rewarding excellent work effort and reducing penalization of failure.</p>
<p>Rewarding and recognizing employees is a substantial part of encouraging innovation, the report says. To encourage research and innovation, 67% of companies were most likely to create a culture that encourages free thinking and responsible risk-taking, 57% collaborated with external scientific researchers, and 53% financially rewarded employees who contributed to innovation. But at 22%, implementing &#8220;blue sky&#8221; research was regarded the least effective of the research and innovation strategies.</p>
<p>Dr Peter Andersen, Executive Vice President for Research at Lundbeck, added: &#8220;Leaders have to understand that innovation comes from the individual who is working in the organization, and they should create a space around people [to think].&#8221;</p>
<p>Overall, respondents identified the top three key obstacles preventing product innovation as regulatory restrictions, cost and time required to develop the drug/product. Additional impediments included lack of necessary research or talent, cultural attachment to current approaches and company structures that interfere with collaboration.</p>
<p style="text-align: right;"><em>Beth Kennedy</em></p>
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		<title>The Most Influential Pharma Leader Or Institution?</title>
		<link>http://blog.pharmexec.com/2011/06/28/the-most-influential-pharma-leader-or-institution/</link>
		<comments>http://blog.pharmexec.com/2011/06/28/the-most-influential-pharma-leader-or-institution/#comments</comments>
		<pubDate>Tue, 28 Jun 2011 10:37:30 +0000</pubDate>
		<dc:creator>Julian Upton</dc:creator>
				<category><![CDATA[People]]></category>
		<category><![CDATA[leadership]]></category>
		<category><![CDATA[CEO]]></category>
		<category><![CDATA[leaders]]></category>
		<category><![CDATA[Pharma]]></category>
		<category><![CDATA[survey]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=2860</guid>
		<description><![CDATA[
Ahead of Pharm Exec&#8217;s 30th Anniversary Issue later this year, we are assembling a list of pharma leaders who have made the most impact on the industry.
Which individual(s) or institution(s) do you think has had the most influence of the industry in the last 10–30 years?
Please leave a comment in the box below or drop [...]]]></description>
			<content:encoded><![CDATA[<div style="background-image: initial; background-attachment: initial; background-origin: initial; background-clip: initial; background-color: #ffffff; font: normal normal normal 13px/19px Georgia, 'Times New Roman', 'Bitstream Charter', Times, serif; font-family: Times; line-height: normal; font-size: small; padding: 0.6em; margin: 0px;">
<p>Ahead of Pharm Exec&#8217;s 30th Anniversary Issue later this year, we are assembling a list of pharma leaders who have made the most impact on the industry.</p>
<p>Which individual(s) or institution(s) do you think has had the most influence of the industry in the last 10–30 years?</p>
<p>Please leave a comment in the box below or drop the editor at line at <a href="wlooney@advanstar.com">wlooney@advanstar.com</a> We look forward to receiving your suggestions.</p>
<p>Julian Upton<br />
News and Online Editor</p></div>
]]></content:encoded>
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		<item>
		<title>The Most Influential Pharma Leader Or Institution?</title>
		<link>http://blog.pharmexec.com/2011/05/25/the-most-influential-pharma-leaders/</link>
		<comments>http://blog.pharmexec.com/2011/05/25/the-most-influential-pharma-leaders/#comments</comments>
		<pubDate>Wed, 25 May 2011 13:38:04 +0000</pubDate>
		<dc:creator>Julian Upton</dc:creator>
				<category><![CDATA[People]]></category>
		<category><![CDATA[leadership]]></category>
		<category><![CDATA[CEO]]></category>
		<category><![CDATA[leaders]]></category>
		<category><![CDATA[opinion]]></category>
		<category><![CDATA[Pharma]]></category>
		<category><![CDATA[survey]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=2691</guid>
		<description><![CDATA[Ahead of Pharm Exec&#8217;s 30th Anniversary Issue later this year, we are assembling a list of pharma leaders who have made the most impact on the industry.
Which individual(s) or institution(s) do you think has had the most influence of the industry in the last 10–30 years?
Please leave a comment in the box below or drop [...]]]></description>
			<content:encoded><![CDATA[<p>Ahead of Pharm Exec&#8217;s 30th Anniversary Issue later this year, we are assembling a list of pharma leaders who have made the most impact on the industry.</p>
<p>Which individual(s) or institution(s) do you think has had the most influence of the industry in the last 10–30 years?</p>
<p>Please leave a comment in the box below or drop the editor at line at <a href="wlooney@advanstar.com">wlooney@advanstar.com</a> We look forward to receiving your suggestions.</p>
<p>Julian Upton<br />
News and Online Editor</p>
]]></content:encoded>
			<wfw:commentRss>http://blog.pharmexec.com/2011/05/25/the-most-influential-pharma-leaders/feed/</wfw:commentRss>
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		<title>New Roster of Players to Debate Comparative Effectiveness Standards</title>
		<link>http://blog.pharmexec.com/2011/01/25/new-roster-of-players-to-debate-comparative-effectiveness-standards/</link>
		<comments>http://blog.pharmexec.com/2011/01/25/new-roster-of-players-to-debate-comparative-effectiveness-standards/#comments</comments>
		<pubDate>Tue, 25 Jan 2011 13:58:48 +0000</pubDate>
		<dc:creator>William Looney</dc:creator>
				<category><![CDATA[People]]></category>
		<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[healthcare]]></category>
		<category><![CDATA[pricing]]></category>
		<category><![CDATA[comparative effectiveness]]></category>
		<category><![CDATA[health care economics]]></category>
		<category><![CDATA[PCORI]]></category>
		<category><![CDATA[QALY]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=2289</guid>
		<description><![CDATA[Methodologies are the heart of any consistent approach to certifying comparative effectiveness for new medicines—semantics aside, it’s the way payers and providers are going to determine clinical “value” and, by subtle extrapolation, their cost against existing alternative therapies. Last week, the Patient Centered Outcomes Research Institute [PCORI] created through federal health reform legislation moved one [...]]]></description>
			<content:encoded><![CDATA[<p>Methodologies are the heart of any consistent approach to certifying comparative effectiveness for new medicines—semantics aside, it’s the way payers and providers are going to determine clinical “value” and, by subtle extrapolation, their cost against existing alternative therapies. Last week, the Patient Centered Outcomes Research Institute [PCORI] created through federal health reform legislation moved one step closer to viability with the selection of a new Methodology Committee composed of 15 experts selected with support from the independent General Accountability Office.</p>
<p><span id="more-2289"></span>The Patient Protection and Affordable Care Act authorizes PCORI as a non-profit corporation to assist patients, clinicians, purchasers, and policymakers in making informed health decisions by providing quality, relevant evidence on how best to prevent, diagnose, treat, and monitor diseases and other health conditions. Before it can do so, however, it needs to build a consensus on methodologies that will bind researchers and analysts to a common structural approach in furnishing the required evidence to its stakeholder communities. Hence the designation of the Methodology Committee represents an important milestone for PCORI in ensuring the $1.1 billion in research funding initially authorized under the federal stimulus legislation will be well spent—or at least minimally understood by the intended users of the evidence.</p>
<p>The 15 members selected are well known to the inbred community of professional practice experts and academics that tend to dominate the discussion on value in medicine.  Significantly, only one payer organization is represented on the group – from the major non-profitl Blue Cross/Blue Shield.  And predictably, no one from the industries whose medicines and diagnostics will eventually be evaluated by PCORI through the guidelines process is represented due to conflict of interest issues. Nevertheless, a few prominent critics of QALYs and other rigid comparative effectiveness assessment tools linked to rationing in markets outside the US are included in the group, most notably Professor David Meltzer of the University of Chicago.</p>
<p>Professor John Ioannidis of Stanford University is in many ways a surprising choice as well, given his reputation as a critic of the utility of most such research, which he contends is undermined by patient selection bias, poor study profiling, late compilation of findings, and other inherent design flaws. Most research is usually simply overtaken by events or the march of medical progress, which results in few such studies being able to stand the test of time.</p>
<p>The 15 new members are:</p>
<p>o    Naomi Aronson, PhD, Executive Director, Blue Cross and Blue Shield Association Technology Evaluation Center.<br />
o    Ethan Basch, MD, MSc, medical oncologist and health services researcher, Department of Medicine and Department of Epidemiology, Memorial Sloan-Kettering Cancer Center.<br />
o    Alfred Berg, MD, MPH, Professor, Department of Family Medicine, University of Washington.<br />
o    David Flum, MD, MPH, Professor, Department of Surgery and Adjunct Professor, Department of Health Services, University of Washington Schools of Medicine and Public Health; Attending physician, General Surgery, University of Washington Medical Center.<br />
o    Sherine Gabriel, MD, MSc, Professor of Medicine and of Epidemiology, and the William J. and Charles H. Mayo Professor, Mayo Clinic.<br />
o    Steven Goodman, MD, PhD, Professor of Oncology, of Pediatrics, of Epidemiology and of Biostatistics, Johns Hopkins School of Medicine and Bloomberg School of Public Health.<br />
o    Mark Helfand, MD, MS, MPH, Professor of Medicine and of Medical Informatics and Clinical Epidemiology, Oregon Health &amp; Science University; Staff physician, Portland VA Medical Center.<br />
o    John Ioannidis, MD, DSc, the C.F. Rehnborg Professor in Disease Prevention, Professor of Medicine and Director, Stanford Prevention Research Center, Stanford University School of Medicine.<br />
o    David Meltzer, MD, PhD, Director, Center for Health and the Social Sciences, Chief of the Section of Hospital Medicine, and Associate Professor, Department of Medicine, Department of Economics, and Graduate School of Public Policy Studies, University of Chicago.<br />
o    Brian Mittman, PhD, Director, VA Center for Implementation Practice and Research Support, Department of Veterans Affairs Greater Los Angeles Healthcare System.<br />
o    Robin Newhouse, PhD, RN, Assistant Dean, Doctor of Nursing Practice Program and Associate Professor, Organizational Systems and Adult Health, University of Maryland School of Nursing.<br />
o    Sharon-Lise Normand, MSc, PhD, Professor of Health Care Policy, Harvard Medical School and Professor of Biostatistics, Harvard School of Public Health.<br />
o    Sebastian Schneeweiss, MD, ScD, Associate Professor, Department of Medicine, Harvard Medical School and Associate Professor, Department of Epidemiology, Harvard School of Public Health; Vice Chief and Director, Drug Evaluation and Outcomes Research, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital.<br />
o    Mary Tinetti, MD, Professor of Medicine, Epidemiology, and Public Health, Division of Geriatrics, Yale University School of Medicine; Director, Program on Aging, Yale University School of Medicine.<br />
o    Clyde Yancy, MD, MSc, Chief, Cardiology, Northwestern University Feinberg School of Medicine; Associate Director, The Bluhm Cardiovascular Institute, Northwestern Memorial Hospital.</p>
<p>In addition to these 15 members, the Director of the Agency for Healthcare Research and Quality and the Director of the National Institutes of Health, or their designees, will also serve on the committee. If anything, this will ensure some basic “political minding” to ensure the group stays out of trouble with Congress and the “death panel” crowd.</p>
<p>As is always the case with health care economics, the technocrats will carry the strongest voice. But where is the patient?</p>
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		<title>Former EMA Head Back in the Regulatory Saddle</title>
		<link>http://blog.pharmexec.com/2011/01/17/former-ema-head-back-in-the-regulatory-saddle/</link>
		<comments>http://blog.pharmexec.com/2011/01/17/former-ema-head-back-in-the-regulatory-saddle/#comments</comments>
		<pubDate>Mon, 17 Jan 2011 19:35:16 +0000</pubDate>
		<dc:creator>Julian Upton</dc:creator>
				<category><![CDATA[Europe]]></category>
		<category><![CDATA[Global]]></category>
		<category><![CDATA[Market Access]]></category>
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		<category><![CDATA[Thomas Lönngren]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=2282</guid>
		<description><![CDATA[His decade-long tenure as head of the European Medicines Agency (EMA) may have ended, but Thomas Lönngren is already back in the regulatory saddle as a strategic advisor to NDA Group, an independent consulting group focused on reducing wasted drug development costs, ensuring new medicines get to market faster, and &#8220;improving the performance of the [...]]]></description>
			<content:encoded><![CDATA[<p>His decade-long tenure as head of the European Medicines Agency (EMA) may have ended, but Thomas Lönngren is already back in the regulatory saddle as a strategic advisor to <a href="http://www.ndareg.com/?services">NDA Group</a>, an independent consulting group focused on reducing wasted drug development costs, ensuring new medicines get to market faster, and &#8220;improving the performance of the pharmaceutical industry&#8221;.<span id="more-2282"></span></p>
<p>Lönngren left EMA at the end of last year (after granting an exclusive <a href="http://pharmexec.findpharma.com/pharmexec/Global+Report/The-Sum-of-All-His-Parts-Career-Reflections-of-Eur/ArticleStandard/Article/detail/700435">&#8216;exit interview&#8217; with <em>Pharmaceutical Executive</em></a>), but his new role will again see him providing top level advice on strategic drug development related topics, including regulatory strategy and Health Technology Assessment, and working alongside fellow ex-regulators (NDA’s team comprises more than 25% ex-regulators from major EU Agencies, plus a specialist Advisory Board that consists of leading regulatory experts).</p>
<p>“I’ve recognized for a long time that the whole area of market access needs new ideas and a new vision,&#8221; said Lonngren of his new role. &#8220;I plan to further develop my ideas surrounding International Regulatory Strategies, coupled with pushing for a joined-up approach to HTA, to enable the best medicines to reach needy patients as efficiently as possible.&#8221;</p>
<p>NDA consults more than 400 drug development companies in the US and Europe, including 90% of the world’s top twenty pharmaceutical companies. It provides advice on drug development and helps companies to cut poor development candidates before costs escalate. Lonngren&#8217;s advisory board appointment is alongside other new specialists who will advise pharmaceutical companies how to best prove the value of their products to national agencies.</p>
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		<title>Exclusive Interview: The European Medicine Agency&#039;s Thomas Lönngren</title>
		<link>http://blog.pharmexec.com/2010/12/14/exclusive-interview-the-european-medicine-agencys-thomas-lonngren/</link>
		<comments>http://blog.pharmexec.com/2010/12/14/exclusive-interview-the-european-medicine-agencys-thomas-lonngren/#comments</comments>
		<pubDate>Tue, 14 Dec 2010 13:18:07 +0000</pubDate>
		<dc:creator>William Looney</dc:creator>
				<category><![CDATA[Europe]]></category>
		<category><![CDATA[Global]]></category>
		<category><![CDATA[People]]></category>
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		<category><![CDATA[EMA]]></category>
		<category><![CDATA[EU]]></category>
		<category><![CDATA[European Medicines Agency]]></category>
		<category><![CDATA[Thomas Lönngren]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=2219</guid>
		<description><![CDATA[The European Medicines Agency (EMA) is a unique institution, pursuing a mandate shared with a complex web of national and regional groups, each able to place a distinctive imprint around the delicate task of certifying the safety and efficacy of new drugs. In return, EMA has made a virtue of necessity. It filled the regulatory [...]]]></description>
			<content:encoded><![CDATA[<p>The European Medicines Agency (EMA) is a unique institution, pursuing a mandate shared with a complex web of national and regional groups, each able to place a distinctive imprint around the delicate task of certifying the safety and efficacy of new drugs. In return, EMA has made a virtue of necessity. It filled the regulatory space opened by the relentless progress of science and new information technologies to gradually expand its remit in a way that has maintained consensus among stakeholders.</p>
<p>In fact, EMA has escaped the toxic politics that the US FDA is now mired in by securing a reputation for such predictability that it attracts scant attention from headline-seeking media and the political classes, even as the issues that surround drug approvals become more prominent and controversial.<span id="more-2219"></span></p>
<p>Yes, there is bureaucratic merit to being boring, as reflected in EMA’s record of having achieved its prime commitment to meet legislated review deadlines for new drug applications in every one of its 15 years of operation. Much of the credit is attributed to the Agency’s outgoing Executive Director, Thomas Lönngren of Sweden, whose five-year term — his second and final, as required by statute — expires on 31 December. An advantage for Lönngren has been that, unlike the FDA, the Agency is autonomous.</p>
<p>It does not report directly to the EU Commission or the European Parliament but to a Management Board composed of a cross-section of institutions ranging from the member states to the EU agencies and even patient representatives. In that regard, the European process remains in many ways an insider game — you know which stakeholders count and how to target them. With Lönngren now poised to move on — to a post advising governments, professionals, and the industry on the drug regulatory process — <em>Pharm Exec</em> sat down with him in London last month to review his record, sift through the next wave of regulation, and highlight what’s not [vital] on the industry’s own reform agenda — but should be.</p>
<div id="attachment_2228" class="wp-caption alignright" style="width: 174px"><img class="size-full wp-image-2228 " title="Lonngren" src="http://blog.pharmexec.com/wp-content/uploads/2010/12/Lonngren.jpg" alt="Lonngren" width="164" height="215" /><p class="wp-caption-text">Thomas Lönngren</p></div>
<p><strong>William Looney: Your decade as Executive Director might best be characterized as an era of institution building. Has what you’ve achieved helped preserve Europe’s position as the world’s largest market for medicines?<br />
Thomas Lönngren</strong>: The Agency is a relative newcomer to medicines regulation, having begun operations only in January 1995 — some seven decades after the creation of FDA in 1930. So we have had a short learning curve. We are also an institution unique to Europe, with a mandate to coordinate scientific assets from the 27 EU member states and three European Economic Areas (EEA) countries for the evaluation, supervision, and pharmacovigilance of medicinal products for human and veterinary use.</p>
<p>What this means in practice is that we are an institution built around partnership, with our principal contacts being the national registration authorities with whom we administer a single, centralized EU-wide marketing authorization for new medicines granted through the European Commission.</p>
<p>This task is a delicate one, as we must balance the need for process coordination with a complex web of policy interactions. Partnering well requires political wisdom; the metric for success is being accountable to the European institutions and the member states through good science, strong evidence, independent professional judgment, and — most importantly — a high level of transparency and communication.  The “incentive to consult” avoids the hubris that sometimes accompanies the exercise of power in the public trust. It gives us a rich portfolio of expertise to draw on.</p>
<p>We are constantly exposed to different perspectives and are expected to explain and justify our actions to the same competent authorities in each of the member states, which is a guard against complacency and the bureaucratic mindset. This is one of the benefits of our approach, as it fosters a capacity for continuous innovation in the way we regulate. We have to be networked — it’s wired into our DNA. The fact that national authorities still have a role in issuing a marketing licence makes us nimble and doubly aware of how we impact public health.</p>
<p><strong>This was also a period of significant expansion where the Agency was expected to take on new responsibilities. Which of these were most important in defining what the Agency is today?</strong></p>
<p><strong></strong><img class="size-full wp-image-2229 alignright" title="Lonngren-2" src="http://blog.pharmexec.com/wp-content/uploads/2010/12/Lonngren-2.jpg" alt="Lonngren-2" width="162" height="228" /></p>
<p>When I became Executive Director in January 2001, we had about 150 employees; today we are at more than 850. The Agency administers a network of more than 5,400 experts distributed among 44 drug-licensing authorities in 30 countries. We manage six scientific committees responsible for our centralized authorization procedure, which is now mandatory<br />
for all new technologies, including biologics, with a seventh committee — on pharmacovigilance — in preparation. On top of that there are 35 expert working parties that supervise the development of clinical guidelines and support the preparation of dossiers. What happened here was the political leadership in Brussels recognized that completion of the internal market required a stronger European basis for regulating the safety and efficacy of medicines.</p>
<p>Directives were introduced in 2001 to clarify and expand our mandate in the human and the veterinary medicines area, with new scientific evaluation committees established in critical areas of unmet health needs, such as orphan drugs. Then in 2004, we had the “big bang” — the entry into our network of 10 new EU member states, followed by two more in 2007. This brought significant challenges in coping with more players at the table while maintaining the commitment to efficient dossier management and timely appraisals.</p>
<p>We also saw the introduction of risk and surveillance management planning and the conditional approval track, where companies can gain expedited decisions on products for diseases that are severe and life-threatening and do not have substitutes on the market. Next, we had to respond to pressure to help speed the development of pediatric medicines, resulting in the creation of yet another scientific review committee. Because of the policy sensitivities and the complexity of the science, it was probably the most complicated set of rules anyone has ever had to introduce in Europe.</p>
<p>The Commission Regulation of 2004 also defined a role for the Agency in tracking the pace of scientific discovery to ensure our standards are relevant and supportive to what industry is seeking to deliver for patients. It resulted in legislation to create a Committee on Advanced Therapies to facilitate introduction of novel technologies, such as gene or cell therapies or tissue engineering. This is a real innovation for Europe, as no other national regulatory body has such a group dedicated to fostering timely introductions of the new medicines of the future. One of our key objectives at the Agency — in addition to certifying safety and efficacy — is to stimulate innovation and promote the availability of new medicines. Good regulation can facilitate that; the Advanced Therapy Committee is an example I am quite proud of.</p>
<p><strong>Now that it’s largely complete, where would you say were the successes and the gaps of the first ‘road map’?</strong><br />
We achieved progress in three key areas, each of which was based on a close assessment of the environment for drug approval. One was the review of all our policies to benchmark whether they added to or detracted from the capacity of industry to conduct R&amp;D, so that European patients would gain the clinical benefit from new therapies.</p>
<p>The second was to rigorously test our commitment to the highest level of safety, including ways to encourage the rational use of medicines to reduce the incidence of adverse events and to secure better rates of compliance.</p>
<p>Third, we re-examined the entire organization structure to see how to improve the flow of information, to communicate with external constituencies more effectively, and to make transparency the basis for everything we do. The one area where there is still a gap is transparency. Progress has been made but it is clearly a moving target. Compared to other agencies, we are ahead. But my sense is that here in Europe, our stakeholders are expecting more.</p>
<p>For example, a better definition is needed to classify what is commercially sensitive information. The European Ombudsman believes that the Agency should widen access to documents, and in the last few weeks we have moved further in that direction, making a pledge to allow disclosure of all documents — including adverse event reports — within 15 days of a request, subject to the conditions of data protection.</p>
<p>Another challenge is making sense of the enormous amount of data we generate on a daily basis. That data has to be transformed into useful information. It’s not easy; you cannot just go to the bottom of the pile and say, “This will be public and this will stay confidential.” Hence one of our objectives for the 2015 road map is to build the internal capabilities to leverage the volume of information productively.</p>
<p><strong>What are the key priorities of the 2015 road map?</strong><br />
Final action on this awaits the decision of the Management Board, which meets this month and is slated to endorse both the road map and an accompanying “Vision to Reality” white paper. I would summarize the priorities to 2015 as follows:<br />
1) maintain our core mission in approving new products through the European Regulatory Network;<br />
2) fill gaps in the development of medicines for urgent health needs, such as antibiotics and the diseases of aging, and work with industry to address high attrition rates for many therapies;</p>
<p>3) adapt regulatory capacity to manage the growth of personalized medicine, through such means as setting standards for the qualification of biomarkers in cancer;<br />
4) improve the scope of legislation covering veterinary medicines and finding better ways to create synergies with our work in the human field; and 5) create a stronger preparation/alert platform to manage public health crises as well as control the distribution of counterfeit drugs. There is a lot of continuation here, which is good, as we are building on success.</p>
<p><strong>W</strong><strong>hat do you think are the most important trends that will influence the actions of regulators, particularly in the relationship with the R&amp;D industry?</strong></p>
<p>Globalization represents a real game change for the regulator. The perception has been that there is a fixed geographic limit to our mandate. But over the last decade we have discovered that the products we regulate are researched in numerous sites, involving parties with different levels of skill or expertise; are subjected to clinical trials among increasingly diverse patient populations, in dozens of different countries; and are manufactured outside our territory, based on active ingredients formulated increasingly in China and India. The fundamental question is, can we trust that all this critical work done outside our “span of control” is safe, reliable, and in conformity to our rules?<strong></strong></p>
<p><strong>Now that your tenure as Executive Director is ending, do you have any advice for the pharmaceutical industry going forward?</strong><br />
Drug companies need to do a better job at linking their prospects to the treatment and prevention of disease — not just today but especially for the future. Association with the development of advanced therapies like tissue replacement and modification of the immune system through vaccines is vital. Industry leaders also have to face the question of the limited resources available for health: Are we as a society spending these resources in the right way?</p>
<p>This in turn requires the possibility of acknowledging that pharmaceutical interventions are often overvalued. The best tool to solve a health challenge could be something other than a drug. Process innovation is not recognized by the industry as a source of growth. Horizontal prevention strategies, designing devices along with drugs to facilitate improved diagnoses and raise the patient response rate — these are ripe for new approaches. The current business model has to yield to something more holistic.</p>
<p><strong>What advice might you have for your successor?</strong><br />
A firm commitment to transparency is critical to success in this position. Transparency is fundamental to trust. Trust is what fosters confidence in our networked authorization system and helps ensure that when there are problems, you have the political leverage to do what is right for public health. This is particularly important given EMA’s expanded remit in supervising the pharmacovigilance process.</p>
<p>The next Executive Director will also have to keep pace with progress in science and technology. New areas of regulation are opening up; more needs to be done to clarify standards, as we are doing now for biosimilar antibody drugs, where we are specifying approaches to postauthorization follow-up studies to better ensure patient safety.</p>
<p><strong>The full version of this interview is available in December&#8217;s <em>Pharm Exec</em>.</strong></p>
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		<title>Pfizer: A Sudden Change at the Helm</title>
		<link>http://blog.pharmexec.com/2010/12/06/pfizer-a-sudden-change-at-the-helm/</link>
		<comments>http://blog.pharmexec.com/2010/12/06/pfizer-a-sudden-change-at-the-helm/#comments</comments>
		<pubDate>Mon, 06 Dec 2010 20:28:37 +0000</pubDate>
		<dc:creator>Jennifer Ringler</dc:creator>
				<category><![CDATA[News]]></category>
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		<category><![CDATA[Pfizer CEO]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=2192</guid>
		<description><![CDATA[Pfizer veteran insider succeeds Jeffrey Kindler as CEO—with more to come 
Pfizer’s Board of Directors has elected Ian C. Read, currently head of the company’s global biopharmaceutical operations, as President, CEO, and director.  Read succeeds Jeff Kindler in a transition that was sudden and unexpected:  occurring on a Sunday night, by early Monday morning Kindler’s [...]]]></description>
			<content:encoded><![CDATA[<p><em>Pfizer veteran insider succeeds Jeffrey Kindler as CEO—with more to come </em></p>
<p>Pfizer’s Board of Directors has elected Ian C. Read, currently head of the company’s global biopharmaceutical operations, as President, CEO, and director.  Read succeeds Jeff Kindler in a transition that was sudden and unexpected:  occurring on a Sunday night, by early Monday morning Kindler’s name was nowhere to be seen on the company’s directory or website.  Orderly succession planning it was not, which indicates that Pfizer is once again at a strategic crossroads that could either profit or penalize investors.<span id="more-2192"></span></p>
<p>Read, 57, joined Pfizer in 1978. Since 2006, Read has led Pfizer’s Worldwide Biopharmaceutical Businesses, which now comprises five global business units—Primary Care, Specialty Care, Oncology, Established Products, and Emerging Markets—and accounts for approximately 85 percent of Pfizer’s annual revenues. Read can point to a track record that is truly global—his latest assignment heading the human pharmaceuticals business units buttressed his lengthy background in managing Pfizer’s international operations with exposure to the mission-critical US market, where he directed an overhaul of the company’s sales and marketing operations around primary care.</p>
<p>The abrupt timing of Kindler’s departure suggests that the company still has some work to do to ensure that revenues deriving from the Wyeth merger will compensate for the unprecedented loss in 2011 of exclusivity for the world’s largest selling drug, Lipitor.  A recent company filing to the US SEC indicates that much of the burden is going to fall on employees, at least in the short-term, with expectations that as many as 3,000 to as many as 5,000 additional jobs will be shed in 2011, on top of the 19,000 Kindler committed to as part of the Wyeth combination. Analysts are expecting more scale efficiencies, noting that Pfizer’s current annual operating costs are still in the high $30 billion range. Kindler focused those efforts on R&amp;D and sales—the company is moving gradually toward an all contract sales force—but allowed staffing to balloon in less prominent platform functions like communications and public affairs.</p>
<p>The Board will elect a non-executive chairman from its current membership at its next regularly scheduled meeting, which will take place within the next two weeks.  That choice is going to be important:  if the Board opts for an activist business leader member like former Gilette CEO Jim Kilts or ex Armstrong Holdings chair George Lorch, then expect a commitment to more internal change, particularly in resolving a longstanding internal dispute over the scale of its investments in in-house R&amp;D, as well as a wide-open race for whoever succeeds Read to the top post. In fact, Read has to be seen as a transitional figure whose background in operations will help right the ship for the next phase—making the combination with Wyeth a viable business capable of generating long-term organic growth, rather than simply an amalgamation of adjacent businesses.</p>
<p>It must be noted as well that the business unit structure put in place during Kindler’s tenure can facilitate the separation of different business lines into independent entities, much like the deal Pfizer engineered with GSK last year around the HIV therapeutic franchise. This may be one answer to the widespread conclusion that Pfizer has become too big for anyone to manage successfully, particularly when the stakes depend on institutionalizing that elusive combination of scientific creativity and organizational enterprise. A big culture change will require that, and there is no management cookbook that the new team can apply to make it happen, because it’s personality-driven.</p>
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		<title>Moving On + Up &#8211; 5/6/2010</title>
		<link>http://blog.pharmexec.com/2010/05/06/moving-on-up-562010/</link>
		<comments>http://blog.pharmexec.com/2010/05/06/moving-on-up-562010/#comments</comments>
		<pubDate>Thu, 06 May 2010 21:03:12 +0000</pubDate>
		<dc:creator>George Koroneos</dc:creator>
				<category><![CDATA[People]]></category>
		<category><![CDATA[Chairman]]></category>
		<category><![CDATA[Chief financial officer]]></category>
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		<category><![CDATA[William Mills]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=1587</guid>
		<description><![CDATA[
Merck upped Ken Frazier to president. He had been president of Global Human Health worldwide sales and marketing.
PharmAthene appointed Mitchel Sayare to its board.
Michael Marine joined the Sabine Vaccine Institute as CEO.
Interleukin Genetics added William Mills to its board.
Rigel Pharmaceuticals was named one of the recipients of the 2010 Innovators Award of Excellence by the [...]]]></description>
			<content:encoded><![CDATA[<div id="attachment_1588" class="wp-caption alignright" style="width: 235px"><img class="size-full wp-image-1588" title="Ken_Frazier" src="http://blog.pharmexec.com/wp-content/uploads/2010/05/Ken_Frazier.jpg" alt="Ken Frazier" width="225" height="315" /><p class="wp-caption-text">Ken Frazier</p></div>
<ul>
<li><!--StartFragment--><span style="font-family: Calibri,Verdana,Helvetica,Arial;"><span style="font-size: 11pt;">Merck upped <strong>Ken Frazier</strong> to president. He had been president of Global Human Health worldwide sales and marketing.</span></span></li>
<li>PharmAthene appointed <strong>Mitchel Sayare</strong> to its board.</li>
<li><strong>Michael Marine</strong> joined the Sabine Vaccine Institute as CEO.</li>
<li>Interleukin Genetics added <strong>William Mills</strong> to its board.</li>
<li><strong>Rigel Pharmaceuticals</strong> was named one of the recipients of the 2010 Innovators Award of Excellence by the San Mateo County Economic Development Association.</li>
<li>VIVUS appointed <strong>Michael Miller</strong> SVP and CCO.</li>
<li>Simbionix added<strong> Glen Mayfield</strong> and <strong>Raanan Cohen</strong> to its board.</li>
<li>PharmAthene’s board upped <strong>Eric Richman </strong>to interim CEO.</li>
<li>China Medicine appointed Fred<strong> Wai-Kuen Cheung</strong> its new CFO.</li>
<li>Chimerix promoted <strong>Kenneth Moch </strong>from COO to president and CEO and added him to its board. The company also named <strong>George Painter </strong>chief scientific officer and chairman of the board.</li>
<li>Genecor CEO <strong>Tjerk de Ruiter </strong>was elected chair of the industrial and environmental section of BIO, as well as its board.</li>
<li><strong>Fran Dramis </strong>joined US Oncology’s board.</li>
</ul>
<p><!--EndFragment--></p>
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