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    <title type="text">Cognigen</title>
    <subtitle type="text">Cognigen:</subtitle>
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    <updated>2010-09-01T21:27:23Z</updated>
    <rights>Copyright (c) 2010, Wendy</rights>
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    <id>tag:,2010:08:24</id>


    <entry>
      <title>Ferumoxytol PK Model Published</title>
      <link rel="alternate" type="text/html" href="http://www.cognigencorp.com/index.php/cognigen/comments/ferumoxytol_pk_model_published/" />
      <id>tag:,2010:/site/index/1.938</id>
      <published>2010-08-24T18:06:22Z</published>
      <updated>2010-09-01T21:27:23Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="News and Events"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C7/"
        label="News and Events" />
      <content type="html"><![CDATA[
        <p>Results of a population pharmacokinetic analysis of ferumoxytol were published in the August 2010 issue of <i>Clinical Pharmacology and Therapeutics</i>. A 2-compartment open model with 0-order input and Michaelis–Menten elimination best described the data from a study of 58 healthy volunteers who received ferumoxytol in two 510-mg doses administered 24 h apart. The population mean estimates for volume of distribution of the central compartment (V1), maximal elimination rate, and ferumoxytol concentration at which the rate of metabolism would be one-half of Vmax were 2.71 L, 14.3 mg/h, and 77.5 mg/L, respectively. When the effect of body weight on V1 was added in the analysis, interindividual variability was found to be reduced. Ferumoxytol (Feraheme) is a novel IV iron formulation for treatment of iron-deficiency anemia in patients with chronic kidney disease. The study was sponsored by AMAG Pharmaceuticals in collaboration with Cognigen Corporation and the Albany Nephrology Pharmacy Group.<br><br><br />
Pai AB, Nielsen JC, Kausz A, Miller P, Owen JS. Plasma pharmacokinetics of two consecutive doses of ferumoxytol in healthy subjects. <i>Clin Pharmacol Ther.</i> 2010:88(2):237–242. doi:10.1038/clpt.2010.80.</p> 
      ]]></content>
    </entry>

    <entry>
      <title>Kinda like standing in front of a development team, huh?</title>
      <link rel="alternate" type="text/html" href="http://www.cognigencorp.com/index.php/cognigen/comments/kinda_like_standing_in_front_of_a_development_team_huh/" />
      <id>tag:,2010:/site/index/1.936</id>
      <published>2010-08-24T12:46:10Z</published>
      <updated>2010-08-26T20:30:11Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="Blog"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C5/"
        label="Blog" />
      <category term="Knocked My Socks Off"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C24/"
        label="Knocked My Socks Off" />
      <content type="html"><![CDATA[
        <p>G.H. Hardy* said, &#8220;A mathematician, like a painter or a poet, is a maker of patterns. And just as in poetry and painting, the mathematician&#8217;s patterns must be beautiful. Beauty is the first test,&#8221; he said. &#8220;There is no permanent place in the world for ugly mathematics.&#8221;<br><br></p>

<p><b>If that knocked your socks off, just wait until you see our next cool topic. And if you want to peruse all of the previous sock-knocking blog entries, visit the <a href="http://www.cognigencorp.com/index.php/cognigen/blog_knocked_my_socks_off/" title="Knocked My Socks Off "><b>Knocked My Socks Off </b></a>archive. </b><br><br></p>

<HR WIDTH="25%"ALIGN=LEFT></hr>

<p>* Hardy GH. <i>A Mathematician’s Apology</i>. Cambridge, UK: Cambridge University Press; 1940.<br><br>
</p> 
      ]]></content>
    </entry>

    <entry>
      <title>Not too complicated for words.</title>
      <link rel="alternate" type="text/html" href="http://www.cognigencorp.com/index.php/cognigen/comments/not_too_complicated_for_words/" />
      <id>tag:,2010:/site/index/1.935</id>
      <published>2010-08-19T17:13:20Z</published>
      <updated>2010-08-26T20:44:21Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="Blog"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C5/"
        label="Blog" />
      <category term="Pharma Of The Future"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C23/"
        label="Pharma Of The Future" />
      <content type="html"><![CDATA[
        <p>Jackson Pollock’s <i>Autumn Rhythm</i> (seen here) is an example of a complex painting that can be grasped with a few moments of contemplation, according to <a href="http://www.cognigencorp.com/index.php/cognigen/comments/lifes_too_short/" title="Terry Teachout">Terry Teachout</a> in the <i><a href="http://online.wsj.com/article/SB10001424052748704911704575327163342009080.html?mod=WSJ_Books_LS_Books_5." title="Wall Street Journal">Wall Street Journal</a></i>. Pollock worked during the mid 20th century, when nature was assumed to be random. However, as <a href="http://www.uoregon.edu/~msiuo/taylor/art/scientificamerican.pdf" title="Robert Taylor">Robert Taylor</a> explained in a 2002 <i>Scientific American</i> article:<br>
</p><p style="margin-left:40px;margin-right:60px;">During the 1960s, scientists began to examine how natural systems, such as the weather, change with time. They found that these systems are not haphazard; instead, lurking underneath is a remarkably subtle form of order. They labeled this behavior “chaotic,” and a new scientific field called chaos theory grew up to explain nature’s dynamics. Then, in the 1970s, a new form of geometry emerged to describe the patterns that these chaotic processes left behind. Given the name “fractals” by their discoverer, Benoit Mandelbrot, the new forms looked nothing like traditional Euclidean shapes. In contrast to the smoothness of artificial lines, <a href="http://www.youtube.com/watch?v=zFzxRBERaT4&amp;feature=related" title="fractals consist of patterns that recur on finer and finer magnifications">fractals consist of patterns that recur on finer and finer magnifications</a>, building up shapes of immense complexity. Twenty-five years before their discovery in nature, Pollock was painting fractals.</p><p>
The worlds of art and science also intersect in pharmaceutical research and development. Information generated during new product development takes on the texture of a Pollock painting as it drips and flows through the complex structure of a pharma company. Scientists in pharmaceutical R&amp;D are finding that challenging problems encountered during early development can only be solved using fully-integrated, interdisciplinary communication.<br><br />
For me, the beauty of <i>Autumn Rhythm</i> and its value in addressing the challenge of interdisciplinary collaboration is two-fold. First, upon quiet contemplation, the initial perception of randomness in the lines, blotches, and squiggles gives way to distinct patterns and themes. The smooth thin curves of black and the fluffy clouds of white seem to describe two of the many themes in the painting. Applied to drug development, these themes might represent the workflow of various functional areas in pharma R&amp;D.<br><br />
Second, by studying the fractal patterns in the painting at one level, one can gain insight into other, higher levels of patterns. By analogy, studying the communication between one set of stakeholders in R&amp;D can tell you what information other stakeholders need for decision-making. This careful analysis can also provide feedback on the gaps in knowledge that must be addressed in order to move to the next level of synthesis and questioning.<br><br />
Finding the order lurking beneath the chaos is the focus of several new projects here at Cognigen Corporation. Our challenge is to help our clients improve interdisciplinary communication and collaboration. The important thing is to look for the common patterns that emerge in communications with other scientists. These patterns hold the key to more efficient and relevant communications across stakeholders and ultimately to improved  productivity of pharmaceutical research and development programs. Increasing the transparency, speed, and reliability of information flow among researchers in integrated project teams is a critical step in improving research productivity.<br><br></p>

<p><b>Be sure read the next Pharma of the Future℠ blog entry, coming soon. If you missed the last posting, click on over to: <a href="http://www.cognigencorp.com/index.php/cognigen/comments/a_drug_is_not_a_jet_plane_or_is_it/" title="A Drug Is Not a Jet Plane, or Is It?">A Drug Is Not a Jet Plane, or Is It?</a></b><br><br></p>

<HR WIDTH="25%"ALIGN=LEFT></hr><p><br><b>Bibliography</b><br><br />
Pollock J (American, 1912–1956). <i>Autumn Rhythm</i> (Number 30), 1950, enamel on canvas, 266.7 cm by 525.8 cm. ©1999 Pollock-Krasner Foundation/Artists Rights Society (ARS), New York.<br><br />
Taylor RP. Order in Pollock’s chaos. <i>Scientific American</i>. 2002;287(6):116-121.<br><br />
Teachout T. Too complicated for words: are our brains big enough to untangle modern art? <i>Wall Street Journal</i>. June 26, 2010. <a href="http://online.wsj.com/article/SB10001424052748704911704575327163342009080.html?mod=WSJ_Books_LS_Books_5">http://online.wsj.com/article/SB10001424052748704911704575327163342009080.html?mod=WSJ_Books_LS_Books_5</a>. Accessed August 19, 2010.
</p> 
      ]]></content>
    </entry>

    <entry>
      <title>Enterprise Productivity Lecture at ACDRS</title>
      <link rel="alternate" type="text/html" href="http://www.cognigencorp.com/index.php/cognigen/comments/enterprise_productivity_lecture_at_acdrs/" />
      <id>tag:,2010:/site/index/1.933</id>
      <published>2010-08-17T14:19:58Z</published>
      <updated>2010-08-17T15:25:59Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="News and Events"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C7/"
        label="News and Events" />
      <content type="html"><![CDATA[
        <p>Cognigen CEO Ted Grasela will speak on enterprise productivity during Session 1 of the American Course on Drug Development and Regulatory Sciences (ACDRS), which starts October 25, 2010, in San Francisco. Grasela will discuss the concept that model-based drug development can be used to guide the design, analysis, and interpretation of innovative trials that can be done faster, at less cost, and with a greater yield of information than possible with the current empirical drug development paradigm.<br></p>

<p>ACDRS Session 1 is titled: The Pharmaceutical Development Enterprise: Current and Future Perspectives. In addition to lecturing, Grasela will chair the session along with Fritz Bühler, MD, of the University of Basel, Switzerland.<br></p>

<p>The 2010-2012 cycle of ACDRS consists of 23 teaching days divided into 6 sessions over a period of 2 years. For details and to register, visit the <a href="http://bts.ucsf.edu/acdrs/" title="ACDRS website">ACDRS website</a>. 
</p> 
      ]]></content>
    </entry>

    <entry>
      <title>Shanghai: A Cacophony of People (Update)</title>
      <link rel="alternate" type="text/html" href="http://www.cognigencorp.com/index.php/cognigen/comments/shanghai_a_cacophony_of_people/" />
      <id>tag:,2010:/site/index/1.875</id>
      <published>2010-08-10T12:30:07Z</published>
      <updated>2010-08-26T20:22:08Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="Blog"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C5/"
        label="Blog" />
      <category term="Knocked My Socks Off"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C24/"
        label="Knocked My Socks Off" />
      <content type="html"><![CDATA[
        <p><b>Update:</b> For another perspective on tech employment in the United States and China, see<a href="http://www.businessweek.com/magazine/content/10_28/b4186048358596.htm" title=" Andy Grove's recent article"> Andy Grove&#8217;s recent article</a> in <i>Bloomberg Businessweek</i>. <br></p>

<p><b>Original Post: </b>An experienced traveler knows that the reality on the ground often fails to match expectations based on second-hand knowledge from books and newspapers. Further, perceptions of a specific locale or event can be colored by jet lag, hunger, traveling companions, and weather, to name only a few. Consequently, even first-hand reports can disappoint or even be a source of irritation to other experienced travelers who arrived in a different frame of mind. With that said, I recently had the opportunity to see China in the up-close way that one can as a tourist. I came away with a new appreciation of what has been variously described in the press as a threatening competitor, a waking giant, a polluting behemoth, a producer of cheap and unreliable goods, and so forth.<br><br />
What emerged for me was that China is a place of constant, nearly inchoate growth that is engaged in a frenzied, yet optimistic, sprint to the future. To me, China is a truly awe-inspiring reflection of what it must have been like in New York City at the beginning of the 20th Century.<br><br />
Walking through Shanghai, I was struck by the crowds, nearly all people in their 20s and 30s, hurrying in a thousand different directions. Most seemed to smile, most were in a group of friends. Neighborhoods go from affluent to poor, sometimes within a very short distance. Everywhere the 80/20 rule seems to be rigorously followed. Careful attention is paid to the 80% that gives the most value; little attention is paid to the remaining 20%. So a beautiful modern hotel has a poorly functioning phone system, and a Maglev train capable of 430 km per hour has a station with a single escalator for an exit. There is always something to suggest that the person who planned the process got distracted as the project came to a close and had to move on to the next big thing. I’m not just complaining about minor annoyances. Because the problem is you can never tell what part of a project will fall into the overlooked 20%. It could be a minor annoyance if it is a malfunctioning phone, but a major problem if it’s an adulterated product.<br><br />
Nonetheless, the Chinese have a lot to do and a large population waiting for their turn to work their way out of poverty. They won’t be denied and, anyway, who are we to stop them? Just meeting their own peoples’ basic needs for goods and services will result in an economy larger than our own. Who can complain if we choose to import the surplus from this engine driven by cheap, enthusiastic labor?<br><br />
Many foreign companies have begun to invest in China, bringing in capital and expertise to build a skilled labor pool. The Chinese workforce is starting out from a lower base of education and experience than the workforce in Western countries. Therefore, this labor is capable of producing goods and services more cheaply than is possible in Western countries. During my visit, I heard from several business leaders about the patience that is required as the workforce comes up to speed. And therein lies the core lesson for American companies and labor that I took away from my visit. The reason labor is cheaper at present is because the core workforce is drawn primarily from a relatively unskilled population (notwithstanding the growing number of US-trained scientists returning to China). We can expect these salaries to increase rapidly over the next few years—Shanghai for the middle-class is not cheap.<br><br />
Consequently, the productivity in the emerging industries is much less than in the United States. Even if Chinese productivity doubles in 3 to 5 years, it is unlikely to match Western productivity, especially for more technically sophisticated activities of scientific synthesis and innovation.<br><br />
So our competitive advantage is derived from the fact that we start from a much higher level of productivity. But are we as a country prepared to do what it will take to improve our productivity year over year? If we do that and continue to do it, we could retain our preeminence in science, technology, and innovation―along with our standard of living. I came away from this trip convinced that our future as the world’s leader in science and technology innovation is in our own hands.<br><br />
We cannot expect anything less from the people of other countries than a fierce desire to achieve a higher standard of living. The world may be flat, but whether we choose to compete or not lies in our desire for the future that arises within our own national or industrial boundaries.<br><br />
<i><a href="http://pubs.acs.org/cen/coverstory/87/8741cover.html" title="Chemical &amp; Engineering News">Chemical &amp; Engineering News</a></i> recently reported that 21,000 jobs were cut by US drug companies in 2008, many of them in R&amp;D. However, one drug company executive stated that the global pharmaceutical and biotech industry spent nearly $100 billion in R&amp;D last year, of which, at most, $500 million went to China. The loss of R&amp;D jobs in the US was not caused by sending jobs overseas. These jobs were lost because management believed that the required level of value was missing and that continued funding for these positions was not warranted. Expect this to happen more, but don’t blame the Chinese.<br><br />
So from my perspective as a traveler and entrepreneur, the only course of action is to look in the mirror every day and ask the very hard question, “How can I become more valuable to my employer so that I keep my job and make more money?” The hardest part? Asking that question with the same intensity as Chinese laborers do—workers who know that they won’t eat if they don’t find a good answer.<br></p>

<p><br />
<b>If that knocked your socks off, be sure to read our next blog entry: <a href="http://www.cognigencorp.com/index.php/cognigen/comments/kinda_like_standing_in_front_of_a_development_team_huh/" title="Kinda like standing in front of a development team, huh?">Kinda like standing in front of a development team, huh?</a><br />
If you want to peruse our previous posts, visit the <a href="http://www.cognigencorp.com/index.php/cognigen/blog_knocked_my_socks_off/" title="Knocked My Socks Off"><b>Knocked My Socks Off</b></a> archive. </p> 
      ]]></content>
    </entry>

    <entry>
      <title>Enterprise Productivity Paper Published</title>
      <link rel="alternate" type="text/html" href="http://www.cognigencorp.com/index.php/cognigen/comments/enterprise_productivity_paper_published_in_clinical_pharmacology_and_therap/" />
      <id>tag:,2010:/site/index/1.932</id>
      <published>2010-07-28T15:52:45Z</published>
      <updated>2010-08-17T15:27:46Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="News and Events"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C7/"
        label="News and Events" />
      <content type="html"><![CDATA[
        <p>A paper by Ted Grasela and Bob Slusser has been published in the August 2010 issue of <i>Clinical Pharmacology and Therapeutics.</i> Grasela and Slusser propose in the paper (titled Improving Productivity With Model-Based Drug Development: An Enterprise Perspective) that model-based drug development can be used to guide the design, analysis, and interpretation of innovative trials that can be done faster, at less cost, and with a greater yield of information than possible with the current empirical drug development paradigm. According to the authors, a shift to model-based drug development, effective integrated project teams, and a structured, disciplined, and continual evaluation of the probability of new drug’s success will improve productivity and thus help ensure the survival of the pharmaceutical industry.<br></p>

<p><br />
<a href="http://www.nature.com/clpt/journal/v88/n2/pdf/clpt2010117a.pdf" title="Grasela TH, Slusser R. Improving productivity with model-based drug development: an enterprise perspective. Clin Pharmacol Ther. 2010;88(2):263-268."><b>Grasela TH, Slusser R. Improving productivity with model-based drug development: an enterprise perspective. <i>Clin Pharmacol Ther.</i> 2010;88(2):263-268.</b></a></p> 
      ]]></content>
    </entry>

    <entry>
      <title>Robots</title>
      <link rel="alternate" type="text/html" href="http://www.cognigencorp.com/index.php/cognigen/comments/robots/" />
      <id>tag:,2010:/site/index/1.929</id>
      <published>2010-07-26T15:00:56Z</published>
      <updated>2010-08-26T20:24:57Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="Blog"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C5/"
        label="Blog" />
      <category term="Knocked My Socks Off"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C24/"
        label="Knocked My Socks Off" />
      <content type="html"><![CDATA[
        <p>Take a look at <a href="http://bits.blogs.nytimes.com/2010/07/15/five-robots-to-watch/?emc=eta1" title="BigDog">BigDog</a> and his amazing robot pals in this link to the <i>New York Times</i>.&nbsp; Or, if you love cute and cuddly, you should check out <a href="http://www.nytimes.com/2010/07/05/science/05robot.html?pagewanted=1" title="Paro">Paro</a>. <br></p>

<p>I hope that the creators of these robots are heeding the three laws of robotics, as stated by Isaac Asimov in his 1950 classic, <i>I, Robot:</i><br></p>

<ul>
<li>A robot may not injure a human being or, through inaction, allow a human being to come to harm.</li>
<li>A robot must obey orders given to it by human beings except where such orders would conflict with the First Law.</li>
<li>A robot must protect its own existence as long as such protection does not conflict with the First or Second Law.</li>
</ul>

<p> &#160;&#160;&#160;&#160;&#160;&#160;&#160;<i>Handbook of Robotics</i>. 56th Edition. 2058 AD<br><br></p>

<p><b>If that knocked your socks off, just wait until you see our next cool topic: <a href="http://www.cognigencorp.com/index.php/cognigen/comments/shanghai_a_cacophony_of_people/" title="Shanghai"><b>Shanghai</b></a>. And if you want to peruse all of the previous sock-knocking blog entries, visit the <a href="http://www.cognigencorp.com/index.php/cognigen/blog_knocked_my_socks_off/" title="Knocked My Socks Off">Knocked My Socks Off</a> archive.</b><br><br></p>

<p>&nbsp;</p><HR WIDTH="25%"ALIGN=LEFT></hr><p>Asimov I. <i>I, Robot</i>. New York: Gnome Press; 1950.
</p> 
      ]]></content>
    </entry>

    <entry>
      <title>ACDRS Course on New Drug Development</title>
      <link rel="alternate" type="text/html" href="http://www.cognigencorp.com/index.php/cognigen/comments/course_on_new_drug_development/" />
      <id>tag:,2010:/site/index/1.928</id>
      <published>2010-07-23T15:00:55Z</published>
      <updated>2010-07-27T15:48:56Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="News and Events"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C7/"
        label="News and Events" />
      <content type="html"><![CDATA[
        <p>Enrollment is now open for the <a href="http://bts.ucsf.edu/acdrs/" title="American Course on Drug Development and Regulatory Sciences"><b>American Course on Drug Development and Regulatory Sciences</b></a> (ACDRS) that starts October 25-27, 2010, in San Francisco.<br></p>

<p>The <a href="http://www.cognigencorp.com/images/uploads/ACDRS_flyer_2010.pdf" title="ACDRS">ACDRS</a> is a postgraduate level education program designed for professionals who are involved in the medical product development process and have at least 1 to 2 years of working experience. Participants in ACDRS receive a rigorous, in-depth, comprehensive, and systematic immersion into modern medical product development, regulation, and market introduction. Last year, FDA sent 20 students to the course to join with about 45 students from industry and academia.<br></p>

<p>The ACDRS was established in 2006 as a nonprofit educational course by the Department of Biopharmaceutical Sciences, School of Pharmacy, University of California, San Francisco (UCSF) and the Center for Drug Development Science (CDDS), UCSF, working with the FDA, professional societies, a network of universities, biopharmaceutical companies, and the European Course in Pharmaceutical Medicine (ECPM), University of Basel, Switzerland. The ACDRS has more than 120 faculty members: about 50% are from regulated industry; 30% are from regulatory agencies; and 20% are from academia.<br></p>

<p>The six sessions listed below will be held at Mission Bay Conference Center at UCSF, San Francisco, CA. For details of each session, see the <a href="http://www.cognigencorp.com/images/uploads/ACDRS_brochure_2010-1.pdf" title="brochure ">brochure </a>for the previous course. To register, visit the <a href="http://bts.ucsf.edu/acdrs/" title="ACDRS website">ACDRS website</a>. <br />
1. October 25-27, 2010: The Pharmaceutical Enterprise: Current and Future Perspectives<br />
2. February 28-March 3, 2011: Learning Trials: From Discovery to First in Humans<br />
3. June 13-16, 2011: Learning and Confirming Trials: Finding and Confirming the Right Dose<br />
4. October 17-20, 2011: Confirmatory Trials: Methodology and Biostatistics<br />
5. February 27-March 1, 2012: The Global Registration and Approval Process<br />
6. June 11-14, 2012: Integrated Product Development Strategy, Execution and Program Management
</p> 
      ]]></content>
    </entry>

    <entry>
      <title>Bone Turnover Model Presented</title>
      <link rel="alternate" type="text/html" href="http://www.cognigencorp.com/index.php/cognigen/comments/bone_turnover_model_presented/" />
      <id>tag:,2010:/site/index/1.927</id>
      <published>2010-07-22T16:24:25Z</published>
      <updated>2010-07-27T15:56:26Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="News and Events"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C7/"
        label="News and Events" />
      <content type="html"><![CDATA[
        <p>A poster titled <a href="http://www.cognigencorp.com/images/uploads/posters/poster94_Leiden_odanacatib_2010apr21.pdf" title="Semi-mechanistic PK/PD model of the effect of odanacatib, a cathepsin K inhibitor, on bone turnover to characterize lumbar spine bone mineral density in two Phase II studies of postmenopausal women">Semi-mechanistic PK/PD model of the effect of odanacatib, a cathepsin K inhibitor, on bone turnover to characterize lumbar spine bone mineral density in two Phase II studies of postmenopausal women</a> was presented in April 2010 at the International Symposium on Measurement and Kinetics of <i>In Vivo</i> Drug Effects, which was held in Noordwijkerhout, The Netherlands. The poster resulted from collaboration of Cognigen with Merck Research Laboratories.</p>

<p>The subject of the poster was base model development of a semi-mechanistic model of bone turnover to describe creatinine adjusted urinary aminoterminal crosslinked telopeptides of Type I collagen (uNTx), a bone resorption biomarker, and lumbar spine bone mineral density data from two Phase II dose-ranging studies during and after treatment with odanacatib. Odanacatib, a potent, orally active inhibitor of cathepsin K, is under clinical development for treatment of postmenopausal osteoporosis.&nbsp; </p> 
      ]]></content>
    </entry>

    <entry>
      <title>Drug Development Boot Camp</title>
      <link rel="alternate" type="text/html" href="http://www.cognigencorp.com/index.php/cognigen/comments/drug_development_boot_camp/" />
      <id>tag:,2010:/site/index/1.925</id>
      <published>2010-07-15T17:30:53Z</published>
      <updated>2010-07-15T18:43:54Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="News and Events"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C7/"
        label="News and Events" />
      <content type="html"><![CDATA[
        <p>Cognigen CEO Ted Grasela will lecture on dose selection and justification using pharmacometrics at the <i><b><a href="http://www.cognigencorp.com/images/uploads/Bootcamp_Program.pdf" title="Drug Development Boot Camp: An Intensive Two Day Course for Biotech and Pharma Company Executives">Drug Development Boot Camp: An Intensive Two Day Course for Biotech and Pharma Company Executives</a></b></i>.<br></p>

<p>Boot Camp will be held September 9 and 10, 2010, at Weill Cornell Medical College in New York City, and will be hosted by the <a href="http://www.cctec.cornell.edu/" title="Cornell Center for Technology Enterprise and Commercialization">Cornell Center for Technology Enterprise and Commercialization</a> and <a href="http://www.drugstomarket.com/index.html" title="Speid Associates, Inc">Speid Associates, Inc</a>. <br></p>

<p>The program will provide a unique opportunity to obtain hands-on insight into the drug development process from drug discovery (designation of a lead) to registration. For more information or to register for Boot Camp, go to <a href="http://www.drugstomarket.com/drugbootcamp/Register-and-Pay.html" title="http://www.drugstomarket.com/drugbootcamp/Register-and-Pay.html">http://www.drugstomarket.com/drugbootcamp/Register-and-Pay.html</a>.
</p> 
      ]]></content>
    </entry>

    <entry>
      <title>World (Cup) Cultures</title>
      <link rel="alternate" type="text/html" href="http://www.cognigencorp.com/index.php/cognigen/comments/world_cup_cultures/" />
      <id>tag:,2010:/site/index/1.924</id>
      <published>2010-07-13T14:21:23Z</published>
      <updated>2010-08-26T20:26:24Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="Blog"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C5/"
        label="Blog" />
      <category term="Knocked My Socks Off"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C24/"
        label="Knocked My Socks Off" />
      <content type="html"><![CDATA[
        <p>One of the true pleasures of my job is the opportunity to travel and meet people from all over the world. Different cultures presume different business and social behaviors, of course.* But I have found that in spite of the differences, there are at least two similarities among world cultures: a passion to cheer for your national team to win the World Cup and a nearly universal reviling of the vuvuzelas.<br><br />
I was in Europe for the opening matches of this year’s World Cup. Although I had the misfortune of being in Germany when the French played their first game and being in France when the Germans played theirs, the cheers and jeers of the crowds at the pubs were just as loud in both countries. <br><br />
Congratulations to Spain and to all of their maravilloso fans for their World Cup victory.<br><br><br />
<b>If that knocked your socks off, just wait until you see our next cool topic: <a href="http://www.cognigencorp.com/index.php/cognigen/comments/robots/" title="Robots"><b>Robots</b></a>. And if you want to peruse all of the previous sock-knocking blog entries, visit the <a href="http://www.cognigencorp.com/index.php/cognigen/blog_knocked_my_socks_off/" title="Knocked My Socks Off">Knocked My Socks Off</a> archive.</b><br><br>
</p><HR WIDTH="25%"ALIGN=LEFT></hr>

<p>*The <i>World Business Culture</i> website gives interesting food for thought about how different cultures value different behaviors. <a href="http://www.worldbusinessculture.com/ " title="http://www.worldbusinessculture.com/ ">http://www.worldbusinessculture.com/ </a><br><br></p>

<p>&nbsp;</p> 
      ]]></content>
    </entry>

    <entry>
      <title>Life&#8217;s Too Short</title>
      <link rel="alternate" type="text/html" href="http://www.cognigencorp.com/index.php/cognigen/comments/lifes_too_short/" />
      <id>tag:,2010:/site/index/1.923</id>
      <published>2010-07-08T13:20:15Z</published>
      <updated>2010-08-26T20:28:16Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="Blog"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C5/"
        label="Blog" />
      <category term="Knocked My Socks Off"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C24/"
        label="Knocked My Socks Off" />
      <content type="html"><![CDATA[
        <p>In a recent <a href="http://online.wsj.com/article/SB10001424052748704911704575327163342009080.html?mod=WSJ_Books_LS_Books_5" title="Wall Street Journal column">Wall Street Journal column</a>, Terry Teachout had a wonderful essay questioning the complexity of modern art.* He quotes from James Joyce&#8217;s <i>Finnegans Wake</i>, which contains sentences like this: 
</p><ul>It is the circumconversioning of antelithual paganelles by a huggerknut cramwell energuman, or the caecodedition of an absquelitteris puttagonnianne to the herreraism of a cabotinesque exploser?</ul><p>
A subsequent exchange between HG Wells and Joyce is priceless:
</p><ul>&#8220;You have turned your back on common men, on their elementary needs and their restricted time and intelligence,&#8221; HG Wells complained to Joyce after reading <i>Finnegans Wake</i>. 
That didn&#8217;t faze him. &#8220;The demand that I make of my reader,&#8221; Joyce said, &#8220;is that he should devote his whole life to reading my works.&#8221;</ul>

<p>So is the rejoinder by Mr. Teachout:<br>
</p><ul>To which the obvious retort is: Life&#8217;s too short.</ul><p><br></p>

<p><b>If that knocked your socks off, just wait until you see our next cool topic: <a href="http://www.cognigencorp.com/index.php/cognigen/comments/world_cup_cultures/" title="World (Cup) Cultures"><b>World (Cup) Cultures</b></a>. And if you want to peruse all of the previous sock-knocking blog entries, visit the <a href="http://www.cognigencorp.com/index.php/cognigen/blog_knocked_my_socks_off/" title="Knocked My Socks Off">Knocked My Socks Off</a> archive.</b><br><br>
</p><HR WIDTH="25%"ALIGN=LEFT></hr>

<p>*Teachout T. Too complicated for words: are our brains big enough to untangle modern art? Wall Street Journal. June 26, 2010. <a href="http://online.wsj.com/article/SB10001424052748704911704575327163342009080.html?mod=WSJ_Books_LS_Books_5">http://online.wsj.com/article/SB10001424052748704911704575327163342009080.html?mod=WSJ_Books_LS_Books_5</a>. Accessed July 2, 2010.<br> <br></p>

<p>&nbsp;</p> 
      ]]></content>
    </entry>

    <entry>
      <title>A Drug Is Not a Jet Plane, or Is It?</title>
      <link rel="alternate" type="text/html" href="http://www.cognigencorp.com/index.php/cognigen/comments/a_drug_is_not_a_jet_plane_or_is_it/" />
      <id>tag:,2010:/site/index/1.922</id>
      <published>2010-07-01T15:27:27Z</published>
      <updated>2010-08-26T20:45:28Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="Blog"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C5/"
        label="Blog" />
      <category term="Pharma Of The Future"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C23/"
        label="Pharma Of The Future" />
      <content type="html"><![CDATA[
        <p>In a previous Pharma of the Future℠ blog entry, we described the <a href="http://www.cognigencorp.com/index.php/cognigen/comments/origins_of_pharma_of_the_future/" title="Factory of the Future">Factory of the Future</a> program created by the US Air Force in the 1970s. The success of the Factory of the Future program grew from these innovations:
</p><ul><li>A systematic approach to problem definition;</li>
<li>Development of an information technology (IT) infrastructure to make information accessible to all stakeholders;</li>
<li>Use of modeling and simulation to formalize the relationships between design parameters and performance; and</li>
<li>Development of efficient and sustainable solutions to manufacturing challenges.</li></ul><p>
Each change alone was not sufficient to overhaul the system.<br><br />
Even though biological systems are more complex than aeronautical systems, similarities abound between the pharmaceutical industry of today and the aerospace industry of the 1970s: low productivity; late-stage failures; withdrawal of new products after commercialization; and high cost of implementing new processes.<br><br />
Every sector of the drug industry has tried to increase productivity or reduce costs. Many of these initiatives have merit, ranging from new technologies and better IT to outsourcing and off-shoring, but they have created “islands of innovation” that are analogous to the “islands of automation” that were a problem in the aerospace industry. To solve the pharmaceutical crisis, innovations must be integrated into a <a href="http://www.cognigencorp.com/images/uploads/Fig3_Grasela.jpg" title="radically new enterprise for drug discovery, development, and commercialization">radically new enterprise for drug discovery, development, and commercialization</a>. <br><br />
Science-based businesses, such as the pharmaceutical and biotechnology industries, have unique challenges in managing and mitigating risk. The heterogeneous nature of their knowledge base requires knowledge integration across wide areas of expertise. In addition, the rapid pace of scientific progress requires effective strategies for cumulative learning. Use of modeling and simulation was a key improvement in the aerospace industry, and model-based drug development can be an equally important innovation for the drug industry. <br><br />
Pharmacometric modeling combines knowledge of disease state, biomarkers, and findings from preclinical and clinical studies with knowledge of placebo responses and drop out rates to gain insights into the determinants of efficacy and safety outcomes. These disease-drug models, particularly those that are detailed regarding disease mechanisms and drug effects, support knowledge integration, risk assessment, and informed decision-making. Continuous reassessment of models as new information becomes available can guide design of studies needed to close knowledge gaps.<br><br />
To realize the benefits of model-based drug development, pharma companies must address current limitations. Timely results are delayed or derailed by a lack of infrastructure. Knowledge management systems and attendant data definitions are inadequate. Lack of sufficient computing capacity, particularly for complex models, adds greatly to the time needed to develop models. Scientists who have skills in both the technical aspects of modeling and the strategic implications of the results are difficult to find. Few university programs are available to train these scientists.<br><br />
While time, money, and continued experience could address some of these limitations, changes in management approaches to program governance and decision making are needed. The innovations of model-based drug development must be implemented with full attention paid to its effects on the upstream and downstream components of the larger enterprise, including manufacturing, marketing, preclinical and clinical research, and regulatory affairs. <a href="http://www.nature.com/clpt/journal/v88/n2/pdf/clpt2010117a.pdf" title="This integration is critical to achieving a new model-based drug development paradigm, and this integration is one of our key motivations for the Pharma of the Future program at Cognigen."><b>This integration is critical to achieving a new model-based drug development paradigm, and this integration is one of our key motivations for the Pharma of the Future℠ program at Cognigen.</b></a> <br><br></p>

<p><b>Be sure to come back for the next Pharma of the Future℠ blog entry: <a href="http://www.cognigencorp.com/index.php/cognigen/comments/not_too_complicated_for_words/" title="Not Too Complicated for Words"><b>Not Too Complicated for Words.</b></a> And don&#8217;t forget to peruse the previous post: <a href="http://www.cognigencorp.com/index.php/cognigen/comments/disambiguation/" title="Disambiguation">Disambiguation</a>.</b>
</p> 
      ]]></content>
    </entry>

    <entry>
      <title>Sense and Sensibilities of Science</title>
      <link rel="alternate" type="text/html" href="http://www.cognigencorp.com/index.php/cognigen/comments/sense_and_sensibilities_of_science/" />
      <id>tag:,2010:/site/index/1.921</id>
      <published>2010-06-09T18:00:36Z</published>
      <updated>2010-08-26T20:32:37Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="Blog"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C5/"
        label="Blog" />
      <category term="Knocked My Socks Off"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C24/"
        label="Knocked My Socks Off" />
      <content type="html"><![CDATA[
        <p>If you want to understand <a href="http://www.cognigencorp.com/images/uploads/Pharmacometrics_Process_Map.png" title="process formalization">process formalization</a>, read Jane Austen. <br></p>

<p>As James Collins wrote <b>[comments added]</b> in the <i><a href="http://online.wsj.com/article/SB10001424052748703683804574531863687486876.html?KEYWORDS=jane+austenKEYWORDS%3Djane+austen" title="Wall Street Journal">Wall Street Journal</a></i>,*<br></p>

<p>Austen&#8217;s emphasis on good order and propriety <b>[process definition]</b> can seem dry and stiff. But anyone who reads <i>Mansﬁeld Park</i> will feel the same relief that Fanny does at the change from the rackety disorder of her family&#8217;s house in Portsmouth <b>[current drug research]</b> to the order of the Park <b>[process-oriented research]</b>. Similarly, Austen&#8217;s regard for self-control, especially as expressed in <i>Sense and Sensibility</i>, can seem hard, but it must be remembered how the author clearly regards Marianne&#8217;s emotionalism <b>[science as an artistic endeavor]</b> with the greatest compassion. Austen is not advocating a suppression of the feelings <b>[creative efforts]</b> themselves— despite her faultlessly correct behavior, Elinor undergoes great suffering and feels every bit of it. What Austen is saying, as a modern psychologist might urge, is that one should try to prevent the disintegration of one&#8217;s personality <b>[endless <a href="http://www.cognigencorp.com/index.php/cognigen/comments/kerfuffle_pt_1/" title="kerfuffles">kerfuffles</a>]</b>.<br><br></p>

<p><b>If that knocked your socks off, just wait until you see our next cool topic: <a href="http://www.cognigencorp.com/index.php/cognigen/comments/lifes_too_short/" title="Life's Too Short">Life&#8217;s Too Short</a>. And if you want to peruse all of the previous sock-knocking blog entries, visit the <a href="http://www.cognigencorp.com/index.php/cognigen/blog_knocked_my_socks_off/" title="Knocked My Socks Off">Knocked My Socks Off</a> archive.</b><br><br></p>

<HR WIDTH="25%"ALIGN=LEFT></hr><p>
*Collins J. What would Jane do? <i>Wall Street Journal</i>. Nov 14, 2009. <a href="http://online.wsj.com/article/SB10001424052748703683804574531863687486876.html?KEYWORDS=jane+austenKEYWORDS%3Djane+austen" title="http://online.wsj.com/article/SB10001424052748703683804574531863687486876.html?KEYWORDS=jane+austenKEYWORDS%3Djane+austen ">http://online.wsj.com/article/SB10001424052748703683804574531863687486876.html?KEYWORDS=jane+austen KEYWORDS%3Djane+austen</a>.&nbsp; Accessed May 12, 2010.</p> 
      ]]></content>
    </entry>

    <entry>
      <title>PAGE Meeting in Berlin</title>
      <link rel="alternate" type="text/html" href="http://www.cognigencorp.com/index.php/cognigen/comments/page_meeting_in_berlin/" />
      <id>tag:,2010:/site/index/1.917</id>
      <published>2010-05-26T12:45:05Z</published>
      <updated>2010-06-09T20:21:06Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="News and Events"
        scheme="http://www.cognigencorp.com/index.php/cognigen/C7/"
        label="News and Events" />
      <content type="html"><![CDATA[
        <p>Cognigen presented 2 posters at the <a href="http://www.page-meeting.org/default.asp?id=34&amp;keuze=program " title="19th annual meeting">19th annual meeting</a> of the <b><a href="http://www.page-meeting.org/" title="Population Approach Group in Europe (PAGE)">Population Approach Group in Europe (PAGE)</a></b> from June 8 to 11, 2010. The 2010 PAGE meeting was hosted by <a href="http://www.uni-halle.de/universitaet/" title="Martin-Luther-Universität Halle-Wittenberg">Martin-Luther-Universität Halle-Wittenberg</a> and the <a href="http://www.agah.info/en/the-agah/news.html" title="Arbeitsgemeinschaft für Angewandte Humanpharmakologie (Association for Applied Human Pharmacology)">Arbeitsgemeinschaft für Angewandte Humanpharmakologie (Association for Applied Human Pharmacology)</a> and was held at the <a href="http://www.langenbeck-virchow-haus.de/" title="Langenbeck-Virchow-Haus">Langenbeck-Virchow-Haus</a> in Berlin, Germany.<br><br></p>

<p>The Cognigen posters, titled <a href="http://www.cognigencorp.com/images/uploads/posters/poster92_PAGE_forensic_pmetrics_part1_2010jun08.pdf" title="Forensic Pharmacometrics: Part 1 Data Assembly">Forensic Pharmacometrics: Part 1 Data Assembly</a> and <a href="http://www.cognigencorp.com/images/uploads/posters/poster93_PAGE_forensic_pmetrics_part2_2010jun08.pdf" title="Forensic Pharmacometrics: Part 2 Deliverables for Regulatory Submission">Forensic Pharmacometrics: Part 2 Deliverables for Regulatory Submission</a> present processes for independent validation of analysis-ready datasets, models, and technical reports intended for regulatory submission.
</p> 
      ]]></content>
    </entry>


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