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    <title type="text">Cognigen</title>
    <subtitle type="text">Cognigen:</subtitle>
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    <updated>2010-07-28T19:11:24Z</updated>
    <rights>Copyright (c) 2010, Wendy</rights>
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    <id>tag:,2010:07:28</id>


    <entry>
      <title>Enterprise Productivity Paper Published in Clinical Pharmacology and Therapeutics</title>
      <link rel="alternate" type="text/html" href="http://cognigencorp.com/index.php/cognigen/comments/enterprise_productivity_paper_published_in_clinical_pharmacology_and_therap/" />
      <id>tag:,2010:/site/index/1.932</id>
      <published>2010-07-28T15:52:06Z</published>
      <updated>2010-07-28T18:37:08Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="News and Events"
        scheme="http://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://cognigencorp.com/index.php/cognigen/comments/robots/" />
      <id>tag:,2010:/site/index/1.929</id>
      <published>2010-07-26T15:00:27Z</published>
      <updated>2010-07-28T18:08:28Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="Blog"
        scheme="http://cognigencorp.com/index.php/cognigen/C5/"
        label="Blog" />
      <category term="Knocked My Socks Off"
        scheme="http://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. 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://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://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://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://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://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://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://cognigencorp.com/index.php/cognigen/comments/world_cup_cultures/" />
      <id>tag:,2010:/site/index/1.924</id>
      <published>2010-07-13T14:21:53Z</published>
      <updated>2010-07-13T19:17:54Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="Blog"
        scheme="http://cognigencorp.com/index.php/cognigen/C5/"
        label="Blog" />
      <category term="Knocked My Socks Off"
        scheme="http://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. 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://cognigencorp.com/index.php/cognigen/comments/lifes_too_short/" />
      <id>tag:,2010:/site/index/1.923</id>
      <published>2010-07-08T13:20:32Z</published>
      <updated>2010-07-13T19:17:33Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="Blog"
        scheme="http://cognigencorp.com/index.php/cognigen/C5/"
        label="Blog" />
      <category term="Knocked My Socks Off"
        scheme="http://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. <br>
&#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. 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://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>2010-07-01T15:27:23Z</published>
      <updated>2010-07-28T19:11:24Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="Blog"
        scheme="http://cognigencorp.com/index.php/cognigen/C5/"
        label="Blog" />
      <category term="Pharma Of The Future"
        scheme="http://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: <i>Meeting the Challenge of Delivering Modeling and Simulation. </i> And don&#8217;t forget to peruse the previous post: <i><a href="http://www.cognigencorp.com/index.php/cognigen/comments/disambiguation/" title="Disambiguation">Disambiguation</a></i>.</b>
</p> 
      ]]></content>
    </entry>

    <entry>
      <title>Sense and Sensibilities of Science</title>
      <link rel="alternate" type="text/html" href="http://cognigencorp.com/index.php/cognigen/comments/sense_and_sensibilities_of_science/" />
      <id>tag:,2010:/site/index/1.921</id>
      <published>2010-06-09T18:00:30Z</published>
      <updated>2010-07-13T19:07:31Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="Blog"
        scheme="http://cognigencorp.com/index.php/cognigen/C5/"
        label="Blog" />
      <category term="Knocked My Socks Off"
        scheme="http://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. 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://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://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>

    <entry>
      <title>Cognigen Supports Institut Pasteur</title>
      <link rel="alternate" type="text/html" href="http://cognigencorp.com/index.php/cognigen/comments/cognigen_supports_institut_pasteur1/" />
      <id>tag:,2010:/site/index/1.915</id>
      <published>2010-05-18T18:38:09Z</published>
      <updated>2010-05-19T20:36:10Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="News and Events"
        scheme="http://cognigencorp.com/index.php/cognigen/C7/"
        label="News and Events" />
      <content type="html"><![CDATA[
        <p>Cognigen Corporation contributed to the <b><a href="http://www.pasteurfoundation.org/gala.shtml" title="2010 Pasteur Foundation Gala">2010 Pasteur Foundation Gala</a></b>, a fundraising event for the <b><a href="http://www.pasteur.fr/ip/easysite/go/03b-00002j-000/en" title="Institut Pasteur">Institut Pasteur</a></b>. The Gala was held May 17, 2010, in New York City.<br><br />
 
At the Gala, Frank Riboud, chairman and CEO of Danone, and Professor Muhammad Yunus, managing director of Grameen Bank, were honored with the <b>Pasteur Foundation 2010 Award</b>. Riboud and Yunus have formed a joint venture, Grameen Danone Foods, Ltd., that aims to provide a reliable source of nutritious dairy products in rural Bangladesh. The Pasteur Foundation Award recognizes individuals who have demonstrated an outstanding devotion to improving public health worldwide.<br></p>

<p>The <b><a href="http://www.pasteurfoundation.org/" title="Pasteur Foundation">Pasteur Foundation</a></b> works to raise funds for research, to introduce the research conducted at the Institut Pasteur in Paris to the American public, and to develop exchanges between Pasteurian and U.S. scientists. Institut Pasteur&#8217;s 3 principal vocations are biological research (focused historically on infectious diseases but extending today to include allergies, genetic diseases, and cancer), the development of public health applications arising from this research, and teaching and training programs.
</p> 
      ]]></content>
    </entry>

    <entry>
      <title>Mesmerizing Machine</title>
      <link rel="alternate" type="text/html" href="http://cognigencorp.com/index.php/cognigen/comments/mesmerizing_machine/" />
      <id>tag:,2010:/site/index/1.914</id>
      <published>2010-04-28T13:55:16Z</published>
      <updated>2010-07-13T19:09:18Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="Blog"
        scheme="http://cognigencorp.com/index.php/cognigen/C5/"
        label="Blog" />
      <category term="Knocked My Socks Off"
        scheme="http://cognigencorp.com/index.php/cognigen/C24/"
        label="Knocked My Socks Off" />
      <content type="html"><![CDATA[
        <p>As you study the <a href="http://blueballfixed.ytmnd.com/" title="blue ball machine"><b>blue ball machine</b></a>, it is easy to see how you can be mesmerized by a process that doesn’t actually do anything. See if you can find the part where the ball replaces the worker’s head. Then find the little sign that every now and then flashes <FONT COLOR="RED"><b>NO</b></FONT>. It never says <FONT COLOR="RED">yes</FONT><p> — another indication of a process gone wild.<br><br><br />
<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">Knocked My Socks Off</a> archive.</b></p> 
      ]]></content>
    </entry>

    <entry>
      <title>Disambiguation</title>
      <link rel="alternate" type="text/html" href="http://cognigencorp.com/index.php/cognigen/comments/disambiguation/" />
      <id>tag:,2010:/site/index/1.913</id>
      <published>2010-04-28T12:33:45Z</published>
      <updated>2010-07-01T19:53:46Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="Blog"
        scheme="http://cognigencorp.com/index.php/cognigen/C5/"
        label="Blog" />
      <category term="Pharma Of The Future"
        scheme="http://cognigencorp.com/index.php/cognigen/C23/"
        label="Pharma Of The Future" />
      <content type="html"><![CDATA[
        <p>I first came across the word “disambiguation” at a weekend workshop called <i>Ontology in Science</i>. (There is so much that’s just wrong about what I just admitted, but never mind.) I like this word a lot because it makes people ask, “for goodness sake, what <b>are </b>you talking about?” But disambiguation is a serious word, especially in science. It means “to remove ambiguity.” Once you learn that there is a word for getting rid of ambiguity, you begin to realize how much ambiguity there is in the world, especially when people communicate. And it seems to me that the smarter the people and the more complex the topic, the more disambiguation is necessary.<br><br />
A real-life example of disambiguation gone awry is a 1950s trial in Great Britain. <a href="http://news.bbc.co.uk/onthisday/hi/dates/stories/january/28/newsid_3393000/3393807.stm" title="Derek Bentley"><b>Derek Bentley</b></a> was tried for murder after his accomplice, who was a minor, allegedly shot a policeman during a burglary. Bentley was accused of yelling “Let him have it, Chris” before the fatal shot was fired. Did he mean “shoot him!” as the prosecution claimed? Or, did he mean “give it [the gun] to him [the policeman],” as the defense argued?* <br><br />
Fortunately, most disambiguation does not have such life-altering consequences. My favorite statements to disambiguate are those that contain two separate, not necessarily related, thoughts. For example, here is a common statement in industry: “I don’t have time to do what I know is necessary; I only have time to do it quickly.” Does that mean the results will be inaccurate? Or just incomplete? I have previously written about the genesis of <b><a href="http://www.cognigencorp.com/index.php/cognigen/comments/kerfuffle_pt_1" title="kerfuffles">kerfuffles</a></b>, so I won’t say more on this point. <br><br />
I heard another statement recently that needs disambiguation: “Serendipity is antagonized by process-oriented organizations.” Does it mean that profitable accidents don’t happen when scientists follow defined processes? Or does it mean that when processes are defined, scientific creativity is suppressed? As I heard it, the statement was intended to denigrate the value of process definition in pharmaceutical R&amp;D. I understand where this sentiment comes from. Many of us have had to deal with processes gone bad. In fact, I recently stumbled upon a great animated <b><a href="http://blueballfixed.ytmnd.com/" title="cartoon ">cartoon </a></b>of a truly mesmerizing process. <br><br />
But my own experience with process definition is that there is no substitute for a well designed and implemented process to free scientists and their staffs from low-value mundane activities. The challenge is to understand the process thoroughly and to formalize it carefully and correctly. <br><br />
Formalizing a process is a true test of disambiguation. First, identify all the subtasks. Then, arrange the subtasks in a hierarchy. Consider inputs, outputs, and deliverables for each. Once these entities and their interrelationships are worked out, define performance metrics, timelines of critical milestones, and governance strategies. Failure to disambiguate the process, that is, to determine what needs to be done, how it is to be done, and when it is considered finished, is a reason why processes go wild.<br><br />
Admittedly, process formalization in the pharmaceutical industry has opponents. Many scientists resist the very idea that a scientific process can be formalized. To them, science is an artistic endeavor that should not be managed professionally. Even those who admit to the importance of process formalization can have an extraordinarily difficult time achieving consensus on what indicates the successful completion of a task. And, while many inputs can be defined, it is often difficult to align the inputs and outputs for related, but separate, <a href="http://www.cognigencorp.com/images/uploads/Pharmacometrics_Process_Map.png" title="processes ">processes </a>so that their meaning is clear to all stakeholders.<br><br />
So, on-the-job disambiguation is an important skill to develop, and, like anything else, practice makes perfect. But beware where you practice! I offer some dos and don’ts from my own experience:<br>
</p><ul><li>Don’t disambiguate outloud a statement made by your significant other. ‘Nuff said.</li><br>
<li>Do attempt to disambiguate statements made by your children, but beware that you will be given a look suggesting that the nursing home can’t be far along.</li><br>
<li>Do practice your disambiguation skills in front of your pet, preferably a dog. A wagging tail can be a remarkable confidence booster. And it is very unlikely that you will get a similar look of adoration from your vice president of research. </li></ul><p><br></p>

<p><b>Be sure read the next Pharma of the Future℠ blog entry: <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?"><i>A Drug Is Not a Jet Plane, or Is It?</i></a> If you missed the last posting, click on over to: <i><a href="http://www.cognigencorp.com/index.php/cognigen/comments/origins_of_pharma_of_the_future/" title="Origins of Pharma of the Future">Origins of Pharma of the Future℠</a></i>.</b><br><br>
</p><HR WIDTH="25%"ALIGN=LEFT></hr>

<p>* Derrick Bentley and his accomplice were convicted of murder. The jury believed that the statement “Let him have it, Chris” was intended to incite the younger man to shoot (however, there is doubt those words were ever said). Bentley was hanged in 1953, just 3 months after the bungled break-in. The shooter went to jail and was released after 10 years. In 1998, Bentley was granted a full pardon, posthumously.
</p> 
      ]]></content>
    </entry>

    <entry>
      <title>Innovating and Imaginating</title>
      <link rel="alternate" type="text/html" href="http://cognigencorp.com/index.php/cognigen/comments/innovating_and_imaginating/" />
      <id>tag:,2010:/site/index/1.912</id>
      <published>2010-04-20T12:48:43Z</published>
      <updated>2010-05-05T18:03:44Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="News and Events"
        scheme="http://cognigencorp.com/index.php/cognigen/C7/"
        label="News and Events" />
      <content type="html"><![CDATA[
        <p>Check out an interview with Ted Grasela in the <b><i><a href="http://pharmaqualitybydesign.blogspot.com/2009/11/are-you-innovating-and-imaginating-all.html" title="Pharma Quality by Design">Pharma Quality by Design</a></i></b> blog. Senior Editor Paul Thomas reviewed Ted&#8217;s lecture at the AAPS meeting in November 2009. He says, &#8220;I stopped by the Cognigen booth afterwards for a chat with Grasela and Cognigen colleagues, and came to appreciate their ideas of bringing more science to the development process.&#8221;</p>

<p>The <a href="http://www.pharmaqbd.com/" title="PharmaQbD"><b><i>PharmaQbD</b></i></a> blog has recently been redesigned. </p> 
      ]]></content>
    </entry>

    <entry>
      <title>Hands&#45;On NONMEM Workshop</title>
      <link rel="alternate" type="text/html" href="http://cognigencorp.com/index.php/cognigen/comments/cognigen_presents_hands-on_course_using_nonmem/" />
      <id>tag:,2010:/site/index/1.905</id>
      <published>2010-04-06T11:24:41Z</published>
      <updated>2010-05-18T16:42:42Z</updated>
      <author>
            <name>Wendy</name>
            <email>Wendy.Bachhuber@cognigencorp.com</email>
                  </author>

      <category term="News and Events"
        scheme="http://cognigencorp.com/index.php/cognigen/C7/"
        label="News and Events" />
      <content type="html"><![CDATA[
        <p>Jill Fiedler-Kelly, vice president and chief scientific officer of Cognigen Corporation, presented a <b><a href="http://www.cognigencorp.com/images/uploads/flyer_UB_NONMEM_2010may13.pdf">3-day introductory workshop</a></b> in population PK data analysis from Thursday May 13 through Saturday May 15, 2010. The workshop was geared to pharmaceutical and biotech industry scientists and to advanced graduate students in pharmaceutics and clinical pharmacology who had little or no modeling experience. <br></p>

<p>This workshop, given in conjunction with the University at Buffalo (UB) <b><a href="http://pharmacy.buffalo.edu/" title="School of Pharmacy and Pharmaceutical Sciences">School of Pharmacy and Pharmaceutical Sciences</a></b>, provided a comprehensive understanding of the population PK approach to data analysis using formal lectures; review of data, code, and data analysis results; and hands-on exercises. Participants learned how to code control streams, interpret the NONMEM output, and evaluate model results at individual computer terminals with assistance from the instructors. In addition, participants received a full set of lecture notes and a USB flash drive loaded with a PERSPECTIVE Hypertext Data Analysis Map containing a fully documented pharmacometric modeling project, including control streams for more than 60 different models.<br></p>

<p>Fiedler-Kelly is adjunct assistant professor in the Department of Pharmaceutical Sciences at UB and is in her 10th year of presenting the workshop in conjunction with UB. “Even though the essence of the material has not changed dramatically over the years,” says Fiedler-Kelly, “Each time I teach the course, I get new insight from my interactions with participants and the questions they ask. I use real-life examples based on my work at Cognigen, and the practical nature of the lectures, anecdotes, and tips that I embed throughout the material exemplify my Cognigen experience.”<br></p>

<p>Fiedler-Kelly also teaches a graduate-level course at UB on population pharmacokinetic–pharmacodynamic modeling in which students learn the theory and application of the population approach.<br></p>

<p>The 3-day workshop preceded <b><a href="http://www.cognigencorp.com/images/uploads/Jusko_flyer_2010may16.pdf">Pharmacokinetic–Pharmacodynamic Modeling: Concepts and Applications</a></b>, a workshop presented by William J. Jusko, PhD, distinguished professor and chair of pharmaceutical sciences in the School of Pharmacy and Pharmaceutical Sciences at UB and director of the Center of Excellence in Pharmacokinetics and Pharmacodynamics.<br></p>

<p>The <b><a href="http://pharmacy.buffalo.edu/files/uploads/about/International_Reputation.pdf" title="Department of Pharmaceutical Sciences">Department of Pharmaceutical Sciences</a></b> at UB is considered one of the top departments in the world in pharmacokinetics, pharmacodynamics and biopharmaceutics.
</p> 
      ]]></content>
    </entry>


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