libxml-ruby 1.1.2-x86-mswin32-60 → 1.1.3-x86-mswin32-60

data/ext/libxml/ruby_xml_node.h

@@ -1,4 +1,4 @@
-/* $Id: ruby_xml_node.h 758 2009-01-25 20:36:03Z cfis $ */
+/* $Id: ruby_xml_node.h 850 2009-03-21 22:21:14Z cfis $ */
 
 /* Please see the LICENSE file for copyright and distribution information */
 
@@ -8,7 +8,6 @@
 extern VALUE cXMLNode;
 
 void rxml_init_node(void);
-void rxml_node_mark_common(xmlNodePtr xnode);
+void rxml_node_mark(xmlNodePtr xnode);
 VALUE rxml_node_wrap(xmlNodePtr xnode);
-VALUE check_string_or_symbol(VALUE val);
 #endif

data/ext/libxml/ruby_xml_parser_context.c

@@ -1,4 +1,4 @@
-/* $Id: ruby_xml_parser_context.c 826 2009-03-06 09:13:19Z cfis $ */
+/* $Id: ruby_xml_parser_context.c 851 2009-03-21 22:21:36Z cfis $ */
 
 /* Please see the LICENSE file for copyright and distribution information */
 
@@ -55,6 +55,16 @@ static VALUE rxml_parser_context_document(VALUE klass, VALUE document)
   xmlDocDumpFormatMemoryEnc(xdoc, &buffer, &length, xdoc->encoding, 0);
 
   ctxt = xmlCreateDocParserCtxt(buffer);
+
+  if (!ctxt)
+    rxml_raise(&xmlLastError);
+
+  /* This is annoying, but xmlInitParserCtxt (called indirectly above) and 
+     xmlCtxtUseOptionsInternal (called below) initialize slightly different
+     context options, in particular XML_PARSE_NODICT which xmlInitParserCtxt
+     sets to 0 and xmlCtxtUseOptionsInternal sets to 1.  So we have to call both. */
+  xmlCtxtUseOptions(ctxt, rxml_libxml_default_options());
+
   return rxml_parser_context_wrap(ctxt);
 }
 
@@ -70,9 +80,16 @@ static VALUE rxml_parser_context_document(VALUE klass, VALUE document)
 static VALUE rxml_parser_context_file(VALUE klass, VALUE file)
 {
   xmlParserCtxtPtr ctxt = xmlCreateURLParserCtxt(StringValuePtr(file), 0);
+
   if (!ctxt)
     rxml_raise(&xmlLastError);
 
+  /* This is annoying, but xmlInitParserCtxt (called indirectly above) and 
+     xmlCtxtUseOptionsInternal (called below) initialize slightly different
+     context options, in particular XML_PARSE_NODICT which xmlInitParserCtxt
+     sets to 0 and xmlCtxtUseOptionsInternal sets to 1.  So we have to call both. */
+  xmlCtxtUseOptions(ctxt, rxml_libxml_default_options());
+
   return rxml_parser_context_wrap(ctxt);
 }
 
@@ -95,10 +112,16 @@ static VALUE rxml_parser_context_string(VALUE klass, VALUE string)
 
   ctxt = xmlCreateMemoryParserCtxt(StringValuePtr(string),
                                    RSTRING_LEN(string));
-
+  
   if (!ctxt)
     rxml_raise(&xmlLastError);
 
+  /* This is annoying, but xmlInitParserCtxt (called indirectly above) and 
+     xmlCtxtUseOptionsInternal (called below) initialize slightly different
+     context options, in particular XML_PARSE_NODICT which xmlInitParserCtxt
+     sets to 0 and xmlCtxtUseOptionsInternal sets to 1.  So we have to call both. */
+  xmlCtxtUseOptions(ctxt, rxml_libxml_default_options());
+
   return rxml_parser_context_wrap(ctxt);
 }
 
@@ -125,12 +148,19 @@ static VALUE rxml_parser_context_io(VALUE klass, VALUE io)
                                        (void*)io, XML_CHAR_ENCODING_NONE);
     
   ctxt = xmlNewParserCtxt();
+
   if (!ctxt)
   {
     xmlFreeParserInputBuffer(input);
     rxml_raise(&xmlLastError);
   }
 
+  /* This is annoying, but xmlInitParserCtxt (called indirectly above) and 
+     xmlCtxtUseOptionsInternal (called below) initialize slightly different
+     context options, in particular XML_PARSE_NODICT which xmlInitParserCtxt
+     sets to 0 and xmlCtxtUseOptionsInternal sets to 1.  So we have to call both. */
+  xmlCtxtUseOptions(ctxt, rxml_libxml_default_options());
+
   stream = xmlNewIOInputStream(ctxt, input, XML_CHAR_ENCODING_NONE);
 
   if (!stream)

data/ext/libxml/ruby_xml_version.h

@@ -1,9 +1,9 @@
 /* Don't nuke this block!  It is used for automatically updating the
  * versions below. VERSION = string formatting, VERNUM = numbered
  * version for inline testing: increment both or none at all.*/
-#define RUBY_LIBXML_VERSION  "1.1.2"
-#define RUBY_LIBXML_VERNUM   112
+#define RUBY_LIBXML_VERSION  "1.1.3"
+#define RUBY_LIBXML_VERNUM   113
 #define RUBY_LIBXML_VER_MAJ   1
 #define RUBY_LIBXML_VER_MIN   1
-#define RUBY_LIBXML_VER_MIC   2
+#define RUBY_LIBXML_VER_MIC   3
 #define RUBY_LIBXML_VER_PATCH 0

data/lib/libxml/node.rb

@@ -312,6 +312,17 @@ module LibXML
         self.to_s
       end
 
+      # --- Deprecated DOM Manipulation ---
+      def child_add(node)
+        warn('Node#child_add is deprecated.  Use Node#<< instead.')
+        self << node
+      end
+
+      def child=(node)
+        warn('Node#child= is deprecated.  Use Node#<< instead.')
+        self << node
+      end
+
       # --- Deprecated Namespaces ---
       def namespace
         warn('Node#namespace is deprecated.  Use Node#namespaces instead.')

data/test/tc_document.rb

@@ -31,7 +31,7 @@ class TestDocument < Test::Unit::TestCase
     }
   end
 
-  def test_ruby_xml_document_compression
+  def test_compression
     if XML.enabled_zlib?
       0.upto(9) do |i|
         assert_equal(i, @doc.compression = i)
@@ -98,5 +98,16 @@ class TestDocument < Test::Unit::TestCase
     xhtml_dtd = XML::Dtd.new "-//W3C//DTD XHTML 1.0 Transitional//EN", "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd", nil, doc, true
 		assert doc.xhtml?
 	end
-  
+
+  def test_import_node
+    doc1 = XML::Parser.string('<nums><one></one></nums>').parse
+    doc2 = XML::Parser.string('<nums><two></two></nums>').parse
+
+    node = doc1.root.child
+
+    doc2.root << doc2.import(node)
+
+    assert_equal("<nums>\n  <two/>\n  <one/>\n</nums>",
+                 doc2.root.to_s)
+  end
 end

data/test/tc_dtd.rb

@@ -11,7 +11,7 @@ class TestDtd < Test::Unit::TestCase
     EOS
     @doc = xp.parse
   end
-  
+
   def teardown
     @doc = nil
   end
@@ -41,7 +41,7 @@ class TestDtd < Test::Unit::TestCase
 		assert_equal "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd", xhtml_dtd.uri
 		assert_equal "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd", xhtml_dtd.system_id
 	end
-  
+
   def test_external_subset
     xhtml_dtd = XML::Dtd.new "-//W3C//DTD XHTML 1.0 Transitional//EN", "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd", nil
 		assert xhtml_dtd.name.nil?
@@ -55,7 +55,7 @@ class TestDtd < Test::Unit::TestCase
 		assert_equal "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd", xhtml_dtd.uri
 		assert_equal "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd", xhtml_dtd.system_id
 	end
-  
+
   def test_valid
     assert(@doc.validate(dtd))
   end
@@ -104,7 +104,7 @@ class TestDtd < Test::Unit::TestCase
     doc = XML::Parser.string(xml).parse
     assert_equal(0, errors.length)
 
-    errors = Array.new
+    errors.clear
     XML.default_load_external_dtd = true
     doc = XML::Parser.string(xml).parse
     assert_equal(1, errors.length)
@@ -117,6 +117,7 @@ class TestDtd < Test::Unit::TestCase
     assert_equal("Warning: failed to load external entity \"test.dtd\" at :1.",
                  errors[0].to_s)
   ensure
+    XML.default_load_external_dtd = false
     XML::Error.reset_handler
   end
 end

data/test/tc_node.rb

@@ -178,4 +178,4 @@ class TestNode < Test::Unit::TestCase
 		affected.last.output_escaping = false
 		assert node.output_escaping?.nil?
   end
-end
+end

data/test/tc_node_edit.rb

@@ -10,19 +10,19 @@ class TestNodeEdit < Test::Unit::TestCase
   def teardown
     @doc = nil
   end
-  
+
   def first_node
     @doc.root.child
   end
-  
+
   def second_node
     first_node.next
   end
-  
+
   def third_node
     second_node.next
   end
- 
+
   def test_add_next_01
     first_node.next = XML::Node.new('num', 'one-and-a-half')
     assert_equal('<test><num>one</num><num>one-and-a-half</num><num>two</num><num>three</num></test>',
@@ -97,6 +97,30 @@ class TestNodeEdit < Test::Unit::TestCase
                  @doc.root.to_s.gsub(/\n\s*/,''))
   end
 
+  def test_append_existing_node
+    doc = XML::Parser.string('<top>a<bottom>b<one>first</one><two>second</two>c</bottom>d</top>').parse
+    node1 = doc.find_first('//two')
+
+    doc.root << node1
+    assert_equal('<top>a<bottom>b<one>first</one>c</bottom>d<two>second</two></top>',
+                 doc.root.to_s)
+  end
+
+  def test_wrong_doc
+    doc1 = XML::Parser.string('<nums><one></one></nums>').parse
+    doc2 = XML::Parser.string('<nums><two></two></nums>').parse
+
+    node = doc1.root.child
+
+    error = assert_raise(XML::Error) do
+      doc2.root << node
+    end
+
+    assert_equal(' Nodes belong to different documents.  You must first import the by calling XML::Document.import.',
+                 error.to_s)
+  end
+
+
   # This test is to verify that an earlier reported bug has been fixed
   def test_merge
     documents = []

data/test/tc_xml.rb

@@ -46,9 +46,11 @@ class TestXml < Test::Unit::TestCase
   def test_default_keep_blanks
     XML.default_keep_blanks = false
     assert(!XML.default_keep_blanks)
+    assert_equal(XML::Parser::Options::NOBLANKS, XML.default_options)
 
     XML.default_keep_blanks = true
     assert(XML.default_keep_blanks)
+    assert_equal(0, XML.default_options)
 
     XML.default_keep_blanks = false
     assert(!XML.default_keep_blanks)
@@ -72,9 +74,11 @@ class TestXml < Test::Unit::TestCase
   def test_default_substitute_entities
     XML.default_substitute_entities = false
     assert(!XML.default_substitute_entities)
+    assert_equal(0, XML.default_options)
 
     XML.default_substitute_entities = true
     assert(XML.default_substitute_entities)
+    assert_equal(XML::Parser::Options::NOENT, XML.default_options)
 
     XML.default_substitute_entities = false
     assert(!XML.default_substitute_entities)
@@ -97,9 +101,11 @@ class TestXml < Test::Unit::TestCase
   def test_default_validity_checking
     XML.default_validity_checking = false
     assert(!XML.default_validity_checking)
+    assert_equal(0, XML.default_options)
 
     XML.default_validity_checking = true
     assert(XML.default_validity_checking)
+    assert_equal(XML::Parser::Options::DTDVALID, XML.default_options)
 
     XML.default_validity_checking = false
     assert(!XML.default_validity_checking)
@@ -108,9 +114,11 @@ class TestXml < Test::Unit::TestCase
   def test_default_warnings
     XML.default_warnings = false
     assert(!XML.default_warnings)
+    assert_equal(XML::Parser::Options::NOWARNING, XML.default_options)
 
     XML.default_warnings = true
     assert(XML.default_warnings)
+    assert_equal(0, XML.default_options)
 
     XML.default_warnings = false
     assert(!XML.default_warnings)
@@ -209,4 +217,8 @@ class TestXml < Test::Unit::TestCase
   def test_libxml_parser_features
     assert_instance_of(Array, XML.features)
   end
+
+  def test_default_options
+    assert_equal(0, XML.default_options)
+  end
 end

data/test/tc_xpath.rb

@@ -163,16 +163,6 @@ class TestXPath < Test::Unit::TestCase
     assert_equal('Envelope', nodes.first.name)
   end
 
-  def foo
-    puts nodes.length
-    doc = nil
-    assert_equal(4, nodes.length)
-    GC.start
-    node = nodes.first
-    nodes = nil
-    GC.start
-  end
-
   def test_xpath_namespace_nodes
     doc = XML::Document.string('<feed xmlns="http://www.w3.org/2005/Atom" xmlns:xhtml="http://www.w3.org/1999/xhtml"><entry/></feed>')
     nodes = doc.find('//atom:entry|namespace::*', :atom => "http://www.w3.org/2005/Atom")

metadata

@@ -1,7 +1,7 @@
 --- !ruby/object:Gem::Specification 
 name: libxml-ruby
 version: !ruby/object:Gem::Version 
-  version: 1.1.2
+  version: 1.1.3
 platform: x86-mswin32-60
 authors: 
 - Charlie Savage
@@ -9,7 +9,7 @@ autorequire:
 bindir: bin
 cert_chain: []
 
-date: 2009-03-14 00:00:00 -06:00
+date: 2009-03-21 00:00:00 -06:00
 default_executable: 
 dependencies: []
 
@@ -133,7 +133,6 @@ files:
 - lib/xml
 - lib/xml/libxml.rb
 - lib/xml.rb
-- test/cro_events.html
 - test/etc_doc_to_s.rb
 - test/ets_doc_file.rb
 - test/ets_doc_to_s.rb

data/test/cro_events.html

@@ -1,740 +0,0 @@
-<!DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN" 
-"http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd">
-<html xmlns="http://www.w3.org/1999/xhtml">
-
-<head>
-<meta content="text/html; charset=utf-8" http-equiv="Content-Type" />
-</head>
-
-<body>
-
-<table>
-  <tr>
-	<td valign="top">
-	<h1>Innovation in a Reduced Cost and Enhanced Efficiency Environment</h1>
-	<p>With the increasing cost of doing business and budget constraints, clinical 
-	professionals need to do more than ever before with less, while still increasing 
-	productivity and maintaining quality. Sponsors are operating with fewer resources 
-	and need to outsource more but must do so with less money. And with a high number 
-	of product failures, available dollars for outsourcing are being threatened 
-	– this being especially true in smaller companies. Due to the increase in outsourcing, 
-	CROs and Labs have a surplus of business right now and rate structures and pricing 
-	have risen because of this. To top it all off, ever-rising turnover for both 
-	sponsors and providers causes increased time and cost to complete studies. Centerwatch 
-	reports that 94% of projects run over either or both time and budget. How can 
-	we do better? </p>
-	<p>How can CROs and Sponsors collaborate to reduce non-value added activities 
-	so that more and better resources can be directed to more important work?</p>
-	<p>How is large pharma employing cost saving innovations internally as well 
-	as externally e.g. Flexible staffing from CROs for monitoring , data management, 
-	safety, off-shoring, etc</p>
-	<p>How can suppliers be more proactive in creating new business models to reduce 
-	costs and maintain quality? </p>
-	<p>Forecasting outsourcing demand and matching capacity increases with demand 
-	growth and managing that growth - better planning with more transparency allows 
-	partners to more effectively forecast the outsourcing demand and its impact 
-	on both parties</p>
-	<p>Identifying and implementing operational efficiencies to contain cost and 
-	keep on timelines</p>
-	</td>
-	<td valign="top" rowspan="2">
-	<h1>Wall Street’s 2009 Forecast and Analysis of Outsourcing Trends</h1>
-	<p>Back by popular demand and with double the dedicated time, our Wall Street 
-	perspective offers an assessment of the outsourcing environment from 2008-2009 
-	as well as an outlook for the next few years. Our presenters each offer a brief 
-	commentary to kick off this very interactive session that welcomes audience 
-	questions and comments. Special focus is given to the following issues, with 
-	a</p>
-	<p>Wall St and Private Equity view on:</p>
-	<p>The CRO industry, summarizing 2008 financial trends</p>
-	<p>Outlook for 2009 and beyond</p>
-	<p>The issue of CRO consolidation and the trade-offs of being public vs. private, 
-	given the growing role of private equity finance</p>
-	<p>Assessment of the pharmaceutical landscape and how it impacts CROs</p>
-	<p>Other industry trends such as risk-sharing, etc.</p>
-	<p>'</p>
-	</td>
-	<td valign="top">
-	<h1>Defining and Managing Quality in Clinical Trials </h1>
-	<p>Timelines to get drugs to market are being shortened, budgets are being decreased, 
-	and quality expectations are increasing. Most of outsourcing focus is on time, 
-	cost and scope but a major challenge is in the quality of the process and the 
-	major deliverables. There is no doubt quality is front of mind with drug companies 
-	and regulatory agencies alike. Though it must be conceded that many current 
-	practices were reactively triggered in response to quality problems, the future 
-	will require that quality management be more proactively and comprehensively 
-	integrated into study planning and execution. Quality must be considered not 
-	as something imposed upon us, but as something that helps us. But how does one 
-	go about defining quality, changing the mindset, specifying quality standards 
-	and managing a team to those standards? This session sets out to explore this 
-	key question and others including: </p>
-	<p>How can quality be defined and measured? </p>
-	<p>How do we manage the apparent contradiction between increasing quality and 
-	reducing cost? </p>
-	<p>How can teams focus on quality while dealing with competing priorities on 
-	multiple studies they are managing?</p>
-	<p>What skills/characteristics are needed for team leaders and team members 
-	(on both the Sponsor and Provider sides)?</p>
-	<p>In a sourcing relationship who is primarily responsible for quality?</p>
-	<p>How do partners work together to achieve quality goals?</p>
-	</td>
-	<td valign="top">
-	<h1>Leading Virtual Teams Around the Globe</h1>
-	<p>Companies are increasingly building teams, networks and groups that are working 
-	together virtually. </p>
-	<p>How you manage and oversee outsourced work?</p>
-	<p>How can we ensure regulations are being met with ex-US?</p>
-	<p>Sourcing professionals and project managers need information on how to work 
-	with a virtual team with those sitting in other offices around the globe</p>
-	<p>What does the future project manager/sourcing professional look like in today's 
-	complex trials?</p>
-	<p>Are we providing team members with the right skills to work in these models?</p>
-	<p>Having offices in global locations does not make you a "global company"; 
-	how to harmonize teams for a global project</p>
-	</td>
-	<td valign="top">
-	<h1>Standardization: The Holy Grail? The 2009 Update</h1>
-	<p>A major frustration across the industry is the different methodologies for 
-	the operations, conduct and management of clinical trials, site recruitment 
-	and management, communications and performance, audit readiness (site and sponsor), 
-	clinical project management, and the use of metrics to manage studies and training 
-	of CTM personnel. The problem runs even deeper for small companies with less 
-	resources, infrastructure and tools. There is little to no consistency across 
-	companies which in turn affect costs dictated by service providers as they must 
-	work on different platforms. Can the pharma and CRO industries work together 
-	to inspire a new level of standardization? This lively panel is in follow up 
-	to last year's serious-minded out-of-the-box discussion on the formation of 
-	standards.</p>
-	</td>
-  </tr>
-  <tr>
-	<td valign="top">
-	<h1>Developing Efficiencies Using a Central Lab &amp; CRO Together</h1>
-	<p>Pharmaceutical and biotech companies often independently select central lab 
-	and CRO suppliers. Considering the cross-industry tradition of achieving efficiencies 
-	in only two of the three project drivers, time – quality –cost, this session 
-	will present a case study of efficiencies realized in all three drivers when 
-	using a resource partner which provides both central lab and CRO services. Specifically 
-	discussed will be the unique efficiencies provided to the pharma client by the 
-	central lab and the CRO data vendor perform real-time date management via a 
-	proprietary connection. In addition, this session will highlight how resource 
-	partnerships are welcomed within a pharma company's support areas of finance 
-	and operations. </p>
-	</td>
-	<td valign="top">
-	<h1>Ensuring Quality at the Sponsor, Site and CRO Levels </h1>
-	<p></p>
-	<p>Achieving quality in a highly regulated and scrutinized industry where time, 
-	patients, resources and sometimes funding are limited is a major challenge facing 
-	companies today. Choosing suppliers who deliver quality work, while following 
-	FDA and GCP guidelines, SOPs and monitoring plans and training to ensure personnel 
-	understand their responsibilities and are in compliance is at top of minds. 
-	This interactive discussion explores: </p>
-	<p>How do you establish an appropriate quality standard? </p>
-	<p>Is Quality Assurance/Management a standard part of your project team? </p>
-	<p>Is quality management fee-for-service or the cost of doing business?</p>
-	<p>Successfully partnering with CROs, labs, and sites to conduct efficient yet 
-	effective studies as quickly as possible and ensure data integrity</p>
-	<p>Meeting regulatory expectations for quality and company expectations of timeliness 
-	and cost </p>
-	<p>effectiveness</p>
-	<p>Working with Project team and sites to educate sites on the importance of 
-	adhering to the Protocol</p>
-	</td>
-	<td valign="top">
-	<h1>Successfully Applying Technology to Clinical Trials Across World Regions</h1>
-	<p>Understand the application of technology in making traditional clinical research 
-	easier</p>
-	<p>Identify cultural and infrastructural challenges</p>
-	<p>Integrate modern technologies in developing nations</p>
-	<p>Learn how to realistically integrate technology to local situations</p>
-	<p>Manage technology globally at the site level</p>
-	</td>
-	<td valign="top">
-	<h1>RFP Management &amp; Contracting with CROs to Minimize Change Orders</h1>
-	<p>What type of detail do CROs want in the RFP to help them get a better understanding 
-	of what is being outsourced?</p>
-	<p>How to develop an RFP that allows the sponsor to compare like proposals while 
-	allowing the CRO to distinguish themselves and show creativity?</p>
-	<p>Developing and creating contracts and RFPs that can be managed under metrics</p>
-	<p>What type of information is useful to have in a proposal that is found lacking 
-	in the average CRO bid?</p>
-	<p>The RFP and the budgeting process with government contracts</p>
-	<p>RFP ethics – competitive underbidding with hidden change orders/equal sharing 
-	of information with all providers</p>
-	<p>RFP process and budgeting for Big Pharma vs. smaller company </p>
-	<p>Establishing the basis for paying sites</p>
-	<p>Need for transparency in communication of the assumptions, responsibilities 
-	and budgeting process leads to more collaborative agreements</p>
-	</td>
-  </tr>
-  <tr>
-	<td valign="top">
-	<h1>Early Sponsor/Supplier Team Collaboration for More Effective Design of Your 
-	Clinical Program </h1>
-	<p>Large pharma companies are moving toward engagement on a strategic level 
-	in the early design and feasibility work by brining partners in early. As many 
-	are going into a new territory, whether geographic or therapeutic, with new 
-	molecules, they want the CRO input that much sooner. Smaller and mid size companies 
-	also want a more collaborative relationship with CROs because they don't have 
-	the throughput to gain the experience the CROs have and while there are large 
-	gaps in time between when they have to perform certain tasks, CROs are expected 
-	to keep up with regulations, etc. In addition, small companies want participation 
-	from CROs at time of RFP and appreciate the time, energy and thought put into 
-	proposals in addition to cost.</p>
-	<p>Providing Sponsors with feedback based on experience and expertise versus 
-	making decisions on budgets </p>
-	<p>Avoiding the 'cookie cutter' proposal</p>
-	<p>Collaborating with suppliers in the planning stage to set the team up for 
-	success</p>
-	</td>
-	<td valign="top">
-	<h1>Transforming Drug Development Outsourcing with a Virtual Model</h1>
-	<p>Virtual companies essentially outsource every component of development. Historically, 
-	virtual companies have been comprised of only a handful of individuals (e.g. 
-	researchers who have come from larger companies) or venture capitalists. These 
-	new companies are being formed by those who are recognizing that the big pharma 
-	model is losing its sustainability, and so they move their ideas (brain trust) 
-	outside of the big company to start their own initiative. Now the model is beginning 
-	to move into a construct where there is a whole portfolio of products being 
-	managed virtually. As the industry aspires to a lower cost basis for drug development, 
-	CROs must find ways to accommodate this by having a real stake in the success 
-	of the client with risk-sharing models of rising interest. </p>
-	<p>Is the rise of the Virtual Pharma business model a "fad" or a permanent change 
-	in the Pharma industry?</p>
-	<p>Changing the mindset of those who have 'grown up' in big pharma to results 
-	driven vs. task driven</p>
-	<p>Virtual pharma's expectation of the CRO</p>
-	<p>CRO understanding of how the virtual model differs from traditional models 
-	and having an internal 'champion' looking out for the interests of the virtual 
-	pharma company</p>
-	<p>Empowering CROs to drive the outcome of the outsourced work</p>
-	<p>Lessons from virtual companies that can benefit big pharma</p>
-	</td>
-	<td valign="top">
-	<h1>The Implications of Post-Marketing Requirements on the Future of Drug Development 
-	Partnerships </h1>
-	<p>Post-marketing requirements (PMRs) required by FDA and other regulatory authorities 
-	are becoming more demanding and increasing in complexity. While the information 
-	ascertained by PMRs is crucial to expanding safety and efficacy information 
-	on the drug, they are not always adhered to. PRMs place a large burden on the 
-	R&amp;D function already struggling to get new products launched and the cost of 
-	these added trials are great. While traditional Phase IV trials are done primarily 
-	for marketing purposes, FDA is now looking for signals in large scale studies 
-	for adverse events in real world situations. The parameters are not relative 
-	to Phase IV so companies can't use phase IV approach for PMRs. Instead, they 
-	are conducted by the same groups who do the initial pre-registration work. What 
-	is the best approach to get the work done effectively? Sponsors are looking 
-	to CROs to provide solutions, but many are still presenting their Phase IV teams 
-	for these demanding trials. What used to be the exception is increasingly becoming 
-	the rule for new drug approvals and the FDA will now have the ability to impose 
-	financial penalties on pharma companies who do not comply. This development 
-	is critical to the Pharma/CRO relationship as the CRO must be on board with 
-	the time commitments and deliverables.</p>
-	<p>Managing post approval studies - what is the best approach with inherent 
-	regulatory uncertainty?</p>
-	<p>Learning to perform these studies efficiently as the cost of these programs 
-	can exceed the cost of the drug registration program </p>
-	<p>From a sourcing perspective, how do niche providers and CROs collectively 
-	work on this to support the PMR effort?</p>
-	<p>Europe and other countries are also requiring more post-approval commitments 
-	– how are companies preparing?</p>
-	</td>
-	<td valign="top">
-	<h1>Approaches to Address the Impact of Increasingly Complex Clinical Trials
-	</h1>
-	<p>Increasingly complex clinical trial protocols demand more of investigative 
-	sites and study volunteers, leading to longer cycle times, more AEs and increasing 
-	difficulty in recruiting and retaining patients, according to research by Tufts 
-	CSDD. Combining the influx of less experienced investigators from emerging markets 
-	and increasing churn among &#39;established&#39; investigators with not only an increase 
-	in the number of trials but also an increase in their complexity opens up a 
-	major grey zone for clinical trial quality. What are some of the pragmatic approaches 
-	to overcome these challenges? This session explores the answers and sets the 
-	stage for introducing a proactive approach to predict and prevent protocol violations, 
-	both from a drug development service provider perspective, and from a site/investigator 
-	perspective. Key clinical trial success factors to be discussed include:</p>
-	<p>Successfully leveraging emerging market investigators who may be less experienced 
-	for trials that are becoming more complex and demanding</p>
-	<p>Architecting a site management plan that promotes primary data quality and 
-	consistency yet allows flexibility based on country-specific differences</p>
-	<p>Best practice for investigators to absorb a clinical trial into regular site 
-	operations</p>
-	<p>Reducing non-core activities to free up resources to focus on their key responsibilities</p>
-	</td>
-	<td valign="top">
-	<h1>Developing Scope of Work for Solid Project Foundation and Minimal Project 
-	Setbacks</h1>
-	<p>A solid scope provides the best project foundation and minimizes both the 
-	likelihood and impact of project upsets. </p>
-	<p>Ripple effect beyond the contracting phase</p>
-	<p>Avoiding costly change orders due to hurried or misinterpreted scopes</p>
-	<p>Developing the scope with your partner leads to a well defined scope and 
-	strong foundation for success</p>
-	<p>Proposal development as an exercise in collaborative solution seeking to 
-	develop a mutually agreeable and achievable plan</p>
-	</td>
-  </tr>
-  <tr>
-	<td valign="top">
-	<h1>Shared Risk: Getting Beyond the Sponsor/Vendor Paradigm </h1>
-	<p></p>
-	<p>Trust can not be built on transactional relationships. It is built on transparency 
-	and commitments between companies where relationship management is blended with 
-	a very candid understanding of business interests for both CROs and Sponsors. 
-	When Sponsors and CROs do not share the same end goal (e.g. regulatory approval) 
-	or the same risks how can their interests be aligned? Would pharma companies 
-	be willing to put in significant incentives, monetary or otherwise, tied to 
-	approval if the CRO is charged with running a registration trial? Are Sponsors 
-	adept at identifying the risks appropriate to transfer to CROs? Are CROs prepared 
-	to take the risk burden or is it a gamble?</p>
-	<p>Developing and maintaining relationships: sharing and understanding your 
-	partners' interests, and fostering a commitment to share risks</p>
-	<p>Constructing an agreement that fosters shared risk and demonstrates a commitment 
-	to partnership</p>
-	<p>How do you get to this level of trust with your supplier? </p>
-	<p>KPIs for relationship building and performance management</p>
-	</td>
-	<td valign="top">
-	<h1>Creating Collaborative Partnerships for Strategic Outsourcing, Forecasting 
-	and Decision Making</h1>
-	<p>Otsuka Pharmaceutical Development and Commercialization (OPDC) has embarked 
-	on an ambitious plan to create collaborative partnerships with a very few CROs. 
-	This strategy includes a staffing forecasting model that allows Otsuka to forecast 
-	internal, outsource and outsource-management requirements and a risk reduction 
-	methodology for ensuring better project performance. This talk will focus on 
-	the research that led us to take this path, the approach we have used to select 
-	an initial partner and the relationship that we have built. Learn about OPDC's:</p>
-	<p>Implementation and Methodology</p>
-	<p>Supplier selection process</p>
-	<p>Staffing model to forecast sponsor and partner needs based on the pipeline</p>
-	</td>
-	<td valign="top">
-	<h1>Fulfilling Post-Marketing Requirements Utilizing Endpoint Trials</h1>
-	<p>Post-Marketing Requirements are being imposed with greater frequency by the 
-	FDA and other regulating agencies, in many cases, to obtain additional safety 
-	data in a long-term or niche population. The more commercially-oriented Phase 
-	IV studies of the past are no longer sufficient to fulfill the scientific rigor 
-	required in the current regulatory environment. Endpoint point trials as a means 
-	of fulfilling these obligations are becoming more common, allowing evaluation 
-	of a treatment on mortality or major morbidity within a disease entity. There 
-	are challenges associated with the implementation of endpoint trials which require 
-	close collaboration to ensure the quality and consistency of the safety data 
-	collected. In this session, the following points will be discussed:</p>
-	<p>What are the advantages of utilizing an endpoint trial to fulfill post-marketing 
-	commitments?</p>
-	<p>What are the some of the challenges faced in designing and executing endpoint 
-	trials? And how can Sponsors and CROs effectively collaborate to overcome these 
-	challenges?</p>
-	<p>What strategies have proven successful in implementing endpoint trials?</p>
-	</td>
-	<td valign="top">
-	<h1>Clinical Trials: What Does Global Mean to You?</h1>
-	<p>The first step in working with a global provider is analyzing whether working 
-	with one makes sense for your project. Once you&#39;ve examined the criteria around 
-	your project&#39;s needs, you must carefully investigate the growing range of providers 
-	offering global service. There are many CROs claiming to be global, but what 
-	constitutes this?</p>
-	<p>How many studies?</p>
-	<p>How do you identify the right partner on a regional basis?</p>
-	<p>How do you best evaluate your needs as a sponsor?</p>
-	<p>How much of the global CRO staff belongs to a &quot;partnering CRO&quot;?</p>
-	<p>If the partners become financially unstable, what recourse is there for the 
-	sponsor?</p>
-	<p>Who manages the partners? Should the sponsor have to cover management fees 
-	for the primary CRO to manage/interact with their partners?</p>
-	<p>Are CROs always up front about their global capabilities?</p>
-	<p>Even though the &quot;global&quot; CRO carries the contractual relationship with their 
-	partner, do they take and hold responsibility for performance?</p>
-	<p>What due diligence is expected from the sponsor of these partners? Should 
-	the primary CRO hold the responsibility? How will the regulators view this?</p>
-	</td>
-	<td valign="top">
-	<h1>Supplier Identification and Selection</h1>
-	<p>Using RFIs, vendor days, and capability presentations to identify service 
-	provider options</p>
-	<p>Developing a vendor assessment and selection process</p>
-	<p>RFPs, bid grids, scorecards, bid defenses, and more</p>
-	<p>Successes/challenges of working with a functional outsourcing model</p>
-	<p>Necessary time and skill set to partner with new CROs that are a good fi 
-	t and provide what is expected without a</p>
-	<p>number of change orders</p>
-	<p>Selecting suppliers that really will do what the BD sales people promise</p>
-	</td>
-  </tr>
-  <tr>
-	<td valign="top">
-	<h1>Streamlining the Outsourcing Process and Minimizing Internal Resources through 
-	the Use of External Provider Management Teams</h1>
-	<p>In order to streamline the outsourcing process and the delivery of clinical 
-	trials, AstraZeneca created External Provider Management Teams (EPMTs). EPMTs 
-	are delivery teams comprised of a limited number of AstraZeneca and CRO members 
-	who direct CRO study teams to deliver a portfolio of studies. One external partner 
-	was selected to work with each therapy area EPMT to deliver all the outsourced 
-	work within that area. While still in the early stages, the model has already 
-	provided substantial internal resource savings. This panel discussion will take 
-	you through the model and its current, as well as future, expected benefits.</p>
-	<p>No more RFPs!</p>
-	<p>Save internal resources</p>
-	<p>One outsourcing model</p>
-	<p>Increase partnerships </p>
-	<p>with external providers</p>
-	<p>Maximize synergies and improved quality</p>
-	</td>
-	<td valign="top">
-	<h1>Creating a Competitive Advantage through Sourcing</h1>
-	<p>The speaker will share his personal insights on how Sourcing can be a catalyst 
-	for driving transformational performance that can be seen and measured by the 
-	business. He will discuss how Sourcing professionals can increase their sphere 
-	of influence within the businesses they service to enable change, how to gain 
-	the endorsement of their business leaders, and important components of delivering 
-	a successful outcome.</p>
-	<p>What is an SME</p>
-	<p>How collaboration makes the difference</p>
-	<p>Seizing the opportunity</p>
-	<p>Insuring a successful outcome</p>
-	</td>
-	<td valign="top">
-	<h1>Assuring Project Excellence through Quality Metrics Management</h1>
-	<p>At Paragon, we meet and exceed the expectations of our clients by focusing 
-	on project excellence in all areas of service. To support our focus on project 
-	excellence, we have adopted a global metrics management approach that allows 
-	us to proactively identify potential problems and anticipate the need to develop 
-	strategic management plans to assure project success. In this session we will 
-	walk through our comprehensive approach to metrics management, share our Project 
-	Management Dashboard and discuss how metrics can benefit you and provide you 
-	peace of mind. </p>
-	<p>Defining metrics for a global project</p>
-	<p>Standardizing metrics tracking and reporting</p>
-	<p>Metrics tools: Project Management Dashboard </p>
-	<p>-Philosophy and Thresholds</p>
-	<p>Metrics management </p>
-	<p>-The Monthly Project Review</p>
-	<p>-Issue escalation</p>
-	<p>The benefit to you, the Sponsor</p>
-	<p>-Early detection of potential issues</p>
-	<p>-Proactive strategic planning to avoid project execution failures </p>
-	<p>-Identification of process inefficiencies</p>
-	<p>-Peace of mind</p>
-	</td>
-	<td valign="top">
-	<h1>Optimizing Science and Project Management to Minimize the Impact of Regulations, 
-	Logistical Concerns and Economics on Managing Chinese Specimens in Global Trials</h1>
-	<p>Harnessing the right resources to balance the needs of global trials and 
-	mitigate the pitfalls of Chinese specimen management: This session explores 
-	the scientific and management issues that are often overlooked when sourcing 
-	global trials that include Chinese specimens. The importance of ensuring strong 
-	management and scientific methodologies is critical for success and Quality, 
-	On-Time. Key factors for consideration are establishing clear understanding 
-	of the regulatory and cultural environment, ease of management through a central 
-	lab and oversight through a single global point of contact. This session will 
-	explore the science, technologies and program management methodologies to maximize 
-	the benefit and mitigate the pitfalls of conducting trials in China.</p>
-	<p>Chinese specimen &amp; Regulatory roadblocks that impact global studies</p>
-	<p>Incorporating biomarker data to optimize study scientific investment</p>
-	<p>Harmonizing program management on global trials to avoid regional requirement 
-	conflicts</p>
-	</td>
-	<td valign="top">
-	<h1>Impact of Global Currency Fluctuation on Project Budgets: Who Holds the 
-	Risk?</h1>
-	<p>Global currency fluctuation has become an increasing challenge as more and 
-	more trials are conducted outside the United States which impacts charge rates 
-	regionally and daily. Multi-year contracts are becoming unwieldy, and R&amp;D Finance 
-	has added the management of the fluctuations to its already full load of responsibilities.</p>
-	<p>History and implications of currency fluctuations</p>
-	<p>What happens when a once-cost effective country becomes more expensive?
-	</p>
-	<p>How currency fluctuations are being managed </p>
-	<p>Operationalizing a plan to address this challenge </p>
-	<p>Overcoming any distrust between sponsor and provider caused by fluctuations
-	</p>
-	<p>What is in scope for consideration as a currency risk </p>
-	<p>Things to consider and "what if " scenarios </p>
-	<p>Who is at risk? </p>
-	<p>Strategies for managing risk: To hedge or not to hedge </p>
-	<p>How is VAT managed/payment and reimbursement?</p>
-	</td>
-  </tr>
-</table>
-<p><span></span></p>
-<table border="1" cellpadding="0" cellspacing="0" summary="layout table">
-  <tr>
-	<td valign="top">
-	<h1>Adapting to Constant Change: How Partners are Working Through the Organizational 
-	Stages </h1>
-	<p>Changes are more dramatic than ever before in today's pharmaceutical industry 
-	with layoffs impacting resources and mergers effecting increased competition 
-	and long periods of inactivity. The trickle down delay to CROs is frightening. 
-	From a business development perspective dealing with change management as the 
-	industry deals with ever increasing pressures on trial design, timelines and 
-	budgets can be frustrating and costly when a study is delayed or cancelled, 
-	or when new management comes in changing strategy and objectives. As Sponsors 
-	increasingly share more responsibility with CRO partners and have less time/resources 
-	for oversight, how are companies dealing with the changes that ensue? </p>
-	<p>Changing doers into managers - How providers need to change to respond to 
-	this</p>
-	<p>Risk tolerance providers must bear in an uncertain environment </p>
-	<p>IP, manpower, time management </p>
-	<p>Dealing with sometimes inexperienced or difficult teams on both sides</p>
-	</td>
-	<td valign="top">
-	<h1>Evolving the Key Strategies of Clinical Development Sourcing -- Current 
-	and</h1>
-	<h1>Future Direction</h1>
-	<p>Our presenters discuss ÉLAN and the alliance model resourcing strategy, including:</p>
-	<p>Decision point/ROI to move to this model from a clinical development strategy 
-	perspective</p>
-	<p>Applying operational learnings from large to mid-size organizational strategies</p>
-	<p>Adoption curve to newer strategic resourcing directions</p>
-	<p>Measuring operational success and continuous opportunities</p>
-	<p>Governance and operating model with RPS</p>
-	</td>
-	<td valign="top">
-	<h1>Adaptive Clinical Trials: Innovations in Trial Design and Management</h1>
-	<p>With pharmaceutical companies facing the increasing challenge of diminishing 
-	pipelines, drug developers are always looking for new methods to shave time 
-	off of discovering and developing new molecules. Tools such as adaptive trial 
-	designs allow clinicians the ability to "fail faster." This is accomplished 
-	by utilizing accumulating data to direct potential modifications to the trial 
-	as it progresses, while at the same time keeping the validity and integrity 
-	of the study in tact. In addition to cost and time savings, adaptive trials 
-	require fewer patients – a distinct benefit as patient enrollment is an ongoing 
-	obstacle to speedy trial management. Planning and executing these trials, however, 
-	can be much more intricate than traditional trial approaches and teams from 
-	clinical operations and trial management, data management, statistics and must 
-	align early in the process and work together judiciously for proper study conduct.</p>
-	<p>Discuss the advantages and disadvantages of adaptive designs</p>
-	<p>Learn how sponsors and suppliers are effectively collaborating on adaptive 
-	trials</p>
-	<p>Understand the regulatory nuances of these special designs</p>
-	</td>
-	<td valign="top">
-	<h1>Outsourcing Clinical Trials in Emerging Regions</h1>
-	<h1>I. Outsourcing Clinical Trials in India and China</h1>
-	<p>Off shoring clinical trials to emerging markets around the world is receiving 
-	increasing attention as a very attractive alternative in the clinical development 
-	process. Do clinical research capabilities comparable to the US in terms of 
-	sophistication and FDA-compliance exist anywhere else in the world? And if they 
-	do, are they ready to handle the marked increase in demand from the US? Our 
-	panelists discuss in detail the demographics, challenges and opportunities, 
-	expertise of individual countries and the opportunities to optimize project 
-	budgets and reduce development time and regulations with global implications 
-	including:</p>
-	<p>How cost control and investor expectations is leading to increased off-shoring 
-	opportunities</p>
-	<p>Understanding regulatory and operating environment of emerging markets as 
-	well as cultural intricacies and how</p>
-	<p>to place and execute clinical trials there</p>
-	<p>How to offshore a project in such a manner that the work is seamless to the 
-	end user, i.e. the offshored partner performs the work in the same manner as 
-	an internal colleague</p>
-	<p>Complexity of protocols vis-a-vis emerging country capabilities / infrastructure
-	</p>
-	<p>Coordination of projects across multiple companies on a global basis</p>
-	<p>Must-have contractual requirements for commonly used international countries</p>
-	<p>Managing multi-national projects with fluctuating timelines (enrollment, 
-	government regulations, IRB approvals, etc).</p>
-	<p>Global integration of data, processes and cultures</p>
-	<p>Utilization of low cost countries with available subject populations and 
-	GCP trained investigators</p>
-	<p>Ethical considerations in deciding on trial placement</p>
-	</td>
-	<td valign="top">
-	<h1>The Functional Service Provider Model: Exploring the Challenges and Benefits</h1>
-	<p>As sponsor companies continue to feel the effects of increased performance 
-	pressures with flat or negative headcount growth, loss of exclusivity with fewer 
-	revenue replacement prospects, tightened regulatory environs with increasing 
-	scrutiny of obligations, and more intense cost containment demands, alternative 
-	sourcing paradigms are becoming the norm and no longer the exception. Specifically, 
-	the Functional Service Provider model of outsourcing has continued to grow in 
-	primarily large biopharmaceutical companies; however, mid and even small companies 
-	are looking toward the FSP model as a way to respond to the changing development 
-	environment. This session will focus on functional approaches seen in practice 
-	and in theory to present for discussion the value platform proposed by this 
-	model. From highly transactional, commodity-like services to the value-add hybrid 
-	approach, the panel will seek to engage the audience to debate the challenges 
-	and benefits in the FSP paradigm.</p>
-	</td>
-  </tr>
-</table>
-<table summary="layout table">
-  <tr>
-	<td valign="top">
-	<h1>Small BioPharma Partnerships: Challenges and Opportunities for Transactional 
-	vs. Strategic Approaches</h1>
-	<p>Small pharma and biotech companies tend to bring in partners very early to 
-	discuss development and often gravitate to biggest most global CROs who can 
-	run the entire study. Is this the best operational choice? Small company clinical 
-	operations look to the project manager at the CRO to be their virtual internal 
-	clinical leader but CROs are not all set up to engage in this way. Many small 
-	companies do not have the pipeline to engage in strategic relationships, and 
-	must be transactional, but how do those companies get attention from a large 
-	CRO? The issues are the same as those at Big Pharma, but large companies have 
-	different perspectives and engage CROs on multiple strategic levels (feasibility, 
-	expertise). Who is the person at the supplier who will advocate to their senior 
-	management for your organization when things go wrong? How have small and mid-size 
-	pharma/biotech partnered for success as they have more to lose if a trial and/or 
-	provider relationship does not go well due to poor planning, miscommunication, 
-	etc? When strategic outsourcing/partnerships don't resonate with small companies, 
-	sponsors and suppliers must have a meeting of the minds on the challenges that 
-	small companies face on a tactical level. </p>
-	<p>How emerging Biotechs have managed to stay top of mind when working with 
-	a large CRO </p>
-	<p>What are the benefits and challenges of working with a smaller CRO? Or multiple 
-	CROs (e.g. network of small regional CROs rather than one large global one)?</p>
-	<p>Is there any one right model or does it depend on what phase you're working 
-	in?</p>
-	<p>How does the CRO get the right team to its clients?</p>
-	<p>How are CROs staffing their organizations to deliver to smaller companies?</p>
-	<p>What technology and infrastructure is needed among parties?</p>
-	</td>
-	<td valign="top">
-	<h1>How Do Mergers, Acquisitions and Licensing Impact Outsourcing Decisions 
-	and the Role of the CRO?</h1>
-	<p>With so many Big Pharmas working within M&amp;As and constantly changing portfolios, 
-	mid-size companies no longer developing their own compounds but acquiring them 
-	instead, and small companies seeking only enough drug registrations so that 
-	another company can buy them out, there is a change in the business we need 
-	to respond to which opens the door for thinking about sourcing differently. 
-	The lack of history and emotional attachment which comes with acquired compounds 
-	affords the opportunity for culture change. No matter what size company however, 
-	for successful development, partners need to understand what the ultimate goal 
-	is.</p>
-	<p>What can Big Pharma learn from small companies?</p>
-	<p>What is the role of the CRO is helping a sponsor develop a compound that 
-	has been acquired or licensed?</p>
-	<p>After the service provider is chosen, how do you build trust – when in the 
-	process of selecting, how much info are companies willing to provide and share 
-	so they can collectively make a good decision?</p>
-	<p>How do IP and commercial implications factor in for more sophisticated portfolios 
-	rather than simply a virtual company with one compound?</p>
-	<p>In the case of M&amp;A, what happens to the Suppliers working with the company 
-	being acquired? Does it affect their position/relationship with the company? 
-	Does the company keep them informed about their status as the</p>
-	<p>event progresses? Are they in a more secondary role?</p>
-	<p>What if the M&amp;A is on the CRO side?</p>
-	</td>
-	<td valign="top">
-	<h1>What Does FDA Expect Regarding Quality Oversight of Third Parties?</h1>
-	<p>Outsourcing of clinical research activities is increasingly common in FDA-regulated 
-	medical product development.</p>
-	<p>Last year, Frost &amp; Sullivan calculated that drug and biotech companies spent 
-	$57 billion on outsourcing; contract research organizations (CROs) got almost 
-	30 percent, or $17 billion. U.S. companies in particular outsourced 40 percent 
-	of their clinical trials and that's expected to rise to 65 percent by 2013. 
-	As a result, FDA has seen the emergence of an alarming trend regarding the submission 
-	of unreliable clinical research data to the agency. Therefore, FDA's medical 
-	device center began analyzing this trend and found some common threads that 
-	lead to these unwanted situations. This presentation will uncover some of those 
-	warning signals and outline methods employed by industry to mitigate their occurrence.</p>
-	</td>
-	<td valign="top">
-	<h1>II. Outsourcing Clinical Trials in Latin America</h1>
-	</td>
-	<td valign="top">
-	<h1>Educating Procurement and Outsourcing: How a Better Domain Knowledge Makes 
-	Your Job Easier and More Effective</h1>
-	<p>Biomarkers is an innovative new tool that clinical operations and study management 
-	teams are increasingly utilizing which afford them the ability to cut down on 
-	costs and resources and make faster decisions within the overall drug development 
-	programs for clinical trial endpoints and timelines. In many cases, however, 
-	outsourcing/procurement professionals may not fully understand the use of such 
-	procedures/services: 1) why they are necessary and being utilized within drug 
-	development programs, 2) how the primary endpoints of a trial are enhanced by 
-	their use, 3) what the Procedure/test/service/analysis actually is, and 4) the 
-	variety of services that exist. As the first and sometimes only contact reaching 
-	out to vendors, the education on the use of biomarkers and the impact they have 
-	on the clinical trial progression and deliverables is crucial to having Sponsors 
-	bulk up their knowledge of what's out there to better support their respective, 
-	internal study management teams across all phases of trials. </p>
-	<p>Our speakers address:</p>
-	<p>Ramping up for increasing internal customers' request for Purchasing and 
-	Outsourcing assistance in this area of biomarkers</p>
-	<p>Understanding and overcoming opposing needs; clinical operations' pursuit 
-	of speed and quality vs. purchasing's directive to save money vs outsourcing's 
-	requirement of consistency of performance and quality deliverables.</p>
-	<p>Understanding why certain services and capabilities exist and how these fit 
-	or are necessary within clinical trial work and the drug development process</p>
-	<p>Building and maintaining alliances and relationships with internal stakeholders 
-	and external service providers so you are in communication and with current 
-	knowledge all the time</p>
-	<p>Becoming more proactive in anticipating and meeting clinical research needs 
-	and the needs of the trial's and/or</p>
-	<p>program's needs</p>
-	</td>
-  </tr>
-  <tr>
-	<td valign="top">
-	<p>OPEN SESSION</p>
-	</td>
-	<td valign="top">
-	<h1>ACADEMIC OVERVIE W: "Sourcing 2015: Projecting Sponsor-CRO Relationships 
-	of the Future"</h1>
-	<p>Biopharmaceutical R&amp;D outsourcing is poised to change dramatically over the 
-	next decade as sponsor companies look for additional capacity, standardization 
-	and efficiency, and higher levels of infrastructure utilization. This session 
-	looks at macroeconomic trends, strategies and practices as well as analogies 
-	drawn from other R&amp;D intensive industries to project where sponsor-CRO relationships 
-	are headed. Particular emphasis will be placed on relationship models and their 
-	implications for small, medium and large biopharmaceutical companies. </p>
-	<p>Review major trends impacting outsourcing relationships in biopharmaceutical 
-	R&amp;D</p>
-	<p>Project changes in discovery, preclinical, early clinical and later stage 
-	clinical outsourcing</p>
-	<p>Discuss outsourcing strategies and practices in similar R&amp;D intensive industries</p>
-	<p>Apply implications from outsourcing analogies</p>
-	</td>
-	<td valign="top">
-	<h1>Patient Recruitment: Understanding Internet Health Seekers and Why an Online 
-	Strategy is Important</h1>
-	<p>Over 90% of clinical trials miss deadlines. Slow enrollment continues to 
-	be a leading cause of study delays. Slow enrollment costs sponsors hundreds 
-	of thousands of additional dollars every day. There are many factors and trends 
-	impacting clinical trial recruitment including niche product development, competing 
-	studies and protocol complexity.</p>
-	<p>To meet current and future enrollment needs, organizations need to expand 
-	their strategies and reach out to a rapidly growing Internet health seeker audience. 
-	Internet health searches are growing at three times the rate of the Internet. 
-	More than 66% of users have searched online for health information and 33% search 
-	monthly. It is also important to note that 25% visit the Internet prior to a 
-	physician visit. Disease information along with alternative treatment options 
-	are frequently researched topics. Through the use of actual survey data, this 
-	presentation will enable individuals and organizations focusing on patient recruitment 
-	to build effective Internet based recruitment programs.</p>
-	</td>
-	<td valign="top">
-	<h1>III. Outsourcing Clinical Trials in Eastern Europe </h1>
-	</td>
-	<td valign="top">
-	<h1>Improving Outsourcing Effectiveness and Quality Through the Use of Data 
-	Standards</h1>
-	<p>Sponsors of clinical research sometimes do not achieve the benefits anticipated 
-	from outsourcing because of many variations in processes from study to study. 
-	The result is that sponsors spend a considerable amount of time trying to understand, 
-	QC, reconcile and integrate supplier/CRO data. Data standards, while not a panacea, 
-	can help address these issues. If data are exchanged/delivered via an industry 
-	standard specification (e.g. the CDISC Study Data Tabulation Model (SDTM) or 
-	LAB Model), costs to develop specifications for data exchange are lower, there 
-	are few errors in specifications and less ambiguity as to what the biopharmaceutical 
-	company wants their partner(s) to deliver. There also are fewer communication 
-	breakdowns and hand-off delays, and it is easier to integrate data from a variety 
-	of providers, including CROs, laboratories and EDC suppliers. In this presentation, 
-	we will consider the benefits of standards to improving the effectiveness of 
-	outsourcing by examining multiple different outsourcing scenarios or use cases 
-	including (1) data exchange during various phases of clinical research between 
-	a biopharmaceutical company and CRO(s); (2) laboratory data exchanged between 
-	a biopharmaceutical company and an external central lab; and (3) data exchanged 
-	between a biopharmaceutical company and an EDC supplier.</p>
-	<p>Understand the role of data standards in improving the effectiveness, efficiency, 
-	and quality of clinical research outsourcing</p>
-	<p>Examine several scenarios or use cases that demonstrate how to best deploy 
-	standards in support of outsourcing</p>
-	<p>Review best practices on when and how to use clinical data standards for 
-	help in establishing and communication expectations to an outsourcer in a structured 
-	way at project start</p>
-	</td>
-  </tr>
-</table>
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