libxml-ruby 1.1.1-x86-mswin32-60 → 1.1.2-x86-mswin32-60

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@@ -1,9 +1,9 @@
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  /* Don't nuke this block! It is used for automatically updating the
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  * versions below. VERSION = string formatting, VERNUM = numbered
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  * version for inline testing: increment both or none at all.*/
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- #define RUBY_LIBXML_VERSION "1.1.1"
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- #define RUBY_LIBXML_VERNUM 111
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+ #define RUBY_LIBXML_VERSION "1.1.2"
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+ #define RUBY_LIBXML_VERNUM 112
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  #define RUBY_LIBXML_VER_MAJ 1
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  #define RUBY_LIBXML_VER_MIN 1
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- #define RUBY_LIBXML_VER_MIC 0
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+ #define RUBY_LIBXML_VER_MIC 2
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  #define RUBY_LIBXML_VER_PATCH 0
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data/lib/libxml/node.rb CHANGED
@@ -1,3 +1,5 @@
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+ require 'stringio'
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+
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  module LibXML
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  module XML
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  class Node
@@ -11,6 +13,23 @@ module LibXML
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  def clone
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  copy(false)
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  end
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+
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+ # call-seq:
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+ # node.inner_xml -> "string"
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+ # node.inner_xml(:indent => true, :encoding => 'UTF-8', :level => 0) -> "string"
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+ #
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+ # Converts a node's children, to a string representation. To include
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+ # the node, use XML::Node#to_s. For more information about
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+ # the supported options, see XML::Node#to_s.
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+ def inner_xml(options = Hash.new)
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+ io = StringIO.new
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+
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+ self.each do |node|
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+ io << node.to_s(options)
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+ end
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+
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+ io.string
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+ end
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  # :call-seq:
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  # node.dup -> XML::Node
@@ -0,0 +1,740 @@
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+ <!DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN"
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+ "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd">
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+ <html xmlns="http://www.w3.org/1999/xhtml">
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+
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+ <head>
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+ <meta content="text/html; charset=utf-8" http-equiv="Content-Type" />
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+ </head>
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+
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+ <body>
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+
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+ <table>
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+ <tr>
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+ <td valign="top">
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+ <h1>Innovation in a Reduced Cost and Enhanced Efficiency Environment</h1>
15
+ <p>With the increasing cost of doing business and budget constraints, clinical
16
+ professionals need to do more than ever before with less, while still increasing
17
+ productivity and maintaining quality. Sponsors are operating with fewer resources
18
+ and need to outsource more but must do so with less money. And with a high number
19
+ of product failures, available dollars for outsourcing are being threatened
20
+ – this being especially true in smaller companies. Due to the increase in outsourcing,
21
+ CROs and Labs have a surplus of business right now and rate structures and pricing
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+ have risen because of this. To top it all off, ever-rising turnover for both
23
+ sponsors and providers causes increased time and cost to complete studies. Centerwatch
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+ reports that 94% of projects run over either or both time and budget. How can
25
+ we do better? </p>
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+ <p>How can CROs and Sponsors collaborate to reduce non-value added activities
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+ so that more and better resources can be directed to more important work?</p>
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+ <p>How is large pharma employing cost saving innovations internally as well
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+ as externally e.g. Flexible staffing from CROs for monitoring , data management,
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+ safety, off-shoring, etc</p>
31
+ <p>How can suppliers be more proactive in creating new business models to reduce
32
+ costs and maintain quality? </p>
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+ <p>Forecasting outsourcing demand and matching capacity increases with demand
34
+ growth and managing that growth - better planning with more transparency allows
35
+ partners to more effectively forecast the outsourcing demand and its impact
36
+ on both parties</p>
37
+ <p>Identifying and implementing operational efficiencies to contain cost and
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+ keep on timelines</p>
39
+ </td>
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+ <td valign="top" rowspan="2">
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+ <h1>Wall Street’s 2009 Forecast and Analysis of Outsourcing Trends</h1>
42
+ <p>Back by popular demand and with double the dedicated time, our Wall Street
43
+ perspective offers an assessment of the outsourcing environment from 2008-2009
44
+ as well as an outlook for the next few years. Our presenters each offer a brief
45
+ commentary to kick off this very interactive session that welcomes audience
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+ questions and comments. Special focus is given to the following issues, with
47
+ a</p>
48
+ <p>Wall St and Private Equity view on:</p>
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+ <p>The CRO industry, summarizing 2008 financial trends</p>
50
+ <p>Outlook for 2009 and beyond</p>
51
+ <p>The issue of CRO consolidation and the trade-offs of being public vs. private,
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+ given the growing role of private equity finance</p>
53
+ <p>Assessment of the pharmaceutical landscape and how it impacts CROs</p>
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+ <p>Other industry trends such as risk-sharing, etc.</p>
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+ <p>'</p>
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+ </td>
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+ <td valign="top">
58
+ <h1>Defining and Managing Quality in Clinical Trials </h1>
59
+ <p>Timelines to get drugs to market are being shortened, budgets are being decreased,
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+ and quality expectations are increasing. Most of outsourcing focus is on time,
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+ cost and scope but a major challenge is in the quality of the process and the
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+ major deliverables. There is no doubt quality is front of mind with drug companies
63
+ and regulatory agencies alike. Though it must be conceded that many current
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+ practices were reactively triggered in response to quality problems, the future
65
+ will require that quality management be more proactively and comprehensively
66
+ integrated into study planning and execution. Quality must be considered not
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+ as something imposed upon us, but as something that helps us. But how does one
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+ go about defining quality, changing the mindset, specifying quality standards
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+ and managing a team to those standards? This session sets out to explore this
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+ key question and others including: </p>
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+ <p>How can quality be defined and measured? </p>
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+ <p>How do we manage the apparent contradiction between increasing quality and
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+ reducing cost? </p>
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+ <p>How can teams focus on quality while dealing with competing priorities on
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+ multiple studies they are managing?</p>
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+ <p>What skills/characteristics are needed for team leaders and team members
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+ (on both the Sponsor and Provider sides)?</p>
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+ <p>In a sourcing relationship who is primarily responsible for quality?</p>
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+ <p>How do partners work together to achieve quality goals?</p>
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+ </td>
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+ <td valign="top">
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+ <h1>Leading Virtual Teams Around the Globe</h1>
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+ <p>Companies are increasingly building teams, networks and groups that are working
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+ together virtually. </p>
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+ <p>How you manage and oversee outsourced work?</p>
86
+ <p>How can we ensure regulations are being met with ex-US?</p>
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+ <p>Sourcing professionals and project managers need information on how to work
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+ with a virtual team with those sitting in other offices around the globe</p>
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+ <p>What does the future project manager/sourcing professional look like in today's
90
+ complex trials?</p>
91
+ <p>Are we providing team members with the right skills to work in these models?</p>
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+ <p>Having offices in global locations does not make you a "global company";
93
+ how to harmonize teams for a global project</p>
94
+ </td>
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+ <td valign="top">
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+ <h1>Standardization: The Holy Grail? The 2009 Update</h1>
97
+ <p>A major frustration across the industry is the different methodologies for
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+ the operations, conduct and management of clinical trials, site recruitment
99
+ and management, communications and performance, audit readiness (site and sponsor),
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+ clinical project management, and the use of metrics to manage studies and training
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+ of CTM personnel. The problem runs even deeper for small companies with less
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+ resources, infrastructure and tools. There is little to no consistency across
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+ companies which in turn affect costs dictated by service providers as they must
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+ work on different platforms. Can the pharma and CRO industries work together
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+ to inspire a new level of standardization? This lively panel is in follow up
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+ to last year's serious-minded out-of-the-box discussion on the formation of
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+ standards.</p>
108
+ </td>
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+ </tr>
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+ <tr>
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+ <td valign="top">
112
+ <h1>Developing Efficiencies Using a Central Lab &amp; CRO Together</h1>
113
+ <p>Pharmaceutical and biotech companies often independently select central lab
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+ and CRO suppliers. Considering the cross-industry tradition of achieving efficiencies
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+ in only two of the three project drivers, time – quality –cost, this session
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+ will present a case study of efficiencies realized in all three drivers when
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+ using a resource partner which provides both central lab and CRO services. Specifically
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+ discussed will be the unique efficiencies provided to the pharma client by the
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+ central lab and the CRO data vendor perform real-time date management via a
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+ proprietary connection. In addition, this session will highlight how resource
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+ partnerships are welcomed within a pharma company's support areas of finance
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+ and operations. </p>
123
+ </td>
124
+ <td valign="top">
125
+ <h1>Ensuring Quality at the Sponsor, Site and CRO Levels </h1>
126
+ <p></p>
127
+ <p>Achieving quality in a highly regulated and scrutinized industry where time,
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+ patients, resources and sometimes funding are limited is a major challenge facing
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+ companies today. Choosing suppliers who deliver quality work, while following
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+ FDA and GCP guidelines, SOPs and monitoring plans and training to ensure personnel
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+ understand their responsibilities and are in compliance is at top of minds.
132
+ This interactive discussion explores: </p>
133
+ <p>How do you establish an appropriate quality standard? </p>
134
+ <p>Is Quality Assurance/Management a standard part of your project team? </p>
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+ <p>Is quality management fee-for-service or the cost of doing business?</p>
136
+ <p>Successfully partnering with CROs, labs, and sites to conduct efficient yet
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+ effective studies as quickly as possible and ensure data integrity</p>
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+ <p>Meeting regulatory expectations for quality and company expectations of timeliness
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+ and cost </p>
140
+ <p>effectiveness</p>
141
+ <p>Working with Project team and sites to educate sites on the importance of
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+ adhering to the Protocol</p>
143
+ </td>
144
+ <td valign="top">
145
+ <h1>Successfully Applying Technology to Clinical Trials Across World Regions</h1>
146
+ <p>Understand the application of technology in making traditional clinical research
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+ easier</p>
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+ <p>Identify cultural and infrastructural challenges</p>
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+ <p>Integrate modern technologies in developing nations</p>
150
+ <p>Learn how to realistically integrate technology to local situations</p>
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+ <p>Manage technology globally at the site level</p>
152
+ </td>
153
+ <td valign="top">
154
+ <h1>RFP Management &amp; Contracting with CROs to Minimize Change Orders</h1>
155
+ <p>What type of detail do CROs want in the RFP to help them get a better understanding
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+ of what is being outsourced?</p>
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+ <p>How to develop an RFP that allows the sponsor to compare like proposals while
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+ allowing the CRO to distinguish themselves and show creativity?</p>
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+ <p>Developing and creating contracts and RFPs that can be managed under metrics</p>
160
+ <p>What type of information is useful to have in a proposal that is found lacking
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+ in the average CRO bid?</p>
162
+ <p>The RFP and the budgeting process with government contracts</p>
163
+ <p>RFP ethics – competitive underbidding with hidden change orders/equal sharing
164
+ of information with all providers</p>
165
+ <p>RFP process and budgeting for Big Pharma vs. smaller company </p>
166
+ <p>Establishing the basis for paying sites</p>
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+ <p>Need for transparency in communication of the assumptions, responsibilities
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+ and budgeting process leads to more collaborative agreements</p>
169
+ </td>
170
+ </tr>
171
+ <tr>
172
+ <td valign="top">
173
+ <h1>Early Sponsor/Supplier Team Collaboration for More Effective Design of Your
174
+ Clinical Program </h1>
175
+ <p>Large pharma companies are moving toward engagement on a strategic level
176
+ in the early design and feasibility work by brining partners in early. As many
177
+ are going into a new territory, whether geographic or therapeutic, with new
178
+ molecules, they want the CRO input that much sooner. Smaller and mid size companies
179
+ also want a more collaborative relationship with CROs because they don't have
180
+ the throughput to gain the experience the CROs have and while there are large
181
+ gaps in time between when they have to perform certain tasks, CROs are expected
182
+ to keep up with regulations, etc. In addition, small companies want participation
183
+ from CROs at time of RFP and appreciate the time, energy and thought put into
184
+ proposals in addition to cost.</p>
185
+ <p>Providing Sponsors with feedback based on experience and expertise versus
186
+ making decisions on budgets </p>
187
+ <p>Avoiding the 'cookie cutter' proposal</p>
188
+ <p>Collaborating with suppliers in the planning stage to set the team up for
189
+ success</p>
190
+ </td>
191
+ <td valign="top">
192
+ <h1>Transforming Drug Development Outsourcing with a Virtual Model</h1>
193
+ <p>Virtual companies essentially outsource every component of development. Historically,
194
+ virtual companies have been comprised of only a handful of individuals (e.g.
195
+ researchers who have come from larger companies) or venture capitalists. These
196
+ new companies are being formed by those who are recognizing that the big pharma
197
+ model is losing its sustainability, and so they move their ideas (brain trust)
198
+ outside of the big company to start their own initiative. Now the model is beginning
199
+ to move into a construct where there is a whole portfolio of products being
200
+ managed virtually. As the industry aspires to a lower cost basis for drug development,
201
+ CROs must find ways to accommodate this by having a real stake in the success
202
+ of the client with risk-sharing models of rising interest. </p>
203
+ <p>Is the rise of the Virtual Pharma business model a "fad" or a permanent change
204
+ in the Pharma industry?</p>
205
+ <p>Changing the mindset of those who have 'grown up' in big pharma to results
206
+ driven vs. task driven</p>
207
+ <p>Virtual pharma's expectation of the CRO</p>
208
+ <p>CRO understanding of how the virtual model differs from traditional models
209
+ and having an internal 'champion' looking out for the interests of the virtual
210
+ pharma company</p>
211
+ <p>Empowering CROs to drive the outcome of the outsourced work</p>
212
+ <p>Lessons from virtual companies that can benefit big pharma</p>
213
+ </td>
214
+ <td valign="top">
215
+ <h1>The Implications of Post-Marketing Requirements on the Future of Drug Development
216
+ Partnerships </h1>
217
+ <p>Post-marketing requirements (PMRs) required by FDA and other regulatory authorities
218
+ are becoming more demanding and increasing in complexity. While the information
219
+ ascertained by PMRs is crucial to expanding safety and efficacy information
220
+ on the drug, they are not always adhered to. PRMs place a large burden on the
221
+ R&amp;D function already struggling to get new products launched and the cost of
222
+ these added trials are great. While traditional Phase IV trials are done primarily
223
+ for marketing purposes, FDA is now looking for signals in large scale studies
224
+ for adverse events in real world situations. The parameters are not relative
225
+ to Phase IV so companies can't use phase IV approach for PMRs. Instead, they
226
+ are conducted by the same groups who do the initial pre-registration work. What
227
+ is the best approach to get the work done effectively? Sponsors are looking
228
+ to CROs to provide solutions, but many are still presenting their Phase IV teams
229
+ for these demanding trials. What used to be the exception is increasingly becoming
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+ the rule for new drug approvals and the FDA will now have the ability to impose
231
+ financial penalties on pharma companies who do not comply. This development
232
+ is critical to the Pharma/CRO relationship as the CRO must be on board with
233
+ the time commitments and deliverables.</p>
234
+ <p>Managing post approval studies - what is the best approach with inherent
235
+ regulatory uncertainty?</p>
236
+ <p>Learning to perform these studies efficiently as the cost of these programs
237
+ can exceed the cost of the drug registration program </p>
238
+ <p>From a sourcing perspective, how do niche providers and CROs collectively
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+ work on this to support the PMR effort?</p>
240
+ <p>Europe and other countries are also requiring more post-approval commitments
241
+ – how are companies preparing?</p>
242
+ </td>
243
+ <td valign="top">
244
+ <h1>Approaches to Address the Impact of Increasingly Complex Clinical Trials
245
+ </h1>
246
+ <p>Increasingly complex clinical trial protocols demand more of investigative
247
+ sites and study volunteers, leading to longer cycle times, more AEs and increasing
248
+ difficulty in recruiting and retaining patients, according to research by Tufts
249
+ CSDD. Combining the influx of less experienced investigators from emerging markets
250
+ and increasing churn among &#39;established&#39; investigators with not only an increase
251
+ in the number of trials but also an increase in their complexity opens up a
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+ major grey zone for clinical trial quality. What are some of the pragmatic approaches
253
+ to overcome these challenges? This session explores the answers and sets the
254
+ stage for introducing a proactive approach to predict and prevent protocol violations,
255
+ both from a drug development service provider perspective, and from a site/investigator
256
+ perspective. Key clinical trial success factors to be discussed include:</p>
257
+ <p>Successfully leveraging emerging market investigators who may be less experienced
258
+ for trials that are becoming more complex and demanding</p>
259
+ <p>Architecting a site management plan that promotes primary data quality and
260
+ consistency yet allows flexibility based on country-specific differences</p>
261
+ <p>Best practice for investigators to absorb a clinical trial into regular site
262
+ operations</p>
263
+ <p>Reducing non-core activities to free up resources to focus on their key responsibilities</p>
264
+ </td>
265
+ <td valign="top">
266
+ <h1>Developing Scope of Work for Solid Project Foundation and Minimal Project
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+ Setbacks</h1>
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+ <p>A solid scope provides the best project foundation and minimizes both the
269
+ likelihood and impact of project upsets. </p>
270
+ <p>Ripple effect beyond the contracting phase</p>
271
+ <p>Avoiding costly change orders due to hurried or misinterpreted scopes</p>
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+ <p>Developing the scope with your partner leads to a well defined scope and
273
+ strong foundation for success</p>
274
+ <p>Proposal development as an exercise in collaborative solution seeking to
275
+ develop a mutually agreeable and achievable plan</p>
276
+ </td>
277
+ </tr>
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+ <tr>
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+ <td valign="top">
280
+ <h1>Shared Risk: Getting Beyond the Sponsor/Vendor Paradigm </h1>
281
+ <p></p>
282
+ <p>Trust can not be built on transactional relationships. It is built on transparency
283
+ and commitments between companies where relationship management is blended with
284
+ a very candid understanding of business interests for both CROs and Sponsors.
285
+ When Sponsors and CROs do not share the same end goal (e.g. regulatory approval)
286
+ or the same risks how can their interests be aligned? Would pharma companies
287
+ be willing to put in significant incentives, monetary or otherwise, tied to
288
+ approval if the CRO is charged with running a registration trial? Are Sponsors
289
+ adept at identifying the risks appropriate to transfer to CROs? Are CROs prepared
290
+ to take the risk burden or is it a gamble?</p>
291
+ <p>Developing and maintaining relationships: sharing and understanding your
292
+ partners' interests, and fostering a commitment to share risks</p>
293
+ <p>Constructing an agreement that fosters shared risk and demonstrates a commitment
294
+ to partnership</p>
295
+ <p>How do you get to this level of trust with your supplier? </p>
296
+ <p>KPIs for relationship building and performance management</p>
297
+ </td>
298
+ <td valign="top">
299
+ <h1>Creating Collaborative Partnerships for Strategic Outsourcing, Forecasting
300
+ and Decision Making</h1>
301
+ <p>Otsuka Pharmaceutical Development and Commercialization (OPDC) has embarked
302
+ on an ambitious plan to create collaborative partnerships with a very few CROs.
303
+ This strategy includes a staffing forecasting model that allows Otsuka to forecast
304
+ internal, outsource and outsource-management requirements and a risk reduction
305
+ methodology for ensuring better project performance. This talk will focus on
306
+ the research that led us to take this path, the approach we have used to select
307
+ an initial partner and the relationship that we have built. Learn about OPDC's:</p>
308
+ <p>Implementation and Methodology</p>
309
+ <p>Supplier selection process</p>
310
+ <p>Staffing model to forecast sponsor and partner needs based on the pipeline</p>
311
+ </td>
312
+ <td valign="top">
313
+ <h1>Fulfilling Post-Marketing Requirements Utilizing Endpoint Trials</h1>
314
+ <p>Post-Marketing Requirements are being imposed with greater frequency by the
315
+ FDA and other regulating agencies, in many cases, to obtain additional safety
316
+ data in a long-term or niche population. The more commercially-oriented Phase
317
+ IV studies of the past are no longer sufficient to fulfill the scientific rigor
318
+ required in the current regulatory environment. Endpoint point trials as a means
319
+ of fulfilling these obligations are becoming more common, allowing evaluation
320
+ of a treatment on mortality or major morbidity within a disease entity. There
321
+ are challenges associated with the implementation of endpoint trials which require
322
+ close collaboration to ensure the quality and consistency of the safety data
323
+ collected. In this session, the following points will be discussed:</p>
324
+ <p>What are the advantages of utilizing an endpoint trial to fulfill post-marketing
325
+ commitments?</p>
326
+ <p>What are the some of the challenges faced in designing and executing endpoint
327
+ trials? And how can Sponsors and CROs effectively collaborate to overcome these
328
+ challenges?</p>
329
+ <p>What strategies have proven successful in implementing endpoint trials?</p>
330
+ </td>
331
+ <td valign="top">
332
+ <h1>Clinical Trials: What Does Global Mean to You?</h1>
333
+ <p>The first step in working with a global provider is analyzing whether working
334
+ with one makes sense for your project. Once you&#39;ve examined the criteria around
335
+ your project&#39;s needs, you must carefully investigate the growing range of providers
336
+ offering global service. There are many CROs claiming to be global, but what
337
+ constitutes this?</p>
338
+ <p>How many studies?</p>
339
+ <p>How do you identify the right partner on a regional basis?</p>
340
+ <p>How do you best evaluate your needs as a sponsor?</p>
341
+ <p>How much of the global CRO staff belongs to a &quot;partnering CRO&quot;?</p>
342
+ <p>If the partners become financially unstable, what recourse is there for the
343
+ sponsor?</p>
344
+ <p>Who manages the partners? Should the sponsor have to cover management fees
345
+ for the primary CRO to manage/interact with their partners?</p>
346
+ <p>Are CROs always up front about their global capabilities?</p>
347
+ <p>Even though the &quot;global&quot; CRO carries the contractual relationship with their
348
+ partner, do they take and hold responsibility for performance?</p>
349
+ <p>What due diligence is expected from the sponsor of these partners? Should
350
+ the primary CRO hold the responsibility? How will the regulators view this?</p>
351
+ </td>
352
+ <td valign="top">
353
+ <h1>Supplier Identification and Selection</h1>
354
+ <p>Using RFIs, vendor days, and capability presentations to identify service
355
+ provider options</p>
356
+ <p>Developing a vendor assessment and selection process</p>
357
+ <p>RFPs, bid grids, scorecards, bid defenses, and more</p>
358
+ <p>Successes/challenges of working with a functional outsourcing model</p>
359
+ <p>Necessary time and skill set to partner with new CROs that are a good fi
360
+ t and provide what is expected without a</p>
361
+ <p>number of change orders</p>
362
+ <p>Selecting suppliers that really will do what the BD sales people promise</p>
363
+ </td>
364
+ </tr>
365
+ <tr>
366
+ <td valign="top">
367
+ <h1>Streamlining the Outsourcing Process and Minimizing Internal Resources through
368
+ the Use of External Provider Management Teams</h1>
369
+ <p>In order to streamline the outsourcing process and the delivery of clinical
370
+ trials, AstraZeneca created External Provider Management Teams (EPMTs). EPMTs
371
+ are delivery teams comprised of a limited number of AstraZeneca and CRO members
372
+ who direct CRO study teams to deliver a portfolio of studies. One external partner
373
+ was selected to work with each therapy area EPMT to deliver all the outsourced
374
+ work within that area. While still in the early stages, the model has already
375
+ provided substantial internal resource savings. This panel discussion will take
376
+ you through the model and its current, as well as future, expected benefits.</p>
377
+ <p>No more RFPs!</p>
378
+ <p>Save internal resources</p>
379
+ <p>One outsourcing model</p>
380
+ <p>Increase partnerships </p>
381
+ <p>with external providers</p>
382
+ <p>Maximize synergies and improved quality</p>
383
+ </td>
384
+ <td valign="top">
385
+ <h1>Creating a Competitive Advantage through Sourcing</h1>
386
+ <p>The speaker will share his personal insights on how Sourcing can be a catalyst
387
+ for driving transformational performance that can be seen and measured by the
388
+ business. He will discuss how Sourcing professionals can increase their sphere
389
+ of influence within the businesses they service to enable change, how to gain
390
+ the endorsement of their business leaders, and important components of delivering
391
+ a successful outcome.</p>
392
+ <p>What is an SME</p>
393
+ <p>How collaboration makes the difference</p>
394
+ <p>Seizing the opportunity</p>
395
+ <p>Insuring a successful outcome</p>
396
+ </td>
397
+ <td valign="top">
398
+ <h1>Assuring Project Excellence through Quality Metrics Management</h1>
399
+ <p>At Paragon, we meet and exceed the expectations of our clients by focusing
400
+ on project excellence in all areas of service. To support our focus on project
401
+ excellence, we have adopted a global metrics management approach that allows
402
+ us to proactively identify potential problems and anticipate the need to develop
403
+ strategic management plans to assure project success. In this session we will
404
+ walk through our comprehensive approach to metrics management, share our Project
405
+ Management Dashboard and discuss how metrics can benefit you and provide you
406
+ peace of mind. </p>
407
+ <p>Defining metrics for a global project</p>
408
+ <p>Standardizing metrics tracking and reporting</p>
409
+ <p>Metrics tools: Project Management Dashboard </p>
410
+ <p>-Philosophy and Thresholds</p>
411
+ <p>Metrics management </p>
412
+ <p>-The Monthly Project Review</p>
413
+ <p>-Issue escalation</p>
414
+ <p>The benefit to you, the Sponsor</p>
415
+ <p>-Early detection of potential issues</p>
416
+ <p>-Proactive strategic planning to avoid project execution failures </p>
417
+ <p>-Identification of process inefficiencies</p>
418
+ <p>-Peace of mind</p>
419
+ </td>
420
+ <td valign="top">
421
+ <h1>Optimizing Science and Project Management to Minimize the Impact of Regulations,
422
+ Logistical Concerns and Economics on Managing Chinese Specimens in Global Trials</h1>
423
+ <p>Harnessing the right resources to balance the needs of global trials and
424
+ mitigate the pitfalls of Chinese specimen management: This session explores
425
+ the scientific and management issues that are often overlooked when sourcing
426
+ global trials that include Chinese specimens. The importance of ensuring strong
427
+ management and scientific methodologies is critical for success and Quality,
428
+ On-Time. Key factors for consideration are establishing clear understanding
429
+ of the regulatory and cultural environment, ease of management through a central
430
+ lab and oversight through a single global point of contact. This session will
431
+ explore the science, technologies and program management methodologies to maximize
432
+ the benefit and mitigate the pitfalls of conducting trials in China.</p>
433
+ <p>Chinese specimen &amp; Regulatory roadblocks that impact global studies</p>
434
+ <p>Incorporating biomarker data to optimize study scientific investment</p>
435
+ <p>Harmonizing program management on global trials to avoid regional requirement
436
+ conflicts</p>
437
+ </td>
438
+ <td valign="top">
439
+ <h1>Impact of Global Currency Fluctuation on Project Budgets: Who Holds the
440
+ Risk?</h1>
441
+ <p>Global currency fluctuation has become an increasing challenge as more and
442
+ more trials are conducted outside the United States which impacts charge rates
443
+ regionally and daily. Multi-year contracts are becoming unwieldy, and R&amp;D Finance
444
+ has added the management of the fluctuations to its already full load of responsibilities.</p>
445
+ <p>History and implications of currency fluctuations</p>
446
+ <p>What happens when a once-cost effective country becomes more expensive?
447
+ </p>
448
+ <p>How currency fluctuations are being managed </p>
449
+ <p>Operationalizing a plan to address this challenge </p>
450
+ <p>Overcoming any distrust between sponsor and provider caused by fluctuations
451
+ </p>
452
+ <p>What is in scope for consideration as a currency risk </p>
453
+ <p>Things to consider and "what if " scenarios </p>
454
+ <p>Who is at risk? </p>
455
+ <p>Strategies for managing risk: To hedge or not to hedge </p>
456
+ <p>How is VAT managed/payment and reimbursement?</p>
457
+ </td>
458
+ </tr>
459
+ </table>
460
+ <p><span></span></p>
461
+ <table border="1" cellpadding="0" cellspacing="0" summary="layout table">
462
+ <tr>
463
+ <td valign="top">
464
+ <h1>Adapting to Constant Change: How Partners are Working Through the Organizational
465
+ Stages </h1>
466
+ <p>Changes are more dramatic than ever before in today's pharmaceutical industry
467
+ with layoffs impacting resources and mergers effecting increased competition
468
+ and long periods of inactivity. The trickle down delay to CROs is frightening.
469
+ From a business development perspective dealing with change management as the
470
+ industry deals with ever increasing pressures on trial design, timelines and
471
+ budgets can be frustrating and costly when a study is delayed or cancelled,
472
+ or when new management comes in changing strategy and objectives. As Sponsors
473
+ increasingly share more responsibility with CRO partners and have less time/resources
474
+ for oversight, how are companies dealing with the changes that ensue? </p>
475
+ <p>Changing doers into managers - How providers need to change to respond to
476
+ this</p>
477
+ <p>Risk tolerance providers must bear in an uncertain environment </p>
478
+ <p>IP, manpower, time management </p>
479
+ <p>Dealing with sometimes inexperienced or difficult teams on both sides</p>
480
+ </td>
481
+ <td valign="top">
482
+ <h1>Evolving the Key Strategies of Clinical Development Sourcing -- Current
483
+ and</h1>
484
+ <h1>Future Direction</h1>
485
+ <p>Our presenters discuss ÉLAN and the alliance model resourcing strategy, including:</p>
486
+ <p>Decision point/ROI to move to this model from a clinical development strategy
487
+ perspective</p>
488
+ <p>Applying operational learnings from large to mid-size organizational strategies</p>
489
+ <p>Adoption curve to newer strategic resourcing directions</p>
490
+ <p>Measuring operational success and continuous opportunities</p>
491
+ <p>Governance and operating model with RPS</p>
492
+ </td>
493
+ <td valign="top">
494
+ <h1>Adaptive Clinical Trials: Innovations in Trial Design and Management</h1>
495
+ <p>With pharmaceutical companies facing the increasing challenge of diminishing
496
+ pipelines, drug developers are always looking for new methods to shave time
497
+ off of discovering and developing new molecules. Tools such as adaptive trial
498
+ designs allow clinicians the ability to "fail faster." This is accomplished
499
+ by utilizing accumulating data to direct potential modifications to the trial
500
+ as it progresses, while at the same time keeping the validity and integrity
501
+ of the study in tact. In addition to cost and time savings, adaptive trials
502
+ require fewer patients – a distinct benefit as patient enrollment is an ongoing
503
+ obstacle to speedy trial management. Planning and executing these trials, however,
504
+ can be much more intricate than traditional trial approaches and teams from
505
+ clinical operations and trial management, data management, statistics and must
506
+ align early in the process and work together judiciously for proper study conduct.</p>
507
+ <p>Discuss the advantages and disadvantages of adaptive designs</p>
508
+ <p>Learn how sponsors and suppliers are effectively collaborating on adaptive
509
+ trials</p>
510
+ <p>Understand the regulatory nuances of these special designs</p>
511
+ </td>
512
+ <td valign="top">
513
+ <h1>Outsourcing Clinical Trials in Emerging Regions</h1>
514
+ <h1>I. Outsourcing Clinical Trials in India and China</h1>
515
+ <p>Off shoring clinical trials to emerging markets around the world is receiving
516
+ increasing attention as a very attractive alternative in the clinical development
517
+ process. Do clinical research capabilities comparable to the US in terms of
518
+ sophistication and FDA-compliance exist anywhere else in the world? And if they
519
+ do, are they ready to handle the marked increase in demand from the US? Our
520
+ panelists discuss in detail the demographics, challenges and opportunities,
521
+ expertise of individual countries and the opportunities to optimize project
522
+ budgets and reduce development time and regulations with global implications
523
+ including:</p>
524
+ <p>How cost control and investor expectations is leading to increased off-shoring
525
+ opportunities</p>
526
+ <p>Understanding regulatory and operating environment of emerging markets as
527
+ well as cultural intricacies and how</p>
528
+ <p>to place and execute clinical trials there</p>
529
+ <p>How to offshore a project in such a manner that the work is seamless to the
530
+ end user, i.e. the offshored partner performs the work in the same manner as
531
+ an internal colleague</p>
532
+ <p>Complexity of protocols vis-a-vis emerging country capabilities / infrastructure
533
+ </p>
534
+ <p>Coordination of projects across multiple companies on a global basis</p>
535
+ <p>Must-have contractual requirements for commonly used international countries</p>
536
+ <p>Managing multi-national projects with fluctuating timelines (enrollment,
537
+ government regulations, IRB approvals, etc).</p>
538
+ <p>Global integration of data, processes and cultures</p>
539
+ <p>Utilization of low cost countries with available subject populations and
540
+ GCP trained investigators</p>
541
+ <p>Ethical considerations in deciding on trial placement</p>
542
+ </td>
543
+ <td valign="top">
544
+ <h1>The Functional Service Provider Model: Exploring the Challenges and Benefits</h1>
545
+ <p>As sponsor companies continue to feel the effects of increased performance
546
+ pressures with flat or negative headcount growth, loss of exclusivity with fewer
547
+ revenue replacement prospects, tightened regulatory environs with increasing
548
+ scrutiny of obligations, and more intense cost containment demands, alternative
549
+ sourcing paradigms are becoming the norm and no longer the exception. Specifically,
550
+ the Functional Service Provider model of outsourcing has continued to grow in
551
+ primarily large biopharmaceutical companies; however, mid and even small companies
552
+ are looking toward the FSP model as a way to respond to the changing development
553
+ environment. This session will focus on functional approaches seen in practice
554
+ and in theory to present for discussion the value platform proposed by this
555
+ model. From highly transactional, commodity-like services to the value-add hybrid
556
+ approach, the panel will seek to engage the audience to debate the challenges
557
+ and benefits in the FSP paradigm.</p>
558
+ </td>
559
+ </tr>
560
+ </table>
561
+ <table summary="layout table">
562
+ <tr>
563
+ <td valign="top">
564
+ <h1>Small BioPharma Partnerships: Challenges and Opportunities for Transactional
565
+ vs. Strategic Approaches</h1>
566
+ <p>Small pharma and biotech companies tend to bring in partners very early to
567
+ discuss development and often gravitate to biggest most global CROs who can
568
+ run the entire study. Is this the best operational choice? Small company clinical
569
+ operations look to the project manager at the CRO to be their virtual internal
570
+ clinical leader but CROs are not all set up to engage in this way. Many small
571
+ companies do not have the pipeline to engage in strategic relationships, and
572
+ must be transactional, but how do those companies get attention from a large
573
+ CRO? The issues are the same as those at Big Pharma, but large companies have
574
+ different perspectives and engage CROs on multiple strategic levels (feasibility,
575
+ expertise). Who is the person at the supplier who will advocate to their senior
576
+ management for your organization when things go wrong? How have small and mid-size
577
+ pharma/biotech partnered for success as they have more to lose if a trial and/or
578
+ provider relationship does not go well due to poor planning, miscommunication,
579
+ etc? When strategic outsourcing/partnerships don't resonate with small companies,
580
+ sponsors and suppliers must have a meeting of the minds on the challenges that
581
+ small companies face on a tactical level. </p>
582
+ <p>How emerging Biotechs have managed to stay top of mind when working with
583
+ a large CRO </p>
584
+ <p>What are the benefits and challenges of working with a smaller CRO? Or multiple
585
+ CROs (e.g. network of small regional CROs rather than one large global one)?</p>
586
+ <p>Is there any one right model or does it depend on what phase you're working
587
+ in?</p>
588
+ <p>How does the CRO get the right team to its clients?</p>
589
+ <p>How are CROs staffing their organizations to deliver to smaller companies?</p>
590
+ <p>What technology and infrastructure is needed among parties?</p>
591
+ </td>
592
+ <td valign="top">
593
+ <h1>How Do Mergers, Acquisitions and Licensing Impact Outsourcing Decisions
594
+ and the Role of the CRO?</h1>
595
+ <p>With so many Big Pharmas working within M&amp;As and constantly changing portfolios,
596
+ mid-size companies no longer developing their own compounds but acquiring them
597
+ instead, and small companies seeking only enough drug registrations so that
598
+ another company can buy them out, there is a change in the business we need
599
+ to respond to which opens the door for thinking about sourcing differently.
600
+ The lack of history and emotional attachment which comes with acquired compounds
601
+ affords the opportunity for culture change. No matter what size company however,
602
+ for successful development, partners need to understand what the ultimate goal
603
+ is.</p>
604
+ <p>What can Big Pharma learn from small companies?</p>
605
+ <p>What is the role of the CRO is helping a sponsor develop a compound that
606
+ has been acquired or licensed?</p>
607
+ <p>After the service provider is chosen, how do you build trust – when in the
608
+ process of selecting, how much info are companies willing to provide and share
609
+ so they can collectively make a good decision?</p>
610
+ <p>How do IP and commercial implications factor in for more sophisticated portfolios
611
+ rather than simply a virtual company with one compound?</p>
612
+ <p>In the case of M&amp;A, what happens to the Suppliers working with the company
613
+ being acquired? Does it affect their position/relationship with the company?
614
+ Does the company keep them informed about their status as the</p>
615
+ <p>event progresses? Are they in a more secondary role?</p>
616
+ <p>What if the M&amp;A is on the CRO side?</p>
617
+ </td>
618
+ <td valign="top">
619
+ <h1>What Does FDA Expect Regarding Quality Oversight of Third Parties?</h1>
620
+ <p>Outsourcing of clinical research activities is increasingly common in FDA-regulated
621
+ medical product development.</p>
622
+ <p>Last year, Frost &amp; Sullivan calculated that drug and biotech companies spent
623
+ $57 billion on outsourcing; contract research organizations (CROs) got almost
624
+ 30 percent, or $17 billion. U.S. companies in particular outsourced 40 percent
625
+ of their clinical trials and that's expected to rise to 65 percent by 2013.
626
+ As a result, FDA has seen the emergence of an alarming trend regarding the submission
627
+ of unreliable clinical research data to the agency. Therefore, FDA's medical
628
+ device center began analyzing this trend and found some common threads that
629
+ lead to these unwanted situations. This presentation will uncover some of those
630
+ warning signals and outline methods employed by industry to mitigate their occurrence.</p>
631
+ </td>
632
+ <td valign="top">
633
+ <h1>II. Outsourcing Clinical Trials in Latin America</h1>
634
+ </td>
635
+ <td valign="top">
636
+ <h1>Educating Procurement and Outsourcing: How a Better Domain Knowledge Makes
637
+ Your Job Easier and More Effective</h1>
638
+ <p>Biomarkers is an innovative new tool that clinical operations and study management
639
+ teams are increasingly utilizing which afford them the ability to cut down on
640
+ costs and resources and make faster decisions within the overall drug development
641
+ programs for clinical trial endpoints and timelines. In many cases, however,
642
+ outsourcing/procurement professionals may not fully understand the use of such
643
+ procedures/services: 1) why they are necessary and being utilized within drug
644
+ development programs, 2) how the primary endpoints of a trial are enhanced by
645
+ their use, 3) what the Procedure/test/service/analysis actually is, and 4) the
646
+ variety of services that exist. As the first and sometimes only contact reaching
647
+ out to vendors, the education on the use of biomarkers and the impact they have
648
+ on the clinical trial progression and deliverables is crucial to having Sponsors
649
+ bulk up their knowledge of what's out there to better support their respective,
650
+ internal study management teams across all phases of trials. </p>
651
+ <p>Our speakers address:</p>
652
+ <p>Ramping up for increasing internal customers' request for Purchasing and
653
+ Outsourcing assistance in this area of biomarkers</p>
654
+ <p>Understanding and overcoming opposing needs; clinical operations' pursuit
655
+ of speed and quality vs. purchasing's directive to save money vs outsourcing's
656
+ requirement of consistency of performance and quality deliverables.</p>
657
+ <p>Understanding why certain services and capabilities exist and how these fit
658
+ or are necessary within clinical trial work and the drug development process</p>
659
+ <p>Building and maintaining alliances and relationships with internal stakeholders
660
+ and external service providers so you are in communication and with current
661
+ knowledge all the time</p>
662
+ <p>Becoming more proactive in anticipating and meeting clinical research needs
663
+ and the needs of the trial's and/or</p>
664
+ <p>program's needs</p>
665
+ </td>
666
+ </tr>
667
+ <tr>
668
+ <td valign="top">
669
+ <p>OPEN SESSION</p>
670
+ </td>
671
+ <td valign="top">
672
+ <h1>ACADEMIC OVERVIE W: "Sourcing 2015: Projecting Sponsor-CRO Relationships
673
+ of the Future"</h1>
674
+ <p>Biopharmaceutical R&amp;D outsourcing is poised to change dramatically over the
675
+ next decade as sponsor companies look for additional capacity, standardization
676
+ and efficiency, and higher levels of infrastructure utilization. This session
677
+ looks at macroeconomic trends, strategies and practices as well as analogies
678
+ drawn from other R&amp;D intensive industries to project where sponsor-CRO relationships
679
+ are headed. Particular emphasis will be placed on relationship models and their
680
+ implications for small, medium and large biopharmaceutical companies. </p>
681
+ <p>Review major trends impacting outsourcing relationships in biopharmaceutical
682
+ R&amp;D</p>
683
+ <p>Project changes in discovery, preclinical, early clinical and later stage
684
+ clinical outsourcing</p>
685
+ <p>Discuss outsourcing strategies and practices in similar R&amp;D intensive industries</p>
686
+ <p>Apply implications from outsourcing analogies</p>
687
+ </td>
688
+ <td valign="top">
689
+ <h1>Patient Recruitment: Understanding Internet Health Seekers and Why an Online
690
+ Strategy is Important</h1>
691
+ <p>Over 90% of clinical trials miss deadlines. Slow enrollment continues to
692
+ be a leading cause of study delays. Slow enrollment costs sponsors hundreds
693
+ of thousands of additional dollars every day. There are many factors and trends
694
+ impacting clinical trial recruitment including niche product development, competing
695
+ studies and protocol complexity.</p>
696
+ <p>To meet current and future enrollment needs, organizations need to expand
697
+ their strategies and reach out to a rapidly growing Internet health seeker audience.
698
+ Internet health searches are growing at three times the rate of the Internet.
699
+ More than 66% of users have searched online for health information and 33% search
700
+ monthly. It is also important to note that 25% visit the Internet prior to a
701
+ physician visit. Disease information along with alternative treatment options
702
+ are frequently researched topics. Through the use of actual survey data, this
703
+ presentation will enable individuals and organizations focusing on patient recruitment
704
+ to build effective Internet based recruitment programs.</p>
705
+ </td>
706
+ <td valign="top">
707
+ <h1>III. Outsourcing Clinical Trials in Eastern Europe </h1>
708
+ </td>
709
+ <td valign="top">
710
+ <h1>Improving Outsourcing Effectiveness and Quality Through the Use of Data
711
+ Standards</h1>
712
+ <p>Sponsors of clinical research sometimes do not achieve the benefits anticipated
713
+ from outsourcing because of many variations in processes from study to study.
714
+ The result is that sponsors spend a considerable amount of time trying to understand,
715
+ QC, reconcile and integrate supplier/CRO data. Data standards, while not a panacea,
716
+ can help address these issues. If data are exchanged/delivered via an industry
717
+ standard specification (e.g. the CDISC Study Data Tabulation Model (SDTM) or
718
+ LAB Model), costs to develop specifications for data exchange are lower, there
719
+ are few errors in specifications and less ambiguity as to what the biopharmaceutical
720
+ company wants their partner(s) to deliver. There also are fewer communication
721
+ breakdowns and hand-off delays, and it is easier to integrate data from a variety
722
+ of providers, including CROs, laboratories and EDC suppliers. In this presentation,
723
+ we will consider the benefits of standards to improving the effectiveness of
724
+ outsourcing by examining multiple different outsourcing scenarios or use cases
725
+ including (1) data exchange during various phases of clinical research between
726
+ a biopharmaceutical company and CRO(s); (2) laboratory data exchanged between
727
+ a biopharmaceutical company and an external central lab; and (3) data exchanged
728
+ between a biopharmaceutical company and an EDC supplier.</p>
729
+ <p>Understand the role of data standards in improving the effectiveness, efficiency,
730
+ and quality of clinical research outsourcing</p>
731
+ <p>Examine several scenarios or use cases that demonstrate how to best deploy
732
+ standards in support of outsourcing</p>
733
+ <p>Review best practices on when and how to use clinical data standards for
734
+ help in establishing and communication expectations to an outsourcer in a structured
735
+ way at project start</p>
736
+ </td>
737
+ </tr>
738
+ </table>
739
+ </body>
740
+ </html>