libxml-ruby 1.1.1-x86-mswin32-60 → 1.1.2-x86-mswin32-60
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- data/CHANGES +7 -0
- data/Rakefile +2 -0
- data/ext/libxml/{cbg.c → ruby_xml_cbg.c} +86 -86
- data/ext/libxml/ruby_xml_node.c +1432 -1428
- data/ext/libxml/ruby_xml_version.h +3 -3
- data/ext/mingw/libxml_ruby.dll.a +0 -0
- data/ext/mingw/libxml_ruby.so +0 -0
- data/lib/libxml/node.rb +19 -0
- data/test/cro_events.html +740 -0
- data/test/tc_node_write.rb +7 -0
- metadata +4 -3
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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.
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#define RUBY_LIBXML_VERNUM
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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
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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/ext/mingw/libxml_ruby.dll.a
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Binary file
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data/ext/mingw/libxml_ruby.so
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data/lib/libxml/node.rb
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require 'stringio'
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module LibXML
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module XML
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class Node
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def clone
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copy(false)
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end
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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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self.each do |node|
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io << node.to_s(options)
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end
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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
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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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<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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<body>
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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>
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<p>With the increasing cost of doing business and budget constraints, clinical
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professionals need to do more than ever before with less, while still increasing
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productivity and maintaining quality. Sponsors are operating with fewer resources
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and need to outsource more but must do so with less money. And with a high number
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of product failures, available dollars for outsourcing are being threatened
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– this being especially true in smaller companies. Due to the increase in outsourcing,
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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
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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
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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>
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<p>How can suppliers be more proactive in creating new business models to reduce
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costs and maintain quality? </p>
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<p>Forecasting outsourcing demand and matching capacity increases with demand
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growth and managing that growth - better planning with more transparency allows
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partners to more effectively forecast the outsourcing demand and its impact
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on both parties</p>
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<p>Identifying and implementing operational efficiencies to contain cost and
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keep on timelines</p>
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</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>
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<p>Back by popular demand and with double the dedicated time, our Wall Street
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perspective offers an assessment of the outsourcing environment from 2008-2009
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as well as an outlook for the next few years. Our presenters each offer a brief
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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
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a</p>
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<p>Wall St and Private Equity view on:</p>
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<p>The CRO industry, summarizing 2008 financial trends</p>
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<p>Outlook for 2009 and beyond</p>
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<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>
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<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">
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<h1>Defining and Managing Quality in Clinical Trials </h1>
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<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
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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
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will require that quality management be more proactively and comprehensively
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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>
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<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
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complex trials?</p>
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<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";
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how to harmonize teams for a global project</p>
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</td>
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<td valign="top">
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<h1>Standardization: The Holy Grail? The 2009 Update</h1>
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<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
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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>
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</td>
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</tr>
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<tr>
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<td valign="top">
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<h1>Developing Efficiencies Using a Central Lab & CRO Together</h1>
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<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>
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</td>
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<td valign="top">
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<h1>Ensuring Quality at the Sponsor, Site and CRO Levels </h1>
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<p></p>
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<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.
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This interactive discussion explores: </p>
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<p>How do you establish an appropriate quality standard? </p>
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<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>
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<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>
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<p>effectiveness</p>
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<p>Working with Project team and sites to educate sites on the importance of
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adhering to the Protocol</p>
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</td>
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<td valign="top">
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<h1>Successfully Applying Technology to Clinical Trials Across World Regions</h1>
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<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>
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<p>Learn how to realistically integrate technology to local situations</p>
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<p>Manage technology globally at the site level</p>
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</td>
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<td valign="top">
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<h1>RFP Management & Contracting with CROs to Minimize Change Orders</h1>
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<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>
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<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>
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<p>The RFP and the budgeting process with government contracts</p>
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<p>RFP ethics – competitive underbidding with hidden change orders/equal sharing
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of information with all providers</p>
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<p>RFP process and budgeting for Big Pharma vs. smaller company </p>
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<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>
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</td>
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</tr>
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<tr>
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<td valign="top">
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<h1>Early Sponsor/Supplier Team Collaboration for More Effective Design of Your
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Clinical Program </h1>
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<p>Large pharma companies are moving toward engagement on a strategic level
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in the early design and feasibility work by brining partners in early. As many
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are going into a new territory, whether geographic or therapeutic, with new
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molecules, they want the CRO input that much sooner. Smaller and mid size companies
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also want a more collaborative relationship with CROs because they don't have
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the throughput to gain the experience the CROs have and while there are large
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gaps in time between when they have to perform certain tasks, CROs are expected
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to keep up with regulations, etc. In addition, small companies want participation
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from CROs at time of RFP and appreciate the time, energy and thought put into
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proposals in addition to cost.</p>
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<p>Providing Sponsors with feedback based on experience and expertise versus
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making decisions on budgets </p>
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<p>Avoiding the 'cookie cutter' proposal</p>
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<p>Collaborating with suppliers in the planning stage to set the team up for
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success</p>
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</td>
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<td valign="top">
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<h1>Transforming Drug Development Outsourcing with a Virtual Model</h1>
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<p>Virtual companies essentially outsource every component of development. Historically,
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virtual companies have been comprised of only a handful of individuals (e.g.
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researchers who have come from larger companies) or venture capitalists. These
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new companies are being formed by those who are recognizing that the big pharma
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model is losing its sustainability, and so they move their ideas (brain trust)
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outside of the big company to start their own initiative. Now the model is beginning
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to move into a construct where there is a whole portfolio of products being
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managed virtually. As the industry aspires to a lower cost basis for drug development,
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CROs must find ways to accommodate this by having a real stake in the success
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of the client with risk-sharing models of rising interest. </p>
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<p>Is the rise of the Virtual Pharma business model a "fad" or a permanent change
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in the Pharma industry?</p>
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<p>Changing the mindset of those who have 'grown up' in big pharma to results
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driven vs. task driven</p>
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<p>Virtual pharma's expectation of the CRO</p>
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<p>CRO understanding of how the virtual model differs from traditional models
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and having an internal 'champion' looking out for the interests of the virtual
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pharma company</p>
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<p>Empowering CROs to drive the outcome of the outsourced work</p>
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<p>Lessons from virtual companies that can benefit big pharma</p>
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</td>
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<td valign="top">
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<h1>The Implications of Post-Marketing Requirements on the Future of Drug Development
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Partnerships </h1>
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<p>Post-marketing requirements (PMRs) required by FDA and other regulatory authorities
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are becoming more demanding and increasing in complexity. While the information
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ascertained by PMRs is crucial to expanding safety and efficacy information
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on the drug, they are not always adhered to. PRMs place a large burden on the
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R&D function already struggling to get new products launched and the cost of
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these added trials are great. While traditional Phase IV trials are done primarily
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for marketing purposes, FDA is now looking for signals in large scale studies
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for adverse events in real world situations. The parameters are not relative
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to Phase IV so companies can't use phase IV approach for PMRs. Instead, they
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are conducted by the same groups who do the initial pre-registration work. What
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is the best approach to get the work done effectively? Sponsors are looking
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to CROs to provide solutions, but many are still presenting their Phase IV teams
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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
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financial penalties on pharma companies who do not comply. This development
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is critical to the Pharma/CRO relationship as the CRO must be on board with
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the time commitments and deliverables.</p>
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<p>Managing post approval studies - what is the best approach with inherent
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regulatory uncertainty?</p>
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<p>Learning to perform these studies efficiently as the cost of these programs
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can exceed the cost of the drug registration program </p>
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<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>
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<p>Europe and other countries are also requiring more post-approval commitments
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– how are companies preparing?</p>
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</td>
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<td valign="top">
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<h1>Approaches to Address the Impact of Increasingly Complex Clinical Trials
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</h1>
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<p>Increasingly complex clinical trial protocols demand more of investigative
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sites and study volunteers, leading to longer cycle times, more AEs and increasing
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difficulty in recruiting and retaining patients, according to research by Tufts
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CSDD. Combining the influx of less experienced investigators from emerging markets
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and increasing churn among 'established' investigators with not only an increase
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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
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to overcome these challenges? This session explores the answers and sets the
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stage for introducing a proactive approach to predict and prevent protocol violations,
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both from a drug development service provider perspective, and from a site/investigator
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perspective. Key clinical trial success factors to be discussed include:</p>
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<p>Successfully leveraging emerging market investigators who may be less experienced
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for trials that are becoming more complex and demanding</p>
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<p>Architecting a site management plan that promotes primary data quality and
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consistency yet allows flexibility based on country-specific differences</p>
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<p>Best practice for investigators to absorb a clinical trial into regular site
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operations</p>
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<p>Reducing non-core activities to free up resources to focus on their key responsibilities</p>
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</td>
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<td valign="top">
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<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
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likelihood and impact of project upsets. </p>
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<p>Ripple effect beyond the contracting phase</p>
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<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
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strong foundation for success</p>
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<p>Proposal development as an exercise in collaborative solution seeking to
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develop a mutually agreeable and achievable plan</p>
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</td>
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</tr>
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<tr>
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<td valign="top">
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<h1>Shared Risk: Getting Beyond the Sponsor/Vendor Paradigm </h1>
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<p></p>
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<p>Trust can not be built on transactional relationships. It is built on transparency
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and commitments between companies where relationship management is blended with
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a very candid understanding of business interests for both CROs and Sponsors.
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When Sponsors and CROs do not share the same end goal (e.g. regulatory approval)
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286
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or the same risks how can their interests be aligned? Would pharma companies
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be willing to put in significant incentives, monetary or otherwise, tied to
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approval if the CRO is charged with running a registration trial? Are Sponsors
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adept at identifying the risks appropriate to transfer to CROs? Are CROs prepared
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to take the risk burden or is it a gamble?</p>
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<p>Developing and maintaining relationships: sharing and understanding your
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partners' interests, and fostering a commitment to share risks</p>
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<p>Constructing an agreement that fosters shared risk and demonstrates a commitment
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to partnership</p>
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<p>How do you get to this level of trust with your supplier? </p>
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296
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<p>KPIs for relationship building and performance management</p>
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297
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</td>
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<td valign="top">
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299
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<h1>Creating Collaborative Partnerships for Strategic Outsourcing, Forecasting
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300
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and Decision Making</h1>
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<p>Otsuka Pharmaceutical Development and Commercialization (OPDC) has embarked
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on an ambitious plan to create collaborative partnerships with a very few CROs.
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This strategy includes a staffing forecasting model that allows Otsuka to forecast
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internal, outsource and outsource-management requirements and a risk reduction
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methodology for ensuring better project performance. This talk will focus on
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the research that led us to take this path, the approach we have used to select
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an initial partner and the relationship that we have built. Learn about OPDC's:</p>
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<p>Implementation and Methodology</p>
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<p>Supplier selection process</p>
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<p>Staffing model to forecast sponsor and partner needs based on the pipeline</p>
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</td>
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<td valign="top">
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<h1>Fulfilling Post-Marketing Requirements Utilizing Endpoint Trials</h1>
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<p>Post-Marketing Requirements are being imposed with greater frequency by the
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FDA and other regulating agencies, in many cases, to obtain additional safety
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data in a long-term or niche population. The more commercially-oriented Phase
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IV studies of the past are no longer sufficient to fulfill the scientific rigor
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required in the current regulatory environment. Endpoint point trials as a means
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of fulfilling these obligations are becoming more common, allowing evaluation
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of a treatment on mortality or major morbidity within a disease entity. There
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are challenges associated with the implementation of endpoint trials which require
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322
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close collaboration to ensure the quality and consistency of the safety data
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collected. In this session, the following points will be discussed:</p>
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<p>What are the advantages of utilizing an endpoint trial to fulfill post-marketing
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commitments?</p>
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<p>What are the some of the challenges faced in designing and executing endpoint
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trials? And how can Sponsors and CROs effectively collaborate to overcome these
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challenges?</p>
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<p>What strategies have proven successful in implementing endpoint trials?</p>
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</td>
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<td valign="top">
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332
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<h1>Clinical Trials: What Does Global Mean to You?</h1>
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333
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<p>The first step in working with a global provider is analyzing whether working
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with one makes sense for your project. Once you've examined the criteria around
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your project's needs, you must carefully investigate the growing range of providers
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offering global service. There are many CROs claiming to be global, but what
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337
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+
constitutes this?</p>
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338
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+
<p>How many studies?</p>
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339
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+
<p>How do you identify the right partner on a regional basis?</p>
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340
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+
<p>How do you best evaluate your needs as a sponsor?</p>
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341
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+
<p>How much of the global CRO staff belongs to a "partnering CRO"?</p>
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342
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+
<p>If the partners become financially unstable, what recourse is there for the
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343
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+
sponsor?</p>
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344
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+
<p>Who manages the partners? Should the sponsor have to cover management fees
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345
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+
for the primary CRO to manage/interact with their partners?</p>
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346
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+
<p>Are CROs always up front about their global capabilities?</p>
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347
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+
<p>Even though the "global" CRO carries the contractual relationship with their
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348
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+
partner, do they take and hold responsibility for performance?</p>
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349
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+
<p>What due diligence is expected from the sponsor of these partners? Should
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350
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the primary CRO hold the responsibility? How will the regulators view this?</p>
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351
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+
</td>
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352
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+
<td valign="top">
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353
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<h1>Supplier Identification and Selection</h1>
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354
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<p>Using RFIs, vendor days, and capability presentations to identify service
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355
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+
provider options</p>
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356
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+
<p>Developing a vendor assessment and selection process</p>
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357
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+
<p>RFPs, bid grids, scorecards, bid defenses, and more</p>
|
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358
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+
<p>Successes/challenges of working with a functional outsourcing model</p>
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359
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+
<p>Necessary time and skill set to partner with new CROs that are a good fi
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360
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+
t and provide what is expected without a</p>
|
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361
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+
<p>number of change orders</p>
|
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362
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+
<p>Selecting suppliers that really will do what the BD sales people promise</p>
|
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363
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+
</td>
|
|
364
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+
</tr>
|
|
365
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+
<tr>
|
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366
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+
<td valign="top">
|
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367
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+
<h1>Streamlining the Outsourcing Process and Minimizing Internal Resources through
|
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368
|
+
the Use of External Provider Management Teams</h1>
|
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369
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+
<p>In order to streamline the outsourcing process and the delivery of clinical
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370
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+
trials, AstraZeneca created External Provider Management Teams (EPMTs). EPMTs
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371
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+
are delivery teams comprised of a limited number of AstraZeneca and CRO members
|
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372
|
+
who direct CRO study teams to deliver a portfolio of studies. One external partner
|
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373
|
+
was selected to work with each therapy area EPMT to deliver all the outsourced
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374
|
+
work within that area. While still in the early stages, the model has already
|
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375
|
+
provided substantial internal resource savings. This panel discussion will take
|
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376
|
+
you through the model and its current, as well as future, expected benefits.</p>
|
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377
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+
<p>No more RFPs!</p>
|
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378
|
+
<p>Save internal resources</p>
|
|
379
|
+
<p>One outsourcing model</p>
|
|
380
|
+
<p>Increase partnerships </p>
|
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381
|
+
<p>with external providers</p>
|
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382
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+
<p>Maximize synergies and improved quality</p>
|
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383
|
+
</td>
|
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384
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+
<td valign="top">
|
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385
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+
<h1>Creating a Competitive Advantage through Sourcing</h1>
|
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386
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+
<p>The speaker will share his personal insights on how Sourcing can be a catalyst
|
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387
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+
for driving transformational performance that can be seen and measured by the
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388
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+
business. He will discuss how Sourcing professionals can increase their sphere
|
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389
|
+
of influence within the businesses they service to enable change, how to gain
|
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390
|
+
the endorsement of their business leaders, and important components of delivering
|
|
391
|
+
a successful outcome.</p>
|
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392
|
+
<p>What is an SME</p>
|
|
393
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+
<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">
|
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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
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+
<p>Metrics tools: Project Management Dashboard </p>
|
|
410
|
+
<p>-Philosophy and Thresholds</p>
|
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411
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+
<p>Metrics management </p>
|
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412
|
+
<p>-The Monthly Project Review</p>
|
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413
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+
<p>-Issue escalation</p>
|
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414
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+
<p>The benefit to you, the Sponsor</p>
|
|
415
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+
<p>-Early detection of potential issues</p>
|
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416
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+
<p>-Proactive strategic planning to avoid project execution failures </p>
|
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417
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+
<p>-Identification of process inefficiencies</p>
|
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418
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+
<p>-Peace of mind</p>
|
|
419
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+
</td>
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420
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+
<td valign="top">
|
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421
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+
<h1>Optimizing Science and Project Management to Minimize the Impact of Regulations,
|
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422
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+
Logistical Concerns and Economics on Managing Chinese Specimens in Global Trials</h1>
|
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423
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+
<p>Harnessing the right resources to balance the needs of global trials and
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424
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+
mitigate the pitfalls of Chinese specimen management: This session explores
|
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425
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+
the scientific and management issues that are often overlooked when sourcing
|
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426
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+
global trials that include Chinese specimens. The importance of ensuring strong
|
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427
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+
management and scientific methodologies is critical for success and Quality,
|
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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
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+
<p>Chinese specimen & 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
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+
<td valign="top">
|
|
439
|
+
<h1>Impact of Global Currency Fluctuation on Project Budgets: Who Holds the
|
|
440
|
+
Risk?</h1>
|
|
441
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+
<p>Global currency fluctuation has become an increasing challenge as more and
|
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442
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+
more trials are conducted outside the United States which impacts charge rates
|
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443
|
+
regionally and daily. Multi-year contracts are becoming unwieldy, and R&D Finance
|
|
444
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+
has added the management of the fluctuations to its already full load of responsibilities.</p>
|
|
445
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+
<p>History and implications of currency fluctuations</p>
|
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446
|
+
<p>What happens when a once-cost effective country becomes more expensive?
|
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447
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+
</p>
|
|
448
|
+
<p>How currency fluctuations are being managed </p>
|
|
449
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+
<p>Operationalizing a plan to address this challenge </p>
|
|
450
|
+
<p>Overcoming any distrust between sponsor and provider caused by fluctuations
|
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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
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+
<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
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+
</table>
|
|
460
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+
<p><span></span></p>
|
|
461
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+
<table border="1" cellpadding="0" cellspacing="0" summary="layout table">
|
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462
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+
<tr>
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463
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+
<td valign="top">
|
|
464
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+
<h1>Adapting to Constant Change: How Partners are Working Through the Organizational
|
|
465
|
+
Stages </h1>
|
|
466
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+
<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
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+
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
|
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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
|
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476
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+
this</p>
|
|
477
|
+
<p>Risk tolerance providers must bear in an uncertain environment </p>
|
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478
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+
<p>IP, manpower, time management </p>
|
|
479
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+
<p>Dealing with sometimes inexperienced or difficult teams on both sides</p>
|
|
480
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+
</td>
|
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481
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+
<td valign="top">
|
|
482
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+
<h1>Evolving the Key Strategies of Clinical Development Sourcing -- Current
|
|
483
|
+
and</h1>
|
|
484
|
+
<h1>Future Direction</h1>
|
|
485
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+
<p>Our presenters discuss ÉLAN and the alliance model resourcing strategy, including:</p>
|
|
486
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+
<p>Decision point/ROI to move to this model from a clinical development strategy
|
|
487
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+
perspective</p>
|
|
488
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+
<p>Applying operational learnings from large to mid-size organizational strategies</p>
|
|
489
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+
<p>Adoption curve to newer strategic resourcing directions</p>
|
|
490
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+
<p>Measuring operational success and continuous opportunities</p>
|
|
491
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+
<p>Governance and operating model with RPS</p>
|
|
492
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+
</td>
|
|
493
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+
<td valign="top">
|
|
494
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+
<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
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+
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&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&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&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 & 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&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&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&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&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>
|