libxml-ruby 1.1.1-x86-mswin32-60 → 1.1.2-x86-mswin32-60
This diff represents the content of publicly available package versions that have been released to one of the supported registries. The information contained in this diff is provided for informational purposes only and reflects changes between package versions as they appear in their respective public registries.
- 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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<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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<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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<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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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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<p>KPIs for relationship building and performance management</p>
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</td>
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<td valign="top">
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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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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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<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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334
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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>
|
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364
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+
</tr>
|
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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
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+
was selected to work with each therapy area EPMT to deliver all the outsourced
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374
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+
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
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+
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
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+
<p>Save internal resources</p>
|
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379
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+
<p>One outsourcing model</p>
|
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380
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+
<p>Increase partnerships </p>
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381
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+
<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
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+
</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>
|
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393
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+
<p>How collaboration makes the difference</p>
|
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394
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+
<p>Seizing the opportunity</p>
|
|
395
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+
<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>
|
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407
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+
<p>Defining metrics for a global project</p>
|
|
408
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+
<p>Standardizing metrics tracking and reporting</p>
|
|
409
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+
<p>Metrics tools: Project Management Dashboard </p>
|
|
410
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+
<p>-Philosophy and Thresholds</p>
|
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411
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+
<p>Metrics management </p>
|
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412
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+
<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>
|
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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>
|
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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
|
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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
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+
</td>
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438
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+
<td valign="top">
|
|
439
|
+
<h1>Impact of Global Currency Fluctuation on Project Budgets: Who Holds the
|
|
440
|
+
Risk?</h1>
|
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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
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+
</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
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+
</tr>
|
|
459
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+
</table>
|
|
460
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+
<p><span></span></p>
|
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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
|
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467
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+
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
|
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470
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+
industry deals with ever increasing pressures on trial design, timelines and
|
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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
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+
<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
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+
<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
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+
<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
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+
off of discovering and developing new molecules. Tools such as adaptive trial
|
|
498
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+
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
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+
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&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>
|