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    • Accelerate Clinical Trials by Simplifying Data Quality
      Accelerate Clinical Trials by Simplifying Data Quality John Jones, Life Science IT Strategist and Bryan Balding, Senior MDM Solution Specialist, Informatica Recorded: Jun 7 2016 5:00 pm UTC 57 mins
    • There is no challenge more critical or costly in life sciences R&D than effectively managing the subject and operational data used in the development of new medical approaches. Poor data quality impacts the overall design, execution, quality, and management of clinical trials.

      "The drug development process is predicated upon the availability of high quality data with which to collaborate and make informed decisions during the evolution of a product or treatment." - Informatica customer and CIO of leading Contract Research Organization.

      Simplifying the complexity of clinical trials data management requires certain procedural steps that lead to reduced costs, shorter time to market, increased veracity of results, and improved compliance with industry standards and regulations.

      Join John Jones, IT strategist focused on life sciences, and Informatica, the industry leader in all things data, for a webinar showcasing industry best practices that lower the direct cost of poor data management in clinical research studies.

      You'll learn more about the strategic data management capabilities needed to positively affect clinical trial cost and duration.

      View this on-demand recording now to learn how to:

      • Automate the application of CDISC standards
      • Obtain quality and timely data to support risk based monitoring (RBM)
      • Prepare for the future of alternate data sources, for example from devices, wearable technology, and patient forums

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    • Resource Management & Planning for Successful Clinical Trials
      Resource Management & Planning for Successful Clinical Trials Rick Morris, President of R2 Consulting & Edward Davis, Director of Advisory & Solutions at Kforce Inc. Recorded: Nov 11 2015 6:00 pm UTC 47 mins
    • Clinical Trial planning and resource management can be one of the most complex management challenges facing life sciences organizations and CROs. Often these organizations are managing hundreds of studies across thousands of sites and investigators making it extremely difficult to understand how and where to deploy costly clinical resources. With the variability of the studies and the massive competition in the industry, finding a solution to understand how and where all clinical resources are being utilized and a solution with the ability to perform predictive analysis on this information to improve site and investigator selection can give companies a competitive edge.

      CA PPM for Clinical Research Planning from R2 Consulting gives you all of the tools needed to perform predictive analysis, plan and manage resource utilization, lower costs on expenses, and gather valuable information to assist in recruitment planning for sites and investigators.

      Join us for a webinar on Tuesday, 11/11 to learn how several life sciences and Clinical Research Organizations (CROs) have been able to leverage CA PPM for Clinical Research Planning to lower the complexity associated with clinical trial design resulting in reduced costs and more effective clinical trial management.

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    • Patient engagement: the future for outcomes research and clinical trials?
      Patient engagement: the future for outcomes research and clinical trials? Dominic Tyer Recorded: Jun 25 2015 2:00 pm UTC 60 mins
    • There is growing momentum and recognition among researchers, regulatory agencies, policy makers and payers towards a more patient-centric approach to health outcomes research, including development and validation of Clinical Outcome Assessments, and participation of patients in clinical trials.

      On 25th June 2015 at 3pm (GMT) PMGroup, in association with Adelphi Values, will host a free webinar that shows how a more patient-centered approach can be used to enhance outcomes research and conduct of clinical trials, providing examples from research in oncology and inflammatory disease.

      The webinar will also demonstrate the importance of patient engagement at all stages of PRO development and will include direct feedback from a patient advisor, so you can learn about their experience as a partner in the research process.

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    • Pitfalls in Post-Grant Trials
      Pitfalls in Post-Grant Trials Eugene Perez & Gerald Murphy, partner, Birch Stewart Kolasch Birch LLP; Michael Loney, Americas editor, Managing IP Recorded: May 12 2015 8:00 pm UTC 66 mins
    • Managing IP’s next webinar, run in cooperation with Birch Stewart Kolasch Birch LLP, will take place on May 12 at 4pm (eastern standard time); 1pm (pacific standard time) and will discuss ‘Pitfalls in Post-Grant Trials’.

      The popularity of USPTO post-grant patent trials have only increased. Whether the PTAB institutes an inter partes review, a post-grant review, or a post-grant validity review of qualified business method patents, each trial has procedural pitfalls with considerable strategic considerations during the Second Phase of the trial (from the institution decision to the final written decision by the Board). This webinar will explore the most common mistakes the third party petitioner or patent owner during the 2nd Phase, with an explanation of key decisions by the PTAB (including those posted on the USPTO microsite) as well as the Federal Circuit. The focus will be on discovery, the patent owner motion to amend, oral hearing, and estoppel.

      Speakers include:
      •Michael Loney, Americas editor, Managing IP (moderator)
      •Eugene Perez, partner, Birch Stewart Kolasch Birch LLP
      •Gerald Murphy, partner, Birch Stewart Kolasch Birch LLP

      With post-grant trials becoming increasingly popular, having an in-depths understanding of the pitfalls and challenges is essential for sustaining a strong presence in the market place. The live audience will be able to ask questions of the speakers during the webinar, which will be in English and will last one hour.

      This webinar relates to our April 16 discussion focusing on ‘Pitfalls in the first phase of Post Grant Proceedings’. You can listen to it here: https://www.brighttalk.com/webcast/327/149005

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    • WIPR and BSKB present: Obviousness in PTAB Trials for Chem/Pharma/Bio Patents
      WIPR and BSKB present: Obviousness in PTAB Trials for Chem/Pharma/Bio Patents Gerald Murphy (BSKB), Eugene Perez (BSKB), Kristi Sawert (USPTO), Peter Scott (WIPR) Recorded: Oct 13 2016 3:30 pm UTC 66 mins
    • Challenging patents involving unpredictable technologies for obviousness is particularly difficult due to the well-established factor of “reasonable expectation of success” and the related KSR factor of “limited number of predictable solutions”. This webinar, presented by attorneys that have successfully argued on both sides of this issue for chem/pharma/bio patents, will discuss two to three leading PTAB decisions, including related appeals, that illustrate when obviousness challenges have and have not been successful. The case discussions will provide (1) a summary of the documentary evidence relied on, including critical excerpts from that evidence, (2) a summary of the “story” that was being told by each party and (3) the role that expert testimony appeared to play in the PTAB decisions. This one-hour seminar will also briefly explore what types of cases are better challenged in court and what types of cases are better challenged at the PTAB. The goals of the seminar are to allow parties to evaluate the chances of success for a contemplated or recently filed PTAB challenge and to help parties to a PTAB proceeding develop a record to support their respective positions. CLE available.

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    • The JDSU Verdict: Lessons from a Securities Class Action Trial
      The JDSU Verdict: Lessons from a Securities Class Action Trial Jordan Eth, Allan Kleidon, Bruce Carton Recorded: Mar 25 2009 6:00 pm UTC 63 mins
    • On March 25, 2009, Cornerstone Research is sponsoring a webcast entitled "The JDSU Verdict One Year Later: Lessons from the Largest Securities Class Action Trial in History" that will feature two of the key players in that historic trial.

      Jordan Eth, co-lead trial counsel for JDS Uniphase and several individual defendants, and Allan Kleidon, testifying expert for the defense on damages and causation issues, will lead a discussion of the extraordinary lessons learned from the rarest of events: a jury trial in a securities class action lawsuit. The panel will discuss their experience in defending this massive securities class action at trial, including the unique challenges, trial tactics and considerations posed by a trial in this type of case. In addition, the panel will discuss the effective use of expert witnesses in a securities class action trial.

      Please join Jordan Eth, a partner at Morrison & Foerster LLP, and Allan Kleidon, Senior Vice President with Cornerstone Research, as they address these topics as well as your questions in a free, one-hour webcast. Moderated by Securities Docket's Bruce Carton.

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    • Supporting emerging R&D companies to deliver research in the NHS
      Supporting emerging R&D companies to deliver research in the NHS Matt Cooper, Business Development and Marketing Director, NIHR Clinical Research Network Recorded: Oct 20 2015 10:00 am UTC 38 mins
    • •Is your company seeking to enter the clinical trial process?
      •Do you need expert advice on setting up a study?
      •Would you like help developing your protocol for the NHS environment?

      Supporting high-quality commercial contract clinical research across all therapeutic areas is a high priority for the National Institute for Health Research Clinical Research Network – the research delivery arm of the NHS.

      We support the full spectrum of commercial clinical research including medical technology, device and diagnostic studies in addition to pharmaceutical products. We have dedicated research support staff and services to assist with study delivery at site level. This infrastructure provides you with unparalleled access to, and understanding of, the NHS research environment.

      As well as helping you to navigate the NHS, we offer a range of practical services that can be tailored to your needs and are designed to help you set-up and deliver commercial research studies to time and target, whatever their size, design or therapeutic area. These include:

      •Feasibility; early feedback during protocol development, site intelligence and site identification
      •Commercial costing templates to expedite cost negotiations
      •Streamlined processes for gaining NHS permissions
      •Model agreements for faster contracting
      •Study management and delivery by our dedicated GCP-trained research workforce

      If you would you like to know more about our services you can join our live webinar hosted by Matt Cooper, Business Development and Marketing Director. This live online event will include a 30 minute presentation followed by an opportunity to ask questions.

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    • Social Media Trials and Tribulations in Pharma
      Social Media Trials and Tribulations in Pharma John Mack, Pharma Marketing News Recorded: Feb 9 2012 2:00 pm UTC 41 mins
    • "Pharma's Social Media Trials and Tribulations"

      A Record of Social Media Events Impacting the Pharmaceutical Industry

      The pharmaceutical industry is at a turning point in its adoption of new social media tools and applications for communication with healthcare professionals, consumers, patients, policymakers, and payers. Practically every pharmaceutical company has launched a social media project or application of one sort or another. To be sure, not all these efforts have been successful. This presentation will explore what worked and what didn't by highlighting the major trials and tribulations of pharma's social media "road trip"

      Topics and discussion points include:

      Is the Industry Ready for Social Media? Results of the Pharmaguy Social Media Readiness Self-Assessment Survey
      History of FDA's Promise to Provide Social Media Guidelines. What's Gumming Up the Works?
      The Major Milestones of Pharma Use of Social Media: The Good, the Bad, and the Ugly. All Offer Useful Lessons.

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    • Insider Trading Enforcement Update
      Insider Trading Enforcement Update Lawrence Gerschwer, Allen D. Applbaum Recorded: Mar 11 2014 5:00 pm UTC 62 mins
    • This webcast will highlight important recent developments in the government’s ongoing crackdown on insider trading, including lessons learned from recent high-profile criminal trials and debated legal issues. The panel will address:

      • The recent separate trials of former SAC Capital portfolio managers Mathew Martoma and Michael Steinberg in the Southern District of New York.
      • The effect prosecutions involving information from expert networks may have on the “mosaic theory.” Mosaic theory is the concept under which the SEC theoretically permits investors to piece together immaterial nonpublic information to form an investment thesis.
      • The sentences—usually no jail time—handed down to defendants who plead guilty and cooperate with the government’s investigation, versus the relatively long sentences of defendants who are convicted at trial.

      The speakers will include Lawrence Gerschwer, Partner, Morrison & Foerster LLP, and Allen D. Applbaum, Senior Managing Director and Global Leader of FTI Consulting’s Global Risk & Investigations Practice. Mssrs. Gerschwer and Applbaum are both former Assistant US Attorneys for the Southern District of New York.

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    • Accelerating the Timeline to First-in-human Trials
      Accelerating the Timeline to First-in-human Trials David Edwards, Capsugel; Tim Scott, Pharmatek Laboratories; Joseph Forth, AMRI Recorded: Jul 13 2010 3:00 pm UTC 85 mins
    • Accelerating the Timeline to First-in-human Trials: NEW Case Studies on API in Capsule Technology

      Accurately and precisely dispensing drug substances alone, in tiny amounts as low as 100 micrograms into capsules, excipients or bulking agents is changed the process of drug development.

      Today, Pharma companies use micro-dosing technology to shorten drug development by reducing the need for costly time-consuming stability and pre-formulation studies. Reducing the time it takes to reach the critical "first in human" clinical decision point allows an increase in throughput of candidate compounds for development, thereby enabling pharma development departments to focus their resources on potential winners.

      This webinar will feature NEW case studies on the Capsugel technology. Speakers include:

      David Edwards, Director of Pharmaceutical Technology, Capsugel
      Tim Scott, President, Pharmatek Laboratories
      Joseph Forth, Manager, Pharmaceutical Development AMRI

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    • Effective obviousness arguments in district court and PTAB
      Effective obviousness arguments in district court and PTAB Robert A. Surrette, President, McAndrews, Held & Malloy; Mary Elizabeth Mauro, Intellectual Property Counsel, Stryker Corp Recorded: Nov 4 2015 5:00 pm UTC 61 mins
    • Managing IP’s upcoming webinar ‘Effective obviousness arguments in district court and PTAB’, held in association with McAndrews, Held & Malloy, will take place on November 4 at 5:00pm London time (12pm Eastern/11am Central/9am Pacific).

      In this webinar speakers will discuss:

      •Obviousness: the evolving legal standard and its policy rationale
      •What PTAB/district data tells us (does not tell us) about trends in obviousness holdings
      •Patent holder tactics to combat obviousness during prosecution and after
      •Strategies for challenging and defending a patent with no validity presumption and a broadest reasonable interpretation
      •Best practices for petitioners at the PTAB and defendants in litigation
      •Practical tips for deploying and combating the objective indicia of non-obviousness

      Confirmed speakers:

      •Robert A. Surrette, President, McAndrews, Held & Malloy
      •Mary Elizabeth Mauro, Intellectual Property Counsel, Stryker Corporation
      •Michael Loney, Americas editor, Managing IP (moderator)

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    • Common Challenges in Evaluating the Reproductive System in Nonclinical
      Common Challenges in Evaluating the Reproductive System in Nonclinical Justin Vidal, PhD, DVM, DACVP Recorded: Feb 9 2017 7:00 pm UTC 53 mins
    • According to the ICH Harmonised Tripartite Guideline: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3(R2), both men and women of child bearing potential (WoCBP) can be included in Phase I and II trials before the conduct of the male and female nonclinical fertility studies, since an evaluation of the male and female reproductive organs is performed in the repeat-dose toxicity studies. As such, much of the early assessment of potential test article-related effects on the reproductive system falls on the nonclinical toxicologic pathologist. This requires the pathologist to have a have a sound understanding of spermatogenesis, stage-aware evaluation of the testis, estrous and menstrual cyclicity, and normal physiology and endocrinology in order to carefully and thoroughly evaluate potential xenobiotic-related effects on the reproductive system. However, even with the most thorough pathology assessment, the design and conduct of nonclinical general toxicity studies can greatly impact the pathologist’s evaluation of the reproductive system. Commonly encountered challenges include age (onset of puberty and reproductive senescence), body weight changes and systemic toxicity, husbandry practices, strain differences, small sample size (non-rodents), and even histologic sectioning patterns.

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    • How Do I Get My Compound Into Phase I?
      How Do I Get My Compound Into Phase I? Scott Boley, PhD, DABT, Greg Ruppert, BA Recorded: Nov 3 2016 3:00 pm UTC 58 mins
    • Careful assessment of the relationship between efficacy and toxicity is vital to drug developers as they seek advancement of their compounds. Nonclinical testing is required to establish a safe starting dose for the initial human clinical trials. In partnering with our pharmaceutical and biotechnology Sponsors, our goal is to improve the odds of selecting the right lead candidates, and to conduct the right studies in the right way, taking all factors into consideration to ensure a successful IND submission.
      As part of this webinar we will outline the nonclinical studies needed to progress a therapeutic into a Phase I clinical trial. We will cover small molecules to vaccines to biopharmaceuticals as well as standard indications to life-threatening and rare/orphan indications.

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    • Regain control of your SSL Environment
      Regain control of your SSL Environment Alan Goh & Helen Lew Recorded: Feb 16 2017 4:00 am UTC 26 mins
    • With numerous certificates sited across multiple locations and geographies, ensuring continuity and compliance has become a time-consuming, costly, and risky business for enterprises. In this 30-45 minute webinar you'll learn how Symantec Discovery can help to ensure continuity and compliance, and deliver peace of mind when it comes to your SSL/TLS certificate real estate.

      - Discover your entire certificate infrastructure
      - Instantly assess every certificate for security risks
      - Reduce your risk of being non-compliant
      - Learn about our free trial

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