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ICON Webinars

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  • NASH Clinical Trials - Challenges and Considerations
    NASH Clinical Trials - Challenges and Considerations Dr. Andrew Roche, PhD, Scientific Director, Global Validation, Scientific Affairs, ICON Recorded: Jul 30 2018 47 mins
    Overview of current challenges associated with NASH Clinical Trials and examination of potential strategies to address during trial design or study execution.
  • Real World Evidence Across the Product Lifecycle: Regulatory and Payer Landscape
    Real World Evidence Across the Product Lifecycle: Regulatory and Payer Landscape Jane Turner, Senior Principal, Real World Evidence, ICON Recorded: Nov 17 2017 46 mins
    The shift towards a value-based, patient-centric approach to health care continues to increase the need to measure the impact of biopharma products and devices in a real world setting. It’s now more important than ever for sponsors to understand how Real World Evidence (RWE) can play a role in developing a product’s value story across the development continuum.

    Payment models and federal reforms are increasingly focused on the real world impact of treatments and devices. Regulatory bodies are looking to real world evidence to close the gap between how a product performed in clinical trials and how a product performs in the clinical setting on a broader patient population. As the capture and connectivity of health records and data continue to move towards digitization, the ability to assess and analyse these data increases in ease and efficiency.

    Innovative late phase research approaches are benefitting from this move towards digitization, at the same time as more regulatory guidance is released in both the US and EU around the use of RWE to support and enhance submissions and product uptake. Combined, these two activities are making a high impact on the importance of assessing and realizing a real world evidence product strategy.

    The increased interest in RWE not only lies with regulatory bodies, however, it also stands to make a large impact on how payers may cover a product based on the real world value it brings to the patient and the market. Understanding what evidence will best support a product’s value story is paramount for sponsors to ensure payers can make an informed decision about the product’s impact in a real world setting.
    Speakers: Jane Turner, Senior Principal, Real World Evidence, ICON & Alexander Gee, Lead Consultant, Principal, Pricing & Market Access, Commercialisation and Outcomes, ICON
  • Evolving Best Practices for Working with Authors – Authorship and Beyond
    Evolving Best Practices for Working with Authors – Authorship and Beyond Janet Galliera, Executive Director Business Development, PubsHub, an ICON plc company Recorded: Oct 24 2017 32 mins
    Developing scientific publications and manuscripts is a complex and time-intensive process. Each publication often involves managing multiple authors and KOLs through numerous review rounds, while gathering actionable and meaningful input and meeting stringent publication deadlines.

    Join us to learn good publication practices that will help to streamline your interactions with scientific authors, while enhancing the quality, efficiency and effectiveness of your industry sponsored research projects.

    Key Insights:
    We will review best practices for ensuring that authors meet ICMJE guidelines in manuscript development and submissions, and offer suggestions and solutions to help you meet the high demand for rapid publication. Learn more about:

    Best practices for working with scientific authors who write their own manuscripts from sponsored trials
    What to do when an internal investigator/author has left the company
    How to limit the number of authors listed on a publication, with examples of how this can work in everyday practice
    Criteria to determine appropriate authorship and how to credit each author
    Strategies to manage author expenses and other payments, including travel and reimbursements, and when it is appropriate to pay an author
    Easy to use technology solutions that provide compliant and efficient means to support your strategic and tactical publication management processes.

    Speakers: Janet Galliera, Executive Director Business Development, PubsHub, an ICON plc company; Surendra Sharma, Medical Communications Leader, Spark Therpeutics
  • Linking Evidence and Value Strategies with the Right Stakeholder
    Linking Evidence and Value Strategies with the Right Stakeholder Paul Just, Senior Principal, Medical Device Health Economics, Commercialisation and Outcomes Recorded: Oct 13 2017 45 mins
    In these days of austerity, a new healthcare intervention, defined as a drug, medical device, procedure, program, or service, must establish a robust and credible value proposition before or soon after its introduction into mainstream practice. Various healthcare stakeholders have different requirements for and definitions of value. Satisfying their demands is paramount to an intervention’s success and results in more favourable pathways to rapid adoption and market access.

    Join us as we discuss an approach to evidence-generation strategies in drug and medical device development that enables integrated teams to develop and implement targeted and effective value propositions.

    Get Insights on:
    Development of stakeholder value maps as a guide for evidence development
    Encouraging interdisciplinary collaborations to define differentiating value
    Prioritization of stakeholders as customers for robust evidence
    Conceptualizing a stakeholder targeted evidence planning process

    Speakers: Paul Just, Senior Principal, Medical Device Health Economics, Commercialisation and Outcomes & Sarah Clifford, Senior Principal, Clinical Outcomes Assessments, Commercialisation and Outcomes
  • Outcomes-Based Agreements and Innovative Contracting for Biopharmaceuticals
    Outcomes-Based Agreements and Innovative Contracting for Biopharmaceuticals Michael Pace, Senior Principal, Pricing and Market Access, Commercialisation and Outcomes, ICON Recorded: Sep 22 2017 59 mins
    Launching a new drug often requires a compromise between the manufacturer and payer’s objectives and priorities. While ensuring patient access to new drugs is an objective for both parties, payers also need to make certain that new therapies comply with budgetary constraints and that any associated risks of uncertainty are minimised. In this context, contracting represents mutually valuable agreements that address the needs of both the manufacturer and the payer.

    Traditional contracting agreements have focused purely on price negotiations. These simple agreements such as, price discounting/rebates, caps and free goods, in themselves are not novel; however, their combination or inclusion in the context of a more complex agreement can be considered in the design of innovative contracting agreements.

    When designing a contract, the aim is to find a cohesive solution that meets the needs of the payer while still achieving manufacturer objectives. Sometimes, “traditional” contracting is not sufficient to achieve this compromise, necessitating the adoption of more advanced, and sometimes complex, innovative contracting agreements.

    Speakers: Michael Pace, Senior Principal, Pricing and Market Access, Commercialisation and Outcomes, ICON & Guy Sherwin, Lead Consultant, EU Pricing and Market Access, Commercialisation and Outcomes, ICON
  • Using Early Economic Models in Developing your Evidence Strategy
    Using Early Economic Models in Developing your Evidence Strategy Victoria Paly, Senior Health Economist, ICON Commercialisation & Outcomes Recorded: Jun 7 2017 50 mins
    The demand from regulators and payers for health economic models is increasing, as these key decision makers struggle to manage budget constraints and provide access to new therapies.

    Health economic models are required to demonstrate product value and support reimbursement submissions; however, early economic models can also be used to inform clinical development decisions, develop HEOR and real world evidence (RWE) generation planning and support early pricing and market access discussions.

    Key Insights
    Join us to learn best practices for developing early economic models to inform key strategic decisions. Through discussion and a case study, get insights on:

    - Types of early economic models and why are they important
    - Guidelines on their development and the selection of data sources
    - Case-examples of use in evidence strategy generation
    - How early economic models are used to identify evidence gaps

    Speakers: Victoria Paly, Senior Health Economist, ICON Commercialisation & Outcomes & Dhvani Shah, Lead Health Economist, ICON Commercialisation and Outcomes
  • Glucose Clamping in Humans
    Glucose Clamping in Humans Dariush Elahi, Director of Metabolic Research, Early Phase Services, ICON Recorded: May 15 2017 63 mins
    Establishing Early Proof-of-Concept int eh Development of Diabetes Interventions

    Speakers: Dariush Elahi, Director of Metabolic Research, Early Phase Services, ICON & Dennis Ruff, VP, Medical Director, Early Phase Services, ICON
  • Optimise Medical Publishing and Avoid "Predatory Journals"
    Optimise Medical Publishing and Avoid "Predatory Journals" Janet Galliera, Executive Director Business Development, PubsHub, an ICON plc company Recorded: May 9 2017 52 mins
    Open access journals are scholarly publications, available across the internet. They are freely accessible, with no subscription costs. From 2012 to 2017, the number of open access journals increased from 4,034 to 9,405. [1]

    While open access journals bring clear cost and accessibility advantages, it is important for authors to be able to accurately assess the quality and reputation of any potential publisher.

    What are predatory publishers?
    Predatory publishers are profiteering individuals or companies, who use the open access publishing model to take advantage of and exploit authors, by charging them article processing fees without providing the high quality editorial services associated with legitimate journals [2]. The term “predatory publisher” was first coined by Jeffrey Beall, who tracked them on his Scholarly Open Access blog from 2012 until January 2017.

    Speakers: Jeffrey Beall, Scholarly Communications Librarian and Associate Professor, University of Colorado Denver; Janet Galliera, Executive Director Business Development, PubsHub, an ICON plc company; Nicolle Watts,
    Database Manager, PubsHub an ICON plc company

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