Name: Development and Validation of Clinician-Reported Outcomes Measures (ClinROs)
Start: 2016-11-16T17:45:00Z
End: 2016-11-16T17:46:05.000Z
Location: BrightTALK
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BioPharma companies and Medical Devices manufacturers face growing operational, regulatory and economic challenges when it comes to developing their drug or device. ICON provides analysis and key insights on these challenges, with practical advice and recommendations.

This webinar explores:

- The evolution of health technology assessment in the US and possibilities for the future
- Opinions of manufacturers and US payer stakeholders on the role of - - ICER in the US healthcare system, as learned through a primary research study of more than 50 participants
ICER methodologies and approaches to evaluation of clinical and health economic evidence
- Ways manufacturers can begin to more proactively prepare for an ICER assessment

Industry Perceptions and Expectations - The Role of ICER as an Independent HTA

Despite the increasing availability of mHealth technologies that can successfully capture physiological data, and digital platforms that can ingest and analyze the data to date, the adoption of these technologies is only cautiously embraced in clinical research.

This webinar discuss the main challenges in the areas of:

- Patient Engagement and Burden
- Device Suitability
- Data Complexity and Insight Generation
- Operationalization
- Privacy and Security Issues
- Regulatory Acceptance

The Template for a Successful Digital Trial

If you are curious about the latest digital trends and how that innovation is being implemented into real world communication needs, don't miss this webinar. 

We review current trends and how digital technology and innovation are being applied to patient, healthcare professional, payer, and other decision maker communications. 

With a world population of 7.6 billion people using over 21 billion internet connected devices, digital interactions are not only fundamental, they require continued evolution to maintain appropriate reach and responsiveness.   

You’ll gain insights from our collection of case studies, and learn how companies are applying the latest digital trends in Artificial Intelligence (AI),  including voice enablement and chatbots, wearables, point of care electronic health record messaging, social media, transportation, do-it-yourself healthcare, and more.

Applying the latest Digital Trends to Patient, Provider and Payer Communications

The new European Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) represent some of the most wide-ranging and disruptive changes to recently affect the world’s second-largest medical technology market. Now, with just a two- to four-year transition period before full compliance is required in 2020 for MDR and 2022 for IVDR, device developers will need to implement changes to help new and existing products succeed.

This webinar discusses:

- The key changes that are occurring under the new regulations
- How to prioritize your product portfolio
- The importance of early planning in preparing clinical studies to certify new devices and to recertify existing ones
- How early transition can give your products an advantage in the market

Overcoming New EU MDR & IVDR Regulation Challenges

Risk based monitoring has been emerging for years. The 2017 release of ICH E6 R2 introduced the world of technology to a 20-year-old guideline with increased focus on delivering quality and efficiencies in clinical trials. This webinar explores the evolution of centralised, risk based monitoring, specifically addressing the impact on sites, examining the growing pains, and fostering dialogue and awareness between CROs, sponsors and sites.

Topics covered include:

- Advancing our quest for quality management to continually improve the way we monitor clinical trials by placing emphasis on what really matters
- Focusing on data and processes that are critical to patient safety and data integrity, putting the patient first 
- Leveraging technologies that enhance a quality-driven perspective and discussing what all of this means for the industry

Risk Based Monitoring: The Site Perspective

- Real World Evidence Dynamics and Alignment with Late Phase Research
- Developing an RWE Strategy
- Connecting TEchnology to an RWE Strategy

How Real World Evidence Continues to Shape the Late Phase Landscape

A short questionaire to assess alcohol use.

The Obsessive Compulsive Drinking Scale (OCDS) - A Mapi Webinar

Overview of current challenges associated with NASH Clinical Trials and examination of potential strategies to address during trial design or study execution.

NASH Clinical Trials - Challenges and Considerations

Our experts explore how manufacturers can successfully implement this guidance and integrate new communication channels with payers. This webinar will cover:

- The history of FDAMA section 114 and rationale for amendment legislation
- Differences between the draft and final FDA guidance
- Industry and public concerns and questions
- “CFL guidance” related to consistency of labelling in medical communications
- Challenges with the promotional versus scientific exchange debate
- Key opportunities and considerations for industry

Imapct of FDA's Recent Guidance on Payer Communications

This is a Mapi Research Trust recorded webinar. Presented by Pamela J. Angle, University of Toronto and Marie Dulac Trimoreau, Mapi Research Trust

Measuring Pregnancy and Labour Pain Using Clinical Outcome Assessments

Using the Inventory of Depressive Symptoms Scales (IDS-C and IDS-SR) in Clinical

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

Real World Evidence Across the Product Lifecycle: Regulatory and Payer Landscape

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

Evolving Best Practices for Working with Authors – Authorship and Beyond

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

Linking Evidence and Value Strategies with the Right Stakeholder

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

Outcomes-Based Agreements and Innovative Contracting for Biopharmaceuticals

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

Using Early Economic Models in Developing your Evidence Strategy

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

Glucose Clamping in Humans

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

Optimise Medical Publishing and Avoid "Predatory Journals"

In the broader family of Clinical Outcomes Assessments (COAs), ClinROs are appropriate for outcomes that cannot be reported by a patient, and are observable but require judgment or interpretation by a trained health professional.

This webinar will focus on the methodology for developing and validating Clinician-Reported Outcomes (ClinROs) for implementation in clinical trials and to support labeling claims. As there are no regulatory guidelines specific to ClinROs, we will share how we apply the Patient Reported Outcome guidance (FDA/SEALD Guidance for Industry 2009) as a framework for ClinRO development and validation.

Key insights:
Using two recent case examples we will illustrate the challenges in developing and validating ClinROs and share lessons learned in the development of a novel ClinRO. Attendees will learn:

- What is a ClinRO, and when is it appropriate to use one over other types of COAs?
- What are best practices for developing and validating ClinROs?
- What are some of the key challenges and potential solutions in ClinRO development and validation?
- What are some of the key considerations for implementing ClinROs in a clinical study?

Speakers: Magdi Vanya, Lead Outcomes Researcher, ICON; Olga Moshkovich, Outcomes Researcher, ICON; Katy Benjamin, Principal, ICON.

Development and Validation of Clinician-Reported Outcomes Measures (ClinROs)

ClinRO

HEOR

Regulatory

Risk Management

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Development and Validation of Clinician-Reported Outcomes Measures (ClinROs)

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