Webinars

Perinatal Mood Disorders

10am CST (China)

11am KST (Korea)

3pm CET (EU-Central)

Who has the job of leading the evaluation of pharmaceutical value and pricing? What impact will ICER have on payer decision-making? Will manufacturers begin to adjust their list prices to reflect valuations made in ICER reports? These questions and more continue to be at the heart of discussions surrounding how to gauge value in the US healthcare system.

As manufacturers begin to be more proactive in preparation for ICER evaluations, earlier monitoring of updates to ICER value frameworks and consideration of competitor and analog ICER assessments should be a priority, particularly in relation to the development of economic models, pricing strategies, and contracting approaches. Gathering of proactive scientific advice from ICER influencers and stakeholders will better prepare manufacturers for the inevitable challenges that stem from a negative ICER assessment. Incorporation of ICER guidelines, similar to other tactics like the development of an AMCP dossier, should be considered as early as possible when developing market access strategies. Only time will tell if ICER becomes the next NICE—but for now, it is a force that is here to stay and to be reckoned with.

This webinar will explore:

• 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

Join Andrew Roche, PhD, a senior member of ICON's NASH team, as he speaks about overcoming the challenges and considerations associated with NASH Clinical Trials and examination of potential strategies to address during trial design or study execution.

New regulatory developments in both the US and Europe are promoting a radical change to accelerate the approval of new medications for rare disease. These include the 21st Century Cure Act in the US and the Adaptive Regulatory Pathway in Europe.

This webinar recording explores the latest industry and regulatory developments relating to the use of eConsent in clinical trials and what sponsors and sites need to consider before they deploy this in clinical trials.

This webinar will discuss how real world evidence is playing a larger role across the entire product life cycle, with a focus on late phase regulatory discussions and payer decision-making.

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.

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 a deeper understanding of the changing contracting landscape and to learn ways to leverage innovative approaches to improve the commercial success of your biopharmaceutical products.

Register to receive a recording of the webinar and get a deeper understanding of the use of early economic models to inform key strategic decisions.

Join ICON’s expert Dr. Andrew Roche, PhD as he speaks about overcoming challenges when developing Diabetes trials. Addressing these challenges via use of high quality tools is critical to successful completion of a clinical trial.

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.

This webinar explores the novel uses of smartphone sensor measurement in the areas of health, wellness and clinical research and appraises the promise of these approaches in clinical trials.

How will payers assess innovative therapies which still have to prove their duration of efficacy? How do manufacturers price a drug that has the potential to cure, or confer lifelong benefit from a single administration? How will already financially stretched healthcare authorities fund patient access to these therapies?

This webinar will discuss the market access and reimbursement challenges around cell and gene therapies.

This webinar draws on experience in validating a select group of PerfO assessments in orthopaedics, an area with a strong history of performance measurement, with the intention of supporting future labelling claims. The PerfO assessments were Timed Up and Go, Stair Climbs and Repeated Chair Stands which were administered in hip fracture and elective hip and elective knee replacement patients in a multi-site study.​

This webinar will explore the patient's perspective on the barriers to patient engagement in the clinical trials. We discuss the clinical trials of the future in a world of cognitive computing and predicative analytics and how to engage patients further. It also provides a pharma and CRO view on issues to produce more engaging, cost- effective clinical trials.

This webinar will explain and provide examples to illustrate the importance of cultural adaptation and the steps in the linguistic validation process. The points will be made from a linguistic as well as a regulatory perspective paying particular attention to recent developments in the COA field.

Join ICON’s experts Dr. Marc Golightly, PhD and Domenica Gandini as they speak about considerations when developing Multiple Myeloma trials. A knowledge of the pitfalls, how to avoid them, and newer diagnostic testing will all contribute to the success of the study design and analysis of responses. 

Using a case study approach, webinar participants will learn more about developing ObsROs and implementing them in clinical studies. We’ll discuss some of the key challenges faced in developing and using an ObsRO, along with potential solutions.

Discussion will centre around the regulatory landscape for medical devices in digital health. We will highlight the key differences between the regulatory landscape for medical devices in digital health in the US and the European Union. As well as provide a forum to ask your own questions.

Join Prof. Brendan Buckley, (Chief Medical Officer of ICON), Dairine Dempsey, (Vice President of Strategic Regulatory Affairs at ICON) and Anand Iyer, Chief Strategy Officer of WellDoc for this joint HealthXL/ICON webina

Wearables are making a big impact on the consumer scene, with the Apple Watch setting the trend for general-purpose devices and FitBit well-established in wellness and fitness related applications.

With general-purpose consumer devices available widely and at relatively low cost, is it worth continuing to develop the existing ranges of specialist medical grade devices for this market, or could we make better use of the technology that already exists by re-purposing it with custom apps? How will such technology drive future clinical trial strategies in the pharma industry?

Join Richard Lingard (Dotmatics), Matt Jones (Tessella), Marie McCarthy (ICON), and Christian Gossens (Roche) for this Pistoia Alliance Debates webinar.