45

Real World Data: Unlocking Valuable Insights Throughout the Lifecycle

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Objectives:

Real world data (RWD), when captured and analyzed, produces the Real-World Evidence (RWE) that underpins the economic case for innovative medicines. Furthermore, RWD can inform the understanding of disease, help identify new therapeutic intervention points, and improve the efficiency of research and development (R&D), especially clinical trials. Unlocking the potential of any promising tool like RWD is not free from challenge and its full potential has yet to be realized. This Webinar aims to provide practical insight into the challenges surrounding RWD and RWE generation with interactive conversation on how individual companies are approaching these challenges.

By participating in this Webinar and/or the subsequent workshop at the MAPS EMEA 2018 Annual Meeting, attendees will be better able to:

  • • Understand the full spectrum of challenges around the use & integration of RWD & RWE including data availability, reliability, quality of data sources, the cost of data acquisition and integration, and acceptance by key stakeholders
  • • Realize the full opportunity of RWE throughout the product life-cycle supporting all cases from clinical research, pre-regulatory approval and post-approval.
  • • Understand the limitations of RWE, including patient confidentiality, data quality and accessibility, and how they can be overcome
  • • Use this evidence effectively and within frameworks defined by regulators at a country or regional level

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47

Navigating Career Transitions: How to Maximize Your Impact – Without the Burnout

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Objectives:

Transitioning into new roles can prove a real test for even the most senior of executives. Up to 40% of new leaders fail, leave or burn out within the first 18 months. Painful and costly for all involved!

This webinar looks at how to navigate the “rollercoaster” of starting a new role, accelerating your career transition and building confidence early on.

Learning Objectives:

We explore during this Webinar how you can successfully navigate your next career transition:

  • • Explore the pitfalls of career transitions, and how to overcome them
  • • Look at the key foundations required to make a successful career transition
  • • Hear real-life stories, and learn actionable tips, from others who have navigated complex career transitions
  • • Explore why health & wellbeing should be a priority on your transition agenda

 

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8

Now More Than Ever, HEOR Plays a Central Role in Forging the Modern Healthcare Agenda

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Objective:

Join Dr Omar Dabbous, Vice President, Health Economics and Outcomes Research (HEOR) and Real World Evidence (RWE) at AveXis, and Russell Becker, MA, HEOR Consultant, demonstrate HEOR’s front-and-center role in forging the modern healthcare agenda.

As healthcare systems worldwide become increasingly budget-constrained and cost conscious, stakeholders are placing greater emphasis on health economics demonstration and product potential in real-world practice. Once viewed solely as a support function, HEOR now often takes center stage in the internal decision-making process. As life sciences companies bring HEOR professionals and brand strategists together to formulate streamlined value chains, the function now provides essential data for licensing and R&D, as well as pricing and market access strategies, helps dictate research, planning and sales strategies.

This MAPS eCademy Webinar will:

  • • Examine the current state & future of HEOR data in healthcare decision-making
  • • Discuss strategies to build strong relationships with payers, the medical community, and patient advocacy groups
  • • Determine the impact and value of evidence-based pricing and payment

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59

Best Practices for Managing the Life Cycle of an Investigator-Initiated Research (IIR)

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Objectives:

Investigator Initiated Research is defined as ‘unsolicited‘, independent research where the Investigator or the Institution (academic, private or governmental) serves as the ‘Sponsor’ and a pharmaceutical or medical device company provides support in the form of drug/device and/or funding. A well-designed investigator initiated study can gain insights related to disease state and/or the clinical or scientific profile of a companies products. This may ultimately lead to improved evidence-based medicine and outcomes for patients.

We will discuss the process of investigator initiated research program followed across industry. The process is initiated externally by submission of IIR application via company website followed by internal company review and decision making process. This results in the execution of IIR study contract between the company and the Institution after which the study is initiated by the Investigator.

  • • Describe how to create an IIR Strategy
  • • Define how to optimize submission and review process
  • • Evaluate external engagement

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52

Patient Centric Real World Data & Evidence Generation

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Objectives:

Making the best possible choices about health care requires the best possible evidence upon which to base these important decisions. High quality evidence comes from many sources including real world data (RWD). The sources of RWD are numerous including electronic health records, claims and billing data, product and disease registries and patient-reported data.

Analysis of RWD leads to clinical evidence known as real world evidence (RWE) regarding the usage and risks and benefits of a therapy. Under the right conditions, RWD and the RWE that follows may be used to support regulatory decisions and contribute to the knowledge of a drug or therapy. RWE may help to support improved decision-making about health and health care.

After completing this Webinar, participants will be able to:
•List the sources of real world data (RWD),
•Understand how real world evidence (RWE) can help to support a regulatory decision,
•Recognize when in the product life cycle RWD/RWE may be useful,
•Utilize a patient-centric framework to develop a RWD/RWE generation plan.

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Agility Medical Affairs Strategy

Building Agility into Medical Affairs Strategy: Global-Regional-Local Dynamics

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Agility Medical Affairs Strategy

Objectives:

Join Dr. Leon Rozen, Senior Medical Director, Global Oncology at AbbVie, and Dr. Kirk Shepard, Senior Vice President, Head of Global Medical Affairs Oncology at Eisai as they explore how to build agility into your Medical Affairs strategy.

Medical Affairs organizations have a central and strategic role in creating and communicating strategy, and it is critical to build agility into the strategy. Building agility into Medical Affairs strategic planning can be achieved incrementally as you execute. To be more effective we need to host regular review meetings that alternately review strategy and execution and involve the people who are responsible for insights.

After this Webinar, you will be able to:

  • Recognize why networking and alignment is key to a successful Medical Affairs strategic plan
  • Discuss the steps involved in strategic planning process and associated tools and templates
  • Describe Global-Regional-Local alignment and implementation… where do you start?
  • Select which functions you include when building your global Medical Affairs strategy

 

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