Entries by MGluckle@MedicalAffairs.org

Using Real-World Evidence for Label Expansions

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Using Real-World Evidence for Label Expansions

Objectives:

It is hard to overstate the expansion of Real-World Evidence (RWE) over the last 5 years. ISPOR has designated RWE the #1 trend in Health Economics for 2022-2023. Most new drug and biologics applications to FDA now include RWE information.

The use of RWE to support product label expansion has been a primary driver of interest in RWE. The 21st Century America Cures Act, enacted in 2016, required FDA to evaluate RWE in support of new drug indications. Since the Cures Act, FDA has issued multiple guidances and draft guidance statements regarding use of RWE for regulatory applications. The Agency has also utilized RWE in approving expanded indications for drug products. As FDA states at the top of its RWE web page, “Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions.”

This virtual presentation will focus on 3 aspects of RWE:

1) What are RWE and Real-World Data (RWD), and how are they different?

2)  What are relevant legal and regulatory considerations associated with using RWE for product label expansion?

3) How have applicants successfully used RWE to obtain approval for new drug and medical device indications?

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WEBINAR: Commercialization

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Commercialization

Objectives:

In every successful organization there are fundamental business processes that create value and deliver a desired output. In life science companies, one of these processes is called commercialization. Commercialization of a health care product begins from the moment of concept creation. At that point, the innovator is thinking about how to treat a disease, make a patient’s life better, or meet an unmet medical need. Over time, value is built into the asset as it moves through the product development/commercialization pathway. Medical Affairs has a key role in this product development/commercialization pathway. Often referred to as a bridge between product development and commercial, Medical Affairs contributions are essential to deliver a successful commercialization process. Understanding the commercialization process and the role Medical Affairs plays in the overall organization will assist Medical Affairs professionals to make better decisions and optimize their ability to influence the future direction of their company.

This webinar seeks to help Medical Affairs professionals better understand the business of life science companies, how their efforts impact the overall capability to commercialize a product, and contemporary ways to bridge the commercialization interface between their department and Marketing & Sales. Topics included are a discussion on organizational operations and throughput, the importance of understanding the organization/enterprise main functions and how Medical Affairs aligns with functions, and optimizing interface between commercial and Medical Affairs. Our discussants will take a Medical Affairs-centric approach to discussing business operations management issues which should be useful for all Medical Affairs functions but particularly operations, therapeutic area leadership, and aspiring Medical Affairs managers.

Upon completion of the webinar, participants should be able to:

  1. Describe how commercialization understanding is a key to the success of a life sciences company
  2. Identify fundamental components of a life sciences company and their effect on commercial optimization
  3. Explain the commercialization interface between Medical Affairs and Marketing / Sales
  4. Apply three actions to build Medical Affairs activities that can enhance commercialization throughput
  5. Illustrate how to best add value to the commercialization process

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Patient Engagement and Patient Experience Data: Understanding the Use in Medicines Regulation and Healthcare Decision Making and the Implications for Medical Affairs

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Objectives:

This webinar will discuss how MA colleagues are best positioned to explore the fusion of PE and PED in the post-launch phase, including generation and use of RWD and RW evidence, and will share guidance and information on several industry-supported resources, to enable MA colleagues to implement PE and evidence strategies in their function. Importantly, patient and patient advocate perspectives will also be considered, sharing opportunities, and best practice examples of how MA colleagues can overcome perceived barriers, to achieve true and impactful PE.

Following the presentation, participants will have a greater understanding of:

- Current best practice in patient engagement, from both an industry, patient advocate and patient perspective
- The convergence of patient experience data, real world evidence and patient engagement activity and why this is important to Medical Affairs
- What patients and their advocates need from their industry partners for better patient engagement and how this is likely to evolve
- The specific impact patient engagement can have on a Medical Affairs strategy and the various research, tools and guidance available to support this

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WEBINAR: Digital Opinion Leaders

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Digital Opinion Leaders

Objectives:

The webinar discusses how to engage with Digital Opinion Leaders (DOLs) and how they can be a valuable source of insights, with a strong focus on the compliance aspects. Increasing numbers of pharma stakeholders are active in social media and thereby present an open and accessible opportunity for the gathering of insights. When Pharma listens to these DOLs it needs to be done in a compliant way. The same applies to the engagement with DOLs. The webinar addresses these topics and the important role Medical has to play when listening and engaging with DOLs.

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WEBINAR: Evolution of Roles and Talent Management in Medical Affairs Part 2: How Do We Recruit Talent?

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Evolution of Roles and Talent Management in Medical Affairs Part 2: How Do We Recruit Talent?

Objectives:

This Webinar series explores how roles and talent management have evolved, what new roles exist or are needed and what skills and competencies are required to succeed in these roles. From the manager’s perspective, we will discuss potential strategies for staying on top of this ever-changing field to manage and retain highly effective teams.

These presentations will feature real world insights from medical leaders, HR executives and recruiters.

By the end of this series, we hope you will gain:

  1. Practical and actionable insights on how to define, recruit and manage roles in MA more effectively
  2. An understanding of traditional MA roles vs. what next generation roles to expect
  3. As an aspiring new talent in MA, an understanding about what MA processes are like in companies and how you could stand out during the recruitment process

 

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WEBINAR: Demystifying Data in Medical Affairs Part I: What Does Data Mean to Medical Affairs and How Can We Optimize Its Use?

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Demystifying Data in Medical Affairs Part I: What Does Data Mean to Medical Affairs and How Can We Optimize Its Use?

Objectives:

This Webinar series explores the fundamental concept of big data in Medical Affairs, from which sources can we retrieve this, what are the broader considerations when utilizing data in health and what impact this can have on our organizations, physicians, and patients, now and in the future. These presentations will feature real world cases that are relevant to regional and country Medical Affairs leaders, in order to highlight long-term aspirational and short-term tangible projects.

By the end of this series, we hope you will gain:

  1. An understanding of the current real-world uses of data in Medical Affairs
  2. Broader awareness of the future application of data and impact potential
  3. Understand what data sources can be accessed both internally and externally
  4. Greater appreciation for any considerations when preparing to utilize health data

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Digital First Scientific Communications – How Digital is Transforming Medical Communications EPISODE 2: Open Access Part 1-Making Scientific Information More Accessible

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In this our second episode this season, we’ll be discussing open access in medical publishing from the biopharma perspective.

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