How Companies Are Using Real-World Evidence for Regulatory Purposes

How Companies Are Using Real-World Evidence for Regulatory Purposes

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How Companies Are Using Real-World Evidence for Regulatory Purposes

Objectives:

Product Developers are using Real-World Evidence (RWE) for regulatory purposes in an expanding range of contexts. Drug sponsors are directly using RWE as an external control arm in clinical trials. Companies also use RWE to obtain label expansions and to satisfy post-market approval requirements. RWE is also being used to help design traditional clinical studies, to help select clinical trial sites and identify study endpoints. This presentation looks at different regulatory contexts in which product developers are using RWE.

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2023, the year of personalization? Omnichannel principles for Training Strategies

2023, the year of personalization? Omnichannel principles for Training Strategies

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2023, the year of personalization? Omnichannel principles for Training Strategies

Objectives:

This webinar highlights the continued importance of omnichannel engagement for healthcare practitioners and learners and the need to equip our internal teams appropriately. It will further explore practical examples of how to implement learning and development training through the use of insights and personalization and measuring for success, with examples for big and small budgets alike.

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Innovations in External Education Episode 01: The Power of the Podcast Format of Medical Education

Innovations in External Education Episode 01: The Power of the Podcast Format of Medical Education

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This series of the Elevate Podcast illuminates the path scientific communication takes from teaching to diagnosis to treating all the way to changing, prolonging, and saving patient lives.

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Highlights from the APPA/MAPS Joint Medical Affairs Summit 2022

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From space biology to patient voice to best practices for onboarding, here are highlights of the APPA/MAPS Joint Medical Affairs Summit in Sydney, Australia.

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Monica de Abadal

Medical Affairs Leadership Interviews from the MAPS 2022 Global Annual Meeting

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At the MAPS 2022 Global Annual Meeting in New Orleans, we sat down with Medical Affairs leaders in attendance to discuss a range of issues important to the function. Now as we prepare for the MAPS 2023 Global Annual Meeting in Nashville, March 26-29 (early bird registration open until December 31!), join us in looking back at these important opinions. Have a topic you’d like covered at the 2023 meeting? Email MAPS Communications/Marketing Director, Garth Sundem, with your suggestions!

Rob Kaper discusses his vision for the future of Medical Affairs
Charlotte Kremer, Bjorn Oddens and Danie du Plessis discuss whether Medical Affairs has truly achieved its position as the third strategic pillar in industry
Lobna Salem discusses building a Medical Affairs department from scratch
John Pracyk and Bill Sigmund discuss the differences in the practice of Medical Affairs between pharma and MedTech
Riad Dirani and Omar Dabbous discuss the emerging importance of Health Economics and Outcomes research (HEOR) in Medical Affairs
Tamas Koncz talks about the evolution and future of the Medical Affairs professional
Jose Borlolla and Augusto Grinspan discuss the practice of Medical Affairs and the emergence of the pharma industry in Latin America
Danie du Plessis describes the new competencies Medical Affairs professionals will need to succeed in a changing industry ecosystem
Monica de Abadal describes the value of Medical Affairs to patients and society
Marija Simin Geertsen describes her changing view on the role of Medical Affairs in patient engagement
Kirk Shepard and Nicole-Selenko-Gebauer discuss the challenges of diversity in Medical Affairs, both in patients and within industry positions
Jaime Blais, Deb Braccia and Karen Jursca discuss what is medical excellence and how do you do it in this Medical Affairs table talk.
Using Real-World Evidence for Label Expansions

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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Commercialization

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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Digital Opinion Leaders

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

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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