Real-World Evidence: What Can You Say to Payers and Patient Advocates?

Real-World Evidence: What Can You Say to Payers and Patient Advocates?

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Real-World Evidence: What Can You Say to Payers and Patient Advocates?

Objectives:

Medical Affairs professionals want to share Real-World Evidence (RWE) about drug products with payers, patient advocates and others, but communications about drug products are highly regulated. Federal laws, including FDAMA Section 114, FDA guidance materials and FDA enforcement actions all provide insight into the types of communications FDA will and will not accept. This presentation will provide insights into the types of communications that FDA has indicated are or are not permissible, and the uncertainties that still remain.

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How ChatGPT Will Disrupt Medical Affairs

How ChatGPT Will Disrupt Medical Affairs

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How ChatGPT Will Disrupt Medical Affairs

Objectives:

In late January, MAPS published an article by Rahul Mandlik describing the use of ChatGPT in Medical Affairs. The result was a LinkedIn Discussion with over 40,000 views in its first 6 days. During this webinar, thought leaders in this space vision how ChatGPT may augment or, at times, undermine the practice of Medical Affairs in areas such as Medical Information, Omnichannel engagement and more. This is your chance to engage in the discussion of this absolutely cutting-edge topic. Is ChatGPT just another techno-fad? Will it fundamentally transform the Medical Affairs? What are the opportunities and dangers of this new technology? Bring your questions and join us for this interactive session.

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Demystifying Data in Medical Affairs Part 2: Approaches to Overcome the Issues with Data

Demystifying Data in Medical Affairs Part 2: Approaches to Overcome the Issues with Data

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Demystifying Data in Medical Affairs Part 2: Approaches to Overcome the Issues with Data

Objectives:

All industries are rushing to harness rich data in order to drive progress, but how can the many data sources help Medical Affairs to show impact and drive improved patient outcomes?

In part two of this four part series, we will discuss:

  1. Real world examples of impactful use of data by MA teams
  2. How to anonymize data
  3. How to encourage data vendors to provide data you use
  4. How to work with government and healthcare authorities on data

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.

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Evolution of Roles and Talent Management in Medical Affairs Part 3: Career Development and How Do We Retain Talent?

Evolution of Roles and Talent Management in Medical Affairs Part 3: Career Development and How Do We Retain Talent?

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Evolution of Roles and Talent Management in Medical Affairs Part 3: Career Development and How Do We Retain 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.

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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The Value and Strategic Implementation of Insights Management

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This White Paper provides a foundational understanding of insights management, including the definition and value of insights, processes and technologies for insights management, and key challenges in implementation.

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Strategic Collaboration with Agency Partners: One Plus One Equals Eleven

Strategic Collaboration with Agency Partners: One Plus One Equals Eleven

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Strategic Collaboration with Agency Partners: One Plus One Equals Eleven

Objectives:

Building and maintaining a strong partnership between an agency and client is critical for both to succeed, yet we frequently get caught up in the daily grind and forget the importance of relationship building. This talk will provide multiple perspectives from both industry and agency partners, examining how to ensure alignment on needs, goals, and mutual accountability, as well as defining what a “best” partner looks like. In addition, the presentation will examine potential challenges but also opportunities to further enhance your current and future partnerships.

1. Ensuring alignment between agency and client on needs, goals, and mutual accountability

2. Defining optimal characteristics for successful partnerships

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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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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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