BIO International 2018: Perspectives from our Reputation & Risk Management Team

Building shared expectations about your drug’s value with key stakeholders is imperative as game-changing medicines are coming under greater scrutiny in the U.S. marketplace than ever before. If you had the chance to attend our BIO session, “Communicating Value through the Eye of the Beholder,” you heard from leading biopharma executives, patient advocates and policy experts on effective and compliant approaches to achieving shared views on value.
 

In rare diseases, where the environment is being reshaped by innovation, policy shifts and payer consolidation, value conversations have never been more important.

Our Reputation & Risk Management practice, led by panel moderator Meg Alexander, has identified five market trends that will shape the orphan category over the next three years and actions drug developers should take.
 

Click here to download the executive summary of that report, “Vision 2020: The Orphan Drug Forecast,” and to receive the full report once released in mid-June.

Our communications counselors are on the speed-dial of healthcare leaders in need of evidence-based solutions for healthcare’s most sensitive, emerging challenges. We provide strategies ranging from topics related to the affordability of medicines, compassionate use, safety, litigation and access barriers. Our counsel and subject matter expertise is gained from decades of experience serving in the U.S. Food & Drug Administration, The Centers for Medicare & Medicaid Services, Congress, consulting, legal communications, and public health and crisis communications.
 

Here are a few of our recent perspectives on pricing, value and finding common ground:
 

Executive Summary - Vision 2020: The Orphan Drug Forecast

For some 30 million Americans living with one of 7,000 known rare diseases, there has never been a more hopeful era. Medical interventions once deemed to be science fiction have crept into clinic. Restore sight to the blind? Yes, that’s happening. But medical miracles come at a cost.

DOWNLOAD EXECUTIVE SUMMARY

Highlights from this year's Food & Drug Law Institute conference

Peter Pitts presented on the “Future of CDER” panel and highlights podium questions on expanded access, real world evidence, opioids, patient-focused drug development and CDER’s Office of New Drugs.

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ICER - Friend or Foe?

Curious how the Institute for Clinical and Economic Review works? Leslie Isenegger explains how the organization determines cost and therapeutic effectiveness, assesses the value of orphan drugs and more.

LISTEN
 

Pricing Front and Center

Leslie Isenegger and Paul Tyahla were featured in the "Pricing Front & Center" article in the January 2018 edition of PharmaVOICE. They talk about the innovation of precision medicines and price models used to pay for them.

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How payers and manufacturers can find common ground in rare diseases
Syneos Health conducted in-depth interviews with pharmacy and medical directors at health plans representing 47.2 million covered lives.

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Can A New Value Framework Help Ease Friction Over Orphan Drug Prices?

Leslie Isenegger addresses the topic of orphan drug pricing in this Pharma Executive article and talks about how manufacturers should respond to framework revisions that ICER has proposed.

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Avoid the Price Crisis

Meg Alexander, Managing Director of our Reputation & Risk Management Practice, writes for PM360.

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