COMPANY CONFIDENTIAL – NOT FOR EXTERNAL COMMUNICATION.
PLEASE DO NOT FORWARD OUTSIDE OF ROCHE/GENENTECH |
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THE FUTURE OF POLA IS NOW The anticipation is building as we move closer and closer to launching POLA. We hope you are as excited as we are!
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POLA has been making a splash in the United States and Europe, with our EMA PRIorities MEdicine (PRIME) designation and an FDA breakthrough therapy designation (BTD) in 2017. We continued this progress in 2018, including accelerated launch timelines through the FDA and EMA and receiving the World ADC Foundation Most Promising Clinical Candidate award.
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In addition, we are about to complete our first FDA submission and have received a confirmation from the EMA on accelerated assessment for POLA, further supporting our planning case timelines for both FDA approval in April 2019 and EMA approval in September 2019.
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To help get us closer to launch, this email shares some key updates, including Launch Readiness Guidance, best practice sharing approach, a Global launch materials update, and the reveal of an exciting milestone: introducing our brand name!
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Becoming Launch Ready
The new cross-functional Launch Readiness Guidance below outlines the POLA strategy, global projects and deliverables, and provides key local tactics to drive a successful launch for R/R DLBCL.
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LaunchPad system  Key global and local activities and milestones from the launch readiness guidance within the LaunchPad project management tool. |
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Short video summaries Videos of presentations from the ASH 2018 Launch Readiness Guidance roll-out meeting providing additional context and overview to the launch roadmaps. |
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Sharing Best Practices for Launch Success
Because the POLA launch planning has highly accelerated timelines, it is critical to engage in best practice experience sharing and to build on the work that has already been done by early launch countries. Global, I8, and I7 teams will work together in 2019 to ensure continuous experience sharing between affiliates in the pre-launch and post-launch period.
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POLA Launch Blueprint A 4-page template for use in local cross-functional team discussions, launch readiness reviews, and sharing with other countries. |
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Expanding the G'n'US Platform The G'n'US platform should be familiar to those of you working on GAZYVA. We are extending this platform to be used for POLA--once you develop your local Launch Blueprint, please share it on the platform! |
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G+ Hematology Community Join the group, ask questions, and engage in conversations on how to successfully launch POLA. |
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Moving Toward the POLA Launch
As part of the launch readiness process, the POLA Global Team has developed materials for your use––the Pre-Launch Campaign Brand Book and Assets and the Launch Messaging Guidance. Descriptions and guidance on the use of the assets can be found on the POLA Intranet. Further global materials will be shared according to the timelines in the Launch Readiness Guidance.
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Launch Messaging Guidance Detailed overview of the most effective messaging approach to communicate the value of POLA in R/R DLBCL for HCPs. |
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And the winner is...
ASH also marked a major milestone as we unveiled our official brand name. Click the video below to reveal the tradename of YOUR polatuzumab vedotin!
Note: The brand name is confidential and for internal use only. It is not allowed to be shared outside of the company.
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Thanks to all of you for making ASH and the launch process a success. Let's continue to be relentless and work hand-in-hand to bring the benefits of POLA to patients in need.
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Sincerely,
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Your POLA Global Team
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Information provided for internal planning purposes only. Action items and promotional strategies may be implemented only upon receipt of local jurisdiction’s regulatory approval of the relevant product indication and following local affiliate legal/regulatory review. The controlling documents in any local jurisdiction are the local affiliate's approved plans.
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