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Achieving Launch Excellence in Biopharma - Session 2

  • 101 Main Street Cambridge, MA, 02142 United States (map)

Join Us to Download the Best Practice from our 9th Session


Achieving Launch Excellence in Biopharma - Session 2

In our previous session, we learned how to put a launch plan together from scratch. Starting from collecting inputs from key stakeholders about activities and tasks necessary to: Prepare the Market, the Organization, and the Product for the launch, to organizing the work into a logical framework in objective-driven workstreams. We experienced firsthand how to use simple tools like an ideation wall and sticky notes to drive a concerted effort by a cross-functional team to produce a strawman launch plan in a single session!

In our upcoming session, we will dive deeper into our strawman launch plan and add pertinent information to make it more robust. We will do this by exploring:

  • Interplay of tasks and activities across various functions and workstreams to reduce surprises, rework, and delays, and improve the quality and timeliness of launch execution

  • Resident launch expertise of an organization and their long-term strategic outlook, to make strategic decisions about what work to outsource and what expertise to strengthen in-house

  • Ballpark budgets needed to execute various launch execution steps, and skillsets needed at different timeframes to ensure the best-fit team members will be available to execute every launch step

We will then compare our strawman plan to actual state-of-the-art launch plans from top-tier biopharma companies of today, to appreciate the effort needed to develop an execution-ready launch plan.

[Biopharma Pro members will be able to download the strawman launch plan from our community site in January 2019]

Following that we will learn how to use scenario planning to prepare for anticipated launch risks that could influence our product’s prescription uptake curves, in a live workshop! See below the Scenario for the workshop, please come prepared to discuss it.

Next, we will look into the critical components of managing and maintaining Launch Excellence through the lens of:

Launch Structure

  • Core Launch Team

  • Execution Workstreams

  • Steering Committee / Leadership

Launch Planning and Execution

  • Meeting Cadence

  • Communication Flows

  • Tracking Launch Success

  • Managing Leadership Expectations

  • Organizational Change Management

We invite you and your colleagues to join us in this hands-on session to round out your launch excellence knowledge from our previous session.

Andy Mehrotra, CEO of EightSpokes will assist Sasha Zbitnoff, Launch Excellence leader at Alkermes, to facilitate this workshop.

Please RSVP to join us for this session in Cambridge, MA on Thursday, December 13, 2018, from 5 – 7.30 pm.

We look forward to seeing you there, then!

Biopharma Pro

 

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Workshop - Scenario: (come prepared to discuss)

Last week, Re-Emergence received Phase III data readout for REP-007.  While promising for filing and approval, the data shows a cohort of subjects in the Phase III study (28%) developed respiratory problems from the prolonged pulmonary administration of the therapy.

These issues were observed earlier during the Phase II readout, but at a significantly diminished level (4%).  The Clinical team does not have a clear understanding of what’s triggering these Adverse Events.

That said, the FDA has given REP-007 Priority Review designation, which means the product could be approved 4 months earlier than previously planned.

Today, BritPharma (a competitor of Re-Emergence) issued Phase II data on their promising new infusion treatment (BP3729) for ALZ, which requires a week-long hospitalization.  BritPharma is also in talks with GloboPharma (Re-Emergence’s strategic investor and REP-007’s originator), and there’s a distinct possibility that if approved, GloboPharma and BritPharma could co-promote BP3729 in the US and UK.

Considering that fast follow-on drugs have a significant impact on the six-month prescription uptake curves of a first-in-class product post-launch, especially in therapy naïve markets such as Alzheimer’s --

How should Re-Emergence prepare to modify their US launch plan for REP-007 in this scenario?-----

Recommended Pre-Read:


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