Join Us to Download the Best Practice from our 8th Session
Achieving Launch Excellence in Biopharma - Session 1
Session 1: PREPARING
One of the greatest success factors in Biopharma is how well companies launch products. For many Biopharma Pros, the opportunity to launch a new product is a career turning point that dramatically accelerates their rise within the corporate world.
Successful product launches orchestrate countless stakeholders, data, constituencies, and market dynamics to meaningfully shape and deliver product attributes to serve patient needs in an ever-evolving healthcare landscape.
Whether it’s interpreting clinical data, managing supply constraints, building field capabilities, mounting marketing campaigns, navigating legislative changes, or overcoming public scrutiny – Launch Excellence is perseverance, and effectively managing complex dynamics to deliver value across multiple customers.
For the next two sessions of Biopharma Pro our aim is to help you discover Launch Excellence for yourself so that you are prepared to answer questions like:
What defines a successful launch?
How to achieve Launch Excellence?
How to shape Launch Excellence to serve patients, physicians, payers, policymakers and stockholders?
The focus of the first session will be to build foundational knowledge about Launch Excellence and the second session will explore the finer nuances of executing a launch to round out our learning:
[Session 1] PREPARING (Nov 15, 2018)
We will review the landscape of Launch Excellence, and critical launch objectives. Participants will participate in an exercise to build a launch plan together in real time based on a case study. We will also review key challenges and opportunities inherent in a commercial launch readiness plan.
[Session 2] ACHIEVING (Dec 13, 2018)
We will look into the critical success factors to manage and maintain Launch Excellence – the team structure, managing market dynamics, Regulatory opinions/decisions, communication plans to effective track success. We will also consider how we measure and track success beyond launch, with multiple products.
We invite you to join both sessions to share and engage in constructive dialogue to learn and share best practices with your peers.
Sasha Zbitnoff, our workshop leader for the Session 1, has worked in biopharmaceuticals for more than 15 years – working at Wyeth, Biogen, Lonza and now Alkermes. He has worked in project/program management roles across the biopharmaceutical landscape supporting Quality, Manufacturing, Development, and now Commercial - currently leading Commercial Project Management for Alkermes. Outside of the complex challenges of biotech, Sasha enjoys playing the piano, practicing yoga, traveling, and supporting community causes.
Please RSVP to join us for this session in Cambridge, MA on Thursday, November 15, 2018, from 5 – 7.30 pm.
We look forward to seeing you there, then!
Session - Case Study: (come prepared to discuss)
Re-Emergence Pharmaceuticals is committed to reviving molecules previously discarded by other companies as a result of failed clinical studies. Re-Emergence has relationships with multiple biotech and pharmaceutical companies and obtained access to scientific data related to specific molecules no longer considered “valuable” – at least in the eyes of these other companies. Re-Emergence has open access to scientific data in exchange for a percentage of any revenues Re-Emergence realizes through successfully commercializing the molecule.
Recently, Re-Emergence completed Phase II clinical studies on compound REP-007, which show extremely promising results for the treatment of Alzheimer’s disease. GloboPharm pursued REP-007 as an injectable. GloboPharm failed to meet clinical endpoints with REP-007 for the treatment of ALZ. GloboPharm observed a greater mortality rate with REP-007 as compared to the placebo arm.
Re-Emergence leveraged its proprietary formulation technology to enable a pulmonary delivery of the molecule. Apparently in a pulmonary formulation REP-007 has much greater bioavailability, and patients (with ALZ) reported meaningful improvements. The data also shows a decreased mortality rate as compared to the placebo arm in the Phase II study. The Phase III trial is designed to understand the optimal dosing administration. It’s believed that REP-007 administered daily over three months can meaningfully reverse the impacts of ALZ. The FDA has fast-tracked REP-007.
Bolstered by the strong clinical data, VCs and GloboPharm have invested an additional $60M to support the launch of REP-007. Phase III results are expected in June 2019, with an interim read in Jan 2020. GloboPharm will provide an additional $100M in milestone payments if Re-Emergence successfully obtains FDA approval and launches REP-007 by the end of 2020.
Re-Emergence is largely a virtual company, with a core team of scientists, a Chief Medical Officer, and a President, who secured the relationship with GloboPharm. The Clinical trials are largely managed by outside vendors. CDOs have been leveraged to manufacture the clinical trial material. GloboPharm has agreed to support validation batches and commercial launch material.
A new commercial team has been hired with an assortment of background and experiences. You have recently joined Re-Emergence and have been asked to help build a Commercial Launch Readiness plan for REP-007.