New Drug Commercialization: A Program Leadership Perspective

A Program Leadership Perspective on Approaching Commercial Launch

A new drug product launch is an exciting time for a pharmaceutical company. New product development is typically a critical organizational priority, with high complexity and diverse stakeholders. Therefore, when the long, difficult, and costly development process is finally coming to fruition, hopes are high, and the pressure is on for successful commercialization.

However, the launch process is fraught with its own set of struggles: increased regulation, market access barriers, low-coverage rates, supply chain challenges, and many other risks. If mishandled, these can result in missed opportunities for patients and loss of market share to competitors.

Integrating project, program, and portfolio management leadership into the product commercialization life cycle can help ease these challenges by ensuring all required efforts are identified, prioritized, assigned, planned, and managed as part of a comprehensive drug launch program.

These five key areas are vital to successful commercialization:

1. Management of cross-functional interactions

Developing and managing a detailed, comprehensive commercialization plan to orchestrate the cross-functional activities (sometimes for multiple organizations) required to execute the launch; and eliminating silos among regulatory, legal, advocacy, medical affairs, R&D, sales, marketing, manufacturing, supply chain network, customer support, and other involved business functions.

2. External stakeholder management

Managing the efforts of a large and diverse collection of stakeholders and the flow of information among them; and focusing on the triad of the patient, healthcare provider (HCP), and payer landscape.

3. Strategic alliance and partnership management

Coordinating efforts, managing complexities, and avoiding potential misalignments with launch partners, including those with shared product ownership.

4. Scope and schedule management

Developing processes to ensure that the launch project’s scope and corresponding schedule are accurately defined and mapped; managing activities pursuant to schedules to keep the launch on track for regulatory approval and to promote predictability of activities; and promoting understanding among stakeholders about individual responsibilities for detailed project deliverables and defining success factors.

5. Risk management

Minimizing risks to avoid issues and proactively defining contingency plans before risks occur.

For a closer examination of how each of these five elements plays out in real-world situations, as well as a look at the impact the pandemic is having on commercialization efforts and how pharmaceutical companies are responding, download the complete article.

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Authors:

Eyal Golan
Senior Project Management Consultant

Ian Pudge
Senior Project Management Consultant
Integrated Project Management Co.

Service: Product Development
Industry: Life Sciences