Launching a New Product: Important Considerations for Chief Medical Officers (CMOs)

As Chief Medical Officer (CMO), it is your job to ensure patient safety throughout the drug development process. You also play an essential role in the activities leading up to a successful launch, including the timing and strategy of building out medical affairs; strategic imperatives to achieve launch readiness; and managing the transition from a research organization to a commercial one. It’s a lot! But if you rush the process or try to cut corners, headaches will surely arise.

In this white paper, we take a closer look at some of the most important factors CMOs should consider before a new product launch. We also provide tips and tricks for streamlining the launch process and avoiding common obstacles.

The Importance of Launch Excellence 

Launch excellence refers to the various steps a pharmaceutical organization needs to take to “drive efficiency, effectiveness, compliance, consistency, and best practices across countries, therapeutics, and management,” according to MedicalAffairs.org. Overlooking any of these factors can significantly affect a drug’s commercialization plan and in turn, its long-term success.

Therefore, CMOs must be involved in launch plans from day one. Building out a qualified medical affairs team and monitoring each phase of a product launch provides peace of mind, ensures all team members are on the same page, and results in quality health outcomes. But where do you begin?

Industry experts say a successful launch strategy features three core components:

1) Strategic plan development early in the product life cycle

2) Assessment of future market and competitive landscapes

3) Establishment of a strong product/profile narrative

Let’s take a closer look at each of these foundational functions.

1) Strategic plan development

For a drug to be considered successful, it needs to make its way through 5 phases: discovery and development; preclinical research; clinical research; FDA review; and safety monitoring.

As CMO, you must monitor the ever-changing research findings and use that information to make informed decisions with maximum clinical impact. Ideally, this work should start as early as the proof-of-concept phase. Waiting any longer can significantly hamper the launch process.

2) Assessment of future market and competitive landscapes

The pharmaceutical industry is highly competitive. Just one advantage can mean the difference between the success and failure of a new drug. As a result, much of your strategic planning should focus on core countries and developing strategies that address each country’s respective market needs.

The more information you gather about country-specific healthcare systems, medical guidelines, drug coverage requirements, and regulatory environments, the easier it is to support your launch goals.

3) Establishing a strong product/profile narrative

A product narrative explains what a drug does and why it’s important. In other words, it’s the story you tell about a medication or medical device to hook stakeholders and patients.

Though product messaging is typically drafted later in the development lifecycle, creating a cohesive, easy-to-understand narrative early on can be a boon to your success. On the one hand, it informs the public of what to expect; On the other, it inspires your team to connect with the product they’re developing. Establishing messaging guidelines early on, also makes it easier to stay focused while drowning out background noise.

Changing Mindsets: From Research & Development to Commercialization 

Launching a pharmaceutical product with the foundational principles listed above can help you stay on track, but the real challenge is shifting from a research and development (R&D) mindset to one of commercialization. Here too, a little bit of planning goes a long way.

In a 2023 article for Fast Company, Lawrence Ganti, a seasoned executive who specializes in leading companies through transformations, transitions, and scale-ups, suggests honing in on 5 areas. Specifically, Ganti recommends:

1) Defining product expectations (e.g., Defining your product and identifying when it is ready for market)

2) Defining your team (e.g., Identifying your organization’s role and structure before, during, and after the transition)

3) Assessing your team’s motivations (e.g., Ensuring your employees are all on the same page)

4) Defining what you won’t do, just as much as what you will do

5) Making and acting on these decisions

Admittedly, these recommendations can seem somewhat nebulous, especially if you’re preparing to launch a drug or medical device for the first time. But you don’t have to navigate these challenges alone. Enter the contract research organization.

The benefits of partnering with a Contract Research Organization (CRO)

As a CMO, your to-do list is never-ending, and that list only gets longer in anticipation of a product launch. Rather than working nonstop, around the clock, consider partnering with a CRO.

CROs, like Harbor Clinical, provide various resources through outsourcing. Whether you need assistance with clinical operations and regulatory affairs, or niche services, such as biometrics support, Clinical Monitoring, or Trial Master File (TMF) hosting and management. We can effectively ease some of the pressure you’re feeling and help you stay on track for launch.

To learn more about working with a CRO and the benefits we can provide for product launches, please visit our website, or call (781) 775-0342 today.