There Is No Such Thing as a Free Launch!

by Kristin Owens, July 2020

One of the things I’ve enjoyed about working with The NemetzGroup is the exposure to so many organizations and the amazing work they are doing for patients. We are fortunate to work with clients of all sizes, whose products are at various stages of their life cycle. But the angst around how to achieve a successful launch is generally the same, no matter the company.

However, in smaller companies preparing for the launch of their first product while simultaneously building the organization, the launch can be especially challenging. The team is new, the product is new, and the company is new. So, there’s a lot of planning and communication required for the launch to be successful.

This month, The NemetzGroup pulled together a panel of our esteemed consultants — a group with diverse experience in launching products across multiple therapeutic areas — to share launch planning insights with one of our clients that is anticipating the transformational experience of its first launch. Colleen Moore moderated the panel; participants included Lori Horvat, Marianne Doherty, Meighan Rock, and me.

Given that so many of our clients are in or are entering the commercial planning process, and there is just one opportunity to launch a product well, we wanted to share some high-level insights from that panel discussion to help you consider how you will plan for your future launches.

To keep it simple, we identified three primary areas of focus — The Clock, The Tools, and The Humans — each of which plays an important role.

The Clock

Establishing the Launch Team.

Each product launch has its peculiarities, such as patient identification, supply management, or introducing a new mechanism of action into an existing treatment algorithm. Each has a different level of urgency and complexity, too. Through previous strategic commercialization planning, having a solid understanding of the brand anomalies’ impact on timing and customer education will play an important role in how early the launch team needs to be organized. (This is why “cookie-cutter” launch approaches are ineffective.)

That said, you can never be too prepared. Typically, we recommend establishing the launch team 12 to 18 months prior to the PDUFA date, with the longer time frame recommended for companies that are building internal functions in parallel and/or have complex requirements. For expedited regulatory reviews, we like to allow for a launch readiness date three months prior to the PDUFA date (one month for non-expedited reviews).

Planning for a date prior to the PDUFA date allows for two scenarios — an earlier than expected approval, and the time to fine-tune launch plan activities, as needed.

Bear in mind that if “launch readiness” is defined differently by functions within the same organization, confusion and missteps, or worse, a delayed launch, can result. Job one is to align on one definition, along with a specific date, and to communicate both of these broadly across the organization. No “wink wink, nod nod” from senior managers on when we “really need to be ready.”

Maximizing “Team Time.”

Choosing the appropriate meeting cadence and structure depends on the company’s culture and the amount of time between the PDUFA date and the initiation of the launch team.

Some organizations prefer a monthly cadence of meetings for T-15 months, increasing their frequency in steps as they move through T-12, T-6, etc., eventually convening daily meetings from T-3 onward, along with weekly updates to senior leadership.

Since the launch plan really is an executional plan, the content of the launch meeting is often tactical. However, it should not be used as a forum for teams to only “report out” on their progress. Instead, the meeting should be focused on cross-functional topics that require discussion or resolution. Identifying and sequencing the types of meetings and the necessary attendees at each will allow for all levels of the organization to stay informed on risk mitigation plans.

As for format, one of our clients kicked off with three-hour meetings, only to find that people lost focus halfway through the session. Shorter, more digestible periods seem to work better, given attention spans and conflicting priorities.

Keep in mind that launch team meetings do not happen in isolation of other functional meetings. In fact, they are structured to help the functional teams identify topics for further discussion and planning during their regular team meetings, and to set the agenda for follow-up, cross-functional discussions, as needed. Of course, the launch team is only one of the many teams focused on the product (e.g., program team, brand team), so ensuring that the launch team has a clearly defined scope and connectivity will ensure collaboration versus duplication of efforts.

Functional representatives of the launch team are responsible for communicating back to their functional teams. The most successful launch teams are not those with everyone and their mother (not that we are against mothers) sitting on them. To that end, providing follow-up minutes for each launch team meeting that can be easily shared by the functional leaders to their respective teams provides consistent messaging around key deliverables and timelines.

The Tools

Leveraging Tools.

The launch team has one mission: to optimize access of the product to all relevant external stakeholders — especially patients — at an identified period of time.

It’s critical to determine early on what the team will track, to what degree, and how it will be captured. We prefer Smartsheet for our clients planning their first launch due to its ease of use and visibility across the team. But the key is to align around the tool(s) being used.

Additionally, each function will need to manage its own, more detailed Gantt chart of activities related to the launch. Therefore, everyone needs to be trained on the use of the tool(s) and understand the value of their contribution to the information flow. In other words, “Do your updates!”

Commitment to the plan is paramount. “Shiny objects” are everywhere during a launch. Effective use of tools will help both leadership and team members stay focused on launch-critical activities and their interdependencies across the organization.

“Day 0” Planning.

Approval can arrive anytime, including December 24th — the team needs to be ready!

We recommend committing the Day 0 plan (in detailed, 15-minute intervals) to Smartsheet or some other project-planning application. Execute a dry run to identify missing steps or incomplete documentation and ensure that everyone understands their role in the chain of command.

Communication is a key element, both inside and outside of the organization. The audience receiving the launch news is diverse, and the messages must be tailored and timed. Prepare a feedback loop for all employees who interact directly with stakeholders, so that incoming insights can be appropriately triaged as needed. Schedule daily debriefs of the Day 0 team for the first week of the launch, to ensure that all functions are aligned on progress and next steps.

The Humans

More than anything, an effective launch depends on the people.

Building a launch team requires the same (or maybe more) governance as any other functional team (goals, roles and responsibilities, ways of working, etc.). Operating rules must be clear, leadership must set expectations, and a commercialization mindset of true accountability must be instilled at all levels and across all functions — so that everyone can own their piece while simultaneously contributing to and feeling part of the larger process.

Alignment and buy-in — from the very beginning — are essential. Communicate and define the assumptions and confirm that functions understand the interdependencies and implications of missed communications or lack of information sharing.

All of this is especially important in companies that are being built in parallel with the launch of their first product. In those environments, there are usually limited resources (especially time), and planning tends to be de-prioritized in favor of “doing.” The value of the planning process must be continually reinforced and adopted by the launch team (which is likely the functional leadership team and the brand team, as well).

The Project Manager.

One of the most important people in the launch process is the project manager. Launches are intense and, given their relative infrequency, far from second nature for those involved.

Hiring a commercially savvy project manager to lead the planning on behalf of the cross-functional launch team — someone with broad experience, high EQ, and the support of executive leadership plus the organization at large — is essential. This person is responsible for facilitating, planning, and guaranteeing that everyone is aligned around the mission and its underlying assumptions, ensuring that most challenges are resolved well before Day 0.

The project manager supports the brand lead, who is (usually) ultimately responsible for the launch. With the two working closely together, the project manager can handle the day-to-day execution activities, which allows the brand lead to maintain his/her focus on strategy and post-launch day execution/performance.

Fun and Energy Has Rewards.

Launching a product takes a ton of work and time, and yet it is a “shared experience” like few others in business. So, make it a high-energy, enthusiastic, positive one. Create a team dynamic that makes it inspiring and fun to be a part of — name the team, hold events, create traditions (e.g., “Bring your favorite mug to Thursday meetings or Zooms”).

And remember to celebrate success along the way. The pressure is unique, and launching a product is a marathon; it requires that the team be “refueled” on a regular basis.

Conclusion

If you’ve ever been part of a launch team, you know that there are few experiences in the biopharma world that are as exciting or exhausting.

In most cases, if you’ve done the detailed planning required and followed the essentials laid out above, your launch day will arrive absent much mystery or chaos, allowing you to provide the critical, long-awaited products to the patients who need them.