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Accelerate Launch Readiness: Strategies to Stay Ahead of the Curve

An Executive Summary

You must have a strategic plan and seasoned medical affairs leadership for a successful product launch.

The months leading up to a drug launch are critical and can prove stressful. Organizations must be equipped to withstand the curve balls that will inevitably be thrown their way. Preparation with a comprehensive plan, a clear team structure, and strong communications will provide the foundation for a successful launch.

As many as 66% of newly approved drugs do not achieve market expectations. Below-level expectations due to an ineffective launch can continue for years, resulting in patients missing out on effective new treatments (Figure 1). Organizations truly only get one chance to launch a new product and Medical Affairs must be the strategic leader in this process.

This article will discuss the importance of:

• A cross-functional, integrated medical launch team • Timing and mapping out launch activities• Strategic scenario planning • Consistent and clear internal communications

Peg Crowley-Nowick, PhD, MBA President and Founder

Zipher Medical Affairs Co., LLC

Christopher Keir, MD, MS Vice President and

Global Head, Medical AffairsGrail, Inc.

Figure 1: Launch effectiveness.

ACCELERATE LAUNCH READINESS: STRATEGIES TO STAY AHEAD OF THE CURVE

Critical Success Factors for Launch ReadinessFigure 2 illustrates a pathway toward market launch preparedness.

Data awareness and expert advocacy. Strong relation- ships with investigators are critical. Equally important are the relationships and engagements with Key Opinion Leaders (KOLs) who understand the clinical data and what the data means in the treatment landscape. These experts can support educational goals and serve as credible advocates.

Ground force preparation. It is also important to have a strong, well-trained Medical Science Liaison (MSL) team. MSLs comprise the “ground force” that knows the data and the landscape to garner the respect for these scientific interactions. The ability to recognize the most critical insights from your in-house and field teams is essential to maximizing your launch efforts by providing medical affairs organizations with the ammunition necessary to capitalize on the data to build your medical affairs plans and strengthen your engagement with KOLs.

Their ability to converse about the data and engage in scientific exchange in order to recognize KOL perspectives regarding the strengths and weaknesses in the data set is an essential part of launch readiness and provides the insights to focus additional research as well as commercial planning.

Active data generation program. Data generation is another crucial element that must begin well in advance of launch, as there is a significant lead time to planning and executing these studies. The data derived from these studies will help to create the narrative of the treatment landscape, the unmet needs, and how the new drug brings value to providers, patients and payors. Additionally, new studies and real-world studies may also be necessary to generate data to support clinical therapeutic decisions regarding specific patient populations.

Rapid and timely flow of publications. The availability of publications and access to data is essential for clinical decision making. In addition, publications are necessary for both MSLs and the sales organization at launch. Therefore, a thoughtful, impactful and targeted publication strategy, including where and when publications should be submitted to meet objectives, should be developed and in progress well before the launch readiness date.

Strategies to Stay Ahead of the CurveOrganizational structure, medical strategy and timely execution. A successful launch requires strong leadership, a strategy to win, and well-planned execution (Figure 3). Medical leadership must have knowledge of the pieces of the launch, the science, and the clinical activities. Often the medical director acts as the central point person, making sure everyone is focused and

Figure 2: Fundamental needs for medical launch readiness.

ACCELERATE LAUNCH READINESS: STRATEGIES TO STAY AHEAD OF THE CURVE

moving in the same direction. Success of the Medical Affairs organization depends on consistent and regular communication with the global team to keep everyone abreast of developments, sharing data freely, and staying the course.

Cross-functional partners. Integrated cross-functional partners are also key to success. This coordination creates team awareness of issues and activities across functions including Clinical Development, Commercial, Safety, Legal, Advocacy, Regulatory and Medical Affairs Figure 4. Roles and responsibilities should be established early in the process. Not only does this ensure that all the bases are covered, but it also helps team members “stay in their lanes.” Organizations that foster habits of strong communication find that awareness of roles, responsibilities and status can help everyone and build camaraderie among the group.

The PlaybookOnce the team is assembled, build the launch playbook and understand what must be accomplished to achieve success. Start with a situation analysis, examine the insights gathered from advisory boards and field activities, and evaluate the landscape and competitive trials. Use this information to determine the greatest challenges in getting the product into use in the clinic and identify the greatest medical opportunities. From there, define the activities that will allow you to overcome the challenges and build on the opportunities. This playbook is not meant to be a checklist or an extensive slide deck. It is a strategic plan that explains “the why” and is designed to provide guidance for the activities the team must perform during launch preparation. Rather than just checking boxes for activities, the team should actually think about how everything ties together (Figure 5).

"Roles and responsibilities

should be established early in

the process. Not only does this

ensure that all the bases are

covered, but it also helps team

members ‘stay in their lanes.’”

Figure 3: Medical Affairs is the core of a successful launch.

Figure 4: Build a complete medical launch team beyond Medical Affairs.

ACCELERATE LAUNCH READINESS: STRATEGIES TO STAY AHEAD OF THE CURVE

Be your toughest critic when putting together this playbook, knowing that others will critically evaluate this.

As activities begin, the plan will need to be modified and refined. That’s why scenario planning is so important. This involves thinking ahead and evaluating what could go wrong, such as publications not being readily available

at launch, research being delayed, or an unexpected significant adverse event. Identify points that might influence the strategic planning ahead of time, and be ready to pivot (Figure 6). The whole purpose of scenario planning is to help decrease reaction time so that the team is better prepared to deal with surprises.

Figure 5: Medical Affairs strategic planning.

Figure 6: Scenario panning is key for successful launch.

ACCELERATE LAUNCH READINESS: STRATEGIES TO STAY AHEAD OF THE CURVE

Also, focus on priorities. Your Medical Affairs organization has a long list of things they must do throughout the year. It helps to identify tactics that are absolutely critical and consider how the tactics tie into and influence other functions. For instance, a publication team knows that they must have their data at an upcoming meeting. The abstract deadline impacts various functions involved in delivering the data set, as well as the abstract for submission. When planning for these “can’t miss” tactics, set expectations with the team early on by “writing planning dates in ink and living with them.” (Christopher Keir, MD, MS)

Another critical factor for a successful launch is the assignment of one leader responsible for each deliverable. When you spread out the responsibility, it’s less likely to get done on time.

Among the many factors to consider for a successful launch is regular and consistent messaging. For global product launches, the consistency of the messaging and cadence of meetings with the team must extend across various countries. Although strategy and verbiage can be tweaked from country to country, the strategy and core messages should be consistent. This requires clear internal team communications from the outset including when launch teams and timetables are created, allowing for collaboration and resource sharing to keep everyone on the same page.

How Much Time Should Launch Readiness Take?Ideally, organizations should start their medical affairs planning and launch activities 12–18 months before a launch. Allow 2–3 months to write, tweak and gain approval for the launch plan. Then, execute the pre-launch program over the next 9–15 months. However, the reality is that organizations sometimes start their planning 30–90 days before launch. This preparation is expensive and organizations may not be in a position to make the investment early.

Within 12–18 months before a launch, assess the data gaps and initiate key evidence generation programs to have data in time to support launch. Consider initiating an Investigator Sponsored Trial (IST) program. Then, build the narrative and the training, all of which take a considerable amount of time. Allow 9–10 months to implement a Medical Information call center with all the standard response letters and FAQs. During the six-month lead-up period, education programs begin to roll out. (Ideally, advocacy has already been built). Build in time to hire and train additional team members if needed.

Medical Affairs planning and launch can be accomplished in 30–90 days, but the reality is, the more time you have dedicated to launch, the better the chance that you will have a successful launch. Remember the statistic that 66% of new approvals do not achieve their market expectations? How much of that percentage can we

attribute to inadequate planning time? You can't cram for launch and you will never regret starting early.

As the launch date approaches, Medical Affairs leaders face the challenge of providing quantifiable progress to senior management. It is important that senior management understands what is being accomplished through controlled updates. Know what’s important and be prepared to talk to those priorities.

Communication is important throughout the planning and launch process. A robust schedule of meetings should be created. Meetings can be canceled more easily than they can be scheduled. A regular cadence of launch meetings creates a team relationship internally in which people feel free to ask for help or admit that something isn’t working as planned. A program manager can also prove beneficial. The program manager’s role is to provide readily accessible data related to launch readiness and create access to the program’s updates through the use of automated dashboards.

Finally, launches are stressful. Take time to celebrate the successes and the milestones achieved. Making the team know they are appreciated creates an environment for success.

SummaryMedical Affairs launch excellence requires a clear structure with clear decision-making, leadership, and defined roles and responsibilities, so that everyone understands how they fit into the team. Develop the medical strategies, take the time to perform situation analyses, identify the challenges and opportunities for your product, and think about what must be accomplished and how to achieve organizational goals. Subsequently, take a step back and do some scenario planning. Assess what can go wrong, how the landscape or data may change and most importantly, be prepared for the unexpected.

Take the time for real communications, not just updates of what’s happening. Team members should have an avenue to communicate honestly and present challenges as well as concerns about timing with the assurance that the right decisions will be made by the right people.

During the execution phase, focus on prioritized activities for which there are specific timelines and deadlines for the completion of those activities. This will ensure that you have a coordinated execution with an integrated team that has the materials, tools and deliverables they need. Precision timing is the key.

It is certainly possible to accelerate your launch readiness, improve the outcomes of your launch and ensure that patients have access to the medicines and treatments that are going to help them in the future. By focusing on your stakeholders and inspiring an insight-driven culture, your organization will have a solid foundation for a successful launch.