Navigating the complexities: Strategies for a successful US Alliance product launch

With contributions from: Chris Cubra, Mindy McGrath, and Everly Petruzzelli

Product launches bring a wave of excitement as they introduce cutting-edge therapeutics aimed at enhancing patient care. Nonetheless, these launches are fraught with challenges, involving complex, time-consuming, and costly processes. Against a backdrop of macro-economic uncertainties, crowded markets, constrained budgets¹, and underperforming launches², pharmaceutical companies are tirelessly searching for innovative, yet cost-effective strategies for their product introductions.

A key strategy that has emerged is the formation of licensing or marketing Alliances, leveraging the collective strength, resources, and expertise of partnering companies. These Alliances are particularly beneficial for companies embarking on their inaugural product launch as they can tap into the robust infrastructure and market presence of established players to increase visibility in targeted areas or therapeutic fields. Similarly, established companies find these partnerships valuable for expanding and enhancing their product portfolios. The effectiveness of such strategic Alliances is evident from the impressive statistics: in 2022 and 2023 alone, there were over 1,600 Alliances, with 117 deals exceeding the $1 billion mark.³ This approach not only navigates the myriad challenges of product launches but also strategically capitalizes on opportunities to stand out in the competitive pharmaceutical landscape.

While these Alliance deals are meant to strengthen the commercialization of a product, they also present unique complexities by merging two launch teams from different organizations, each with their own processes, culture, and ways of working. A traditional launch alone is comprised of many interdependencies across cross-functional teams, involving team members with varying degrees of launch experience and high pressure to quickly ensure patients have access to the new drug upon approval. With an Alliance Launch, those intricacies are practically doubled.

To enhance collaboration within Alliance teams, we propose tackling the intricate challenges often encountered in areas such as culture, governance and processes, and asset review. Our approach involves a detailed examination of each complexity, identifying the root causes of these challenges and offering actionable solutions. We believe that through careful planning and a committed investment of time and resources, these obstacles can be effectively addressed. Our goal is to equip Alliance Launch teams with the strategies and tools they need to overcome these hurdles and achieve success. By focusing on these critical areas, we aim to foster a cohesive culture, streamline processes, and ensure that assets are managed efficiently, setting the foundation for a successful partnership and launch.

Culture: Developing a healthy Alliance team culture will set the foundation for success

One of the most important, but overlooked, aspects of Alliance Launches is culture. Teams are often focused on the tactical aspects of launch planning (what needs to be accomplished by when) and neglect to think strategically about how team members from different organizations will work together to deliver a successful launch.

Building a foundation for effective cross-functional collaboration is a key component to any launch, but doing so in an Alliance setting presents additional complexities. Not only are team members working across functions, they are also navigating different organizational cultures and norms, leadership styles, and organizational structures. The Alliance partners might also differ in the level of priority placed on the launch itself. These challenges can manifest into ineffective ways of working, tension and conflict, and ultimately an underperforming team. This can put the launch itself at risk as timelines can be compromised, assets can be delayed, critical steps can be missed etc.

Setting the right tone upfront and establishing a healthy culture within the Alliance Launch team will accelerate the team’s success. Key steps in building this cultural foundation include building trust and psychological safety among team members, aligning around common values and goals, and establishing clear norms and expectations around communication, ways of working, and feedback. Investing time upfront to establish these cornerstones of culture will pay dividends in team performance by helping to prevent conflict and dysfunction during periods of tension, which are expected in a high-pressure launch environment.

Studies have shown that focusing on establishing and maintaining a healthy culture substantially increases team engagement, productivity, and even revenue.⁴ Empowering teams with the right tools and resources to foster an effective Alliance team culture can enable launch success by helping preempt challenges or overcome issues as they arise.

Governance and processes: Establishing clear Alliance governance and processes to facilitate smart and effective ways of working

Clear governance models are important for any launch, but they are especially important for an Alliance Launch. As each organization brings their own launch team to the table, Alliance teams may double up on resources for each functional area, which might sound like a benefit – double the resources – but it can also be a challenge. While collaboration is key in an Alliance, it is also important to figure out the best way to utilize resources and structure teams in the most optimal way, which can sometimes be difficult to determine.

First, it is important to decide which functions will be shared across the Alliance (i.e. HCP/Patient Marketing, Market Access, Medical Affairs), and which functions will be led more independently (i.e. Sales/Field Teams, Sales Operations, Insights & Analytics). For a shared function, this often means that there are team members at both companies working collaboratively together on activities. They may have separate budgets and responsibilities, but they can jointly make decisions, set strategies, and develop assets together. While independent functions may still interact to some degree with their Alliance partner, they should have strong guardrails in place to ensure select proprietary information and strategy is kept separate. Some companies may not have the same one-to-one cross-functional teams, which can also impact how Alliance Launch teams are structured. Other factors to consider in making these decisions include company size, brand loyalty, company reputation with customers, and established presence in the relevant therapeutic area.

It is critically important to ensure there is one key decision maker for shared functional areas, otherwise teams can fall into endless swirl. Aligning with Alliance leadership upfront about which organization and individual will lead and be ultimately accountable for each shared function is a must.

It is also important to acknowledge at the inception that leadership at the Alliance, brand, or functional level may not, and probably will not, agree on everything. Setting guidelines upfront for how to handle conflict resolution, including how and when to escalate, can help ease tension when disagreements arise. Developing guiding principles to help ground the launch team can also help – is it a guiding principle that all core assets should be 100% aligned across Alliance partners, or is there room for deviation?

Another Alliance process to be mindful about involves handling embargoed data. Each Alliance partner may have a different protocol for how and when launch team members can be made aware of sensitive, embargoed data. If only half of the team has access to sensitive data, this obviously makes it difficult for Alliance partners to work together effectively. Planning for these types of scenarios at the partnership onset can save a lot of headache down the road.

When Alliance partnerships are formed, detailed rules of engagement are often defined for how the two organizations will work together. However, this information is not always shared with launch teams in a digestible way (or at all). It is important to start an Alliance Launch with basic education for the broader team on why the Alliance was formed, what the rules of engagement are, and how each Alliance partner typically operates in pre-launch mode. This step may appear simple, but it is often neglected, even though it can significantly enhance launch team members’ comprehension and appreciation of the Alliance processes they must adhere to.

Asset review: Building efficient and streamlined asset review processes that accelerate, as opposed to slow down, asset development  

Although asset review could easily fall under the process bucket, it warrants separate mention since it is a tremendous challenge with Alliance Launches. Launch teams put immense effort into the development of assets to help educate HCPs, payers, patients, and others. The asset review process is arduous for the entire team, including reviewers, functional leads, and their agencies, but this process is critically important to ensure that assets are 100% factual, clear, and not misleading.

Alliance Launch teams frequently express frustration with the time and effort expended during asset reviews, especially when both Alliance companies are involved. Careful planning must be done to ensure that asset review processes are streamlined as much as possible, while still honoring the Medical, Legal, Regulatory (MLR) needs of each respective organization. It is crucial to estimate the time needed by reviewers during the pre-launch phase, on Day 0, and after launch. This ensures alignment between both organizations’ review teams, enabling proper planning for the required time. If available time is incongruent, it is important to identify this early in the launch planning process and develop mitigation strategies to ensure no critical launch assets are delayed as a result.

Transparency around the steps in asset review processes is also key to ensure launch team members and partner agencies can plan appropriately for the review process. While marketers will know their internal asset review processes well, it is important to educate each team, and their agencies, on the differences in the Alliance processes.

Alliance Launches can be challenging, but they don’t have to be

With thoughtful planning to develop a healthy culture, clear governance and processes, and an efficient asset review process, your Alliance Launch team will be set up for success. Vynamic has extensive experience supporting Launches in these ways and bringing expertise to Life Science organizations. More than 125 Vynamic team members have supported a product launch. We have served on 450+ product launch engagements, including unique Alliances and partnerships, across 60 therapeutic areas. Our team has partnered with 35+ diverse pharmaceutical and biotech clients on more than 40 new-to-market products. Our experts can work closely with you to bring clarity to complexity with Alliance Launch.

Learn more about our Alliance Launch capabilities as well as our other Product Launch offerings, or contact our Alliance Launch Lead, Colleen Lawlor, to discuss how our team can support your strategic initiatives.

End notes:

1. The 2024 Outlook For Global Pharma Calls For More Difficult Days Ahead (forbes.com)
2. Pharma can no longer rely on traditional marketing for launch (fiercepharma.com)
3. Fewer Acquisitions And Alliances In 2023, But Valuations Increased
4. Culture & Cash Connection: New Report Ties Revenue Growth to Companies with Healthy Cultures | Grant Thornton