Event Recap: Avoiding Common Traps in Commercial Launch

The commercial launch of a new drug is a make-or-break moment for a company. It represents the culmination of years of R&D, and the potential for significant benefit to patients, as well as financial gain for the company. Emerging pharmaceutical and biotechnology companies often partner with Converge Consulting to develop strategy and drive execution of commercial preparation and launch activities. Our work supporting recent launches provides unique perspective on effective practices and common pitfalls in the journey to commercialization.

Avoiding traps in commercial launch

We recently hosted an event in Cambridge, Massachusetts, for leaders in the life sciences. Todd Applebaum, Managing Director of Converge Consulting, and Jeff Goldberg, President and CEO of Aeglea BioTherapeutics, were our keynote speakers. The program started with Todd introducing the three pitfalls our clients seem to encounter most frequently.

Trap 1: Starting Too Late

Todd discussed the timing of launch planning activities in relation to the timing of major milestones. Some of his examples were companies that started early – often more than 2.5 years before the launch date. They planned well, executed well, and had ample time to pivot as new information and new business needs arose. However, he also shared examples of what frequently happens when companies start too late. While the products were ultimately successful in receiving approval and commercial launch, the process was high-risk and high-stress. Several launches were delayed, and most were high wear-and-tear on the employees involved, which resulted in a high level of turnover. Early planning is cheap insurance, he maintained, for executing a launch with the ability to adapt to emerging information.

Trap 2: Fragmented Planning

Many Converge clients start out believing that the Commercial team is solely responsible for launch preparation and planning. In these situations, where there is no integrated project plan across the company, interdependencies between functional areas are misunderstood or even hidden. Everyone may be working hard and making great decisions for their group, but when we speak with the teams, we often find conflicting assumptions and goals. To avoid this trap, charter an integrated launch planning team for communication and elevating issues. This ensures alignment across functional groups, so they are progressing together toward the same goals on an integrated launch roadmap.

Trap 3: Best Case Thinking

Commercial launch teams are often tasked with “planning for success” since that is the outcome all stakeholders want to see. Success is the proper goal, but teams need to define success broadly rather than only plan for the most opportunistic or most likely scenario. There is incredible uncertainty in this industry from many directions, including the regulatory process, scientific feasibility, market uptake, and commercial reimbursement. Success should then be defined by the ability to identify the key uncertainties, prioritize risks, and rapidly pivot to alternative strategies.

Lessons from the Launch Pad

Jeff Goldberg then shared his own practical experience leading commercial launch efforts. He has launched six drugs and is the first one to acknowledge falling “into every one of these traps…some multiple times.” Jeff spoke from the heart, telling stories – good, bad, and ugly – from his early experiences with drug launches.

His first experience was a positive one. It was expected to be a relatively simple launch, but his team did not dust off a generic launch plan. They started planning early. They considered every detail and the implications of each decision. Planning was integrated across functions, with defined roadmaps for what they would accomplish each week. As they encountered areas of risk and complexity, key early-stage decisions were discussed and planned with an understanding of long-term implications.

Jeff’s next launch was not so smooth. Launch planning was not integrated or even coordinated across the company. Instead, Jeff found himself chasing people down and going from office to office to get updates and discuss progress. This launch was ultimately considered a success although he described it as “a painful and bumpy road.” Jeff’s message was that if you approach your launch in this way, you can do it, but it hurts. There is little celebration, and no one wants to work together again.

In his third example, Jeff’s team started three years before the launch date. They built an integrated and motivated team, and planned for every scenario. However, on their PDUFA date, they received a CRL from the FDA, which stopped their launch planning activities. The effort was not lost because they picked up another late-stage asset and developed launch plans on an accelerated timeline. Jeff stressed that you cannot recycle everything from one launch to the next, but you can leverage key learnings. Early planning efforts are never a waste.

Key Takeaways

  • Do not confuse gating capital investment with the gating of planning activities. Early planning is good insurance and allows time to adjust to new information. Some simple, low investment activities can align tactical preparations with strategic commercial goals.
  • Successful commercial launch requires expertise across virtually all areas of the company. Many companies operate lean organizations, so people in key roles are often preparing for the first commercial launch of their careers.
  • Communication and alignment across functional areas is critical, so chartering and empowering an integrated launch team can ensure all stakeholders are working towards the same goal.
  • Identify and understand your risks and uncertainties. Prepare for contingencies. Many organizations tend to only plan for the best-case outcomes. However, taking a realistic view of the risks and actively planning for multiple scenarios will enable both smooth transitions and reprioritization based on new information.