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.

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.

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.

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.