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.