It’s a big deal for an established biotech to launch a new product, but it can be an ordeal for an emerging life science (ELS) company launching its first product.
An established biotech is just that – established. The company is already operating commercially with its business functions, processes and systems in place. An ELS company needs to simultaneously launch its first product and build a commercially ready organization from scratch. The SVA Bio-Ops team calls this the corporate build effort. We have worked with dozens of biotech and medtech organizations helping them plan and execute a successful corporate build. We’ve learned many valuable lessons along the way. Here are three suggestions we regularly offer to executive teams undertaking this daunting effort:
- Create an “integrator” role. Every ELS company is moving at 85 mph while paving the road. Hundreds of decisions need to be made as the company experiences massive transformational change in a very short time frame. Executive teams with a strong integrator role experience fewer problems and conflict. Ideally, this person has accountability, authority and executive presence to set clear direction, make tough decisions and allocate resources. They cannot be afraid to make mistakes, understanding that decisions must be made with limited information and imperfect hypotheses.
- Start planning as early as Phase II. Without appropriate planning, ELS companies experience unnecessary risk, missteps and often stressful team heroics to take on unplanned work. As early as Phase II, create commercialization scenarios, come up with best guess assumptions and put an execution plan in place. It will be flawed and it will change – accept that. Working without a defined planning process will fan the flames of chaos as you march towards Prescription Drug User Fee Act (PDUFA).
- Identify and assign accountabilities to your orphan projects. To build a commercially ready organization that can manufacture, market, take orders and fulfill regulatory and reporting requirements requires dozens of implementation projects. Most are clearly owned by functions, but some are destined to fall through the cracks because they do not have an obvious functional owner – these are the orphan projects. Initiatives such as the enterprise contact center, medical and promotional review processes, sales and operations planning process, state licensing, pricing committee, enterprise information management, learning management and training are often put on the back burner or not even recognized as needed until late in the game. In the weeks prior to PDUFA, the orphan projects surface, creating more demands on an already stressed out team. The integrator role can reduce the risk of neglected orphan projects by making them a priority and defining an accountable owner.
ELS companies that take these suggestions to heart will be better equipped to handle the challenges and avoid the pitfalls of commercialization.
The mission of the SVA Bio-Ops team at SVA Consulting is to partner with leaders of Emerging Life Science (ELS) companies to reduce chaos as they transition from clinical development to being commercially ready for first product launch and subsequent success in-market. For more information, go to SVAConsulting.com. To discuss the content of this blog and how it might apply to your company, please contact Andrew DeMarco at firstname.lastname@example.org.