A development-stage pharmaceutical company based outside the US made a gutsy decision to establish their own commercial operations and launch their first product completely on their own in the US, despite not having expertise in the country nor having pharmaceutical commercial experience. Not a small feat but certainly the reward appeared to be worth the risk!
Starting From the Beginning – a Bit Scary but Liberating!
Leisa Dennehy, founder of BioPharma Consultants, was the first person the newly-appointed president of the US operating company contacted. The brand had just been approved by the FDA, and commercial launch supply would be ready in 8 months. Wow! That’s a bit scary knowing how much needs to get done, but what an opportunity!
To speed things up, a decision was made to out-source sales support, payer and trade activities, several analytic functions, and the call center. Along with the founder and his # 2 person in the international office, the Company’s president, the VP of Sales, and Leisa Dennehy negotiated & signed the scope of vendor work to support major elements of launch, agreed on the launch plan & timing, conducted three sets market research on messaging / positioning, built the product forecast, and developed the brand’s strategic plan. First two phases achieved: understanding the opportunity and building the right plan to deliver it. Ok…not bad for the first 16 weeks.
It’s Harder Than You Think
Starting up commercial operations entails every aspect of day-to-day operations. The scope ranges from: “Geez, we need an office!” to organizational design and decisions on hire vs contract; contracts negotiation; hiring and training; company policies on everything including pharma compliance; brand strategy and positioning; launch tactical planning, forecasting, manufacturing demand planning, distribution activities such as state licenses and other formalities; payer contracts and CMS agreements; pricing decisions and best price management; promotional materials; medical science liaisons and materials, PR and IR communications; call center and pharmacovigilance monitoring; and more….
Phase 3 of a commercial startup is delivering on the plan. Delivery means grueling, day-to-day intensity. Every day you need to bring your best insights, constantly critique the plan to ensure nothing has been missed, and manage to get the huge volume of work completed on time and budget. Stepping into uncharted territory means there will be things that were overlooked or didn’t go as planned. Flexibility, problem solving skills, and a sense of humor help!
Amazing What a Small Team of Committed People Can Accomplish
Although the entire US organization consisted of ~ 14 people, the group was aligned, passionate, and committed. No one wanted to let their team mates down. Everyone believed in the brand’s blockbuster potential, signed on for the goal, and agreed to the plan. We had team alignment! Each person worked tirelessly to deliver on their promises, which meant 60-80 hour weeks for several months. Did we make it? Yes! The sales launch meeting and product shipment to wholesalers went exactly to plan. Early feedback suggests the Company will capture the blockbuster potential that we envisioned.
Company startup done! Product launch done! Shortly after launch, Leisa Dennehy transitioned her responsibilities to the permanent team, who now continue in a more typical role working in an established company on a major brand. Goal accomplished!