What challenges did you face in gaining marketing approval for mass-manufactured medical products containing living cells?
I would hope that the challenges that we faced in gaining approval would not all be replicated for others. We acted as pioneers at every step of the way—we worked with the FDA to create policy and also with Centers for Medicare and Medicaid Services (CMS Medicare) to resolve reimbursement issues. We also had no distribution models to follow. We had to invest approximately $400 million to blaze the trail. While it was money well spent, I’d hope that wouldnt be the model for other companies in future. The main challenge for companies following in our footsteps will be the decision, up front, on what business model they require. They will need to be very introspective regarding what they have the competence to achieve. Also, people tend to automatically look for a partner but, in fact, most partnerships fail. In most cases the junior partners—the biotech partners—are dissatisfied by them. This usually happens because the parties interests are no longer aligned and the larger partner is ju
