If there was one piece of advice the great and good of the cell therapy field agreed on it was this: to be successful in bringing a therapy to market, it is critical that you think about the end game.
Anthony Davies, CEO of Dark Horse Consulting, has over 20 years experience in the field and advises his clients to, “start at the end and work backwards to the beginning”. He explains that it’s often difficult in a start-up or academic environment to see your product in its final commercial embodiment and work backwards from there, but it’s of huge importance to avoid any pitfalls along the way.
Aby Mathew from BioLife Solutions says oftentimes companies set up their processes for clinical feasibility, which is not not necessarily aligned with commercial viability. They often forget to focus on scaling up or how they can deliver the product globally. Aby says the danger of not focusing on the end game could cost companies crucial time and money. “They might find that they’re spending a lot of money to redo experiments, to redo trials, to do their validation and process development at a larger scale when they might have been able to do it earlier.” Ultimately, he says, they may only realize this after spending several hundred millions of dollars, as opposed to realizing early on that they don’t actually have a viable commercial therapy.
Putting in the hard work at the beginning is crucial to gaining regulatory approval, says Christopher Bravery, director of Consulting on Advanced Biologicals Ltd. He believes that, up until now, many have been in denial about how hard it is to develop a medicine. He points out that it is relatively easy to get into the clinic in the first place, but if you want your product to be approvable you need to be, “doing more work than regulators are asking for early on.” By Phase II, he believes you should have a process that you can take into early commercial and you need to have characterized that and have a reproducible product.
Christopher says many in the industry typically don’t want to hear this, and often complain they already have enough to do at such an early stage. But he thinks this is a risky attitude and that it is a shame for products to fail by simply not putting in that early work.