How to Make Outsourcing Work
According to “PABORD” speakers you need to be able to select partners that can meet the needs of the projects to have any chance of having a successful outsourcing relationship. “We look at their track record in process development and scale up, what level of regulatory compliance they work to, facilities, capacity, and cost. However, once we have established that all of this meets our project’s criteria we tend to go for the company with the best quality chemists in its team because you can have the best building and equipment in the world but if the people are poorly trained, you’ll never get the right results,” Dr. Mathur said.
Once a new partner is in place, outsourcing is not all smooth sailing. According to Jim Rennie, Ph.D., COO of contract research organization Prova (www.prova.co.uk), common chemistry manufacturing and controls (CMC) mistakes can be a problem.
Some firms use just one CMO as a one-stop shop for all their drug development needs. This is ill-advised because no single provider can supply everything. “There are different drivers for different projects so you need to look for providers that specialize in these areas, for example it is no good asking a Phase I specialist to manufacturer hundreds of kilos of a compound,” Dr. Judd commented.
Other issues, such as lack of solubility data and a shortage of appropriate pharmaceutical ingredients, were cited as sure-fire methods of preventing scale-up of a molecule and escalating production costs. Mistakes, such as expressing the amount of drug as a free base rather than a salt, can lead to the drug being formulated at an incorrect dose. Also discussed were drug formulation. The more complex the formulation, the more expensive it is to develop and manufacture.
Speakers agreed that to overcome or prevent these types of CMC problems, regular communication was essential. “No matter how bad the problem is I want to know. Good news can wait two weeks, but I need to be told bad news within 24 hours,” said Dr. Mathur.
“A collaboration is easy to manage when everything is going well, but the five percent of the time when we have problems, if this is not properly communicated, it can take 95 percent of our time to manage,” Judd added.
“Practice good project management with regular meetings, agendas, and action plans or nothing will get done,” Dr. Mathur concluded. “Treat your external chemistry manufacturers as partners by providing both negative and positive feedback. And most importantly, be realistic in your expectations. For example, don’t outsource them a synthesis you can’t do in-house as it is unlikely they will be able to do it either. They are chemists, not magicians.”