The global pharmaceutical contract manufacturing market is growing at nearly 7%, a healthy rate, according to industry sources. Part of the reason pharma and biopharma companies are increasingly relying on outsourcing partners is to help deal with cost pressures and speed time to market in a competitive landscape. To do so they are turning to external service providers that support not only commercial manufacturing but all stages of drug development.

Sounds like a good time to be in the service business, right? Well, it’s not that simple. As UPM Pharmaceuticals’ chief exec James Gregory explains, while it is true that pharma and biopharmal companies large and small are increasingly relying on third-party providers, to realize efficiencies, they are at the same time reducing the number of suppliers to a preferred few with whom they can partner up. Analysts have predicted that as many as 30% of existing CMOs will disappear in the coming years. Beginning on page 44, find out why he says that only CDMOs that offer specialized capabilities while being flexible, responsive and innovative will survive to succeed in today’s market conditions.

In “Differentiate By Being Specific” (page 48) authors Paul Shields and Angelo Consalvo from Enteris BioPharma also tout the benefits of specialization in today’s market, making  the case for nimble niche CMOs and bucking the recent trend espousing the one-stop-shop CMO model. They say the ability to provide quality services across a wide range of biotech processes is difficult to pull off, particularly with large molecule biologics because of the type of expertise required to develop and manufacture protein-based drugs. On the other hand, the authors argue, a niche specialty CMO partner often times leads to a partnership with deeper experience to solve problems and in that process, may offer a higher level of open communication, less bureaucracy and an agile approach to handling issues as they arise. What do you think? Do you have an experience you’d like to share? I’d love to hear and possibly share with out audience.

To cover the topic of Process Validation for this issue, we called on expert Peter Calcott, who offers his insight into what has changed since the issuance of the FDA and EMA guidances issued a few years back. While both guidances have become the recommended method for process validation in the industry, Mr. Calcott wants us to know how well has it actually been implemented? With no definitive answer, he says it really depends on the company, its size and level of progressiveness. He sheds light on areas where challenges exist, including misperceptions of what the FDA and EMA really want, ways companies make things harder for themselves, which leads to unforeseen obstacles and ultimately failure. Turn to page 60 to begin reading Mr. Calcott’s advice that will help your company stay on track with this initiative.

If you’re a CRO reading this, market conditions look pretty good with outsourcing expected to grow to 35% by 2018 and up to 60% in the longer term. Anais Colin from Technical Resources International says that because CROs are being called upon more and more, it is the quality of the relationship between Sponsors and CROs that should be the highest priority with strategies implemented at the very beginning of the CRO selection process. If your looking for ways to better plan for a successful Sponsor-CRO relationship turn to page 69, and as always, let us know your thoughts!

Tim Wright
Editor
twright@rodmanmedia.com