The New Strategic CDMO: Bringing End-To-End Solutions For Better And Faster Drug Development
By William E. Weiser, Executive Director, Global Head Analytical Sciences, Patheon
While Big Pharma historically has kept development activities and CMC management in-house, unpredictable pipelines and increasing drug complexity have compelled the industry to look more seriously at outsourcing drug development and manufacturing to increase productivity and throughput. Bill Weiser, the executive director and global head of analytical sciences at Patheon, discusses how a new generation of CDMOs have positioned themselves to provide more strategic solutions that not only complement product development but also drive therapies to patients faster.
What is it about the CDMO model that has become inevitable, based on the dynamics of the pharma market?
In order to coordinate the drug development process, a considerable amount of dedicated management is necessary. If a company leverages the resources to do this through a CDMO, it will achieve a more effective development program than if it were to try orchestrating it all within its own company. This is especially true if it can find a company with a true breadth of experience and efficiency to manage pharmaceutical development programs.
Where have you seen resistance to CDMOs, and how are today’s new CDMOs overcoming these objections?
One of the chief areas of resistance is the opinion that CDMOs lack technical expertise and scientific knowledge. What they may not know is that several CDMOs have brought more drugs to market through successful NDAs than many of today’s large pharma companies. For example, we’ve manufactured or developed more than 900 drugs at Patheon. It’s highly likely that someone in a global network like ours has the technical expertise needed to tackle any problem. In addition, CDMOs don’t have a patent-protected drug that secures their profitability or longevity. CDMOs are driven to meet, and even exceed, clients’ timelines and develop their therapeutics so that they can be successful as a company.
What evaluation criteria should be used when choosing a CDMO?
Regardless of the size of your company, you have to find a partner that has the goals of your organization in mind first. The company you work with must understand that it’s not there to look at one tactical piece of what you need right now, but to look at how what they’re doing fits into your bigger development process. A CDMO should demonstrate that they’re thinking holistically about fitting the whole of your drug development program together and figuring out what you need to do to get that drug into patients, and to be a therapeutic as well as a commercial success.
Obviously you work for Patheon. What do you think sets Patheon apart from other tier-one CDMOs?
Over the past few years, Patheon has advanced and expanded our capabilities through a combination of organic growth, globalization, and the disciplined and focused acquisition of core capabilities. Within our pharmaceutical development services, for example, we have a global project management system that guides all of our projects in terms of resource tracking, on-time delivery, and getting it right the first time. Our development sites are co-located with commercial production, which is key to our rapid tech transfer capability, and we have a very good working model at all those sites that allows us to achieve commercial production and market launch quantities quickly when drugs are approved. There are only a few CDMOs in the market that have this capability. Our success in the market is proof of our strategic approach to this business.