Sean Knight, Senior Director, Pharmaceutical Business Development

Sean serves as the primary point of contact for Simtra Biopharma Solutions' clients, helping them navigate the complexities of product transfers, manage relationships with Simtra BioPharma Solutions' internal subject matter experts at the manufacturing facilities, and perform long-term strategic planning based on their anticipated outsourcing needs. Sean has more than 17 years of experience in the medical device and pharmaceutical industries. In this interview, Sean provides his perspective on the role he plays in helping large pharma clients work seamlessly with a contract development and manufacturing organization (CDMO). 

How do the needs of a large pharmaceutical company differ from those of a small pharma or biotech company?

Most of the time, a large pharma company has experience launching products to the market. Therefore, they know what is required and look at a CDMO as an extension of their manufacturing network, measuring them using the same metrics and expecting the same performance as their own facilities. This requires a high degree of mutual trust and partnership between a pharmaceutical company and a CDMO.

“Trust” and “partnership” are buzz words that are thrown around a lot in this industry.  How do you help build trust with your clients?

We can help build trust by “speaking the same language,” which requires business development executives like me to have a high level of technical knowledge and prior experience. That way, when the client is explaining their needs, I understand what they are looking for, what the constraints potentially could be, and how our capabilities best align to their needs. Trust is also achieved through the building of multi-level cross-functional relationships. It is important for me to ensure that my cross-functional team is aware and engaged throughout the process, which helps in further establishing and building client relationships. This requires involvement from teams focused on quality, regulatory affairs and procurement, as well as technical subject matter experts, among others.

Why would a large pharmaceutical company consider outsourcing?

There are several reasons. First, by partnering with a CDMO like Simtra BioPharma Solutions, the company leverages our specialized expertise and capabilities. Many clients may not have manufacturing capabilities for products like cytotoxic compounds, which require specialized containment, or platforms such as prefilled syringes, and they come to us for our expertise in those areas.

Another reason is risk mitigation, as we can help complement existing capabilities, so clients aren’t reliant on manufacturing in a single facility or in one specific region. Speed to market is another key consideration. Thanks to our extensive experience and flexibility, we can achieve accelerated release times that surpass what some pharma clients may be able to achieve internally. For example, our facility in Bloomington supports several seasonal vaccine campaigns, which require multiple activities to take place in very tight predefined timelines. Finally, it might come down to a matter of capacity, where we can bolster manufacturing volume for a blockbuster product.

What key aspects should large pharmaceutical companies consider when identifying a CDMO?

At the top of the list would be quality and capability — by which I mean, does a CDMO have demonstrated regulatory and quality compliance, and do they operate at your expected level of performance? The second key aspect would be a CDMO’s ability to operate as a part of your network. Can they do the job, be flexible and overcome challenges to the same extent as they would if they had ownership of the product in the manufacturing facility?

Finally, there is the ability to grow with a company’s needs. This is a very dynamic industry, as we have seen with the rapid evolution of new complex modalities (such as mRNAs/nucleotide-based products, ADCs, oncolytic virus therapies) and the increasing number of new biotech companies who either partner with large pharma or end up being acquired by them. So, you really need a CDMO who, like Simtra BioPharma Solutions, is continually assessing and investing in its infrastructure to support organic growth and help ensure that it is “future-proofing.”  For example, in 2020 we announced a $50 million client-dedicated investment in our Bloomington facility to support a large pharmaceutical project, and in 2021 we announced a $100 million investment in our Halle/Westfalen facility to help accommodate future growth.  

In my role, I stay very close to my pharma clients so that I have a clear line of sight into their growing pipeline and strategic direction. I am constantly assessing their needs and demands — clinical as well as commercial — and how they align with our capabilities so that I can offer them solutions today and into the future. My goal is to build on our relationship and grow together.