BioTen video series: Operating model design

Interviewer: Mitali Bose, Senior Client Partner, Organization Strategy, Korn Ferry

Speaker: Jonathan Wildman, Senior Client Partner, Biopharma/Med Device Advisory Lead, Korn Ferry

Jonathan Wildman: Continuing with the BioTEN series. I'm back here with Mitali and we're going to flip the script this time. So Mitali you're going to ask me some questions about operating model design.

Mitali Bose: Yes, thank you Jon. We decided that we would put Jon on the spot since he's been doing that to us for the last few times. And Jon's done a lot of work with biotechs in the last year in helping them scale up their operating model. Jon would like to share a story with us.

Jonathan Wildman: Yes, no I'd love to. I think the space is particularly interesting because when you think about small and mid-cap biotech trying to reach to the next level, to do that quickly, often you're not building your own facilities you're not building your own operations you are looking to outsource and partner or collaborate for those things.

We're working with one client for example that was trying to bring a product to market that didn't have the manufacturing capability, they actually sold that off a few years before and then had to partner with not just one but several CMOs, CDMOs to bring their product and have it come to market. They also had some questions on the front end of that process as well.

So, they had their own lab space but because of the demand for their product, they actually had to look for contract research organizations to partner with as well and that brought up some key questions around their analytical development process, how the assets were measured and tracked, the process development process as well. How could you mimic or how could you ensure that one process with one facility was the same as another which led to tech transfer questions and when you're trying to submit and file your BLA. The tech transfer piece really has to be consistent if you're using different manufacturing or development facilities.

So, I think this is going to be more and more of a question for a lot of clients in this space and over time, it'll also bring up another question which is efficiency. If you've got four to six CDMOs that you're working with or if you're working with another contract research organization, at what point do you start to bring process in-house at what point you start to do things yourself to be more efficient versus just managing a wide network of partners.

Mitali Bose: Yeah, Jon, that's interesting. We are, what you're talking about is the need for making these rapid decisions in an agile way whether it's about deciding on your portfolio, applying a digital technology to shorten your clinical trials or increase the quantity and quality of your therapies. There's a lot of decisions that need to be made in really short time. Thank you for sharing.

Jonathan Wildman: Yeah, and just linking back to something we talked about before. This would be a team accountability. It's not just the accountability of the head of manufacturing or the head of operations. It really is something the team needs to own as well. Thank you for filling in Mitali. That was great.

Watch all of the BioTEN Video Series