Jens Vogel, President & CEO, BI Fremont Inc., can’t help seeing two sides to most everything associated with the development and manufacturing of biologics.
For example, he says we are in an era that at the same time can be dubbed “Death of the Blockbuster” and “Return of the Blockbuster.”
His career has a certain dualism as well. He spent years in leadership roles at Bayer and Boehringer Ingelheim (e.g., Global Head, CMC Strategy at BI’s biopharma headquarters, in Biberach, Germany), and currently heads a state-of-the-art and rapidly expanding biologics facility in Fremont, CA, that also serves other drug owners as a CDMO.
None of this duality bothers him much. In fact, he says it creates a landscape of opportunity within the world of modern-day biologics development and manufacturing.
Let’s start with his two “blockbuster” worldviews.
Blockbuster Or Not, Plenty Of Work
“When I look at the industry, you have this interesting trend,” Vogel remarks. “We’ve said we are witnessing the ‘death of the blockbuster.’ There are more, lower volume products for manufacture and launch, on a smaller and quicker scale.” Part of that, he says, is driven by more highly potent drugs, “but when you really look at future trends, I see precision medicine becoming common. That’s quite revolutionary, and I think where the industry is moving. We’re going from large patient populations down to thousands or even hundreds of patients. For that, we need a flexible manufacturing network.”
At the same time, continues Vogel, “We see what I call the ‘return of the blockbuster,’ where you have in particular immunotherapies – such as checkpoint inhibitors where one drug, by the fact it helps your immune system fight the cancer, will end up working on a wide range of cancer indications. Suddenly, we’re back to the blockbuster, and again you need very large-scale, high-capacity manufacturing facilities.”
What’s a drug owner to do? Or for that matter, contract development and manufacturing organization?
Vogel says similar to the design of BI’s biologics facility in the Bay Area, new thinking around “innovative, flexible manufacturing platforms and global networks, capable of employing both large scale stainless reactors and smaller-scale dedicated capabilities.” This should also include new development in technology and continuous improvement.
“We spend a lot of effort, time and money at BI on developing next generation manufacturing technologies and platforms,” explains Vogel. “And also partner with other big Pharma players out there, with biotech customers and equipment-design companies, to accomplish this.”
When it comes to these next-generation technologies and platforms, Vogel talks a lot about aiming at “process intensification.”
“Anything from intensifying processes in existing fed-batch facilities, to then using fully integrated continuous manufacturing platforms has to be the aim today,” he says. These integrated continuous manufacturing systems are and will play a large role in facilitating – and co-locating – both high volume and much smaller volume products.
BI has established “Project Independent Development Teams” with dedicated budgets to pursue – much like a think tank – the design, engineering and partnering of new equipment.
One example he mentions is something being called iSkid. These are “integrated skids that bring together multiple-unit operations in a highly automated fashion, and can take on completely continuous automated manufacturing.”
Advice For Both Sides
Within this world of both big and small volumes Vogel offers, as you might expect, thoughts for both sides of the outsourcing equation. We’ll start with some advice to drug owners.
Number one is to work with an organization having deep knowledge of the entire biologics value chain, from early phase development to routine commercial supply. “That would always be my preference, and it was when I was considering outsourcing for Bayer early in my career and throughout my years at BI.”
“Basically, you’re looking to avoid hiccups and potential delays you might otherwise have if you’re starting with someone who has always only done early phase, and then try to switch later,” he says. “It is possible, and sometimes necessary I agree, but I think it’s beneficial to work with someone who knows the entire value chain end to end.”
Next, along with the requisite technological and capacity needs that drive decisions for selecting partners, “don’t underestimate the importance of the cultural fit.”
“Think about whether your partner shares the same approaches, has a similar culture, and if it is an organization you can work with not only today, but tomorrow and five years from now,” he says.
And while many in the industry point the finger at Big Pharma as needing to be more open in those partnerships, Vogel believes CDMOs also have work to do. There’s no hesitation in Vogel’s answer when I ask what CDMOs need to work on most: “Transparency,” he replies in a word.
“Transparency through full communication,” he explains. “You especially want to be open with your clients when it comes to challenges, risks, and capabilities. You want to build long-term partnerships. For that, you have to develop trust; to develop trust, you have to earn it. You can only earn it if you are transparent from the get-go, and again, you put all challenges on the table. That’s when you can work together on developing optimal solutions for bringing a drug to patients.”
Too Much Of A Good Thing?
Before I take my leave of Vogel, I can’t help but ask the question that’s been on my mind throughout 2017, knowing full well most anybody I ask will have some level of vested interest in the answer: Are we reaching a point where we are starting to overdo it? We’re an industry striving to outsource better and more, but are we beginning to reverse the risk profile – or bend business models too much – by outsourcing at this ever increasing scale?
“Honestly, I don’t think so,” replies Vogel, after a few moments of some serious thought. “I’m not saying that based on my current role. When I look back through my career, with everything you do, you should ask yourself the question: ‘Make or buy?’ There are compelling reasons to go with an established CMO or CDMOs in biologics, first for that risk mitigation. In some cases it might be for contingency purposes. You might use a partner for launch, then establish supply chain redundancy, and even bring production in-house, while still keeping CMOs engaged for supply chain robustness. The whole model has proven to be flexible, and proven to work very well. I don’t necessarily see a downside with regards to risk.”
Finally, we get Vogel committed to just one side of a topic.
Vogel will be joining us as a panelist at Outsourced Pharma San Francisco in October.