2024: An Outsourcing Future of Information Sharing
By Louis Garguilo, Chief Editor, Outsourced Pharma
“I'm a big believer in open-source information as much as possible,” says Nana Collett, VP Program Management, NervGen Pharma Corp. “I understand companies need proprietary information, but I'm a bit radical this way. I believe that as an ecosystem, we're going to get stronger if we can find our way to more data-sharing.”
So begins my investigation into what outsourcing professionals think about the future of working with contract development and manufacturing organizations (CDMOs). Along with Collett, I spoke to Thierry Bilbault, Senior VP, Tech Ops, at Ardelyx, Inc. His career includes roles at Alcon, Pfizer, Novartis, and biotechs. When we spoke, Bilbault focused on the future in terms of the ultimate goal of drug and therapy developers: achieving commercial approval, and successfully establishing a supply chain to serve markets and patients. It’s a “future” he has realized before, and is manifesting yet again at Ardelyx, which he joined in March of this year.
But let’s start with Collett, and her thoughts on our industry as a closely integrated and sharing ecosystem. Part two will bring us “Thierry’s Theories.”
Come Together
“I think CDMOs need to do this, in terms of sharing what works and what doesn’t, so we can all learn from other’s experiences, instead of making mistakes repeatedly within silos,” says Collett. If sponsors and CDMOs can find a way to share more on the development/clinical, and manufacturing fronts, she believes, “we'll all become stronger.” That strength will result in improved medicines. “I think we all want that rather than just viewing this industry as a competition,” she says. “I hope we can evolve to that future.”
Collett has been thinking about ecosystems for many years. She has a master’s in ecosystem science (as well as an MBA, to match her B.SC in biology). Those pursuits have led her predominantly to project management roles, where she’s applied her more global view of organizations, external relationships, and our entire industry. “This is simply a belief in systems-thinking, right?” she asks rhetorically. “A belief you need to look across different factors, and different sectors. Ours is a for-profit industry. I think profit is healthy,” she adds, no pun intended. “It drives innovation more than any other model. I really believe in that. At the same time, we are in this because we want to help other people. We work in medical-product development because that purpose excites and motivates us. There is a balance that can be found between sharing information and seeking profits to drive innovation and successful companies.”
Regarding outsourcing, Collett says the best CDMOs act as information-sharing partners. When these service providers see themselves in that vein – and program sponsors do the same – optimal results are obtained on both sides. But that’s not enough. She’d like to take more of those specific experiences outside those relationships, and into the greater community. Protect IP, yes. But have as much knowledge as possible made public in journals, and at meetings and conferences. Perhaps some of this is starting to take place; no reason it can’t be practiced more widely in 2024.
Ecosystem Reality
Collett’s not caught up in some idyllic worldview. Industry experiences have only added to her “sharing” convictions – and in many regards, proven her thesis works in practice. (We might say her career actually started in 1993, when as a grad student she served as a “Way Cool Scientist” for Bill Nye the Science Guy.) In fact, she’s had a “pretty diverse career” in biopharma, and encountered various situations where “open-source” thinking was important. “Like many others in program management, we haven’t traveled in a linear path to that position,” she explains. “My first job was actually funding R&D for start-up companies in health technology.” Soon, though, she realized she wanted to be “on the inside doing drug development.”
Her first biopharma industry job was at Vancouver-based QLT, a biotech with a commercial product. That provided an opportunity to learn “the different functions from research through a product’s life cycle, such as analytical development and manufacturing activities,” and where she first “intersected” with CDMOs. She ended up working in management at QLT for a number of years, including in new-product planning. “I got an MBA because I wanted to work in administration; the business aspects really interested me. That’s when I also started working on the strategic side,” she explains. Today at NervGen in program management, she says she feels right at home.
One commonality for most every position she’s had is “manufacturing has been a key to drug development.” “It really is critical,” she says. “In terms of my interface with outsourcing and working with CDMOs, I've been closely involved with manufacturing both on the alliance management and program management sides.” A takeaway from that dual-sided understanding? What comes to mind for her is “the transfer of data, knowhow, and analysis is vital.”
Another major contributor to her ecosystem view were roles at organizations with both drug pipelines and service-provider components. One such role was at Tekmira Pharmaceuticals (now Arbutus BioPharma), an organization pursuing independent product development, and also “acting like a CDMO and manufacturing for partners.”
“For quite a long time,” she says, “I was responsible for the interface between our partners who were developing a drug, and the work we did internally, as well as managing our own internal drug development.” Mostly, she says, this interlacing came down to sensible but open communication and information sharing on all sides and among organizations, and seeing the individual activities and program parts as a whole, all in the pursuit of what’s best for patients. All of it, she says, resides within the same ecosystem.
Today, Collett feels that NervGen is working with “really good partners,” those that for the most part satisfy her ideals for sharing. As we end our conversation, I ask her where all this openness might lead us.
“We need continued innovation; that's the lifeblood of our industry,” she replies. “We are in the midst of a promising time. It seems to me there's more emphasis on innovation than ever. There was a period with a lot of ‘me-too’ drugs. I don't think that was all that interesting for CDMOs or sponsors. Now there's a ton of innovation, whether it's gene therapy or more complex biologics. CDMOs that focus on continued innovation are going to succeed, and can help lead the entire industry in knowledge sharing.”
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Next up, we'll continue our look into the new year, with Thierry Bilbault, Senior VP, Tech Ops, at Ardelyx, Inc.