COVID-19 certainly has created unique challenges for the pharmaceutical industry, but the pandemic is not the only factor making the job of a life-sciences professional more difficult than ever. Rapid technological evolution, changing global conditions, and increasing pressure to get treatments from idea to market launch rapidly also are impacting the field.
Gordon Bates, president of small molecules for Lonza Group, recently shared his perspective on the various forces impacting the industry, and how professionals in the field are rising to the occasion.
OSP: What challenges and opportunities are small-molecule manufacturers and developers facing today?
GB: We continue to see small molecules being the predominant technology and products that are approved in the clinical pipeline, so that is leaving us feeling really positive.
Small molecules will continue to be the number one new technology for new products being approved, and about two-thirds of them are on accelerated pathways of one designation or another. More and more, we see smaller companies commercializing themselves, where perhaps 10 years ago, these smaller companies may have sold much earlier in development to a larger pharma.
The opportunities and challenges are very close to each other. Smart, smaller companies don’t have so many people on their teams, and they rely heavily on outsourcing--not just for access to resources, but also for the quality of conversations that they're having with our team.
At Lonza, we have great heritage and experience in the number of molecules that we've developed and that we've taken successfully through commercialization. That helps small companies who perhaps don't necessarily have all that expertise, or their expertise is in one specific area, and we see them using consultants to help close those gaps.
As I mentioned, two-thirds of those molecules approved in 2020 were on an accelerated pathway. The ability to be able to move quickly, or slow down if necessary, or move at the same pace that our customer wants to move, to be able to ramp up activities quickly and know what to do, or accelerate to get through to commercialization, that certainly is a challenge. It’s also an opportunity for those that can move quickly and that can help those smaller customers through that process.
OSP: How does the Lonza service model flex to support the requirements of small and emerging companies?
GB: More and more large pharma is working in collaboration with smaller companies on their development programs, or even perhaps being an investor in some of these companies. I don't see it as kind of a competition; it’s more that large pharma has started thinking about different ways in which they can work to further innovation needs.
From our perspective, about 90% of our customers are what we would call small customers—and we have a lot of customers. We see the kind of guidance and support they need, and I think having the capacity to be able to respond quickly is a real challenge that we need to balance.
Mostly, what I hear when I talk to people is that many of the lead CDMOs, those with great track records are extremely busy. I hear that the capacity is tight, and not having the capacity to be able to move at the pace that smaller companies want to move when they get great data readout, or perhaps they get other funding, that challenge of being able to be flexible and accommodating with what's important to their business, or what's important to our business model.
And here, you know, I think that simply comes down to do you talk to the customers enough to really understand what the key drivers are in the business, and perhaps demonstrating that empathy and understanding what the drivers are to be able to adapt and move at the pace that they want to move.
OSP: Do you find it's harder to have those conversations now that COVID has impacted the industry?
GB: You know, none of this technology is new. You're speaking to someone who's spent the last 10 years every week on an airplane, so to not have been on an airplane since March of last year is a strange experience for me.
When the pandemic first reached the West, there was a bit of a slow down for a couple of months, then things pretty quickly got back to a normal level of activity in demand. We did several things which were really exciting because they’ve challenged (if we ever get to a new normal) how we'll think about them in the future.
Firstly, because I couldn't travel, I wasn't spending as much time talking to customers, so we invited customers to participate in our leadership team meeting and dial in; that’s been a spectacular success that the customers have been able to participate, have a seat at the table and give us feedback on how we're doing or what opportunities could come through.
Another part of it that's been really interesting is how the sites have responded to setting up virtual visits and audits. We provided all the technology needed to support that, but the creativity that came from the sites of how to actually conduct a virtual audit—imagine you're talking in a room one minute, then you want to hand over to someone in the laboratory or in the factory—they choreographed this so fantastically well to keep it flowing, that it felt like a really immersive experience.
Adapting and learning different ways and new technologies to be able to support that, changes our thinking going forward forever.
I don't feel as though I'm missing out and having fewer conversations now because we've embraced the technology so much. This actually brings a different level of intimacy to relationships, When I'm talking to customers, they can see my house, or if my dogs run past and bark in the background or my kids come and pick something up off the printer. I've met people's husbands and kids. I've had a tour of someone's boat, and of someone’s cabin. It changes the dynamic and intimacy is an interesting point.
OSP: What market trends do you expect in 2021 and over the next several years in small molecule? How do you advise pharma and biotech to capitalize on these trends?
GB: Using the technology will actually become a little bit more than the norm. The growth of specialty medicines, where we see smaller volumes than traditionally experienced in the past and accelerated timelines, are more and more migrating into those types of supply chains that don't have special breakthrough designations. That speed is becoming the new norm.
Smaller companies are continuing to own most of those pipeline products coming through, and outsourcing as a result of that. I don't know whether the location of manufacturing will become more of a topic; we're seeing more and more people talking about manufacturing within national boundaries, as opposed to in the global environment, but it’s hard to judge how that will play out.
In my area of responsibility, Lonza Small Molecules, our integrated network is globally located from China to Oregon.
The EU made a list of medicines that they would like to be manufactured within their boundaries. We have a very healthy presence of a footprint in the US, but what we don't have is drug substance in the US, and that is an area that we continue to explore in small molecules. We have strong investments that we're making in small molecule and large molecule, and we’re extremely proud of the role that we play in supporting some of the vaccine production work that's going on in development programs as well.
OSP: How are CDMOs like Lonza helping accelerate development of innovative drug products to trials and to patients?
As referenced earlier, more drugs are getting some form of accelerated designation. When you’ve got robust processes of how you are able to take those through development cycles, the regulatory support that you can provide, pitfalls that you've seen elsewhere, you're able to bring all of those experiences with the processes that you have. You can offer regulatory support, you can offer clinical packaging and distribution capability. The ability to have all of that in one house is something that definitely helps with particularly smaller companies that want to accelerate.
The ability to come to a company that has all of those services helps. One of the challenges to make sure that you're successful in moving more quickly because it's always the handoffs between one step and another that either slow down or have the greatest propensity to have risk. Our intent is to be able to co-locate drug product and drug substance development on one site to get rid of all of that complication or on logistics.
OSP: Is there anything else you want to add about developments in personalized medicines and how Lonza is helping clients facilitate growth and innovation in that space?
Our estimate is about 30% of pipelines require highly potent manufacturing capability. We have made multiple investments in HPAPI capacity over the last several years, primarily at our Visp site. More recently, in April 2021 we announced a new manufacturing complex for small molecules, including antibody drug conjugate payloads, at our site in Visp, Switzerland.
We also see that 70% of these molecules require some degree of solubility or bioavailability improvement; we have multiple technologies that support making drugs that in the past weren't considered to be druggable. By applying these technologies, to be able to resolve those bioavailability challenges or bring a different technology that perhaps makes a drug druggable is possible. We have a facility in Bend, Oregon, and it's probably one of the industry-leading shops for supporting and bringing different technologies to resolve bioavailability challenges. In November 2020, we made significant new investment in 12 new suites, including our Bend facility, because our commercial portfolio is evolving and it's consuming more capacity.
We're going to add more clinical capacity to address that trend of bioavailability and solubility challenges. We have a high degree of expertise, and we’re adding capacity to be able to support clinical pipelines in that direction. It’s kind of a nice problem; we're seeing more products being commercialized there, so we need more capacity to support clinical, rather than seeing it being consumed by clinical and commercial.
OSP: How does Lonza plan to keep ahead of the competition?
GB: Almost anyone can buy the equipment, almost anyone could sink capital into the ground, in any part of the world. The things that make the difference in how you work with customers are your technical competence, which comes from the experience that you have in the teams, and making sure that we attract to continue to develop great people that can help solve those complex problems.
Most important is asking, what's that customer journey like? Do they have a great experience when they're with us, both from a perspective of helping solve problems, but also feeling like we really care and that we listen. It comes down to the caliber of people and the conversations that you have, and how that experience makes a difference.
It’s a competitive advantage to be able to have that great customer feedback. We test feedback all the time in various different mechanisms because you run the risk of living in an ivory tower otherwise. It’s a great way of connecting so that you stay in the reality of how customers feel from a technology perspective. We continue to invest, to say what technologies we think are important to be able to solve some of those challenges.