DCAT Week 2024, hosted in New York City from March 18 to 21, 2024, differs from many other conventions. While most conventions are typically highlighted by booths, panels, and other public-facing opportunities, DCAT Week is instead predominantly focused on private meetings between industry professionals, which result in many of the key deals in the life sciences market.

These business-to-business discussions, spread out across various lavish hotels in midtown Manhattan, present companies with a unique opportunity to meet with peers in a concentrated flurry of private meetings. These candid discussions have the potential to not only result in long-term provider-client partnerships, but usher in blockbuster deals with the potential to fundamentally shift the balance of the greater life sciences market.

The ancillary benefit of these critical discussions is self-evident: the best and brightest minds in the life sciences business are accessible for interviews. And while one is obliged to sift through a deluge of canned phrases and company posturing, the effort is well worth it when one considers what can be gleaned from responses concerning ongoing trends in the broader life sciences market – as well as their ramifications for the future.

Integrating Artificial Intelligence

Interest in AI is evident everywhere. A study from the Organization for Economic Cooperation and Development found that venture capitalists poured approximately $75 billion into artificial intelligence projects in 2020 (1). While current estimates are harder to accurately measure, this number actually undercounts contemporary interest in the area. For instance, the New York Times reported in March 2024 that the Saudi Arabian government planned to invest $40 billion into AI technologies (2). Its increasing relevance was a hot topic at the conference, as Thierry Van Nieuwenhove, CEO of Quotient Sciences, a pharma CDMO and CRO, discussed in our interview.

“I think AI is a revolution for the industry,” says Thierry Van Nieuwenhove, CEO of Quotient Sciences, “This is really what’s going to change the industry substantially. And the whole industry is still looking at how this could actually accumulate, being implemented into the shop and into the value chain of developing a drug but also later on of adding a drug on the market.”

While much of contemporary venture capital funding is contingent on the perception of tremendous growth potential – a practice that could perhaps prove costly if overextended into areas that AI either isn’t capable or ready for – astute trendsetters have begun to drill down and identify concrete uses. For instance, Kieron Hall, Chief Marketing Officer at Quotient Sciences, touched on the question of AI’s scope in depth.

“[When] you’re generating batch manufacturing records from SOPs, that is something that we should certainly be looking at. It’s something that’s very time consuming, a repetitive task,” says Hall. “Similarly, the writing of clinical protocols and the clinical outputs. There are ways in which we can use AI to do that. But I think these are all very discrete scopes of work that we need to investigate with a very clear endpoint, that we draw a line rather than just at the moment.”

In this question of scope, Hall also talked about the potential for AI to take his companies existing molecule data – formulation, molecule characteristics, etc. – that’s been linked with clinical outcomes as a means to accelerate future drug development research. Saurabh Gurnurkar, Managing Director of Uquifa, a CDMO specializing in small molecules, echoed these thoughts, but also alluded to the idea that it could move to even more areas of biopharmaceutical production.

“From an on the ground perspective, I think the impact will probably be higher today in terms of the drug discovery end of the value chain, where you are shortlisting a molecule or going from lead to optimization. I think AI could play a role in that part of the value chain,” said Gurnurkar. “But eventually, as the test cases establish themselves, you’ll probably see AI playing a role in supply chains. You’ll probably see AI play a role in R&D. You’ll probably see AI play a role in even human resources in terms of recruitment and performance management. So I think it’s a theme which will be applied increasingly in our sector.”

Anticipating Personalized Medicines

Another trend brought up by DCAT attendees was the rising expectations for personalized medicines, which tailor medicines on a patient-by-patient basis. Among its many advocates was Dave Stevens, Chief Commercial Officer at Kindeva Drug Delivery, a CDMO specializing in drug combination products.

“Personalized medicine and care is impossible to ignore,” says Stevens. “If you think about things like HIV care, companies are looking at ways to create controlled sustained release products, which means that patient’s might need an injection two or three times a year. I think that’s a really important trend.”

Personalized medicines, which are tailored based on a patient-by-patient basis, present an opportunity not only for better, more efficacious results for patients, but core structural changes to the industry’s underlying operations. For instance, Himanshu Gadgil, CEO of Enzene, a biosciences company, discussed how personalized medicines could alter the status quos surrounding current standard manufacturing processes.

“If you look at conventional biopharma products, you make a lot of the protein dose. Monoclonal antibodies, for instance — we are looking at 400, 500 mgs of doses per patient. And that’s why you needed these big 20,000 to 40,000 liters stainless steel bioreactors,” said Gadgil. “But that is shifting, and that is shifting because the modalities are shifting. They’re becoming more personalized, and becoming more efficacious, more potent… and so you’re not going to need metric tons of drug substance because the medicine is getting personalized, the medicine is getting more potent and these new modalities are more potent.”

While Gadgil was quick to note this wouldn’t spell the end of bulk manufacturing, it does reinforce the trickle-down effect that drug design can have on manufacturing practices. If enough treatments are present and it becomes fiscally advantageous to change course, companies will adjust their manufacturing schemes as needed. Notably, one aspect he touched on is how this directly contradicts a mindset that evolved post-World War II, wherein issues were generally addressed through large manufacturing plants and scale.

In this vein, Dave Stevens, Chief Commercial Officer at Kindeva Drug Delivery, a CDMO specializing in drug combination products, stressed that this shift presents a dilemma to companies who built their operations within the large scale model.

“[Between] gene therapy, viral vectors, mRNA, I think you’ll see a continued trend of these smaller products,” said Stevens. “What’s interesting about that, is that if you look at a lot of the capacity that’s been built, it’s built for large populations and high utilization and facilities with very large batch sizes. That causes a bit of a challenge, because most contract manufacturing has been set up for large scale products for commercial [production]. That’s a reality that the industry is wrestling with a little bit.”

While the increased prominence of this niche certainly won’t eliminate the large manufacturing operations touted by many of the businesses in attendance at DCAT Week 2024, the overall sentiment among attendees seemed to reinforce the notion that personalized medicines are a key facet in pharma’s future. Consequently, as they gain more prominence, more companies will likely examine whether streamlining manufacturing operations in this fashion might be beneficial to their bottom line.

Sustaining the Supply Chain

Another core topic of discussion among attendees was the state of the supply chain and how to mitigate various challenges surrounding it. The COVID-19 pandemic caused significant disruptions to the just-in-time supply model, leading to vocal calls for onshoring and near-shoring, particularly for critical supplies. Concurrently, efforts to diversify suppliers through practices like dual sourcing have also been made, such that disruptions to any one country do not undermine a company’s entire manufacturing operation. Post-pandemic, these movements have remained popular amid various geopolitical events like the war in Ukraine and the China-U.S. trade war.

Of those two efforts, companies seemed to have opted toward dual sourcing more often than near- or on-shoring. A 2021 survey from McKinsey found that across all industries, while 45 percent of respondents said they planned to both near-shore and expand its original supplier base in May 2020, only 15 percent had done so within the next 12 months. Comparatively, 53 percent had said they planned to implement dual sourcing, whereas 55 percent ultimately did. (3).

“If you look at dual sourcing, we have gone from 70 percent dependency of raw material supply from China down to about 30 percent,” Rob Haxton, Vice President of Integration at Syngene International, a contract research, development, and manufacturing company. “By enabling us to have dual source capabilities, what we’re also able to do is give clients an opportunity to have a global source, or a non China source, depending on what their needs are.”

However, while these solutions loom large in popular discourse, many other solutions to supply chain strain were being discussed at the conference. Some companies have instead opted to invest in technologies that are more resilient to supply chain disruption than conventional alternatives. Zack McGahey, Chief Operating Officer of Antheia, a pharmaceutical ingredient manufacturer, discussed his company’s involvement in scaling up supply of APIs and KSMs through synthetic biology techniques.

“What our technology enables us to do is produce [products] in a method in which they cannot be done today. These target molecules currently are only globally made by extracting compounds from plants – and as you might expect, those sorts of supply chains are fragile subjects to issues such as climate change, and routinely lead to large fluctuations in supply against demand that often lead to drug shortages,” says McGahey. “And so what this technology can do is allow us to build a more robust supply chain for these globally consumed products and prevent situations where these target molecules are unavailable to the general public because they are in shortage and because the current supply chain methodology cannot meet the fluctuations that happened within the market.”

Others, like Uwe Hanenberg, Head of Product Development and Implementation at Recipharm, have looked toward simpler, more accessible product designs in order to simplify the types of supply chains needed for a given product. Biologics have been rising in terms of growth and FDA approvals, but an injectable delivery format raised concerns for Hanenberg and Recipharm. To resolve this, the company has been working on developing oral biologics, which are designed to fill tandem roles of increasing patient compliance and reducing manufacturing complexity.

“There’s a huge trend in research and development to find out ways for an oral application of biologics,” says Hanenberg. “Oral solid dose manufacturing is much cheaper than sterile. And it is very pleasant for the patient to take. And when it is pleasant for the patient to take, they will adhere to the therapy… with this, you do not only reduce the manufacturing costs and have a better supply chain, an advantage in the supply chain. You have a massive impact on the compliance of the patients to the therapy and with this a much better therapy success.”

The Future of Pharma

While these were three key themes attendees continuously brought up, they’re fortunately just the tip of the iceberg. Various other trends, like the increasing role of biologics or the modern role of outsourcing companies, were also hot topics throughout the convention, among many others. For more on DCAT Week 2024, we encourage you to view the one-on-one, on-site interviews conducted by Life Sciences Knowledge Hub.

References

1. Tricot, R. Venture capital investments in artificial intelligence: Analysing trends in VC in AI companies from 2012 through 2020. OECD Digital Economy Paper 2021;319. ISSN: 20716826 (online) https://doi.org/10.1787/20716826.
2. Farrell M. and Copeland R. Saudi Arabia Plans $40 Billion Push Into Artificial Intelligence. The New York Times. 2024:B1.
3. Alicke K., Barriball E., and Trautwein V. How COVID-19 is reshaping supply chains. McKinsey & Company. Nov. 23, 2021.