Susan Haigney

Industry Outlook 2025: Talent Up for Grabs

The post-COVID-19 era has seen the consequences of ambitious programs launched during the pandemic, according to Erik Wiklund, CEO of Circio, such as a lack of capital for small biotech and employee layoffs, and Wiklund sees this impacting the industry during 2025. “Many companies launch great ambitions, large valuations. People flow into the industry, and then the breaks set in, but then what happens is that the companies that survive, they then suddenly have access to a broad talent pool, and then the capital comes back,” Wiklund says. “So, I think the consequence of that is that you see some consolidation. You see access to talent, and you see new stronger companies emerge, and maybe that's what will happen now. After the reset in biotech, a broad set of companies are gone, but this may create fertile ground for the future successes once the capital markets and the industry start to normalize, and hopefully this will happen during 2025.”

This increase in available talent is a trend that Wiklund sees continuing in the coming year. “What we've seen is that there's been increasing cost levels in the [United States] in particular, strong dollar and increasing inflation has driven up prices,” Wiklund says. “Salaries are high, and I think that, to a certain degree, is starting to make European or other companies look elsewhere for development opportunities. It's become cheaper by comparison to develop drugs in Europe, Asia, and Australia, and I think maybe if that trend continues with a strong US economy and increasing prices, then you may see that kind of European, eastwards-oriented trend continuing.”

Click the above video to watch the interview.

Erik Wiklund, PhD, is CEO of Circio. He has deep scientific knowledge in RNA and cancer biology, and 13 years of pharma and biotech industry experience in a variety of functions including R&D, finance and business development. Previous employment includes the radiopharmaceutical company Algeta, which was acquired by Bayer in 2014, Aker Biomarine, and management consulting experience from the Pharma & Health Care practice of McKinsey & Company. Wiklund holds a PhD in Molecular Biology from Aarhus University, Denmark, and the Garvan Institute of Medical Research, Sydney, Australia

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Pharmaceutical Technology® Group spoke with Erik Wiklund, CEO of Circio, about the impact of the post-COVID-19 world on the pharmaceutical industry and how that has shifted the talent pool.

Industry Outlook 2025: Cell Therapy Advancement

Edwin Stone, CEO of Cellular Origins, sees two themes having the biggest impact to the bio/pharma industry: the expansion of glucagon-like peptide-1 (GLP-1) and the growth of cell therapies from fourth- and third-line treatments to second-line treatments. “It really opens up that question of, when do we start to see first line treatments? And of course, part of that comes down to not just the safety and efficacy profiles, but the cost of goods, which still no one has a good answer to,” Stone says. “So, I think that really links the two parts that we've seen through this year, the GLP-1 and advanced therapies really all come down to that manufacturing piece.”

“The other big thing on cell therapies that I think has been really important this year, and I think really hopefully points to future … moving now into new indications, particularly solid tumor. Again, we don't have to go back that far for there to be real questions with Iovance’s approval in that space and then later Adaptimmune. Solid tumors now are right [on] the cutting edge of where cell therapies are at, and I think that gives great excitement for their potential. Again, we're going to need to make sure we can show that we can manufacture those,” Stone adds.

Stone also sees messenger RNA, the diversity of biologics, and new biological mechanisms as areas to pay attention to for the future of the industry. “I think the thing … we're perhaps just at the start of now, is being able to really broaden our ability to harness biology to go after diseases that we previously haven't been able to tackle. And of course, that's incredibly exciting,” Stone says.

Click the video above to watch the full interview.

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about the bio/pharmaceutical trends from 2024 that continue to impact the industry in 2025.

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

SkyCell announced on April 7, 2025 that it is collaborating with Microsoft to integrate SkyMind, SkyCell’s artificial intelligence (AI)-powered supply chain solution, with Microsoft Teams and Copilot based on Azure OpenAI Service. The collaboration will enable those working in the pharmaceutical supply chain to access real-time shipment data, predictive insights, and automated alerts within a Microsoft system, according to SkyCell (1).

SkyCell will use Microsoft’s ecosystem to enhance monitoring and provide full visibility of the supply chain using Azure AI Foundry. It will also use SkyCell’s K.AI intelligent assistant, which monitors shipments, assesses risks, and suggests real-time solutions. It also allows for the streamlining of product release through automated reporting and electronic resource planning integration. Data can be quickly accessed by stakeholders, who can then share that data with relevant parties, making communication more seamless. The partnership is combined with SkyCell’s 24/7 AI-enabled control tower and support team.

“SkyCell’s intelligent assistant, K.AI, along with Microsoft's Teams and Copilot, are revolutionizing the pharmaceutical logistics industry by ensuring real-time monitoring, risk assessment, and seamless communication,” ‍Richard Ettl, CEO of SkyCell, said in a press release (1). “This collaboration is crucial for transforming data into actionable insights, thus preventing product loss and enhancing efficiency in the supply chain.”

“Pharma companies already have established platforms and workflows that they use to manage their operations efficiently,” Nico Ros, CTO of SkyCell, said in the release. “We understand this, which is why our collaboration with Microsoft ensures that pharma companies and supply chain teams can leverage SkyMind’s power directly within Microsoft Teams and Copilot.”

"By harnessing the transformative power of AI through Microsoft Azure OpenAI, SkyCell is advancing pharmaceutical logistics to create safer, more efficient supply chains,” Elena González-Blanco García, EMEA Digital Natives Technical Director at Microsoft, said in the release. “This approach will ensure that vital treatments reach patients swiftly and securely, ultimately driving impactful progress in the industry."

SkyCell currently monitors five million shipments a year and believes the collaboration with Microsoft will accelerate digitalization in the pharma industry.

Automation, AI, and machine learning are hot topics in the pharma industry. At INTERPHEX 2025, held in New York City in April, “Pharma 4.0” was discussed heavily. Data collected as part of CRB’s Horizon Life Sciences report showed that 31% of industry stakeholders saw automation and digital transformation as key priorities for capital investment projects presently or in the near future. In a presentation at 

, Peter Walters, fellow, advanced therapies at CRB, discussed additional results from the report that shed light on priorities in both the lab and on the production floor, including AI, 

There is still caution around the use of AI in pharma, however (2). “I know for some people the idea of AI in a cGMP [current good manufacturing practice]-regulated setting could be a little unnerving, but it doesn't mean that we're handing over the sole finish to our robot overlords; it's a lot more like mechanical systems that have AIs on board to moderate themselves and look for mechanical issues in advance of them happening,” Walters explained. “I think where we also are seeing it is where you've got manufacturing steps that have to have very complex decision trees; you're still having a person make those decisions, but you're having AI models that can support that decision-making.”

Automation is being utilized in the areas of quality, throughput, and operator autonomy within the pharmaceutical industry, according to Peter Sarvey, head of Sales for Automation NTH, and the cost of using automation has decreased in the past two years. Meanwhile, the accuracy of these tools is increasing. The use of AI, which has been used in the “vision side” of automation according to Sarvey, is also increasingly starting to be used in the inspection side of manufacturing (3).

 interviewed Sarvey at INTERPHEX 2025. The full interview can be found on 

1. SkyCell. SkyCell and Microsoft Announce Collaboration to Bring Copilot into Pharma Supply Chains. Press Release. April 7, 2025.

2. Bigica, A. Pharma 4.0: What are Industry Leaders Prioritizing in the Modernization of Pharmaceutical Manufacturing? PharmTech.com. April 3, 2025. 

https://www.pharmtech.com/view/pharma-40-what-are-industry-leaders-prioritizing-in-the-modernization-of-pharmaceutical-manufacturing-

3. Lavery, P. and Haigney, S. INTERPHEX 2025: 

Articles

SkyCell is working with Microsoft to incorporate SkyCell’s AI-powered supply chain solution into Microsoft Teams and Copilot.

Microsoft and SkyCell Collaborate on Pharma Supply Chain Logistics

Industry Outlook 2025: Evolving Pipelines and Supply Chain

In the post-COVID world, pharmaceutical companies have been looking to reconfigure their supply chains and work with global partners, according to Krishna Kanumuri, CEO of Sai Life Sciences. “I think people are looking for the next-generation partners they need [for their] business, which is a challenge, both for providers as well as customers, because customers need to develop new relationships, need to get [these up to speed], and still need to deliver on their programs,” Kanumuri says.

“I think [the] pharma industry itself is looking at what their pipelines [will] look like going forward,” Kanumuri says. “If you look three, four years back, pharma was talking about gene therapy, cell therapy. But right now, thanks to GLP-1s [glucagon-like peptide-1], I think the three main modalities which are getting very exciting at this point are peptides, oligonucleotides, and ADCs [antibody drug conjugates], along with small molecules which seem to be back, and also the fact that all these modalities, about 80% of the work is actually small molecules.”

Krishna Kanumuri is CEO of Sai Life Sciences.

Pharmaceutical Technology® spoke with Krishna Kanumuri, CEO of Sai Life Sciences, about which trends from 2024 will carry over and impact the bio/pharma industry in 2025.

INTERPHEX 2025: Advancing Treatments for Ultra-Rare Diseases

According to Joe Katakowski, director of Research at the RTW Foundation, parents of children with rare diseases are the driving force behind the development of treatments for ultra-rare diseases. “[RTW Foundation has] funded a lot of academic research grants, but the missing component was the embedment of these parents and patients in those efforts. So, we've restructured our granting approach now to make the rare disease parents and foundations, the owners, and the accountable party to the academic researchers,” Katakowski explains. “And we think this model is going to be far more successful than just funding academic researchers directly. Even though our current model still gets funding to the academic researchers, it makes those rare parents and the rare disease foundations the central player in the space. We empower them with knowledge related to drug development, and we empower them with funding and resources, and we engage with them for a prolonged period. It's not just a quick boot camp; it's not a weekend course. We're working with these foundations, oftentimes in excess of 16 months, perhaps two years, to really help them solve all the challenges that will come up inevitably during their drug development campaign.”

Katakowski and Deanna Portero, VP, Partnerships & Innovation, Orphan Therapeutics Accelerator, gave a presentation titled, 

“A Novel Pathway for Ultra-Rare Disease Treatment Development, Commercialization and Access”

 at INTERPHEX 2025, in which they discussed approaches to advancing treatments for ultra-rare diseases. PharmTech Group sat down with Katakowski to discuss how organizations like the RTW Foundation work to advance the development of treatments for rare diseases.

INTERPHEX 2025 was held in New York City from April 1–3.

Click the video above to watch part one of PharmTech’s interview with Joe Katakowski.

Joe Katakowski is director of Research at the RTW Foundation

In part two of Pharmaceutical Technology® Group's discussion with Joe Katakowski, director of Research at the RTW Foundation, the work of organizations like RTW Foundation in promoting the development of treatments for ultra-rare diseases is discussed. 

Nitrosamine Impurities inscription on wooden chips with stethoscopes on white background. Nitrosamine Impurities in certain drugs and pharmaceutical products concept. | Image credit: ©Debalina - stock.adobe.com

Nitrosamines occurring in pharmaceuticals became a developing problem in 2018, and regulatory agencies have been working with pharmaceutical companies since to mitigate the risk of these cancer-causing chemicals in drug products (1). In January 2025, FDA posted “Determining Recommended Acceptable Intake Limits for 

-nitrosamine Impurities in Pharmaceuticals: Development and Application of the Carcinogenic Potency Categorization Approach” in the Spotlight on CDER Science on the FDA.gov website (2).

® spoke with Josh Hoerner, general manager of Purisys, which specializes in a small volume custom synthesis and specialized controlled substance manufacturing, to gain his perspective on FDA’s recommendations for acceptable intake limits for 

What are nitrosamine drug substance-related impurities (NDSRIs)?

 NDSRIs are nitrosamine impurities that share structural similarities with the API and are generally unique to each API. These impurities are considered more complex and require more sophisticated testing methods to detect and quantify. The presence of NDSRIs is considered a higher risk, especially when the impurity forms as a result of the API’s chemical structure or the processes used during production.

The advanced testing conducted to determine the presence of NDSRIs involves sophisticated and sensitive mass spectrometry (MS) technology, including Triple Quadrupole Technology, which enables liquid chromatography-tandem mass spectrometry (LC-MS/MS). A high-sensitivity, low-level quantitation technology is particularly advantageous for detecting nitrosamines and other impurities that must remain within low permissible levels (based on safety data, a comparator, or the CPCA Potency score).

 What can you tell us about the recommendations FDA published in January 2025 for the development and application of carcinogenic potency categorization approach to nitrosamines? 

 Safety data (e.g., animal carcinogenicity data) for many potential NSDRIs or comparators are not readily available. FDA worked with the Nitrosamine International Technical Working Group (NITWG) to develop a methodology called the Carcinogenic Potency Categorization Approach (CPCA). The approach is based on a training set of 81 nitrosamines to establish five potency categories (1 high–5 low), reflecting carcinogenic risk. Essentially, the CPCA applies the knowledge that the α-hydroxylation mechanism of metabolic activation and the associated number of α-hydrogens as well as associated activating and deactivating features, drives nitrosamine potency. This allows a potency score for a potential NDSRI to be calculated along with the associated an AI to be calculated without direct safety data. Using this framework, a drug product manufacturer can then assess their drug products for NDSRIs below the [acceptable intake] and ensure patients are not exposed to levels exceeding or approaching the [acceptable intake].

What makes determining acceptable intake so challenging?

 There is a lack of direct safety data on NDSRIs and comparator compounds to establish a basis for potency. Prior to the CPCA framework, one might default to higher [acceptable intake] limits such as the 1500 ng/day, whereas those with higher potency scores have higher carcinogenicity risk, and therefore, should be controlled to lower [acceptable intake] levels.

What can pharma manufacturers do to manage the nitrosamine risk?

 There are two key guidelines included in the FDA-published compliance recommendations that define the framework for nitrosamine assessment and control:

Risk assessment and control of nitrosamine formation

. Manufacturers should evaluate and control two types of nitrosamine impurities:
--Small-molecule nitrosamines (structurally different from the API)
--NDSRIs, structurally similar to the API.

. Risk assessments should determine if nitrosamines are likely present, followed by testing. If testing shows nitrosamine impurity is present at a level 10% above the acceptable intake limit for that specific nitrosamine, FDA recommends that manufacturers develop specifications to keep nitrosamine levels within limits.

A comprehensive approach includes an initial paper-based assessment of technical risks (e.g., chemistry, solvents, excipients), followed by testing according to USP [

] General Chapter 1469.11. Risk ratings (low, medium, high) are assigned based on the likelihood of nitrosamine formation, with secondary amines posing the highest risk.

Manufacturers should partner with experienced CDMOs [contract development and manufacturing organizations] that offer a comprehensive solution for testing, synthesis, and risk assessment to ensure compliance with these complex requirements.

FDA. FDA Statement on the FDA’s Ongoing Investigation into Valsartan and ARB Class Impurities and the Agency’s Steps to Address the Root Causes of the Safety Issues. Press Release. Jan. 25, 2019.

FDA. Determining Recommended Acceptable Intake Limits for N-nitrosamine Impurities in Pharmaceuticals: Development and Application of the Carcinogenic Potency Categorization Approach. Spotlight on CDER Science. FDA.gov. Jan. 10, 2025.

Josh Hoerner, general manager of Purisys, provides his perspective on FDA’s recommendations for acceptable intake limits for N-nitrosamine impurities.