Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Felicity Thomas

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.

Magnifying glass and check mark icon. Business concept,idea,right choice, quality control, approval and contract assignment | Image Credit: ©olyphotostories - stock.adobe.com

The bio/pharmaceutical industry is, understandably, strictly regulated and, as such, companies seeking commercialization of a therapeutic product must ensure they meet the relevant requirements at all stages of development through to dossier submission and beyond. Unfortunately, the breadth of knowledge and level of expertise required to ensure full regulatory compliance, the requirements for which can differ depending upon geographic location, is not always found within a company’s internal team.

However, when seeking out support for quality-related matters and regulatory affairs, sponsor companies need to understand how to qualify external employees or consultants correctly to avoid potential pitfalls and issues with the regulatory authorities later down the line.

Applying modern technologies in development

Artificial intelligence (AI) is being increasingly used across many aspects of everyday life. Within the bio/pharmaceutical industry, AI is also being employed for various tasks, including formulation of novel drug products. However, with novel technologies comes uncertainty and usually a lack of expertise.

“Of course, using modern methodologies, technologies, is not only making sense from a commercial perspective, but the regulators are also really encouraging [their use],” remarked Siegfried Schmitt, vice president, Technical at Parexel, during episode two of Pharmaceutical Technology®’s Ask the Expert video series (1). “Now, when you apply something that new, then it’s very likely that you may need external support by experts, external experts, and when you use a third party to help you, especially with GMP [good manufacturing practice], GxP [good practice]-related activities like development, then you need to apply some vendor assessment process.”

Yet, with such a new technology, Susan J. Schniepp, distinguished fellow and quality assurance expert at Regulatory Compliance Associates, a Nelson Labs company, questioned how it is even possible to qualify the external experts that will be required. “I think, when putting in an AI system or looking at it, the one thing I would highly recommend companies do is quality management risk assessment,” she noted. “[Companies] cannot put in a system without doing that very comprehensive risk assessment.”

Requirements for submitting regulatory applications

When specifically looking at the requirements for a new drug (NDA) or biologics license applications (BLA), Schniepp explained, during episode three of the Ask the Expert video series (2), there is basic information that is required, which can be easily researched on FDA’s website.

FDA provides guidance on the information that they require to ensure successful submission of an NDA (3) or BLA (4), including notes on critical information that, if it isn’t included, will mean rejection of the application as an incomplete file, Schniepp added. “But the best way to make sure that you’re giving [FDA] what they need is to really talk with them,” she said.

Communication with the agency is particularly imperative when dealing with novel biologic therapeutics, Schniepp advised. “When we talk about ATMPs [advanced therapeutic medicinal products] that are probably going to go in a BLA, [there will be] a lot of complications, and [companies] need to be working with the agency up front to make sure [they] are handling those filing issues,” she noted.

“It’s not just with FDA,” continued Schmitt in the same Ask the Expert video series episode (2). “All the agencies I know of have provided the opportunity to applicants for pre-approval meetings, pre-submission meetings, and you should take note of this and make good use of it.”

Within the biologics space too, Schmitt explained that many companies are smaller in size. “Of course, these [companies] are the ones who need the most support, and when you look at the agencies, they have special support programs for such companies,” he said. “Now, of course, [the company] can ask the agency [and they] hopefully have some in-house expertise, but again, it is sensible to understand, where are the gaps? Where would [the company] perhaps need external support?”

Understanding the need for the right people

For smaller companies, the expertise is not always available in-house, leading to some companies outsourcing quality functions, Schniepp specified. “But the relationship of how [a company] qualifies contract employees or consultants is very critical,” she asserted.

As quality consultants themselves, Schniepp and Schmitt emphasized that they need their clients, the sponsor company seeking expert assistance, to understand all the relevant background information and not simply choose a quality consultant based solely on the cheapest price option. “[Companies] need to look into the consulting firms they’re going to use and make sure they have the right expertise to support the [regulatory] filing,” Schniepp explained.

“[Companies] have to understand when outsourcing critical functions that [it is imperative] to have the right people,” Schniepp continued. Ultimately, when the filing has been completed, the consultant’s work is done and they are no longer needed, which means the sponsor company must understand the work that has been done to complete the filing as they are then responsible in the eyes of the regulator, she stressed.

If a company hires a quality consultant who doesn’t have the expertise needed for the task, but they were the cheapest for example, then there will more than likely be regulatory problems later down the road, Schniepp warned.

“[Companies] need to have a quality system that makes sure that whatever external support [they’re] calling for [they] select those who are most suitable for [their] needs and can provide quality expertise,” confirmed Schmitt.

Thomas, F.; Haigney, S. Quality Considerations for Using AI in Bio/Pharma. 

Thomas, F.; Haigney, S. Submitting Regulatory Applications Connects to Quality. 

www.fda.gov/drugs/types-applications/new-drug-application-nda

FDA. Biologics License Applications (BLA) Process (CBER). 

www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber

Felicity Thomas is former associate editorial director of 

®
Vol. 49, No. 3
April 2025
Pages: 32-33

When referring to this article, please cite it as Thomas, F. Qualifying Expertise for Quality Support. Pharma

Articles

Bringing in external expertise may be necessary when internal knowledge is lacking, but it is critical that any contract employee or consultant is comprehensively assessed to ensure the right person is employed.

Qualifying Expertise for Quality Support

Industry Outlook 2025: Political Impacts on Supply Chains

Diversifying where a company sources ingredients and products is an important part of keeping the supply chain robust, says Will Gordon, senior vice president of Product Management, ArisGlobal, and companies must be able to adapt to geopolitical instability to continue to secure the supply chain.

“If something happens in X country, are you able to quickly shift capacity to develop whatever it is to another country or another area? And if we look at what's happening in the United States, there's this BIOSECURE Act, and that's kind of similar, right? So, the US government could, at any point say, ‘Okay, this company is associated to this government, and they're a non-friendly government, and so we're no longer going to allow you to source products from that if you have any federal funds.’ Well, most pharmaceutical companies receive federal funds because government is a large purchaser of pharmaceutical product, right? So, you have to be able to say, okay, how can we shift capacity? How can we shift our supply chains? And I think the pharmaceutical companies of the world have done a really good job at creating that robustness across the supply chain, from sourcing all the way to delivery, and they just have to continue to be nimble and shift as political changes come up,” says Gordon.

Will Gordon, senior vice president of Product Management, ArisGlobal.

Will Gordon is senior vice president of Product Management, ArisGlobal.

Pharmaceutical Technology® spoke with Will Gordon, senior vice president of Product Management, ArisGlobal, about how the geopolitical instabilities might impact the bio/pharmaceutical industry. 

Industry Outlook 2025: Business Viability and Global Collaboration

Being realistic about the viability of business, finances, technology, and the success of drug products, as well as getting back to the basics, are trends from 2024 that have impacted the bio/pharmaceutical industry, according to Alexander Seyf, CEO and Co-Founder of Autolomous. “We're seeing people going back to the drawing board and thinking at the same time [not just the] science, but also the viability of having it as a business,” says Seyf. “I think that's a very positive [trend], because sometimes we need little bit of nudge in the in the shoulder to really guide us forward.”

Seyf also stresses that the industry needs to break out of a “siloed” mentality and embrace working together. Part of making business viable is harmonization and thinking globally. “And one of the key elements, I would say, is we need support from governments. We need support from policy makers,” Seyf says. “And right now, I've seen a good trend in the United States this year that they begin to realize that this is an industry to invest in, and we need to think a little bit differently than we do for pharma. However, I also see the whole kind of healthcare situation in US can be little bit difficult to move it to a more rational change, or to more radical change. However, in Europe, we have the benefit of national health services, and … politicians start realizing the new modality of medicine. There have been a number of talks, and, also, I believe it was mentioned in the parliament. So, we see good trends, both from a Europe perspective, but also a UK [United Kingdom] perspective.”

Alexander Seyf, CEO and Co-Founder of Autolomous

Alexander Seyf is CEO and Co-Founder of Autolomous.

Pharmaceutical Technology® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about which trends from 2024 he expects to impact the bio/pharmaceutical industry in 2025.

Industry Outlook 2025: Large Language Models

Barriers to the use of artificial intelligence (AI) and machine learning (ML) in the pharmaceutical industry include the cost of implementation and training, according to Will Gordon, senior vice president of Product Management at ArisGlobal. “As you're training your models, and you're starting to use them in the industry, some of them were successful, some of them were not. But one of the things that always took a long time was the actual training. So, you have to go out and source the data. If you had [the data] in house, or you had to go get it externally, [it] was costly and time-consuming, from not only trying to find it, but then cleaning it, and then understanding the data and then training the models.”

Large language models (LLMs) have made implementation easier, according to Gordon. “As LLMs are coming into the industry, you can actually change the speed to which you can pull some of this technology, AI/ML, into your business, right? And so, of course, there's privacy concerns, intellectual property concerns, and I have to think that that will just get sorted … in time. But if you're not playing with this technology, if you're not trying to look for every space of what you do, no matter what department you're in, whether it's R&D, post-market, [or] sales, you have to be using [AI/ML], and the large language models have really kind of sped your ability to test.”

Pharmaceutical Technology® spoke with Will Gordon, senior vice president of Product Management, ArisGlobal, about the impact of artificial intelligence and machine learning on the bio/pharmaceutical industry.