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

Felicity Thomas

Industry Outlook 2025: The Impact of Politics on Pharma

The political landscape is evolving and unpredictable at the moment, according to Edwin Stone, CEO of Cellular Origins, and the development of an inward focus by the United States might have a negative impact on the development and manufacturing of emerging treatments. Collaboration when tackling complex biology to treat complex diseases is necessary between the US, Europe, and beyond, says Stone.

“For a long time, I've always been hopeful and optimistic, and frankly, my confidence is a little shaken now that Asia, and particularly China, can be bought into the fold,” Stone says. “There's an awful lot going on in advanced therapies in China that we do not see in Europe or the US, and similarly, vice versa. Unfortunately, it looks like in the immediate term, we may see a backing off on that. Now, what we don't know is how much narrative transfers into reality there. And there is some suggestions, I think, that perhaps actually the reality will be a bit more tempered, some saber rattling and some strong signals early on to get some positioning. And hopefully, actually what we're seeing is a level of pragmatism come into that, because I really am a great believer that for the sort of problems we attack on now, if we work together, we'll have a chance to actually move these things forward and move these things forward a lot quicker. And let's remember this is for the benefits of patients and for people. It is not just about profits.”

Click the video above to watch the full interview.

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The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about the impact of the changing political landscape on the pharmaceutical industry.

Alexander Seyf, CEO and Co-Founder of Autolomous

Alexander Seyf, CEO and co-founder of Autolomous, sees the advancement of artificial intelligence (AI) and machine learning (ML) as tools to support pharmaceutical scientists and manufacturers in their work.

“AI and ML can help us to do the leg work, but the main work is going to need to be done by our own brain, but by human being,” Seyf insists. “I think it will be more segregation of mechanical work rather than intellectual work. And for identifying the progression of biology and the discovering the different solutions for different diseases, you've seen an amazing trend today. There are companies in the United States that we're looking at using off-the-shelf drugs for different indications that it was not intended from beginning. And I believe that's a huge, huge progression in the right direction. And for drug discovery, we're going to look at cross fertilization, of what we have already enhanced for the solution to the diseases that we don't have any treatment for. So, we will see examples of that practically, ML and AI can help us to progress the pharma and other industries, for that matter, more in the right direction.”

Alexander Seyf is CEO and Co-Founder of Autolomous.

Pharmaceutical Technology® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about the use of artificial intelligence and machine learning in pharmaceutical development and manufacturing.

Industry Outlook 2025: Technology as a Supporting Element

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

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.

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. 