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

Felicity Thomas

Industry Outlook 2025: European Political Impacts on the Supply Chain

The instability in the European geopolitical climate, as well as other areas of the world, has created some nerves in many industries, but the increased focus on the need to have a healthy and safe supply chain for pharmaceuticals is one positive outcome of a tumultuous time, according to Edwin Stone, CEO of Cellular Origins.

“I think for a long time, people took [supply chains] for granted. There was a narrative that has been born over the last 20-plus years that just in time, was the right model,” says Edwin Stone, CEO of Cellular Origins. “And of course, that's very true in a situation where you're putting a box of corn flakes on a shelf, and every extra week that corn flakes packets on the shelf is probably knocking a quarter off of your margin on it. So, by week four, effectively you're giving away for free. That's not so true in medicines. In medicines, we need to take a bigger picture view. We need to look at the accounts differently. I know companies that took very pragmatic views 10 years ago, to set up facilities where they would hold stock of 18-month supply of certain consumables. And it took a lot of warehousing to do it. This was equipment, supply people. But what it meant was, through the construct supply constraints, we saw, for example, through COVID, that they were able to actually continue to supply where others couldn't. The rationale, actually, the shelf space of these high-value consumables was a fraction compared with the value when they sold them to the customer. So, I think what's been really good is [the instability] has caused that focus on supply chain. I think it's managed to remove some of the assumptions of certainty and some of the lack of risk consideration that we'd got into.”

Click the video above to watch the full interview.

Videos

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about how geopolitical instability in Europe, and beyond, has impacted the bio/pharmaceutical supply chain.

Industry Outlook 2025: The Future of Technology in the Biopharma Industry

Technologies such as artificial intelligence (AI) and machine learning (ML) are advancing quickly in many industries, including the biopharmaceutical industry. One challenge in the implementation of these technologies in biopharma, according to Edwin Stone, CEO of Cellular Origins, is the data sets and the sensitivity surrounding it.

“There's a huge amount of proprietary data,” Stone says. “And so, I think [this is] something actually, as an industry, we're really going to have to think about a lot harder than we had previously. And remembering here, we're in an industry where, by solving these problems, we help make people better. How do we collaborate better? How do we understand and separate out the competitive landscape from our ability to make enormous strides for us? And I think [it] will be a massive shame for the industry if we all operate in our silos and we miss out on the benefit that I think a lot of those data processing technologies could have. I think the other piece, of course, with this is AI and ML are having a huge impact on [drug] discovery, and I think in the world, in the virtual world, in the software world, that's unsurprisingly, where they found their home.”

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about how technological advances will impact the biopharma industry in the future.


Alexander Seyf, CEO and Co-Founder of Autolomous

Political shifts in the United Kingdom and Europe may have a negative impact on research efforts for gene therapies performed by universities and other research organizations, says Alexander Seyf, CEO and co-founder of Autolomous. However, the impact on the bio/pharmaceutical industry is more likely to be minimal.

“The established companies in Europe, they still have a huge market in [the United States], and we've seen the growth and establishment of these companies expanding their operation to the United States and elsewhere in the world,” Seyf assures. “So, [because of the BIOSECURE Act], they might actually also consider [expanding] their activities in Asia. And the UK government gradually, but certainly, they [will] start also realizing they need to put more support through Catapult, cell and gene therapy, and other activities to boost the industry. [It] is a very ample opportunity for United Kingdom to put itself back in the map for cell and gene therapy and for new medicine.”

Alexander Seyf is CEO and Co-Founder of Autolomous.

Pharmaceutical Technology® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about the impact geopolitical changes in Europe might have on the bio/pharmaceutical industry.

Industry Outlook 2025: European Geopolitical Impact on Pharma

Industry Outlook 2025: Political Implications for Pharma

The fundamentals of healthcare are established and supported in the United States, Alexander Seyf, CEO and co-founder of Autolomous, says, and while the changing political landscape might come with some bumps in the road, he believes the mission to treat patients will continue forward.

“I hope that [politicians realize] they can be one of the customers of the pharma and biotech,” Seyf says. “So, I would say at the core of it, we all are human, and sometimes we need to have a little bit of selfish kind of motivation to do the right thing. So, either we going to see a lot of people who have a higher ground, and they will push the support [of] pharma and biotech forward, or they might have a selfish kind of objective at the end, [which] will yield to a positive result. So, I'm pretty positive, because I believe you can change people, but the system will take longer than four years to change.”

Pharmaceutical Technology® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about how the political landscape may impact the pharmaceutical industry.

Ask the Expert: EU Data Protection

 that the agency and the Heads of Medicines Agencies (HMA) have revised their guidance on identification of commercially confidential information (CCI) and personal data used in marketing authorization applications. The revision was done as part of the agency’s commitment to transparency in the disclosure of information in response to access-to-document requests and the publication of data for authorized medicines (1).

 video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss the impact of the revised guidelines and what manufacturers should do to secure such data.

“It was always felt that one should not have concerns when sending anything to the agencies such as the European Medicines Agency, or any agency within the European Union or the European Economic Area, because you would think that they understand what is confidential and what is not; however, this document is really a wakeup call, as the agencies only feel obliged to not disclose anything that is blindingly obvious secret, such as the manufacturing formula,” Schmitt says.

“So, this is completely different to what most companies had in the back of their mind. There are perhaps less obvious data in an application that could potentially cause enormous harm to the applicant if they were disclosed. For example, the listing of the clinical study sites and the names and contact details of the principal investigators; competitors could try and poach the patients and/or the investigators. The guidance only says that such data and information may be considered secret, but it doesn't say it is secret,” Schmitt explains.

Click the video above to watch Sue and Siegfried answer the following question:

“Our company handles a variety of personal data in our regulatory applications, and we saw that EMA has revised guidelines on the use of personal data in applications. What should we focus on when securing these data?”

1. EMA. A Common EU Approach to Data Transparency in Medicine Regulation. Press Release. Dec. 18, 2024.

Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates and a member of 

Siegfried Schmitt is vice president, Technical at Parexel and a member of 

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to 

, and it may appear in a future episode or print column.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss EMA’s revised guidelines on data protection in marketing authorization applications.

Industry Outlook 2025: Mergers, Acquisitions, and Funding

According to Erik Wiklund, CEO of Circio, the bio/pharmaceutical industry has seen a trend toward fewer, but larger mergers and acquisitions. During the COVID-19 pandemic, biotechs had ample access to venture capital and public funding; however, since the pandemic, capital has dried up, as valuations have plummeted and investors have lost money. In addition, a looming patent cliff is also straining revenue expectations.

“Both of these forces can converge into larger and later-stage deals, so investors are likely to buy into later-stage de-risked programs with clinical validations, Stage II, Stage III, [with a] clear path to approval, and that's probably where the M&A deals are and will continue to happen,” Wiklund says. “Investors are looking for lower-risk assets with a clear development path closer to the clinic. Unfortunately, for a company like ours, which is building a really exciting new gene therapy technology platform, it has become difficult to fundraise in the current environment. This forces companies like Circio to prioritize asset generation, picking a track and going deep in one single area, rather than to scientifically develop the platform to its full potential which would have been the standard strategy three years ago, where Big Pharma and investors were looking for technology platforms with broad therapeutic potential.”

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 future of M&A in the bio/pharmaceutical industry and the struggle small biotech companies face raising funds.

Felicity Thomas

Articles