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

Felicity Thomas

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.”

Click the video above to watch the full interview.

Alexander Seyf is CEO and Co-Founder of Autolomous.

Videos

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.

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.”

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, 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.”

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.

Felicity Thomas

Articles