Susan Haigney

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.”

Click the video above to watch the full interview.

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


AAPS National Biotechnology Conference 2025: AAV Vector Production

Adeno-associated virus (AAV) vectors are commonly used for gene therapies, according to Noah Kopcho, field application scientist at Gyros Protein Technologies. AAV vectors come with challenges in productions, however. “Namely, compared to other vectors, AAV often has lower titers,” says Kopcho. “This can present problems with scalability. During the production and purification workflow, there are several different contaminants that need to be kept in mind, and purity is often essential. And at the at the end of the workflow, you know all of these measurements that need to be made can present several different bottlenecks that that can be very time consuming and can often eat into efficiency.”

 sat down with Kopcho to find out how these challenges can be overcome. Click the video above to watch the interview.

Kopcho’s spoke on this topic at the AAPS National Biotechnology Conference 2025, which is happening May 4–7, 2025 in Boston. His presentation, “

Accelerate Development of AAV-based Gene Therapies with Automated Viral Vector Titer and Impurity Analysis

Noah Kopcho is field application scientist at Gyros Protein Technologies.

BioPharm International® sat down with Noah Kopcho, field application scientist at Gyros Protein Technologies, to talk about the challenges in the production of AAV vectors.

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On May 1, 2025, Aviva Capital Partners and mixed-use developer Socius announced plans for a new £1 billion (US$1.33 billion) investment to create a cancer research and treatment center in Sutton, London. The 12-acre site will be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.

The plans are to create approximately 1 million square feet of state-of-the-art research and laboratory space where life sciences companies can come together with academic researchers and clinicians to push cancer research forward. The project is expected to create 3000 new jobs including high-skilled R&D and small-scale manufacturing life sciences positions.This will increase the workforce of the London Cancer Hub to 13,000 and contribute £1.2 billion per year to the economy in the United Kingdom.

“We invest to grow the economy, drive regeneration, and create jobs and homes in the UK,” David Epstein, managing director of Aviva Capital Partners, said in a press release (1). “We’re delighted to be investing in world-class cancer research in Sutton. As well as helping the UK to grow and get ready for the future, this investment will be a boost for the local area, with thousands of new jobs created.”

The development will feature large-scale facilities, smaller lab and incubator spaces for start-up companies, wet labs, good manufacturing practice facilities, specialist equipment, and office space. In addition, a Learning Lab will include a classroom and education spaces. Amenities will include restaurants, cafes, and affordable housing for workers. Buildings will exceed sustainability and energy efficiency standards with a net-zero carbon goal.

“There is a unique opportunity at the London Cancer Hub to deliver state-of-the-art lab and research facilities alongside two world-renowned institutions, The Institute of Cancer Research and The Royal Marsden, to supercharge investment into cancer research,” Barry Jessup, managing director of Socius, said the in the release. “Our plans are not just about delivering new facilities to attract cutting-edge businesses, it is about reorienting the district so there is better connectivity between the buildings, more natural ‘collision points’ and places to meet to drive collaboration and innovation.”

The new development will expand the London Cancer Hub, which already includes the Institute of Cancer Research, with more than 1000 scientific and profession staff, and the Centre for Cancer Drug Discovery, which opened in 2021. The Centre has been successful in discovering 21 potential cancer drugs, including 13 that have gone into clinical trials.

“We’re very pleased to be working with Aviva Capital Partners and Socius on plans to further build the thriving multidisciplinary research district in Sutton, and we’re hoping that the project will attract a range of companies to locate here alongside us, as well as provide a home for companies that spin out from our science in the future,” Kristian Helin, chief executive of The Institute of Cancer Research, London, said in the release. “The London Cancer Hub has great potential to enhance our scientific partnerships with companies in the pharmaceutical and broader life-sciences industries, in areas from the discovery and development of new cancer drugs to the creation of new treatment and diagnostic technologies.”

Dame Cally Palmer, chief executive of The Royal Marsden NHS Foundation Trust expressed support for the new project in the press release. “The Royal Marsden’s Sutton site is home to a flourishing research community between The Royal Marsden and The Institute of Cancer Research, London, that consistently translates innovative ideas in drug discovery from the laboratory to the clinical setting for the benefit of cancer patients worldwide,” Palmer stated. “We support the vision for The London Cancer Hub and the investment from Aviva Capital Partners to bring life sciences industry on to the site. We anticipate this will facilitate greater collaboration and foster an environment of excellence to further our work developing new and improved ways to diagnose, treat, and care for our patients.”

“The London Cancer Hub will position Sutton as London’s global center for oncology. Already recognized as a leading life science cluster in the capital, the site’s uniqueness lies in its current delivery of world-class cancer research, discoveries, and treatment all within a single location,” Councillor Bary Lewis, leader of the London Borough of Sutton, said in the release. “The life science sector and associated development will be pivotal to the future growth of the capital over the coming years as recognized by the Mayor of London’s growth plan that names the London Cancer Hub as the key engine for this growth. The submission of this planning application marks a significant step forward in the is exciting development for Sutton and the capital.”

1. Aviva. Aviva Capital Partners and Socius Submit Plans for £1 Billion Development to Create the World’s Leading Centre for Cancer Research and Treatment. Press Release. May 1, 2025.

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Aviva Capital Partners and developer Socius are investing £1 billion to develop a cancer research and treatment center in Sutton, London.

Cancer Research and Treatment Center Planned for London

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?”

*Scroll below for a full transcript of the video.

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.

Editor's note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

Welcome to the Ask the Expert video series, brought to you by Pharmaceutical Technology, pharmaceutical Technology, Europe, and Biopharm International. This series is an extension of the pharmaceutical technology groups long running print column in which industry experts answer common quality and regulatory questions.

This new video series will expand on topic areas and development and manufacturing concerns to help those working in the industry better understand biopharmaceutical requirements. We hope you enjoy the discussion.

So thanks very much again for joining me today, Sue and Siegfried. It's great to have you on as always. for our ask the Expert series, we've got a question here from one of our viewers and they are asking, that their company handles a variety of personal data in their regulatory applications, and they have seen that the EMA, the European Medicines Agency has revised the guidelines on the use of personal data in applications.

So what should they focus on when securing such data? So you see in the minds of many a company, anything that is in a dossier, IE an application to the regulators is by default, confidential, and must not be disclosed by the agencies. it was always felt that one should not have concerns when, sending anything to the agencies such as the European, medicines Agency.

so 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 wake up call as the agencies only feel obliged to not disclose anything that is blindingly obvious secret, such as the manufacturing formula.

So, this is completely different to what most companies had in the back of their mind. So there are perhaps less obvious data in application that could potentially cause enormous harm to the applicant if they were disclosed. So take for example, the listing of the clinical study sites. 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. anything you would like to add, Sue? I think it segues nicely into, if that information is, Siegfried said the clinical trial directors got out. There. My company is interested in cybersecurity and I think that there are a lot of scams that are using AI now in replicating voices.

And if you have, you know, a conference attendee, who's referenced in your application and they speak at a and you can see how that can go down a little rabbit hole. But, I think a lot of the concern has to do with what Siegfried, mentioned. It's protecting, the company. In a little bit stronger way and preventing some of these, sophisticated cyber, attacks that are going on all over the place.

What you just said, that the company needs to be protected. Absolutely. And you see, I believe that in many regulatory affairs departments who put together these submissions, they aren't really fully aware of these risks. don't really know how to take appropriate precautions. And when I say precautions, what I mean by this is.

To have a procedure in place that identifies what is actually commercially confidential information and personal data in an application. So this procedure then needs to provide instructions what information and data can and should be included in the application in the first place. If you can leave it out even better, then furthermore.

As regulators now demand that the applicant provides an acceptable reasoning why certain information or data should not be disclosed, then the company should have already made templates, reasoning text in place. So you need to have instructions, you need to have a procedures manual, so to speak.

And of course, people need to be trained in this. Yes, absolutely. So I think the, the key point here for companies is that you want to be proactive. You don't want to be reactive or it was be unprepared altogether. So you don't want to be caught off guard by an agency telling you, well, no, we don't accept that.

You just tell us. It's in your view, in your view, confidential. You don't give us a good reasoning, so be ready for it. Okay. And perhaps one aspect that this document doesn't really address is what about the correspondence between the applicant . And the agency in relation to a submission?

Have to be disclosed if someone applies for it or not. Do we now have to do this similar thing as you already do in the US and STEM every document as private and confidential to be disclosed? Perhaps this is something that has to happen, so maybe we have more of a similar approach in future in Europe, as you already have in the us.

I think it's all about protection, further protection, for the companies really is what is and for the employees too, right? It's protection for the employees in the company and that's really what we need. So it needs more awareness and that is clearly the message from us. Yes, absolutely. Perfect.

Thank you both. It's been great talking to you.

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More information about how to connect with our team can be found on our websites, farm tech.com and biopharm international.com. Thanks to everyone for joining us for this video series. We'll look forward to seeing you next time.

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.