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

Felicity Thomas

Pharmaceutical Technology® discusses industry trends from 2024 and those expected to have an impact in 2025 from the perspective of a software developer with Mike Baird from Schlafender Hase.

Industry Outlook 2025: From the Perspective of a Software Developer

Looking at the various industry trends from the technology side of things, Mike Baird, director of product management for Schlafender Hase, a German software company, specifies that digitization has been hugely interesting. “When I say digitization, I'm not talking about emailing an Excel spreadsheet around to people. I'm talking about dedicated tools and solutions that that link workflows and processes together to try and make them as seamless as possible,” he says. “As as far as I'm concerned, digital maturity is a measurable thing, and we can we use certain tools to help us educate our customers, to help us understand them and their needs.”

Another key trend for industry has been the drive from regulators to move from paper to electronic product information. During 2024, within the European Union, the European Medicines Agency completed its Fast Healthcare Interoperability Resources program— aimed at determining whether a move to more digital based products would work— successfully, Baird specifies.

Additionally, another big trend from 2024, and a few years prior too, was artificial intelligence (AI), which has had its ups and downs in terms of acceptance and denial by industry but is now starting to settle down, Baird adds. “People are getting some level of acceptance in how and where [AI] can be used,” he says.

Mike Baird, Director of Product Management for Schlafender Hase

Mike Baird is Director of Product Management for Schlafender Hase—a German software company. Mike’s role is to develop software to meet and exceed the needs of customers. He has more than 25 years of experience working with global packaging, labelling, pre-media, and artwork management leaders in the pharmaceutical and medical device sectors.

Videos

Industry Outlook 2025: Interesting Relations and Detailed Discussions on Data

The political landscape in the United States has shifted, and while industry is learning about the various changes and new appointments, the full impact is hard to predict, not least because of the continuation effect from previous governments, points out Preeya Beczek, managing director and co-founder of Beczek.COM Ltd. However, there are three or four areas that she believes will be of potential interest with the new administration in place.

“I'm quite interested to think about China relations with the US and this BIOSECURE Act. I think that's going to perhaps impact the import tariffs, and then this could have a ripple effect on the global pharma industry, pharma economy,” Beczek explains. “The second thing, and this is not a new thing, is around anti-vaccine, anti-pharma sentiments, perhaps with the RFK [Robert F. Kennedy, Jr.] influence.”

Additionally, there is also discussion around the cost of drugs and provision of care and privatization that will continue throughout 2025, Beczek adds. “And then this final point I'm going to make is around digital health, health technology, AI [artificial intelligence], and mix that in the balance with data privacy,” she says.

Looking across the Atlantic, towards Europe, which has also undergone political shifts in 2024, industry is still working to get to grips with recent legislative changes, such as the new pharmaceutical legislation and the European Union clinical trials regulation, Beczek remarks. “So, coming back to that thing around information, data security, and what data [are] out in the public domain, right? There're still decisions that need to be made there at the very detailed level, and companies can expect to have detailed discussions around this,” she says.

Preeya Beczek, Managing Director and Co-Founder of Beczek.COM Ltd

Preeya Beczek is Managing Director and Co-Founder of Beczek.COM Ltd, a specialist in regulatory affairs and compliance. Preeya has worked in the regulatory affairs and compliance space for over 25 years, focusing on regulatory affairs activities at a strategic and operational level. Prior to her current role, Preeya worked in industry performing a lot of infrastructure and process development to support companies with new systems, initiatives with AI automation, regulatory, information management, system software modernization, and so on.

Preeya Beczek from Beczek.COM gives her thoughts on the areas to watch with the new US administration and how Europe might be finalizing preparations for previous legislative changes in an interview with Pharmaceutical Technology®.

Ask the Expert: Complying with 21 CFR 211.110

In January 2025, FDA published a draft guidance document that provides considerations for complying with 21 

) 211.110 (1). This specific section of the 

 focuses on production and process controls for sampling and testing of in-process materials and drug products. The guidance, 

Considerations for Complying With 21 CFR 211.110, Guidance for Industry, Draft Guidance

, applies to human drug products and biologics, but not to the manufacture of APIs. The guidance document also discusses how process models can be incorporated into commercial manufacturing control strategies.

 video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss the implications of this draft guidance and best practices for complying.

“What [the guidance document] really seems to be aimed at is new manufacturing techniques that are coming on board and some flexibility for biopharmaceuticals as we get into, you know, personalized medicines, continuous manufacturing, and the use of artificial intelligence (AI) to identify some of the key process parameters for new manufacturing and processes … giving manufacturers more flexibility in that arena,” explains Schniepp.

“FDA is trying to look to the future, is trying to address what's current, what's happening now. And as you said, use of AI; although, I don't think a lot of companies are really, really implementing this yet in day-to-day operations. Perhaps another aspect here of this guidance is it speaks a lot about continuous manufacturing, which, again, in my experience, is a process that's rarely applied in most of manufacturing because the vast majority of processes are still back by batch,” says Schmitt.

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

"I saw that FDA posted a new draft guidance for complying with 21 

) 211.110. How will this impact how my company performs batch uniformity testing?"

https://www.fda.gov/media/184825/download

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

Siegfried Schmitt, PhD, 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 the implications of FDA’s new draft guidance on complying with 21 CFR 211.110.

Industry Outlook 2025: Personalizing Precision Medicine and Adopting AI

“I do think there's a number of areas that are going to be trends for 2025 and somewhat continuation from this year,” says Preeya Beczek, managing director  and co-founder of Beczek.COM Ltd, a specialist in regulatory affairs and compliance. “There's a real focus on personalizing precision medicine, including cell and gene therapies, and, you know, there's expected to be quite a major trend in this area to really focus on the personalized part of that.”

Additionally, there has been a lot of talk from industry about digital manufacturing and using cloud-based systems to improve efficiency, Beczek continues. And, going hand-in-hand with the data-driven approach is the ability for companies to realize the potential return on investment for their R&D efforts, she adds. “It's really looking at that end to end, moving away from functional silos to looking at the R&D end to end, which I find very exciting, actually, because it can really improve health outcomes and really allow companies to focus on the patient,” Beczek says.

A key trend for 2025 will be artificial intelligence (AI), Beczek specifies. “I think we're just going to have lot more people adopting [Generative AI and] that way of working, in their day-to-day work,” she says. “I think that there's going to be some push to get speed, [in] things like manufacturing timelines, [so] they become shorter.”

Preeya Beczek, Managing Director and Co-Founder of Beczek.COM

Pharmaceutical Technology® chatted with Preeya Beczek, managing director and co-founder of Beczek.COM, about industry trends from 2024 and which of those might impact the industry in 2025, including the big trend of AI.

In this exclusive Drug Digest video interview Anil Kane from Thermo Fisher Scientific will be tackling the topic of advances in small-molecule manufacturing and we have a selection of comments on associated topics. 

Advances in Small-Molecule Manufacturing

In this exclusive Drug Digest video interview, Felicity Thomas, Associate Editorial Director, and Patrick Lavery, Editor, 

Group, will be tackling the topic of advances in small-molecule manufacturing with Anil Kane from Thermo Fisher Scientific. Additionally, we will also have some extra commentaries on the trends shaping the oral solid dosage market with Uwe Hannenberg from Recipharm, the manufacturing hurdles associated with challenging molecules with Jens Schmidt from Lonza, and some advice from our Ask the Expert columnists about changing excipient providers.

Anil Kane, PhD, MBA, Global Head of Technical & Scientific Affairs, Pharma Services, Thermo Fisher Scientific

Dr. Kane has more than 25 years of experience in the science and business of taking molecules through the entire drug development process, spanning early-stage development to scale-up and commercial manufacturing and includes technical transfers between global sites and drug life cycle management. Dr. Kane received his Bachelors, Masters and PhD degrees from the Bombay College of Pharmacy, University of Bombay, India, and served as a post-doctoral fellow at the School of Pharmacy, University of Cincinnati, Ohio. He has also earned an executive MBA from Richard Ivey School of Business, University of Western Ontario, Canada. Dr. Kane is a member of various international pharmaceutical professional organizations and is often asked to speak about scientific topics on formulation, technology and other technical aspects at major industry events. He has also published many articles in international journals and delivered many talks at meetings and conferences across the globe.

Uwe Hanenberg, Head of Product Development, Oral Solid Dose

Dr. Uwe Hanenberg, Head of Product Development, Oral Solid Dose (OSD) at Recipharm. Uwe is responsible for implementing and executing the OSD Product Development strategy that assures science driven, timely development of new products or services. Uwe has 25 years of experience in the pharmaceutical industry with Bayer, Altana, Grünenthal and Catalent. He has held several leading positions in quality, manufacturing and packaging, product development, project management within the Science & Technology sphere. His areas of expertise are oral formulation development, oral manufacturing technologies, stick pack technologies and pharmaceutical contract services and project management.

Jens Schmidt, Associate Director of Manufacturing, Science, and Technology (MSAT) at Lonza

Jens Schmidt is the Associate Director of Manufacturing, Science, and Technology (MSAT) at Lonza. In this role, he leads a team of MSAT scientists and serves as the technology lead for high-throughput experimentation focused on small molecules.

Before joining Lonza in 2017, Jens gained valuable experience as a research associate at the University of Oxford and the California Institute of Technology (Caltech). He is an organic chemist by training and holds a Master of Science in Chemistry from the University of Leipzig and a PhD from the University of Hamburg.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs company

Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates, a Nelson Labs company and member of the Editorial Advisory Boards for 

Pharmaceutical Technology, Pharmaceutical Technology Europe, 

. Susan is a regular contributor to the Ask the Expert print and video series and has offered thought leadership and expert insight into quality and regulatory concerns for Pharm Tech Group’s publications. She has also served as the past-chair of the Parenteral Drug Association and was previously a chair with the US Pharmacopeia.

Siegfried Schmitt, vice president, Technical at Parexel

Dr. Siegfried Schmitt is a Fellow of the Royal Society of Chemistry, Chartered Chemist and Chartered Scientist. He started his career with F.Hoffmann-La Roche in Basel, Switzerland, where he worked as Senior Production Chemist in Active Pharmaceutical Ingredients and Vitamin production. Following a move to the UK, he worked for several years as consultant and validation manager for Raytheon E&C, followed by two years with ABB Eutech as Senior Lead Consultant. In 2002 Dr Schmitt joined Amersham Health (now GE Healthcare) as global Quality Assurance Director in Information Management. In July 2007 he joined PAREXEL Consulting in the UK as Principal Consultant. Dr Schmitt regularly publishes articles on scientific and business subjects, and has written several books. He speaks on a variety of topics at international conferences and industry meetings.

Drug Digest is a tech talk video series with the 

 editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

Innovations in Biopharmaceutical Development

In this exclusive Drug Digest video interview Anil Kane from Thermo Fisher Scientific will be tackling the topic of advances in small-molecule manufacturing and several other experts will provide brief commentaries on associated topics. 

Drug Digest: Advances in Small-Molecule Manufacturing

There have been numerous events over the course of 2024 that have had an impact on many industries from all over the globe, such as significant political shifts, ongoing conflicts in some regions, and a boom in artificial intelligence (AI). To gain a greater understanding of the specific trends and  changes from 2024 and those predicted for 2025 that will shape the global bio/pharma industry, 

® spoke with a selection of industry experts.

Adam Sherlock, CEO at Qinecsa, discusses industry trends from the perspective of a service provider.

According to Adam Sherlock, CEO of Qinecsa Solutions, a pharmacovigilance technology and services solution provider there have been three key trends from 2024 that have impacted the bio/pharma industry: An increased pressure on price; the rise of AI: and therapeutic success of the glucagon-like peptide (GLP-1) class of products.

Looking at the AI and technology agenda in more detail, Sherlock specifies that there are two key areas that will be impacted. The first being how the technology can be used to improve efficiency and production, he states. “Then the other is, in the truest sense of AI, what innovative, new, generative output can be created by the industry using AI, whether that's around truly novel therapies, the use of data to find different patient cohorts, etc.?”

Ben Sidders, chief scientific officer for Biorelate, chats about the rising prominence of AI in pharma.

The key trend from 2024 for Ben Sidders, chief scientific officer for Biorelate—an AI platform company that provides data solutions to pharma companies—was AI. The AI trend manifested in a few ways, such as shifting the way drug discovery is undertaken, being used across traditional pharma processes, and leading to the rise of digital health and the use of real-word data.

“AI will obviously continue to rise in prominence and to dominate," says Sidders. "I think that evolutionary process of adopting AI into pharma will really start to fulfill the promise, and maybe not all of the hype, but some of the hype that's been around over the last few years.”

Kate Coleman from Arriello talks about trends from 2024 and the potential progression of technological advances in the future.

For Kate Coleman, vice president regulatory affairs, quality and compliance at Arriello, 2024 was an interesting year where many companies in the bio/pharma industry started to take stock of everything and identify areas of future value creation. A hot topic for industry, and one that is set to continue, is that of AI, she notes; however AI is still very much in its infancy for industry, particularly in relation to how it will be regulated. 

“You know, often people don't fully understand what an AI tool actually does and what the operations are behind the black boxes," Coleman says. "So, I think there's a lot of discussion going on at the moment, a lot of difference in opinion, even across regulators, in terms of how it's going to be regulated in the future.”

Personalizing Precision Medicine and Adopting AI

Preeya Beczek from Beczek.COM chats about industry trends from 2024 and those that might continue in 2025, including the big trend of AI.

While there have been numerous trends shaping industry from 2024 and continuing into 2025, Preeya Beczek, managing director and co-founder of Beczek.COM Ltd, explains that there has been a significant focus on personalizing precision medicine. In addition to this trend, data-driven approaches to improve efficiency and AI are also key for 2025, she adds.

“I think we're just going to have lot more people adopting [Generative AI and] that way of working, in their day-to-day work,” Beczek says. “I think that there's going to be some push to get speed, [in] things like manufacturing timelines, [so] they become shorter.”

Articles

Experts provide their insights into the trends that have shaped the global bio/pharma industry in 2024 and give their predictions as to what may be impactful in 2025 and beyond.