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

Felicity Thomas

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In January 2025, FDA published a draft guidance document that provides considerations for complying with 21 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Considerations for Complying With 21 CFR 211.110, Guidance for Industry, Draft Guidance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Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss the implications of this draft guidance and best practices for complying.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"I saw that FDA posted a new draft guidance for complying with 21 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.

Videos

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 is Director of Beczek Consulting

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.

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

futuristicPill. Image credit: ©Jackie Niam - stock.adobe.com

During the course of the past 12 months, there have been numerous events that have impacted global industries. For example, some key moments from 2024 for the United States include the Democrats being voted out of the White House in favor of the Republican candidate, Donald Trump; the occurrence of several devastating weather events that wreaked havoc across multiple states; and the artificial intelligence (AI) boom riding the stock markets to new heights (1–3).

For the bio/pharma industry, in particular, stakeholders have experienced increased pressure on drug pricing and the cost of health care provision; huge therapeutic successes; less access to financing for smaller companies in the post-COVID era; greater digitalization; and an increased focus on advanced technologies, such as AI.

“Undoubtedly, 2024 was the year of AI in pharma, I think, and this manifested in several ways,” notes Ben Sidders, chief scientific officer for Biorelate, which is an AI platform company that provides data solutions to pharma companies. “Firstly, we had the rise of the AI-first companies that really started to dominate and be successful, and that’s driving a fundamental shift in the way drug discovery is undertaken. In addition, within traditional pharma, we’ve also seen the maturation of AI in applications like chemistry, pathology, and knowledge graphs for target discovery, which have really led the way and demonstrated tangible success and returns. And then, there’s also been the rise of real-world data and digital health more broadly, to really help in that more kind of clinical trial set up, design, and success.”

For Tore Bergsteiner, managing partner at MAIN5, a European consulting firm specializing in digitally enabled change for life sciences R&D organizations, “the accelerated adoption of AI/machine learning (ML) is reshaping drug discovery, clinical trial optimization, and personalized medicine. Implementing applied data ontologies, FAIR [findability, accessibility, interoperability, and reusability] data culture, and robust data governance across R&D, manufacturing, and distribution is essential to fully leverage AI and ML, and many larger pharma companies are recognizing and preparing for this reality now,” he specifies.

AI is proving to be a critical tool in R&D, especially for rare diseases and where a greater proportion of the appropriate patient cohort are being picked up through data analysis, agrees Michelle Bridenbaker, COO of Unbiased Science and vice-president of the Medical Information Leaders in Europe. Additionally, she highlights that the advances in AI are also enabling improvements within the communication space, which is allowing companies to augment their abilities to reach healthcare professionals and patients in a more efficient and comprehensible way.

While industry is embracing new technologies, such as AI and ML, it is doing so with open eyes and considering its purpose and design from a fundamental standpoint, emphasizes Alexander Seyf, CEO, Autolomous, a company that uses smart technology to help advanced therapy medicinal product manufacturers. “Right now, we are embracing ML and AI, generative AI, but also at the same time, we are questioning the fundamentals: Is it correctly designed? Is its intention right? What’s the architecture, kind of objective, behind what we are doing and what we want to do? And I think these considerations are fundamental,” he says.

AI and ML have been key talking points at conferences throughout 2024, owing to the potential benefits that may be achieved from their use in daily work tasks, adds Kate Coleman, vice president regulatory affairs, quality and compliance at Arriello, a life sciences consultancy. “But when it comes to implementing [AI] in bio/pharma, I think we’re still at the early days where we know the potential that it has,” she asserts.

“The regulators don’t fully know yet how they’re going to legislate or regulate for [AI]. There are disagreements in terms of how much or how little validation it needs, how much understanding, or how little understanding you need to implement [AI],” Coleman continues. While there is general consensus over the potential benefits of AI, it still won’t be a replacement for humans within the industry, she specifies. There will still be a need for people with good analytical techniques, and so, AI will more likely be used as a supportive tool, Coleman remarks.

Next steps for industry’s technology agenda

Moving into 2025, the technology agenda for the bio/pharma industry can be viewed in two dimensions, asserts Adam Sherlock, CEO at Qinecsa, an international pharmacovigilance technology and services solution provider. “The first is, what can AI, ML, robotic process automation, and digitization do for efficiency and productivity? As a service provider, we’re looking to use these technologies to be more productive, more efficient, faster, and [provide] higher quality in terms of what we do for our clients, but we’re also baking that into our own technology solutions that we are then selling to clients, and clients are using within their own businesses,” he states. “So, the efficiency agenda, and that, of course, drives towards not just better productivity, but also, lower cost.”

Secondly, Sherlock points out that industry will be figuring out the innovation that may be possible through the use 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, and so on?”, he asks.

Managing and controlling the flow of information across various technical elements will be key for AI relevance to the bio/pharma industry moving forward, notes Miguel Forte, president of International Society for Cell & Gene Therapy, board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics. “For some technologies, it will be important to decentralize manufacturing, and for [this] we need two things: devices that are able to be deployed closer to the patients and information technology (IT) that is able to control those multiple devices,” he specifies. “[With] decentralized manufacturing, you continue to have a single product that needs to be consistently released and consistently have the same characteristics across those multiple devices, which requires flow of analytical data, flow of control in process, control data, and fine tuning that will require significant IT and adaptive IT, which is where AI comes in.”

Another element to consider is from the development standpoint where AI will impact process development, clinical design, and data analysis, Forte continues. “One interesting thing is digital twins, where we’ll be able to control what we do in real life with an alternative hypothesis,” he says. “From a clinical trial point of view, that could give us alternative controls, from the process development side, that could give us different scenarios that we can compare.”

The potential impact of AI in the physical world, into robotics for example, is a really exciting area to watch for, according to Edwin Stone, CEO, Cellular Origins—a company focused on enabling scalable, cost-effective, and efficient manufacture of cell and gene therapies. “One thing that I’m slightly nervous about is we don’t lose sight of [AI/ML’s] potential in this area,” he says. “If you look at other industries, such as robotics or automotive, the application of AI and ML to the physical world has been enormous already. I think in bio/pharma, we need to now make sure that we’re looking at things in the same way. The ability for ML to make manufacturing and robotics smarter, more capable, more able to automatically recover from errors.”

As there has been a lot of work with AI and ML in other industries already, it allows the bio/pharma industry the opportunity to apply that prior knowledge and implement these technological advances in a suitable way, Stone confirms. However, he notes, the regulators will need to be heavily involved.

“I think the regulators have demonstrated in recent years a real willingness to try and work with the industry to give them the benefits [of AI/ML],” Stone says. “So, making sure that we’re all coming together and having the right conversations is going to mean that we can [apply AI/ML effectively to industry] in the next two or three years, [rather than] five or 10 years.”

Some forums, such as The Organization for Professionals in Regulatory Affairs (TOPRA) and other industry groups, are already involved in discussions around AI and ML within regulatory operations and medical writing uses, asserts Preeya Beczek, director of Beczek Consulting, a specialist in regulatory affairs and compliance. “Industry is actively working on a handful of use cases that can help to avoid duplication and save time, allowing teams to focus on value added activities. For example, if you could automate the writing of big reports, that are a critical step in a [drug] submission, you can speed up your submission. If you could automate developing answers to Health Authority (HA) questions, based on previous questions and answers so that you’re not having to generate answers from scratch each time, that’s a real help. If you could automate and use AI to give you intelligence around what other companies are doing for a specific disease area, indications, previous HA outcomes and precedence, that’s going to save time for a regulatory lead or strategist,” she explains. “So, there’s so many use cases that apply to AI and ML that industry is probably a little bit inundated with what they can do, what they should adopt, and what they should avoid.”

“It’s also worth remembering AI thrives on scale,” Stone adds. “To work well it needs enormous amounts of data. In cell therapy we are still limited in our access to data. We need connected processing that can centralize these data so that we can access the benefits that ML and AI can bring.”

AI will continue to rise in prominence moving into 2025, driven by investment in three key areas: data, models, and culture, according to Sidders. “As traditional pharma is becoming more mature in its use of AI, it will begin to look to outside platform companies that might support the internal capability, build for AI in drug discovery,” he says. “So, I expect we’ll probably see a picking up of pharma acquisitions of technology platforms that will drive pharma companies’ internal science.”

Over the past year or two, while the bio/pharma industry has seen a lower volume of M&A, it did see some high-value deals and a flurry of activity toward the end of 2024. Key to this trend has been the post-COVID-19 financial dip, where early-stage platform programs became very difficult to finance, stresses Erik Wiklund, CEO of Circio, a biotechnology company developing a novel circular RNA vector platform.

“There is still quite a lot of capital being deployed, but in fewer and larger fundraises, which is linked back to this derisking by the investors,” Wiklund says. “[Investors are] not interested in funding a company for only the next 12 to 18 months; they appear to prefer bigger asset-centric rounds that see a company through to clinical proof-of-concept data. So, then you end up with a few mega-rounds focusing on more mature programs, and limited funds left for everyone else. Therefore, you see very few smaller deals and seed-stage and platform companies suffer. And, I think, that’s a very clear trend that that looks like it will continue for the foreseeable future.”

For several Big Pharma companies, patent cliffs are looming whereby they will need to plug on assets that will generate revenue in either the short- to mid-term, which may lead to larger and later-stage licensing deals in the near future, Wiklund emphasizes. However, for early-stage companies, both fundraising and partnering in such an environment becomes more difficult and forces a prioritization of asset generation versus platform development and expansion, which may hold back scientific development, he adds.

“There’s more recognition of the patent cliffs that are coming in the next couple of years, and companies seem to be really consolidating their costs,” continues Coleman. “So, I think there’s about 169 drugs that are going to be off patent by 2030, so you’re even seeing the very large pharmaceutical companies really trying to take a step back and see how they’re going to organize themselves for growth in the future.”

The year ahead, or possibly just beyond, will be an interesting period in terms of M&A activity, according to Will Gordon, senior vice-president of product management at ArisGlobal, a life sciences technology company specializing in pharmacovigilance, regulatory and quality. Looking across the sector, he points to a large revenue “bump” currently for developers of glucagon-like peptide 1 (GLP-1) drugs. These medications, which help treat type 2 diabetes and support weight loss, have seen a lot of publicity in recent months and are selling quickly, generating a healthy income. Although some of this will be absorbed in addressing supply chain issues, once that has been achieved these companies will start to look at where they can spend that money, Gordon suggests.

“Sometimes [companies] like to stockpile [revenue]. Sure they may use it to fund new internal initiatives, perhaps return some of it to investors in the form of dividends, but once that cash stockpile reaches a certain point, they’re going to want to do something with it,” Gordon comments. “I predict we will see a number of proposed acquisitions or mergers in the near future.”

Another consideration for the recent M&A activity and how it may progress is interest rates, which were pretty high in 2024, comments Mike Baird, director of Product Management at Schlafender Hase, a provider of automated proof-reading software for life sciences. “There is a bit of speculation going forward,” he remarks. “Obviously, a change of administration, new people, new ideas, but interest rates are coming down, and as far as I know, predicted to continue coming down. So, obviously that is a boost to [M&A].”

The Presidential elections have been widely discussed and publicized by global media outlets, but in terms of how the shifting political landscape in the US may impact the bio/pharma industry, it is a complex and difficult-to-predict scenario, emphasizes Forte. However, there are a few aspects to consider, such as the more conservative attitude to business that is expected with a Republican-led government, which will probably have a positive impact on the economy and could give confidence within the investment space, he specifies.

“If you take the market view on [the political situation], then the general sentiment is positive for industry with a switch to the new Trump Republican administration. People expect lower taxes. People expect deregulation. It’ll be easier to do business in the US, and that tends to drive a positive sentiment in the stock market. So, I think that’s good news for the industry in general,” Wiklund adds. From a pricing perspective, however, there may be more challenges for industry, particularly as Trump was vocal about this issue during his previous term in office, Sherlock states. “The debate about the cost of health care is something that I see getting louder and louder within the US,” he says.

“Going back to the technology side of things, one thing that I’m not certain of, but I think might be a good prediction, is that there’ll be a relaxation in the regulations surrounding AI,” asserts Baird. “I think this administration is a big supporter of technology, which is great, but also a big supporter of AI, and where that can take us, and what that can do for the for the industry.”

However, while the new administration is critical of cumbersome regulation, it would be highly risky to downplay controls that safeguard patients’ health, notes Gordon. “Yes, it’s true that regulation change in this industry happens at a glacial pace: it can take years, sometimes decades, before that actual change is put into place,” he says. “But if you remove that, what does that do to the industry? On the one hand, it creates an opportunity for quick movers. But given that it is human health at stake here, what guarantees are there that these new innovators are going to play by the same rules as the large corporations? What happens if they don’t?” The risk is that the whole dynamic could change, and not necessarily for the better, Gordon suggests.

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Cimino, A. History Says the Nasdaq Will Soar in 2025. Here’s the 1 AI Stock to Buy Before It Does. 

Felicity Thomas is associate editorial director of 

®
Vol. 49, No. 1
January/February 2025
Pages: 10–13

When referring to this article, please cite it as Thomas, F. Expanding Pharma’s Horizons Through AI and Acquisitions. 

Articles

Application of AI/ML technology and a burst of M&A activity look to be shaping the future of the pharma industry.

Expanding Pharma’s Horizons Through AI and Acquisitions

Industry Outlook 2025: Regulating Technology for the Future

For the bio/pharma industry, 2024 was an interesting year, remarks Kate Coleman, vice president regulatory affairs, quality, and compliance at Arriello, as pharma companies started to take stock of everything and identify the potential areas for value creation in the future. “There's mergers and acquisitions going on, you know, smaller companies looking for acquisition by the larger companies, larger companies trying to acquire pipelines of new drugs,” she says. “And so really, it is about that value proposition, and also about cutting costs and sustainability into the future.”

A hot topic for the global bio/pharma industry from 2024 was artificial intelligence (AI), Coleman continues. Although the technology has been available for some time beyond just the past 12 months, 2024 was really the year when AI was being implemented to help in the consolidation efforts and value creation, she asserts.

“So, you're seeing [AI] a lot in drug development, where [it] can be used to predict and model outcomes. You're also seeing AI being used right across clinical trials for data analytics. You're seeing [AI] in quality management systems, so things like data leaks and support with deviations, change controls, all of the different aspects,” Coleman remarks. “There's a huge amount of possibility with AI in terms of what it can do, even in daily work.”

Moving into 2025, Coleman expects AI to more than likely support the bio/pharma industry in some of the more mundane aspects, but it won’t be a replacement for people. “The other thing about technology, particularly with AI, is we're still in the infancy in terms of knowing how we're going to regulate it, how we're going to inspect it, how much validation is needed for AI tools,” she says. “You know, often people don't fully understand what an AI tool actually does and what the operations are behind the black boxes. 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.”

Kate Coleman, vice president regulatory affairs, quality and compliance, Arriello

Kate Coleman is vice president regulatory affairs, quality and compliance at Arriello. She has spent approximately 23 years in the pharmaceutical industry across a number of roles in quality assurance. Kate is a qualified person and has recently been working in the area of regulatory affairs and integrated service provision across the drug development life cycle.

Pharmaceutical Technology® sat down with Kate Coleman from Arriello to run through the major trends from 2024, including the importance of technological advances, and how these may progress in 2025.

In this interview, Pharmaceutical Technology® discusses the trend of AI in pharma and how it may play out in 2025 and beyond with Ben Sidders from Biorelate.

Industry Outlook 2025: The Rising Prominence of AI in Pharma

“Undoubtedly, 2024 was the year of AI [artificial intelligence] in pharma,” notes Ben Sidders, chief scientific officer for Biorelate—an AI platform company that provides data solutions to pharma companies—when discussing the key trends of the year. This trend has manifested in several ways, he notes, from the rise of AI-first companies that have shifted the way drug discovery is undertaken, to the increasing use of AI across traditional pharma processes, and the rise of digital health and the use of real-world data.

“AI will obviously continue to rise in prominence and to dominate, and I think this will be driven by three major areas,” Sidders continues. “So, the first is data and its availability, but also the maturation of pharma’s data strategies. [… The] second area is really around the models that are available. I think the realization has been quite clear that causality is key, and so we need to develop a move towards [AI] approaches that embed the underlying causality […]. And then finally, I think probably it's around the culture. So, the culture of these pharma companies will continue to develop in 2025, really adopting a new paradigm driven by a top down mandate, where AI is put at the center of the research programs, [and] also of organizational design […]. And I think if all of this happens, then we'll actually start to realize some of the value and the efficiencies from AI, and 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.”

Dr. Ben Sidders, Chief Scientific Officer for Biorelate

Dr. Ben Sidders is the Chief Scientific Officer for Biorelate, which is an AI platform company that provides data solutions to pharma companies. Ben has 20 years of experience in industry, working for both AstraZeneca and Pfizer, most recently as the head of data science for AstraZeneca oncology research functioning.