Digital Transformation in Pharma Manufacturing

Patent Cliff Deals, Tariff Pressures, and the In Vivo Cell Therapy Bet

Behind the Headlines, Episode 23

ICH Q12 and Post-Approval Changes

Speed, Flexibility Top Large-Molecule Manufacturing Trends

Drug Digest July 2025

Key Insights from Industry Survey Results

Bio/Pharma's Tariff Response

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The International Day of Women and Girls in Science celebrates its 10th anniversary on Feb. 11, 2025. This day recognizes the challenges of gender equality in the fields of science, technology, engineering, and mathematics (STEM) that girls and women face (1). It also celebrates the progress made to combat the bias in these fields and the important contributions women have made in STEM-related industries, such as the bio/pharmaceutical industry.

One such area is the utilization of artificial intelligence (AI) in pharmaceutical development and manufacturing. Regulations in the use of AI in pharma have been rapidly advancing (2), and use of AI requires the assistance of experts in that technology (3). Women may offer unique perspectives in this developing area, specifically when it comes to a broader look at the impact of AI. “I believe AI is set to transform the pharmaceutical industry, and this is already taking place in many real-life use cases,” says Jean Redmond, chief operating officer (COO) at Biologit. “Women in STEM need to be intimately involved in the development and deployment of AI to ensure it is built ethically and representatively and in a fit-for-purpose way for problems that affect women.”

Redmond stresses that AI, and its potential use as a tool must be understood, and the perspective women bring must be heard. “Women in STEM need to provide their input to understand the unique problems and ensure appropriate and impactful application. For example, AI and automation is set to transform the landscape of clinical trials, an area in which women have been historically underrepresented. There is huge scope and opportunity here for women to play a key part,” says Redmond.

Data biases must also be addressed, continues Redmond, and AI models used in healthcare should be trained on relevant and diverse datasets. “In addition to gender diversity, it is also important to consider racial and age diversity and different stages of life, and ensuring the datasets are comprehensive and representative. Women can play a role in advocating for the ethical development of AI.”

Women’s ability to implement such technology-based change is a distinctive benefit, specifically in identifying opportunities to improve productivity, efficiency, and attention to detail, according toMichelle Bridenbaker, COO of Unbiased Science. “We instinctively perform risk assessments, for instance. In an AI context, these qualities are especially important because of the need to consider both the ethics of AI use and also the human impact of process automation. Although it sounds like a generalization, we also tend to be very open to sharing best practice, to collaborating, and to supporting others when they are unsure how to implement AI and technology effectively. Given the speed with which AI is advancing and changing, that’s vital.”

Emotional intelligence, creativity, critical thinking, and problem solving might be characteristics that women specifically contribute to the use of AI in pharma, remarks Agnes Cwienczek, director of Product Management at ArisGlobal. “While some of these are perhaps less directly relevant to defining and developing AI based solutions, they can be important to the implementation of those solutions within an organization,” says Cwienczek.

 for more coverage of the 10th anniversary of the International Day of Women and Girls in Science. Our interview with 

1. UN. International Day of Women and Girls in Science, 11 February. 

https://www.un.org/en/observances/women-and-girls-in-science-day/

2. Schmitt, S. Regulations in AI and Other Digital Technologies. 

3. Thomas, F. and Haigney, S. Quality Considerations for Using AI in Bio/Pharma. 

International Day of Women and Girls in Science: Support and Empowerment

. Feb. 10, 2025. https://www.pharmtech.com/view/international-day-of-women-and-girls-in-science-support-and-empowerment

Articles

In a lead up to The International Day of Women and Girls in Science, Pharmaceutical Technology® takes a look at the unique perspective women bring to the use of artificial intelligence in the pharmaceutical industry.

Women, STEM, and AI in Pharma

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

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FDA has approved Emblaveo (aztreonam and avibactam), an AbbVie product, as the first fixed-dose, intravenous monobactam/β-lactamase inhibitor combination antibiotic in the United States, to be used in combination with metronidazole in adults with either limited or no other options for treating complicated intra-abdominal infections (cIAI) (1).

In a press release on Feb. 7, 2025, AbbVie identified the Gram-negative microorganisms 

 as potential causes of cIAI, and said that such infections are “among the most challenging” for medical professionals to treat because of their high antimicrobial resistance (AMR) (1).

According to AbbVie, AMR is considered an urgent threat to public health and has been projected to contribute to 39 million worldwide deaths by the year 2050 (1). In 2021 alone, the company said, an estimated 1.14 million deaths were attributed to bacterial AMR. Most troubling, AbbVie said, is that a failure to address AMR now could eventually lead to things like routine surgical procedures or minor infections becoming life-threatening or fatal.

"The continued evolution of antimicrobial resistance among Gram-negative bacteria has left some patients with little to no treatment options, resulting in extended hospital stays, additional morbidity, and death," said James A. McKinnell, MD, infectious disease specialist, Milefchik-Rand Medical Group, Torrance Memorial Medical Center in Torrance, Calif., in the press release. "The approval of Emblaveo provides physicians a much-needed therapeutic option to help address some of the most difficult antimicrobial-resistant pathogens and provides doctors an opportunity to treat patients with these challenging infections."

FDA previously granted both Qualified Infectious Disease Product and Fast Track designations to Emblaveo in 2019 (1). The treatment is slated to be available for commercial use in the US in the third quarter of 2025.

"As bacteria evolve, industry, government, and clinical experts must work together to ensure that the infectious disease community has the tools to advance public health," said Roopal Thakkar, MD, executive vice president, research & development, chief scientific officer, AbbVie, in the release. "We're proud to offer this important novel treatment option to urgently address the significant threat of antimicrobial resistance."

 when its Vyalev (foscarbidopa and foslevodopa) treatment was green-lighted for adult patients with advanced Parkinson’s disease, making it the first subcutaneous, 24-hour infusion of levodopa-based therapy for treatment of motor fluctuations in those patients in the US (2).

The company has also announced numerous acquisitions since the middle of 2024. In June 2024, 

 which specialized in anti-inflammatory disease therapies, in a $250 million cash deal (3). Following that, the completion of the acquisition of the neuroscience disease-focused clinical-stage biotherapeutics company Cerevel Therapeutics 

Another pair of transactions made news in December 2024; first, AbbVie confirmed that 

 a biotechnology company centered on central nervous system drug development, had been completed (5). That was followed by the announcement of a definitive agreement for AbbVie 

 another biotech company, this one specializing in oral peptide therapeutics (6).

1. AbbVie. U.S. FDA Approves Emblaveo (aztreonam and avibactam) for the Treatment of Adults with Complicated Intra-Abdominal Infections With Limited or No Treatment Options. Press Release. Feb. 7, 2025.
2. AbbVie. U.S. FDA Approves Vyalev (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson's Disease. Press Release. Oct. 17, 2024.
3. AbbVie. AbbVie Acquires Celsius Therapeutics. Press Release. June 27, 2024.
4. AbbVie. AbbVie Completes Acquisition of Cerevel Therapeutics. Press Release. Aug. 1, 2024.
5. AbbVie. AbbVie Completes Acquisition of Aliada Therapeutics. Press Release. Dec. 11, 2024.
6. AbbVie. AbbVie to Acquire Nimble Therapeutics, Further Strengthening Immunology Pipeline. Press Release. Dec. 13, 2024.

These infections can be caused by certain Gram-negative microorganisms, making the infections challenging to control due to high antimicrobial resistance.

FDA Approves AbbVie Treatment for Complicated Intra-Abdominal Infections

 Anniversary of the International Day of Women and Girls in Science (1), which looks to highlight the challenges and progress of women in the fields of science, technology, engineering, and mathematics (STEM). 

® sat down with Michelle Bridenbaker, COO of Unbiased Science, to gain her perspective on how women can be empowered to excel in these crucial roles, as women provide unique and important perspectives.


 What are some of the benefits of STEM programs for girls in school? How do these programs translate to women building careers in the pharmaceutical industry?

Everything starts at school in terms of cultivating ambition and a sense of what you can achieve. When I was at school and passionate about science, I was at times discouraged from pursuing this as a specialist subject and career on the basis that this would be a tough path for a woman and for raising a family; it was suggested instead that being a teacher was more realistic. Actively promoting STEM subjects to girls from an early age is essential to cultivate their passion, talent, and ambition, first so they have a vision and then so that they believe in themselves enough to pursue it. STEM programs are critical not just for fostering talent from the earliest opportunity, but also for ensuring that enough bright minds come through into scientific fields, to ensure a sustainable, relevant, and representative workforce which is vital to each country’s competitive stance in the fields of medicine, pharma, medical device development, and more. In terms of the pharma industry specifically, a strong scientific background is a solid foundation for the rigour, discipline, and critical as well as innovative thinking that modern pharma success is built on. As employers, pharma companies need to actively encourage women through mentorship and leadership preparation, so that they see and realise their full potential.

 Is there sufficient investment in promoting STEM career paths for girls? Should the pharma industry invest in these types of promotions?

The situation is improving now, but there is always a lot more than could be done. The pharma industry should absolutely be investing in and promoting STEM career paths for girls. It’s incumbent on them to do so. It’s about investing in a sustainable talent base, and about doing the right thing by half of the population. Not to mention accessing the many inherent leadership qualities that women bring to the table, and as drivers of technology-based process innovation.

 Artificial intelligence (AI) is a fast-growing technology in the pharmaceutical industry. Are there unique and specific skills and/or viewpoints women in STEM jobs bring to this area?

Women excel at instigating and implementing technology-based change, because we are inherently good at identifying opportunities to hone productivity and efficiency, while also being methodical and having a close eye on the detail. We instinctively perform risk assessments, for instance. In an AI context, these qualities are especially important because of the need to consider both the ethics of AI use, and also the human impact of process automation. Although it sounds like a generalization, we also tend to be very open to sharing best practice; to collaborating; and to supporting others when they are unsure how to implement AI and technology effectively. Given the speed with which AI is advancing and changing, that’s vital.

 Which countries or regions are at the forefront of advancing women’s role in fields like pharmaceutical development and manufacturing?

I have been a leader with reach across most geographies, and I have to say I think we still have a way to go, despite having made significant gains in the past 20 years. What I can say for certain, is that countries that actively protect women in the workforce have a head start. I’m thinking about the Nordics, the UK and Ireland, and France—where there is generally strong support in the form of maternity and paternity leave, provision for a gradual return to work, and the ability to balance work with having a family. Without good policies here, economies and employers are putting at risk a significant proportion of their workforce and future talent base, and by extension their long-term sustainability.

Click the video above for a more in-depth discussion with Michelle Bridenbaker.

UN. International Day of Women and Girls in Science, 11 February. UN.org (accessed Feb. 7, 2025) 

Michelle Bridenbaker, COO of Unbiased Science

Michelle Bridenbaker owns and is COO of Unbiased Science, a trailblazing health science communications company. She is also VP of Medical Information Leaders in Europe (MILE) and serves on the scientific boards of multiple tech and device firms, contributing to cutting-edge advancements in communications, science, and medicine.

Videos

Pharmaceutical Technology® sat down with Michelle Bridenbaker, COO of Unbiased Science, ahead of International Day of Women and Girls in Science to talk about the role of women in the pharmaceutical industry.

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

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.

CNN Politics. Election 2024: Presidential Results. 

Foerster, J. The Most Significant U.S. Weather Events of 2024. 

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. 

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.

Group of participants engaging in interactive business seminar, with one individual raising hand while seated and another person presenting in background with laptop | Image Credit: © Seventyfour - stock.adobe.com

’s annual survey of employment trends in the bio/pharma industry has been conducted within the prism of the COVID-19 pandemic (1–4).

But now, with the shadow of the outbreak nearly five years into the past, the 2025 survey looks forward into the second half of the decade (5).

This year’s survey reveals more than half of workers feel that adequate time to complete projects is an important factor contributing to their job satisfaction (

Figure 1: Contributing factors to job satisfaction. | Image Credit: © Pharmaceutical Technology

But that has left these employees wondering if they or their colleagues are getting the proper instruction on how to do, and continue to evolve in, their jobs. Workers are even more fractured and uncertain as to how that guidance should be communicated.

The hunt for more knowledge, on and about the job

 asked 166 people in the industry, 142 of whom responded at least in part, questions relating to job satisfaction, with a rating scale of 1 to 5—1 being the least satisfying and 5 being the most. A clear majority of respondents gave a rating of either 4 or 5 to “intellectual stimulation” (82.26%) and “challenging projects” (80.65%) being the main drivers of job satisfaction (

Yet considerably fewer respondents, only about three out of every five (62.10%), gave just as high marks when asked if they were being provided adequate resources and/or infrastructure for their required tasks. While less than 10% admitted their managers were unsupportive in ensuring job satisfaction, less than half (46.77%) also felt the training and career development they are currently receiving were key contributors to that same satisfaction (

When asked whether their place of employment gave them sufficient training tailored to their specific roles, employees who said such training was lacking (51.22%) slightly outpaced those who said they were receiving an adequate amount (48.78%).

And in how these workers viewed the training of those new to their companies, less than half of those polled (45.53%) felt that new employees had an appropriate knowledge base upon entering the workforce.

More than half (51.22%) in the survey said they thought online training modules would be very useful in their work in a general sense, with just about one in eight (12.20%) saying these trainings were unhelpful and that they preferred in-person sessions or workshops only (

Figure 2: Usefulness of online training modules. | Image Credit: © Pharmaceutical Technology

Given more specific choices within that question, two responses were selected by an equal percentage (17.89%): that online training was only useful for new recruits, or was only useful when new techniques, regulations, or technologies are being implemented. Only one respondent to this question picked a fifth option, which was that online training is useful only when seeking a new role (

Salary did not appear to be a chief concern in this year’s survey. One-fifth (20.16%) of respondents said they were not satisfied with their current wages, but more than half (55.65%) reported their pay increased at least slightly over a year ago, with just about one in eight (12.10%) suffering a pay cut.

Still, approximately seven out of every eight employees polled (87.10%) did rate “high salary” either a 3, 4, or 5 when it came to impact on job satisfaction, with slightly fewer (80.49%) giving the same weight to “good benefits” (

While a solid majority of people were at least unequivocal, if not strongly feeling, that they either would not like (73.77%) or do not expect (73.17%) to leave their jobs imminently, just over a quarter (27.64%) felt there was opportunity for career advancement in their current positions (

Figure 3: Change of career/role in the near future. | Image Credit: © Pharmaceutical Technology

Less than 10% of respondents said they were not satisfied overall in their current jobs, and more than 7 in 10 feel they are at least as secure, if not more, in their positions than they were a year ago. Nearly as many (69.67%) said they would not like to change careers anytime soon (

So, choose whatever idiom you like (“don’t rock the boat,” “if it ain’t broke, don’t fix it”, etc.), but the bio/pharma industry overall seems content right where it is as 2025 dawns.

1. Spivey, C. New Therapies Cry Out for New Skills. 

, 48 (1) 16–19.
2. Playter, G. Crossing the Same River Multiple Times. 

, 47 (1) 19–21.
3. Playter, G. The Long Path to Normal. 

, 46 (1) 19–21.
4. Peters, R. Compensation Does Not Necessarily Align with Job Satisfaction. 

, 45 (1) 20–24.
5. Pharmaceutical Technology. 

2024 Pharmaceutical Technology/BioPharm International Employment Survey

®
Vol. 49, No. 1
January/February
Pages: 14–16

When referring to this article, please cite it as Lavery, P. Split Opinions on Training Strategies. 

Survey results show that being intellectually stimulated and getting assigned challenging projects are two key drivers of employee satisfaction, yet job training is lacking.

Split Opinions on Training Strategies

Cheryl Barton is director of PharmaVision, 

Two dosing pens of a fictitious semaglutide drug (GLP-1) on a scale facing a dumbbell. Concept for alternative ways to loose weight. | Image Credit: © Andreas Prott - Stock.adobe.com

Obesity is a major public health threat and is associated with an increased risk of obesity-related complications and mortality. It has proved a challenging target for pharmaceutical intervention, and early strategies using amphetamine-based appetite suppressants resulted in significant side effects and high-profile lawsuits against manufacturers (1).

Better understanding has fuelled product development

A better understanding of the gut-brain axis has led to the development of oral glucagon-like peptide-1 (GLP-1) receptor agonists (RA) and glucose-dependent insulinotropic polypeptide (GIP) RAs for the treatment of type 2 diabetes (T2D) and weight management (

). These include Novo Nordisk’s oral Ozempic/Wegovy (semaglutide) and Saxenda (liraglutide) and Eli Lillys’ once-weekly GIP/GLP-1 dual agonist Mounjaro (tirzepatide), which was approved by the European Medicines Agency (EMA) in 2202 to manage weight (2,3).

Regulatory-approved anti-obesity medicines.

Next-generation anti-obesity medicines are emerging

GLP-1 agonists and GIPs are not without their side effects, so companies are researching new drug targets, combinations, and formulations to overcome these shortfalls and provide safer, more robust, and sustainable body weight loss (3-6). According to IQVIA, 116 new anti-obesity medicines (AOMs) are in clinical development (

). Several of the agents modulate novel targets such as amylin, cannabinoid receptor type 1 (CB-1), diacylglycerol O-acyltransferase 1 (DGAT1), monoacylglyceroltransferase (MGAT2), and solute carrier 6 (SLC6) transporters.

 Anti-obesity agents in clinical development. 

European biotechs active in the AOM space

The AOM space has attracted a lot of attention from pharma and biopharma leading to some high-profile acquisitions during 2024 including US-based Carmot Therapeutics by Roche and US-based Versanis Bio by Eli Lilly and UK Biotech Zihipp by Metsera (7–9). Several European biotechs are making headway in this arena (

), and private investors are keen to get in on the act.

Anti-obesity medicines in clinical development from European biotechs.

European companies worth watching out for in the AOM space include the following.

The company’s lead programme, AT-7687, is a once-weekly subcutaneously administrated GLP-1 receptor peptide antagonist that binds strongly to albumin circulating in the blood to extend its half-life (10). In December 2024, Antag gained US Food and Drug Administration (FDA) investigational new drug (IND) clearance to advance to Phase I in early 2025. The company is evaluating AT-7687 as a monotherapy and in combination with Novo Nordisk’s Ozempic/Wegovy (semaglutide) (11). Antag recently completed an €80 million (US$82.4 million) Series A financing round backed by Versant Ventures and Novo Holdings, and the funds will be used to drive the development of AT-7687 (12). In January 2025, Antag announced that Joerg Moeller formerly of Bayer would succeed Alexander Sparre-Ulrich as chief executive officer, who will move to the chief operating officer role to drive the GLP-1 programme forward.

 Gubra is a pre-clinical contract research organization (CRO)/biotech founded in 2008 and focusing on peptide-based therapies. Its lead program, GUBamy, is a long-acting amylin analogue that is well-tolerated and significantly increased weight loss during the six-week Phase I study (13). Gubra is developing four anti-obesity agents in conjunction with Boehringer Ingelheim (BI) including two clinical progammes with a long-acting neuropeptide Y receptor type 2 (NPY2R) agonist, BI 1820237, and a triple agonist. In October 2024 BI discontinued its development of BI 1820237, and no further details were released (14). In December 2024, Gubra announced a new collaboration with Amylyx Pharmaceuticals to develop a novel long-acting GLP-1 receptor agonist (15). Under the agreement, Gubra will receive upfront and research payments and may receive more than US$50 million (€48 million) on milestones payments and royalties on worldwide net sales. In January 2025, Gubra announced it had appointed Anne-Marie Levy Rasmussen as the company’s new chief operating officer (previously at GlaxoSmithKline and Bavarian Nordic) to help grow and optimize the company (16).

 Verdiva Bio is a private cardiometabolic health company founded in 2024 and headed up by Khurem Farooq, Farooq, formerly chief executive of Aiolos Bio, and Gyroscope Therapeutics before their respective acquisitions by GlaxoSmithKline and Novartis, respectively. In January 2025, Verdiva Bio completed a US$411 million (€391 million) Series A financing co-led by Forbion and General Atlantic, with additional participation from RA Capital Management, OrbiMed, Logos Capital, Lilly Asia Ventures, and LYFE Capital (17). In January 2025, Verdiva acquired global development and commercialization rights outside of greater China and South Korea to their industry-leading portfolio from Sciwind Biosciences in 2024. The partnered portfolio includes:

VRB-101, a Phase II-ready, once-weekly oral GLP-1

VRB-103, a once-weekly, oral dual-acting amylin and calcitonin receptor against (DACRA) agent in preclinical development for use as monotherapy or in combination with VRB-101

VRB-102, once-weekly injectable DACRA for use in combination with VRB-101 in pre-clinical development (18).

 The biopharma company was founded by Bjarne Due Larsen, Lars Hellerung Christiansen, Leif Helth Jensen, Dan Buxbom, and Florian Schönharting in 1997 as Peptide Probe Technologies ApS, focused on the design and development of peptide-based medicine. In June 2024, Zealand Pharma completed an upsized equity offering of 8.35 million new ordinary shares raising DKK 7 billion (US$1 billion) to fund the development of its pipeline (19). The company is developing several AOMs including a long-activating amylin analogue, petrelintide (ZP8396), and GLP-1/GLP-2 receptor dual agonist, dapiglutide. In the first half of 2025, the company expects to initiate a Phase IIb trial with petrelintide in overweight or obese patients without T2D, and a Phase Ib combination trial with petrelintide and dapiglutide (20–21). In January 2025, the company appointed Steven R. Smith, MD as senior global medical advisor in Obesity to help advance Zealand’s peptide-based assets (22).

 January/February2025 digital issue. It was later published in 

The pharma and biotech industry continues to explore new modalities and targets that modulate the brain-gut axis. Late in 2024, Sanofi strategically invested in Italy-based Resalis Therapeutics to gain access RES-010, a first-in-class antisense oligonucleotide targeting miR-22, that plays a pivotal role in the molecular pathways underlying obesity (23). Meanwhile, scientists at the National Cancer Research Centre (CNIO), USA have identified a new mitochondrial protein (MCJ/DnaJC15) involved in brown fat thermogenesis that may present promising new targets for obesity and related metabolic disorders (24). There is still significant room in the multi-billion AOM market to make a mark.

1. Dolgin, E. A History of Drugs on the Weight List. 

 6 Jun.
2. Melson, E.; Ashraf, U.; Papamargaritis, D.; et al. What is the Pipeline for Future Medications for Obesity? 

. https://doi.org/10.1038/s41366-024-01473-y
3. IQVIA. A Look at the R&D Landscape in Obesity, Led by GLP-1s. 

, 19 March 2024.
4. Garza, M. FDA Approves Mounjaro (Tirzepatide) for Diabetes Treatment. 

. 13 May 2022.
5. Müller, T.D.; Blüher, M.; Tschöp, M.H.; et al. Anti-obesity Drug Discovery: Advances and Challenges. 

, 21, 201–223.
6. Quarta, C.; Cota, D. Anti-obesity Therapy with Peripheral CB1 Blockers: From Promise to Safe(?) Practice. 

, 44 (11), 2179–2193.
7. Carmot Therapeutics. Carmot Therapeutics Announces Completion of Acquisition by Roche. News Release. 29 Jan. 2024.
8. Eli Lilly. Lilly to Acquire Versanis to Improve Patient Outcomes in Cardiometabolic Diseases | Eli Lilly and Company. News Release. 14 July 2024.
9. Taylor, P. Metsera Lands with $290m to Take on Obesity Giants. Pharmaphorum. 19 April 2024.
10. Jensen, M.H.; Sanni, S.J.; Riber, D.; et al. AT-7687, a Novel GIPR Peptide Antagonist, Combined with a GLP-1 Agonist, Leads to Enhanced Weight Loss and Metabolic Improvements in Cynomolgus Monkeys. 

, 88, 102006.
11. Antag Therapeutics Antag Therapeutics Announces €80 Million Series A Financing. News Release. 4 Dec. 2024.
12. Antag Therapeutics. Antag Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for Lead Molecule, AT-7687. News Release. 9 Oct. 2024.
13. Gubra. Gubra announces positive GUBamy Phase 1 SAD data (correction). News Release. 13 Nov. 2024.
14. Gubra. Gubra Announces New Collaboration with Amylyx Pharmaceuticals to Develop a Novel Long-acting GLP-1 Receptor Antagonist. News Release. 30. Dec. 2024.
15. Gubra. Gubra Announces Discontinuation of Development of NPY2R in Obesity with Boehringer Ingelheim. News Release. 31 Oct. 2024.
16. Gubra. Gubra Appoints New Chief Operating Officer. News Release. 15 Jan. 2025.
17. Verdiva Bio. Verdiva Bio. News Release. 9 Jan. 2024.
18. Scimind Biosciences. Sciwind Biosciences Announces Global Licensing and Collaboration Agreement for Metabolic Disease Portfolio. 10 Jan. 2025.
19. Zealand Pharma. Zealand Pharma Announces Completion of an Upsized Equity Offering of 8.35 million New Ordinary Shares Raising Proceeds of USD 1 billion/DKK 7 billion. News Release. 25 Jun. 2024.
20. Zealand Pharma. Zealand Pharma Announces the First Participant Enrolled in People with Overweight or Obesity. News Release. 10 Dec. 2024.
21. Zealand Pharma. Zealand Pharma Announces Positive Topline Results From 13-Week Phase 1b Multiple Ascending Dose Clinical Trial With GLP-1/GLP-2 Receptor Dual Agonist Dapiglutide. News Release.
22. Zealand Pharma. Steven R. Smith, MD, joins Zealand Pharma as Senior Global Medical Advisor in Obesity. 7 Jan. 2025.
23. Resalis Therapeutics. Resalis Therapeutics Gains Strategic Equity Investment from Sanofi. News Release. 28 Oct. 2024.
24. Cicuéndez, B.; Mora, A.; López, J.A.; et al. Absence of MCJ/DnaJC15 Promotes Brown Adipose Tissue Thermogenesis. 

Cheryl Barton is director of Pharmavision, info@pharmavision.co.uk.


Vol. 37, No. 1
January/February 2025
Pages: 16–17

When referring to this article, please cite it as Barton, C. Next-Generation Anti-Obesity Medicines. 

European biopharma companies are looking beyond GLP-1s.

Next-Generation Anti-Obesity Medicines

Recipharm, a Stockholm, Sweden-based contract development and manufacturing organization (CDMO), announced on Feb. 5, 2025 that a new and advanced modular sterile filling system, which performs aseptic filling within a Grade A isolator, is now fully operational and operates in full compliance with good manufacturing practice (GMP) standards. The system is tailored for process development and is located at the company’s facility in Wasserburg, Germany (1).

According to the company, the system’s interchangeable modules supporting various product types, such as syringes and vials, help to increase flexibility, and an additional pre-filled syringe module that is included with the installation broadens the capabilities of the system even further (1).

Recipharm said the filling line can deliver anywhere from 500 to 50,000 units per batch, making it useful for all development phases (1). The system is also designed to limit loss of high-value products to less than 500 mL, preserving material for clinical trials and ultimately providing cost savings.

“With this unit, we offer our clients a flexible, high-quality and GMP-compliant solution for their development and clinical production needs,” Gregor Kawaletz, Recipharm chief commercial officer, said in the press release (1). “This installation reflects our commitment to investing in innovative technologies that enable faster and more efficient pharmaceutical development.”

Installation was performed during the summer of 2024, and the system has already successfully completed its first production run for a leading biotech company, although Recipharm did not identify that company by name.

 for the pharmaceutical industry at the beginning of 2025, Pharmapack and CPHI said that the ongoing demand for glucagon-like peptide-1 (GLP-1) drugs would cause aseptic filling capacity to be “tied up” in these drugs’ clinical filling needs, especially with generic GLP-1s entering the market in 2025 (2). This, Pharmapack said, could cause delays in the clinical filling of other therapies with smaller volumes.

“The result is that we will see biotechs widening supplier networks and potentially even Big Pharma searching for new partners for GLP-1s,” Pharmapack said at the time. “Consequentially, contract and device filling is predicted to be a rapid growth area.”

®’s coverage of Pharmapack 2025 can be viewed here.

® had the opportunity to speak to Uwe Hanenberg, Recipharm head of product implementation, about trends, technological advancements, and industry investments (3).

In that interview, Hanenberg predicted the increased need for efficient commercial production capabilities in 2025, specifically noting the burgeoning popularity of GLP-1 diabetes and weight loss drugs.

“There will come further big products. And that is certainly not to be executed on an existing tablet line or blister line,” Hanenberg said at the time (3). “That is something where you need more investment … I expect to see announcement on investment in high-potent capabilities, especially in [the] CDMO space, anything that is related to completion of offerings to reach an integrated solution, which means I expect a further consolidation of the CDMO market. Then I expect a very significant investment in continuous manufacturing. There are big companies who have a commitment to produce, in future, 50–80% of all new launches on continuous manufacturing.”

Watch the full interview with Hanenberg here.

1. Recipharm. Recipharm Expands Aseptic Filling Capabilities for Process Development, Pilot Scale and Clinical Supply. Press Release. Feb. 5, 2025.
2. Mirasol, F. 

Pharmapack Reports on Key Trends for 2025.

CPHI Milan 2024: Trends in Oral Solid Dosage Forms.

Installation was performed during the summer of 2024, and the system has already successfully completed its first production run for a leading biotech company.

Recipharm Launches New Fully Operational Modular Sterile Filling System in Germany

AdvanCell, a Sydney, Australia-based, clinical-stage radiopharmaceutical company founded in 2019 that specializes in the development of cancer therapeutics, has successfully completed an oversubscribed, $112 million round of Series C financing (1). The company announced the milestone in a press release on Feb. 3, 2025.

Funding was co-led by SV Health Investors, Sanofi Ventures, Abingworth, and SymBiosis, with additional support from existing investor Morningside and new investors Tenmile and Brandon Capital, among others (1).

“We are delighted to support AdvanCell’s growth and play a role in its remarkable journey through leading this oversubscribed Series C,” Jamil M. Beg, partner at SV Health Investors, said in the AdvanCell press release (1). “The company’s exceptional team, technologies, robust infrastructure, collaborations with some of the world’s largest pharma companies, and ability to consistently execute position it to truly change outcomes for patients.”

Beg has joined the AdvanCell board of directors as part of the financing, along with Christopher Gagliardi of Sanofi Ventures and Bali Muralidhar of Abingworth (1).

The mission of AdvanCell was originally built around targeted alpha-emitting radionuclides for cancer therapy, and, to that end, the company currently operates a 40,000-square-foot manufacturing facility, with a workforce of 60 (1). AdvanCell plans to expand manufacturing capacity even further and accelerate clinical development of its radionuclide therapy pipeline with the Series C funding.

Patient enrollment is currently underway for the highest-dose cohort of a multi-center, Phase I/II dose escalation clinical trial of ADVC001, which AdvanCell said may be a potentially best-in-class targeted alpha therapy for metastatic prostate cancer. According to the press release, the aim of the trial is to demonstrate the safety and efficacy of radionuclide treatment based on Pb-212, a lead isotope (1).

“This successful Series C round demonstrates strong confidence in our vision and capabilities,” said Andrew Adamovich, CEO of AdvanCell, in the press release (1). “We are grateful for the continued support from our existing investors, particularly the long-term support from Morningside and are excited to welcome new partners who share our commitment to transforming cancer care. With this funding, AdvanCell is well-positioned to scale our manufacturing operations and progress our cutting-edge therapies towards commercialization.”

Elsewhere in Australia, the nonprofit organization Genetic Cures for Kids 

Patient enrollment is currently underway for the highest-dose cohort of AdvanCell’s potentially best-in-class targeted alpha therapy for metastatic prostate cancer.

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