Behind the Headlines Episode 27

Ask the Expert

Small Molecules, APIs, and Excipients—Trends, Challenges, and Opportunities

Drug Digest September 2025

Artificial intelligence, machine learning, and novel instruments are helping drug developers.

Enhancing Bioanalysis and Drug Development with Advanced Tools and Technologies

J.P. Morgan Report Lists Biologics, Obesity, China

Top Trends Reshaping Pharma R&D

Feliza Mirasol is the science editor for 

Outsourcing ADCs development manufacturing technology expertise partnerships

A CDMO’s Perspective on Outsourcing Challenges for ADCs–Part 2

®, Christian Morello, vice president and head of the Bioconjugates Business Unit at Lonza, points out the need for having the right expertise when it comes to developing and manufacturing antibody drug conjugates (ADCs). He points to Lonza’s 

 of the Netherlands-based Synaffix (1), whose technology offers a new way of doing conjugation and closes a technological gap in Lonza’s own repertoire.

“We require this technology because it brings some value to the customer,” Morello says. “[This technology] is something that no one else has.” Synaffix’s technology specifically addresses the challenge of how many linkers and payloads can be connected to the mAb carrier, he explains.

In terms of outsourcing partnerships for ADC development, Morello notes that each ADC program is different, and each company is different. “What is very important is to understand what the company, the ADC developer, the customer, needs. For that, we need to understand what is the clinical development plan? What is the main challenge—is it to be fast? Is it to master a very specific technology? [There] is no ‘one size fits all’,” he says.

Morello also notes that it is more important to have an approach that is customer-specific and program-specific in order to address the developer’s needs. He also emphasizes the importance of capturing the right technologies into one’s toolbox. “In the past, we started out produc[ing] just the conjugation. Now, we are offering a totally integrated solution: we can produce the antibodies; we can produce the drug linker; we can, for sure, produce the bioconjugate [drug] substance—but we can also produce the bioconjugate direct product,” he states.

Christian Morello, Vice President and Head, Bioconjugates Business Unit, Lonza

Christian Morello is vice president and head of the Bioconjugates Business Unit at Lonza. He is responsible for establishing and driving strategy of the business unit developing bioconjugates/antibody-drug conjugate (ADC) manufacturing services for Lonza’s customers worldwide. Prior to joining Lonza, Morello was the head of Global Project Management at Sanofi where he oversaw the development portfolio execution. He is a biochemical engineer and has over 28 years of experience in drug development from discovery to registration, planning, manufacturing, and programs management.

1. Lonza. Lonza to Acquire Synaffix and Strengthen Antibody-Drug Conjugates Offering. Press Release. June 1, 2023.

Articles

Christian Morello, vice president and head of the Bioconjugates Business Unit at Lonza, looks at what is involved in developing modern ADCs. 

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - stock.adobe.com

L.B. Bohle, a Germany-based manufacturer and supplier of processing solutions for pharmaceutical solids, is previewing one of its offerings that will be making its United States debut at INTERPHEX in New York City in April 2025.

A press release on Feb. 10, 2025 said that L.B. Bohle representatives will be giving technical overviews of the company’s QbCon1, which L.B. Bohle describes as a three-in-one module that provides continuous raw material dosing, twin-screw wet granulation, and drying within a compact and mobile design (1). The continuous drying process, which the company has patented for this device, aims to improve product quality, increase flexibility, and enhance operator safety.

Drying capability for pharmaceutical applications, L.B. Bohle said, has typically been limited to semi- or quasi-continuous units, which operate on a per-batch basis (1). To alleviate the inherent problem in this process of filter blocking, QbCon1 employs a novel filter cleaning technique which ultimately permits short residence times for granules in the dryer, traceability of all excipients and active ingredients in a continuous process, uniform and reproducible drying of all particles regardless of size, and lengthened lifespans for exhaust air filters.

L.B. Bohle said that certain tests of QbCon1 showed some processed granules exhibited moisture content below that of the original raw material (1). The system can handle throughputs from 0.5 to 2.5 kilograms per hour—even up to 5 kg per hour for some products—making it versatile either for R&D phases involving very small quantities of APIs or efficient scale-up to commercial-level batches.

Compatibility with data acquisition systems is also available, affording the ability to optimize performance with detailed process insights (1).

Assembly and disassembly of QbCon1, as well as cleaning of the unit with water or detergent solutions, can be performed nearly tool-free, according to L.B. Bohle, in 10 minutes (1).

 Vinay Patil, product development manager at Sharp Services, pointed to advances in granulation, compression, and coating as a few of the factors that have pushed innovation in formulation of drug products forward (2).

“The introduction of high-shear granulators, fluid-bed processors, and roller compaction has enhanced the production of tablets with better mechanical properties and dissolution profiles,” Patil said in the article. “Coating technologies have also advanced, with enteric coatings and controlled-release formulations becoming more common.”

With regard to dryers, the RheaLyo GMP-Flex continuous freeze-dryer +1 2 from RheaVita 

 in the Manufacturing Excellence category at the CPHI Milan conference in October 2024 (3). This dryer was touted as the first continuous freeze-drying system for aseptic good manufacturing practice production.

INTERPHEX will be held from April 1–3, 2025 at the Javits Center in New York City. L.B. Bohle said it is slated to occupy Booth 1519A at the event (1).

®’s coverage of INTERPHEX from 2023 and 2024.

1. L.B. Bohle. At INTERPHEX NYC, L.B. Bohle to Showcase US Debut of Pharma Market’s First Wet Granulator with Integrated, Truly Continuous Dryer. Press Release. Feb. 10, 2025.
2. Haigney, S. Forging Ahead in Formulation. 

 eBook, 2024 September.
3. CPHI. CPHI Excellence in Pharma Award Winners 2024. Press Release. Oct. 8, 2024.

The company says it is the pharmaceutical market’s first wet granulator with an integrated, truly continuous dryer.

L.B. Bohle Wet Granulator to Make US Debut at INTERPHEX

Outsourcing ADCs development manufacturing partnerships

A CDMO’s Perspective on Outsourcing Challenges for ADCs–Part 1

®, Christian Morello, vice president and head of the Bioconjugates Business Unit at Lonza, discusses three challenges he sees with bringing new antibody-drug conjugates (ADCs) to market. The first challenge is tied in with the overall dynamic of innovation as much of this innovation is coming for small biotech firms, and those companies are not equipped with the internal capacity to produce product. Secondly, there is also a lack of expertise for the industrialization and scale up of ADC manufacturing, and thirdly is the complexity of the supply chain, Morello enumerates.

“[These are] the three main challenges that an ADC developer has to face and has to overcome to make clinical supply, or to make commercial supply,” Morello says. “And this is where a CDMO [contract development and manufacturing organization] [such as] Lonza brings in a lot of benefit.

The science of ADC manufacturing has evolved much over the past 20 years, Morello also emphasizes. There has been much improvement in the technology for making the monoclonal antibody (mAb) component (i.e., carrier) as well as in the linker technology. Therefore, Morello explains, “If you want to go fast, you need to make sure that you have the expertise to take care of your drug and the complexity of the manufacturing as well the experience to scale up and go through the different regulatory paths.”

Morello also points out that an ADC developer is not obliged to build in-house capacity, “because then you can allocate [that] money on the clinical development, [which is where] you will create and validate your concept associated to the development of the drug. So, clearly, when you look at the overall portfolio, 70 to 80% of the ADC portfolio is outsourcing.”

Videos

Christian Morello, vice president and head of the Bioconjugates Business Unit at Lonza, discusses the challenges and unmet needs in bringing ADCs to market. 

AstraZeneca has announced that its Lynparza (olaparib) has been accepted within NHS Scotland, that country’s healthcare system, by the Scottish Medicines Consortium (SMC) (1). The approval, according to a Feb. 10, 2025 press release from AstraZeneca, is intended for treatment of adults with human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with germline breast cancer genes 1 or 2 (BRCA1, BRCA2) mutations after chemotherapy.

“This is a significant step forward for Scottish breast cancer patients with germline BRCA-mutations,” Tom Keith-Roach, president of AstraZeneca UK, said in the press release. “We look forward to NHS Scotland expanding BRCA gene testing eligibility to this patient group.”

BRCA1 and BRCA2 produce proteins responsible for repairing damaged DNA; when these genes are mutated or altered, AstraZeneca explained in the release, cells may become unstable due to the DNA damage not being able to be repaired (1). Olaparib, according to AstraZeneca, is a product created in the United Kingdom that is a poly-ADP-ribose polymerase (PARP) inhibitor, a targeted cancer therapy that targets PARP in order to disrupt the DNA repair process and potentially kill tumor cells.

Almost 5000 people in Scotland are diagnosed with breast cancer every year, AstraZeneca said, with mutations in the BRCA genes significantly increasing cancer risk—and being found in up to 10% of breast cancer patients (1). Those who carry the mutations have a 50/50 chance of passing them to their children.

SMC’s decision on olaparib was based on positive results from a Phase III trial (OlympiAD) that met its primary endpoint of median progression-free survival, showing that patients treated with olaparib experienced a 42% reduction in risk of disease worsening or death versus those treated with chemotherapy (1). Some of the most common adverse reactions included nausea, anemia, fatigue, and vomiting.

“Metastatic breast cancer is a challenging diagnosis for patients, who have to expect shortened survival, often experiencing low health-related quality of life, and a significant burden from its treatment,” Professor David Cameron, professor of oncology at Edinburgh University and director of Cancer Services at NHS Lothian, said in the press release. “For those women whose breast cancer has arisen on a background of an inherited (germline) alteration in the BRCA1 or BRCA2 genes, olaparib offers patients a treatment option, with data from the OlympiAD Phase III trial, demonstrating a significant delay in cancer progression or death compared to standard chemotherapies, and to do so as a tablet therapy. This recommendation by the SMC represents a significant milestone for patients in Scotland, addressing an unmet need for targeted therapies for those living with BRCA-mutated HER2-negative breast cancer.”

Olaparib was previously approved throughout the European Union in August 2024 in combination with another AstraZeneca product, Imfinzi (durvalumab), for another type of cancer treatment, that of certain people who have primary advanced or recurrent endometrial cancer (2).

AstraZeneca, meanwhile, has continued to make inroads outside the UK early in 2025, announcing in January that it would be creating more than 700 high-skilled jobs in Canada, specifically around the greater Toronto area, as the result of a C$820 million (US$570 million) investment (3).

1. AstraZeneca. Lynparza (olaparib) Accepted for Use in Scotland to Treat Germline BRCA-Mutated HER2-Negative Locally Advanced or Metastatic Breast Cancer After Chemotherapy. Press Release. Feb. 10, 2025.
2. AstraZeneca. Lynparza and Imfinzi Combination Approved in the EU for Patients with Mismatch Repair Proficient Advanced or Recurrent Endometrial Cancer. Press Release. Aug. 14, 2024.
3. AstraZeneca. AstraZeneca Plans C$820 million (US$570m) Investment in Canada to Advance Growing Global Hub and Clinical Delivery. Press Release. Jan. 23, 2025.

While this approval addresses breast cancer, olaparib in combination with durvalumab was approved by the EU in August 2024 for treatment of endometrial cancer.

Scottish Medicines Consortium Accepts AstraZeneca’s Breast Cancer Treatment

Black female scientist looking through microscope while working in laboratory. | Image Credit: ©Drazen - stock.adobe.com

 anniversary of the International Day of Women and Girls in Science, recognized on February 11. This day puts a spotlight on gender equality in the fields of science, technology, engineering, and mathematics (STEM). Even though progress has been made with the education of girls in STEM fields, there is still a divide when it comes to representation of women in STEM industries, such as the pharmaceutical industry, despite women being half of the world’s population (1,2). According to the United Nations (UN), only 28% of engineering graduates are women, and there are still challenges for the women who do enter into STEM fields, including sexual harassment and a lack of senior positions for women (1).

A variety of pharmaceutical companies and organizations are celebrating the day in a variety of ways. Sanofi is highlighting five employees the company feels are helping to “pave the way for change in science”: Kasey Boynton, senior director, Global Operations & Partnerships, who works to increase clinical trial access in underserved communities; Amy Brennan, cluster head, Manufacturing & Supply, who is a leader in rare diseases, oncology, and immunology, and optimizes productivity across specialty care sites; Alexandra Hicks, head of Type 2 Immunology Research, who leads research in type 2 inflammation across immune-mediated diseases; Brenda Mulligan, global head of Science and R&D Communications, who works to educate on discoveries in the lab and their impact on patients; and Sandrine Samson, head of Global Vaccine Medical Affairs, New Products & Innovation, who states, "Being part of the family of scientists and using science to help the world be healthier and more equitable is the best part" (3).

Medicines Discovery Catapult (MDC) is also highlighting women in science by featuring some of their collaborators, including Kristy Smitten, leader of MetalloBio, who has won awards for the novel antimicrobial class to combat antimicrobial resistance; Helen McCarthy, CEO and co-founder of pHion, who invented a proprietary cell-targeting drug-delivery peptide; Helen Philippou, founder of LUNAC Therapeutics, who is a researcher on blood coagulation and whose company is developing first-in-class, next-generation intravenous anticoagulants; Kate Cameron, founder of Cytochroma, which manufactures multicellular hepatic and cardiac models; and Donna Finch, head of Translational and Clinical Sciences at Alchemab Therapeutics, which was awarded best-emerging biotech start-up in at the 2021 OBN Awards (4).

Research organization MRIGlobal highlighted scientists Chelsey Smith, whose research has supported development of a massively multiplexed detection (MMD) device for early threat detection, and Alison Hart, whose works have helped develop multiple steps for synthetic routes. “For more than 80 years, MRIGlobal’s scientific research contributions have been advancing knowledge and shaping the world. These are but two of our many scientists who are women whom we celebrate,” the company stated (5).

Yasmine Sherif, executive director of Education Cannot Wait, released a statement on Feb. 11, 2025, saying, “The future of the human race hangs in the balance. With science and technology far outpacing the capacity of most humans to keep up, we must arm our future scientists and future leaders with the knowledge, skills and critical thinking abilities they need to survive and thrive in the brave new world of the 21st century. To achieve these goals, we must empower an entire generation of girls in crises to receive the education, training and resources they need to improve their knowledge and skills base in [STEM]” (6). Sherif specifically pointed out the women and girls living in areas of conflict.

“It is not an easy road. For girls living on the frontlines of armed conflict, climate change and forced displacement, the thought of even attending school is elusive at best. In all, there are now nearly a quarter of a billion crisis-affected girls and boys whose right to a quality education fit for the 21

 century is interrupted by these preventable protracted crises. Girls are among the most vulnerable. Rather than studying science or learning about technology, they are exposed to forced child marriage and unwanted pregnancies without their potentials ever being achieved,” Sherif said in the statement (6).

® will be speaking with several women working in STEM fields to discuss the impact women have in the industry. Our 

, COO of Unbiased Science, is now available (7). 

United Nations. International Day of Women and Girls in Science, 11 February. 

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

Sanofi. Celebrating Women in Science. Feb. 11, 2025 

https://www.sanofi.com/en/magazine/our-science/celebrating-women-science

MDC. MDC Celebrates International Day of Women and Girls in Science. 

https://md.catapult.org.uk/news/mdc-celebrates-international-day-of-women-and-girls-in-science/

MRIGlobal. Using Science to Improve People’s Lives. Blog Post, 

Education Cannot Wait. International Day of Women and Girls in Science Statement by Education Cannot Wait Executive Director Yasmine Sherif. 

https://www.educationcannotwait.org/news-stories/directors-corner/brave-new-world

Haigney, S. International Day of Women and Girls in Science: Support and Empowerment. 

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

Feb. 11, 2025 marks the 10th anniversary of the International Day of Women and Girls in Science.

The 10th Anniversary of the International Day of Women and Girls in Science

Futuristic, AI and business woman, cyber data and connectivity, iot overlay and technology innovation. Digital transformation, tech analytics and mockup space, web dashboard and internet holographic | Image credit: © Angelo/peopleimages.com – stock.adobe.com

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. 

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

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

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.

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.

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. 

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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.

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