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 

American Association of Pharmaceutical Scientists

 (AAPS) will spotlight advances in drug manufacturing and technology at the 

 conference, taking place November 9–12 in San Antonio, Texas. This year’s event will kick off with a plenary session on how investment strategies, production innovation, and emerging modalities are transforming pharmaceutical 

 and the scalability of future therapies. Thousands of industry professionals and researchers are expected to attend as the bio/pharmaceutical sector adapts to new operational demands driven by cutting-edge science (1).

, PhD, associate professor of finance at the Carlson School of Management, University of Minnesota, will deliver the opening plenary on November 9. His session will examine the economics driving innovative therapeutic development, with a focus on the rising complexity and cost of manufacturing advanced modalities. His talk will also explore how these developments relate to improving 

This keynote continues a discussion that began during the 2025 National Biotechnology Conference, where 

, PhD, an economist from MIT Sloan School of Management, addressed similar financing challenges and risk-sharing models. That presentation remains available online through 

 for attendees seeking continuity leading into the upcoming discussion (1).

“Many of the attendees are either involved in developing therapeutics using new modalities or planning to move into this burgeoning sector,” said 

, PhD, chair of the 2025 PharmSci 360 Scientific Programming Committee, in a company press release (1). Dr. He gave a 

“This session will offer insights into the economics driving this critical area in a time of rapid and evolving changes," Dr. He stated in the release (1).

How will investment strategies influence new therapeutic modalities?

Bio/pharmaceutical companies are expanding pipelines that include 

, each carrying unique development and scale-up demands. Financing approaches can directly influence research direction, regulatory timelines, and the resilience of supply chains (3,4). AAPS stated in the release that sessions like the opening keynote aim to help drug developers better assess funding risks tied to these modalities (1).

Dr. Thakor is also scheduled to join the executive session, “

Molecule to Milestone: IND-Enabling Strategy for Pharma Leaders

,” on November 10, in which panelists will discuss how to align scientific milestones with realistic business strategies.

How is AI transforming drug development economics?

Industry analysts note that the rapid adoption of artificial intelligence (AI) across discovery, manufacturing optimization, and quality control could shift cost structures (5). PharmSci 360 will also feature multiple sessions on responsible integration of AI and digital tools, reflecting growing investment in automation and data-driven decision-making. These discussions support a broader conference theme: ensuring that technological progress remains economically viable (1).

How can industry support global access to emerging technologies?

AAPS’s programming emphasizes the importance of equitable access alongside innovation. Key sessions will address the challenges of delivering advanced therapeutics to developing countries, where economic barriers often delay treatment availability (6). Understanding financing mechanisms could help ensure that therapeutics derived from new technologies reach more patients worldwide (7).

Both the opening and closing plenary speeches will feature renowned scientists, which is intended to foster high-level discourse on research philosophy, scientific trends, and future directions, Dr. He noted in her interview. The conference is further expanding engagement with hot-topic sessions and spotlight speakers and encourages greater inclusivity and participation from top experts (2).

AAPS PharmSci 360 Opening Session Examines Drug Development Financing

. Press Release. Nov. 6, 2025.
2. Mirasol, F. 2025 

AAPS PharmSci 360 to Showcase Essential AI Integration and Emerging Technologies

Cell & Gene Therapy Clinical Trials: Current Dynamics & Pipeline Outlook

. Market Research Report. 2025.
4. Labcorp. 

Cell & Gene Therapy Answers: The Evolving Cell & Gene Therapy Landscape

, Aug. 5, 2021.
5. Huanbutta, K.; Burapapadh, K.; Kraisit, P.; et al. Artificial Intelligence-Driven Pharmaceutical Industry: A Paradigm Shift in Drug Discovery, Formulation Development, Manufacturing, Quality Control, and Post-Market Surveillance. 

 (accessed Nov. 7, 2025).
7. Kang, S-K.; Lee, B.; Gupta, R.; et al. Research and Development Financing Models for New Biopharmaceuticals in the United States. 

Articles

The 2025 PharmSci 360 conference, organized by the American Association of Pharmaceutical Scientists, will focus on advancements in drug manufacturing and technology. The event will feature discussions on investment strategies, production innovation, and emerging modalities, with a keynote by Richard Thakor, PhD, on the economics of therapeutic development. The conference will also explore the impact of AI on drug development and emphasize equitable access to advanced therapeutics. Sessions aim to help drug developers assess funding risks and align scientific milestones with business strategies.

PharmSci 360 will spotlight the economics behind AI, scale-up, and advanced modalities, addressing cost barriers that influence future drug manufacturing.

Why Investment Strategies Matter for Advancing Pharmaceutical Technologies

AAPS PharmSci 360: Trends in Bioanalysis

® spoke with Long Yuan, PhD, director, Department of Drug Metabolism and Pharmacokinetics, 

, to find out how new types of instrumentation are impacting 

 and what changing regulations may be helping or hurting innovations. Liquid chromatography—mass spectrometry (LC–MS)-based assays and high-resolution mass spectrometry (HRMS) provide exceptional specificity, according to Dr. Yuan.

“Specificity, for example, for oligonucleotides, sometimes the commonly used portable mass spectrometer may not be able to differentiate the parent and metabolites,” Dr. Yuan explains. “HRMS has a unique advantage to provide additional specificity for these type of applications. Another advantage is it has the ability to obtain quantitative and qualitative information in the same run, so later, if needed, people can do data mining to dig out the needed information and avoid reassessing the samples. For chromatography technology, like microflow LC, nanoflow LC, these are very helpful tools to achieve superior sensitivity for the assay.”

Supercritical fluid chromatography (SFC), which is an instrumentation used to separate chiral compounds, is starting to be utilized for quantitative bioanalysis of chiral compounds for sample separation, according to Dr. Yuan. “There are also novel techniques, like hybridization extraction, for bioanalysis of oligonucleotides,” he continues. “This technique can achieve very clean sample extraction with high efficiency. Therefore, it can achieve highly improved sensitivity compared to the traditional sample preparation methods. It can even achieve [it] for LC–MS-based assays. It can achieve similar sensitivity as [an] enzyme-linked immunosorbent assay [ELISA] oligo binding assay. Some other techniques people are also looking into [include] microsampling, or patient-centric sampling. So, this will be very helpful to reduce the sample volumes and improve the patient convenience, and also compliance…and enable the remote home sampling for clinical studies.”

Dr. Yuan will be moderating the symposium, “Oligo Bioanalysis, Platforms and Methods” on Wednesday, Nov. 12, 2025 at 9AM in 221 AB at 

, which is being held from November 10–12 in San Antonio.

Long Yuan, PhD, Director and Head of the Bioanalytical group in the Department of Drug Metabolism & Pharmacokinetics at Biogen

Long Yuan, PhD, is currently the Director and Head of the Bioanalytical group in the Department of Drug Metabolism & Pharmacokinetics at Biogen. He leads a group of scientists to provide bioanalytical support for diverse modalities including small molecule drugs, oligonucleotides, biologics and AAV gene therapies, in drug discovery and development. Long received his B.S. in Medicinal Chemistry from Fudan University (Shanghai, China), and his Ph.D. in Medicinal Chemistry from the College of Pharmacy, University of Illinois Chicago (IL, USA). Before joining Biogen, he worked in the Department of Bioanalytical Sciences at Bristol Myers Squibb (NJ, USA). His research focuses on developing bioanalytical methodologies for various molecules, with recent emphasis on oligonucleotides, including ASO, siRNA and antibody-oligonucleotide conjugates. He has published over 50 peer-reviewed papers, including 7 book chapters.

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

My name is Long Yuan. I'm currently the Director and Head of biomedical group in Biogen DNPK, so I'm needing a group of scientists to provide bionic support for different mortalities, including small molecule drugs, oligonucleotides, biologics and AV gene therapies.

PharmTech: What are some of the new instrumentations that are being used in bioanalysis? What makes these unique?

 There have been significant advances in new instrumentations and technologies applied in Bioanalysis, for example, for LC MS based assays, high resolution mass spectrometry, HRMS has been playing more and more important role because it has the unique advantage to provide exceptional specificity. Specificity, for example, for oligonucleotides, sometimes the commonly used portable mass spectrometer may not be able to differentiate the parent and metabolites. HRMS has a unique advantage to provide additional specificity for these type of applications. Another advantage is it has the ability to obtain quantitative, quantitative and qualitative information in the same run so later, if needed, people can do data mining to dig out the needed information and avoid reassess of the samples for chromatography technology like microflow LC, nanoflow LC, these are very helpful tools to achieve superior sensitivity for the assay. For example, for some biomarker assays, it may require ultra sensitive assay. So in this case, this type of nanoflow or microflow LC will be very helpful. Another new instrumentation for LC system is super critical fluid chromatography. SFC. Traditionally, this technique is more used for the separation of chiral compounds, but nowadays people also starting to use this SFC for the quantitative bio analysis of chiral compounds, for sample preparation. There are also novel techniques like hybridization extraction, for Bioanalysis of oligonucleotides. This technique combines can achieve very clean sample extraction with high efficiency. Therefore, it can achieve highly improved sensitivity compared to the traditional sample preparation methods. It can even achieve for LC MS based assays, it can achieve similar sensitivity as ELISA assay oligon binding assay. Some other techniques people also looking into is the micro sampling, or patient centric sampling. So this will be helpful, very helpful, to reduce the sample volumes and improve the patient convenience and also compliance. This will help to enable the remote home sampling for clinical studies.

How do changing regulations impact advancements in bioanalysis?

Changing regulations in the past few years has had a profound impact on advancement of Bioanalysis, especially for biomarker assays and the bioanalysis of new modalities like gene and cell therapies, for example, for biomarker bioanalysis. In January this year, FDA published a guidance on bioanalysis method validation for biomarkers. So in general, the standards are getting stricter for biomarker assays and the bioanalytic method validation for biomarkers, it should be addressed consistent with the principles of ich MJH guidance. But still, there's some kind of lack of clarity around the context of youth one and how we can apply the ICH guidance or biomarker essays. Another area is new modalities or new bio analytical techniques like qPCR based bilingual essays. There's still lack of clear guidance on those type of new essays or new techniques, regulatory agencies like FDA, EMA, Health Canada, those agencies are working towards harmonization of regulatory guidances. It has been a tremendous achievement with the. The publication of the ICH guidance, but still there have some regional differences, and I think still all the scientists and regulators around the world need to work more towards the harmonization of the guidance in this year's AAPS, I will moderate a session focused on bioanalysis of oligonucleotides. We will have four very interesting talks focused on different techniques has been applied for oligonucleotide Bioanalysis for both the PK assays and also the immunogenicity assay. The first three talks will be focused on the PK assays, three different speakers, they have put together a very interesting comparative study compared different platforms for bioanalysis of oligonucleotides, including LCMS based assay, ligand binding assay, and also qPCR based assays. It will be very interesting to see how these different types of binding platform, when people apply to the same oligo nucleotides, how the results will come out, how is, what's the pros and cons for these different types of methods? And the last presentation will be a speaker talk about the immunogenicity, as seen for only oligonucleotides. It will be also very interesting talk. Welcome to my session. I look forward to seeing you there. Thank you. Bye.

Videos

Long Yuan, PhD, director of the Department of Drug Metabolism and Pharmacokinetics at Biogen, provides a look into some of the trends impacting bioanalysis in biopharmaceutical development and manufacturing.

AAPS PharmSci 360 2025: Trends in Bioanalysis

AI is transforming pharma R&D, bioanalysis, and manufacturing. The industry faces intense competition (obesity wars) and FDA regulatory instability

PharmTech Weekly News Roundup – Week of November 3, 2025

In this PharmTech video feature, we highlight the week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week.

Two major themes cut across the week’s news: the profound integration of advanced technology, particularly Artificial Intelligence (AI), and the complexity of the modern pharmaceutical business landscape, characterized by intense competition and regulatory uncertainty.

The AAPS PharmSci 360 2025 (AAPS) annual meeting, held Nov 9-12 in San Antonio, 

will center on the transformative role of AI

, highlighting its integration into every facet of bio/pharmaceutical research, including basic discovery, analytics, formulation, and manufacturing. Cutting-edge topics like AI-designed drugs, spatial transcriptomics, and gene therapy progress will also be featured at this essential platform for pharmaceutical innovation.

Ahead of his presentation at AAPS, Steve Lowes, senior director of Scientific Affairs at IQVIA Laboratories, tells us that 

liquid chromatography–mass spectrometry (LC–MS) is becoming the preferred tool for bioanalysis

 of complex molecules like protein-based biologic drugs and oligonucleotide therapeutics, offering benefits over traditional ligand binding assays. This shift occurs as LC–MS actively addresses past sensitivity challenges and helps mitigate issues related to critical reagents used in immunoassays.

The pharmaceutical landscape is currently defined by significant regulatory uncertainty, stemming from an accelerating loss of expertise and a fractious organizational structure within the FDA’s vaccine center, according to our 

. Intense corporate battles dominate the lucrative obesity drug market, exemplified by major lawsuits and massive revenue guidance increases for key industry players.

, Long Yuan, PhD, director of the Department of Drug Metabolism and Pharmacokinetics at Biogen, explains that AI, machine learning, and large language models are poised to significantly enhance bioanalysis, promising improvements in quality, efficiency, compliance, and reduced human errors. These technologies are utilized to automate tasks, predict optimal assay conditions for method development, and streamline the entire biomedical workflow, including data processing and report generation.

planned acquisition of Kenvue by Kimberly-Clark for approximately $48.7 billion

, which underscores the convergence of consumer health and pharmaceutical markets. This deal necessitates reviews of supply chain resilience, may influence regulatory risk tolerance due to ongoing Tylenol litigation, and could lead to manufacturing footprint consolidation.

AI is transforming pharma R&D, bioanalysis, and manufacturing. The industry faces intense competition (obesity wars) and FDA regulatory instability.

Scene from the laboratory with pipette, test tube, microscope, DNA and formulas with copy space | Image Source: ©gopixa -stock.adobe.com

Bioanalysis, which is utilized in drug development to determine pharmacology, bioavailability, and bioequivalence, includes pharmacokinetic, toxicokinetic, or biomarker concentration measurements (1) in animal safety and clinical studies. Bioanalytical methods are required by regulators to be validated to ensure their data’s reliability (1). Artificial intelligence (AI), machine learning (ML), and other complex tools are helping drug developers evaluate the complex data involved in these types of studies.

® spoke with Dr. Mark Arnold, owner and principal, Bioanalytical Solution Integration to find out how bioanalysis enhances bio/pharmaceutical drug development. Arnold will be presenting the keynote session, “Reflections on Transformations in Drug Development, Bioanalysis, and Regulations”, at AAPS PharmSci 360 on Monday, Nov. 10, 2025 at 1:30 PM.

PharmTech: How can AI and ML be used to enhance bioanalysis in bio/pharmaceutical development?

Arnold (Bioanalytical Solution Integration):

 AI, large language models [LLMs], natural language processing, and ML have been discussed for a few years in bioanalysis but are now making actual inroads with deployed validated applications and others in development.

The earliest implementations are for reports and quality control (QC) of assay validations and study sample analysis. As the capabilities of the AIs have advanced, so have the applications in bioanalysis. New applications are looking at taking GLP [good laboratory practice] or GCP [good clinical practice] protocols and bioanalytical contracts to write bioanalytical plans. Other applications perform quality control checks that integrate ELN [electronic lab notebook], instrument, and LIMS [laboratory information management system] data on a daily basis to catch errors early and identify trends that lead to failure before they happen, and data analysis as part of investigations into assay failures.

Building on design of experiment concepts, AI will utilize databases of knowledge to improve method development for immunoassays and LC–MS [liquid chromatography—mass spectrometry] methods. I’ve heard that a mass spectrometer manufacturer is looking to apply AI to chromatogram integration to go past algorithm rules to more intelligent peak detection.Ultimately, biotech and pharma companies will be using AI to write the bioanalytical sections of filings. Health authorities are also looking at AI as a tool to analyze bioanalytical data in submissions and during on-site or remote inspections of bioanalytical labs. The resulting analyses will highlight both compliance with regulations and detect problems and errors that need further review.

PharmTech: How can large language models be applied to bioanalytical workflows?

 As noted above, AI, natural language processing, and ML are being implemented in bioanalysis for report writing and bioanalytical plans. Many LLM AIs are designed as predictive tools and operate as black boxes where it cannot be determined how they do what they do. A challenge in regulated bioanalysis in the use of LLM AIs is in their training and predictive nature; they need to find data (content) in different sources and formats and place it appropriately in the report.

For regulated bioanalysis, controls must be in place for the AI or the risk of hallucination (creation of data or content not provided) can occur as has been seen in some AIs. Not knowing if the report content is correct is not something bioanalytical labs can risk and would result in utilizing the same or greater QC and QA [quality assurance] resources to make sure of the report’s accuracy. Which is contrary to what AI is supposed to do: reduce human involvement and improve accuracy.

To address this, at least one AI-based vendor for bioanalytical labs has constraints in place to prevent hallucinated data creation and is including an audit trail in its report generation steps to demonstrate the data reached the right location. Pharma companies have started using LLMs for writing some portions of eCTDs [electronic common technical documents] and the bioanalytical sections are well-structured, making them good candidates for early implementation of AI writing.

Arnold (Bioanalytical Solution Integration): 

Most of the technologies in use for pharmacokinetic, immunogenicity, and pharmacodynamic measurements have been around but are being refined for improved sensitivity, accuracy, and precision. These include the various forms of immunoassays, hyphenated chromatographic assays (e.g., LC–MS/MS [liquid chromatography—tandem mass spectrometry], LC–HRMS [liquid chromatography—high-resolution mass spectrometry]), PCR [polymerase chain reaction], flow cytometry, and cell-based technologies. The improved flow cytometry instruments, with some instruments having 30 and 40 color detection ability, are being used not only for cellular characterization, but the improved sensitivities allow them to be applied to circulating exosome biomarkers that can detect and characterize many diseases. Mass cytometry is being used in research, and once suitable applications are identified, likely in measuring biomarkers, it will move into regulated bioanalysis. 

PharmTech: How do changing regulations impact advancements in bioanalysis?

ICH [International Council for Harmonisation] M10 standardized regulations for pharmacokinetic bioanalysis using immuno- and chromatographic assays. Having a standard accepted in many major markets eliminated the need for bioanalysts to have to keep up with changes in each of the individual countries and adjust their practices, especially when there were conflicting expectations. WHO [World Health Organization] recently published M10 which may expand its acceptance beyond the ICH-adherent countries. The expansion of gene and cell therapies require technologies (e.g., PCR, FLOW cytometry) not covered in ICH M10, and so far, the scientific community has been promoting science-based approaches to these technologies. These technologies have been used in clinical laboratories and adapted for use in pharmacokinetic assays.

For immunogenicity, a few countries have developed regulations that are reasonably similar so that achieving a consistent approach is not difficult. However, with the extensive experience for monoclonal antibody drugs, bioanalysts are proposing alternative approaches to simplify the traditional tiered-immunogenicity assay designs that generate as informative data with less effort and cost. Regulators have not formally responded to these proposals.

Another area without a global regulatory perspective is the analysis of biomarkers. In the United States, measuring biomarkers for a medical decision (i.e., those used by doctors and in hospitals) must follow the Clinical Laboratory Improvement Amendments, while those used to support the safety and efficacy of a new drug are to follow a 2025 FDA guidance which is focused on immuno- and chromatographic (e.g., LC–MS/MS) assays.The European Union and Japan have totally separate and different sets of regulations. These differences create not only challenges for the bioanalyst but also add complexities when trying to run clinical trials in multiple global regions.

To be successful in delivering data accepted globally, bioanalysts must be aware of a variety of regulations and how they apply to the purpose of the analysis, type of samples they are analyzing, and the technologies. When no regulations exist, scientists must continue to collaborate on science-based best practices. Since the science is always advancing faster than the regulations, regulators must learn about the science of the technologies and evaluate practices that generate quality data, and when they have enough understanding of the science generate regulations; hopefully, based on or in collaboration with the recommendations of the scientific community.

Bioanalytical Method Validation, Guidance for Industry

Mark E. Arnold, PhD, Owner and Principal of Bioanalytical Solution Integration

Mark E. Arnold, PhD is Owner and Principal of Bioanalytical Solution Integration; consulting with biotech and pharma companies to advance their portfolios to bring new therapies to patients in need. In that role, he collaboratively develops the bioanalytical scientific and regulatory strategy to meet current and future client needs. Mark was previously Executive Director of the Bioanalytical Sciences Department at Bristol-Myers Squibb Co. and Director of Science for the Scientific Affairs Department at Labcorp supporting bioanalytical and clinical laboratories. He received a B.S. in biology from Indiana University of Pennsylvania and a PhD in pharmacology from the University of Pittsburgh. For 40 years, Dr. Arnold has been involved in the application of bioanalysis to developing new therapies, including the review and interpretation of regulations and guidance as they apply to the evolving science in bioanalytical and clinical laboratories. He was co-chair of both the AAPS-FDA Crystal City V and VI Workshops and has been a member of AAPS since 1988 holding a variety of committee positions including 2023-2024 Scientific Advisory Chair, 2022 PharmSci360 Scientific Program Committee Chair, 2018 PharmSci360 Bioanalytical Track Chair and is an AAPS Fellow (2014). Dr. Arnold has over 115 peer-reviewed publications and numerous invited podium presentations.

Artificial intelligence (AI) and machine learning (ML) are increasingly integrated into bioanalysis, enhancing drug development by improving data evaluation and method development. AI applications in bioanalysis include report writing, quality control, and bioanalytical plan creation, with constraints to prevent data inaccuracies. New instrumentation, such as advanced flow cytometry and mass cytometry, offers improved sensitivity and precision. Regulatory changes, like ICH M10, standardize bioanalytical practices globally, but challenges remain in areas like biomarker analysis. Bioanalysts must navigate diverse regulations and collaborate on science-based best practices to ensure globally accepted data.

Pharmaceutical Technology® spoke with Dr. Mark Arnold, owner and principal, Bioanalytical Solution Integration, ahead of AAPS PharmSci 360 to find out how bioanalysis enhances bio/pharmaceutical drug development.

AAPS PharmSci 360: Enhancing Bioanalysis with AI and Other Technologies

AAPS PharmSci 360 2025: The Role of LC–MS in Bioanalysis

The field of bioanalysis in the development of bio/pharmaceutical products is advancing, and a variety of techniques is available to those working in the discipline. One such tool is liquid chromatography–mass spectrometry (LC–MS). 

® spoke with Steve Lowes, senior director of Scientific Affairs at IQVIA Laboratories, ahead of AAPS PharmSci 360 to discuss how LC–MS is used in bioanalysis.

According to Lowes, while LC–MS can be more expensive and less sensitive than ligand binding assays (LBAs) for biologic analytes, the use of LC–MS is challenging the status quo. “Historically, we would also hear that the sensitivity is not what can be achieved with an immunoassay. I do think this latter challenge to LC–MS is being actively addressed, and I'm sure we'll get to talk about that in a moment,” he says. “However, the benefits of mitigating the challenges and the reliance on critical reagents associated with immunoassays leads to some interesting cost and efficiency assessments of LC–MS versus LBA.”

“I'm not saying that LC–MS is replacing LBA, but rather, with increasing frequency, we're seeing LC–MS to be the best tool for the job, including in biologic bioanalysis,” Lowes continues. “By that, I mean protein-based biologic drugs and oligonucleotide therapeutics. Integral to both of these are also the conjugated drug structures in a lot of oncology applications, where an antibody is directed to a tumor-associated antigen to deliver a cytotoxic payload. These are inherently complex molecules, and subsequently, so are the assays that we develop to address them. That is, we often are needing a free payload drug assay, a conjugated payload (i.e., the drug itself) and then the total antibody measurement as well.”

Steve will be monitoring the Rapid Fires: AI/ML in Bioanalysis session on Monday, Nov. 10, 2025 at 3PM CT at 

 being held Nov. 9–12 in San Antonio, Texas.

Click the video above to watch the interview.

Steve Lowes, Senior Director, Scientific Affairs, IQVIA Laboratories

Steve Lowes is Senior Director, Scientific Affairs at IQVIA Laboratories. Steve has 30+ years’ experience in bioanalysis with a focus on LC-MS and regulatory aspects and has been with the legacy LC-MS regulated bioanalytical lab of IQVIA Laboratories in Ithaca, NY since 1995. He is a regular presenter and author of publications on regulated bioanalysis, is co-editor of the text “Regulated Bioanalysis: Fundamentals and Practice,” and is the primary contributor to the popular 

 bioanalysis blog from IQVIA Laboratories. His most recent interests are the application of LC-MS to regulated bioanalysis of biologics and biomarkers. He received his bachelor’s degree in Analytical Chemistry at Sheffield Hallam University in the UK (1987) and a PhD in Biochemistry from the Open University, Milton Keynes, UK (1991).

Pharmaceutical Technology® spoke with Steve Lowes, senior director of Scientific Affairs at IQVIA Laboratories, ahead of AAPS PharmSci 360 to discuss how LC–MS is used in bioanalysis.

How AI, Machine Learning, and Large Language Models Enhance Bioanalysis

Artificial intelligence (AI), machine learning (ML), and large language models are tools that are seeing increasing use in a variety of pharmaceutical development and manufacturing areas. 

, to find out more about how these technologies can enhance 

“There is significantly increased interest and a great potential for AI to make a significant impact on various aspects of bioanalysis, including improving the quality, efficiency, compliance, and also reducing human errors,” Dr. Yuan says.

He believes these tools can be utilized to enhance bioanalytical method development, such as using AI to predict optimal conditions for bioanalytical assays. “This will be especially useful for assays that require significant method development, like the kind of trial-and-error type of method development, for example, for nick and binding assays, the optimization of capture and detection regions conditions,” he says.

He also points to the benefit of using AI in data processing and interpretation. “For example, AI can help to do the automated peak detection integration, calculate and generate the concentration data, and even integrate with the downstream report generation process,” he explains. AI can also be used to create study protocols and validation reports.

The specialized form of ML, large language models, can also be used to enhance the automation of biomedical workflows as well as streamlining and integrating various bioanalytical tasks, according to Dr. Yuan. “For example, we can help streamline and automate the whole biomedical process, including sample preparation, instrument calibration, routine sample analysis, data processing, documentation, and even reporting of the data,” he explains.

PharmTech: How can artificial intelligence and machine learning be used to enhance bioanalysis in bio/pharmaceutical development and manufacturing?

 AI and machine learning is still in a relatively early stage for the application in Bioanalysis. However, I do see there is significantly increased interest and a great potential for AI to make a significant impact on various aspects of biomanac sales, including improving the quality, efficiency, compliance and also reducing human errors. Here are some examples, I think they may be applied first is to enhance bioanalytical method development. For example, AI can predict optimal conditions for bioanalytical assays. This will be especially useful for assays require significant method development like that, kind of trial and error, type of method development, for example, for nick and binding assays, the optimization of capture and detection regions, conditions. The second area is the data processing and interpretation. For example, AI can help to do the automated peak detection integration, calculate and generate the concentration data and even integrate with the downstream report generation process. The other area is like to generate the study protocol, Biennale reports, validation reports to improve the compliance with regulatory.

How can large language models be applied to bioanalytical workflows?

Large language models are a specialized form of machine learning.These large language models, like ChatGPT, can significantly enhance the biomedical workflow by automating, streamlining and integrating various tasks for Bioanalysis. For example, we can help streamline and automate the whole biomedical process, including sample preparation, instrument calibration, routine sample analysis, data processing, documentation and even reporting of the data. It can also help to improve the regulatory compliance the QC, QA, large language models can help review electronic lab load books and audit trails to ensure the compliance with FDA or EMA guidelines. It may also help to connect to the new system or year end systems to pull the data, to prepare the report and draft the SOPs like those type of tasks. One unique features for large language models is it can also serve as it can be also more interactive with human. It's more like a real human. So so energies can interact with large language models to get guidance and assistance on troubleshooting a regular biological workflow, those type of tasks.

Long Yuan, PhD, director of the Department of Drug Metabolism and Pharmacokinetics at Biogen, explains how artificial intelligence, machine learning, and large language models are used in performing bioanalysis.

PharmSci 360 will spotlight AI advances, gene therapy progress, and leading pharma research insights this year, says programming chair Mei He.

2025 PharmSci 360 to Highlight Next-Gen AI for Drug Development

, in San Antonio, Texas, from Nov. 9–12, highlighting cutting-edge innovations shaping the bio/pharmaceutical sector. 

, Chair, 2025 PharmSci 360 Scientific Programming Committee, and associate professor, University of Florida College of Pharmacy, shares an exclusive preview of this year’s agenda and discusses the transformative role of 

 (AI) and advanced technologies in bio/pharmaceutical research with the 

What are the key trends shaping the 2025 annual meeting?

This year’s conference brings together leading researchers to discuss trending topics, including basic research 

, and the clinical-to-translational research pipeline, Dr. He emphasizes. She notes that more than 800 abstracts for posters and over 200 oral presentations have been submitted, reflecting rapid advances in the industry.

A central theme this year is the integration of AI into all aspects of bio/pharmaceutical research. “You will find a lot [of] interesting topics in this year’s annual meeting…we have a lot of spotlights for the scientists to present in [the] meeting,” Dr. He notes.

AI-powered analytics and manufacturing processes are set to take center stage, along with emerging technologies, such as spatial transcriptomics and 

The event will host opening and closing plenary speeches from renowned scientists, fostering high-level discourse on research philosophy, scientific trends, and future directions, she adds. The conference is further expanding engagement with hot-topic sessions and spotlight speakers, encouraging greater inclusivity and participation from top experts. With AI and 

 trends at the forefront, the 2025 meeting offers an essential platform for scientists aiming to stay ahead in bio/pharmaceutical innovation, Dr. He asserts.

Mei He, PhD, Chair, 2025 PharmSci 360 Scientific Programming Committee and Associate Professor, University of Florida College of Pharmacy

Dr. He is a senior member of the National Academy of Inventors, and chair of the American Association of Extracellular Vesicles scientific program. She is also an editorial board advisor for the journals 

 and the Royal Society of Chemistry’s (RSC’s) 

. Dr. He’s research innovation has led to more than 20 pending and issued patents, of which most have been licensed and launched as products on the market by multiple companies. Dr. He received the National Institutes of Health’s Maximizing Investigator’s Research Award and the RSC’s 

Hi everyone. I'm associate professor from the University of Florida, College of Pharmacy, and serve as the chair of the certificate program of the AAPs and especially for this year, AAPs 2025, annual meeting in San Antonio. My research expertise focused on the drug delivery, formulation, the gene therapy and theoretical development, especially, we use the latest modality of the actual cellular vesicles for gene therapy treatment.

This is a great question, and well, this year especially, we have quite a few hot topics in the APS meeting. And every session that we have mainly focused on the six of the same we have the basic research discovery and the formulation drug delivery by analytics and the manufacturing and the clinical size, translational research and with all those different theme and we can see the AI Artificial Intelligence actually plug into the each application very tightly from this year, and they catch up the latest development. And using artificial intelligence, and using the AI approach to develop for each application, and especially their hot topic, is from the translational research session, and also from the formulation drug delivery session, and even in the manufacturing session, we also have the AI plug in to develop the artificial intelligence, and they enhance the manufacturing process. So all those could be very interesting and cutting edge.

This year, we have more than 800 abstract submission and for poster. And we have more than 200 of the submission for the simplest and we also have the hot topics and the rapid fair. And all those sessions are catch up the change in the frontier of the pharma industry and research developments, and especially for the submission trending using the new techniques, and some techniques like artificial intelligence and also the spatial transcriptomics And the gene therapy and AI designed drug so all they use the into therapeutic development, which are the trending right now? So if you want to catch up the frontier of the former development and know what's new of the technology, definitely, you will find a lot interesting topic in this year annual meeting

for today of the top scientists, and we have a lot of spotlights for the scientists to present in APS meeting, and especially for the opening plenary speech, and also for the closing plenary speech, we have those top scientists to present in the to catch up their philosophy and also the research development and also share their experience and the perspectives and during those opening remarks. And we also have hot topics that we are going to develop this hot topics and the spotlight speakers and more and more in the future of the APS annual meeting, which actually have much more engagement of the speakers compared to the past few years. And this also will open the submission for the hot topics and also spotlight speakers, and we want to be more inclusive to accept the more top scientists to be engaged in our meeting.

AAPS PharmSci 360 will spotlight AI advances, gene therapy progress, and leading pharma research insights this year, says programming chair Mei He.

2025 AAPS PharmSci 360 to Highlight Next-Gen AI for Drug Development

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

We conclude our CPHI discussion with Thermo Fisher Scientific.

Jennifer Cannon Interview Part Two

, PhD, president, Commercial Operations, Pharma Services at 

, at CPHI Frankfurt 2025, the discussion shifts from artificial intelligence (AI)—typified by Thermo Fisher’s recently announced strategic collaboration with OpenAI—to the results yielded by the company’s Accelerator Drug Development platform in its first year of offering the formally integrated contract development and manufacturing organization (CDMO), contract research organization (CRO), and clinical supply services.

“We're getting to the point where we've got so much experience in doing it that we want to move more toward an outcome-based contracting, where we commit to a certain timeline that is significantly faster than the fragmented supply chain where customers use different vendors throughout their CMC (chemistry, manufacturing, and controls) and clinical trials and testing,” Cannon says in the interview.

This experience, she says, naturally builds trust between Thermo Fisher and its partners.

“Just speaking about the development in the manufacturing side, there's going to be bumps in the road, through your development, as you're approaching commercialization,” Cannon says. “You want to work with a partner that's going to help you through those bumps in the road.”

Cannon also spoke about the annual experience of CPHI and how it has evolved over the last decade-plus.

“I've been to CPHI for 13 years, and it was always historically very small-molecule modality-based,” she says. “Now we're seeing a lot more customers, of course, coming in with large-molecule and emerging cell and gene therapies.”

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

I am Jennifer Cannon. I head up the commercial organization for Thermo Fisher’s CDMO, contract manufacturing. We call it the Pharma Services group.

We've actually mapped that out. We continue to lean on the Tufts Center for the Study of Drug Development and Design, and they use our data as well as data that that models out, if we're working with a customer in Phase I or II, they're modeling out, if that molecule continues on, what that benefit will be long-term. And so it's some of their data and our data combined.

For Phase III programs, that's where we see the bigger return on investment, just because the cost of the trial [and] the number of patients involved in the trial is so much more significant. And so the cost and time savings benefit[s are] that much more significant. We're seeing between a 20- [and] 100-fold return on investment. The net present value of these are quite significant. We're getting to the point where we've got so much experience in doing it that we want to move more toward an outcome-based contracting, where we commit to a certain timeline that is significantly faster than the fragmented supply chain where customers use different vendors throughout their CMC (chemistry, manufacturing, and controls) and clinical trials and testing.

When we make that commitment, we're actually providing a guarantee to performance. Imagine if you're a biotech, you have limited funding, you know then that you can advance your IND (investigational new drug) filing, or you can move to your next Phase II or Phase III that much faster. It's a pretty bold commitment that we're making, but it's because we've got enough of these trials under our belt, both on the CMC and the clinical trial side, that we're ready to introduce this in 2026.

Just speaking about the development in the manufacturing side, there's going to be bumps in the road, through your development, as you're approaching commercialization. You want to work with a partner that's going to help you through those bumps in the road. And so as we come to CPHI again, we've built really strong relationships. We've managed through some difficult supply chain issues.

For customers that have been working with us for many years, even pre-COVID, so much has to come together to be ready for commercialization. Might be through the process development status, the procurement of materials, the readiness of the line. Being able to have very open and transparent discussions and using data during it, we use [the] MySupply [platform]—that was something we rolled out about a year and a half ago, which we give our customers full access to. Not many CDMOs will do this. MySupply allows a customer to go in and see, did my batch start filling? Is my batch on track for on-time delivery? Is my batch in full? How does the yield look? If there’s a particular—if it's in the red, if a program's not performing as originally planned between the partner and Thermo Fisher, what actions are we doing, which are on a glide path, and how are those actions being implemented to ensure we get back on track? So we believe a lot in data, and we believe in full transparency to our customers.

We also really appreciate and value when our customers come to our sites and work with us and understand the complexity of what we're delivering together.

Thermo Fisher’s Jennifer Cannon reviews the first year of the company’s Accelerator Drug Development suite of services and the overall experience of attending the CPHI conference.

Building Trusted CDMO Relationships: A CPHI Conversation with Thermo Fisher Scientific, Part Two

We conclude our CPHI conversation with Lonza Capsugel.

Frank Romanski Interview Part Two

, PhD, vice-president of Strategic Growth & Revenue Management and head of Global Pharma Solutions at 

® about the importance of adhering to current good manufacturing practice (cGMP) guidelines in a world in which regulatory shifts and an ongoing push for digitalization are constantly keeping companies on their toes.

“This is really a license to operate in this space,” Romanski says in the interview. “This reduces risk, this manages product recalls. We're ensuring consistent product quality, simplifying regulatory approval processes, and ultimately saving costs and conserving resources in drug manufacturing.”

The move to digital recordkeeping in particular, Romanski says, is in many ways unavoidable for pharmaceutical companies—and it is crucial.

“The world of regulatory and quality has a tendency to be very heavy on the paperwork side of things,” he says. “And if you're not leveraging the digital technologies that we have today, I think it's a missed opportunity.”

Of course, contract development and manufacturing organization (CDMO) partners must align on these standards, making quality even more paramount, according to Romanski.

“Once you get downstream and you start talking about the CDMO sites that we manage, this is something that's, of course, absolutely critical to what we're doing,” he says in the interview. “We really embed quality into every step of our manufacturing processes, all of the interactions that we have with our clients, and with any agencies that they're in.”

My name is Frank Romanski. I head the Strategic Growth and Revenue Management group and am the head of the Global Pharma Solutions business at Lonza Capsugel.

I know that your audience in particular knows the criticality of cGMP manufacturing. This is really a license to operate in this space. This reduces risk, this manages product recalls. We're ensuring consistent product quality, simplifying regulatory approval processes, and ultimately saving costs and conserving resources in drug manufacturing.

For us at Lonza Capsugel, let's talk about two different pieces of this. We of course have the drug product manufacturing facilities, which always operate under the appropriate cGMP. But I want to talk a little bit about the capsule side of the business, the excipient side of business, if you will. Our manufacturing facilities are independently certified for the appropriate cGMP standards, and we do that across our entire network. We have a network of sites that go in all of the major different markets, and we operate each one of them at the appropriate cGMP standards. And we set a global bar so that there's interchangeability and there's robust supply chains that can be brought to our customers.

We also offer to our customers comprehensive regulatory support, compliance support, to help drug developers navigate these pathways all the way from the concept into the clinic, into the commercialization pathway, and we have a very strong track record of commercial drug manufacturing.

One other thing that I think is really important that we're putting a lot of emphasis on is digitalization. The world of regulatory and quality has a tendency to be very heavy on the paperwork side of things. And if you're not leveraging the digital technologies that we have today, I think it's a missed opportunity. So what we have done is we've taken a lot of our paperwork that [is] needed for our clients, with which to interact with regulatory authorities, quality agencies, etc., and we've put that all online in our ACHIEV portal. And this enables people to have a one-stop shop, [you] don't need to call somebody on the phone, you don't need to use a fax machine or some of these technologies that are long outdated. You can get everything online. It's always up to date. You get notifications when things change, etc.

And finally, as we're producing our products and our services, we're always building quality-by-design into those products themselves, and we're leveraging a tremendous amount of technology to make sure that we are consistent always with those highest standards.

When it comes to making drug product, it really starts with a lot of the raw materials that are being used. And something that, of course, at Lonza Capsugel, we can speak very intelligently about is the capsules themselves. In order to make them to the highest standards, we really have to start with the quality of the raw materials. And we work with all of our partners in the supply chain when we're sourcing things like gelatin or HPMC (hydroxypropyl methylcellulose), which are the bedrock of the capsules that we're ultimately producing.

We have really robust quality management systems, and really, we set the bar in terms of industry-leading standards across our network. We're also a founding member of EXCiPACT, which is an independent third party that really sets the standards for excipient manufacturing. And that's something that has been really quite important of late, because as most manufacturers are also manufacturing excipients for different parts of different industries, it's really important that on the pharma side, that we're all following the appropriate cGMPs.

In addition to that, we continue to really focus on the processes that we have. We document everything that's there. And once you get downstream and you start talking about the CDMO sites that we manage, this is something that's, of course, absolutely critical to what we're doing. We really embed quality into every step of our manufacturing processes, all of the interactions that we have with our clients, and with any agencies that they're in.

Frank Romanski of Lonza Capsugel dives into the excipient side of manufacturing and the emerging prevalence of digitalization.

Regulatory, cGMP, and CDMO Challenges: A CPHI Conversation with Lonza Capsugel, Part Two

A recent analysis of FDA’s 505(b)(2) regulatory pathway approvals that was presented at AAPS PharmSci 360, held Nov 9-12, 2025 in San Antonio, Texas, provides detailed insight into current trends in pharmaceutical formulation and manufacturing. For a study, Manasa Singirikonda, PhD-candidate, Long Island University, and Ahmed Abu Fayyad, PhD, RPh, examined approval data from 2024–2025 aimed to provide a comprehensive understanding of the characteristics of these reformulated drugs, including their therapeutic targets and the challenges inherent in developing them. Their investigation focused specifically on identifying the approaches used to overcome technical hurdles, such as stability, palatability, and manufacturing consistency, alongside meeting specific pharmacokinetics and bridging requirements. Data from FDA’s public database and corresponding product labels were processed to document relevant attributes, including dosage form, physicochemical properties, and patient-centric considerations like compliance, ease of use, and dosing accuracy.

How are manufacturers utilizing the 505(b)(2) pathway?

The study tracked 69 FDA-approved submissions classified as reformulations of previously approved drugs, which could involve a new dosage form, a new combination, a novel formulation, or a change in manufacturer. The most prevalent category was the Type-3 New Drug Application, which signifies a new dosage form, accounting for 41 submissions. Submissions related to a new formulation or manufacturer (Type-5) followed, totaling 24, while submissions for a new combination (Type-4) made up four approvals, and a single submission was filed for a Type-2 New Active Ingredient.

When reviewing the structure of the resulting products, injectable formulations represented the largest category, at 33.4% of the approvals (see pie chart). Oral dosage forms constituted the majority of the remaining approvals, with oral tablets (20.3%), oral solutions (13.1%), oral suspensions (10.15%), and oral capsules (8.7%) as the most common. The approvals also included various other formats, such as nasal sprays, ophthalmic formulations, oral films, pellets, granules, powders, and intrauterine systems. Furthermore, the approvals reflect an industry focus on high-priority therapeutic areas, with 8.7% of the products indicated for rare (orphan) diseases and 10.1% designated as cancer-related.

What technical challenges are driving pharmaceutical reformulation?

The effort to improve drug performance, enhance patient adherence, and ensure manufacturing reliability is reflected in the technical challenges identified and addressed in these submissions. The primary challenge tackled through these reformulations was related to stability, which was relevant to 26% of the products. Manufacturing consistency, another significant factor, was a challenge that drove 5% of the reformulation efforts.

Addressing patient comfort and ease of use remains a central theme in these new approvals. Taste or palatability was a challenge addressed in 17% of the products. Other patient-centric factors included dosing accuracy or flexibility (12% of products) and ease of use (5%). Furthermore, 10% of the products involved innovation in the device or delivery system. Complex regulatory and technical requirements, such as pharmacokinetics and bridging requirements, also posed challenges, influencing 12% of the reformulations.

To overcome these formulation obstacles, innovative technologies were recorded in the study, including the strategic use of amorphous solid dispersions and prodrug strategies. The overall pattern for 2024–2025 demonstrates the ongoing importance of formulation science in addressing stability issues and enhancing patient comfort. The increasing incorporation of sophisticated delivery systems, particularly lipid- and 3D-printing technologies, suggests promising avenues for future pharmaceutical product development. These developments offer valuable lessons that can inform subsequent candidate formulation and regulatory strategies.

The analysis of FDA's 505(b)(2) regulatory pathway approvals from 2024-2025 reveals significant trends in pharmaceutical reformulation. The study highlights the prevalence of Type-3 New Drug Applications, focusing on new dosage forms, and identifies injectable formulations as the largest category. Key technical challenges include stability, manufacturing consistency, and patient-centric factors like palatability and dosing accuracy. Innovative technologies, such as amorphous solid dispersions and prodrug strategies, are employed to address these challenges. The findings underscore the importance of formulation science and advanced delivery systems in future pharmaceutical development.

Analysis of FDA 505(b)(2) data (2024–2025) shows 69 drug reformulations, with a  focus on enhancing stability and patient comfort, utilizing new dosage forms, and innovative strategies.

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