Susan Haigney

.AI, Machine learning, Business analysis, Science and artificial intelligence technology, Cloud computing, Network, Big data, communication, Digital transformation, Innovation and futuristic. | Image Credit: ipopba -stock.adobe.com

For pharmaceutical scientists, the integration of artificial intelligence (AI) and machine learning (ML) into workflows represents a fundamental paradigm shift in how the industry discovers, develops, and manufactures medicines (1). AI is no longer a futuristic concept but a present-day reality, reshaping everything from early-stage drug discovery and clinical trial optimization to real-time process control on the factory floor (1). The synergy between groundbreaking science and innovative, AI-driven manufacturing may well define the next decade of bio/pharma, creating more personalized, effective, and accessible therapies.

How is AI accelerating discovery and streamlining development?

AI is looking to be invaluable during the early stages of drug development as it can rapidly screen vast compound libraries and predict a drug candidate's properties from just its chemical structure (2). ML algorithms can identify complex patterns in high-dimensional data, allowing scientists to de-risk projects by predicting absorption, distribution, metabolism, elimination, and toxicity (ADMET) properties 

 before committing to resources (2, 3). This capability is particularly crucial for complex molecules with poor solubility or narrow therapeutic windows, where traditional modeling may fall short (2).

Beyond initial screening, digital tools are creating a bridge between R&D and manufacturing (3). AI-powered analysis of preclinical data can help optimize formulation conditions, while virtual models of a process or product (i.e., digital twins) offer extensive 

 testing, scenario elaboration, and process optimization (1, 3, 4, 5). These tools have the potential to save time and resources by reducing the need for physical experiments. They also have the potential to accelerate tech transfer by capturing and standardizing process knowledge, ensuring consistency from a small lab batch to a large manufacturing run (3, 5).

The impact of AI extends into manufacturing, where Industry 4.0 is driving the adoption of smart machinery, interconnected sensors, and AI-driven control systems (4). In both small-molecule and large-molecule manufacturing, the goal is to leverage data to achieve high levels of process understanding and control (4, 5). By combining AI/ML models with process analytical technology, manufacturers can monitor critical quality attributes in real time, moving toward real-time release (4, 5).

This integration enables a move from reactive to predictive—and eventually prescriptive—manufacturing (4). An AI/ML model can analyze real-time sensor data from a bioreactor, predict the final batch outcome, and drive a closed-loop optimization to adjust parameters before a deviation occurs (4,5). This can lead to improved yields, reduced variability, and more consistent product quality, when compared with standard, non-AI/ML approaches (4,5).

How can one navigate the data and regulatory landscape?

Realizing the full potential of AI hinges on high-quality, contextualized data (1,2). Process data from the factory floor is often unstructured, making it difficult for algorithms to use effectively (5). Adopting findable, accessible, interoperable, and reusable (FAIR) data principles and creating centralized data platforms are essential first steps to building a scalable, AI-ready environment (1,5). Without context, the value of data diminishes, hindering their ability to drive meaningful action (5).

Simultaneously, the regulatory landscape is rapidly evolving to keep pace with technology (6). While regulators may be open to AI-driven approaches, they emphasize the need for transparency, validation, and managing bias (2, 5, 6). The "black box" nature of some algorithms is a significant concern, pushing the industry toward hybrid models that combine the predictive power of AI with the interpretability of mechanistic models (2, 3). Establishing "good machine learning practice" will be crucial for ensuring these tools are fit-for-purpose and gaining regulatory confidence (2).

As the industry moves forward, AI will continue to augment human expertise, requiring a workforce upskilled in data analysis and robotics (1, 4). The journey ahead involves navigating these data and regulatory challenges, but the destination may be a more efficient, intelligent, and patient-centric pharmaceutical industry.

Visit PharmTech.com to watch industry experts discuss the use of AI/ML in pharma. Below is a selection of video interviews.


Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates, joins PDA CEO Glenn Wright and Melissa Seymour, Executive Vice President, Global Quality, Eli Lilly and Company, to talk about the regulatory and quality topics discussed at the 2025 PDA Regulatory Conference.


https://www.pharmtech.com/view/pda-regulatory-conference-2025-wrap-up

Industry Outlook 2025: Technology as a Supporting Element

® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about the use of artificial intelligence and machine learning in pharmaceutical development and manufacturing.


https://www.pharmtech.com/view/industry-outlook-2025-technology-as-a-supporting-element

Drug Digest: Keeping Pace with Progressive Technologies in Biopharma Development


This episode of Drug Digest will discuss where the significant bottlenecks are in the development and manufacturing of new molecules resulting from progressive technologies, such as AI and ML, and how best to approach these challenges.


https://www.pharmtech.com/view/drug-digest-keeping-pace-with-progressive-technologies-in-biopharma-development

Quality Considerations for Using AI in Bio/Pharma


In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice-president, Technical, at Parexel, discuss the quality requirements needed when incorporating AI in bio/pharmaceutical development and manufacturing.


https://www.pharmtech.com/view/quality-considerations-for-using-ai-in-bio-pharma

Thomas, F. Expanding Pharma’s Horizons Through AI and Acquisitions." 

Challener, C. A. Overcoming PK/PD Modeling Challenges. 

Haigney, S. Advancements in Biopharma Spur Innovation. 

Mirasol, F. Accelerating Adoption of Smart Tools to Advance Manufacturing." 

Markarian, J. Optimizing Data Use for Digital Transformation." 

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

Articles

AI and ML are transforming pharmaceutical workflows, from drug discovery to manufacturing, by enabling rapid screening of compounds, predicting drug properties, and optimizing processes. These technologies facilitate the transition from reactive to predictive manufacturing, enhancing process control and product quality. High-quality, contextualized data and evolving regulatory frameworks are crucial for maximizing AI's potential. The industry must address data challenges and regulatory concerns, such as algorithm transparency, to fully leverage AI's capabilities. Upskilling the workforce in data analysis and robotics is essential for future advancements.

This article takes a look at the developing use of AI in pharmaceutical development and manufacturing.

How AI is Accelerating Pharmaceutical Development

The Story of Nitrosamines

Nitrosamines occurring in pharmaceuticals became a developing problem in 2018, and regulatory agencies have been working with pharmaceutical companies since to mitigate the risk of these cancer-causing chemicals in drug products. Over the years, 

® has covered the issue through news reports, interviews, and technical articles. PharmTech's nitrosamine coverage can be found in the reference list below. 

Click the above audio summary to learn about how the nitrosamines situation began and is continuing. And check out the video summary below.

 This media was created using NotebookLM using articles found on PharmTech.com. Please see below list of references. AI-generated content may not be correct.

The graphic below breaks down some of the basics involved and what manufacturers should look out for. 

Nitrosamines Contamination. Image Credit: Created using Canva AI

The discovery of nitrosamine impurities in pharmaceutical drugs, beginning in 2018, has prompted extensive regulatory action and industry-wide changes to ensure patient safety (1,2). The issue first came to light when N-nitrosodimethylamine (NDMA), a probable human carcinogen, was found in valsartan, an angiotensin receptor blocker (ARB), from a Chinese active pharmaceutical ingredient (API) manufacturer, Zhejiang Huahai Pharmaceutical Company (1, 3). This led to widespread recalls of sartan-based medicines (1).

Investigations soon revealed other nitrosamines, like N-nitrosodiethylamine (NDEA), in different sartan drugs, including losartan and irbesartan (1,4). The contamination was traced to specific manufacturing processes, particularly those involving certain solvents, reagents, and recycled materials (5, 6,7). The problem was not isolated to sartans; NDMA was later found in other widely used drugs such as ranitidine (Zantac), metformin, and pioglitazone, triggering further recalls and investigations (3,9). One study suggested the ranitidine molecule itself might be inherently unstable, capable of forming NDMA under conditions mimicking the human stomach (9).

In response, global regulators, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have issued comprehensive guidance (10, 11). They now require pharmaceutical companies to conduct rigorous risk assessments for all chemically synthesized APIs to identify and mitigate nitrosamine risks (3, 10, 7). Both agencies have established acceptable daily intake limits for various nitrosamines and mandated confirmatory testing if a risk is identified (3, 12). The FDA has also developed advanced analytical methods, such as liquid chromatography-mass spectrometry (LC-MS), to detect trace levels of these impurities and avoid false positives that could occur with older testing protocols (1, 9, 13). This ongoing challenge has underscored the critical need for continuous safety surveillance and robust quality control throughout the pharmaceutical supply chain (3, 14).

 This summary was created with NotebookLM using articles found on PharmTech.com. AI-generated content may not be correct.

After Valsartan Recalls, Regulators Grapple with Nitrosamine Contamination in APIs

Detecting Apparent Total Nitrosamine Content in Pharmaceutical Drugs.

Complying Confidently? Learning Lessons from Nitrosamine Impurities

FDA Hits Valsartan Manufacturer with Warning Letter. 

5. PharmTech Editors. FDA Gives Update on NDMA Investigation. 

FDA Releases List of 'Safe' Valsartan and ARBs While Experts Explore and Debate Root Causes of Contamination. 

 Investigating NDMA Impurities at EMA’s Request.

Pharma Industry Contends with Contamination-Based Recalls.

Problems With Ranitidine May Transcend Manufacturing Issues

EMA Issues Final Opinion on Nitrosamines.

FDA Publishes Guidance on Control of Nitrosamines

Nitrosamine Impurities in Medicinal Products. 

Understanding Nitrosamine Impurities in the Pharmaceutical Industry

What Goes Wrong When API Quality is Compromised? 

Development of a Validated Method of Testing for NDMA in Ranitidine. 

• Curran, T. and Bercu, J. P. (2021, March 15).

 Managing the Risk of Nitrosamine Impurities

European Pharmacopoeia Updates: EDQM Tackles Nitrosamine Impurities

N-Nitrosamine Impurities and FDA’s Recommendations for Acceptable Intake Limits

Strategies for Mitigating Nitrosamine Risk

FDA Releases Guidance on Intake Limits for Nitrosamine Drug Substance-Related Impurities. 

European Authorities Continue Work to Prevent and Manage Nitrosamine Impurities.

. Sartan Manufacturers Should Review Manufacturing Processes, Says EMA

FDA Approves New Generic Valsartan. Pharmaceutical Technology. 

EMA Provides Guidance on How to Avoid Nitrosamines in Human Medicines

FDA Expands Scope of API Impurity Investigation.

Latest ARB Recall Triggered by New Impurity. 

Metformin HCl Extended Release Tablets Recalled.

Nostrum Laboratories Expands Recall of Metformin HCl Extended Release Tablets

What Does the FDA's Recent Update of the Nitrosamine Guidance Convey?

Nitrosamides–Should They Be Treated the Same as Nitrosamines?

Videos

This review of the nitrosamines contamination problem in pharmaceuticals takes a look at how the crisis started and developed.

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

The European Medicines Agency (EMA) announced on Sept. 29, 2025 that it has published a draft reflection paper on the use of patient experience data in the regulation of drugs (1,2). The reflection paper was written to encourage drug developers to gather and include data on real-life experiences of patients throughout a drug’s lifecycle so that regulators can use that insight in regulatory decisions. The draft reflection paper is open for public consultation until Jan. 31, 2026.

What can the patient perspective provide?

According to EMA, patient perspectives are of “great value” and include data such as cancer patients choosing quality of life over clinical endpoints. These data can play a “complementary role” to other scientific data during the regulatory review process. These types of data can be provided through Patient Reported Outcomes (PROs), Patient Preference Studies, and other patient engagement activities.

“Recent years have seen efforts by regulators internationally to steer medicine development toward programs that not only meet the requirements for quality, safety and efficacy of individual products, but also incorporate the broader perspectives of patients and carers. This is because patients may value different aspects of their disease and available treatments than medicine developers, including the type of relevant outcome measures to be assessed (e.g., quality of life), populations or stages of disease to be studied, or risk tolerability. An optimal patient-relevant medicine development program incorporates patients’ perspectives and documents their experience. Such patient experience data are directly collected from patients or carers experienced in managing the disease and capture their needs and preferences,” the paper states.

The reflection paper provides drug developers with principles on the generation, collection, and analyzation of these data. The paper also provides sources for where the data can be obtained, such as clinical trials and real-world data from safety surveillance systems. Also included in the paper are discussions on training and capacity building, challenges related to using PROs, study design, transparency issues, and considerations for systemic implantation of these data.

The paper does not include detailed methodological guidance; however, EMA is working with the International Council for Harmonisation (ICH) to harmonize existing global methodological guidelines. The EMA reflection paper is a complement to the ICH work and focuses on development programs and regulatory submissions in the European Union. EMA is supporting developers by offering early interaction platforms to discuss development plans and proposals for regulatory submissions.

What is the importance of real-world evidence?

Real-world evidence, such as the patient experience, is gathered after a drug goes on the market. Data are used to determine the continued safety of the product. In the September 2025 episode of Ask the Expert, Siegfried Schmitt, vice president, Technical, at Parexel, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, discussed the role real-world evidence plays in drug development and manufacturing (3).

“Real-world evidence is part of the pharmacovigilance activities, and these are obviously mandatory for all marketed medicines,” explains Schmitt. “Real-world evidence collation wasn't really required in the past, but it is now. And, in my opinion, it's very likely to stay, given the benefits that real-world evidence delivers. And so, therefore, the real-world evidence for the product must be gathered for as long as you keep the product on the market.”

Schniepp goes on to explain that data about a product must be collected for the product’s lifetime, because of the potential for unknown side effects once used by patients. “You get indications or side effects, [when] you are in the clinical trials. But then once you open it up to the greater population, and everybody can take the medicine, you get more side effects, because it's going to affect everyone differently.”

EMA. A Path to Better Include Patients’ Perspectives in the Regulation of Medicines. Sept. 29, 2025. 

https://www.ema.europa.eu/en/news/path-better-include-patients-perspectives-regulation-medicines

EMA. Reflection Paper on Patient Experience Data. Sept. 18, 2025. 

https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-patient-experience-data_en.pdf

Schniepp, S.; Schmitt, S.; Haigney, S. Ask the Expert: Questions about Real-World Evidence and Supply Chain Security. PharmTech.com. Sept. 25, 2025. 

https://www.pharmtech.com/view/ask-the-expert-questions-about-real-world-evidence-and-supply-chain-security

The European Medicines Agency (EMA) has released a draft reflection paper to encourage the integration of patient experience data in drug regulation. This initiative aims to incorporate real-life patient insights throughout a drug's lifecycle, enhancing regulatory decisions. Patient perspectives, including quality of life considerations, are deemed valuable and can complement scientific data. The paper outlines principles for data collection and analysis, emphasizing real-world evidence's role in ongoing drug safety assessment. The EMA collaborates with the International Council for Harmonisation to align global methodological guidelines.

A draft reflection paper on patient experience data is up for public consultation until Jan. 31, 2026.

EMA Looks to Include Patient Perspectives in Drug Regulation

Radiopharmaceuticals: A Development Platform

In September 2025, Medicines Discovery Catapult (MDC), a national life sciences service dedicated to drug discovery, and Crown Bioscience, a contract research organization, announced they are collaborating on an integrated translational biology platform to develop radiopharmaceuticals (1). According to the National Institutes for Health, radiopharmaceuticals may reduce side effects associated with other cancer treatments; therefore, there has been a surge of research and clinical trials for these drugs (2). The new MDC/Crown Bioscience platform is being created to support this surge in radiopharmaceutical development and will provide a workflow for more-efficient studies and high-quality translational data.

To learn more about the platform and radiopharmaceuticals, 

® spoke with Bryan Miller, Director of Scientific and Technical Operations at Crown Bioscience UK.

“Radiopharmaceuticals offer exciting prospects for the treatment of cancer by coupling an isotope to a test article that recognizes a specific target on a tumor, we can deliver a targeted dose of radiation that will kill the tumor without harming healthy tissue,” Miller explains. “This offers increased safety and efficacy for anti-cancer treatments, and I am very excited by the prospect of widening the range of tumors where radio pharmaceutical therapies are available for patients.”

“Radiopharmaceutical preparation requires careful planning and expert execution. Selecting the correct pre-clinical model is crucial,” Miller continues. “Determining the correct targeting strategy for the tumor is absolutely vital as well, and you need to select an appropriate isotope and correct labeling position. It's absolutely vital to develop a robust labeling strategy and conduct a thorough QC of the methods we are able to offer advice and support across all of these areas for the design of a successful radio pharmaceutical project.”

Click the video above to watch the interview.

MDC and Crown Bioscience. Medicines Discovery Catapult and Crown Bioscience Form Strategic Global Alliance for Radiopharmaceutical Innovation. Press Release. Sept. 11, 2025. 

https://www.businesswire.com/news/home/20250911458780/en/Medicines-Discovery-Catapult-and-Crown-Bioscience-Form-Strategic-Global-Alliance-for-Radiopharmaceutical-Innovation

NCI Staff. Radiopharmaceuticals: Radiation Therapy Enters the Molecular Age. National Cancer Institute. 

https://www.cancer.gov/news-events/cancer-currents-blog/2020/radiopharmaceuticals-cancer-radiation-therapy

Bryan Miller, Director of Scientific and Technical Operations, Crown Bioscience UK

Bryan Miller completed his PhD in Biochemistry at the University of Leicester. He subsequently performed two post-doctoral fellowships at the University of Toronto and the Beatson Institute where he focused on 

 models of colorectal and pancreatic cancer. He has worked in the CRO field since 2015, and joined Crown Bioscience UK in 2019 where he currently serves as Director of Scientific and Technical Operations.

Pharmaceutical Technology® spoke with Bryan Miller, Director of Scientific and Technical Operations at Crown Bioscience UK, to learn more about Crown Bioscience’s collaboration with Medicines Discovery Catapult on a new development platform for radiopharmaceuticals.

Ask the Expert: Questions about Real-World Evidence and Supply Chain Security

The lifecycle of a drug product doesn’t end once the drug is put on the market. It extends beyond, where real-world evidence from patient use of the product provides data that are often relied on in the continued safety testing of drugs or in the development of new drug products.

“Real-world evidence is part of the pharmacovigilance activities, and these are obviously mandatory for all marketed medicines,” explains Siegfried Schmitt, vice president, Technical, at Parexel. “Real-world evidence collation wasn't really required in the past, but it is now. And, in my opinion, it's very likely to stay, given the benefits that real-world evidence delivers. And so, therefore, the real-world evidence for the product must be gathered for as long as you keep the product on the market.”

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, goes on to explain that data about a product must be collected for the product’s lifetime, because of the potential for unknown side effects once used by patients. “You get indications or side effects, [when] you are in the clinical trials. But then once you open it up to the greater population, and everybody can take the medicine, you get more side effects, because it's going to affect everyone differently.”

What kind of supply chain problems can occur during the transportation of pharmaceutical products?

“We are not talking about a breakdown necessarily,” Schmitt says. “We are talking about facts like we heard of from the news, where, say, in the United States, a whole truck [of product] vanished into thin air. They stole a complete truck. They didn’t just break into a truck and steal something. There are some ports in Europe where you should never, ever transport pharmaceuticals through; they get stolen by default. A lane risk assessment is a necessity to understand ‘how can you transport safely, securely? Where should you, for example, stop your truck overnight? Is it illuminated? Is it secured? Is it just in the backyard of a motel?’”

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

My company just launched a novel, small-molecule drug into the market. For how long do we need to gather real-world evidence to monitor its safety and efficacy?

My company is investigating options for a novel cell therapy for the oncology market. How can we leverage real-world evidence from our own research and from post-market drugs already on the market to choose which direction to go in?

We are a drug product manufacturer, and we take supply chain security very seriously. As part of our internal assessment, we have identified transportation as a critical element of the supply chain. We use several third parties for the transport of our goods. What security aspects should we address?

Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.

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

Siegfried Schmitt, PhD, vice president, Technical, Parexel

Siegfried Schmitt is vice president, Technical at Parexel and a member of 

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to 

, and it may appear in a future episode or print column.

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates, and Siegfried Schmitt, PhD, Parexel, answer questions on the use of real-world evidence for both small-molecule and large-molecule drug development. In addition, they tackle a question on supply chain security problems that arise during transportation of pharmaceutical goods.

Converging Fronts of Cancer Treatments

In this PharmTech video feature, we take a look at a few of the latest news stories about advancements and research in the oncology field.

Cancer research and treatment center planned for London

In May 2025, Aviva Capital Partners and mixed-use developer Socius announced plans for a new £1 billion (US$1.33 billion) investment to create a cancer research and treatment center in Sutton, London, with approximately 1 million square feet of state-of-the-art research and laboratory space where life sciences companies can come together with academic researchers and clinicians to push cancer research forward.

https://www.pharmtech.com/view/cancer-research-and-treatment-center-planned-for-london

Emerging modalities for cancer treatment have been advancing. Cell and gene therapies, peptides, monoclonal antibodies, antibody drug conjugates, tumor-infiltrating lymphocytes (TILs), and vaccines such as messenger RNA, as well as a variety of other treatments have developed in recent years. While Chimeric antigen receptor (CAR T)-cells have been a focus for the industry, TILs are focused on treating solid tumors, according to Jason Bock, co-founder and CEO of CTMC. 

"TILs have been around for decades, especially in academic centers, and have a slightly different approach, where we take a piece of the tumor and extract the cells, the immune cells that [have] already found their way into the tumor and are presumably fighting that tumor, and then we can have methods to expand, in some ways, rejuvenate those cells to large numbers and then reinfuse those to the same patient,” says Bock. “Another really exciting aspect about TILs is that they have inherent specificity for the tumor that allows us the opportunity to further genetically engineer them for improved fitness, persistence, or durability.”

https://www.biopharminternational.com/view/emerging-treatments-for-cancer

In other news, CellCentric, a Cambridge, UK-based clinical-stage biotechnology company, is developing as a potential first-in-class oral treatment, inobrodib, for several specific types of cancer, notably multiple myeloma. The company received $120 million in Series C funding to support a Phase II/III study in May 2025.

https://www.pharmtech.com/view/cellcentric-completes-120-million-series-c-funding-round-for-multiple-myeloma-treatment-inobrodib

Medicines Discovery Catapult (MDC), a national life sciences service dedicated to drug discovery, and Crown Bioscience, a contract research organization, announced in September 2025 that they are collaborating on an integrated translational biology platform to be used to develop radiopharmaceuticals. The collaboration will support the advancement of radiopharmaceuticals, including new isotopes and optimizing targeting agents, and will enable testing of how radiopharmaceuticals perform in the body.

https://www.pharmtech.com/view/medicines-discovery-catapult-and-crown-bioscience-create-alliance-for-radiopharmaceuticals

In August 2025, FDA published a draft guidance document titled 

Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development

 that was created to assist drug sponsors with identifying an optimized dosage for radiopharmaceutical therapies (for oncology indications during clinical development. The guidance addresses clinical development before submitting a marketing application for a new indication and usage.

https://www.pharmtech.com/view/fda-releases-guidance-on-oncology-therapeutic-radiopharmaceuticals

Advancements for novel cancer therapies are booming. This video takes a look at some of the latest efforts in the cancer research and therapy arena.