IAHJ - Volume 11, Issue 4

Volume 11 Issue 4

PEER REVIEWED

Advancing Animal Performance and Welfare for a Sustainable Future Towards Effective Vaccination Strategy Against Bird Flu Creating Global Harmony in Regulation of Veterinary Medicinal Products Campaigning for Improved Radiation Safety in Veterinary Practices

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CONTENTS 04 EDITORS LETTER REGULATORY & MARKETPLACE 06 Creating Global Harmony in the Regulation of Veterinary Medicinal Products

MANAGING DIRECTOR Mark A. Barker MANAGING EDITOR Chloe Euripides chloe@senglobalcoms.com EDITORIAL MANAGER Kelly Woods kelly@senglobalcoms.com RESEARCH AND CIRCULATION Chloe Euripides chloe@senglobalcoms.com DESIGNER Jana Sukenikova www.fanahshapeless.com BUSINESS DEVELOPMENT Jerome D’Souza info@senglobalcoms.com ADMINISTRATOR Jessica Chapman info@senglobalcoms.com FRONT COVER © istockphoto PUBLISHED BY Senglobal Ltd. 2 Larch Court, London, United Kingdom, SE1 3GB

VICH is a trilateral programme aimed at harmonising technical requirements for veterinary product registration. The programme works to establish and implement technical product requirements which meet the high quality, safety and efficacy standards, overall reducing the use of animal tests and cost of development. Rick Clayton of HealthforAnimals describes the recent developments that took place at conference VICH7 and what their vision is for the future.

10 Campaigning for Improved Radiation Safety in Veterinary Practices Radiation safety is an essential requirement for any practice using ionising radiation, and radiation safety breaches represent a significant health and safety incident and risk to the health of veterinary team members and their patients. Liz Barton and Manuel Pinilla of VET.CT explore the challenges that come with implementing regulations and safety guidelines, and propose solutions on how to best improve radiation safety in companion animal practice.

LIVESTOCK AND DISEASES 16 Towards Effective Vaccination Strategy Against Bird Flu A scientific field study commissioned by the Dutch Ministry of Agriculture, Fisheries, Food Security and Nature (LVVN) has been running since September 2023 aiming to investigate the effectiveness of vaccination against bird flu. Sjaak de Wit of Royal GD examines the results of a field trial, explaining the most effective vaccination strategies that can be used to tackle both HPAI and LPAI avian influenza.

Tel: +44 (0) 2045417569 Email: info@senglobalcoms.com www.international-animalhealth.com International Animal Health Journal – ISSN 2752-7697 is published quarterly by Senglobal Ltd.

The opinions and views expressed by the authors in this journal are not necessarily those of the Editor or the Publisher. Please note that although care is taken in the preparation of this publication, the Editor and the Publisher are not responsible for opinions, views, and inaccuracies in the articles. Great care is taken concerning artwork supplied, but the Publisher cannot be held responsible for any loss or damage incurred. This publication is protected by copyright.

Volume 11 Issue 4 Winter 2024 Senglobal Ltd. www.international-animalhealth.com

International Animal Health Journal 1

CONTENTS

RESEARCH AND DEVELOPMENT 20 Advancing Animal Performance and Welfare for a Sustainable Future

but also improves organisational reputation, operational efficiency, and market competitiveness.

26 CMO Quality Management Insights

In any livestock production system, the management of an animals’ gut health and the nutrition of the diet is fundamental in the potential performance and welfare of the animals. Thus, Dr. Jules Taylor-Pickard, Dr. Hazel Rooney and Dr. Harriet Walker of Alltech explain just how important Gut Health Technologies can be in offering a comprehensive solution for advancing animal performance, welfare, and sustainability.

The pharmaceutical industry’s growth has increased reliance on contract manufacturing organisations (CMOs), which offer expertise, reduce costs, and accelerate drug development. Londa Ritchey at Pharmalex a Cencora Company describes how robust oversight includes initial facility audits, ongoing quality management, and clear agreements outlining expectations.

SAFETY & PROCESSING

TECHNOLOGY

24 The Strategic Imperative of Quality Management in Pharmaceuticals and Biotechnology In the highly regulated pharmaceutical and biotechnology industries, quality management serves as the bedrock for ensuring product safety, efficacy, and regulatory compliance. Alok Mehortra of Syngene International explains the importance of effective quality management and how this not only safeguards patients 2 International Animal Health Journal

28 Harnessing AI in Pharmaceutical Supply Chains: A Strategic Imperative There is a transformative role of AI and machine learning in reshaping pharmaceutical supply chains. Will Robinson of LogiPharma explores AI-driven innovations in inventory management, forecasting and order automation are positioning AI as a strategic imperative for the industry's future success.

Volume 11 Issue 4

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EDITORS LETTER To round off 2024 in the animal health space, this winter issue draws on the prospects of development in regulations, quality management and technology.

Safety, welfare and strategy are key to the topic discussion across this edition, with many companies urging for greater care and time being taken towards these factors as we move into a new year.

Rick Clayton begins volume 11, issue 4 with an overview of the recent VICH7 Conference, outlining the improvements they have made in reducing animal testing and increasing the availability of safe veterinary medicines, as well as revealing the movements the programme hopes to make upcoming years.

VET.CT explains the challenging nature of regulated and safe veterinary practices, specifically in using radiation, highlighting the difficulty that can come with implementing these, and thus, resulting in the lack of focus placed on ensuring they are still put in place. In their piece they propose a rather interesting idea of global campaigning, to help encourage accessible education and free resources on the

complexities of radiation safety, aiming to harbour a culture of care and welfare.

Syngene Interantional gives an insight into quality management not only being a key consideration in the means of animal welfare but also in operational efficiency, pinpointing the importance of maintaining robust quality measures, to not only benefit the patient but too the organisational structure itself. Alok Mehrotra places technology and digital transformation at the forefront of seeing progression here, a factor that has become unescapable in the industry’s evolution and is prominent across the entirety of this winter issue. One article in particular that stands out, is Alltech’s research and development piece on employing gut health technologies. In this, they explore studies on the significance of maintaining better animal gut health and through adopting the means to do so one could ultimately maximise animal performance, welfare and sustainability.

This issue is truly packed full with some insightful points of discussion and I do hope you enjoyed IAHJ 2024. I look forward to what exciting things 2025 has instore for the world of animal health. Happy New Year All! Chloe Euripides, Managing Editor

EDITORIAL ADVISORY BOARD

Amanda Burkardt, MSc, MBA – CEO of Nutripeutics Consulting Germán W. Graff – Principal, Graff Global Ltd

Fereshteh Barei – Health Economist & Strategy Advisor, Founder of BioNowin Santé Avenue Association Carel du Marchie Sarvaas Executive Director Health For Animals

Kimberly H. Chappell – Senior Research Scientist & Companion Animal Product Development Elanco Animal Health Dr. Sam Al-Murrani – Chief Executive Officer Babylon Bioconsulting & Managing Director at Bimini LLC Sven Buckingham – Buckingham QA Consultancy Ltd.

Dan Peizer – Director Animal Health at Catalent Pharma Solutions

Dawn Howard – Chief Executive of the National Office of Animal Health (NOAH) Jean Szkotnicki – President of the Canadian Animal Health Institute (CAHI) Dr. Kevin Woodward – Managing Director KNW Animal Health Consulting

Norbert Mencke – VP Global Communications & Public Affairs Bayer Animal Health GmbH 4 International Animal Health Journal

Volume 11 Issue 4

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REGULATORY & MARKETPLACE

Creating Global Harmony in the Regulation of Veterinary Medicinal Products What is VICH? VICH is a trilateral (EU-Japan-USA) programme aimed at harmonising technical requirements for veterinary product registration. Its full title is the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products.

Setting the Scene There is an African proverb: if you want to go fast, go alone. If you want to go far, go together. Thus began the opening words from Alice Sigobodhla, Head of Veterinary Medicines Unit, South African Health Products Regulatory Authority, as she opened an inspiring session on “Opportunities from international guidelines and regional collaborations” at the 7th VICH Conference “VICH and a new era.”

In fact, the warm and collegial tone of the conference was set from the very first session, as Javier Yugueros-Marcos, Head of Department, Antimicrobial Resistance and Veterinary Products Department at WOAH, introduced the keynote speakers to the conference participants. He commented “This conference brings together a group of people who want to create harmony in this world”.

The nearly 200 conference participants seeking harmony had travelled to Amsterdam from 26 countries, from as far away as New Zealand, Australia, India, Brazil, Chile, Korea, and Japan, and from as near as the Netherlands, Belgium, Germany, France and UK. They were roughly split between one third regulatory authorities and two-thirds industry (regulatory affairs professionals from, or servicing, manufacturers of veterinary medicinal products).

A Little Bit About VICH Before exploring more about the conference, perhaps first a few words about VICH, for those not familiar with the project.

VICH was officially launched in April 1996 at the instigation of the World Organisation for Animal Health (WOAH, formerly known as OIE), with Founding Members of the European Union, the USA and Japan. New Zealand, Australia, and Canada came on-board as Standing Members (which participate but do not have a say in final decisions), and were later joined by South Africa and UK. Other countries, fulfilling a set of criteria, can apply to the VICH Steering Committee (SC) to become silent observers at the annual SC meetings.

The two first objectives of the VICH project are: •

•

Establish and implement harmonised technical requirements for the registration of veterinary medicinal products in the VICH regions, which meet high quality, safety and efficacy standards and minimise the use of test animals and costs of product development.

Provide a basis for wider international harmonisation of registration requirements.

VICH works by the SC reviewing ‘concept papers’ proposing the creation or revision of a VICH guideline, and if approved, an expert working group (EWG) on that topic is created. A stipulation of the VICH process is that the EWGs, just like in the steering committee, must contain a balance of experts from both the regulatory authorities and the industry from the VICH countries or regions. All decisions (in SC and the EWGs) are made by consensus. There are currently 9 EWGs working on new guidelines or on updating existing ones.

6 International Animal Health Journal

VICH7 Conference VICH organises public conferences every 4/5 years.

The 7th conference was held at the European Medicines Agency in Amsterdam on sponsorship of AnimalhealthEurope.

What has VICH Achieved?

The achievements of the VICH initiative since its launch 28 years ago were elaborated in a conference keynote address from the VICH secretary, Hervé Marion. The principal achievement is the development of 61 internationally harmonised guidelines covering all the main technical requirements of quality and manufacturing, safety and clinical efficacy required for the Registration of Veterinary Medicinal Products.. VICH guidelines also cover in-market safety surveillance (pharmacovigilance).

The harmonisation of data requirements between regions can bring the following benefits: • • • • •

Reduction of animal testing Reduction of costs of product development Increased availability of Veterinary Medicines Increased speed to market of Veterinary Medicines Increased Product Safety and Consumer Safety

But it is the secondary benefits of the VICH project that really shone out at the VICH7 Public Conference, and these relate to the encouragement of global regulatory convergence. There was palpable enthusiasm in networking to share knowledge and best practice, and in the opportunity to learn from the experience of other regulators.

VICH Underpins Regulatory Convergence Several speakers during the VICH7 Conference emphasised that VICH has enabled greater international collaboration in the regulatory processes for the market authorisation of veterinary medicinal products. It does this in two ways.

First, by providing a set of international guidelines on technical requirements, regulators from different jurisdictions now have a common language and common standards and expectations. This has created the possibility for joint reviews, shared reviews and simultaneous reviews of dossiers between two or more jurisdictions. It has also underpinned the creation and the operation of regional mutual cooperation systems such as the East African Community and ZAZIBONA regional collaboration project.

Secondly, VICH supports regulatory convergence by being a vibrant international network. It is based on trust, common Volume 11 Issue 4

REGULATORY & MARKETPLACE interest and cooperation. In addition to the trust to negotiate a common guideline, VICH is about sharing knowledge and building relationships around the world. In 2012 VICH took the decision to reach out to the rest of the world, and created a VICH Forum that other countries could join and become involved. This has been so welcomed that recently VICH had to adapt its structure to reflect its broadening reach and increasing global interest, thus, becoming more inclusive and transparent.

Some Inspiring Examples In his presentation of “The view of a VICH Forum member”, Yuriy Kosenko, SCIVP, Ukraine, pointed out that international GLs are very important to Ukraine, which has 130 marketing authorisation holders from 33 countries. VICH guidelines have helped Ukraine to identify gaps in their regulatory system and also unnecessary requirements and studies which have now been deleted.

VICH GLs are key references that have supported the creation of the East African Community mutual recognition procedure. Adelaide Ayoyi Ogutu, the MRP Coordinator, reported that 80% of their guidelines are VICH guidelines and they now consider VICH guidelines first. VICH guidelines allow reliance on the work already done by the authority where the product was first registered.

In another example of mutual reliance, Innocent Ravengai, BOMRA (Botswana), described the ZAZIBONA regional collaboration project, which is developing a system for the joint assessments of application dossiers. The project has established a Technical Working Group with active members from 7 countries (Zambia, Zimbabwe, Botswana, Namibia, Malawi, South Africa, and Tanzania). The aim is to share the workload to make better use of limited local resources, including the recognition of Good Manufacturing Practice (GMP) inspections from other trusted jurisdictions, and to establish a platform for capacity building.

need organisational and political will and to find champions within your organisation (both within agencies and within the applicant company). At VICH the relationships between regulators have flourished, bringing a change of mindset, so that these review processes are no longer seen as special submissions but as the way to go.

The Single Dossier As has been illustrated by these examples, it is now acceptable for a single dossier to be submitted to several jurisdictions. As a result of this VICH now wants to go one step further and in November 2024 the VICH Steering Committee agreed to establish a new Expert Working Group to work on a Global Regulatory Dossier Framework. This has been warmly welcomed by those working in collaborations such a joint reviews or simultaneous reviews.

Some Challenges The adoption of VICH guidelines by the ‘younger’ regulatory agencies outside of the VICH Founding Members can present challenges. Perhaps the biggest of these is the need for translations. The conference delegates were reminded that good implementation locally is also a critical step in harmonisation, not just the existence of a guideline.

Adelaide reported that their challenge within the EAC is not how to implement VICH GLs, but how to address the gaps left by VICH GLs. For example, there is currently a gap in VICH guidelines covering GMP for veterinary medicinal products.

Hopefully VICH will do more in this space in the near future.

Another challenge is the absence of reference products for bioequivalence work and the absence of local laboratory facilities to conduct bioequivalence studies. This could be a serious issue, as proving the bioequivalence of generic products is very important, to ensure the correct therapeutic dose is delivered particularly to minimise the development of AMR.

The final examples are collaborative review models that were originally enabled through trust and personal relationships built within VICH meetings and through the use of VICH guidelines. Marilena Bassi, Director General, Veterinary Drugs Directorate, Health Canada spoke with enthusiasm of the joint activities of Canada, USA, UK, Australia and New Zealand.

In Brazil a long list of VICH GLs has been adopted. The two main challenges Brazil faced were strict regulations constraining what could be adopted and a lack of resources.

But the legislation is being changed to make it more flexible, and resources are being allocated for training and raising awareness (e.g. a recent seminar on VICH GL9 on Good Clinical Practice).

She explained that Canada uses 3 collaborative review models: 1.

Simultaneous review model with US; the same dossier is submitted to both jurisdictions at the same time: it allows a phased-review process (a.k.a. rolling review).

2. Simultaneous review model with UK: requires a complete dossier at filing meeting the UK/EU requirements (with a ‘crosswalk’ to the Canada file structure).

3. Joint review between Australia, New Zealand & Canada: this is a true collaborative work sharing model, where each jurisdiction takes a section of the dossier, does the technical assessment, which is then peer reviewed by the other 2 jurisdictions.

To overcome the challenges, the recommendation of Health Canada is to focus on ‘the game changers’ such as aligned assessment timelines, one set of questions, and a single product label.

VICH is essential for these collaborative review models.

It allows the regulators to meet and develop new ways to collaborate together. Canada is now looking forward to the VICH project developing a common global regulatory dossier framework, which will further facilitate these collaborative review processes.

The key to all these collaborations has been willingness to try something new and to be flexible. To succeed you also www.international-animalhealth.com

Some Science The progress we have seen in global regulatory convergence would not be possible without the hardwork and commitment of the scientific and regulatory experts from the regulatory agencies and the trade associations who put in the hours in the expert working groups working on developing the harmonised guidelines. VICH is a fantastic forum where scientists from around the world come together sharing knowledge and sharing best practices. One small conversation over coffee can lead to another step towards harmonisation, as misassumptions and misunderstandings melt away.

It is worth noting that VICH is monitoring new developments in therapeutic science, such as novel therapies and novel technologies. But it is critical that sufficient experience is gained with new science before a guideline is written, to avoid stifling innovation. Perhaps VICH could follow the lead of the leading regulatory agencies, and develop “reflection papers, International Animal Health Journal 7

REGULATORY & MARKETPLACE (PIC/S) enable the development of GMP Inspection Reliance Programmes. These can form an important element underpinning the establishment of trade agreements (Mutual Recognition Agreements).

These are also essential to help eliminate the need for multiple inspections of one manufacturing site by different national competent authorities. There is a high cost, in time and resources, of duplicative inspections to both the regulatory authority and the manufacturer.

The Covid pandemic forced regulatory authorities to further refine a risk-based approach, with increased use of remote inspections and inspection reliance. Mutual reliance was shown to be possible and many benefits were described.

It increased trust, knowledge efficiency, use of resources, and increased empowerment of smaller regulatory authorities.

Vision for the Future Continued convergence is the way forward. VICH is a prime enabler but is just one support mechanism. True regulatory convergence is also a combination of: • discussion documents” and consideration documents that describe current regulatory thinking on an active topic, before committing to the elaboration of a guideline.

An interesting trend in drug development in human medicines shows investment in research in small molecules going down and investment in research in biologics going up. The veterinary sector is also at the start of this trend.

There are now 6 monoclonal antibody products on the market or under development in veterinary medicine. The availability of veterinary biologics is expanding by the use of new technologies. Regulatory science needs to keep pace with the rapid development and approval of new biologics, for example by the greater use of fast-track procedures for rapid disease response, conditional approvals and the use of ‘master files’, such as the platform technology master files or vaccine antigen master files.

Another key area of evolving science is the replacement of animal testing for chemical safety with in vitro or in silico tests.

The conference participants heard a strong call for a change in mind set, whereby we stop talking about animal tests as the GOLD standard. They are not. They are the historical standard and they are outdated. In vitro tests are more precise and have better discriminating power and remove the inherent variability of animal tests. Our industry is based on good science and we believe animal testing is not good science.

Good progress is being made toward this, particularly in the area of vaccine batch release. Most regulatory authorities no longer require the target animal batch safety test, and in vitro tests are often already preferred for vaccine batch potency testing.

For these new areas of science international regulatory collaboration will be key and an important recommendation was to start with clear definitions. That is the first important step in harmonisation – agreeing what you mean and what you are talking about!

More Work Needed – Inspections As mentioned previously, one area VICH could research further is manufacturing quality control. Internationally agreed GMP standards and inspection standards agreed through the Pharmaceutical Inspection Co-operation Scheme 8 International Animal Health Journal

• •

Submission of a single dossier in different regions; this would be facilitated by a Global Regulatory Dossier Framework.

Mutual recognition of (parts of) assessment.

Harmonised timelines.

It is about having dreams and changing mindsets, because along the way the challenges of different regulatory systems, different maturity of systems and different classifications of products will need to be overcome. This would be best achieved through the creation of an international forum for regulatory agencies and the shared willingness to try something new and be flexible.

That is one of the dreams for the future. The other is a single dossier, and a single assessment leading to a single global authorisation for veterinary medicines.

Rick Clayton Rick Clayton, Technical Director of HealthforAnimals, has worked for the European industry association since 1997 and comes from a background of product development and registration of veterinary medicinal products. In this role he is in regular dialogue with decision makers within the European institutions and the European medicines regulatory network with the principle aim of supporting the smooth running of regulatory systems. He is also coordinator for the European industry representation to the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (“VICH”). He has a degree in Applied Biology, a diploma in Marketing and is an Honorary Life member of TOPRA. Since recent decades alongside being Technical Director Rick shares his time representing the global animal health industry. His primary interests are in promoting regulatory convergence and standards of good regulatory practices. This includes international harmonisation of technical requirements, including for pharmacovigilance, good manufacturing practice, and the replacement of the use of laboratory animals in the generation of safety data (e.g. batch release of vaccines).

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REGULATORY & MARKETPLACE

Campaigning for Improved Radiation Safety in Veterinary Practices Ionising radiation is frequently used in veterinary practice, primarily for diagnostic imaging. Radiation safety is an essential requirement for any practice using ionising radiation, and radiation safety breaches represent a significant health and safety incident and risk to the health of veterinary team members and their patients.

Despite this, breaches are not uncommon in clinical practice. This article explores regulations and safety guidelines, challenges to implementation, and proposes solutions to improve radiation safety in companion animal practice.

Risks and Regulations Ionising radiation damages living tissue. However, the potential damage from an absorbed dose depends on the type and dose of radiation received and the sensitivity of the tissue or organ. High doses, exceeding those from diagnostic imaging radiation, can produce effects such as skin redness, hair loss, radiation burns, or acute radiation syndrome. These effects are more severe at higher doses and higher dose rates.

If the radiation dose is low and/or it is delivered over a longer period, the risk is substantially lower. However, there is still a risk of effects such as cataracts or cancer that may appear years or even decades later. Studies in humans estimate increased occurrence of cancer in patients screened with CT, and perinatal irradiation was shown to increase neoplasia incidence in young dogs.1,2,3 Studies have found job related exposure to ionising radiation in veterinary practice to be associated with increased risk of spontaneous abortion in female veterinarians and veterinary assistants.4,5 However, the risks of X-ray radiation to both patients and people may be challenging to convey to personnel due to its invisible nature and the lack of acute symptoms following exposure.

The Regulatory Landscape: A Global Overview Ionising radiation regulations for veterinary practices vary between countries and may even differ across regions within a country, e.g. different states in the USA and territories in Australia. However, most include the following principles: 1.

2.

3.

4.

5.

Risk Assessments: Practices are required to identify and mitigate risks associated with radiation exposure.

Equipment Standards: Guidelines to ensure imaging equipment and surrounding shielding meet safety and performance criteria.

Training Requirements: Personnel operating or exposed to radiation must be adequately trained in safety protocols, typically with named radiation safety officers required at each site where ionising radiation is used.

Dose Monitoring: Systems to track radiation exposures and doses received for personnel, including staff and clients (e.g. horse owners restraining a patient for X-rays in the field).

Personal Protective Equipment (PPE): Requirements for the availability and use of shielding such as lead aprons, gloves and thyroid collars.

Recommendations To reduce radiation exposure risk in veterinary practice it 10 International Animal Health Journal

is important to consider the important principle of keeping radiation use and dosage to both personnel and patients As Low as Reasonably Achievable (ALARA).6 In practice, this may include: Justification: Ensure each procedure using radiation is justified, weighing the potential benefits to the animal against the risks to the patient, staff, and public. Consider alternative procedures with lower dose (e.g. X-ray rather than CT) or no radiation exposure (e.g. ultrasound). If ionising radiation is the most appropriate diagnostic modality, consider whether each exposure is necessary to answer the clinical question. Survey X-rays or whole-body CT scans may pose more questions than they answer, highlighting multiple changes, especially in older animals, which may not be clinically significant and could broaden the focus away from relevant findings.

Optimisation: Use the lowest possible exposure settings to achieve good images, optimising the radiation dose for patient size, body area and projection.

Distance: Increase the distance between personnel and the radiation source whenever possible. Ideally, all personnel should leave the imaging room during exposure.

Shielding: Ensure adequate shielding is in place for personnel and members of the public, using leads shielding, such as screens, aprons, gloves, thyroid shields and googles as PPE. Time: Minimise the time spent near the radiation source.

This can include using appropriate restraint techniques and positioning equipment.

Training: Provide comprehensive training to all staff involved in radiation procedures, covering safety protocols, equipment operation, patient preparation and emergency procedures.

Restraint: Minimise manual restraint of animals. Use positioning aids, sedation, or anaesthesia whenever possible.

The number of workers in the room tends to be lower when animals are sedated or anaesthetised.7 In rare cases where manual restraint is unavoidable, appropriate PPE should be available and individuals should be trained in its appropriate use and safe restraint techniques.

Personnel: Where possible, rotate team members working with ionising radiation, especially if manual restraint is used.

Individuals at higher risk from ionising radiation, such as children, teenagers and pregnant women, should be excluded from procedures using ionising radiation.

Monitoring: Implement personal dosimetry for all personnel exposed to radiation to track their doses and ensure they are within acceptable limits.

Quality Assurance: Implement quality assurance and quality control programmes to ensure equipment is functioning correctly and procedures are carried out safely. This includes regular maintenance and performance testing of equipment.

Review: Regularly review exposures as a team to ensure they are optimal and diagnostic. Consider additional training for Volume 11 Issue 4

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International Animal Health Journal 11

REGULATORY & MARKETPLACE

X-rays showing examples of radiation safety breaches, with human hands evident in the primary beam (red circles).

or methods for hands-free imaging. A study showed that even veterinary teaching institutions in the US may not meet equipment licence requirements in this regard.11

any areas requiring improvement. Review radiation safety processes and policy at regular intervals to ensure they are up to date and reminders are provided to staff.

By implementing these measures, veterinary practices can create a safer working environment and reduce the risks associated with radiation exposure for both patients and people.

•

Resource Constraints: • Lack of availability of shielding equipment e.g. lead screens, thyroid collars and goggles.12 • Personnel e.g. sole charge practitioners having to perform diagnostic procedures without assistance.

• Lack of time, e.g. in emergency clinics where the additional time required for safe practice and/or chemical restraint may be seen as prohibitive to rapid triage, diagnosis and management of multiple cases. Correct use of PPE by both veterinarians and veterinary students was less frequent out of hours in one study within a teaching hospital.13

•

Variation in Enforcement: • Inconsistent enforcement of regulations by health and safety departments across regions creates disparities in safety standards.

Challenges in Radiation Safety Compliance There are universal challenges in ensuring compliance with regulatory frameworks and ALARA principles due to varying levels of awareness and resource availability. Studies have shown over-reporting of the use of personal protective equipment (PPE) by veterinary staff compared to reality.8 A survey among female veterinarians showed that of 90% of small animal practitioners taking X-rays, 56% reported physically restraining animals, and only one in five respondents used film holders and lead screens.9 A study of equine practitioners showed poor compliance with radiation safety certification, dose monitoring of personnel and provision of safety protocols within practice in equine practice.10

•

Culture and Habits: • Practices commonly using manual restraint may be reluctant to change, especially where perceived increases in risk, cost and/or time of using chemical restraint may be considered prohibitive.

Improving Radiation Safety in Practice To address these challenges in radiation safety knowledge and compliance, global teleradiology and specialist consultancy company, VET.CT, has launched a global awareness campaign focused on radiation safety in veterinary practice.

The campaign centres on education and provides easily accessible, practical solutions with a suite of free resources tailored to the needs of veterinary teams. It also highlights the importance of fostering a culture of care for both staff and patients by making radiation safety best practice a core value in the clinic.

•

Knowledge Gaps: • Lack of access to training or awareness of regulations, best practice principles, chemical restraint protocols

The downloadable tools include practical guides for equine and small animal practice, and a series of case studies with global veterinary practices, including primary care, referral

Radiation safety is both a legal requirement and a health and safety obligation, which raises questions about what factors contribute to poor compliance. These may include:

12 International Animal Health Journal

Volume 11 Issue 4

REGULATORY & MARKETPLACE

Human hands in the primary beam (left) and scatter radiation (right) circled red.

and emergency clinics, and ambulatory equine practitioners, giving real-life insights into how good standards can be applied in practice.14 The resources are designed to empower veterinary teams to protect themselves, their clients and their patients, while optimising diagnostic accuracy and quality of their imaging, and include: • • • • • •

Step-by-Step Guides: Top tips for successful imaging workflow, application of the ALARA principles to obtain high quality, diagnostic value images.

Positioning posters: Instructions for implementing handsfree techniques using positioning aids, which can be printed to display in imaging suites.

Chemical Restraint Protocols: Guidance for using sedation or anaesthesia based on patient risk level.

Equipment Lists: Recommendations for positioning aids and PPE. Exposure Charts: Templates for recording exposures.

Case Studies: Success stories from veterinary practices around the world with high compliance and a culture of radiation safety best practice and hands-free restraint.

Benefits of Improved Radiation Safety There are many benefits to improving workflows in diagnostic imaging. Ensuring safety is optimised reduces radiation exposure for staff and animals through the adoption of best practices, reducing potential health risks. Enhanced compliance ensures practices meet regulatory requirements.

Taking greater care in good positioning and optimising exposures increases the diagnostic quality of images and the accuracy of interpretation, reducing the need to repeat exposures and contributing to better outcomes for patients.

bridge knowledge gaps, address resource disparities, and create a culture of safety that benefits veterinary teams, their patients and their clients.

REFERENCES 1.

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4.

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Mathews JD, Forsythe AV, Brady Z, Butler MW, Goergen SK, Byrnes GB, Giles GG, Wallace AB, AndersonPR, Guiver TA, McGale P, Cain TM, Dowty JG, Bickerstaffe AC, Darby SC. Cancer risk in 680,000 peopleexposed to computed tomography scans in childhood or adolescence: data linkage study of 11 millionAustralians. BMJ. 2013 May 21;346:f2360. doi: 10.1136/bmj.f2360. PMID: 23694687; PMCID: PMC3660619.

Benjamin SA, Lee AC, Angleton GM, et al. Neoplasms in young dogs after perinatal irradiation. J Natl Cancer Inst1986;77:563–571.

Benjamin SA, Lee AC, Angleton GM, et al. Mortality in Beagles irradiated during prenatal and postnataldevelopment.

I. Contribution of non-neoplastic diseases.Radiat Res1998;150:316–329 Steele, L. L., & Wilkins, J. R. (1996). Occupational Exposures and Risks of Spontaneous Abortion amongFemale Veterinarians.

International Journal of Occupational and Environmental Health,2(1), 26–36.https://doi.org/10.1179/oeh.1996.2.1.26.

Johnson JA, Buchan RM, Reif JS. Effect of waste anesthetic gas and vapor exposure on reproductive outcomein veterinary

Overall, this can result in both cost and time savings to both the practice and the client. In addition, a good day’s imaging and good patient management contributes to motivation and satisfaction for team members, knowing the collective effort has ensured their health and safety is protected, while providing the best experience and service to patients and clients.

Conclusion Radiation safety in veterinary practice is a global issue that requires attention and collective action. Through launching an awareness campaign and providing free, practical resources, the VET.CT radiation safety campaign aims to www.international-animalhealth.com

Human hand evident in the primary beam holding scissors as a position marker (red circle) International Animal Health Journal 13

REGULATORY & MARKETPLACE

Human finger in the primary beam (red circle)

6.

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personnel. Am Ind Hyg Assoc J. 1987 Jan;48(1):62-6. doi: 10.1080/15298668791384373. PMID:3565261. https://www.cdc.gov/radiation-health/safety/alara.html.

Mayer MN, Koehncke NK, Belotta AF, Cheveldae IT, Waldner CL. Use of personal protective equipment in aradiology room at a veterinary teaching hospital. Vet Radiol Ultrasound. 2018 Mar;59(2):137-146. doi:10.1111/vru.12583. Epub 2017 Dec 11. PMID: 29230889.

Mayer MN, Koehncke NK, Belotta AF, Cheveldae IT, Waldner CL. Use of personal protective equipment in aradiology room at a veterinary teaching hospital. Vet Radiol Ultrasound. 2018 Mar;59(2):137-146. doi:10.1111/vru.12583. Epub 2017 Dec 11. PMID: 29230889.

Shirangi A, Fritschi L, Holman CD. Prevalence of occupational exposures and protective practices in Australianfemale veterinarians. Aust Vet J. 2007 Jan-Feb;85(1-2):32-8. doi: 10.1111/j.1751-0813.2006.00077.x. PMID:17300451.

Surjan, Y., Ostwald, P., Milross, C., & Warren-Forward, H. (2015).

Radiation safety considerations andcompliance within equine veterinary clinics: Results of an Australian survey.

Radiography (London 1995), 21(3),224-230. doi:101016/ jradi201411007.

Gregorich, S. L., Sutherland-Smith, J., Sato, A. F., May-Trifiletti, J. A., & Miller, K. J. (2018). Survey ofveterinary specialists regarding their knowledge of radiation safety and the availability of radiation safety training.Journal of the American Veterinary Medical Association,252(9), 1133-1140. Retrieved Nov 25, 2024, fromhttps://doi.org/10.2460/javma.252.9.1133 Moritz SA, Wilkins JR 3rd, Hueston WD.Evaluation of radiation safety in 29 central Ohio veterinary practices.Am J Public Health. 1989 Jul;79(7):895-6. doi: 10.2105/ajph.79.7.895. PMID: 2735484; PMCID: PMC1349679.

Mayer MN, Koehncke NK, Belotta AF, Cheveldae IT, Waldner CL. Use of personal protective equipment in aradiology room at a veterinary teaching hospital. Vet Radiol Ultrasound. 2018

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14.

Mar;59(2):137-146. doi:10.1111/vru.12583. Epub 2017 Dec 11. PMID: 29230889. https://uk.vet-ct.com/articles/radiation-safety-campaign? hsLang=en

Liz Barton Liz Barton, MA VetMB, MRCVS, MCIPR, graduated as a vet from the University of Cambridge in 2004 and enjoyed a varied clinical career across mixed, small animal, shelter medicine and referral practice for 17 years. Alongside clinical work, she developed and hosted wellness initiatives and events, which led to a career diversification and a move into PR and communications. She joined VET. CT as Head of Communications 2021.

Manuel Pinilla Manuel Pinilla, Dr.Med.Vet., CertVDI, DipECVDI, MRCVS, RCVS and European Veterinary Specialist in Diagnostic Imaging, graduated as a vet in 2001 and achieved his European Diploma in Veterinary Diagnostic Imaging after completing his residency at University College Dublin in 2008. He worked as a radiologist and lecturer in Ireland, the UK and Australia, authoring numerous radiology publications. Manuel began working as a teleradiologist at VET.CT in 2001, where he is now Senior Director of Teleradiology.

Volume 11 Issue 4

RADIATION SAFETY GUIDE

YOUR SAFETY MATTERS – BE RADIATION SAFE By following these guidelines and maintaining a strong culture of radiation safety awareness in your veterinary practice, you can help protect both the health of your staff and the animals under your care.

Before you radiate, COLLIMATE. It reduces scatter radiation

Wear ALL your PPE and a dosimeter EVERY time

Practice the ALARA principle

Turn the lights DOWN, often patients RELAX in a darker room. It’s also easier to see where you have collimated

Before you radiate, AVOID remaining in the room or ask if everyone needs to be present

REGULARLY test your PPE

HANDS-FREE BEST PRACTICE Using hands-free techniques and positioning ties for both awake and sedated patients during radiographic procedures is best practice for several reasons:

PROTECT YOURSELF • Lead goggles • Lead gloves • Lead gown • Thyroid shield • Dosimeter

Safety By ensuring you and your colleagues are as far from the main beam as possible, you will minimise your exposure to radiation.

Accuracy Hands-free techniques and positioning ties can help ensure consistent positioning of the patient. Accurate positioning is crucial for obtaining high-quality diagnostic images, which are essential for accurate diagnoses and treatment planning.

Patient Comfort Radiographic positioning can sometimes be uncomfortable.

Using sedation including analgesia and cushioning, gentle positioning and hands-free restraints can reduce discomfort and anxiety for the patient. This approach can also improve the patient experience during the procedure.

S C AT T E R Scatter radiation primarily comes from the patient being imaged. It’s the result of X-rays interacting with the patient’s body tissues and scattering in various directions.

Understanding scatter radiation is essential for safety.

Always tightly collimate to reduce scatter and the risk of accidental exposure.

Remember: scatter comes from the patient.

Lead PPE is designed to protect from scatter radiation – your anatomy should never be in the primary beam.

Never keep gloved hands in the primary beam – the primary beam contains the most intense radiation and should be strictly controlled to prevent unnecessary exposure.

LEAD BY EXAMPLE AND LOWER YOUR EXPOSURE [ALARA] The ALARA principle emphasises keeping radiation exposure “As Low As Reasonably Achievable”, meaning taking every reasonable step to minimise radiation exposure to both staff and patients.

Be efficient – be prepared and remember image quality (settings, straightness, collimation).

Ensure all personnel are as far from the primary beam as possible, ideally outside the X-ray room during exposure.

Keep settings low to reduce exposure and consider a lower exposure system.

Keep manual restraint to a minimum and always wear PPE when staying inside the room.

Please note, this is general advice only. Each person using ionising radiation needs to adhere to their local radiation protection regulations/legislation.

Should you have any queries, please contact: radiation.safety@vet-ct.com

www.international-animalhealth.com

International Animal Health Journal 15

LIVESTOCK AND DISEASES

Towards Effective Vaccination Strategy Against Bird Flu Two bird flu vaccines are being tested in a field study.

A scientific field study commissioned by the Dutch Ministry of Agriculture, Fisheries, Food Security and Nature (LVVN) has been running since September 2023 on two laying farms to investigate the effectiveness of vaccination against bird flu.

Previous research at the laboratory of Wageningen BioVeterinary Research (WBVR) showed that two vector vaccines were effective under laboratory conditions against clinical signs and spread of high-pathogenic H5 bird flu. However, because the effectiveness of a vaccine can be different in a poultry house than in a laboratory, a trial was needed under field conditions. This research is being done by Wageningen University & Research (WUR) including WBVR, Royal GD and Utrecht University's Faculty of Veterinary Medicine. It commenced in September 2023.

Field Trial In the field trial, 1,800 one-day-old layer chicks were vaccinated against bird flu (H5) to investigate the effectiveness of vaccination under field conditions. During the field trial, challenge transmission tests will be carried out at various ages. For this purpose, a number of chickens will be transported from the farm to WBVR and be exposed to the 2.3.4.4b H5 bird flu virus under laboratory conditions. The first trial, eight weeks after vaccination, showed that the vaccines prevented clinical signs and infection with bird flu virus. The second transmission test took place at 24 weeks of age, the time when hens have just reached their peak production.

These results are not yet available.

It is important to know whether vaccines are effective throughout a laying hen's production phase. To this end,

transmission trials will take place at two further ages: at 54 and 84 weeks of age. The final results will be known in the second half of 2025.

Third Vaccine in the Picture The field trial is taking place over the entire laying period of the chickens, so this takes time. In the meantime, time does not stand still. In the current field trial, vaccines from two manufacturers are being scientifically investigated. Recently, a third manufacturer announced that it has developed a vector vaccine that has received a European approval. This vaccine is an HVT vector vaccine, i.e. the same type as the two vaccines tested in the field trial.

Vaccination Pilot Planned In addition to the field study, a pilot is planned by the Dutch government to start on several laying farms using an authorised vaccine. The pilot is intended to provide experience with the practical implementation of vaccination on laying farms, implementing the surveillance programme in line with European guidelines, and monitoring and resolving potentially negative effects on trade. European licensing for the vaccine used is an important condition for carrying out the pilot; this is currently no longer an obstacle.

The field study and the pilot that has been announced are part of a strategy to make responsible, large-scale, risk-based preventive vaccination of poultry against avian flu possible. This is important for animal and public health and animal welfare. In addition, the trials are designed to minimise the potential negative impact of vaccination on trade. The first results of the pilot project are expected in 2025 and will be used to determine the next steps for preventive vaccination. Apart from France, the Netherlands is one of the few exporting countries that is working concretely on vaccination against avian influenza; Other countries are,

Photo: (left) Chicks are vaccinated at the hatchery, (right) Vaccine is prepared for use (Royal GD) 16 International Animal Health Journal

Volume 11 Issue 4

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International Animal Health Journal 17

LIVESTOCK AND DISEASES

therefore, closely following the steps taken by France and the Netherlands.

Avian Influenza Avian influenza (AI) in poultry can be divided into two forms of disease: highly-pathogenic (HPAI) and low-pathogenic avian influenza (LPAI). The former, also known as bird flu or avian flu, is a viral disease that generally progresses extremely acutely in non-vaccinated birds, giving severe general clinical signs. HPAI causes high mortality rates in fowl and many other species of birds. Wild waterfowl in particular are considered to be a major virus reservoir. HPAI is a compulsorily notifiable disease under the Dutch Animal Health Regulation and is actively controlled. By law, the farmer, laboratory and veterinarian must report any suspected presence of the AI virus to the Netherlands Food and Consumer Product Safety Authority.

18 International Animal Health Journal

Sjaak de Wit Prof. Sjaak de Wit, DVM, PhD, DipECPVS gained his veterinary qualification at the University of Utrecht in 1989 and completed a PhD degree, concerning diagnosis and transmission of infectious bronchitis virus, in 1997 at the University of Utrecht. His job as an immunologist and senior researcher at Royal GD has included responsibility for the quality and accreditation of serological tests for poultry pathogens, test development, applied research and on-site consultancy at farms, hatcheries and integrations. Since 2019, he is also professor of Integrated Poultry Health at the Utrecht University.

Volume 11 Issue 4

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International Animal Health Journal 19

RESEARCH AND DEVELOPMENT

Advancing Animal Performance and Welfare for a Sustainable Future In any livestock production system, the management of an animals’ gut health and the nutrition of the diet is fundamental in the potential performance and welfare of the animals. Minerals are essential for animal health and performance, as they are involved in numerous metabolic and endocrine processes within the body.

Consequently, providing trace minerals in the correct form and concentration within the diets improves the performance and wellbeing of the animal. However, no matter how good the animals’ nutrition is, if their gut health isn’t optimum, they will not get the full benefit from the nutrients within the diet.

Firstly, the gut health status of the animal will determine the ability of that animal to digest and absorb nutrients from the diet, and its susceptibility to disease challenges. When gut health is compromised, the animal will not be able to fully utilise the diet provided, feed conversion will worsen and ultimately, so will farm profitability. Therefore, achieving optimal gut health is critical along with the correct nutrition of the animal.

Alltech has created a novel nutritional approach known as Advantage Pak, which has been uniquely designed to advance economic, environmental and social sustainability of pig and poultry businesses. By working together with producers to enhance animal welfare and performance, reduce carbon footprint, and minimise environmental pollution.

The Power of Chelated Trace Minerals Conventionally standard animal diets contain inorganic sources of trace minerals (for example, copper sulphate, zinc oxide and sodium selenite), to meet the needs of the animals for maintaining normal bodily functions, skeletal development, growth performance and reproduction, whether that be eggs or piglets. However, minerals from inorganic sources are extremely reactive in the premix, the feed and in the gastrointestinal tract of the animal, due to their poor stability and reduced bioavailability (Macelline et al., 2024).

Due to this low bioavailability and reactive nature of inorganic minerals, inclusion levels are regularly over formulated to ensure the animals requirements are actually met, however, uptake and utilisation of these minerals are limited, resulting in poor animal performance and high levels of mineral excretion and waste. As a result, dietary mineral levels are coming under added scrutiny from an environmental perspective and ’overfortifying’ the ration will become a less acceptable practice in modern production systems. The interactions of inorganic minerals with other feed components include binding to other components of the premix such as feed additives and vitamins, reducing the efficacy of dietary enzymes such as phytase, and acting as pro-oxidants (which can cause oxidative stress in the gut) (Concarr, Sinkunaite and Murphy, 2021; Concarr, O’Rourke and Murphy, 2021). Therefore, when inorganic minerals are added to an animal’s diet, the animal will not be getting the most out of that diet due to the negative interactions occurring within the feed. For this reason, there is increasing interest in alternative forms of minerals which are better absorbed, stored and utilised by the animal. Trace minerals, that are proteinated or chelated minerals, are a 20 International Animal Health Journal

more stable form of iron (Fe), zinc (Zn), copper (Cu), and manganese (Mn)), as well as minerals in yeast form such as selenium (Se). These are more stable in the premix, the diet and gastrointestinal tract meaning they are more bioavailable than inorganic sources, and provide a metabolic advantage to the animal, which often results in enhanced performance and lower mineral excretion.

Alltech has proven that chelated trace minerals and organic selenium yeast can be included at significantly lower levels while improving animal performance. This optimises animal mineral requirements and reduces negative environmental impacts. We call this innovation Alltech’s Total Replacement Technology™ (TRT). The Advantage Pak combines Alltech TRT and Gut Health Technologies to help pig and poultry producers achieve economic and environmental sustainability benefits, by improving animal performance through improved gut health and welfare, and effective animal nutrition.

Alltech’s Advantage Pak contains chelated trace minerals, which are chelated to amino acids and small chain peptides, making them proteinates. The minerals are protected by the peptides which help the mineral get from the premix through the GI tract to the site of absorption in the animal. The specific organic material that the mineral is bound to is very important and is what determines the bond strength at varying pH levels and their stability, two important factors in trace mineral nutrition. Minerals must be bound strong enough, so that even at a very low pH along the intestinal tract, the mineral continues to be bound and reaches the site of absorption without dissociating. As the minerals within Advantage Pak are more stable and have an enhanced bioavailability, lower levels of inclusion can be used and less mineral are excreted, therefore, reducing the environmental impact. This means that with the Advantage Pak, all inorganic minerals can be removed from the diet and replaced with lower levels of chelated trace minerals, known as Total Replacement Technology (TRT). Consequently, the negative interactions from the inorganic minerals are eliminated, allowing for better animal performance and environmental sustainability; ensuring that the growth, immune function and reproductive health of the animal is supported.

Driving Animal Performance Through Optimal Gut Health Advantage Pak not only supports the mineral nutrition of the animal, but it also ensures optimal gut health and development. The combination of these technologies offers complimentary benefits, the TRT Minerals support key physiological functions in the animal, while the gut health technologies support gut integrity and immune function, leading to better feed efficiency, growth rates, and overall health. Supporting the gut health of the animal is key, because if gut health is compromised the animal won’t be able to efficiently digest and absorb the nutrients in the diet, which will then pass through the gut and be excreted. Gut health and its management are an intricate and complex area affected by numerous factors, including nutrition, stress, management and environment.

One of the most critical determinants of gut health is the diversity of the animals’ gut microbiome, the community of Volume 11 Issue 4

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RESEARCH AND DEVELOPMENT bacteria, fungi, protozoa and viruses within the gut. A diverse microbiome with beneficial microbes acts as a protective barrier covering the gut, thus preventing the colonisation of pathogenic bacteria such as E. coli and salmonella. This can be achieved via several mechanisms, firstly, by the beneficial microbes occupying the space and attachment sites on the gut cells, meaning that pathogens have reduced opportunities to colonise the gut. Secondly, the beneficial microbes are known to secrete metabolites that make the environment less favourable to the growth of pathogenic microbes. Promoting a diverse gut microbiome supports the gut health of the animal and improves the gut integrity, resulting in a large surface area with suitable tight junctions, so the animal can absorb nutrients efficiently and stop pathogens from entering and causing harm.

Alltech’s Advantage Pak contains a combination of gut health technologies, one of which is a Mannan Rich Fraction (MRF). This MRF technology is a unique, second-generation, bioactive fraction derived from a specific yeast strain, Saccharomyces cerevisiae, which promotes gut health by supporting the immune system, improving nutrient absorption and support against unfavourable bacteria. Several research and commercial studies have shown that it boosts overall animal performance, welfare and resilience.

In monogastrics, it has been shown that feeding Advantage Pak also optimise gut health and microbial diversity. Studies indicate that in both layers and broilers, feeding Advantage Pak can influence the microbiome diversity, by changing the β-diversity which shows that Advantage Pak birds have different and more uniform bacterial compositions than control birds (Leigh et al., 2024; Leigh et al., 2022). The same researchers then looked at α-diversity in layers and broilers and saw that the α-diversity was higher in Advantage Pak supplemented birds, indicating a healthier gut environment with more favourable bacteria. In pigs, Advantage Pak promotes a better microbial status of the GI tract and supports the maintenance of gut integrity and function, ensuring an optimal gut environment (Taylor-Pickard, 2011). Consequently, a review of several studies has shown that when Advantage Pak is included in the diet, there are considerable and consistent advantages for both sows and piglet performance, with benefits including (Taylor-Pickard, 2011):

• • •

An increase in the concentration of immunoglobulins in sow colostrum (contributing to better immune status of suckling piglets) An improvement in piglet weaning weight of 0.3kg A reduction in the wean-oestrus period of sows (fewer empty days and therefore more litters born)

Improving the microbiome diversity of an animal helps to protect the gut from damage caused by unfavourable bacteria, reduces inflammation and strengthens the integrity of gut, allowing for better digestion and nutrient absorption, leading to more efficient feed conversion and growth. By fostering a stable and diverse gut microbiome, this ultimately helps improve overall animal health and performance, making it an essential tool for producers looking to boost productivity and welfare in their herds or flock.

Global Research Trials Alltech has recently conducted a number of large-scale commercial studies as part of collaborative projects to determine the effects of Advantage Pak on animal performance and welfare, carbon footprint, and mineral excretion. One such study was conducted over a number of commercial layer farms over an extended period, and during the trial, comments from the farm managers were that “birds appeared to be noticeably calmer, have better feather coverage and drier litter”. Performance results from the study showed that the Advantage Pak achieved improved hen day production, reduced farm seconds by 7% and improved shell strength by 4%. This has also been shown in a recently published meta-analysis showing that feeding Alltech’s chelated trace minerals resulted in 1.5% higher hen-day production, significantly reduced feed conversion (73.1g feed/kg egg), reduced egg loss (0.57%, equates to 41.3%) and improved shell strength by 3.9% (Byrne et al., 2023). Additionally, in both commercial and research studies improvements in minerals excretion have been widely reported. For example, Advantage Pak reduced mineral excretion by up to 38% (P, Zn, Cu, Mn, K, Mg, Na, Se, Ca) and calcium and phosphorus utilisation was improved by 22% and 3% respectively.

In pigs up to 26% reduction in mineral excretion levels (Cu, Zn, Fe and Mn) was observed with a significant improvement

Figure 1: Peer-reviewed meta-analysis on the effect of chelated trace mineral in layer production and sustainability (Byrne et al., 2023 22 International Animal Health Journal

Volume 11 Issue 4

RESEARCH AND DEVELOPMENT in pig growth performance post-weaning. This has also been shown in a recent sow study, whereby feeding Alltech’s chelated trace minerals to sows reduced faecal mineral excretion by up to 77% (Mn, Fe, Zn) in gestating sows and by up to 56% (Mn, Fe, Zn) in lactating sows (Ma et al., 2020). Similar effects have been observed in grow-finisher pigs, whereby faecal mineral levels were reduced by up to 85% (Cu. Fe, Zn) in pigs fed diets supplemented with 50% chelated minerals from Alltech (Burkett et al., 2009).

Putting Sustainable Animal Production into Practice In poultry, tibia bone strength was also analysed and was not negatively affected by reduced mineral levels in the diet, and keel bone deviation were significantly reduced by Advantage Pak. Furthermore, in both pigs and poultry, Advantage Pak improved the economic and environmental sustainability of the business, by reducing the overall carbon footprint, as a direct result of improved animal efficiency and reduced waste. This result is supported by a recently published metaanalysis and life cycle assessment model that show that feeding Alltech technologies can reduce the carbon footprint of egg production by 2.4% in feed and 2.5% total emission intensities per kg eggs (Byrne et al., 2023). In pigs, a 9.6% reduction in overall carbon footprint from farrow to finish was reported, again, as a direct result of improved pig efficiency and less waste.

Based on these results, it shows that similar effects can be seen in both pigs and poultry, with the inclusion of Advantage Pak, resulting in benefits to production performance and improving profitability, while simultaneously contributing to a lower carbon footprint.

In summary, Alltech’s Advantage Pak, which combines the powerful benefits of TRT Minerals and Gut Health Technologies, represents a comprehensive solution for advancing animal performance, welfare, and sustainability. The enhanced bioavailability of chelated trace minerals supports key physiological functions, while the MRF optimises gut health and microbial diversity, improving feed efficiency and overall health. Together, these technologies not only boost productivity but also contribute to better animal welfare and supporting immune function. With a reduced environmental footprint through more efficient nutrient utilisation, Advantage Pak is a valuable tool for producers seeking to meet their sustainability goals while enhancing the well-being and performance of their animals.

REFERENCES 1.

2.

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Macelline, S.P., Selle, P.H., Liu, S.Y., Pineda, L., Han, Y. and Mehdi Toghyani (2024). Inclusion of complexed trace minerals enhance performance of broiler chickens. The Journal of Applied Poultry Research, 33(4), pp.100465–100465. doi:https://doi.org/10.1016/j.japr.2024.100465.

Concarr, M., Sinkunaite, I. and Murphy, R. (2021). The effect of trace minerals on the stability of retinol acetate, cholecalciferol and selenomethionine stability within premixes. Journal of Applied Animal Nutrition, 9(1), pp.57–64. doi:https://doi.org/10.3920/jaan2021.0002.

Concarr, M.J., O’Rourke, R. and Murphy, R.A. (2021). The effect of copper source on the stability and activity of α-tocopherol acetate, butylated hydroxytoulene and phytase. SN Applied Sciences, 3(5). doi:https://doi.org/10.1007/s42452-02104563-y.

Byrne, L., Ross, S.A., Taylor-Pickard, J.A. and Murphy, R. (2023).

The Effect of Organic Trace Mineral Supplementation in the Form of Proteinates on Performance and Sustainability Parameters in Laying Hens: A Meta-Analysis. Animals, 13(19), pp.3132–3132. doi:https://doi.org/10.3390/ani13193132.

www.international-animalhealth.com

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Taylor-Pickard, J.A. (2011). The Influence of MOS on Sow and Piglet Performance. International Animal Health Journal, 2(2), pp 61-63.

Ma L, He J, Lu X, Qiu J, Hou C, Liu B, Lin G, and Yu D (2020). Effects of low-dose organic trace minerals on performance, mineral status, and fecal mineral excretion of sows. Asian-Australas J Anim Sci, 33(1), pp. 132-138. DOI:https://doi10.5713/ajas.18.0861 Burkett J, Stalder K, Powers W, et al. (2009). Effect of Inorganic and Organic Trace Mineral Supplementation on the Performance, Carcass Characteristics, and Fecal Mineral Excretion of Phase-fed, Grow-finish Swine. Asian-Australasian Journal of Animal Sciences, 22(9), pp. 1279-1287. DOI:https:// doi.org/10.5713/ajas.2009.70091 Corrigan, A., Leigh, R.J., Walsh, F. and Murphy, R. (2023).

Microbial community diversity and structure in the cecum of laying hens with and without mannan-rich fraction supplementation. Journal of Applied Poultry Research, [online] 32(2), p.100342. doi:https://doi.org/10.1016/j.japr.2023.100342.

Dr. Jules Taylor-Pickard As the Global Technical Director at Alltech, Taylor-Pickard directs the commercial and research strategies, provides technical support to the sales force and initiates, and supports and interprets multispecies research activities, focusing on providing solutions to optimise animal performance and efficiency.

Dr. Hazel Rooney Dr. Hazel Rooney joined Alltech in 2020 as the pig technical coordinator and is responsible for the development of technical solutions for pigs for the European marketplace, working closely with the Alltech sales, research, and marketing teams.

Dr. Harriet Walker Dr. Harriet Walker is the poultry specialist for the Alltech Technology Group. Within this role she provides technical support to the sales force, supports and interprets poultry research activities, focusing on providing solutions to optimise animal performance and efficiency.

International Animal Health Journal 23

SAFETY & PROCESSING

The Strategic Imperative of Quality Management in Pharmaceuticals and Biotechnology In the highly regulated pharmaceutical and biotechnology industries, quality management serves as the bedrock for ensuring product safety, efficacy, and regulatory compliance. These sectors operate within stringent frameworks established by global regulatory bodies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), necessitating robust Quality Management Systems (QMS). Effective quality management not only safeguards patients but also underpins organisational reputation, operational efficiency, and market competitiveness.

Recent trends in quality management are reshaping how organisations approach compliance and operational excellence. Key trends include the integration of digital technologies, the decentralisation of quality responsibilities, the emphasis on continuous improvement, and the prioritisation of employee training and supplier quality standards. Understanding these trends is crucial as we explore their impact on the effectiveness of quality management practices in the pharmaceutical and biotechnology sectors.

A QMS encompasses a comprehensive set of processes, from supplier qualification and process validation to employee training and continuous improvement initiatives.

By embedding these systems, organisations can standardise procedures, minimise risks, and meet high-quality benchmarks consistently. The importance of fostering a culture of quality, where every employee takes responsibility for maintaining standards, cannot be overstated. Such an environment ensures preparedness for regulatory changes, product recalls, or unexpected disruptions, all of which can significantly impact operations.

Proactive Quality Management Approaches Contract Development and Manufacturing Organisations (CDMOs) play a pivotal role in the pharmaceutical supply chain, offering specialised services that enable pharmaceutical and biotechnology companies to bring products to market efficiently. For CDMOs, quality management is not merely about regulatory compliance but also about creating a competitive advantage. By maintaining exceptional quality standards, CDMOs build trust with clients and differentiate themselves in a crowded marketplace.

To achieve these objectives, CDMOs must integrate robust quality management practices into their operations. A "state of readiness" philosophy, exemplified by Syngene International’s "Anytime Audit Ready" approach, ensures organisations are consistently prepared for audits, moving beyond the reactive approach of preparing only for scheduled inspections. This proactive strategy reflects a deep-seated commitment to quality, enabling companies to maintain compliance amidst evolving regulatory landscapes.

Central to successful quality management is a dynamic QMS, which supports continuous adaptation and improvement.

This system provides a foundation for meeting international regulatory requirements while integrating operational feedback to refine processes. A critical component of the 24 International Animal Health Journal

QMS is the development and maintenance of Standard Operating Procedures (SOPs). These documents guide essential operations, ensuring consistency and adherence to regulatory standards across all functions. Regular updates to SOPs incorporate new regulatory requirements, technological advancements, and industry best practices, ensuring the organisation remains at the forefront of quality management.

However, even the most comprehensive QMS and SOPs are only as effective as the people executing them. Recognising this, organisations invest heavily in ongoing employee training to ensure staff competence. By providing education and development opportunities, companies equip their workforce to adhere to SOPs meticulously, maintaining operational integrity and minimising errors.

Importance of Internal Audits Internal audits form a cornerstone of effective quality management frameworks. Designed to mimic external regulatory inspections, these audits ensure organisations consistently meet or exceed required standards. They serve multiple purposes, including verifying compliance, identifying improvement areas, and maintaining a continuous state of readiness. By addressing potential issues proactively, internal audits mitigate risks, uphold quality standards, and strengthen client trust.

Integrating Digital Technology in Quality Management Strategies The pharmaceutical industry’s shift towards digitalisation has significantly impacted quality management practices.

The adoption of digital tools such as automated quality management systems and electronic document management systems exemplifies how technology can enhance operational efficiency. These tools enable realtime oversight, reduce human error, and improve traceability.

Additionally, transitioning to a paperless environment reflects a broader industry trend towards leveraging digital solutions to streamline processes and boost accuracy.

Learning Management Systems (LMS) further underscore the role of digital innovation. These platforms facilitate continuous employee education, ensuring staff remain upto-date with evolving protocols and regulatory expectations.

In an industry where non-compliance can have severe consequences, such systematic training is invaluable for maintaining high standards.

Continuous improvement is a central tenet of quality management. Quality Improvement Plans (QIPs) focus on enhancing operational efficiency, reducing errors, and maintaining quality at every production stage. A "right first time" approach exemplifies this philosophy by minimising mistakes during laboratory work. Precision and accuracy are critical in pharmaceutical operations, where even minor errors can have far-reaching consequences for product safety and efficacy.

Decentralisation of Quality Responsibility Another distinguishing feature of effective quality management strategies is the decentralisation of responsibility.

Empowering line leaders to take ownership of quality within Volume 11 Issue 4

SAFETY & PROCESSING their areas ensures that accountability is embedded at every organisational level. This decentralised approach fosters a culture where quality is a shared responsibility, integral to all processes and decisions.

Infrastructure and Supplier Quality Standards Investment in state-of-the-art infrastructure underpins the ability to meet modern pharmaceutical and biotechnology demands. Advanced technology and specialised facilities enable organisations to handle complex projects while maintaining high standards. Additionally, rigorous supplier qualification programmes ensure that all materials and components meet stringent quality benchmarks. By prioritising supplier quality, companies strengthen their supply chain’s integrity, directly impacting the safety and efficacy of their products.

Adherence to global quality standards is validated by regulatory approvals from leading bodies such as the FDA, EMA, and PMDA. These certifications reflect a company’s compliance capabilities and ability to navigate complex international regulatory landscapes. Maintaining such approvals requires continuous vigilance and adaptation, underscoring the importance of a robust QMS. Animal Health… A Vital Pillar in Quality Management In the pharmaceutical and biotechnology industries, animal health is an essential focus area within the broader framework of quality management. The development of veterinary pharmaceuticals and biologics is subject to stringent regulatory oversight by bodies such as the US Department of Agriculture (USDA), United States Food and Drug Administration (USFDA) and the European Medicines Agency (EMA). These products not only safeguard the well-being of livestock and companion animals but also play a pivotal role in global food security and public health by preventing zoonotic diseases. High-quality standards in animal health ensure that veterinary medicines are safe, effective, and meet rigorous specifications, ultimately supporting both animal welfare and the interconnected ecosystems they influence.

To achieve these objectives, the integration of advanced Quality Management Systems (QMS) tailored to animal health is indispensable. Processes such as Good Manufacturing Practices (GMP), pharmacovigilance for adverse event monitoring, and robust supply chain management are critical to ensuring the safety and efficacy of veterinary products.

Equally important is the qualification of suppliers for animalderived raw materials, where contamination risks must be meticulously controlled. These proactive measures ensure product integrity, compliance with international standards, and the trust of stakeholders across the veterinary and agricultural industries.

Advancing Quality Management in Animal Health through Digital Transformation The adoption of digital technologies is revolutionising quality management in the animal health sector. Electronic batch records, automated quality control systems, and real-time data analytics streamline production and ensure precision in manufacturing processes. These innovations are particularly significant in vaccine development for veterinary use, where maintaining sterility and batch consistency is paramount.

Additionally, the use of blockchain for supply chain traceability enhances transparency, allowing organisations to track every stage of production and distribution – crucial for preventing counterfeiting and ensuring regulatory compliance.

By integrating Learning Management Systems (LMS), organisations ensure that veterinary professionals and www.international-animalhealth.com

manufacturers stay abreast of evolving regulations and best practices. These efforts not only bolster compliance but also position companies as leaders in an industry where the convergence of animal health, food security, and human health demands an unwavering commitment to quality.

Through innovation and a steadfast focus on excellence, the animal health segment exemplifies the transformative potential of robust quality management systems in addressing some of the most pressing challenges in global healthcare.

The Future of Quality Management As the pharmaceutical and biotechnology industries evolve, quality management remains a critical focus. The increasing complexity of operations and rising regulatory expectations demand a proactive approach to compliance and quality assurance. Insights from industry leaders highlight the importance of prioritising continuous improvement, embracing digital transformation, and fostering a culture of shared accountability to enhance quality management practices and maintain competitiveness.

Quality management extends beyond regulatory compliance; it is a comprehensive strategy that drives efficiency, innovation, and competitive advantage. A proactive approach – anchored in robust systems, advanced technology, and a culture of excellence – serves as a model for these sectors. By investing in infrastructure, empowering employees, and upholding stringent supplier standards, organisations can meet current regulatory demands and position themselves for future success.

As global regulatory frameworks become more rigorous, the emphasis on quality will only increase. Companies that adopt advanced technologies, decentralise accountability, and cultivate a culture of continuous improvement will be better equipped to thrive. This journey underscores the transformative potential of quality management in safeguarding compliance while driving operational excellence in an increasingly complex industry landscape.

Alok Mehrotra Alok Mehrotra holds an M. Tech in Chemical Technology (Food Technology) from Harcourt Butler Technological Institute. He has more than 25 years of experience spread across Manufacturing Operations, Quality Assurance, Sustainability/EHS, Production, and Supplier Technical Assurance across varied industries.

Over the years, Alok has worked with leading corporates, including Dr. Reddy’s, Reckitt Benckiser, Pepsi Foods Ltd, Godrej Foods, and Beverages Ltd. In his recent assignment as Head of Global Quality Management at Dr. Reddy’s, he harmonised and integrated Quality management systems Globally and was also responsible for quality from all external suppliers and vendors. As Syngene’s CQO, Alok leads the Quality and Compliance function and will be in charge of initiatives to further strengthen our track record in quality and compliance.

International Animal Health Journal 25

SAFETY & PROCESSING

CMO Quality Management Insights

The pharmaceutical industry and the creation of new drugs is expected to continue growing at a steady rate over the next decade.1 To keep up with this growth, many companies are turning to contract manufacturing organisations (CMOs) to assist with product manufacturing. A key benefit CMOs provide is to maintain a manufacturing footprint, and the skilled talent needed to support product manufacturing. This reduces the need for the product owners to carry these costs or delay progress of their drug development until these resources are directly available. Often CMOs can also assist in bringing products to market more quickly by providing assistance on process and analytical development aspects as well. However, as with most things, the benefits of CMO use also come with some risks.

A CMO can be an important party in the product supply channel. The product sponsor is expected to ensure the CMO is part of a robust supply channel that minimises the risk to patient safety and product supply.2 To meet this requirement the product sponsor establishes and maintains a diligent quality management strategy for oversight of the CMO. Outsourcing the manufacturing activity does not alleviate the product sponsor from responsibility for the quality and safety of the drug product. This holds true for product manufacturing whenever the product is intended to be consumed by a patient; clinical trials or post-market approval. As outsourcing has become a more common practice, regulatory authorities have evolved their expectations for contract manufacturing oversight.

Regulatory Expectations Regulatory authorities worldwide understand the need for use of contract manufacturers. This is evident in the guidelines and directives that directly address the expectations for quality oversight of a CMO. For example, the European Commission devotes the entire GMP Chapter 7 to Outsourced Activities and outlines the activities of Contract Giver (Product Sponsor) and Contract Acceptor (CMO).3 ICH Q10, contains expectations for oversight of outsourced activities.4 Additionally, the ICH Q9 (R1) updates include the expectation for integrating quality risk management activities into industry operations. That includes the application of QRM to oversight of outsourced activities.5 The regulatory authorities have also reiterated that outsourcing does not mean the product sponsor can outsource responsibility for the quality and safety of the drug.

Here are two examples of statements the USFDA has made in warning letters related to use of contract manufacturing and responsibilities: •

Responsibilities as a Contractor FDA is aware that many drug manufacturers use independent contractors such as production facilities, FDA regards contractors as extensions of the manufacturer.

You are responsible for the quality of drugs you produce as a contract facility regardless of agreements in place with product owners.”2

26 International Animal Health Journal

•

Use of Contract Manufacturers FDA is aware that many drug manufacturers use independent contractors such as production facilities, FDA regards contractors as extensions of the manufacturer.

You are responsible for the quality of your drugs regardless of agreements in place with your contract facilities.”6

More recently a warning letter was issued to a sponsor company utilising a CMO that received a warning letter. The company continued to distribute drug products from their CMO after the CMO received the warning Letter. Specifically, the warning letter captures the following points: •

•

“You also failed to have adequate supplier qualification procedures to ensure that the drug products received were manufactured in compliance with CGMP prior to being distributed.”7 “You received and delivered into interstate commerce products that were found to be adulterated.”7

These statements represent the current thinking of regulators as regards the responsibility for ensuring the quality of the drug products manufactured at CMOs on behalf of product sponsors. It is clear that this is a shared responsibility and both parties are responsible for ensuring drug products are produced under cGMP. Both parties must have a focus on patient safety.

Importance of Proper Qualification and Oversight The key to avoiding negative regulatory actions when utilising a CMO is in the initial qualification activities and ongoing quality management engagement with the CMO. Here are some recommendations based on best practices encountered over years of personal experience. The CMO should be qualified through an onsite audit to ensure the facility and staff are capable of manufacturing, testing, storing, and distributing product in a manner consistent with cGMP. This initial qualification should also consider the capabilities of the CMO to control contamination, including cross-contamination from the other products being manufactured in this the same facility. The initial qualification activity completed prior to agreements to initiate work with the CMO. The initial qualification audit is based on a sample of activities available for review during the agreed time. This may not allow enough time to capture all aspects of the controls needed for ongoing compliance. Therefore, it is also important to have ongoing quality management engagement with the CMO. The expectations for quality performance, responsibilities and communications should be captured in a quality agreement between the CMO and product sponsor. It is essential that each party conduct a comprehensive review to ensure the agreement captures the specifics needed for the product under consideration. Once the agreement is in place, ongoing engagement with the CMO is needed to ensure the product sponsor’s requirements are fulfilled as expected. The expected communication plan and governance should be outlined and agreed in the quality agreement.

It is common for commercial product sponsors to have formal qualification and quality oversight plans with CMOs Volume 11 Issue 4

SAFETY & PROCESSING

already in place prior to commercialisation. It is less common for those product sponsors entering clinical trials. According to FDA’s guideline for cGMP for Phase 1 investigational drugs and EC GMP Annex 13 covering investigational drugs, even at the clinical phase 1 stage these products must be produced under a state of control that ensures these products meet the safety, purity, identity requirements needed for use in patients.8,9 Even in the early phases of clinical trials, it is important that product sponsor must have qualify and maintain quality oversight engagement with the CMO. Unfortunately, failure in this area could result in the product application not being approved due to the CMO site failing the GMP inspection.10 This is not something to be learned at the application stage.

Starting early with qualification of any facilities performing manufacturing on behalf of the product sponsor is essential along with continued oversight to stay on track.

6.

7.

8.

9.

10.

Guideline_Step4_2023_0126_0.pdf FDA Warning Letters. (2021). Warning Letter-Sircle Laboratories, LLC. Retrieved from https://www.fda.gov/inspectionscompliance-enforcement-and-criminal-investigations/ warning-letters/sircle-laboratories-llc-615098-09212021 FDA warning Letter. (2024). Warning Letter-Velocity Pharma LLC. Retrieved from https://www.fda.gov/inspectionscompliance-enforcement-and-criminal-investigations/ warning-letters/velocity-pharma-llc-676434-07172024 FDA.gov (2008). Guidance for Industry CGMP for Phase 1 Investigational Drugs. Retrieved from https://www.fda.gov/ media/70975/download EC.gov(2010). Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 13 Investigational Medicinal Products. Retrieved from https://health. ec.europa.eu/document/download/eb43a2ab-4691-4cab938e-874f2307dca3_en?filename=2009_06_annex13.pdf Cancer Network.com (2023). Retrieved from FDA Issues Complete Response Letter for Cosibelimab in Squamous Cell Carcinoma (cancernetwork.com)

REFERENCES 1.

2.

3.

4.

5.

Precedence Research.com (2024).

Retrieved from Pharmaceutical Contract Manufacturing Market Size, Report 2033 (precedenceresearch.com) FDA-WARNING LETTERS (2023). WARNING LETTER Denison Pharmaceuticals, LLC. Retrieved from https://www.fda. gov/inspections-compliance-enforcement-and-criminalinvestigations/warning-letters/denison-pharmaceuticalsllc-654226-07262023 EC.europa.eu (2012). Chapter 7 Outsourced Activities.

Retrieved from https://health.ec.europa.eu/document/ download/58b5106a-cf6f-4352-9dca-1caf5d27d97e_ en?filename=vol4-chap7_2012-06_en.pdf ICH.org (2008). Pharmaceutical Quality System Q10. Retrieved from https://database.ich.org/sites/default/files/Q10%20 Guideline.pdf ICH.org (2023). Quality Risk Management Q9(R1). https:// database.ich.org/sites/default/files/ICH_Q9%28R1%29_

www.international-animalhealth.com

Londa Ritchey Londa Ritchey is currently a Quality Director at PharmaLex a Cencora Company with 30 years of experience in pharma/biopharma/ATMP quality assurance emphasising sterile drug substance and drug product operations. Londa's experience includes quality risk management, aseptic quality operations, quality systems design and implementation, contamination risk management, supplier quality management, training programme design and inspection readiness. Her educational background includes degrees in Microbiology, Biostatistics, and an MBA.

International Animal Health Journal 27

TECHNOLOGY

Harnessing AI in Pharmaceutical Supply Chains: A Strategic Imperative The pharmaceutical industry is at a pivotal moment in its evolution, as artificial intelligence (AI) and machine learning (ML) technologies reshape supply chain dynamics to better meet modern demands. Historically, pharmaceutical supply chains have faced numerous challenges, from managing fluctuating demand to safeguarding product integrity, particularly for temperature-sensitive goods like biologics and vaccines.

As the world becomes more interconnected and the demand for pharmaceutical products rises, stakeholders must balance operational efficiency with reliability, regulatory compliance, and cost control. AI and ML are emerging as vital tools to address these complexities, driving innovation in how companies approach inventory management, logistics, and planning.

The 2024 LogiPharma AI report, which surveyed 100 European life sciences supply chain leaders, provides valuable insights into AI’s transformative impact across the sector. This report reveals that AI is no longer a luxury or a “nice-to-have” in pharmaceutical logistics – it is becoming a strategic imperative. As the industry witnesses a shift toward a data-driven, interconnected ecosystem, AI is poised to be the foundation on which resilient, transparent, and responsive pharmaceutical supply chains are built. This article explores the key areas where AI is making a difference, the current challenges of widespread adoption, and the strategic potential AI holds for the future.

AI's Role in Optimising Inventory Management The application of AI in inventory management is becoming a priority for many pharmaceutical companies, with 40% of survey respondents indicating a strong focus on using AI and ML technologies to optimise inventory. In the pharmaceutical industry, managing stock levels and anticipating changes in demand are critical to maintaining both product availability and cost-efficiency. AI’s predictive capabilities allow pharmaceutical companies to accurately forecast demand based on historical data, current market trends, and predictive analytics.

This level of accuracy is particularly valuable in situations where there are sudden and unexpected surges in demand, such as during the COVID-19 pandemic, which can place

enormous pressure on supply chains. Through demand forecasting, AI helps pharmaceutical companies prepare for these scenarios, making it possible to prevent stockouts or shortages and ultimately ensuring that patients have access to the medications they need.

AI’s role in inventory management also extends to reducing holding costs. By identifying optimal stock levels, AI-driven models minimise warehousing expenses by determining how much inventory should be held to meet forecasted demand without overproduction. This balance is crucial in the pharmaceutical industry, where regulatory constraints, expiration dates, and the need for cold storage further complicate logistics.

When applied effectively, AI helps manage warehousing in a way that both reduces costs and minimises the risk of stock depletion. In this way, companies can avoid the costly and wasteful consequences of expired products, particularly relevant for perishable and temperature-sensitive items. By optimising inventory levels and reducing waste, AI-driven supply chains can also enhance their sustainable practices by minimising the environmental impact of overproduction and disposal.

Building Confidence with Rapid ROI Expectations AI’s growing role in the pharmaceutical supply chain is also reflected in the rapid return on investment (ROI) that companies expect from these initiatives. The report reveals that 51% of respondents anticipate seeing ROI from AI and ML investments within two to three years. This indicates a strong confidence in AI’s ability to deliver tangible business benefits in the near term. As pharmaceutical companies continue to integrate AI into inventory forecasting and logistics systems, they see improvements in decision-making processes and operational efficiency. The swift ROI timelines make it easier for businesses to justify AI investments and allocate resources towards expanding their digital capabilities.

For many companies, the initial results of adopting AIbased tools are promising, with improvements seen in reduced stockouts and better visibility into supply chain inefficiencies. Thanks to AI-powered tools, supply chain managers gain real-time insights into the health of their inventory, tracking shipments, identifying potential delays, and proactively managing disruptions. This enhanced visibility allows companies to take pre-emptive action, reducing waste and costs associated with delays or lost shipments and increasing overall operational efficiency.

Strengthening Collaboration with AI-Driven Supply Chains A key element of AI’s adoption in the pharmaceutical sector is the growing emphasis on collaboration among trading partners, including suppliers, manufacturers, and logistics providers. However, the report also highlights a significant gap in this area, as only 11–25% of supply chain trading partners are currently engaged in AI-driven processes. This indicates that, while the benefits of an interconnected, AI-enabled ecosystem are clear, widespread adoption among all trading partners is still limited. For AI-driven collaboration to be fully effective, pharmaceutical companies need to extend these technologies across their entire network of partners. The

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Volume 11 Issue 4

Vials with Exceptional Inner Surface Durability For Biotech Less interactions of drug molecules and formulations with the inner glass surface • Optimized lyophilization process (less fogging) • Reduced risk of glass delamination

For Diluents

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Lower pH shift • Reduced risk of glass delamination

International Animal Health Journal 29 NIPRO PHARMAPACKAGING INTERNATIONAL Blokhuisstraat 42, 2800 Mechelen, Belgium | pharmapackaging@nipro-group.com | www.nipro-group.com

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TECHNOLOGY creation of shared data platforms and predictive insights facilitated by AI allows supply chain partners to operate in a more transparent, cohesive manner, which is particularly valuable for tracking and quality control for sensitive products like vaccines and biologics.

AI-Powered Digital Transformation in Planning The report also underscores the importance of digital transformation in supply chain planning, especially in processes such as Sales and Operations Planning (S&OP).

According to our survey, 44% of respondents prioritise digitalisation strategies focused on planning processes, recognising that AI-enabled planning can improve agility and responsiveness to market shifts. By integrating various data sources - such as sales forecasts, market trends, and production schedules - AI enhances companies' planning capabilities, allowing them to dynamically adjust to demand fluctuations.

This agility is especially valuable in an industry where regulatory shifts, supply chain disruptions, and global healthcare demands can quickly impact production and distribution timelines. Enhanced planning capabilities ultimately help pharmaceutical companies reduce bottlenecks, align production with demand, and respond more effectively to changes, supporting better overall supply chain efficiency.

Enhancing Cold Chain Integrity Through AI In addition to optimising planning processes, AI is proving particularly valuable in managing cold chain logistics, which are essential for transporting temperature-sensitive pharmaceuticals. The report highlights that 69% of pharmaceutical companies have implemented automated alerts for temperature excursions or delays in their cold chain logistics. These alerts allow for continuous real-time monitoring of environmental conditions and ensure that any deviations in temperature are promptly addressed. AI’s ability to support cold chain integrity is essential in maintaining the efficacy of products such as vaccines, biologics, and other temperature-sensitive treatments. By receiving instant alerts when temperature or humidity thresholds are breached, logistics teams can act immediately, thereby reducing the risk of spoilage and ensuring patients receive safe, effective treatments.

The integration of AI into cold chain logistics also reduces the financial and reputational risks associated with damaged or ineffective products. Some companies are even exploring advanced AI implementations, such as the use of drones or autonomous vehicles equipped with AI sensors, to improve cold chain monitoring during transport. These technologies further enhance the industry’s capability to safeguard temperature-sensitive products, supporting both product quality and patient safety.

Transforming Quality Control and Compliance with AI and Machine Learning In an industry bound by strict regulations, AI’s role in monitoring production parameters and identifying deviations in real-time is invaluable. By streamlining documentation, data collection, and reporting, AI-based systems facilitate regulatory compliance and help maintain product quality.

Machine learning algorithms used in quality control can detect anomalies – such as contamination risks or quality inconsistencies – that might not be apparent through traditional methods. As a result, AI not only supports compliance with stringent industry standards but also contributes to cost-efficiency by reducing the chances of costly recalls or production shutdowns.

30 International Animal Health Journal

The Expanding Future of AI in Pharma Supply Chains The role of artificial intelligence in pharmaceutical supply chains is set to expand significantly as the technology matures, bringing profound advancements to how the industry forecasts demand, enhances security, and manages orders. As highlighted in the 2024 LogiPharma AI report, as applications are becoming more sophisticated, the sector is likely to witness wider adoption of predictive analytics for forecasting new drug demands, AI-driven security systems to prevent counterfeit drugs, and fully automated order management. These capabilities position this technology as an essential component of the pharmaceutical supply chain, enabling improved accuracy, agility, and reliability.

By embedding such innovations into daily operations, pharmaceutical companies are better positioned to meet patient needs, ultimately enhancing the accessibility and affordability of essential medications. The advantages of AIdriven processes create a competitive edge for companies that embrace the technology, delivering benefits in both operational resilience and patient outcomes. For an industry often navigating complex regulatory, logistical, and healthcare challenges, these advancements offer a transformative path forward.

In this rapidly evolving environment, AI has shifted from being a mere efficiency tool to a vital driver of innovation and an essential part of patient-focused supply chains. With AI fuelling digital transformation across the pharmaceutical landscape, companies are empowered to address industry challenges with new levels of precision and speed, ensuring that critical treatments reach patients worldwide. For pharmaceutical companies dedicated to advancing their supply chains, AI presents a clear route to heightened accessibility, cost-efficiency, and excellence in operations, establishing a new benchmark for reliability in global healthcare logistics.

Will Robinson Will Robinson, Conference Director, LogiPharma, With over a decade of industry experience, Will Robinson is responsible for the strategic direction, editorial content, and commercial growth of a £7m+ portfolio of events as part of the Worldwide Business Research (WBR). With its flagship event, LogiPharma Europe, having taken place in April 2024, as Conference Director, Will works with various leading pharma companies and supply chain heads to decipher industry trends, devise effective approaches, and curate top-notch content. With an attendance of around 200 speakers and 2000 participants, LogiPharma strives to create a platform that facilitates insightful discussions and fosters industry connections.

Volume 11 Issue 4

Media and Communications

IPI

Peer Reviewed, IPI looks into the best practice in outsourcing management for the Pharmaceutical and BioPharmaceutical industry. www.international-pharma.com

JCS

Peer Reviewed, JCS provides you with the best practice guidelines for conducting global Clinical Trials. JCS is the specialist journal providing you with relevant articles which will help you to navigate emerging markets. www.journalforclinicalstudies.com

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Peer Reviewed, IAHJ looks into the entire outsourcing management of the Veterinary Drug, Veterinary Devices & Animal Food Development Industry. www.international-animalhealth.com

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Peer reviewed, IBI provides the biopharmaceutical industry with practical advice on managing bioprocessing and technology, upstream and downstream processing, manufacturing, regulations, formulation, scale-up/technology transfer, drug delivery, analytical testing and more. www.international-biopharma.com

PNP

Pharma Nature Positive, is a platform for all stakeholders in this industry to influence decision making by regulators, governments, investors and other service providers to achieve Nature Net Positive Results. This journal will enable pharma the ability to choose the right services to attain this goal. www.pharmanaturepositive.com

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‘Putting science into conversation, and conversation into science.’Join some of the most esteemed and integral members of the Drug Discovery & Development world as they give insights & introspect into the latest movements, discoveries and innovations within the industry.

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International Animal Health Journal 33

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34 International Animal Health Journal

Volume 11 Issue 4