INTERVIEW ANJA HOLM
New mastitis guideline
FUTURE OF DAIRY FARMING
“Taking a balanced step together towards optimised dairy”
ANIMAL MODEL
Streptococcus suis serotype 9
Proficiency testing schemes in 2025
Why participate?
1. To evaluate laboratory performance
2. To identify problems
3. To maintain or achieve ISO 17025 accreditation
4. To identify interlaboratory differences
Application and questions
More information about our PTS and the application form can be found on our website www.gdanimalhealth.com/PTS.
If you have any questions, please do not hesitate to contact us via pts@gdanimalhealth.com or www.gddiergezondheid.nl/ klinischedagenrund.
Round 1 – January
VLDIA234 PTS for PRRSV antibody detection
VLDIA290 PTS for PRRSV RNA detection
VLDIA225 PTS for IBV antibody detection
VLDIA296 PTS for IBV RNA detection
Round 2 – January
VLDIA323 PTS Bacterial Identification Cattle round 1
VLDIA324 PTS Antibiotic susceptibility of bacterial strains Cattle round 1
VLDIA323 PTS Bacterial Identification Poultry
VLDIA324 PTS Antibiotic susceptibility of bacterial strains Poultry
VLDIA323 PTS Bacterial Identification Companion Animals
VLDIA324 PTS Antibiotic susceptibility of bacterial strains Companion Animals
Round 3 - February
VLDIA294 PTS for App antibody detection
VLDIA340 PTS for Mycoplasma Hyopneunomiae antibody detection
VLDIA345 PTS for Mycoplasma Hyopneunomiae DNA detection
VLDIA226 PTS for Mg/Ms antibody detection
VLDIA303 PTS for Mg/Ms/Mm DNA detection
Round 4 - March
VLDIA336 PTS for Map antibody detection serum
VLDIA337 PTS for Map antibody detection milk
VLDIA219 PTS for NDV antibody detection
VLDIA328 PTS for NDV RNA detection
VLDIA313 PTS for EDS antibody detection
UDDER HEALTH AND MORE
Udder health has long been a key point of interest and expertise of Royal GD. This newest edition of the Update will show you that it still is. Among others, we interviewed Anja Holm, an internationally renowned expert on the regulatory landscape for veterinary medicine in Europe. We asked her to give us a sneak preview on what to expect in the updated guideline for Mastitis studies from the EMA. This guideline is expected to be published early 2025 but you can read about the most important changes already in this interesting interview.
Udder health, however, is only one of the many challenges the dairy farming industry is facing. In collaboration with Beluga
Animal Health we organized a symposium prior to the National Mastitis Council meeting in Ghent in August to discuss these challenges. In this edition of the Update we reflect on the symposium with the CEOs of GD and Beluga Animal Health. A rare occasion to speak with two of the most experienced experts in the field at the same time.
But there is much more to read in this edition. Make sure you check out the 2025 PTS schedule, our Streptococcus suis 9 model, new H5 antigens and our new animal facility. As always the Update is a testimony to the wealth of activities and developments going on at GD. It is a pleasure to be part of it, to contribute to it and to share it.
Berend Oosterhuis, Head of Contract Research & Consulting
CONTACT INFORMATION ROYAL GD
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Berend Oosterhuis Head of Contract Research & Consulting b.oosterhuis@gdanimalhealth.com
Annemiek Kolkman Business manager a.kolkman@gdanimalhealth.com
Jarno Smit Business manager j.smit@gdanimalhealth.com
Mattheus Hekman Business manager m.hekman@gdanimalhealth.com
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Phone +31 (0)88 20 25 575
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Mail address GD
P.O. Box 9, 7400 AA Deventer, the Netherlands
Editor Update Jessica Fiks
Delivery address for samples and post mortem material Royal GD, Attn. CMD, Rigastraat 25, 7418 EW Deventer, the Netherlands
Eveline Peereboom Business manager e.peereboom@gdanimalhealth.com
Fanny Nieuwenhuis Business manager f.nieuwenhuis@gdanimalhealth.com
Ellen Koetsier Sales support support@gdanimalhealth.com
Frank Huis in ‘t Veld Sales support support@gdanimalhealth.com
Janine Boertien Sales support support@gdanimalhealth.com
Hannelore Braam Sales suport support@gdanimalhealth.com
04 Interview Anja Holm. New mastitis guideline: what to expect
06 New facilities at Royal GD: animal facility
07 Jump to the Future Dairy Farming 2050
10 Development of a Streptococcus suis serotype 9 animal model
11 News & communications
12 GD specialist: Christian Scherpenzeel content
UPDATED EMA GUIDELINE AND ITS SIGNIFICANCE FOR STAKEHOLDERS
New mastitis guideline: what to expect
Royal GD is dedicated to advancing animal health by providing expert guidance and innovative solutions to partners in the veterinary and pharmaceutical industries. One of the prominent figures contributing to this mission is Anja Holm, an experienced veterinarian and regulatory expert with a distinguished career in veterinary medicines. Having served at the Danish Medicines Agency and chaired the EMA’s Committee for Veterinary Medicines, Holm has a wealth of knowledge that she now applies as a consultant. Her deep insights help guide pharmaceutical companies through the complex regulatory landscape in Europe, where her expertise in policy, clinical trials, and safety assessments proves invaluable.
Anja Holm
Recently, Holm has worked with the updated EMA guideline on the conduct of efficacy studies for intramammary products used in cattle. This guideline is being revised to reflect the new legislative framework introduced by Regulation 2019/6/EU, which came into force in January 2022. Though Holm herself did not participate in drafting this particular update, her broad experience with veterinary legislation allows her to offer a clear perspective on its significance for stakeholders in the field.
The future of mastitis treatments: innovation beyond antibiotics
Holm: “One of the key changes in the updated mastitis guideline is its stringent approach to the use of antimicrobial intramammary products. In particular, it incorporates Article 107(3) of the new regulation, which emphasizes that the prophylactic use of such products is only permissible in exceptional cases. This restriction applies to both antibiotics and other antimicrobials, with the aim of limiting the risk of antimicrobial resistance development. Only in cases where the risk of infection is very high and consequences are likely to be severe, can these products be used for preventive purposes. This aligns with a broader trend in veterinary medicine to reduce unnecessary antibiotic use, thereby helping to preserve the efficacy of these treatments for future generations.”
The impact of these new guidelines on the development of mastitis treatments is difficult to predict. Holm notes that, at present, there is very little new research into veterinary antibiotics, making it unlikely that new antibiotic substances will reach the market in the near future. However, she remains optimistic that the tightened regulations could stimulate the development of non-antibiotic treatments, or even vaccines, devices, or breeding strategies that focus on improved udder health. Such innovations would not only provide new options for controlling mastitis but could also contribute to a broader paradigm shift in animal health management.
Challenges and opportunities
Implementing these guidelines will present challenges for researchers and pharmaceutical companies alike. According to Holm, the guideline’s clarity and well-defined study requirements have always been a strength. “However, conducting these trials demands a significant investment of resources, as large numbers of animals must be screened and included under strict criteria. This creates a substantial burden for companies, including those developing generic versions of existing products. Yet, the specificity of the guidelines also provides a clear framework for compliance, potentially streamlining the approval process for such products.”
Understanding the broader regulatory process for veterinary medicines in Europe is crucial for companies looking to bring new treatments to market. As Holm explains, veterinary medicines can be authorized either through national agencies or via the European Medicines Agency (EMA), depending on the scope of the intended market. “Applications must include comprehensive data on manufacturing, safety, and efficacy, which are then rigorously assessed by experts. Unlike human medicines, veterinary products must meet safety standards not only for the treated animals but also for the environment, users (such as farmers), and consumers. These considerations can significantly complicate the regulatory process, as each aspect may require specialized studies and technical expertise.”
The Role of the EMA in approving veterinary medicines
Holm: “The EMA plays a pivotal role in the evaluation process, particularly for products seeking approval across multiple EU member states. When a company submits an EU-wide application, the EMA assigns teams from different member states to collaborate on assessing the data. After this review, other member states can provide feedback before the EMA’s veterinary committee makes a final benefit-risk assessment. Only when the committee reaches a positive conclusion does the European Commission formally issue the authorization.”
Even after a veterinary medicine has been approved, pharmaceutical companies must comply with ongoing obligations
Even after a veterinary medicine has been approved, pharmaceutical companies must comply with ongoing obligations. They must maintain high production standards, report sales and marketing activities, and operate a robust pharmacovigilance system. This latter requirement ensures that any adverse effects or unintended outcomes of a product are closely monitored and addressed. Although the new regulation has made these post-authorization requirements more demanding, Holm believes that these changes will ultimately lead to safer and more effective veterinary medicines.
The updated guidelines for mastitis trials are expected to be finalized and ready for implementation by 2025.
OPENING FIRST QUARTER OF 2025
Royal GD: animal facility expansion
Royal GD has built an extension to its animal facilities this year. The current facility focuses on poultry studies, where we have both ground pens and isolators at our disposal. With the expansion, we have better facilities for studies with larger animals, think in particular piglets, pigs, sows and calves, in consultation we can also house other animal species. Housing cows cannot be done in this facility, but GD has had a separate test barn available for studies with cows for several years.
The new facility consists of 6 multifunctional pens for studies. There are 3 pens of 46 square metres and 3 pens of 14 square metres. These pens are all equipped with slatted floors with manure collection. The pens can all be fully individually controlled in terms of temperature, light and monitoring of the animals. Climate control can also be regulated per pens and all measures have been taken to prevent contamination in
studies. In the new facility, studies can be carried out at BSL2 level, where the emphasis will be on safety studies. There is also a laboratory space within the facility, where we can work with BSL3 pathogens.
Currently, the construction phase has been completed and we are busy setting up the facility. In addition, validation of all systems in the facility will run in
autumn 2024 so that we are ready for studies under GLP. The validation is expected to be completed by mid-Q1 2025, from which time the facility will be available for use in studies by our customers.
For our customers directly involved in studies in the animal facilities, we will organise another open day prior to the start of operations. It will then be possible to view the entire facility and discuss further options with our account managers. As soon as the date in Q1 2025 is known, we will inform you.
Should you have any questions about the possibilities at this stage, you can of course contact your account manager.
Taking a balanced step together towards optimised dairy farming in 2050
At a short course entitled ‘Jump to the Future: Dairy Farming in 2050’, held in Ghent in Belgium on 12 August, five experts spoke in front of 140 dairy professionals about the challenges that the dairy sector will face in the future, such as climate change, animal welfare and replacing human labour with robots. For this, it is important not to get caught up in the latest fads but instead to adopt a solid long-term agenda, as well as examining the various challenges in the context of a cohesive whole.
The short course, which was held just before the National Mastitis Council (NMC), was organised by Royal GD and Beluga Animal Health. The level of interest was above expectations, attracting 140 participants from 35 countries. The audience included scientists, people from the dairy farming sector, veterinarians and students.
GD’s CEO Ynte Schukken and Beluga’s founder Rinse Jan Boersma explain why they felt it was important to organise this mini-symposium.
Marije Stomps, freelance editor
Ynte Schukken (on the left) and Rinse Jan Boersma
“Lots of short-term reports appear in the media about dairy farming,” argues Boersma. “People seem to be getting overwhelmed by the issues that need resolving in the shorter term, whereas our opinion is that the sector actually needs a longterm agenda so that solutions can be found for the challenges we’re going to be facing in the future. I mean, you can already think up lots of things that show where dairy farming will be headed by 2050. And that’s something else that we can get down to work on.”
Moving forward together
“Nitrogen, animal welfare, minerals, labour, nutrition and animal health too...” says Schukken, ticking off a number of challenges. “But above all, those things in combination. At Royal GD, we’re all about animal health. And if you start making efforts to reduce nitrogen emissions, for instance, you have to make sure that it isn’t at the expense of the animals’ health. We want to press on as a sector, as a whole, so it’s good to be talking about this with all kinds of parties from the dairy sector.”
Methane reduction
Several key challenges were discussed by specialists during the short course. Rinse Jan Boersma himself discussed the latest understandings about using new technology to reduce methane emissions. This can also be helped by modifying manure management and milk production, as well as by lowering the calving age. Kelly Nichols (University of California-Davis, USA) took a more in-depth look at promising research into feed additives that can reduce methane production.
Animal
welfare
Marina von Keyserlingk (University of British Columbia, Canada) told the audience that animal welfare is going to become increasingly important in the future, and Schukken concurs. “People in the Netherlands are already highly critical of this. Marina gave us the example of calves being separated from cows, for instance. People tend to think that it’s better to keep the calf with the cow because that’s more natural. Studies have shown, though, that keeping the calf and cow together isn’t any better in terms of animal health – the calves then turn out to be much more susceptible to infectious diseases and use of
“The requirements, and above all the costs, are all going to be something that the farmers have to deal with.”
antibiotics is higher, and so forth. This is one of those challenges where you may be able to think up solutions all right, but it isn’t quite as simple as it seems.”
Robotisation
According to Schukken, the same applies for the unceasing march of automation.
“More and more is becoming possible, but it’s important to keep a close eye on the cows’ welfare if you’re going to replace human labour with robots.”
Another speaker, Ilka Klaas (DeLaval, Sweden), argued that using sensor technology and digitalisation can in fact improve cows’ health and welfare too. The ever-more extensive data that is available can help dairy farmers to detect health risks and diseases quickly. However, much more research and innovations is still needed in this area.
Increases in scale
Schukken concludes cautiously that some things are already going quite well.
“All the speakers gave examples. Huge strides can be made in cutting methane emissions without significant consequences for
the cows, for example. Kelly Nichols made clear where the optimum for nitrogen (protein) in the feed intake is going to be. That’s information that a dairy farmer can use. DeLaval offered all kinds of options for replacing labour. AI will be playing a role there too.”
Boersma is also convinced that the dairy farming sector will do just fine in the future, but he argues that the business operations of dairy farms are inevitably going to increase exponentially in size as a result.
“You’re going to need certain economies of scale in the business,” he says, “or else it won’t be worth making the investments. The requirements – and above all the costs – are all going to be something that the farmers have to deal with. Consumers won’t want to pay for that and neither will the government or the dairy produce industry. That process of scaling up even further is already underway, and it’s only going to accelerate from here.”
An open attitude
It is however by no means true that cows on large dairy farms are necessarily worse off, as the public sometimes seem to think.
“It would be wonderful if we were able to collaborate with a lot more parties throughout the world.”
“I’ve seen the best welfare practices put into effect on the biggest farms,” states Boersma. “On a large farm, if they’re paying the right attention to the cows’ health and welfare, there’s more scope for ensuring it in practice. Precisely because of the scale.”
When looking towards the future, it is also not a bad idea to think outside the box more often, for instance when considering farm sizes or the question of separating cows and calves.
“There are two ways of dealing with criticism,” says Boersma. “Being defensive and not changing anything, or looking at what is within our capabilities. The first of those is a no-win situation. I prefer to see the second, and we’re happy to sit down and talk to people about that. An open attitude rather than polarisation, looking at whether there are goals we can achieve together differently. What’s it going to take? Different pens and sheds, perhaps, or different feed or other management approaches or new technology. If we start working on that now, we can set out that agenda for the future. We need to be players who are actively involved, not back-seat drivers.”
Towards the optimum
situation
Ynte Schukken believes it is just as important to keep an eye on the future, including in animal health and welfare aspects, the field GD is involved in.
“What’s important from society’s perspective ebbs back and forth. One moment the focus is on carbon-neutral production, a little later nitrogen becomes a hot topic, then labour or animal welfare... We see all four of these issues as important driving forces in dairy farming. That’s true worldwide, although one thing may get more emphasis than another on different continents. I was the final speaker on the short course and I called for everything to be looked at cohesively, as a whole, because making advances in one area could start to affect others.”
Royal GD, whose slogan ‘Leading the way in animal health’ says it all, will continue to monitor animal health and welfare throughout the process. “That’s what we focus on. We have measuring systems and programmes for IBR, BVD and leptospirosis, for example, that really put us at the forefront globally. That’s also thanks to the dairy produce and dairy cattle sectors in this country. We are all aiming to do things properly, together. It would be wonderful if we were able to collaborate with a lot more parties throughout the world, working towards the optimum situation for dairy farming in the future.”
Marije Stomps, freelance editor
ANIMAL MODEL
Development of a Streptococcus suis animal model
Clinical Streptococcus suis serotype 9 (SSU9) infections occur frequently on pig farms. Pigs and piglets without symptoms carry the bacterium in the tonsils and intestine. At some point in time the bacterium invades the body and creates disease. The infection is difficult to prevent and treatment with antibiotics is under pressure. This demands for the application of other measures. Animal models are necessary to evaluate new interventions to prevent or reduce clinical signs due to SSU9. We performed a validation study to define the most convenient inoculation dose and route with SSU9 in order to develop a SSU9 challenge model.
Material & Methods
Immediately upon arrival, three groups of pigs (7 pigs/group) were all inoculated orally with 109 Colony Forming Units (CFU) SSU9 to achieve intestinal colonisation. In addition, they were inoculated intra-tracheally with 3 increasing doses (108, 109 and 1010 CFU). Animals were observed for clinical signs and sampled frequently up to the end of the study (14 days after inoculation) for bacterial culture and PCR.
Results
After inoculation several animals showed locomotion or neurological disorders. Ten out of 21 pigs were removed before the end of the study and eight of them tested positive for SSU9 in blood culture before euthanasia. In only four pigs SSU9 could
be detected in tissues at post-mortem examination. The surviving pigs carried SSU9 in their tonsils, at various study days after inoculation but not in feces. In three to six pigs per Group SSU9 was detected in jejunum (47%), ileum (57%) or rectum (14%). Group 3 (highest dose) did not show increased morbidity and mortality compared to lower doses.
Discussion & Conclusion
In this set-up, no clear dose-response of tracheal inoculation was found. The group that received the lowest dose had already the strongest response of clinical disease. In 90% of the animals, SSU9 could be found in the tonsils. In half of the pigs intestinal colonization was achieved. It is concluded that when using the selected SSU9 strain, the middle dose (at least 109 CFU/pig, orally and intra-tracheally) is required for clinical response in at least 50% of the pigs. As the lag phase until clinical signs and/or death due to SSU9 was at least two days in Group 1/2 in this study, a time window to evaluate interventions to reduce/prevent clinical signs is available. This model can be used to evaluate the efficacy of interventions to prevent or cure clinical signs. In addition, this model is useful to evaluate interventions that aim to prevent or diminish colonization of the tonsils or the enteric system.
Erik van Engelen
New poultry diagnostics: Avian influenza H5 inactivated antigens
In response to the ongoing global challenge posed by highly pathogenic avian influenza (HPAI), we are pleased to introduce our latest veterinary diagnostic products with the most up-to-date antigens for H5N1 and H5N8 strains. These antigens are inactivated and specifically designed for use in the Haemagglutination Inhibition (HI) test to ensure accurate detection of antibodies in poultry. Our new poultry diagnostic products are:
• VLDIA353 - Inactivated H5N1 antigen
Influenza virus A/Fox/Netherlands/EMC-1/2022, HPAI H5N1, HA clade 2.3.4.4b
• VLDIA354 - Inactivated H5N8 antigen
Influenza virus A/Chicken/Netherlands/EMC-3/2014, HPAI H5N8, HA clade 2.3.4.4b
In addition, we also have a negative chicken serum (VLDIA030) for your veterinary testing needs. These veterinary diagnostics are available now and can be ordered at gdanimalhealth.com/Diagnostics
Visit us at EuroTier, 12 to 15 November
Royal GD will be present at EuroTier 2024 from 12 to 15 November in Hannover, Germany. With over 2,100 exhibitors, EuroTier 2024 is an event for those who innovate in animal agriculture and GD will be there! Visit our booth (Hall 21 Booth B16) and find out how we can help you bring your product to market. We offer insight and knowledge, data and information, support and advice, animal facilities and Europe’s largest veterinary laboratory. We offer a range of animal models and veterinary diagnostic products.
Renewed licence for Cryptosporidium parvum animal model
GD has a validated model and renewed animal licence to evaluate the efficacy of interventions to prevent and/or treat Cryptosporidium in young calves. The Cryptosporidium parvum calf model provides valuable insights into the course of infection and tools to evaluate preventive or therapeutic interventions. The primary outcome parameter of the model is the presence of the challenge organism in faecal samples. Secondary outcome parameters include general health scores, body temperature, faecal production and diarrhoea scores.
IF YOU ARE INTERESTED IN OUR CRYPTOSPORIDIUM MODEL, PLEASE CONTACT US.
Expert session avian influenza
In our recent expert session with poultry specialist Professor Sjaak de Wit, he discussed the latest developments in both low and high pathogenic avian influenza.
Avian influenza is a major concern for poultry farmers and, increasingly, for public health. Recent infections in dairy cattle in the United States have added to these concerns. During the webinar, Sjaak provided an update on the latest developments in the field. He discussed both high and low pathogenic circulating strains, their clinical outcomes, virulence and the models and tools available to control avian influenza.
Webinar Bluetongue 3
We are receiving a lot of questions and requests from international partners to share experience and knowledge about the BTV-3 outbreak. In order to fulfil this request. René van den Brom, DVM, PhD, DipECSRHM, Emma Strous, DVM, DipECBHM and Inge Santman-Berends, MSc, PhD, shared their experience and knowledge with international partners in a webinar on 22 August. The webinar was chaired by Gerdien van Schaik, MSc, PhD.
In recent years, we have seen an increase in the bulk milk somatic cell count (BMSCC) in the Netherlands, a key indicator of udder health in dairy cows. Data from the Dutch Cattle Health Surveillance System, carried out at Royal GD, show that the BMSCC of dairy cattle has been increasing slightly since 2020, and that this increase accelerates from 2022 onwards. This is an unfavourable trend, as it is an indication of reduced udder health in dairy herds in the Netherlands. To explain this unfavourable trend we estimated the influence of various explanatory variables on BMSCC.
The average SCC increased from around 170,000 cells per millilitre at the end of 2019 to more than 200,000 cells per millilitre at the end of 2023. Key factors behind this increase include the growing number of automated milking systems (AMS), larger herd sizes and the older age of dairy cows. Farms using AMS recorded 22,000 more cells per millilitre than conventional systems, while farms with more than 181 adult cows generally saw an above-average increase of around 19,000 cells per millilitre. In addition, each additional month of cow age added around 2,000 cells per millilitre.
However, the sharp increase in 2022 cannot be fully attributed to these factors alone. An important driver is the increase in the milk price to more than 60 euros per 100 kilograms of milk in 2022. In addition, the adjustment of the EU VCA reference values for SCC by Qlip in January 2022 contributed an additional 4,000 cells per millilitre to the SCC of bulk milk.
It is important that udder health and milk quality are properly monitored at national level. As part of animal health monitoring and surveillance, we analyse a wide range of udder health parameters in dairy cows four times a year. This allows us to identify trends and explanations in good time for the cow, the farmer and their veterinarians.
GD specialist: Christian Scherpenzeel