International Conference on Veterinary Medicine and Animal Care

Monday, April 24, 2023

FDA Issues Draft Guidance on Donor Eligibility and Manufacturing of Cellular Therapies for Animals

The U.S Food and Drug Administration issued for public comment two draft guidance documents that, if finalized, will help manufacturers of animal cells, tissues, and cell- and tissue-based products (ACTPs) understand current good manufacturing practice requirements (CGMPs) for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). CGMPs help prevent contamination and help ensure ACTP quality. If finalized, the recommendations are intended to support the development of promising and innovative products that can benefit animal health.

“ACTPs have the potential to make significant changes in how we treat diseases and may provide novel therapies for unmet therapeutic needs of animals. We want to support manufacturers in the safe production of these promising products,” said Dr. Janet Woodcock, Acting Commissioner of the FDA. “It is important to note that the FDA is not imposing any new requirements on the manufacturers of ACTPs with these new draft guidance documents. These draft guidance documents, if finalized, are intended to assist manufacturers by providing product-specific recommendations that will help developers of these products meet existing FDA manufacturing requirements. Our goal is to help manufacturers be successful in their efforts to develop innovative products that can benefit animal health.”

In the draft guidance, ACTPs are defined as products that contain, consist of, or are derived from cells or tissues that are intended for implantation, transplantation, infusion or transfer into an animal recipient. Furthermore, ACTPs refer to products that meet the definition of a new animal drug. In the draft guidance, ACTPs include both cell-based products and animal stem cell-based products. ACTPs are most commonly investigated for regenerative medicine applications because they have the potential to repair diseased or damaged tissues in animals through regeneration and healing. Currently, these products are most commonly investigated and used in companion animals including dogs, cats, and horses; however, ACTPs may be also be developed for use in other species.

All new animal drugs are required to be manufactured in accordance with CGMPs to ensure that such drugs meet the requirements of the FD&C Act for safety, and to have the identity, strength, quality, and purity characteristics which they purport to or are represented to possess. Because the manufacture of ACTPs present unique considerations for complying with CGMPs, the FDA is issuing two draft guidance documents for industry.

The first draft guidance, #253, “Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products” provides manufacturers of ACTPs with recommendations for meeting requirements for CGMPs. It addresses the methods, facilities and controls used for manufacturing ACTPs, including steps in recovery, processing, storage, labeling, packaging and distribution. The draft guidance also addresses methods for preventing contamination and ensuring quality of the ACTP during manufacturing.

The second draft guidance #254, “Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products”, if finalized, will assist sponsors, firms or establishments that participate in the manufacture of ACTPs or perform any aspect of the ACTP donor eligibility determination. Selecting appropriate donors is critical to product quality and preventing the transmission of disease.

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Wednesday, April 19, 2023

Britons urged not to buy exotic pets ‘on a whim’ amid welfare concerns

The British Veterinary Association has urged people to reconsider buying exotic pets because of fears many owners are struggling to look after the animals properly.

More than eight in 10 vets raised concerns about the welfare of exotic reptiles, amphibians, birds and other animals in a BVA report, with most blaming what they called “irresponsible animal ownership”.

A survey of council licensing data in England last year identified nearly 2,500 wild animals in the hands of private collectors, including capuchin monkeys, lemurs, mountain lions, alligators, hyenas, zebras, camels, grey wolves, honey badgers and ostriches.

Vets who treated exotic animals said nearly 60% of the pets they saw did not have their basic welfare needs met, while more than a quarter of the vets reported a rise in the number of exotic animals brought in for treatment in the past year, according to the Voice of the Veterinary Profession survey.

“We understand why so many people would love to have them as pets, as they are often unusual and are a bit different to owning a cat or a dog,” said Justine Shotton, a veterinary surgeon and senior vice-president at the BVA. “But it is so important not to buy exotic species on a whim as they have very complex needs and it can be both challenging and expensive to look after them properly.”

Many exotic pets have particular environmental, dietary and housing needs and require specialist care that may only be available in certain parts of the country, the BVA said. Some animals have specific heating, lighting or ultraviolet needs that could go unmet if people cut back on their energy usage because of soaring bills, it added.

Exotic pet ownership in the UK has risen dramatically since 2000, according to the wildlife charity Born Free. Its 2021 analysis of Dangerous Wild Animals Act licences revealed at least two elephants, more than 300 wild cats including tigers, leopards and pumas, more than 200 primates, and crocodiles, venomous snakes and scorpions all kept in private collections in the UK.

Chris Lewis, a captivity research officer at Born Free, said the charity’s 2021 report on exotic pets highlighted the need for urgent action on the issue. Its recent UK wildlife conservation and animal welfare manifesto urges the next government to conduct a comprehensive review of the trade in and keeping of exotic pets and give due consideration to regulations in place or in development in other countries.

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Moonpig to stop selling cards with pugs over animal welfare concerns

Moonpig is to stop selling cards featuring pictures of pugs and French bulldogs after criticism from vets and campaigners who fear the images fuel demand for the breeds, which often have serious health complaints.

Last year, the British Veterinary Association (BVA) wrote to the Greeting Card Association and card retailers, including Moonpig, Paperchase and WH Smith, urging them to stop using pugs and other flat-faced dogs on cards.

There has been a sharp rise in ownership of flat-faced breeds, including pugs, French bulldogs and English bulldogs in the UK in recent years, with the BVA concerned that their growing presence in advertising as well as on cards and gifts is normalising perceptions of their short noses and big eyes.

While some perceive the squashed wrinkly faces of these breeds as “cute”, vets warn that dogs with short muzzles can struggle to breathe, even when doing day-to-day activities such as walking or eating. Other problems faced by brachycephalic, or flat-faced, dogs include eye disease and an inability to mate or give birth naturally.

A Royal Veterinary College study published in May 2022 suggested “urgent action is needed as many health issues of pugs are associated with their extreme body shape”.

It concluded that the health of pugs in the UK is now substantially different from and largely worse than other breeds, revealing they are almost twice as likely to experience one or more disorders annually compared with other dogs.

Despite this backdrop the popularity of these breeds has surged thanks to celebrity owners and social media exposure and in 2018 the French bulldog overtook the labrador retriever to become the UK’s most popular. That reflected an almost 3,000% increase in numbers in the previous 10 years. Faced with the increase, the BVA has run several campaigns including #HugsNotPugs and #BreedtoBreathe to raise awareness.

On Friday, a search for “pug” and “French bulldog” on Moonpig’s website on Friday did not yield cards showing either breed. However, several cards adorned with images of English bulldogs, which are also flat-faced, remained on sale.

The animal rights lobby group Peta had also raised concerns with Moonpig about promoting “breathing-impaired” dog breeds such as pugs and French bulldogs on its cards. The company has now confirmed to Peta that it is the process of removing any cards that feature pugs or French bulldogs from its website. It also told Peta that it will not be designing or sourcing any card designs featuring these breeds in future.

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Pets could be gene-edited under new English law, says RSPCA

Pets could be subjected to gene editing under a new government act, the RSPCA has warned.

The animal charity has said that the Genetic Technology (Precision Breeding) Act applies to all vertebrate animals, not only farmed animals, and that it could lead to cats and dogs being gene-edited to include extreme features.

The law allows the creation and marketing of “precision-bred” or genome-edited plants and vertebrate animals in England. The government said it would allow farmers to grow crops that are drought- and disease-resistant, reduce the use of fertilisers and pesticides, and help breed animals that are protected from catching harmful diseases.

The UK environment secretary, Thérèse Coffey, described the act, which received royal assent on Thursday, as a “Brexit freedom”, but the RSPCA said it could have dire consequences for animal welfare.

David Bowles, the head of campaigns and public affairs at the RSPCA, criticised what he described as an “ill-judged policy”. He said the charity had tried to get the government to include an exemption for pets, but was “sadly ignored”.

He added: “Gene editing could be a huge step backwards for animals. We do not believe this act should include animals, whether they are farm, pet or wildlife. Invasive procedures are needed to create each line of gene-edited mammals, there is no history of use for this powerful technology, and it can cause unintended changes to the genome, with unpredictable effects. The RSPCA has serious animal welfare and ethical concerns about this.”

Genome editing is a group of techniques that enable changes to an organism’s DNA, and the animal charity warned that editing an animal’s genome involved procedures that could cause “pain, suffering, distress and lasting harm”. Gene editing was previously subject to the strict rules and regulations that control genetically modified organisms (GMOs), but under this new law gene-edited animals and food will not be classed in England as GMOs and will not need to be labelled as such.

There are concerns that a demand for cats and dogs with extreme appearances could cause breeders to use gene editing to create pets with these characteristics.

“We feel there is no justification whatsoever for non-farm animals to be covered by the [legislation],” Bowles said. “Ongoing demands for dogs and cats with harmful physical characteristics and exaggerated conformational features, and relentless pressure on sporting animals, are already of deep concern, and there has been no public consultation on gene editing non-farm animals.”

The government has said it would take a “step-by-step” approach when releasing the regulatory framework that goes with the act. It said in a press release: “While there is great potential for increasing innovation, the government recognises that there is a need to safeguard animal welfare in the new regulatory framework. That is why we are taking a step-by-step approach, enabling use of precision breeding technologies with plants first followed by animals later.”

But the RSPCA does not think vertebrate animals should be in the act at all, let alone non-farmed creatures such as pets.

Bowles continued: “By allowing the inclusion of all vertebrate animals within this [legislation], the UK government is opening a Pandora’s box of what could be allowed in the future.”

A Department for Environment, Food and Rural Affairs (Defra) spokesperson said: “We are clear that we will not compromise on animal welfare and we have no plans to introduce secondary legislation to cover precision-bred companion animals.”

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Cat-astrophe? Whiskas pet food criticised over shrinking servings

The mercurial nature of cats means owners spend a lot of time trying to understand “cat speak”. However, the chances that loud miaowing is about food have increased after Whiskas not only slashed the size of its cat food pouches but changed the recipe .

The price of Whiskas has risen sharply in the past year and pet owners have taken to the brand’s Facebook page to vent their outrage over the smaller packets, which are 85g rather than 100g, but cost the same. Others complain their cat does not like the “new taste” and, in extreme cases, that it disagrees with them.

The practice of reducing product sizes but keeping the price the same effectively increases their cost per gram and is known as “shrinkflation”. Smaller Whiskas packs started arriving in stores last month but many owners did not spot the change until their pets started making a racket.

Cat owner David Reid said he was shocked by the price of Whiskas, with the pack size reduction the final straw. “It’s taken a couple of weeks to dawn on me why the pets were still hungry after being fed. I will now move to a different brand … it is now too expensive to feed them Whiskas pouches, as much as I love my cats dearly.”

Other recent casualties of shrinkflation include Magnum ice-creams, which these days are being sold in three- rather than four-packs, and Mini Cheddars, where a new bag size is “mini” too.

In her post on Whiskas’ Facebook page, Mauri Ann Beardshaw said she had been left wondering why her cats were asking for extra food. “Shrinkflation is probably fine for human snacks but it’s just not fair on the cats to reduce fixed meals. If they weren’t fussy I would be changing brand.”

The upshot of the smaller size meant you were getting just under two pouches fewer per box, commented Stephen La Velle. “The texture and taste has also changed significantly enough for both my cats to turn their noses up at it,” he wrote.

A 12-pack of Whiskas costs £4.50, which is almost £1 more than a year ago (when the Whiskas pouches were bigger), according to the average price across Tesco, Sainsbury’s, Asda and Morrisons. The price is up almost 40% over two years as in 2021 these packs cost £3.25, according to the price analysts Assosia.

Britons spend £2.7bn a year on pet food in a market dominated by big companies such as Whiskas owner Mars Petcare, as well as Nestlé and Colgate-Palmolive, and other brands have gone up in price too. An eight-pack of Nestlé’s Purina One now costs £4.50, which is 10% more than a year ago and 20%, or 75p more, over two years.

Dog owners are also having to dig deeper. The price of a 12-pack of Cesar Senior 10+ costs £6.75 today which is £2.08 more than a year ago, an increase of 45%. The same size pack of Pedigree Pouch Favourites is now £5, up £1.18 or 31% on a year ago, according to the Assosia figures. Both brands are owned by Mars Petcare.

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Communi-cat-ive: cats attentive to owner’s voice, research finds

Any cat owner knows that the correct way to get their pet’s attention is to sing “here, kitty kitty”, rather than utter a flat “come here cat”. Now research suggests cats may routinely tune into their owner’s tone of voice to detect when they are talking to them, rather than to other humans.

Most people automatically adopt a higher-pitched, sing-song tone when speaking to animals and human infants. Although previous research has suggested that such “baby-talk” is more likely to capture dogs’ attention, less was known about how cats react to being spoken to in this way.

To investigate, Charlotte de Mouzon and colleagues from Paris Nanterre University observed how 16 cats responded to hearing pre-recorded sentences spoken by their owner or a stranger, by recording changes in their behaviour, such as moving their ears or tails, suddenly stopping what they were doing, or their pupils dilating – any of which could indicate that a sound had caught their attention.

They found that the cats were largely unresponsive to hearing a stranger’s voice calling their name, but when their owner did it, 10 of the 16 cats displayed a constellation of behaviours suggesting increased attentiveness. Cats also showed more signs of interest when they heard their owner speaking sentences in a tone usually used to address their cat – but not when a stranger used this tone, or when their owner spoke the same sentence as if addressing a fellow adult human.

The research, published in Animal Cognition, adds to mounting evidence that one-to-one relationships are important for cats and humans to form strong bonds. “For a long time it has been thought that cats are very independent creatures, only interested in [humans for] eating and shelter, but the fact that they react specifically to their owner, and not just anybody addressing them, supports the idea that they are attached,” said de Mouzon. “It brings further evidence to encourage humans to consider cats as sensitive and communicative individuals.”

Potentially, the relationship works both ways, as cats have previously been observed to purr differently when trying to solicit food from their owners, compared with, for example, when they are being stroked – and humans judged these “solicitation” purrs as more urgent. “The fact that, in return, cats show a greater reaction when their humans specifically address them brings a new dimension to previous considerations of this reciprocal relationship,” de Mouzon said.

Although it’s not entirely surprising that cats are more responsive to their owners’ voices, the fact that they appear to be filtering out insignificant information is interesting, said Roger Tabor, a biologist and author of 100 Ways to Understand Your Cat. “I’m sure a lot of human partners don’t hear what the other partner is saying a lot of the time because they’re focused on something which, for them, is more immediately significant. It’s interesting that cats are also filtering – although it’s not so strange because one thing has meaning, and the other has less meaning.”

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Study shows antibiotic-resistant 'superbugs' are being passed between dogs and cats and their owners

Evidence that multidrug-resistant bacteria are being passed between pet cats and dogs and their owners will be presented at this year's European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Copenhagen, Denmark (15-18 April).

Six pets in Portugal and one in the UK were carrying antibiotic-resistant bacteria similar to those found in their owners, a Portuguese study found.

The finding underlines the importance of including pet-owning households in programs to reduce the spread of antimicrobial resistance.

Antibiotic resistance is reaching dangerously high levels around the world. Drug-resistant infections kill an estimated 700,000 people a year globally and, with the figure projected to rise to 10 million by 2050 if no action is taken, the World Health Organization (WHO) classes antibiotic resistance as one of the greatest public health threats facing humanity.

Dogs, cats and other pets are known to contribute to the spread of antibiotic-resistant pathogens that can cause human disease. Juliana Menezes and colleagues from the Antibiotic Resistance Lab at the Centre of Interdisciplinary Research in Animal Health, Faculty of Veterinary Medicine, University of Lisbon, Portugal wanted to find out if pets being treated with antibiotics for infections are sharing such pathogens with their owners.

The researchers tested fecal samples from dogs and cats and their owners for Enterobacterales (a large family of bacteria which includes E. coli and Klebsiella pneumoniae) resistant to common antibiotics.

They focused on bacteria resistant to third generation cephalosporins (used to treat a broad range of conditions, including meningitis, pneumonia and sepsis, they are classed among the most critically important antibiotics for human medicine by the World Health Organization) and carbapenems (part of the last line of defense when other antibiotics have failed).The prospective longitudinal study involved five cats, 38 dogs and 78 humans from 43 households in Portugal and seven dogs and eight humans from seven households in the UK.

In Portugal, one dog (1/43 pets, 2.3%) was colonized by a strain of multidrug-resistant OXA-181-producing Escherichia coli. OXA-181 is an enzyme that confers resistance to carbapenems.

Three cats and 21 dogs (24/43 pets, 55.8%) and 28 owners (28/78, 35.9%) harbored ESBL/Amp-C producing Enterobacterales. These are resistant to third generation cephalosporins.

In eight households, two houses with cats and six with dogs, both pet and owner were carrying ESBL/AmpC-producing bacteria. In six of these homes, the DNA of the bacteria isolated from the pets (one cat and five dogs) and their owners was similar, meaning these bacteria were probably passed between the animals and humans. It is not known whether they were transferred from pet to human or vice versa.

In the UK, one dog (1/7,14.3%) was colonized by multidrug-resistant E. coli producing NDM-5 and CTX-M-15 beta-lactamases. These E. coli are resistant to third generation cephalosporins, carbapenems and several other families of antibiotics.

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Why pandemic researchers are talking about raccoon dogs

A few weeks ago, raw data was quietly posted to a virology database by researchers affiliated with China's Center for Disease Control and Prevention. The data was precious, gathered at the Huanan Seafood Wholesale Market in Wuhan, China — the early epicenter of the pandemic — in January and February 2020.

It caught the attention of Florence Débarre, a researcher who works at CNRS, the French national research agency.

After quickly downloading the data, an international team of researchers from Europe, North America and Australia conducted an analysis and uncovered key details about how the SARS-CoV-2 pandemic may have began. They published their findings in a report this week.

Katherine J. Wu, science writer at The Atlantic, broke the story. She talks to Short Wave co-host Emily Kwong about this new analysis — the strongest evidence yet on the pandemic's natural origins — what questions remain and why the genetic material of raccoon dogs being found in the mix matters.

As a scientific endeavor, virus hunting takes years. Data transparency is paramount, and officials in China have been resistant to sharing information. The origins of the 2002-2004 SARS outbreak weren't known for a decade. You can listen to Emily's 2020 conversation with Dr. Lin-Fa Wang about this SARS outbreak — referenced in this episode — here.

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Ruff day? Dogs can detect if people are stressed, research finds

Whether it’s a tricky maths problem or an unexpected bill, daily life is full of stressful experiences. Now researchers have found that humans produce a different odour when under pressure – and dogs can sniff it out.

While previous studies have suggested canines might pick up on human emotions, possibly through smell, questions remained over whether they could detect stress and if this could be done through scent.

“This study has definitively proven that people, when they have a stress response, their odour profile changes,” said Clara Wilson, a PhD student at Queen’s University Belfast, and first author of the research.

Wilson added the findings could prove useful when training service dogs, such as those that support people with post-raumatic stress disorder (PTSD).

“They’re often trained to look at someone either crouching down on the floor, or starting to do self-injurious behaviours,” said Wilson..

The latest study, she said, offers another potential cue.

“There is definitely a smell component, and that might be valuable in the training of these dogs in addition to all of the visual stuff,” said Wilson.

Writing in the journal Plos One, Wilson and colleagues report how they first constructed a stand bearing three containers, each topped by a perforated lid.

The researchers report they were able to train four dogs to indicate the container holding a particular breath and sweat sample, even when the line-up included unused gauze, samples from another person, or samples from the same person taken at a different time of day.

With the team confident the dogs understood the approach, they turned to breath and sweat samples collected from 36 people asked to count backwards from 9,000 in units of 17. The participants reported feeling stressed by the task and, for the 27 who carried it out in the laboratory, their blood pressure and heart rate rose.

The dogs were taught to pick out samples taken just after the task from a line-up that included two containers holding unused gauze.

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