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FDA’s Center for Veterinary Medicine approved Elanco US Inc.’s NADA for ELURA™ on Oct. 16th, 2020. Elura™ is an oral solution of capromorelin developed for the management of weight loss in cats with chronic kidney disease (CKD). This is the first drug specifically approved for weight gain and appetite stimulation in cats diagnosed with CKD and KFI was pleased to conduct the fed/fasted PK study in support of Elanco US Inc.’s new drug approval.
KFI is pleased to announce the addition of Kamelia Mirdamadi to our Study Director/Investigator team.
Kamelia Mirdamadi (BA, BSc, MSc, PhD Candidate) studied pharmaceutical sciences at the Faculty of Pharmacy, University of Toronto for both her undergraduate and graduate degrees. Her PhD research focused on the impact of inflammation on the expression and function of human placental drug transporters. In addition, she earned a certificate in PK/PD modeling from the School of Pharmacy, University at Buffalo and received a Mini-MBA degree from the Graduate Management Consulting Association. Prior to her PhD studies, Kamelia was a drug safety counselor at the Division of Pharmacology, SickKids Hospital in Toronto. Kamelia is looking forward to begin applying her strong pharmacology knowledge and project management skills in KFI’s active pre-clinical study work.
KFI is pleased to announce the addition of Dr. Sabina Romanescu and Renu Jeyapala to our Study Director/Investigator team.
Dr. Sabina Romanescu (BScH, DVM, MSc) graduated from the Ontario Veterinary College in 2017. Prior to joining KFI, Dr. Romanescu worked as an associate veterinarian in private practice where she cared for companion animals. In addition to her veterinary training, Dr. Romanescu obtained her MSc at the University of Toronto in the department of Cells and Systems Biology, studying behavioural neuroscience in rodents. Her graduate training followed completion of her BSc (hons) at the University of Toronto with focused study in Psychology and Biology.Dr. Romanescu is excited to join KFI and put her background in research and veterinary medicine to good use.
Renu Jeyapala (BScH, MSc, PhD candidate) brings diverse research experience from her graduate training to her new role as a Study Director. Prior to joining KFI, Renu worked as a clinical project manager and coordinator leading large multi-national funded research projects and managing lifecycles of clinical trials. Renu obtained her MSc at Ryerson University in the department of Molecular Biology with her PhD research in oncology biomarker identification being conducted at the University of Toronto. Renu is eager to bring her project management and coordination skills as well as her strong scientific training to the KFI team.
KFI is excited to announce the acquisition of an additional 5,000 sq feet of space as of September 1, 2020.
Construction on new state-of-the art canine and feline housing, enrichment, and procedure space will begin this fall. “Our focus remains to deliver high quality and compassionate science to help change and improve the lives of companion animals” said Dr. Niemuller. “We have a unique opportunity to expand our facility subject to the regulations of the CCAC and OMAFRA in order to further support the animal health industry while incorporating the latest animal health and welfare standards.”
KFI carries out the bioequivalence work for FDA approved Enrofloxacin Flavored Tablets for dogs and cats.
FDA’s Center for Veterinary Medicine approved Felix Pharmaceuticals Pvt. Ltd.’s ANADA for Enrofloxacin Flavored Tablets on May 21, 2020. The flavored tablets provide veterinarians with a new treatment option for disease associated with bacteria susceptible to enrofloxacin that may cause skin, urinary, respiratory and other infections. The canine and feline pilot and pivotal bioequivalence studies involved in this application were conducted by Kingfisher International Inc.
Kingfisher International is pleased to announce the role of Test Facility Management (formerly held by Dr. Cheryl Niemuller) will now be held by Dr. Karrie Young.
As TFM, Dr. Young will be responsible for providing an optimal environment for GLP/GCP compliance at our facilities and for oversight of both GLP/GCP studies and non-GLP/GCP studies conducted at KFI.
Dr. Young has been with Kingfisher since 2013 as a facility veterinarian, Study Director/Investigator, and most recently, VP of Research. She brings practical experience conducting regulatory compliant GLP target animal safety studies and non-GLP exploratory studies to the TFM position and is looking to further propel KFI’s high standard of quality in the scientific and regulatory realms to the next level.
Dr.’s Cheryl Niemuller and Karrie Young will be representing KFI this year at the VMX veterinary meeting and expo!
VMX is one of the largest veterinary conferences in the world, bringing together more than 17,000 veterinary professionals including veterinarians, veterinary technicians, clinical experts & key opinion leaders. In addition, the VMX Expo Hall features 700+ exhibiting companies bridging industry representatives, pharmaceutical leaders, and early innovators of veterinary products and services. Kingfisher’s time at VMX will be focused on building relationships with new and existing clients, enhancing market visibility, and discovering new emerging trends and technologies in the animal health space. If you’re heading to Orlando for VMX 2020 and would like further information about our services and capabilities as a first-rate veterinary CRO, please contact email@example.com to set up a meeting with our team.
KFI carries out the bioequivalence work for FDA approval of Baytril® Soft Chew, an antibiotic enrofloxacin for dogs and cats.
FDA’s Centre for Veterinary Medicine approved Piedmont Animal Health’s ANADA for Baytril Soft Chew on July 30th, 2018. The soft chew tablets provide veterinarians with a new treatment option targeting broad spectrum bacteria that cause skin, urinary, respiratory and other infections.
Both the canine and feline bioequivalence studies involved in this application were done by Kingfisher International Inc. https://www.ncbiotech.org/news/piedmont-animal-health-nips-another-fda-ok-chewable-pet-medicine
KFI carries out Bioequivalence Study in support of a supplemental new animal drug approval for Alfaxan.
Alfaxan® Multidose produces rapid, controlled, and short-acting induction of anaesthesia in dogs and cats with minimal impact on cardiac and pulmonary function. This new formulation now comes with a preserved system that reduces the risk of microbial contamination.
FDA’s Center for Veterinary Medicine approved Jurox Animal Health’s supplemental new animal drug approval for Alfaxan® Multidose on June 6, 2018. Both the canine and feline bioequivalence studies supporting this application were carried out by Kingfisher International.
KFI conducts Target Animal Safety study for CVM approval of Mirataz™ (mirtazapine) transdermal ointment.
Mirataz™ is the first and only transdermal medication specifically developed, and FDA approved, for the management of feline weight loss. In cats, weight loss is the leading cause of visits to the veterinarian.
Mirataz™ received approval on May 7, 2018. KFI was pleased to partner with Kindred Biosciences, Inc., to conduct this pivotal study.
KFI conducts Target Animal Safety and Efficacy studies for CVM approval of ITRAFUNGOL (itraconazole) oral solution.
Commonly called ringworm, dermatophytosis is a fungal infection of the skin. Itrafungol works by selectively binding to certain fungal proteins, causing irreversible structural degeneration of the fungi. ITRAFUNGOL received approval on Nov 14, 2016. KFI was pleased to partner with Elanco to conduct these pivotal studies.
Kingfisher International Inc. successfully completes FDA GLP Audit!
During the week of March 7, KFI was audited by the FDA for compliance to Good Laboratory Practice. We were subjected to a facility audit as well as a directed audit of a recently submitted Target Animal Safety Study.
The audit lasted 4 ½ days and the Inspector reported NO findings and NO 483 was issued. In her classification letter the Inspector will be recommending a classification of “NAI” or No Actionable Items. We expect to receive an EIR (Establishment Inspection Report) in the coming months.
We are proud of the fact that our systems and processes, as well as the quality of our work, have been validated in our first FDA GLP audit!
KFI conducts Target Animal Safety study for first ever US veterinary approval of a thyroid supplement
Pets’ Impact on Your Patients’ Health: Leveraging Benefits and Mitigating Risk
Over two thirds of Americans live with pets and consider them important members of the family. Pets benefit human health (zooeyia) in 4 ways: as builders of social capital, as agents of harm reduction, as motivators for healthy behavior change, and as potential participants in treatment plans. Conversely, pets can present risks to their owners. They are potential sources of zoonotic disease and injury. Pets can also challenge a family’s prioritization of financial and social resources. To activate the benefits of zooeyia and appropriately calibrate and mitigate zoonotic risk, physicians first need to know about the pets in their patients’ families. Asking about pets is a simple and feasible approach to assess patients’ environmental history and social capital. Asking about pets is a nonthreatening way to build rapport and demonstrates an interest in the whole family, which can improve the physician–patient therapeutic alliance. Physicians can use an interprofessional, collaborative approach with veterinarians to address zoonotic health risks and leverage zooeyia.
This paper was co-authored by Marcia Darling, Chair of the KFI Animal Care Committee. For the full text of the paper visit: http://www.jabfm.org/content/28/4/526.full.pdf+html
Kingfisher International Inc. joins the National Association for Biomedical Research
KFI is pleased to announce that we have joined the National Association for Biomedical Research (NABR).
Founded in 1979, NABR provides the unified voice for the scientific community on legislative and regulatory matters affecting laboratory animal research. NABR works to safeguard the future of biomedical research on behalf of its more than 350 public and private universities, medical and veterinary schools, teaching hospitals, voluntary health agencies, professional societies, pharmaceutical and biotech industries, and other animal research-related firms that are:
(1) involved directly in the use of animals in biomedical research and are
(2) committed to the responsible and humane use of these animals.
Kingfisher International Inc. Opens New Cat Research Facility - Jan 2015
We are pleased to announce the opening of our new cat research centre!
After extensive design, construction and commissioning throughout 2014, we are confident that “KFI-West” represents a state-of-the-art facility for our feline friends. Located only a block away from our existing lab, our cats will enjoy 100% fresh air flow in a humidity-controlled environment with full barrier protection between rooms. We will have space for approximately 150 cats/kittens. This space will continue to allow us to build on our expertise in feline safety, bioequivalence, and pre-clinical modelling. Like our main facility, “KFI-West” is accredited under the Animals for Research Act and is fully GLP compliant.
For more information about our capabilities in companion animal contract research, contact us here.
KFI conducts pivotal safety study for novel canine chemotherapeutic
Kingfisher International Inc. (KFI) is pleased to announce that Paccal Vet (paclitaxel) has recently been granted conditional approval by FDA. KFI assisted the sponsor (Oasmia Pharmaceutical AB) by conducting the target animal safety (TAS) study in support of this submission.
Look to KFI for our up-to-date experience with regulatory quality studies in animal health!
KFI adds new veterinarian- Feb 2014
Kingfisher International Inc. (KFI) is pleased to announce that Dr. Lisa Sigismondo is joining our staff as a clinical veterinarian! Lisa replaces Dr. Karrie Young who is moving into expanded responsibilities as a Study Director. Dr. Sigismondo is a graduate of the Ontario Veterinary College, class of 2013. She has worked as a research assistant at the University of Toronto and at the OVC, and throughout her education has won several awards for clinical and research proficiency. She has a keen interest in comparative medicine and in her spare time enjoys equestrian sports and running.
KFI starts construction of new feline facility - Jan 2014
Kingfisher International Inc. (KFI) has acquired an additional 5000 square feet of office, laboratory, and vivarium space. Over the next six months, this will be converted into a state-of-the-art feline research centre. With more companies focusing on cat drugs in their developmental pipeline, KFI is ensuring that we can meet the specific scientific study and housing requirements for this species.
KFI conducts pivotal studies for recently approved veterinary drugs - Nov 2013
FOI Roundup November 2013: KFI conducts pivotal studies for recently approved veterinary drugs.
Kingfisher International Inc. conducted pivotal studies in support of the following recently approved veterinary drugs:
- Target Animal Safety Study for OROCAM®(meloxicam) Transmucosal Oral Spray (http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/UCM338139.pdf)
- Bioequivalence study for cefpodoxime proxetil tablets (http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/UCM338192.pdf).
In addition, KFI has been informed that our studies have passed technical review with CVM and EMEA for several other drugs. There approvals are pending and this information is not yet in the public domain.
Look to KFI for our up-to-date experience with regulatory quality studies!
KFI hires new Study Investigator – Oct 2013
We are pleased to announce that Lilly Tsrilnikov PhD, has joined us as a Study Investigator. Her graduate training was in cancer research. She brings a wealth of knowledge to KFI including over 10 years experience in the biotech and pharmaceutical industry with skills in study management, pharmacokinetics, and multi-disciplinary team leadership. We are excited that Lilly is joining us during this active time for our business and look forward to introducing her to our sponsors and clients!
New Surgical Suite - July 2013
Kingfisher International Inc. is pleased to announce that construction of a fully equipped veterinary surgical suite has recently begun!
The KFI team has joined forces with Dr. Mark Hurtig, DVM, MVSc, Dip. ACVS to design the suite which will be equipped with online oxygen delivery, scavenging, electrocautery, and advanced anaesthetic monitoring equipment (SPO2, ETCO2, IBP, NIBP, and ECG). The expansion of our surgical capabilities will allow KFI to develop knowledge and clinical research expertise using complex and innovative surgical models in order to better meet the needs of our Sponsors. Construction and facility upgrades should be completed by the end of August 2013.
Venturing into Veterinary Field Trials - April 2013
Kingfisher International Inc. (KFI) is expanding their in-house capabilities to include designing, conducting and monitoring clinical field trials in support of veterinary pharmaceuticals. There is often a logical extension for pharmaceutical companies to obtain efficacy information prior to regulatory submissions and acquire post-market approval scientific data in support of their products. This expansion is a great fit with some of the core capabilities that KFI already has: GCP regulatory knowledge, precise document management, strong quality assurance and an in-depth knowledge of the veterinary pharmaceutical market.
“Obtaining a collection of qualified, research-minded veterinarians and technicians is vital to completing a field trial with quality results in a timely manner. Our goal is to create long-standing relationships with Ontario veterinarians who are willing to provide their knowledge and time.” - Jonathan Hare, VP Research.
New clinical veterinarian hired – December 2012
We are pleased to announce that Karrie M. Young, BSc(hons), DVM, MSc has joined KFI as a clinical veterinarian. “Dr. K” graduated with distinction from the Ontario Veterinary College and has extensive research experience in pathobiology. Karrie will be overseeing colony health and will be prime veterinarian on all non-GLP and GLP studies once she has finished her orientation.
FDA GLP Audit – Quality Confirmed! (June 2012)
Kingfisher International Inc. (KFI) underwent an FDA GLP audit administered by Standards Council of Canada (SCC) auditors the week of April 16, 2012. The SCC was acting on behalf of the FDA’s Center for Veterinary Medicine to perform directed audits on five GLP studies dating back as far as 2006. There were no 483 findings or any other findings that impacted the data integrity of any of the studies. The SCC did document several required and minor actions and these are being completed in partnership with the Sponsors in question.
In the words of Amy Davidson, VP, Operations: “This was our first big regulatory audit and the lack of significant findings underscores the quality of our work and the professionalism of our people.”
Pharmacokinetics Analysis and Modelling (April 2012)
Kingfisher International Inc. (KFI) has purchased Phoenix® WinNonlin® 6.2.1. This software program will allow Dr. Albert Licollari (Study Director – Toxicology and Pharmacokinetics) to provide pharmacokinetic analysis and modelling of data obtained from early stage drug development, bioavailability, and bioequivalence studies. This capability expands KFI’s offering in these areas, ones in which we are seeing significant activity as sponsors look to KFI for assistance in first-in-species ADME studies and complex bioequivalence designs.