Azzur Group Welcomes FDA Veteran, Kimberley Buytaert-Hoefen, PhD, as Director of Preclinical Consulting
Dr. Buytaert-Hoefen will oversee direction and coordination of preclinical client consulting, specializing in the expansion and implementation of preclinical drug discovery and development plans from concept through preclinical studies including interactions with regulatory agencies
HATBORO, Pa., Jan. 28, 2021 /PRNewswire/ -- Azzur Group today announces the appointment of Kimberley Buytaert-Hoefen, PhD, as Director of Preclinical Consulting. Kimberly brings to Azzur more than 20 years of experience in research and development, commercial pharmaceutical, and the medical device industry. In her new role, she is responsible for the planning and execution of entire preclinical development programs, offering consulting for regulatory interactions, as well as supporting the overall growth of Azzur throughout the United States.
Throughout her career, Kimberley has become a subject matter expert in performing gene and cellular therapy and medical device inspections with an emphasis on sterile processing. Most recently, Kimberley served as Principal Consultant, Strategic Compliance, at a global clinical research organization (CRO) where she specialized in solid oral dosage, biologics, gene and cellular therapy, medical device, and combination products. Kimberley also spent seven years as a field investigator with the U.S. Food & Drug Administration (FDA) where she performed pre-approval, post-approval, bi-annual and for-cause GxP inspections for medical devices and pharmaceuticals.
A highly qualified expert in regulatory affairs, she will be consulting, authoring, and reviewing non-clinical regulatory documentation at Azzur for Investigator Brochures (IBs), Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Applications (BLAs). Additionally, she will be advising on studies relating to Pharmacology, Toxicology Pharmacokinetics, and ADME.
"Throughout my career, I've developed a true passion for the gene and cell therapy space. I am excited to join Azzur Group and work hand-in-hand with innovators throughout the country to treat and potentially cure unmet medical needs, as well as consult on expedited programs to facilitate the progress from discovery to commercialization of these therapies," said Kimberley.
Kimberley obtained a bachelor of science degree in psychology from the State University of New York at Binghamton and went on to complete her masters of science and doctorate degrees in neuroscience at the University of Colorado at Boulder. Additionally, she completed two post-doctoral fellowships at the University of Colorado Health Sciences Center where she specialized in embryonic and adult stem cell research.
"I am excited to have Kimberley join our Quality, Regulatory, and Compliance group. She will be supporting all regional offices and consultants with high level compliance strategies, as well as hands-on execution of solutions to meet client's needs. Clients will benefit from Kimberley's FDA field experience and passion for gene and cell therapies," said Cinta Burgos, Vice President of Consulting Services, Azzur Group.
About Azzur Group
A nationwide network of experts delivering professional services across the life sciences industry, Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 500 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest-growing private companies in America, Azzur Group provides clients with the consulting, engineering, validation, IT, technical, training, and laboratory services and cGMP manufacturing solutions they need to remain innovative and competitive. Learn more at Azzur.com. Follow us on LinkedIn, Twitter, and Facebook.
SOURCE Azzur Group, LLC
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