Tackling Challenges in First-In-Human Trials
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The purpose of First-In-Human (FIH) trials is to study the human pharmacology, pharmacokinetics (PK) and pharmacodynamics (PD), tolerability, and safety of an investigational medicinal product (IMP) having already gone through preclinical studies, and to evaluate how the effects translate from animals to humans. They allow sponsors to determine potential risks associated to the drug at each step of its development and determine the safe dose range in the course of its clinical progression. In this issue of The Altascientist, we discuss:
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Altasciences Welcomes Two New Veterinarians to their Preclinical Team
Laval, Quebec, September 17, 2019 – Altasciences is pleased to be adding Drs. Andrew Gorman and Sylvia West to their team of clinical veterinarians. Both will play key roles in providing clinical care, research, and surgical support, as well as insight into protocol development.
Dr. Gorman has a DVM from VA-MD College of Veterinary Medicine, Blacksburg, VA, and has experience in animal health in veterinary hospitals, emergency, and research settings. In addition to his previous veterinary role at Columbia University, Dr. Gorman was an active participant in the IACUC and contributed to the commissioning of Columbia’s largest vivarium. Dr. Gorman became a diplomate of the American College of Laboratory Animal Medicine in 2018.
Dr. West obtained her DVM from Tuskegee University School of Veterinary Medicine in 2015, and brings experience in small animal medicine and laboratory animal care. She recently completed her training in laboratory animal medicine, in which she was the primary reviewer for IACUC protocols and worked extensively with all laboratory animal species.
“Altasciences’ preclinical services team is driven to offering best-in-class veterinary care, and we are excited to be adding Dr. Gorman and Dr. West to our team. I believe the skills, passion, and energy that they bring to our animal care programs will go a long way to achieving our goals, and deepens Altasciences’ commitment to animal welfare. I personally look forward to working with them,” said Mike Broadhurst, General Manager at Altasciences’ Seattle site.
About Altasciences
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
CONTACT:
Julie-Ann Cabana
Altasciences
913 304-4505
jcabana@altasciences.com
Assessing an animal welfare program
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When choosing an outsourcing partner for your nonclinical studies, it is imperative to evaluate the strength of a contract research organization's animal welfare program. Since animal welfare is the cornerstone for achieving high quality scientific results, understanding the components of a successful program can guide you in your assessment. |
Top 10 Drug Discovery & Preclinical CROs to watch as we inch closer to Q4 and 2020, Brandon Miller
Altasciences – Private Equity-backed and recent rebranding with digital marketing and media that plays like you’re watching a flick in the theatre, Altasciences is making noise with the vertical integration of its end-to-end capabilities since the acquisition of SNBL USA’s preclinical site in Everett, WA. The company’s leadership comes from a vast background of preclinical, beginning with CTBR – now Charles River. We’ve seen this approach before, but for some reason (I think much of it is company culture and leadership oriented / familiarity with preclinical AND clinical) Altasciences looks to have the winning formula. It will also be interesting to watch their strategic partnership with WuXi and how it impacts pulling preclinical programs into the clinic.