Altasciences Welcomes Dr. Beatrice Setnik as Chief Scientific Officer
Laval, Quebec, August 7, 2019 – Altasciences is pleased to welcome Dr. Beatrice Setnik, Ph.D. to the role of Chief Scientific Officer, supporting our internal and external clients with her expertise in all areas relating to early drug development.
Beatrice has a Ph.D. in Pharmacology and Neuroscience from the University of Toronto and since 2005 has been involved in clinical trials in Canada and the U.S.A.; with Ventana Clinical Research in Canada, King Pharmaceuticals and Pfizer in North Carolina, and since 2014 with Syneos Health (formerly INC Research). She has extensive experience in the design, conduct, and reporting of trials in a wide range of therapeutic areas, including expertise in the assessment of abuse and dependence potential of CNS-active drugs. In addition, she is an Adjunct Professor in the Department of Pharmacology and Toxicology at the University of Toronto and regularly participates in FDA meetings and workshops.
Beatrice’s wealth of knowledge and experience will ensure high-level scientific guidance and input on study designs, protocols, and medical and scientific feasibility for new inquiries for current and prospective clients.
“We are extremely fortunate to add a candidate of such caliber and talent to our team. We look forward to Dr. Setnik’s contributions which will reinforce Altasciences’ extensive offerings in early phase preclinical and clinical research,” said Chris Perkin, CEO at Altasciences.
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
A Distinct Approach to Human Abuse Potential Studies
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Altasciences has conducted over 40 HAP studies since 2008 and has been awarded repeated multi-year contracts with the NIH and the FDA. Our studies evaluate the safety of both New Chemical Entities (NCEs) that are CNS-active, chemically or pharmacologically similar to other drugs with known abuse potential, or produce psychoactive effects such as sedation or euphoria. We also evaluate the effectiveness of abuse-deterrent formulations (ADFs) to assess the ability of the new formulation to be tampered with and abused. Well-controlled studies are critical in ensuring effective scheduling decisions for NCEs and labeling claims for ADFs. Our fully integrated offering includes comprehensive clinical studies in healthy normal human volunteers and patient populations. Our specially designed smoking rooms also allow for the controlled evaluation of abuse potential for tobacco and nicotine products. Sponsors choose Altasciences as their preferred partner for HAP and ADF studies because of our unique expertise: |
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If you have questions on your HAP or ADF studies, our experts will be happy to chat with you and guide you in the best strategic approach for your drug development program. |
Driving Simulation Studies to Assess Cognitive Impairment
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The FDA requires that all new drugs be evaluated for adverse effects on the central nervous system during first-in-human (FIH) studies. If adverse effects are observed, such as somnolence, further clinical trials must be conducted with the addition of cognitive test batteries. In collaboration with Cognitive Research Corporation (CRC), Altasciences designs and conducts specialized driving studies. Watch our experts explain in more detail. |
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Integrating Anatomic and Clinical Pathology into reports
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Anatomic and Clinical Pathology datasets are critical when evaluating the safety and efficacy of a drug during the preclinical stage of drug development. Since anatomic and clinical pathology identify and characterize toxicity by different, yet complementary means, integrating both datasets provides a more comprehensive assessment for predicting important toxicities that could occur in humans. Successful integration requires that anatomic and clinical pathologists collaborate closely. At least one of them must also understand the utility and limitations of both disciplines. |
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To ensure seamless integration of pathology data into the overall study report, our teams work closely with one another and follows established workflows and communication systems for every project. Additionally, our team can offer guidance on how to best use an integrated assessment for making critical decisions related to your drug candidate. And, since one of our team members is a dual-certified Anatomic and Clinical Pathologist who brings over 25 years of drug development knowledge to Altasciences, you'll have a trusted partner available to guide you. To learn more about how we can support you, speak to an expert. |
Visit Our Preclinical Facility
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Visit Our Preclinical Facility Evaluating the safety and efficacy of your molecule requires partnering with a trusted Contract Research Organization (CRO). With over 25 years of experience conducting safety assessment studies in both large and small molecules, the Altasciences team has the expertise you need to provide high-quality safety data for your regulatory submissions. Located just north of Seattle, our preclinical facility is convenient to travel to in order to conduct a capabilities overview or quality audit, or for study monitoring. With the recent opening of the Paine Field Airport, getting here has never been easier. The new airport services 9 destination cities and is less than 3 miles from our facility.
Schedule a visit, we would be happy to provide a tour. |
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Preclinical Case Study - Assessing the Safety of Novel Therapeutics for Pediatric Indications
Evaluating the effects of cannabis-based medicinal products
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Altasciences is a world leader in preclinical, clinical, and bioanalytical testing, and has been pioneering cannabis research for over 10 years in support of the FDA's strict guidelines on the use of the plant extract in medicinal products. |
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Sponsors partner with Altasciences in the early phases of their drug development program for our experience and innovative approach to evaluating the effects of cannabis on cognitive abilities. |
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Questions on cannabis studies, regulatory requirements, or how we can help with your early phase drug development program? |
June 2019
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Gut Health Connections to Overall Health - Part 2 of a 2-part series
Gut Health Connections to Overall Health (part 2 of 2)
In part 1 of this series, we discussed how gut bacteria, or the microbiota, affect your health, from metabolism to mood, and contribute to a number of chronic diseases.