Harnessing Bioanalytical Data in Early Phase Clinical Pharmacology
A discussion on how bioanalytical data is used in early phase clinical trials to advance drug development.
Contract Pharma: Altasciences Appoints Senior Director Compliance and RA
C4X Discovery: Altasciences appointed by Indivior to conduct Phase I clinical trial with C4XD’s Orexin-1 for treatment of Opioid Use Disorder
9 December 2019 – C4X Discovery Holdings plc (AIM: C4XD), a pioneering Drug Discovery company, is pleased to note the announcement that Altasciences has been selected by Indivior PLC to conduct "A Phase I, Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of INDV-2000 (C4X3256) Under Fasting and Fed Conditions in Healthy Volunteers”.
Laval, Quebec, December 9, 2019 – Altasciences has been selected by Indivior PLC to conduct "A Phase I, Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of INDV-2000 (C4X_3256) Under Fasting and Fed Conditions in Healthy Volunteers", pursuant to the National Institutes of Health (NIH) Funding Opportunity Announcement RFA-DA-19-002, dedicated to the development of medications to prevent and treat opioid use disorder and overdose. The grant was made to Indivior by the NIH in fiscal year 2019, to apply scientific solutions to reverse the national opioid crisis. In March 2018, Indivior entered into a license agreement with C4X Discovery Holdings PLC (C4X) whereby Indivior obtained exclusive global rights to develop and commercialize INDV-2000 (C4X_3256).
Paul Sidney Joins Altasciences as Senior Director, Compliance and Regulatory Affairs
Laval, Quebec, January 9, 2020 – Altasciences announced the addition of Paul Sidney to their Compliance and Regulatory Affairs team as Senior Director. Paul’s extensive experience working at Charles River Laboratories combined with his direct involvement in various key regulatory initiatives, have made him a highly regarded leader among pharma, CRO, and regulatory representatives in the drug development field.
At Altasciences, Paul will lead the development of the company’s regulatory offering, from preclinical to clinical research, for all services.
Paul graduated from McGill University and maintained an active role in the industry as a member of the SQA (BASS, GLPSS, and CSS) and as the founding President of the Canadian regional chapter of the SQA (CCSQA). As a highly esteemed key opinion leader, he routinely presents on a broad range of regulatory topics at conferences worldwide and at academic and government institutions.
“Several leaders have initiated their career under Paul’s direction, which attests to his capacity to successfully transfer knowledge and cultivate talent. Altasciences is thrilled and honored to welcome Paul to our team, as we continue to develop and expand our regulatory offering and expertise,” said David Grégoire, Vice President, Compliance and Regulatory Affairs, 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
514 601-9763
jcabana@altasciences.com
Up Close and Personal with David Grégoire
David Grégoire joined Altasciences as Director of Quality Assurance in 2012.