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
2019 Year in Review
|
|
2019 was an exceptionally exciting year at Altasciences, and we appreciate you being on the journey with us. We launched our new brand concept to rave reviews, made important additions to our leadership teams, to deliver an integrated discovery to proof of concept service offering. We are confident that 2020 will bring even more exciting times – moving in unison towards a common goal of bringing new drugs to market, faster. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Up Close and Personal with David Grégoire
David Grégoire joined Altasciences as Director of Quality Assurance in 2012.
Quiz – All About Investigational New Drug Submission
Test Your Knowledge —Investigational New Drugs
If you work in, or around, the early phase drug development landscape, you are likely aware of the requirements for an investigational new drug (IND) package.
Altasciences to Conduct Clinical Trial for Opioid Use Disorder under NIH Funding
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).
The first-in-human, single-ascending-dose study will be conducted in two parts — Part I: double-blind, placebo-controlled, randomized, single-ascending-dose study in fasted condition. Part II: open-label, cross-over randomized, food interaction, single-dose study, which will be given once under fasting conditions and once at completion of a standard FDA high-fat breakfast.
Altasciences offers extensive knowledge and expertise in the conduct of opioid use disorder trials and has numerous years of conducting NIH- and FDA-funded clinical studies, prior to undertaking this most recent research.
“We look forward to partnering with Indivior and are proud to continue our long-standing contributions to advancements in the treatment of opioid use disorder. Since our first NIH grant award in 2012, we have consistently contributed to the body of knowledge in the field, and have helped accelerate development of these vital options for treating opioid addiction,” says Chris Perkin, Chief Executive Officer of 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
December 2019
 |
||||||||||||||
| »ACCESS FULL NEWSLETTER | ||||||||||||||
|
Bioanalytical Solutions Throughout the Drug Development Continuum
|
|
Leverage Altasciences' preclinical and clinical bioanalytical expertise to accelerate your drug development programs. We have been delivering premium bioanalytical services to global pharma and biotech companies for over 25 years. We take pride in the diversity, expertise, and bandwidth of our scientific team, many of whom are industry-recognized bioanalytical subject matter experts. From de novo development to rugged and robust validated assays, you can rely on our experience to help you reach your milestones. With Altasciences, you can rest easy knowing that your studies are conducted in our state-of-the art laboratories, either in the U.S. or Canada, whether for small or large molecule programs, using ligand binding or mass spectrometry platforms. In addition, each bioanalytical project is assigned a scientist with whom you can communicate directly, for efficient and effective project progression. |
|
|