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.
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
ISSUE NO. 11 — Navigating the IND Submission Process
There are many challenges associated with early drug discovery and development. With timelines, budget, and market competition being critical factors, advancing your best candidate for regulatory submissions requires a careful assessment of efficacy and toxicity prior to entering human trials. Partnering with the right CRO early on can increase your chances of success and ensure you meet your milestones. In fact, we recommend initiating discussions with a CRO at least six months in advance to ensure that capacity, resource availability, and animal supply are built into your timelines.
In Issue 11 of The Altascientist, we provide a high-level overview of the preclinical component of your drug development program in preparation for regulatory submission, including:
- A submission checklist
- Pivotal toxicology studies
- Small molecules vs. biologics
- Considerations for before you begin (species selection, formulation, test article, bioanalysis, etc.)
- Small and large molecule timelines
- SEND data
- Selecting the right CRO for you
Preparing For Your IND Submission
Your IND application must contain information in the three following areas, as outlined by the U.S. FDA:
Renal Impairment Study Designs Trends, Optimization, Adaptive Approach. A Review.
Use of Thromboelastography (TEG) in Preclinical Studies
Development of an IL-31-Induced Pruritus Model in Cynomolgus Monkeys
Effect of Housing on Stress-Related Parameters in NHPs