We have retained the services of Algorithme Pharma (now Altasciences) since 2011 to perform a series of studies ranging from Phase I to Phase III. Consequently, the study populations requested varied from healthy volunteers to populations with a specific disorder such as healthy volunteers suffering from common cold and persons with type 1 or type 2 diabetes (to address our needs). Although Algorithme Pharma (now Altasciences) has traditionally focused on early stage clinical research, they have clearly shown their ability to recruit for and conduct Phase II and Phase III studies.
Algorithme Pharma (now Altasciences) has been a great partner for us, in the context of key clinical trials for our lead drug candidates. The professionalism and skills of Algorithme Pharma’s staff were crucial to the success of our Gastrointestinal Phase Ib efficacy program, which included food effect and PK evaluations. Their services were delivered as planned, with time and cost efficiencies. Their expertise in bioanalytical development and method validation has proven to be an added value for our small company.
I am writing to recommend the services of Algorithme Pharma (now Altasciences). I have been using Algorithme Pharma (now Altasciences) services to conduct a Proof of Concept Phase I/IIa study in the therapeutic area of the Hepatic C Virus Infection starting in September 2013 and ending in January 2015.
They did an excellent job for this study: they were the 2nd better recruiter of HCV-infected subjects among 6 sites worldwide, always very transparent in their communication and with a focus on the quality.
As proofs of their performance:
Algorithme Pharma (now Altasciences) has been a great partner of ours over the years, in performing Phase I studies in healthy volunteers. Recently, we entrusted them with a pharmacokinetic study involving hepatic-impaired subjects (Child Pugh A to C) and healthy volunteers. This study was completed within 10 months, to our satisfaction.
For this latter study, Algorithme Pharma (now Altasciences) has distinguished itself by:
I am writing to recommend the services of Algorithme Pharma (now Altasciences), with whom Isis Pharmaceuticals Inc. (now Ionis) have partnered to conduct ultrafiltration protein binding, multiplexing through an innovative platform, and quantitative Hybridization ELISA assays for concentration determination. Several matrices in various species were assayed, including Plasma, Brain, Spinal Cord, Liver, Kidney and Ocular tissues.
Throughout the entirety of the programs, Algorithme Pharma (now Altasciences) has distinguished itself by:
The right CRO for your preclinical and clinical biosimilar studies
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Companies developing biosimilars are collaborating with us because of our firsthand preclinical and clinical experience, distinctive recruitment strategies and speed in conducting biosimilar studies that require a customized approach based on the therapeutic indication and study-specific goals. |
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We have the scientific, toxicological, medical, and bioanalytical know-how to design studies that meet your objectives and timelines, manage any associated risks, and develop the methods required to analyze your product and its potential immunogenicity. |
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How we help move your biosimilar programs forward: |
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View our issue of The Altascientist on the topic and contact one of our experts to learn how we can help with your biosimilar programs. |
Altasciences Leads Research on Chemical Nerve Agent Therapeutic from Preclinical to Clinical Phase I
Laval, Quebec, May 22, 2019 – Altasciences announced today that they have been selected by Leidos Health to guide and support the development of the CCR5 antagonist peptide RAP-103, licensed property of Creative Bio-Peptides Inc., as a chemical nerve agent therapeutic on behalf of the Medical CBRN Defense Consortium and funded by the Defense Threat Reduction Agency (DTRA).
Altasciences will conduct the required Safety Testing, all IND-enabling studies (non-GLP and GLP), the necessary Phase I clinical trials, and associated bioanalytical analysis.
“Altasciences’ preclinical and clinical teams are collaborating with Leidos Health on this important program. Together, we have developed a plan to move RAP-103 from preclinical, safely through early clinical trials. As a mid-size CRO specializing in a flexible, innovative approach to providing comprehensive early stage drug development, we have the experience and team in place to complete this program successfully, on time and within budget,” explained Steve Mason, Vice President, Site Operations, at Altasciences.
For over 25 years, Altasciences has been helping sponsors move from one key milestone to the next with the goal of helping them make informed, faster and more complete early phase drug development decisions. Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, and data management — all of which can be tailored to specific sponsor requirements.
“We have selected Altasciences for their ability to take us seamlessly from one key milestone to the next. The fact that we have one Altasciences program manager at our disposal through all phases is a true benefit and ensures seamless handoffs and communication along the way,” stated Dr. Vinayaka Kotraiah, Preclinical Discovery Lead/Program Manager at Leidos Health.
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
Outsourcing-Pharma: WuXi Apptec Taps Altasciences to Support IND Platform
WuXi AppTec taps Altasciences to support IND platform
By Maggie Lynch
Altasciences will work with WuXi AppTec to support its investigational new drug platform designed to manage and accelerate IND applications.
Altasciences and WuXi AppTec Enter Into Collaboration for WIND Projects
Laval, Quebec, May 16, 2019 – Altasciences, a mid-size CRO specializing in a flexible, innovative approach to providing comprehensive early stage drug development from lead candidate selection to proof of concept, announced today that they have entered into an agreement to support WuXi AppTec’s Investigational New Drug (WIND) platform. WIND combines world-class CRO services with cross-functional program management and global regulatory expertise to support IND applications. WuXi Clinical, the clinical CRO arm of WuXi AppTec, will be responsible for managing the partnership and ensuring a seamless experience.
Altasciences will provide its full-service solutions, including clinical pharmacology, first-in-human and proof-of-concept trials, program management, medical writing, biostatistics, and data management to support and conduct comprehensive early phase clinical services for WuXi AppTec’s multiple ongoing WIND programs.
“WuXi AppTec and Altasciences share the same vision, which is to provide a seamless, integrated transition from one key milestone to the next during the early phases of drug development. I am confident that together, we will continue on our path to help sponsors research and develop potentially life-saving therapeutics, faster,” stated Chris Perkin, CEO, Altasciences.
With integrated capabilities in toxicology, DMPK, pharmacology, CMC, and analytical services, WuXi AppTec supports the full scope of drug development programs, from IND-enabling studies to regulatory support for both pre-IND and post-IND stages, as well as document preparation and submission.
“Altasciences has strong expertise and deep experience in early phase clinical research. The partnership is an excellent complement for WuXi to help our global collaborators to expedite the R&D process from pre-IND to clinical stages and bring better therapies to patients far faster,” said Edward Hu, Co-CEO, WuXi AppTec.
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.
WuXi AppTec is a leading pharmaceutical and medical device open-access capability and technology platform company with global operations. As an innovation-driven and customer-focused company, WuXi AppTec provides a broad and integrated portfolio of services to help our customers and partners worldwide shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions. With its industry-leading capabilities such as small molecule R&D and manufacturing, cell and other therapy R&D and manufacturing, and medical device testing, the WuXi platform is enabling more than 3,500 innovative collaborators from more than 30 countries to bring innovative healthcare products to patients, and to fulfill WuXi's dream that "every drug can be made and every disease can be treated."
CONTACT:
Julie-Ann Cabana
Altasciences
913 304-4505
jcabana@altasciences.com