This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Altasciences’ Commitment to Supporting Pharma and Biotech With Comprehensive Bioanalytical Services pmjackson Wed, 11/13/2024 - 14:50 Greater Montréal, Québec, 11/13, 2024 — Altasciences , a trusted drug development research partner for over 30 years, continues its commitment to providing world-class bioanalytical services.
Patient advocacy groups, such as Friends of Cancer Research, are also encouraging regulators to ensure drug developers in the oncology space invest in the optimisation of dosing regimens to help better balance efficacy and safety and thereby deliver more effective patient outcomes. Translational and ClinicalPharmacology [Internet].
The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. However, making informed labelling decisions during preclinical stages is complex and requires expertise in a variety of areas, including clinicalpharmacology, toxicology, regulatory affairs and medical writing.
James joined Altasciences, having previously worked as Vice President of Research at Akron Children’s Hospital, and most recently as Vice President of Research Operations for Circuit Clinical.
Our integrated CRO/CDMO services combine bioanalytical services with preclinical and clinical study solutions, manufacturing services, and all complementary research support services, for maximum efficiency.” This is Altasciences’ third purpose-built laboratory.
In this on-demand webinar, Ingrid Holmes , Vice President of Global Clinical Operations at Altasciences, and Dr. Gary G. President of Cognitive Research Corporation , examine simple and cognitive domains in clinical and pharmacology studies, including analysis of driving impairment.
Altasciences is committed to using cutting-edge technology to support its ocular research. From comprehensive ocular assessments to complex surgical interventions, Altasciences is equipped to handle the full spectrum of ophthalmic research needs. What advanced instruments does Altasciences utilize to conduct these ocular studies?
Altasciences Receives 2024 CRO Leadership Award for Capabilities aasimakopoulos Wed, 05/29/2024 - 17:54 Laval, Québec, May 29, 2024 – Altasciences announced today that it has been recognized for excellence in contract research with a 2024 CRO Leadership Award for Capabilities.
You can expect a robust program suited to your unique needs to support your IND submission and minimize potential risks, so you can transition smoothly from preclinical to clinicalpharmacology. png Tags Preclinical Research Weight 10
Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses pmjackson Wed, 09/20/2023 - 13:48 Laval, Québec, September 21, 2023 - Altasciences is pleased to have been chosen by Virpax Pharmaceuticals, Inc.
Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinicalpharmacology units. Clinical Supply Manufacturing Integration with our manufacturing team, ensuring flexibility and adaptability to meet the evolving needs of your studies throughout your drug development program or study.
HK) (“Pharmaron”), a fully integrated contract research and manufacturing organization offering laboratory, CMC and clinical development services for the life science industry, announced today that it has acquired 100% of the equity of Absorption Systems for up to US$137.5 BEIJING–( BUSINESS WIRE )– Pharmaron Beijing Co.,
Discover the considerations and assessments necessary for performing preclinical research for ophthalmic therapies in this new eBook, that covers everything you need to know, from species selection and routes of administration, to preparing for first-in-human trials. Read or listen now. Listen here.
Dr. Löbenberg holds Health Canada licences for research and analytical testing of a wide range of psychedelic compounds under the Controlled Drugs and Substance Act and research and analytical testing licences for cannabis under the Cannabis Act.
DMT (N,N-dimethyltryptamine).
Prof. About XPhyto Therapeutics Corp.
4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder.
The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021.
Patient enrollment of EXCELLENCE pivotal trial reaches 98%. SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec.
Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.
We wish the team at Ischemix continued success on the next Phase of clinicalresearch.” That is incredibly rewarding,” stated Dr. Morelli, MD, Chief Medical Officer and Principal Investigator for Altasciences. “We
A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year.
This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. Enriching Possibilities for Rare Disease Patients Drug discovery and research starts with in vivo and in vitro models to select drug candidates.
BY AMANDA CONTI | OCT 4, 2023 10:40 PM CDT A quick note: How AgencyIQ gathers data on drug approvals AgencyIQ reviews drug approvals from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). Featuring previous research by Kedest Tadesse, Kari Oakes and Alec Gaffney.
I am a pharmacist by training and continued with a PhD in ClinicalPharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as ClinicalResearch Manager at AstraHässle, a mid-size Swedish pharma company.
WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.
Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation. The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda.
Title Type Comments Close Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the Federal Food, Drug, and Cosmetic Act Guidance June 5 Patient Preference Information—Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in (..)
formed a Partnership Advisory Committee comprised of former multi-national pharmaceutical veterans and industry leaders. Prior to joining Inozyme, Sabbagh served as the head of rare renal and musculoskeletal diseases research at Sanofi. Processa Pharmaceuticals – Michael Floyd was named COO of Processa. Katherine S.
Our intention is to help bring these findings to the attention of the broader cancer research community. All articles need to be critically assessed and viewed in their broader research context. Please get in touch if you’re interested in discussing research based on the findings presented below ( info@anticancerfund.org ).
Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)
October 2023 Amendments to the Final Rule Regarding the List of Bulk Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act (Proposed Rule) FDA has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound (..)
But there are some potential hints, such as an upcoming Friends of Cancer Research event at which several of FDA’s top officials will be speaking on the “implementation of diversity plans.” The documents describe all the guidance documents that are under development and that may be published in a given year.
Vice President, Late Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. “In In our commitment to advance the science and treatment of prostate cancer, these findings will help inform our research efforts in developing novel approaches and combinatory regimens to improve outcomes for these patients.”.
EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 5 Lawsuit (Vanda vs. FDA) FDA required to have resolved dispute with Vanda Pharmaceuticals or hold a hearing. The following PDUFA dates were obtained from publicly available sources.
12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.
"This recognition reflects our CDMO teams unwavering dedication and expertise of our CDMO team, as well as our unrelenting commitment to advancing drug development in collaboration with leading pharmaceutical and biotech innovators, says Marie-Hlne Raigneau, Co-Chief Operating Officer at Altasciences.
These advances are reshaping how pharmaceutical and biotechnology companies approach clinical trial design, with a focus on patient-centric dosing strategies. This article explores how innovations in precision medicine are reshaping clinical trials, followed by a discussion on Project Optimus and its impact on dose optimisation.
Advanced techniques like liquid chromatography tandem mass spectrometry (LC-MS/MS) and Meso Scale Discovery (MSD) provide the kind of comprehensive and reliable data increasingly favoured by regulators, yet many researchers continue to rely exclusively on enzyme-linked immunosorbent assay (ELISA). Cancer research. per sample.
We organize all of the trending information in your field so you don't have to. Join 15,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content