The primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials. By Dr. Scott E. Boley and Greg Ruppert
Dr. Thomas C. Wessel, former chief medical officer for Acorda Therapeutics, recently shares his expertise acquired from working with the clinical development and operations, regulatory affairs, biostatistics, data management and drug safety functions.
The healthcare contract research outsourcing market is expected to grow from $25.1 billion in 2011 to $65 billion by 2018. Eight industry experts discuss how to turn your CRO into a strategic partner.
Quality by design, oh my … is it salvation or mere vexation for manufacturing and other suppliers to pharma and biotech companies — or something else entirely?
A large pharmaceutical company with globally distributed preclinical R&D operations including externalized services implemented an advanced assay/ study tracking and optimization system in conjunction with its enterprise electronic lab notebook.
Norwich Clinical Services is a contract research organization that provides Bioanalytical Services, Pharmacovigilance and Clinical Research Programs to the pharmaceutical and biotech industries.
Clinilabs, a contract research organization (CRO), was selected to characterize the pharmacokinetic pro le of XXXX following the administration of four doses of XXXX to healthy Japanese and non-Japanese subjects aged 20 to 45 years by assessing serum concentration data over time.
ICON is one of the world’s largest providers of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialise in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies.
ICON’s experience supporting early phase studies in subjects with renal and hepatic impairment, as well as our close contact with local IRBs, allows our team to expedite study start-up project activities and meet enrollment objectives.
With over 1,500 assays developed in support of over 2,500 studies and with management experience averaging 21 years, ICON Development Solutions has the bioanalytical expertise and track record required to deliver rapid, dependable results.
ICON Development Solutions has industry-recognized expertise in the application and presentation of pharmacokinetic (PK) and pharmacodynamic (PD) principles critical for successful drug approval, with experience over the past 5 years that includes the following.
The clinical pharmacology team at ICON Development Solutions (ICON) has extensive experience in the design, study conduct and interpretation of clinical pharmacology studies across all major therapeutic areas.
For over 20 years, the bioanalytical services group of ICON Development Solutions has provided analytical testing services to meet the research and development challenges of the pharmaceutical and biotechnology industries.
Accelrys, Inc., a leading provider of scientific innovation lifecycle management software, recently announced that the cloud-based Accelrys HEOS information management and collaboration workspace is now live on BT for Life Sciences R&D cloud platform.
NeuroDerm, Ltd. announced today the results of a Phase I safety and pharmacokinetic trial of ND0612, a novel drug formulation for the treatment of Parkinson's disease. ND0612 is a proprietary levodopa/carbidopa liquid formula administered continuously sub-cutaneously through a patch pump. It is designed to provide steady levodopa blood levels for the reduction of motor complications in Parkinson's disease. Results of this study support the continued development of ND0612 for the treatment of Parkinson's disease.
PARIS and TARRYTOWN, N.Y., March 2, 2013 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that pooled data from two Phase 1b trials with dupilumab (REGN668/SAR231893), an investigational, high-affinity, subcutaneously administered, fully-human antibody targeting the alpha subunit of the interleukin 4 receptor (IL-4R alpha), were presented at the 71st Annual Meeting of the American Academy of Dermatology (AAD) in Miami.
Ability Pharmaceuticals, a privately held biopharmaceutical company, announced recently that it was awarded a 36 month 1.2 Million Euros grant under the INNPACTO-2012 Collaborative Program from the Ministry of Economy and Competitiveness of the Government of Spain.
Xceleron, a U.S.-based leader in the application of ultra-sensitive analytical technology to novel clinical designs, has announced a partnership that will offer drug developers early bioavailability data that will lead to optimized solid-state forms and formulations. The partnership with Crystal Pharmatech, a China-based, technology-driven, solid-state research CRO, will enable sponsors to make faster decisions in the early stages of development.
Lorus Therapeutics Inc. (TSX:LOR) ("Lorus"), a biopharmaceutical company specializing in the discovery, research and development of pharmaceutical products and technologies for the management of cancer, today announced that its Phase I clinical study of LOR-253 has successfully escalated to the target dose level based on predicted and observed clinical effects without limitation by toxicity.
Theravance, Inc. (NASDAQ: THRX) announced the initiation of a dose ranging Phase 2b study with TD-4208 as a nebulized aqueous solution in patients with moderate to severe COPD.
Vince & Associates Clinical Research announced it has been awarded a contract with the National Institute on Drug Abuse, part of the National Institutes of Health (NIH), to carry out clinical pharmacology studies to determine the pharmacokinetics and pharmacodynamics of new medication in humans.
ImmusanT announced recently that it has initiated clinical trials in New Zealand, Australia and the U.S. to evaluate Nexvax2, the first therapeutic vaccine for patients with celiac disease.
Laurantis Pharma today announced that it has completed a phase 1 clinical study with its Cis-urocanic acid eye drops. The objective of the study was to investigate the tolerability and safety of the ophthalmic product as well as pharmacokinetics after single and repeated dosing.
Xcovery, a developer of next-generation targeted therapeutics for cancer, today announced that investigators will present data from its Phase 1 clinical study which evaluated X-82, an oral VEGFR tyrosine kinase inhibitor (TKI), in patients with advanced solid tumors.
BASi (Bioanalytical Systems Inc.) has named David Reynolds as its director of discovery services. Reynolds will oversee studies and staff of the company’s new Discovery Center at corporate headquarters in West Lafayette, Ind.
Abbott (NYSE: ABT) and Enanta Pharmaceuticals announced complete data from the study known as "Pilot" – Abbott's initial interferon-free study of its direct-acting antiviral agents for the treatment of hepatitis C (HCV) – showing that 91 percent of genotype 1 infected, treatment-naive patients taking ABT-450/r and ABT-072 combined with ribavirin administered for 12 weeks, achieved sustained viral response at 24 weeks (SVR24).
