505(b)(2): It’s A Different Animal
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News headlines
- US House Bill Aims to Expand Release of Clinical Trials Data
- Harlan Doubles Number of Isolators at Two US Research Facilities
- Covance Pushes Further into Biologics Development, Lead Optimization
- UK ‘animal research’ labelling plan may have unintended consequences says Cyprotex
- Derma Acquisitions and Need for Development Drive MedPharm Investment
- Covance Sees Healthy Growth in First Quarter of 2013
- Quintiles Seeks to Raise as Much as $790M in IPO Next Month
Products
Live Supplier Webinar
Antibody Drug Conjugate Development and Manufacture - Piramal
03-May-2013 -
With the recent approvals of brentuximab vedotin (Adcetris) and ado-trastuzumab emtansine (Kadcyla,T-DM1), antibody–drug conjugates (ADCs)are a rapidly growing area in oncology with great potential. Development and manufacture of ADCs can be a challenge with the requirement to handle both biologics...
Technical / white paper
ePathology Improves Data Accuracy & Study Productivity! – Amicus Study Confirms - Aperio
20-Mar-2013 -
With current glass slide methods, sharing and scoring slides within a study from one pathologist to another at a different organization or site, meant that slides had to be packed, shipped and tracked. Often the reading pathologist was required to...
Data sheet
Quantify biodistribution, enhance in vivo decisions - Molecular Imaging Inc.
04-Feb-2013 -
Non-invasive preclinical SPECT imaging of test agent biodistribution, kinetics and targeting in discovery and safety applications has key advantages over pre-existing methods including:
full 3-dimensionality with tissue and sub-tissue localization
fine kinetics, targeting, binding and clearance pathways can be examined
clinical translatability
isotope multiplexing...
Technical / white paper
Biomarkers of Toxicity Panel in Clinical Trials - ACM Global Central Lab
18-Sep-2012 -
Most drug candidates are discontinued because of induced organ toxicity and half of them owe this to liver toxicity. This issue explains why drug developers need to be aware of the latest options for liver and kidney laboratory safety testing,...
Technical / white paper
Utility of FDG PET in Drug Development - Molecular Imaging Inc.
20-Aug-2012 -
Imaging metabolism with FDG PET offers reliable and clinically translatable biomarkers for evaluation of candidate compounds.
Technical / white paper
Novel Biomarkers for Diabetic Nephropathy - Pacific Biomarkers, Inc.
18-May-2011 -
Type 2 diabetes is the major cause of end-stage renal disease. In the present decade, 30% of the predicted $1.1 trillion medical costs of dialysis world-wide will result from diabetic nephropathy. There is an unmet need for highly sensitive biomarkers...
Technical / white paper
Guiding Development of Novel Drugs - PBI
16-Mar-2011 -
Increased use of therapeutic proteins such as monoclonal antibodies, engineered proteins and other biological products has resulted in a growing number of biotherapeutic drugs. New biotherapeutic drugs bring tremendous advancement in the treatment of a number of diseases. To ensure...
On-Demand Supplier Webinar
Biomarkers of Metabolic Syndrome in Clinical Trials - PBI
11-Feb-2011 -
PBI scientists will discuss latest developments in biomarkers for metabolic syndrome. Topics: 1) Pre-analytical and analytical concerns regarding gut and incretin hormones, 2) Dysfunctional HDL biomarkers in metabolic syndrome, and 3) Kidney Injury Markers and their usefulness in diabetic nephropathy....
Technical / white paper
Reducing Dosing Errors in Preclinical GLP Infusions - Solomon Scientific
09-Feb-2011 -
The White Paper explains that the Orchesta™ Automated Infusion System from Solomon Scientific reduces dosing error opportunities by 99% in preclinical GLP infusion studies. The system is validated for GLP and Part 11 compatibility. A typical preclinical GLP infusion study...
Technical / white paper
Incretins & gastrointestinal hormones - PBI
26-Jan-2011 -
The digestion and absorption of nutrients subsequent to food intake is associated with increased secretion of multiple gastrointestinal (GI) peptides. Testing for incretins, and other GI hormones, presents numerous challenges because of their instability. The degradation and modification of gut...
Suppliers
Piramal Healthcare Ltd
Piramal Pharma Solutions is the Contract Development and Manufacturing (CDMO) arm of Piramal Healthcare and is one of the only CDMOs providing support throughout the entire pharmaceutical drug product life-cycle. We also provide specialty services of Antibody Drug Conjugation & Clinical Trial Supplies for Pharmaceutical Companies across geographies.
Corden Pharma ~ Experts Taking Care
CordenPharma is a full-service CMO partner in the cGMP Contract Development and Manufacturing of oral, sterile, highly potent and antibiotic pharmaceutical Drug Products, their Active Pharmaceutical Ingredients (APIs), and associated Global Supply Chain and Packaging Services.
DPT Laboratories
With a specialized focus on semi-solids and liquids, DPT offers pharmaceutical companies the broadest range of capabilities in the industry. From R&D formulation to commercial-scale manufacturing, small batches to large, liquids to emulsions, sterile or non-sterile, we offer clients of all sizes the most effective resources for meeting challenges.
Founded by Ben Chien in 1995, QPS is a GLP/GCP-compliant contract research organization (CRO) that offers the highest grade of discovery, preclinical, and clinical drug development services. From a humble bioanalysis shop, it has grown into a full service CRO of 900+ employees spread across the US, Europe, India and Asia. Today, it offers a wide array of pharmaceutical contract R&D services and its areas of expertise encompass Neuropharmacology, DMPK, Toxicology, Translational Medicine, and Early Stage & Phase II - IV Clinical Research.In recent years, QPS expanded its later stage capabilities and extended its Asia Pacific and European presence by acquiring Qualitix (Taiwan) and JSW Clinical Investigations (Austria). This growth enabled QPS to facilitate global late stage clinical trials of new drug candidates in diverse therapeutic areas. By acquiring toxicology and neuropharmacology units at DCB (Taiwan) and JSW Life Sciences, respectively, QPS increased its preclinical services as well. The company also expanded its Phase I clinic in the Netherlands, in order to meet growing market demands. By constantly upgrading its capacities and skills, QPS is always more than ready to fulfill its promise to deliver superior quality, skilled performance and trusted service to its valued customers. For more information, visit www.qps.com
LabConnect, LLC
LabConnect provides global central laboratory services including routine and esoteric laboratory testing, kit building, sample management and tracking, biostorage and scientific support services for our biopharmaceutical and CRO clients.LabConnect’s services include:Specialized Testing. With more than 4,000 validated tests across our network, LabConnect can handle everything from general safety testing to the most complex molecular diagnostics and biomarker analyses. LabConnect’s extensive test menu includes a broad range of validated assays and diagnostic platforms as well as method development and validation services.Specimen Tracking. LabConnect’s real-time specimen tracking service, SampleGISTICS™, follows the clients’ specimen samples from collection through logistics to receipt at any lab or storage location in the world. LabConnect provides enhanced visibility of each individual sample and our advanced virtual accessioning process enables immediate query resolution, thereby improving efficiencies and saving time and money for our clients.Scientific Operations Support. LabConnect provides dedicated contract scientific professionals based upon the specific functional expertise our clients require. Our SciOps services give our clients management control without the time and cost strains of managing internal headcount, payroll and human resource issues.Biostorage Solutions. LabConnect offers a comprehensive suite of biostorage solutions for multiple sample types.Clinical Kits. LabConnect custom designs, builds and distributes visit-specific collection kits with pre-labeled tubes to minimize errors. Our kits are consistently rated as some of the best in the industry by investigator sites.
ROVI Contract Manufacturing
Contract manufacturing and pharmaceutical co-development through our 2 manufacturing plants located in Madrid, Spain. Both plants belong to Laboratorios Farmacéuticos ROVI: pharmaceutical company founded in 1946 and listed in the Madrid Stock Exchange Market since 2007. Revenues from 2011 were 184.7€ M and it takes count with over 840 employees.
Kemwell Biopharma Inc
Kemwell Biopharma is contract provider of CMC services to the pharmaceutical industry. With manufacturing locations in Bangalore India, and Uppsala Sweden, Kemwell offers services ranging from Clinical (CTM) Manufacturing, Commercial Manufacturing, Biopharmaceutical Manufacturing, Formulation Development, Analytical Development, Stability Testing & Packaging/Storage/Distribution.
SGS Life Science Services
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 75,000 employees, SGS operates a network of over 1,350 offices and laboratories around the world.
Almac Group
Integrated Solutions from Research to Commercialisation. Almac is a financially secure, privately owned organisation with over 3,300 employees located within the US and UK. Over 600 companies worldwide, including all the market leaders, use our services, testament itself to the quality, innovation and efficiency of our business as proven over the past 30+ years.
Solomon Scientific
The Orchesta™ Automated Infusion System from Solomon Scientific reduces dosing error opportunities by 99% and labor costs by 50% in preclinical GLP infusion studies.
