505(b)(2): It’s A Different Animal
Camargo
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Products
Data sheet
505(b)(2): It’s A Different Animal - Camargo
13-May-2013 -
505(b)(2) is more than just a regulatory pathway, it is a distinctly different animal — a unique strategy that can often result in product approval with lower risk, reduced development cost and faster speed to market. Find out if 505(b)(2)...
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...
Case study
A risk assessment framework for donor and recipient companies to jointly analyze and document the technical and business risks associated with the technical transfer of pharmaceutical product - Alkermes
22-Apr-2013 -
Every technical (tech) transfer is different, with companies taking different paths toward reaching their goal. Each one presents a unique set of challenges. These challenges are most often technical, but at times they may also be business related. However all...
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...
Technical / white paper
What Makes 505(b)(2) Different? - Camargo
19-Mar-2013 -
When it comes to developing a compound, the 505(b)(2) drug development pathway is not just a regulatory platform — it’s a different animal. This pathway offers a holistic approach for developing products that offer differentiated benefits with Lower Risk, Reduced...
Technical / white paper
Identifying the Product - Camargo
06-Feb-2013 -
When it comes to developing a compound, the 505(b)(2) pathway can make changes to reference products for greater profit potential and lower risk. Camargo Pharmaceutical Services offers a clear process from concept through commercialization to identify products with documented market differentiation:
Selection...
Video
The Best of Both Worlds: Swiss Quality, Made in China - Lonza
05-Feb-2013 -
Lonza brings you the best of both worlds with Swiss quality manufacturing of APIs available at our FDA approved facility in Nansha, China. From backward integration to tailored production concepts for efficient manufacturing, Lonza offers sustainable solutions for regionally important...
Case study
Blinding Techniques for Inhaler Devices - Development of a Novel Blinding Methodology for a Market Leading DPI - Almac Group
21-Jan-2013 -
Blinding inhalers for use in clinical studies is a challenging and specialised area of clinical trial supplies. In this case study, Almac provide a real life overview of their unique inhaler blinding services which have been successfully developed and validated,...
Case study
Alkermes successful approach to commercial-scale, final dosage manufacture of drug product containing highly potent API for a global pharmaceutical company. - Alkermes
18-Dec-2012 -
As part of Alkermes plc, Alkermes Contract Pharma Services, provides solid oral dosage product development, scale–up and manufacturing services as well as sterile fill finish capabilities to the global pharmaceutical market. This case study demonstrates how a commercial manufacturing partnership...
On-Demand Supplier Webinar
Using FDA’s Draft Guidance on Risk-Based Monitoring to Improve Clinical Data Quality - Rho
15-Oct-2012 -
The Industry’s changing approach to clinical data monitoring requires the tools and team structure to effectively plan and execute risk-based monitoring. Join Lynn King and Rob Woolson as they discuss multi-disciplinary approaches to implementing alternative monitoring plans and specialized tools...
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.
Baxter BioPharma Solutions
Sterile Contract ManufacturingWith over 80 years of parenteral experience, BioPharma Solutions (a business unit of Baxter) offers a variety of contract manufacturing form/fill/finish services and solutions for injectables , designed to meet complex and traditional sterile manufacturing challenges. In addition, we are the only CMO to offer a manufacturer-prepared, commercial-scale aseptic filling process for premixed drugs in flexible IV bags.
A global force in central lab testing
ACM Global Central Lab is a global force in central laboratory testing for clinical trials. We specialise in delivering the highest quality laboratory science in support of clinical research services. Our flexible approach, attention to detail and customer service sets us apart from the competition.
CRF Health
CRF Health delivers electronic Clinical Outcome Assessments (eCOA) solutions for global clinical trials. The most innovative Pharmaceutical and Biotechnology companies partner with CRF Health to develop electronic Clinical Outcome Assessment strategies, transition from legacy paper instruments, and manage Clinical Outcome data to gain immediate visibility to patient assessments.
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.
Alkermes Contract Pharma Services
Alkermes Contract Pharma Services provides product development scale-up and manufacturing services to the pharmaceutical market and is part of Alkermes plc. With over 40 years in the service business, we have assisted our blue chip list of partners in the successful launch of multiple products in more than 100 countries, including North America, Europe and Asia.
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.
Eurofins Global Central Laboratory
Reliable, high quality laboratory data is pivotal to the success of drug development. At Eurofins Global Central Laboratory, laboratory science is our sole focus. With over 20 years of experience and scientific expertise, we utilize our global central laboratories to continually attain the most cost effective and efficient solutions for your clinical trial needs.
