Pharma Seeks Long Tail Of Flexible Manufacturing
The pharmaceutical industry is at the cutting edge in terms of types of products and technologies offered and under development. The last 30 years has seen the biopharm boom, and most recently, the marriage of therapies with high-tech delivery systems, particularly prefilled syringes and other injection devices. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 18, 2016 Category: Pharmaceuticals Source Type: news
The Creation Of Shire's Outsourcing Model
Approaching $7 billion in annual sales, and fully reliant on outsourcing, no other biopharma today engenders more wonder at its business model than Shire. How does it all fit together? How is it managed? We learn firsthand here. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 18, 2016 Category: Pharmaceuticals Source Type: news
Advances In Clinical Trials
By Sam Herbert, Chief Operating Office, World Courier Management
Better local resources around the world and more sophisticated technology are changing the dynamics of logistics services
Sam Herbert, chief operating officer, World Courier, a part of AmerisourceBergen Pharmaceutical manufacturers face a multitude of challenges as they work to bring new products to market. Rising R&D costs, difficult recruitment and retention of patient populations for clinical trials, increased competition among manufacturers of all sizes, more stringent scrutiny over medication prices: All of these factors and countless others are...
Source: Pharmaceutical Online News - May 18, 2016 Category: Pharmaceuticals Source Type: news
Exploring Collaboration With Third Parties And The Impact On Document Management
The trend towards virtual pharma is accelerating and as it does, the life sciences industry is undergoing a profound structural change. The areas of development and commercialization which were once conducted within the confines of one company have now become a collaboration within an ecosystem of entities, both public and private. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 18, 2016 Category: Pharmaceuticals Source Type: news
Improve The Delivery Of Critical Documentation To Employees
Overview video of the BIOVIA Biologics Manufacturing Solution. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 18, 2016 Category: Pharmaceuticals Source Type: news
How To Avoid 5 LIMS Nightmares
Traditional Laboratory Information Management System (LIMS) implementations are notorious for keeping people awake at night. Industry analysts like Strategic Directions and ARC Advisory Group have estimated the failure rate of commercial LIMS solutions to be as high as 60 percent with many of them failing to deliver original customer requirements after lengthy and expensive deployments. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 18, 2016 Category: Pharmaceuticals Source Type: news
Improve Operations, Collaboration, And Time-To-Market: The Digital Lab
Many leading life sciences companies have introduced cost-reduction initiatives to automate routine, non-value-added tasks related to data capture, cataloguing and documentation activities as products move from discovery through development to late-stage quality control, manufacturing and commercial operations. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 18, 2016 Category: Pharmaceuticals Source Type: news
Following FDA Guidance: Continuous Improvement In An Outsourced Environment
In May 2013 the U.S. Food and Drug Administration (FDA) released its draft guidance, “Contract Manufacturing Arrangement for Drugs: Quality Agreements,” with recommendations representing its “current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy.&rdqu...
Source: Pharmaceutical Online News - May 18, 2016 Category: Pharmaceuticals Source Type: news
Marken Adds Key Service Providers To Global Network
Marken announced recently that they have expanded their network of qualified third party service providers and customs brokers to reinforce the company’s infrastructure and prepare for a significant increase in drug, vaccine, API and ancillary shipment volume. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 18, 2016 Category: Pharmaceuticals Source Type: news
Marken Launches New Allegro Booking Service For Investigator Sites
Marken recently announced the launch of its customized, on-line booking tool specifically for investigator sites. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 18, 2016 Category: Pharmaceuticals Source Type: news
The New Strategic CDMO: End-to-End Solutions for Better and Faster Drug Development
While Big Pharma historically has kept development activities and CMC management in-house, unpredictable pipelines and increasing drug complexity have compelled the industry to look more seriously at outsourcing drug development and manufacturing to increase productivity and throughput. Bill Weiser, the executive director and global head of analytical sciences at Patheon, discusses how a new generation of CDMOs have positioned themselves to provide more strategic solutions that not only complement product development but also drive therapies to patients faster. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 17, 2016 Category: Pharmaceuticals Source Type: news
Capsugel Expands Micro-Dosing Services To Help Accelerate Customers' Product Development Timelines
Capsugel, a global leader in delivering high-quality, innovative dosage forms and solutions, recently announced that it is expanding its micro-dosing services offering for early-phase feasibility work. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 17, 2016 Category: Pharmaceuticals Source Type: news
A New Approach To Passive Pallet Shipper Design For Bulk Products
With the global growth of bulk pharmaceutical shipping products transportation has become an integral and tightly controlled extension of the manufacturing process. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 16, 2016 Category: Pharmaceuticals Source Type: news
05.18.16 -- The Building Blocks Of A Successful Drug Delivery Device
05/18/16 The Building Blocks Of A Successful Drug Delivery Device (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 16, 2016 Category: Pharmaceuticals Source Type: news
BioMarin Gives Supplier Scorecards Failing Grades
Isaac Young, senior director, supply chain operations, BioMarin Pharmaceutical Inc., gives a lot of today’s CMO/supplierscorecards an“F.”“Stop confusing precision with accuracy,” he says. In this article, he helps us understand how to do better, and provides an example of a scorecard that gets a passing grade. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 16, 2016 Category: Pharmaceuticals Source Type: news
