Newsletter | February 27, 2013

02.27.13 -- Competition Yields Benefits For Pharma Companies Outsourcing API Manufacturing

Pharmaceutical Online Newsletter
Preclinical Development
Dosage Form Production
Clinical Development
Dosage Form Development
Drug Substance Production
Featured Focus: Drug Substance Production
Competition Yields Benefits For Pharma Companies Outsourcing API Manufacturing
By Kate Hammeke, Director of Marketing Intelligence, Nice Insight
Pharmaceutical innovators are at an advantage as a result of companies competing for outsourcing API services, and compounded by the emergence of low-cost manufacturers in Asia.
WHITE PAPER: Signature Requirements For The eTMF
By Kathie Clark , Director of Product Management, Wingspan Technology
Sponsors and CROs want to ensure that the processes and workflows they use in their electronic trial master files (eTMF) comply with all regulatory requirements, resulting in a robust system that will produce complete documentation able to withstand an agency audit. To provide a solid basis for decision making, we've researched both the regulatory basis for signatures and the technology implications concerning how to collect signatures. Since the goal of any eTMF system is to streamline processes and increase compliance, implementing valid signature processes in the least cumbersome manner is always of concern.
SERVICE BROCHURE: Navigating The Validation Process For Drug Substances
» Preclinical Development
ARTICLE: So You Want To Be A Preclinical CRO Study Director?
By Chris Papagiannis, MPI Research
The scientist or toxicologist working as a study director (SD) in a preclinical CRO can find it to be a rewarding and also continually challenging career. The research for which you are responsible is critical in the development of new drugs for the treatment, cure, or management of many diseases or physical conditions.
» Clinical Development
ARTICLE: Bridging Clinical To Commercial: The Important Evolution Of Observational Research
By Leanne Larson, MHA, Vice President, Evidence Development, PAREXEL
Biopharmaceutical product development today faces a very different set of challenges and drivers than in the past. In addition to the purely scientific challenges in developing new and innovative treatments for diseases of staggering complexity, the market today is demanding answers far beyond those that the traditional clinical development and clinical trial processes can deliver.
ARTICLE: Lessons In Medical Image Transfer Security From A Smartphone Crash
By Chris Englerth, BioClinica
When it comes to data security, most people fall into one of two categories: those who constantly fear the loss of data, and those who don't realize it can be lost. For those of you in the second category, make no mistake — your data can be lost!
ARTICLE: Challenges, Prechallenges, Dechallenges, And Rechallenges
By Bart Cobert, Sentrx
This is an interesting topic for which several confusing points have arisen and which merits an in-depth look. These concepts are frequently used in the discussion of causality, and regulatory agencies pay particular attention to them in assessing individual case safety reports, particularly in the post-marketing setting.
CASE STUDY: Effective Use of Health Technology Assessment To Maximize Market Access: Start Early And Update Often
NEWS: Cubist Announces Exclusive Option To Acquire Adynxx
» Dosage Form Production
POSTER/WHITE PAPER: Ion Exchange Resins Used For A Controlled Release Orally Disintegrating Tablet (ODT)
CASE STUDY: FirstDoc Migration: Documentum
NEWS: Vetter Offers Answers For The Future At The Pharma Congress 2013
NEWS: Third Annual Medical Pharmacy Trend Report Illuminates Hidden Healthcare Costs
NEWS: Amneal Pharmaceuticals Receives FDA Approval For Generic Suboxone
» Dosage Form Development
ARTICLE: Successful Drug Device Development Begins At The Earliest Stage
By Wayne Koberstein, Contributing Editor, Life Science Leader
Drug-device combinations generally have two alternative purposes: to enable a new use, indication, or effect, or, to extend a product's life cycle. Each alternative brings a particular set of technology choices and influences the timeline in product development. But both demand a level of coordination and planning — starting at the earliest possible point — that companies often cannot or do not achieve.
WHITE PAPER: Solvent Considerations In Solid-Dose Manufacturing
NEWS: Kemwell Appoints Dr. Ninad Deshpanday To Head Global R&D
» Packaging/Assembly
WHITE PAPER: Key Steps To Consider When Working With A CDMO To Identify Optimal Packaging Options
WHITE PAPER: Overall Quality Of Medical Devices Predicated Upon Exceeding GMP At Each Step In The Production Continuum
» Logistics
PODCAST: The Importance Of Asset Tracking In The Pharmaceutical Supply Chain
By Wally Deveraux, Director of Cargo Sales
When shipping pharmaceutical and other medical products, time is critical. Many items are sensitive to environmental changes — and it's vital that valuable cargo is moved on time and that the shipper can stay aware of temperature, location, and other critical information along the supply chain.
VIDEO: Theft Prevention In The Supply Chain