Newsletter | January 23, 2013

01.23.13 -- Defining A Partnership Strategy For Personalized Medicine

Pharmaceutical Online Newsletter
Discovery Research
Drug Substance Production
Clinical Development
Dosage Form Production
Primary Process Development
Dosage Form Development
Featured Focus: Primary Process Development
The Central Role Of Analytic Method Development And Validation In Pharmaceutical Development
By Robert W. Lee, PhD; and Laurie Goldman, Particle Sciences
Analytic method development, validation, and transfer are key elements of any pharmaceutical development program. This article will focus on development and validation activities as applied to drug products. Often considered routine, too little attention is paid to them with regard for their potential to contribute to overall developmental time and cost efficiency.
» Discovery Research
ARTICLE: Biopharms Embrace Companion Diagnostics To Advance Personalized Medicine And Address Drug Costs Concerns
By Cathy Yarbrough, Life Science Leader
Even though oncology dominates the CDx market, biopharmaceutical companies have not ignored other disease areas. CDx provides a way for biopharma companies to address payers' concerns about costs of medical treatment due to its potential to limit new drugs to only those patients who stand to benefit.
» Clinical Development
ARTICLE: Defining A Partnership Strategy For Personalized Medicine
By Alexander Vadas, Life Science Leader
Personalized medicine is still in its infancy, and is expected to drive new levels of partnership activity across the life sciences spectrum, including molecular profiling, outcomes data mining, healthcare IT, and data integration.
» Drug Substance Production
POSTER: Enhancing The Solubility Of Poorly Water-Soluble Drugs In The Presence Of Nano-Emulsion Particles
» Dosage Form Production
SERVICE – VIDEO: Suzhou Pharma Services Video
» Dosage Form Development
ARTICLE: CROs And CMOs Continuing Drug Delivery Innovation
By Kate Hammeke, Nice Insight
More and more these days, healthcare manufacturers are experiencing ever-changing demands and finding the need to outsource their advanced logistics functions to third-party service providers. Choosing that partner is a big decision, and one that requires careful consideration of supply chain expertise in governmental and regulatory guidelines, warehouse operations, transportation, new technology, and managing people processes and procedures.
SERVICE: High-Containment Services
» Packaging/Assembly
ARTICLE: What Is Enterprise Serialization?
By John DiPalo, Acsis
For those who haven't checked their watch lately, we'd like to remind you there are only two years remaining until California's serialization mandates take effect. Stiff penalties will await those who haven't serialized half of their products in the state's supply chain. So, no doubt many reading this paper are trying to wrap their heads around how to meet the requirement.