Newsletter | January 16, 2013

01.16.13 -- DMPK: Straightforward Or Challenging?

Pharmaceutical Online Newsletter
Discovery Research
Primary Process Development
Preclinical Development
Dosage Form Production
Clinical Development
» Discovery Research
ARTICLE: DMPK: Straightforward Or Challenging?
By Jim Vrbanac, PhD, MPI Research
Medical research dramatically reduced overall morbidity and mortality in the 20th century. For example, in his book, The Devil Under the Microscope, Thomas Hagar describes the discovery of sulfa drugs and the first observations of the effects of penicillium fungi on bacteria. These discoveries had an immediate and dramatic impact on alleviating human suffering and are good examples of what Carl Sagan meant by his often quoted remark, "Science delivers the goods."
CASE STUDY: Informatics For Neglected Diseases Collaborations
» Preclinical Development
WHITE PAPER: Implications Of Immunogenicity In Drug Development
By Michele Gunsior, PhD, Covance Laboratories
Biotherapeutics emerged in the 1970s as a viable alternative to small molecule drugs when the advent of recombinant DNA technology allowed for the cost-efficient, large-scale manufacture of proteins in cultured cells under controlled conditions. In 1982, recombinant human insulin, developed by Genentech and Eli Lilly, was the first biotechnology therapy to be approved by the FDA. Since then, the biotechnology industry has reached more than 50 billion dollars in annual revenue, and continued growth is expected as pharmaceutical companies shift more resources into large-molecule drug development, or make high-value acquisitions of biologics companies.
» Clinical Development
ARTICLE: Accelerating Drug Development By Harnessing Technology
By Thomas (Tom) Grundstron, Quintiles
The biopharma industry has always taken well-deserved pride in being rooted in the life sciences, using the fields of medicine and biology to develop a vast range of life-changing therapies. Today, however, in order to meet the challenges of rising product development costs, generics, and patent cliffs, the industry must reach out to another discipline — information technology — to accelerate clinical development and to bring drugs to market faster, better, and cheaper.
ARTICLE: A Unique Approach To Clinical Trial Optimization: Respiratory Disorder, Phase III
ARTICLE: Persistence Leads To High Enrollment: PRA Convinces Client To Stick With Recruitment Strategies
ARTICLE: Wanted: A Revolution In CNS Drug Development
» Primary Process Development
GUEST COLUMN: New Custom Conjugated APIs: A Targeted Drug Delivery Paradigm Shift
By Joseph Guiles, PhD, Hauser Pharmaceutical Services, Inc.
New research approaches in the pharma/biotech industry are yielding some amazing, innovative therapeutics focused on unmet medical needs. Gone is the "me-too" approach to drug development and the silo mentality to chemistry and biology — both hallmarks of the industry. New trends in the way pharmaceutical companies approach research now focus on highly cross-disciplinary types of development, such as chemical biology.
» Dosage Form Production
GUEST COLUMN: Chinese CMO Landscape
By Oliver Mueller and Clifford Mintz, PhD, Suzhou Pharma Services
Most of the CMOs operating in China today offer mainly API and bulk drug materials manufacturing. China recently surpassed India as a world leader in the manufacture of APIs and bulk drug materials (India still exports substantially more finished dose medications).
» Packaging/Assembly
ARTICLE: Understand The Source Of Product Damage With Data Loggers
By Kevin Kohleriter, ShockWatch, Inc.
Products that experience temperature excursions, impacts from drops and rough handling, or other issues during shipping may end up being used or installed without the problem being identified. The results could be deadly in the case of medicine, or extremely expensive in the case of high-value equipment and lost opportunity cost.
ARTICLE: Transporting Billions Of Dollars' Worth Of Healthcare Products
BROCHURE: Custom Packaging And Pouching
» Logistics
ARTICLE: Creating A More Flexible Supply Chain
By Mark Wiesman, President, DDN
The globalization of the life sciences industry — coupled with the shift from blockbuster drug development toward sophisticated, targeted molecular development — is resulting in a highly complex supply chain. To successfully meet the demands of globalization, while mitigating associated risks, the life sciences supply chain must become extremely flexible.
ARTICLE: From Premium Logistics To A True Partner In Global Life Sciences Supply Chain Management
CASE STUDY: Speedy Response Characterizes The Relationship Between MD Logistics And A Major Pharmaceuticals Company
PODCAST: Overcoming Obstacles That Face The Pharmaceutical Supply Chain
VIDEO: Theft Prevention In The Supply Chain