Biosimilar Competition is Only One of Several Threats Facing Biopharma...
By Patti Seymour (pseymourbptccom) Biopharmaceutical products will dominate the list of top ten best selling drugs in 2012. Abbott Laboratories’ arthritis drug Humira® (adalimumab) is forecasted to...
View ArticleEuropean Commission Finally Publishes Changes to GMP Guidelines
By: Patti Seymour (pseymourbptccom) , Alex Kanarek (akanarekbptccom) , and Sheila Magil (smagilbptccom) Almost two years after the initial changes were proposed, the European Commission (EC)...
View ArticleHow Will Changes to EU GMP Guidelines Chapter 7 Impact Your Outsourcing...
By: Patti Seymour (pseymourbptccom) , Alex Kanarek (akanarekbptccom) and Sheila Magil (smagilbptccom) Our previous blog commented on the changes to Chapter 1, Chapter 7 and Annex 2 of EudraLex...
View ArticleInforma Life Sciences’ 10th Annual Clinical Trials Supplies and Packaging
Patti Seymour, Senior Consultant, will deliver a presentation titled, “Utilizing just-in-time labeling to increase flexibility in clinical supplies” and a workshop titled “Clinical Supply Chain...
View ArticleWTG’s 5th Annual Biomanufacturing Summit 2013
Dr. Susan Dana Jones (sjonesbptccom) and Dr. Howard Levine (hlevinebptccom) will be participating in panel discussions at the upcoming 5th Annual Biomanufacturing Summit to be held from January...
View ArticleThe 6th Annual Bioinnovation Leaders Summit
Dr. Howard Levine will be chairing The 6th Annual Bioinnovation Leaders Summit to be held in London on Feb 13-14, 2013. Dr. Susan Dana Jones will be joining Dr. Levine at this leading conference...
View ArticleRaw Material Change? When were you planning on telling me?!
Tom Ransohoff (transohoffbptccom) and Sheila G. Magil (smagilbptccom) It’s a given that the quality of raw materials impacts the quality of biopharmaceuticals. When manufacturers change the...
View ArticleLittle-Known Factors That Affect COGS
By Rick Stock (rstockbptccom) As competition, product price sensitivity, and insurance drug coverage concerns for biopharmaceuticals increase, understanding cost of goods sold (COGS) has never been...
View ArticleContracting – how to make it a win-win
By Al Doig (adoigbptccom) and Patti Seymour (pseymourbptccom) Global prescription spending exceeded $1 trillion in 2014 and revenues from biopharmaceuticals accounted for nearly 15% of this...
View ArticleEmerging Therapies: CMO’s Tackle Biomanufacturing Challenges
Innovative cell and gene therapies and the resurgent interest in ADC’s (antibody drug conjugates) are emerging therapies that are creating these challenges. The roundtable discussion entitled;...
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