Client Success

08/29/2016
Phase III trials are the big, expensive ones that come right before a drug is submitted to a regulatory agency for approval. Phase III trials cost about $20 million, so you can see why the fact that about 50% of them fail is a big problem. Sy Pretorius, Chief Scientific Officer of PAREXEL, a...
07/24/2016
The FDA has mandated that by May 2017 all new drug applications must be submitted electronically in a format called eCTD. For drug developers to comply, they will need new tools, workflows, and publishing strategies. PAREXEL is a leading international drug consulting firm, and the Bloom Group...
06/07/2016
If formulation problems surface late in the process of turning active pharmaceutical ingredients (APIs) into beneficial drugs, developers may have to change their API production processes, and, in the worst cases, redo Phase I and Phase II trials Anil Kane, Global Head of Formulation Sciences at...
05/24/2016
Simon-Kucher & Partners is a $200 million+ management consulting firm specializing in marketing, sales and pricing strategies. In 2015, the Bonn, Germany-based firm asked  us to turn its expertise and client experiences on product innovation into a book. After finding an agent (who secured a...
05/09/2016
This was the first of two Harvard Business Review articles that Bloom Group helped Simon-Kucher & Partners' Madhavan Ramanujam and Georg Tacke prepare and secure to help publicize their book Monetizing Innovation.  In this article (titled “In Product Development, Let Your Customers Define...
05/02/2016
Simon Kutcher & Partners (SKP) is a global management consulting firm. Bloomberg Business Week called it “the world leader in giving advice to companies on how to price their products.” As a frightening percentage of excellent new products and services either fail to gain traction in the market...
04/30/2016
The FDA has created several new pathways that can shorten the time it takes for needed new medicines to receive regulatory approval. These pathways certainly benefit patients that need these medicines by getting them to market more quickly, and they also can benefit drug developers by providing a...
04/13/2016
Hudson Institute Senior Fellow Hank Cardello weighs in on the latest round between the NFL and the growing number of activists who are attacking its stand on concussions. In his latest Forbes.com post, Cardello suggests that the NFL should recognize those who are railing against it as an important...
01/02/2016
Developers must make important decisions about product formulation and process design to move a drug from preclinical through Phase II trials as quickly as possible. Over-engineering a Phase I or Phase II drug that ultimately fails in the clinic wastes resources. But neglecting sound science during...
11/04/2015
An Oregon woman opens a box of Halloween decorations she bought at her local K-Mart and out falls a note pleading for help, written by a man in a Chinese prison camp. How does this happen? According to FTI Consulting Forensic & Litigation Consulting Senior Director Greg Hallahan, Western...

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