Articles

1. What Beer Can Teach Us About Outsourcing 5/6/2014

   I’m not a biologist or chemist, but apply these disciplines to beer and my interest is immediately piqued. Mix in a discussion of outsourcing – contract brewing, if you will – and we add a dose of professional relevance as well. Yes, this article is related to the pharma industry, so stay with me here if the beer reference didn't wet your thirst.

   First, though, an anecdote about the beer. It starts years ago when the production of my favorite brew was outsourced abroad to serve international markets. The taste never matched up to the original, as confirmed by aficionados of this brand around the world. I was recently reminded of this situation while reading a review in the Wall Street Journal of the new book The Craft Beer Revolution by Steve Hindy. For one thing, it appears outsourcing in the microbrew industry – the biotechs of beer – is being questioned. Would a microbrew from, for example, Brooklyn Brewery, be less than honest with its customers if they outsourced production far from the five boroughs?

2. Company Confronts, Conquers Capacity Crisis 4/15/2013

   Upon acquiring several successful product lines from an established global company, a young U.S.generic and branded pharmaceutical manufacturer inherits more than 30 chargeback accounts, introducing a challenge well beyond its processing capacity.By DDN

3. Generic Pharma Start-Up Competitive On Day One 4/1/2013

   The subsidiary of a global pharmaceutical company entering hyper-competitive U.S. generic pharmaceuticals market but lacking efficient supply chain infrastructure to operate profitably. By DDN

4. Pharma Beyond Borders: India As An Outsourcing Destination 2/1/2012
   The only thing that is constant in life (and that goes for the global pharma industry too!) is change. The need to access emerging markets with new and cost effective drugs, the diminishing blockbuster product model, and the far more complicated life cycle management programs are just some of the new and ever changing challenges that innovator pharmaceutical companies face in today’s environment. By Manoj Mehrotra
5. Greg Weilersbacher's Expert Advice On Selecting A CMO 11/11/2011

   Life Science Leader magazine put together an executive roundtable article on the CMO selection process for a 2011 special supplement. The intent — to gain a better understanding of the some of the challenges faced during the partnering and provide insights on how to overcome. By Rob Wright

6. White Paper: Foreign Clinical Trial Data 8/5/2011
   Given the high cost of moving a promising drug candidate through years of clinical trials, it’s no wonder that more and more drug manufacturers have begun conducting at least some of their clinical trials in foreign countries. With lower costs and shorter recruiting times, the use of foreign sites is appealing to all drug developers, but especially to those involved in generic and “fast-track” approval programs.
7. White Paper: FDA Requirements For Clinical Studies In Pediatric Patients 5/11/2011

   FDA rules around pediatric drug trials have been tightening, to ensure more targeted data on drug efficacy and safety in children.

8. Late Phase Research 5/11/2011
   The post-marketing environment is evolving rapidly — and without the right strategy, new challenges can squeeze precious value out of your investment.
9. Mastering The Extended Clinical Supply Chain Whitepaper: Strategic Advantages For Clinical Trials 4/28/2011

   The core of any good clinical supply chain system is a supply management system that addresses all of the nuances of clinical supplies.

10. Strong Collections Bring Robust Return 3/11/2011
    A US subsidiary of one of the top providers of branded and generic medications in India needs to improve collection performance on its accounts receivable (AR) for branded products. By DDN