01/01/2011

"2011 Industry Predictions"

Bikash Chatterjee, President & Chief Science Officer

As we emerge into the New Year, it is as good a time as any to take stock of where we are as an industry and what we might expect in the months to come. There can be no doubt that 2010 was a watershed year.

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12/01/2010

"Achieving High Performance through Analytics"

Bikash Chatterjee, President & CTO

Applying analytics throughout the organization, rather than in pockets of activity as pharma typically has, can be a catalyst for business performance.

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10/01/2010

"The Performance Conundrum"

Bikash Chatterjee, President & CTO

In my last editorial I spoke about the challenges facing the FDA and industry with regard to the effectiveness of the current regulatory structure. If we were to take a step back and look at our performance as an industry along with the effectiveness of the FDA’s
regulations, I think we definitely have some work to do.

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10/01/2010

"Using Lean to Catalyze Pharmaceutical Product Development"

Bikash Chatterjee, President & CTO

R&D must harness its inherent scientific horsepower and apply it through statistically unbiased experimental designs.

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09/01/2010

"Deciphering The Regulations For Facility Design and Environmental Control"

Wai Wong, General Manager & VP Worldwide Operations

With the FDA under fire in recent years regarding the quality of inspections, the effect on biotech, pharmaceutical, and medical device companies has been to err on the safe side of regulatory requirements by proving more evidence wherever they can.

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09/01/2010

"Point of View: Gauging Regulatory Effectiveness"

Bikash Chatterjee, President & CTO

That the pharmaceutical and biotech industry is in a state of flux is undeniable. Shifts within the U.S. marketplace have intensified the pressures on industry to perform, while the FDA has been struggling with its own charter.

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09/01/2010

"A QbD Implementation Roadmap for the Generics Industry"

Bikash Chatterjee, President & CTO

The passage of H.R. 3962, the Affordable Health Care for America Act of 2009, has changed the healthcare landscape forever, kicking up dust in the U.S. pharmaceutical marketplace.

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08/01/2010

"The Devil Is In The Details"

Bikash Chatterjee, President & CTO

Consolidation on a massive scale amongst the elite of the U.S. pharmaceutical industry raises questions about how to remain competitive, and profound changes to the marketplace can be seen on all fronts.

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06/01/2010

"Special Report: RFID in Pharma Today"

Bikash Chatterjee, President & CTO

A year ago, at INTERPHEX, the RFID Security Alliance described the considerations in implementing RFID as a security solution within the global supply chain (GSC), with regard to asset tracking.

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06/01/2010

"Pharma’s Changing Strategic Planning Landscape"

Bikash Chatterjee, President & CTO

The last few years in the pharmaceutical industry have seen unprecedented upheaval, with changes to the marketplace on all fronts. In the U.S., consolidation on a massive scale amongst the elite of the industry raises new questions about competitiveness and
what it takes to keep it.

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