Final Word - BioPharm International

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Final Word

Patents and Postapproval Batch Testing

December 1, 2012

Can postapproval FDA filings immunize pharma companies from patent lawsuits?

How to Manage Effective Leadership when Change is the Only Constant

November 1, 2012

A disciplined approach to changing behavior can achieve change agility.

FDA and the Importance of Confidentiality

October 1, 2012

Do you have to worry about FDA releasing confidential data? Apparently so.

Technology Transfer: Protecting the True Public Interest

September 1, 2012

Ties between the biotechnology industry and university research are crucial.

Developing Discoveries into New Therapeutics

June 1, 2012

Formulators and developers are at the heart of the industry's basic premise—they are saving lives.

A New Way to Think About Outsourcing Partnerships

May 1, 2012

Future sponsor-contract provider relationships will require more integration.

The Growing Orphan-Drug Paradigm

April 1, 2012

Rather than seeking a single indication for one large group, the orphan-drug approach segments the market for a drug more minutely.

Biosimilar Developers Face a Reference-Product Dilemma

March 1, 2012

Does global development have to entail multiple comparability studies?

Saving the Next Generation of Regulatory Scientists

February 1, 2012

New educational programs are key to the industry's future and to safe, available drugs.

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