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Articles

How pharma leaders can convert data collected for compliance purposes from a cost center into a critical success factor.

Tapping Compliance Data to Drive Success

Amid the limitations of traditional compliance programs that emphasize control measures, here are steps biopharma companies can implement in their own cultures to ensure they’re behaving and performing with integrity.

Culture and Compliance: Building a Culture of Business Ethics

Rob Besse is Vice President, Archbow Consulting.

It is vital to begin asking questions about your company’s DSCSA readiness and compliance, as well as that of your strategic partners, writes Rob Besse.

What You Need to Know about the Drug Supply Chain Security Act

Is Congress harming pharmaceutical research by limiting enforcement of improvement patents?


Attacks on Pharmaceutical Improvement Patents

James Clark â¨is Senior Associate at DLA Piper UK LLP.

James Clark addresses one of the key questions data protection and compliance officers are asking following the implementation of the General Data Protection Regulation -"What role am I playing under the GDPR?"

Identity Crisis: Data Protection Roles for Life Sciences Companies

Daniel Gold is a senior enterprise director for Catalyst, where he advises corporations on technology-driven strategies. He can be reached at dgold@catalystsecure.com.  

Daniel Gold looks at the benefits of centralising an organization's data in a core repository and adopting a comprehensive business intelligence strategy.

Curing Big Pharma’s Litigation Spend Woes with Data-Driven Medicine

Josh Reisberg is counsel at Axinn Veltrop & Harkrider LLP (New York, NY).

Josh Reisberg outlines the foundation of a broad, overall defense strategy for generic companies embroiled in Hatch-Waxman patent infringement litigations.

Beyond the Merits: Generic Company Defense Strategies

Steve Maebius is a Partner and IP attorney for Foley and Lardner LLP. He can be reached at smaebius@foley.com Eva Freel was a law clerk at Foley and Lardner LLP, and is currently a JD candidate at UCLA Law School

For generic firms, Inter Partes Reviews (IPRs) are a cost-effective way to clear out FDA Orange Book-listed patents before or during litigation; for originator companies, they pose a threat to valuable patent portfolios. Steve Maebius reports.

New Challenge to IP Innovation

Peter C. Richardson is a partner in the New York City law firm, Richardson & Rosow. Traci Medford-Rosow is also a partner at Richardson & Rosow and the author of the recently-published, best seller, Inflection Point: War and Sacrifice in Corporate America.

Having lobbied hard to have Inter Partes Review proceedings (IPRs) enacted, the tech industry may now be regretting what it wished for, write Traci Medford-Rosow and Peter C. Richardson.

Cuozzo v Lee:  How Many Bites at the Apple are Enough?

Europe follows the United States with a harsh new spotlight on agreements that slow generic entry for medicines losing exclusivity.

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