Monthly Archives: August 2015

The NDA Marriage – Complementing Regulatory Strategies with Technical Solutions

Jillian Lee

The presentation “The NDA Marriage” was given by Jillian Lee, Senior Global Submission Specialist at Bayer Health Care AG, at LORENZ userBridge.14 in Milan, Italy.

In her presentation, Jillian Lee outlined an approach for concurrent submission applications.

Background: sequential regulatory requirements
Bayer’s mission is “Science For A Better Life”. For the pharmaceuticals division, this means – making available safe, effective, and potential life-saving options to patients as quickly as possible. Currently however, technical barriers prevent the submission of a NEW indication for a drug while the first indication is still in the initial approval process with health agencies.

So a solution is needed to reduce the overall review timelines and potentially help in “fast-tracking” approvals. The answer is simple, although technically complex: enable concurrent applications. Continue reading

The way we do things around here [Part 2]

Follow up from Christian Kaas, our Director Development, and his series of articles talking about “The way we do things around here” at LORENZ.

The LORENZ Heartbeat
What does this expression mean? Broadly, our development teams have created an easy to use and repeatable process for managing our release projects, a rhythm that some people call the “heartbeat” of the development teams. The major beat is manifested in our promise to our customers that we will deliver two major releases per product per year – one in April and one in October.

Continue reading