Newsletter | October 13, 2021

10.13.21 -- Insights For Optimizing Your Product Development Strategy

 
Regulatory Strategy Considerations For Working With The FDA vs. The EMA: Part 1
 

This two-part series explores the regulatory strategy considerations sponsors should bear in mind when working with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), with a focus on the development of drug and biologic products.

Regulatory Strategy Considerations For Working With The FDA vs. The EMA: Part 2
 

In this second installment, learn how applications for conducting clinical studies, expedited programs, pediatric plans, and labeling in the U.S. and EU markets are compared.

A Primer On Cancer Immunotherapy Part 1: Goals And Major Approaches
 

This article provides an introduction to cancer immunotherapy, exploring its immunological basis, and the fundamental principles guiding the development of new treatments.

A Primer On Cancer Immunotherapy Part 2: The Cancer Immune Response And Mechanisms Of Resistance
 

This article examines the rationale for combination therapies, mechanisms of resistance, and where to go from here.

How Commercial Insights Can Be Used To Maximize An Early Exit
 

This webinar provides an overview of the commercial insights that should be gathered in the early phases of development and offers guidance on best practices to use these insights to focus on and drive the development process, identify the right type of commercial partners, and enhance the ability to negotiate better terms for an exit or out-licensing deal.