Newsletter | June 15, 2021

06.15.21 -- Innovation Begins With A Problem

 
 

A panel of pharmaceutical executives were discussing innovation when one of them half-jokingly stated, “The challenge is that everyone wants to innovate, but nobody wants to be first.” For a regulated industry such as ours, bringing groundbreaking discoveries before regulatory bodies for approval is no easy task, and, certainly, being first can be daunting.

 

However, innovation is not limited to new scientific or technology products. Organizational structures, processes, and approaches to leadership can all be innovative, and many innovations are the result of smart people trying to solve problems.

 

Here, we examine better, more innovative ways of doing things, from accelerating the start of a new project to how service providers can help CFOs in pharma companies controlled by private equity. We look at the process of seeking Emergency Use Authorization and its ties to a morning sickness drug administered in the 1950s and provide some problem-solving wisdom from Dr. Tom Ingallinera.

Understanding Emergency Use Authorization (EUA)
 

Emergency Use Authorization (EUA) is a term that became part of the COVID-19 daily news briefings. What exactly is EUA? When is it used? How do the public health community, the FDA, and drug developers authorize emergency use of drugs or other medical products?

Navigating An Ever-Changing Landscape: The Role Of A CFO In A Private Equity-Controlled Pharma Company
 

The role of chief financial officer for a small-to-mid size pharma company controlled by private equity is a challenging one, especially since pharma companies with limited internal resources often rely on CDMOs for support. Learn how these CFOs can use their CDMOs to be more successful.

Parenteral Drug Manufacturing: Innovation Begins With A Problem
 

Developing manufacturing processes for complex parenteral drug formulations often presents some of the most challenging problems pharmaceutical scientists and engineers face and can lead to the most interesting innovative solutions. Effectively employing these problem-solving essentials can lead to success.

Creating A New Dosage Form From An Approved Drug For A New Rare Disease Indication
 

Cure HHT, a foundation representing patients suffering from hereditary hemorrhagic telangiectasia, a genetic blood vessel disorder that causes bleeding in multiple organs, needed assistance in developing a formulation and filing an IND application with the FDA.

Meet The Scientist: Sam Chia
 

Sam is responsible for the sterile injectables facility, including four manufacturing suites and housing R&D, quality control, microbiology, and engineering support. He believes his role is most importantly about people — his colleagues and the patients who rely on the drug therapies they develop and manufacture.

Solutions