Product Launch Optimization by CMK SELECT CMK SELECT CMK SELECT
CMK SELECT CMK SELECT CMK SELECT
When the FDA announced its new Breakthrough Therapy Designation in 2012, it meant that the pharma industry would be able to move new life-saving drugs more efficiently through the approval process, allowing for the right drugs and therapies to reach the right patients at the right time. Any drug that is designated as a breakthrough therapy is fast-tracked through the FDA approval process.
CMK SELECT
43 Route 46 East, Suite 705 Pine Brook, NJ 07058 USA
Rachel Phone: (973) 244-6060

FORGOT YOUR DETAILS?

Product Launch Optimization

by CMK SELECT / /
Red arrow pointing upward

The Challenge

When the FDA announced its new Breakthrough Therapy Designation in 2012, it meant that the pharma industry would be able to move new life-saving drugs more efficiently through the approval process, allowing for the right drugs and therapies to reach the right patients at the right time. Any drug that is designated as a breakthrough therapy is fast-tracked through the FDA approval process.

Shortly after the new designation was instituted, a Top 5 pharmaceutical company was seeking to optimize the launch of a new breakthrough therapy oncology drug, and needed a plan in place that would allow for an adequate supply of the drug at launch – both to avoid any negative press and to open the gates for revenue gain early on.

The Solution

CMK Select first reviewed the existing timeline and assessed the risks and opportunities. We interviewed key stakeholders to better understand the brand objectives and ideal project timelines, and discovered that the existing schedule would send the drug to market two months after launch. Because this would result in a highly unfavorable response from the public, we assembled key decision makers from the manufacturing and distribution teams to critically evaluate the existing process and streamline the tasks that could be completed ahead of time to improve efficiency.

Results

We successfully reduced the pharmaceutical company’s drug availability delay by 60 percent, which placed the breakthrough drug on the market less than two weeks after the fast-tracked launch, rather than the initial estimate of two months. With such an efficient turnaround time, there was ample product available just days after launch. This ensured an additional five weeks to generate revenue and eliminated the threat of negative press. In fact, the abbreviated process worked so well that the client continues to use it today.

Leave a Reply

Your email address will not be published. Required fields are marked *

Share on:

... KNOWLEDGE & INSIGHTS

CMK SELECT

Operations Management  

AUTHOR: CMK SELECT

A reputable pharmaceutical company was experiencing a period of high employee turnover in one of its central departments and did not have a tangible on-boarding system in place to help transition its new hires into their respective roles.…
CONTINUE READING
N. Borinshteyn

The Rising Value of Medical Affairs – Engagement with External Stakeholders (KOLs, TLs, EEs)

AUTHOR: N. Borinshteyn

The ever-evolving relationship between the pharmaceutical industry and its key opinion leaders (KOLs) has been a hot topic for a while, and there are several reasons for that: Recent innovative medicines are so complex that many consumers can’t understand them…
CONTINUE READING

LIKE OUR PAGE

FOLLOW US

GET LINKED IN

TOP