Focus - Summer 2012 - 32

PRODUCTTRAINING

Effective Product Launches on Short Timelines
I By Bob Holliday or many business reasons across the pharmaceutical industry, the expectation to launch new products or indications as quickly as possible a er approval has continued to accelerate. Going back eight to 10 years ago, it was common to wait to have the DDMAC (Division of Drug Marketing, Advertising and Communications), now OPDP (O ce of Prescription Drug Promotion), comment on promotional materials prior to having a formal launch. is allowed you to launch with full promotional materials, but delayed the launch for about ve to six months post PDUFA (Prescription Drug User Fee Act) date or approval date. Over the last few years, that has changed signi cantly and many companies are now launching within a couple of months or even weeks from approval. e following are three key areas to focus on when executing a launch on short timelines.

F

Planning
When planning for a launch, some of the rst things to determine are whether there will be a live meeting for the Package Insert (PI) launch, promotional launch or both? A PI launch is just that, initially launching with only PI-based materials and o en a clinical trial. e promotional launch then includes the full branded messaging and campaign. As mentioned earlier, that usually takes four to six months post approval to receive. O entimes, we’ve run the PI launch as live and the promotional launch as distance. ere isn’t a right or wrong here, just a need for awareness of dates and scale of meeting. It is critical to work with your regulatory lead to stay current on the status of the dra PI, as you’ll need to build as much of the launch training based on the dra PI as possible. A good question for regulatory is where in the dra PI is there likely a low risk of change and where is there a greater risk of change. Based on this, you can prioritize what section to start building training around. Also, keep in mind that regulatory is working with the FDA for weeks to months prior to your PDUFA date on the nal label, so there usually are many dra s to keep up with. In any case, you should strive to have all launch meeting training materials tentatively MLR (Medical, Legal and Regulatory) approved either nal or in PI dra form two weeks prior to the PDUFA date.

Alignment
Most MLR teams have very strict rules for how and when they review materials. It is important to work with leadership to ensure these processes will work, given your very short turnaround from nal PI to launch, or to agree on modi cations because of these timelines. As an example, many MLR processes work with a PDF le where all comments are added by reviewers, and someone then needs to go back and ensure all comments are incorporated before producing nal pieces. When launching so quickly, it is much more e cient to work in a Word le, making all changes in live time, that way you walk out of the live MLR meeting with an approved nal document, that doesn’t require re-reviews. e bottom line here is you need to ensure appropriate MLR review, but nd the most e cient way possible through the approval process. As mentioned, the goal is to have all materials tentatively approved two weeks prior to approval. One of the most important plans to align with the MLR process is to establish what will need to be re-reviewed a er you receive the nal PI and how this will be accomplished. is is the area, depending on how quickly you are launching post PDUFA, which will make or break your readiness. Ideally, highlight any areas of previously approved materials where changes did occur and have the MLR team review just those highlighted sections, as long as the changes didn’t change the context of other materials.

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Focus - Summer 2012

Table of Contents for the Digital Edition of Focus - Summer 2012

Focus - Summer 2012
From the President: How to Build Your Network
Table of Contents
Table of Contents
Guest Editor: The Evolution of Digital Training
Protecting Your Class from Naysayers
2012 SPBT Industry Landscape Study: Trends, Technology & Training
The Lost ROI from Poor Coaching Practices
Getting the Attention You Deserve
Training that Doesn't Break the Bank
Effective Product Launches on Short Timelines
Leadership Secrets from Pharma Legends
Don't Overlook NPs/PAs in Sales Training
The Case for Continuous Learning
Virtual How
Company News
People News
Ad Index
Focus Contacts
5 Questions with…Julie Clow
Focus - Summer 2012 - Focus - Summer 2012
Focus - Summer 2012 - Cover2
Focus - Summer 2012 - 3
Focus - Summer 2012 - 4
Focus - Summer 2012 - 5
Focus - Summer 2012 - 6
Focus - Summer 2012 - From the President: How to Build Your Network
Focus - Summer 2012 - 8
Focus - Summer 2012 - Table of Contents
Focus - Summer 2012 - 10
Focus - Summer 2012 - Table of Contents
Focus - Summer 2012 - 12
Focus - Summer 2012 - Guest Editor: The Evolution of Digital Training
Focus - Summer 2012 - 14
Focus - Summer 2012 - Protecting Your Class from Naysayers
Focus - Summer 2012 - 2012 SPBT Industry Landscape Study: Trends, Technology & Training
Focus - Summer 2012 - 17
Focus - Summer 2012 - 18
Focus - Summer 2012 - 19
Focus - Summer 2012 - 20
Focus - Summer 2012 - 21
Focus - Summer 2012 - 22
Focus - Summer 2012 - 23
Focus - Summer 2012 - The Lost ROI from Poor Coaching Practices
Focus - Summer 2012 - 25
Focus - Summer 2012 - Getting the Attention You Deserve
Focus - Summer 2012 - 27
Focus - Summer 2012 - 28
Focus - Summer 2012 - Training that Doesn't Break the Bank
Focus - Summer 2012 - 30
Focus - Summer 2012 - 31
Focus - Summer 2012 - Effective Product Launches on Short Timelines
Focus - Summer 2012 - 33
Focus - Summer 2012 - Leadership Secrets from Pharma Legends
Focus - Summer 2012 - Don't Overlook NPs/PAs in Sales Training
Focus - Summer 2012 - The Case for Continuous Learning
Focus - Summer 2012 - Virtual How
Focus - Summer 2012 - Company News
Focus - Summer 2012 - People News
Focus - Summer 2012 - Ad Index
Focus - Summer 2012 - Focus Contacts
Focus - Summer 2012 - 5 Questions with…Julie Clow
Focus - Summer 2012 - Cover3
Focus - Summer 2012 - Cover4
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