Frequently Asked Questions During Launch Preparation
When working with companies that are preparing for their product launch, we get asked a lot of questions. Although the specific questions vary from client to client, there are some that are consistently on the list of nearly every company we speak with.
The typical product launch timeline is about two years; however, it is important to note that the timeline for each product will vary slightly depending on the market, therapeutic area, indication, etc. For example, a product indicated to treat a rare disease could be granted fast-track designation by FDA, decreasing the overall launch timeline significantly.
When to Hire…
The first thing you need to start thinking about is when you will bring in the Medical Affairs, Market Access, and Commercial teams. When should you begin hiring these functions? And furthermore, what order should these activities be conducted in?
- Medical Affairs:
- Upper management - 24 months in advance
- MSL Team - 21 months in advance
- Market Access: 24 months in advance
- Marketing team: 21 - 24 Months in advance
- Commercial Operations: 21 - 24 months in advance
- Sales Team:
- Upper management (Vice President and Director-level) - 24 months in advance
- Managers - 9 months in advance
- Sales Reps - 1 - 3 months in advance
Typically, manufacturers should begin the process of building out various field teams, hiring individuals in leadership positions, etc., about 24 months before the product launch. The first team to start with is Medical Affairs. The Vice President of Medical Affairs should be hired first (about 24 months prior to launch), and then subsequently the Medical Science Liaison (MSL) team will be on-boarded by that individual (typically around 21 months out). The key objective for the Medical Affairs team at this point is to identify relevant Key Opinion Leaders (KOLs) and other influential physicians who they can then begin meeting and building relationships with to start generating awareness of your company as well as the soon-to-be-launched product.
At the same time, you should also be hiring the Market Access team as this function will be deployed shortly after Medical Affairs – around 24 months prior to product launch. At this stage, the goal of the Market Access team is getting everything in place for the product’s distribution. As such, they will be focused on setting up specialty pharmacies and specialty distribution channels so when approval is obtained, the logistics have been worked out and your product is able to be distributed smoothly.
From there, both the Marketing and Commercial Operations teams will be brought on-board about 21 - 24 months before launch. These teams will work together to begin developing the product’s marketing strategy as well as customer targeting and segmentation plans.
In addition to working with the Marketing team on the product’s launch strategy, the Commercial Operations team is also focused on analyzing the market data and potentially even go through the data points to identify the customer base, understand the patient journey, complete segmentation-related activities, conduct territory sizing, etc. Essentially, the team’s main objective at this point is to prime the system so when the Sales Force is brought on board, everything is in place and ready to go.
And last, but certainly not least, is the Sales Team. The team’s upper management, including Vice President and Director-level positions, are hired about 24 months in advance of the product launch. After being brought on board, the team’s main focus is on providing expertise related to the planning and the strategic aspects of the launch, by going out into the field and providing expertise as to how to plan the product’s launch.
The rest of the Sales Team - including Sales Managers and Reps - usually get hired and deployed a little bit closer to launch, typically about six to nine months out for the team’s Managers, who then hire the Sales Reps about one to three months prior to the product’s launch. Sometimes, if the data is not crystal clear, the company will start the process of recruiting 6 months out and will hire Reps with a contingency plan and will actually bring them on the team about three months prior to launch.
When initially brought on, the Sales Managers’ and Reps’ goal is primarily to go out and continue raising awareness, continue to get physicians buy in, and of course to eventually convert them to writers.
When to Build the Data Infrastructure
After you have brought on the Medical Affairs, Market Access, Commercial, and Marketing teams, you will need to begin building out the infrastructure that will be used to aid in the entire commercialization process. This is usually done around 18 months before launch and includes:
- An enterprise data warehouse – will enable you to bring in different data sources which can be combined to produce insights and intelligence for your field team
- Master data management system – will allow you to manage your customer base
The IT team is typically brought into the company before the 24 month countdown begins, but will get involved in launch activities at this point (about 18 months prior to product launch) to help get the infrastructure and IT systems in place.
When to Engage with Data Vendors for KOL Lists and Forecasting
With a rare disease, data is critical. As such, while you’re getting the infrastructure in place, you should also be thinking about the actual data. With the data in place, your team will be able to gather the insights and intelligence necessary to help point the team in the direction of possible patients.
Other data-related services also include data integrations or data validation. Some of these can be explored while the data is being gathered and analyzed.
Data-related activities are typically handled by the Commercial Operations team. About 15 - 18 months prior to your product’s scheduled launch date, your Commercial Ops team will start working to acquire data regarding sales numbers, prescription volume, etc. so they can begin the process of customer targeting and segmentation.
At this time the team will also start analyzing the syndicated data so they can begin forecasting and planning for the launch so realistic expectations can be set.
When to Start Contracting Activity with Specialty Distributors
The Market Access team’s main goal when coming on board is to get everything in place for the product’s distribution. As such, they will be focused on setting up specialty pharmacies and specialty distribution channels so when approval is obtained, the logistics have been worked out and your product is able to be distributed smoothly.
When to Connect with Vendors to Gain a Better Understanding of Your Patient Journey
After being brought on board, the goal of the Commercial Operations team is to analyze the market data and potentially even go through the data points to identify the customer base, understand the patient journey, complete segmentation-related activities, conduct territory sizing, etc.
Essentially, the main objective of the Commercial Ops team at this point is to prime the system so when the Sales Force is brought on board, everything is in place and ready to go.
When to Implement a CRM
CRM platforms are needed by all field teams to help in managing customers, collecting field intelligence, facilitating day to day operation, distributing insights and analytics, etc. The system requirements for each team are different and therefore will require specific set up. The field deployments of these teams are on different timeline so the implementation timeline will also be different. The typical implementation timeline for these CRM platform are as follow:
- For MSLs - implementation takes six to twelve weeks
- For Market Access - implementation takes six to twelve weeks
- For Sales - implementation takes twelve to sixteen weeks
In addition, the contracting with a system vendor could take another four to eight weeks to complete. So, if the company is looking to deploy a CRM platform at each team field deployment, their plan will need to account for the time needed for the contracting and implementation for each CRM platform.
How to Evaluate and Select a CRM Platform that Fits Your Needs
Buying a CRM system is a long-term commitment that, if taken seriously and done the right way, is designed to enhance the performance of your field teams. When shopping for a CRM platform, there are many things for pharmaceutical and biotech companies to take into consideration. Some of these include:
- Understand & Evaluate Your Sales Process
Whether this is your first product launch or your 100th, there is always room for improvement within your sales process. Taking time to revisit the way your sales team approaches the process is always a good idea and a worthwhile exercise.
- Determine CRM Functionality Requirements to Enhance Sales Performance
Although many core features and functions remain consistent across most CRM platforms, each system has additional unique and valuable capabilities and features. Defining your company’s requirements in advance will make the evaluation and “shopping” process much easier as you assess the different options.
- Vendor Selection
There are numerous CRM vendors in the market, but the list of CRM platforms tailored to the needs of pharmaceutical, biotech, and medical device companies is not quite as robust. Starting your conversations with these specialized vendors will make the evaluation process less painful and easier for you to find the best solution for your organization.
Interested in learning more about how to evaluate and select the right CRM platform for your organization? Download our CRM Buyers’ Guide to get all the details.
Are you developing a rare disease or oncology product that will be launching in the next two to three years? We can help set your team up for success, ensuring all the critical considerations have been accounted for and increasing your chances of a successful product launch. Contact us today to learn more about how we can help you curate a T-24 month-to-launch plan and determine the appropriate data strategy for your organization.