How to Launch a Product Succesfully
Launching a new drug can be one of the most exciting parts of working in the pharmaceutical industry. However, this Launch also comes with incredible pressure to deliver.
In medical affairs, we don't usually concern ourselves with the data before the phase 3 trial is complete. If you're aware of a company conducting a phase 3 trial for a drug, this is an opportune time to stay close to the data, people and stakeholders involved in the company. Linkedin is excellent for this! From personal experience of being hired into an MSL role, a phase 3 trial completion is when companies look for the best talent.
Furthermore, once the trial is complete, this creates a chain reaction to kick activities into full throttle in anticipation of the product launch.
The 24 months before the Launch are critical in the success or failure of the drug. As the saying goes failing to prepare is planning for failure.
So, what type of activities occur during the pre-launch phase?
24 months until Launch
At the 24 months stage, your medical affairs team ramps up their activities, and a new team can be created or expanded to prepare for the product launch. At this stage, the medical affairs team must understand the current guidelines and patient care pathways for the therapeutic area. Insight generation occurs in the disease area and understanding the target market too.
Lastly, MSLs and Medical advisors will engage with KOLs to build up disease awareness and the current challenges suffering patients face. Raising awareness with healthcare professionals helps them understand the current market gaps and how your new product can fit into the landscape and treatment guidelines.
12 months until Launch
The 12 months stage is when companies will apply for licencing to their national regulatory bodies, FDA (US), EMA (EU) or MHRA (UK); This allows the product to be licensed and for use, and some activities that may take place during this period include:
• Refining the medical strategy
• Disseminating medicines information on the correct administration, dosage and side effects of the product to healthcare professionals
• Gaining medical insights by conducting advisory boards and having face-to-face meetings with key opinion leaders
• Developing the story you want to tell about the product
Launch
So, the time has come, the product has been launched, and it is in the market. They're two primary goals at the launch stage.
1. Educating health care professionals
2. Developing real-world evidence
The first is to educate health professionals and address inquiries about the new product. For example, a healthcare professional may want to understand if your product has evidence of use in pregnant women and what data supports this.
Secondly, real-world evidence, also known as a phase 4 trial, is when the data is gathered regarding the use and benefits of the product in the actual real world. It is all well and good that in your phase 3 trial, 70% of patients had efficacy over the 12 weeks tested, but how does this number correlate in real life, and what are the challenges experienced by both the patient and health care professionals when prescribing and managing patient's on your product.
It is critical to understand these insights to generate new ideas of how you can shape medical strategy beyond the Launch.