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25 Pharmaceutical Product Launches — What did I learn?

I recently had a momentous week in my professional career. I launched my 25th pharmaceutical product into the market. Commercialization is a complex process and rarely do people get to work on it. I’ve been fortunate to work on 25 product launches with some amazing teams across the Diabetes, Obesity, Hemophilia, Oncology, Ophthalmology, Dermatology, Long Term Care and Biologics therapeutic areas.

I sat down to make a note to self, on what I have learnt based on all these launches. Then thought why not share it with all of you as well. So, here it goes…

Processes — repeatability and predictability of processes is the key. Processes make a company person independent. When trained in these processes, every team knows what to expect and what their responsibilities are.

Planning — Scenario planning and risk planning is an integral part of product launch. Mapping out all dependencies, especially for critical path activities is a must. Time spent on planning will help your last mile go smoothly.

People Management — ensuring every team member understands their role and activities is important. There are many tools to help manage projects and team inputs in the market today. Assessing a good tool will definitely help with team engagement, people management and most importantly project management.

Perspective — Understanding where the new product fits in your portfolio, company priorities and customer priorities is extremely important. Especially when you have limited resources, it may make sense to delay a new product launch to ensure the current brand on market has no disruptions.

If you are Merck and you have Keytruda in your portfolio, it makes sense to spin off 90 slow-growth products.

Predictability — The one constant thing in a new product launch is the “Uncertainty”. The approval date, brand name, colors; everything is up for change until FDA approves the label. With this lack of predictability, you need to establish internal milestones that are predictable.

Make your plan predictable by mapping timelines in duration and setting dependencies with multiple approval scenarios

Product Availability — this is the one of the most important steps to map out upfront. You don’t have a launch if there is no product. Understanding your internal and external constraints ensure that you can set expectations that are realistic. If product is manufactured and shipped form outside US, plan for all events; Shipping, Middle point warehousing, Customs clearance, FDA clearance.