Patent Ready, No Launch

Developing a novel pharma product and getting it registered, after surpassing the complex regulatory frameworks, is half story, and launching it successfully, by involving multidisciplinary project team, into the marketplace and distributing across the targeted regions is a challenging move. When all done, that’s the real difference a company makes.

Does it make sense when you maximize your efforts, consume longer time period, and then no returns are predictable?

Let’s say this way: after spending millions of dollars, project period stretching by years, there remains no proper planning and timely execution for launching a new drug.

In some cases, a disruptive focus on the regulatory submission involves haphazard initiatives and delayed decisions that planning for launch remains unheard topic. What matters is how a delay in launch can cost a company and reduce its ability to regain its investment in R&D. An unusual, prolonged inability to launch can allow competitors to grab opportunities and come up early with similar product. Agreed that no one deliberately delays launch, but it all happens when there’s lack of prudence and right scheduling.

In simplicity, when things go awry, more hurdles become apparent and set timelines go messy, then what requires is the ability of the project team to take action effectively. When project blockades remain unsolved, no viable communication continues between team members and no critical tasks are charted out, then there’ll be more problems, more challenges and finally a derailed project plan.

In fact, simple guidelines can help steer a project team through effective product launch planning such as:

1. Preparing Product Launch Plan for New Drug

2. Documenting roles, responsibilities and timelines for launch activities

3. Setting clear priorities and staying focused on the agenda

4. Preparing detailed plans and schedules for commercial launch

5. Dynamic Brainstorming to review performance and situations

6. Creating ‘what if’ flowcharts to depict strategic issues

7. Calculating the probability and level of each risk to understand diverse scenarios

8. Developing action plan to manage project activities to increase efficiency

9. Assigning key person to be accountable for the complete launch effort

10. Identifying opportunities for smooth product launch

What happens when a launch project lacks able leadership and sequential project updates? Probably, everyone starts working in disconnected groups or in individual manner. And then, any miscommunication or lack of communication between team members becomes a major hurdle leading to confusion.

Moreover, what matters most is the unique corporate culture of an organization that integrates expertise of team members and helps to decide launch preparation strategy.

In conclusion, a project manager should play a vital role in building a comprehensive launch plan, harnessing effective working relationships with external parties, driving collaboration among the team members, managing and coordinating launch phases, identifying critical milestones, determining and informing metrics on progress versus objectives for launch activities and coordinating respective site strategic initiatives as and when required.

In fact, with a proper plan and the ability to identify any potential impediments and risks, a company can succeed to launch a new drug product in the market.

Image source: pharmamanufacturing.com