Drug Development: The Key to Success from Concept to US Commercialization

Congratulations! You have a lead candidate formulation for your new drug. You might be thinking to yourself, “okay, now what?” We all know the science and effort to get to this stage is significant. And don’t kid yourself – this is just the beginning. Now starts the intimidating and, at times, overwhelming task of implementing, planning, and executing every step from target product profile (TPP) through to commercialization (and just when you thought you were done, there are post-marketing activities to complete as well).

So, Let's Go! But First, a Little Background

There are multiple pathways to getting a New Drug Application NDA), each pathway depends upon the status of the drug under development and the amount of data amassed before the NDA is filed. And the with regard to a branded product. In ProPharma’s experience, from the moment a sponsor focus on development, it can take anywhere from six years for a [505(b)(2) type NDA] to 15 years [505(b)(1) type NDA] to gain approval on a New Drug Application (NDA). And a generic application – an Abbreviated New Drug Application (ANDA) – can be six years as well. If the appropriate steps from year one all the way through year 15 are not planned and executed appropriately, the re-work and needed corrections could extend any projected timeline and add significant expense. Having the right regulatory consultant and partner with the necessary drug development expertise will ease you through the steps of this development.

High-Level Drug Development Timeline

Throughout this development timeline, typically there are sponsor meetings with the regulatory bodies. These need to be thoughtfully planned and prepared for to achieve success.

Drug Development: The Key to Success from Concept to Commercialization

A Few Key Project Management Tools for Drug Development

It is highly recommended that the process, from concept to commercialization, be mapped. This process flow is used as a road map for the entire project and will be broken down into shorter process maps, with decision points along the way. Once all the process flows are mapped, bottlenecks and areas of concern are brought to light and mitigated. This is done through Risk Assessments, Quality Assessments, Resource Assessments, and Project Plans, among other tools. With an appropriately mapped process in place, you have a greater chance of reaching success.

The Right People, the Right Team

The project team can and should change, depending on the phase of development. At a minimum, the following teams should be established at the appropriate phase:

• Nonclinical team
• Clinical team
• Commercial team

Of course, these teams are made up of the appropriate scientists, engineers, project managers, subject matter experts (SMEs), and stakeholders. Additional support includes Regulatory, Marketing, Quality, Sales, CROs, CMOs, vendors, and many others.

As well as having the right people in place, the right studies at the most appropriate timing also need to be in place. A project schedule, developed by the Project Manager in conjunction with SMEs, is critical, as it outlines all of the studies necessary for success.

Oversight is another key to successful drug development. Appropriate teams and stakeholders, led by the project manager, will usher any project to operational excellence. This is done by stage gate approvals throughout the entire process.

Though there are many steps and tools to be used for successful project management, the most successful tools are those that are reproduceable. Partnering with ProPharma’s team of regulatory consultants for your project management needs ensures that Good Project Management Practices are consistently employed.

Benefits of an Organized Driven Approach

An organized program doesn't just look good, it adds value. Stakeholders and potential investors that observe well-defined milestones, an overall mindset of execution, and a program that is being run like a well-oiled machine will clearly see the value.

Furthermore, saving days, weeks, or months on a development timeline significantly increases the value of a program. Consider the monthly cost of the development program. What is the value of being on the market a week or month earlier?

Your Partner in Successful Drug Development - at Every Step Throughout the Lifecycle

Throughout the process of drug development, activities only become more complex, and as we all know, timelines usually become tighter. Strategic project management is your key to success. Finding a partner that utilizes a consistent, tailored, and successful approach to project management means you are taking a proactive approach to risk mitigation and overall project management. Working together through the various phases, and years, of drug development results in a pathway to success that is not only achievable, but perhaps even, dare we say it, enjoyable.