Launching a new drug requires months of meticulous preparation. But whether you’re lining up your first product or already have a promising pipeline, Vynamic’s Launch Navigation provides the expert guidance and hands-on support you need to maximize your chances of success.
Preparing to launch a product is an exciting time and the culmination of huge investment, years of research, and sheer hard work.
But the months leading up to regulatory approval can be fraught with challenges and potential pitfalls that can seriously restrict the impact you’re aiming for. It’s not surprising why, tensions are often high, time is short, and there are multiple moving parts to orchestrate. Success hinges on having a clear launch plan, cross-functional coordination, and ensuring everyone does exactly what they need to do when they need to do it.
Following successful clinical trial data readouts, the countdown to regulatory approval begins, the clock is ticking, and companies have to be more rigorous about their launch planning to ensure they’ve identified all the potential obstacles and they’re taking into account all cross-functional elements.
Smaller or newer companies, for example, may have never launched a product before and therefore lack the slick, well-worn processes, or institutional knowledge. They may also not have a Commercial team or cross-functional team in place or know what everyone’s role needs to be.
For other larger or more established companies, launching a product might not be new, but that doesn’t make it easy. They may be facing multiple launches in a short period of time or have an off-the-shelf launch plan that’s not quite tailored to that specific product or team. Maybe it’s a new, inexperienced team or perhaps the time to launch is significantly shorter due to better-than-expected clinical trial results and scaling up is a challenge.
Whatever challenges your company faces – whether you’re a start-up biotech, a global company, or an alliance of companies collaborating to co-promote a therapy – Vynamic has the solutions and proven track record to help you launch with success.
The key lies in the way we build trusted partnerships with our clients right from the start, understanding your specific needs, and leveraging the years we’ve spent operating solely in the healthcare industry. In short, we become embedded in your team, working with you to gain a deep understanding of the challenges and opportunities, and determining how we can make your launch team successful with proven solutions bespoke for you.
For most product launches, Vynamic typically gets involved around 12 months before regulatory approval, although it can be 18 months or even longer in some cases. The central part of our Product Launch service is Launch Navigation, a flexible, tailored offering specifically designed to prepare you for launch. It builds a complete, robust launch framework by strengthening governance, tactical planning, communication, and collaboration – as well as taking you through rigorous launch-readiness planning through regulatory approval.
1. Launch standup
Standup is all about laying the groundwork – establishing a core internal launch team, defining roles and responsibilities, and creating a clear governance structure for communication and accountability. In particular, we focus on building a unifying launch team culture, helping to define values, guiding principles, and ways of working and sharing knowledge.
Every function in your organization will play a part in preparing for launch, so we ensure that everyone understands and is fully aligned with the launch strategy and overarching objectives.
Vynamic specializes in not only building a high-level strategy, but also ensuring everyone knows their role within it, connecting team members, and anticipating what needs to be done at every stage. Perhaps most critically, we ensure a robust reporting structure is in place along with clearly defined success metrics and KPIs.
2. Launch coordination
Once the launch team and its roles and responsibilities are defined, we take the strategic vision for your launch and build a detailed, cross-functional tactical plan. Through one-to-one engagements with functional teams, we help to set key launch deliverables against that plan, continually monitoring and tracking.
Vynamic adds value by being the common thread that connects all functions. Not only do we put plans in place, but we use our functional expertise to provide hands-on support to individual teams. This ensures targets are met and colleagues are communicating and collaborating with each other wherever necessary. We’ll also help you set up a brand platform for communication, knowledge sharing, milestones, and accountability, establishing a single, auditable repository for all project information
3. Launch readiness
As regulatory approval draws closer, we move into deep preparation mode, planning and managing launch readiness reviews at 12, six, and three months out from launch, focusing on execution and possible scenarios.
As we get closer still, launch team engagements become more frequent, enabling decision-making and identifying any late emerging risks. We then implement a detailed, minute-by-minute plan for all functions based on day-of-regulatory-approval scenarios, including running a mock launch to make sure people, process, and technology readiness and alignment.
At this stage, we can also support you with the Medical, Legal, and Regulatory (MLR) review process prioritization and execution and the coordination of the customer communication cascade, as well as making sure your Sales team members are fully trained and certified.
As you can see, from setting up your team to post-launch analysis, Vynamic will work in partnership with you to coordinate decision-making, establish clear processes, and ensure you’re on track for a successful product launch.
Preparing for product launch can be a challenging time, even for the most experienced of companies. Vynamic brings clarity to complexity with Launch Navigation. Our external experts work closely with you to implement a completely flexible, tailored service to orchestrate your planning, coordinate your teams, and help you prepare for a successful launch.
Vynamic, an Inizio Advisory company, is a leading management consulting partner to global health organizations across Life Sciences, Health Services, and Health Technology. Founded and headquartered in Philadelphia, Vynamic has offices in Boston, Durham NC, and London. Our purpose is simple: We believe there is a better way. We are passionate about shaping the future of health, and for more than 20 years we’ve helped clients transform by connecting strategy to action.
Through a structured, yet flexible delivery model, our accomplished leaders work as an extension of client teams, enabling growth, performance, and culture. Vynamic has been recognized by organizations like Great Place to Work and Business Culture Awards for being leaders and innovators in consulting, company culture, and health. Visit Vynamic.com to discover how we can help transform your
organization or your career.
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