The value of your therapeutic is driven by the science behind the molecule and its expected or documented medical benefits. If the medical value story isn’t clear and backed up by data, it’s an uphill battle to achieve successful commercialization and reimbursement from payers at targeted prices.
As your therapy gets closer to commercialization, the need for clear scientific communication becomes increasingly important. Establishing an effective Medical Affairs function is vital to communicate the value of your asset(s) to the entire spectrum of medical stakeholders and ensuring you gather the variety of insights you need for your program to succeed.
However, the Medical Affairs build is often deprioritized until it can no longer wait, which is shortly before product launch. Even though it is possible to spin up a Medical Affairs function on a short timeline, most Medical Affairs activities require significant time to yield the expected benefits. Medical Affairs teams established less than 18 months before launch can only deliver on short-term projects, which are not where Medical Affairs can drive the most value for your therapeutic. Ideally, the Medical Affairs team needs to be established much sooner than its commercial counterpart to effectively communicate the value of your asset(s), prepare the clinical and payer space, and support the launch and the early lifecycle. When you clearly communicate the value of your therapeutic with key stakeholders, it becomes easier to:
Secure additional funding
Obtain expert insights to develop and adjust your program, so they meet regulatory milestones and unmet clinical needs
Get proper reimbursement from payers
Build trust in the marketplace
At SSI Strategy, our team will meet you where you are. We start out with a situational analysis to determine the best course of action based on your organization's stage and needs. Then we design a roadmap and strategic plan and roll up our sleeves to execute the plan with your teams. Alongside these key planning initiatives we can also assist with execution of critical tactics that require immediate action.
An agile Medical Affairs support team
Your Medical Affairs requirements ebb and flow. Certain Medical Affairs roles make sense to establish early on. However, hiring full-time employees with specialized skillsets only required in short sprints until key milestones are met isn’t an efficient use of resources. And individual contractors aren’t always considering the entire cross-functional Medical Affairs function.
Our model is built around an agile approach. We bring in the exact skillsets you need at the right time. Instead of trying to find someone that can adequately fulfill disparate skill sets, you can get access to experienced experts for your exact needs.
Here are a few sample projects we execute for our clients:
Typical Initial Projects
Medical Affairs Functional Roadmap / Organizational Design
Launch Readiness Assessment (for a particular asset)
Medical Affairs Plan Development (for a particular asset or a portfolio)
Examples of Additional Follow-on Projects
Investigator Sponsored Study (IST) Program Design and Implementation
Medical Communication Set up & Execution (Publications, Medical information, Congress planning…)
Real World Evidence (RWE) and Health Economics and Outcomes Research (HEOR)
Interim roles such as:
Medical Affairs Lead
Medical Operations Lead
Evidence Generation Lead
Scientific Communications Lead
Medical Operations Program Management
As your funding fluctuates and your Medical Affairs requirements progress and change, we’ll work with you to meet milestones and derisk your organization through proper planning, management documentation, and execution. Our team members embed in your team to ensure your medical story is clear, compelling, and delivered effectively.
