We’ve entered a new era in the U.S. healthcare system with the passage of the Inflation Reduction Act’s (IRA) landmark policy changes. And whether you are an emerging manufacturer bringing your first drug to market or more seasoned about the whole launch process, it’s important to make sure that your strategy includes a focused public policy element.

A focused policy strategy is especially important for drugs that will revolutionize a treatment class or are in under-funded spaces like mental health or rare disease. Federal structures like the FDA Oncology Center of Excellence exist to shepherd innovative products to market. Still, additional due diligence is required to achieve optimal patient access in other therapeutic areas.

Two Labs is currently supporting a mid-size biopharma company with a novel treatment coming to market. Helping prepare for launch, our Public Policy team has partnered with the company’s government affairs team and their legal advisors to prioritize state and federal issues that could impede patient access. This involves developing actionable plans to remove barriers, including amendment proposals, legislation changes, and the potential development of a new drug class for the novel treatment. Furthermore, all materials developed are adapted for government affairs field team use in target states to facilitate impactful discussions with local and federal policymakers.

Clients who engage with the Two Labs Public Policy team receive a holistic suite of deliverables that help effectively communicate and pull through their policy strategy priorities. This includes:

  • Presentations to leadership and boards of directors
  • Education for internal and external stakeholders as well as a field team strategy guide

  • An outline of the current standard of care landscape

  • Key burden of disease messaging
  • Extensive profiles of target states

  • Leave-behinds on proposed legislation

Ideally, all this work leads to overall commercial success, but the true goal is to realize a tangible positive impact on patient lives.

Whether you’re an emerging biopharma company 1-3 years out from a new product launch, or an established pharma company looking toward patent expiry, the non-partisan Public Policy team at Two Labs offers experience in healthcare policy outside of traditional government confines and unbiased opinions to create strategies and provide solutions. 

Have you considered what government roadblocks might be in the way of your product getting in front of patients? Whether a new or existing product, we can help. We empower teams to focus on innovation in their fields while we clear the pathway to patients in need.