To ensure a successful drug launch, biotech companies must start their commercialization planning at least 18 months in advance. This lead time is essential for deeply understanding the patient journey, identifying treatment barriers, and aligning clinical trials with outcomes that truly matter to patients and payers.

A medically effective therapy (a 'good drug') can be a commercial failure if its delivery method is incompatible with existing healthcare systems. For example, a complex cell therapy requiring specialized procedures is a 'bad product' compared to one administered via a standard IV infusion, which plugs into current hospital infrastructure.

The common misconception is that market access teams just set prices. In reality, they are a complete business leadership team with diverse expertise in health economics, strategy, and outcomes research. They must understand the entire business environment to demonstrate a therapy's value and ensure its commercial success, operating far beyond a simple pricing role.

Bio CEO John Crowley defines "winning" in the biotech race as a two-part victory. It's not enough to lead in scientific discovery; the US must also dismantle systemic barriers like insurance hurdles and high out-of-pocket costs to ensure Americans can access these advanced medicines.

Gaining FDA approval is not the finish line. Many innovative devices fail because they lack a clear reimbursement strategy. Founders must build the economic case for payers and providers in concert with their clinical and regulatory strategy from day one.

Successful drug launches require nailing three fundamentals. Common failures include: misjudging the patient population (epidemiology), failing to secure reimbursement and patient access, and lacking clear differentiation against the established "gold standard" treatment in physicians' minds.

True innovation in getting drugs to patients is not about pharma creating pricing models alone. It requires a multi-stakeholder partnership where payers, physicians, and manufacturers work together to solve problems for specific patient subgroups. This collaborative effort, not a unilateral one, is what truly saves lives and reduces costs.

Many biotechs focus R&D solely on regulatory approval. Beren Therapeutics integrates commercial thinking early to ensure clinical development answers a different question: Is what we're building meaningful to patients, payers, and providers? This de-risks the asset for commercial success, not just clinical milestones.

Biotech leaders must stop viewing commercialization as a post-approval task. The critical window is Phase 2 clinical trials. By embedding patient journey and quality of life insights into secondary endpoints, companies can build a compelling value proposition for payers and physicians. Waiting until Phase 3 is too late.