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Breaking through Barriers: Critical Success Factors for Launching Products with Breakthrough Therapy Designation

The FDA’s Breakthrough Therapy Designation (BTD) expedites patient access to innovative new treatments. While speeding up these processes can get new drugs to patients in need faster than they normally would through standard tracks, limited clinical evidence at launch and a compressed launch timeline can present stumbling blocks and uncertainties for commercialization teams tackling launch strategy, planning and execution.

A differentiated product will contribute to broader adoption in the marketplace, but that is not the sole factor determining its success. Launch teams must understand that they can control and shape the product’s trajectory.

Download the white paper to learn more about the implications of launching BTD products and some critical success factors.

Senior Principal

Sid brings 20 years of experience in pharma sales, marketing and management consulting. He partners with pharmaceutical industry clients at various levels and functions (brand team, medical affairs, clinical development, regulatory, product development) to…

Andrew Therrien, PhD
Engagement Manager

Andy is an Engagement Manager at EVERSANA MANAGEMENT CONSULTING with a background in chemistry, chemical engineering and life sciences consulting. Prior to joining EVERSANA, Andy was a consultant at EQUITAS Life Sciences, where he…

Mark is a consultant at EVERSANA MANAGEMENT CONSULTING with a background in business development, neurophysiology and data modeling. Before joining EVERSANA, Mark obtained more than four years of research experience investigating the biological, computational…

Vivienne Ho, PhD
Associate Partner

As an Associate Partner at EVERSANA MANAGEMENT CONSULTING, Vivienne Ho combines over five years of pharmaceutical consulting experience with 10 years of biomedical research and scientific training to provide support from strategy to execution.…