The U.S. market access landscape is complex, proving safety and efficacy is no longer a guarantee of commercial success. Our three-part series will provide the basics of government and commercial payer rules, offer hypotheticals that bring those rules to life, and help prepare you for the market’s evolving focus on value-delivery. At the end of the series, you will understand why your market access strategy can and should start before the initiation of your Phase IIIs, have identified early-stage steps to de-risk those variables with the potential to constrain market access later, and why you should be prepared for investors to ask you these same questions.

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Three startups were selected from the Kansai Life Science Accelerator Program 2023, held in Kobe, to participate in the KLSAP2023 Accelerator Program. The 3-month program, which includes five bi-weekly customized advisory sessions and two presentation advisory sessions, is coordinated by biomedwoRx: Life Sciences Consulting in collaboration with California Life Sciences (CLS).

KLSAP is part CLS’s market access program, which provides commercialization resources and advice to international clusters seeking to establish US subsidiaries. Advisors represent entrepreneurs and business experts specializing in clinical development, regulatory affairs, reimbursement, business development, among other areas of focus.

The program will conclude in December with a CLS Innovation Showcase, where the KLSAP companies will virtually present their work to potential alliance, development, and investment partners.