This funding initiative by the Federal Ministry of Education and Research (BMBF) aims to strengthen the innovation potential of small and medium-sized enterprises (SMEs) in biomedical research. It supports high-risk R&D projects addressing major medical needs with clear application relevance, particularly drug development projects up to clinical phase IIa. Eligible projects may be conducted by SMEs individually or in consortia with academic or industrial partners. The program targets SMEs, including first-time applicants and those with little previous research experience, and facilitates access to federal funding mechanisms.

Key elements include:

• Simplified and accelerated application process

• Risky, pre-competitive R&D projects in red biotechnology (medical biotechnology)

• Focus on drug discovery and development (small molecules, ATMPs, vaccines)

• Support for early-phase clinical studies (up to phase IIa)

• Companion diagnostics only if developed alongside a new drug

• Strong encouragement for regulatory consulting and translational planning

• Exclusion: biosimilars, standalone diagnostics, medical devices, and materials science

Deadlines:

• Continuous submission possible, with two fixed cut-off dates: April 15 and October 15 each year.

Important conditions:

• The project must be initiated and coordinated by an SME.

• At least 50% of the requested funding must benefit SMEs.

• Large enterprises are not eligible for funding.

• Results must be used within Germany, the EEA, or Switzerland.

• Proposals must show clear potential for application, market relevance, and future product/service development.