KLA Breakthrough Consulting

kelly austin phd, ppm and her team specialize in navigating regulatory affairs pathways to achieve orphan drug (odd), pediatric rare disease (prd), fast track (ftd), breakthrough (btd), and regenerative medicine advanced therapy (rmat) designations. our focus is on providing information to biopharma companies with the information they need to create a solid strategy. therapies that are granted these special designations are much more attractive to investors. use an experienced partner known for strong guidance, an understanding of the unwritten rules at the fda, and the most solid arguments possible for successful submissions in the rare disease space. ► 700+ fda submissions ► 300+ fda orphan drug requests ► 100+ fda pediatric rare disease applications ► 50+ fast track, breakthrough, rmat