Karsten Lindhardt, MSc, PhD, DBE

Bio:

Karsten Lindhardt, MSc, PhD, DBE, is a pharmaceutical executive and serial entrepreneur with more than 25 years of global leadership across clinical pharmacology, R&D strategy and company building. Over his career he has raised more than USD 100 million, led a landmark FDA approval, and co-founded four companies.

Since 2019, Karsten has been Founder and CEO of Biograil ApS, which is developing the patented BIONDD® device for oral delivery of biologics. He has raised more than €50 million, built a ten-person executive team, and secured partnerships with leading global pharmaceutical companies. BIONDD® achieved 100% delivery success across seven in vivo studies, becoming the first oral platform to match subcutaneous bioavailability for biologics including mAbs and GLP-1s. He is now advancing the platform toward IND filing and first-in-human clinical trials.

Previously, as CSO and SVP R&D at Egalet Corp. (NASDAQ: EGLT), Karsten led development of ARYMO® ER, the world's first FDA-approved injection-molded oral tablet. He also shaped the R&D narrative for a NASDAQ IPO that raised more than USD 65 million. He began his career in clinical pharmacology at Novo Nordisk and Ferring.

Karsten is co-founder of Dlivery Pharma, co-founder of Scantox A/S and an expert panel member for the Danish Innovation Fund's Innobooster programme. He has represented the industry at an FDA Advisory Committee hearing and is a regular keynote speaker. He holds a PhD in Pharmacology and Pharmaceutics and a Diploma of Business Excellence from CBS and Columbia University.