Karsten Lindhardt

CEO & Founder of Biograil

Roskilde, Region Zealand, Denmark

About

Expertise in Strategy, Value, Research and Development at Highest Level, Green Field Company Platform to a NASDAQ Public Key Player Strategy and Value - Effective transformation from R&D focus to commercial - Strategic Portfolio Management with Clear alignment & communication, structure and tangible targets - Development of Life Cycle Management Strategy - Frequent communication with board Research and Development Leadership at highest level - R&D responsible for FDA approval of ARYMO - Leading activities from Early Discovery to Commercial Stage Assets including responsibility for Phase 1, 2 and 3 clinical studies Green field company platform to a NASDAQ public key player - R&D lead in IPO raising more than USD 65 mill. - R&D lead on Corporate Communication Global Influencer - Founder and organizer of the lobby organisation Cat 1 Focus group and board seat in the mother organization Cross Company Abuse Liability Council - Arranging Global Meeting on Safer Pain Medication - Chosen Global Industry Speaker at an FDA hearing. Characterized by integrity, drive and a pragmatic approach in achieving results as a team. Strong relationship building capabilities and with a great sense of humour

Experience

  • Founder & CEO at Biograil™
    Jul 2019 - Present · 7 yrs

    We're developing breakthrough technology for oral delivery of biologics

  • Chairman at Energipension Brandenburg K/S
    Mar 2019 - Present · 7 yrs 4 mos

  • Co-founder & Non-Executive Director at Scantox at Scantox
    Jan 2021 - Sep 2024 · 3 yrs 9 mos

    Scantox is a GLP-accredited pre-clinical contract research organization originally founded in 1977. Scantox is a renowned world-leader in toxicology studies in mini-pigs. Leveraging its strong track-record and more than 40 years of scientific experience, Scantox’s focus is on providing high quality work within; discovery, pharmacology, toxicology, disease models (anti-obesity, iron deficiency, surgical) histopathology/pathology and regulatory services. Scantox is proud to serve a wide array of biopharmaceutical and medical device companies, ranging from large global biopharmaceutical companies to a growing number of emerging biotech and medical devices companies. Scantox is since 2021, owned by the Nordic based and healthcare focused investment company Impilo

  • Co-founder & Non-Executive Director at Porthos Group at Porthos Group Consulting
    Jun 2019 - Jun 2021 · 2 yrs 1 mo

    Porthos er et rådgivende og udførende konsulenthus som hjælper virksomheder ned at optimere deres drift, økonomi, markedsføring og organisation. Med afsæt i gruppens solide og komplementære erhvervsmæssig baggrund kan vi hurtigt identificere de udfordringer, der påvirker virksomhedens præstationer og muligheder. Vi samarbejder med en række af landets bedste specialister indenfor økonomi, branding, web og HR. www.porthos.dk

  • Egalet Corporation (5 yrs 2 mos)
    • Chief Scientific Officer
      Apr 2017 - Jan 2019 · 1 yr 10 mos

      Areas of responsibilities • Global Scientific Lead with scientific strategic input to business development, commercial and marketing strategies • Invented a novel & potentially disruptive technology for oral delivery of peptides • Cut cost by 80% in 6 months for earlier to profitability

    • Senior VP, Head of R&D, Site Manager
      Dec 2013 - Apr 2017 · 3 yrs 5 mos

      Areas of Responsibility • Lead US manufacturing team completing a PAI audit enabling commercial production • Invented a new opioid product which became the lead candidate and the first product approved with the Egalet Guardian technology • Organisation expanded 40% in 1 year