Karsten Holm, Ph.D., MBA

Business Development Manager, Regulatory Affairs at ProPharma Group
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Contact Information
us****@****om
(386) 825-5501
Location
Greater Boston

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Experience

    • United States
    • Business Consulting and Services
    • 700 & Above Employee
    • Business Development Manager, Regulatory Affairs
      • Jun 2020 - Present

      ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio of regulatory sciences, clinical research solutions, life science consulting, pharmacovigilance, and medical information services to help solve complex challenges in a dynamic regulatory environment. With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle. Our veteran regulatory sciences team has over 30 years of experience using scientific knowledge to strategize viable and efficient drug and device development pathways to achieve successful outcomes with regulatory agencies in the US and Europe. Explore all the ways that ProPharma Group can support your pharmaceutical regulatory affairs needs and product pipeline throughout the entire product lifecycle or speak with one of our regulatory consulting experts. Show less

    • Croatia
    • Biotechnology Research
    • 1 - 100 Employee
    • Business Development Director USA
      • Mar 2019 - Dec 2019

      Fidelta, a wholly-owned subsidiary of Galapagos NV, is a fee-for-service, collaborative drug discovery organization that combines expertise in the areas of chemistry, pharmacology, ADME, pharmacokinetics and toxicology. Fidelta offers fully integrated services, as well as flexible stand-alone solutions for projects in discovery and early pre-clinical development. As an undisputed leader in macrocyclic drug discovery Fidelta has developed a new macrocyclic drug discovery platform, FideltaMacroTM. Fidelta’s objective is to deliver efficacious, safe and differentiated pre-clinical candidates to its clients. For more information, visit www.fidelta.eu. Show less

    • Business Development Manager
      • Nov 2017 - Feb 2019

    • United States
    • Biotechnology
    • 100 - 200 Employee
    • Regional Director, Business Development
      • Aug 2016 - May 2017

    • United States
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Vice President of Business Development
      • Dec 2014 - Aug 2016

    • United States
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Manager, Chemistry and PK/ADME
      • Apr 2012 - Dec 2014

    • Principal
      • Apr 2010 - Apr 2012

      Provide scientific consulting for pre-clinical drug development and regulatory filings. Services include study design review, study design consultation, report writing and report review as well as study site monitoring. Provide scientific consulting for pre-clinical drug development and regulatory filings. Services include study design review, study design consultation, report writing and report review as well as study site monitoring.

    • United States
    • Research Services
    • 300 - 400 Employee
    • Principal Study Director/Director of ADME
      • Jan 2005 - Feb 2010

    • Senior Scientist
      • May 2000 - Jan 2005

    • Principal
      • Jun 1997 - Apr 2000

      • 1997 - 1998

      • 1997 - 1998

      • 1997 - 1998

    • Study Director
      • May 1994 - May 1997

    • Senior Research Scientist
      • Dec 1989 - May 1994

      • 1980 - 1986

      • 1980 - 1986

Education

  • Saint Joseph's University
    Master of Business Administration (M.B.A.), Pharmaceutical and Healthcare Marketing
  • Clark University
    M.S. and Ph.D., Chemistry and Drug Metabolism
  • University of New Hampshire
    Bachelor's Degree, Biochemistry
  • University of Kansas

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