Profile
As your experienced and goal-oriented consultant, I can rely on more than 20 years of hands-on experience in life-science organizations in the pharmaceutical, biopharmaceutical and medical device industry, in which I successfully moved development candidates from research into clinical development
NCMA Consulting offers
List of services
NCMA Consulting has
the education, the skills and the experience to build and lead your Nonclinical Department and your Nonclinical Activities
more than 20 years of hands-on experience in cross-functional matrix management organisations of the life-science industry
the ability to influence people and decision making on all levels of your organization
proven track record of moving (bio-)pharmaceutical projects and medical devices from discovery into clinical development
I have the experience to understand your needs and will advice you on the best nonclinical and regulatory strategy to handle your development candidate. My advice will be tailored exactly to your needs to provide added value for you.
List of services
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Dr Herbst is a consulting Nonclinical Manager with more than 20 years of experience in the (bio-)pharmaceutical and medical device industryList Item 1
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He exerts strong leadership by fostering communication between stakeholders and is able to influence decision making on all levels of your (Bio-)Pharmaceutical and Medical Device life-science organizationList Item 2
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As a results-oriented Nonclinical Manager and Safety Expert he is experienced in defining robust and reliable development programs with a translational approach for your development candidate includingList Item 3
- Timelines and budget
- Implementation: selection of suitable CROs; placement, planning, monitoring and finalization of nonclinical GLP and non-GLP studies
- Risk-Benefit-Assessments, Justification of the MRSD/FIH, Safety Assessments
- Gap Analysis and Issue Management
- Regulatory Writing
- Setting up a GLP conform nonclinical SOP package
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His strength is his regulatory knowledge in various regions, regulatory environments, and therapeutic indications with a range of molecular scaffolds and his experience in interactions with regulatory authorities. This expertise is completed with a comprehensive knowledge of nonclinical guidance and safety assessment approaches.List Item 4
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These skills allow him to advise his clients to design their programs according to their needs with closely monitoring the implementation and execution.
Education
- Diploma in Chemistry
- PhD in Biochemical Toxicology
- Expert in Toxicology (Fachtoxikologe DGPT)
- European Registered Toxicologist (ERT)
- Diplomate of the American Board of Toxicology (DABT)
Previous positions
1999-2003: Human Safety Assessment, Syngenta AG, Basel
2003-2006: Head of Toxicology, Merckle/ratiopharm GmbH, Ulm
2006-2009: VP Pharmacology / Toxicology, Apogenix GmbH, Heidelberg
2009-2012: Director Toxicology, MorphoSys AG, Munich
2013-2020: Director Toxicology, Molecular Partners AG, Zürich
2020-2021: VP Nonclinical, Auregen Biotherapeutics AG, Zürich
NonClinical Management and Advice