Huebert, Norman D.
Dr. Norman D Huebert, Ph.D.
Company: NormanD Pharmaceutical Consulting Services, LLC.
Business Description: DMPK (in vitro and in vivo), PK/PD relationships, Discovery (LO) and Early development Strategy
Dr. Huebert has more than 30-years of experience in the pharmaceutical industry working in both small and large pharmaceutical companies and collaborating on global cross-company and integrated inter-company outsourcing or collaborative global projects. He has extensive experience in working with CRO organizations in evaluating, training, mentoring, monitoring bioanalytical and pharmacological method development and data interpretation of their operations and design of IT solutions for data sharing from a scientific perspective.
He has played a significant role in the discovery and development of 7 marketed products in various therapeutic areas and has been involved in several dozen projects during the lead discovery, lead optimization and early development stages.
Integration of physicochemical and pharmaceutical properties into the LO and Early Dev process to optimize the drug-like properties of candidates for clinical candidate status.
Knowledge of biochemical and cell-based ADME assays, bioanalytical methodology including both small and large molecule method development and validation.
Knowledge in LC, LC/MS, Eliza, GC, GC/MS, PK modeling, in silico ADME modeling, PK/PD modeling
Experience in broad range of therapeutic areas including: cardiovascular, metabolic diseases, neuroscience (including mood disorders, neurology and analgesia), oncology, respiratory, enterology and immunology.
Experience with small molecules (drugs as well as biomarkers), large molecules (proteins, peptides, pegylated-peptides and -proteins) and prodrugs including bioanalysis and data modeling and interpretation.
Experience in design, analysis and interpretation of pharmacokinetic studies.
Elucidation of pharmacokinetic/ pharmacodynamics (e.g. biomarker) relationships
Strategy for de-risking drug candidates and chemotypes to strengthen drug-like properties and avoid toxicological issues due to metabolic turnover and production of reactive metabolites.
Extensive experience in identifying, selecting, and validating CROs and implementing workflows.
Establishing biological/chemical databases in collaboration with IT in order to increase the efficiency of data sharing and decision making.
Dr. Huebert worked for 21 years in Aventis (and precedent companies, Richardson-Merrell, Merrell Dow Lepetit, Marion Merrell Dow, and Hoechst Marion Roussel) in Europe and the United States in various capacities before joining the biotechnology company, 3-Dimensional Pharmaceuticals (3DP), where he was Director of Pharmacokinetics and Analytical Chemistry. His latest position was with Janssen R&D LLC where he was Head of Discovery ADME and Scientific Director in the Pharmacokinetics, Dynamics and Metabolism group working primarily on Project and Pharmacokinetic Strategy with both chemists and biologists in teams in the Cardiovascular/Metabolic Diseases, Immunology and Oncology Therapeutic Areas. He has recently formed his own consulting company, NormanD Pharmaceutical Consulting Services, LLC.
Dr. Huebert earned both his bachelor's degree in Honours Biochemistry and his Ph.D. in Biological Psychiatry from the University of Saskatchewan in Saskatoon, Canada. He is a member of the American Chemical Society (ACS), the American Society of Pharmaceutical Scientists (AAPS), the International Society of Pharmacometrics (ISoP) and the International Society for the Study of Xenobiotics (ISSX). He has held the post of Adjunct Professor in the Ernest Mario School of Pharmacy at Rutger’s University and has given invited lectures in Europe, North America and Asia.