Basic Safety Sciences: Pharmacoepidemiology, Clinical Pharmacology, Pharmacogenomics, and Toxicology Studies
Authors
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Beate Aurich
- Pharmacovigilance and Drug Safety Consultant
- conect4children, France
Dr. Beate Aurich is a pharmacovigilance/ drug safety physician, general paediatrician (MRCPCH London) and a methodological expert for paediatric pharmacovigilance in the 'conecting4children' (c4c) network. She has twenty years of pharmacovigilance and drug safety experience in pharmaceutical industry and academia. She is a member of ISOP, ISPE and ESDPPP and fellow of the governance, ethics, evidence, policy, practice (GE2P2) Global Foundation. Currently she is the head of Drug Safety Consulting S.A.S.U., an independent pharmacovigilance and drug safety consultancy for academic and industry sponsored paediatric and adult clinical research.
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Laurie Iciek, PhD
- Senior Consultant, Nonclinical
- Biologics Consulting, United States
Laurie is currently a Sr. Nonclinical Consultant for Biologics Consulting. Previously she spent 17 years in industry as a lead Toxicologist for MedImmune/AstraZeneca, Abbott Laboratories, and Bristol-Myers Squibb. Her academic training is in cellular and molecular immunology and her professional experience includes: 1) designing, executing, and defending preclinical safety assessment packages for multiple modalities/indications; 2) authoring nonclinical sections for regulatory submissions; 3) conducting due diligence, target safety risk assessments, and gap analyses; and 4) directing/monitoring GLP toxicity studies. She has worked with monoclonal antibodies, antibody-drug conjugates, proteins, vaccines, cell therapies, and small molecules.
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Maria Learoyd, PhD
- Senior Clincial Pharmacologist
- AstraZeneca, United Kingdom
Maria is a Clinical Pharmacology Director, with more than 20 years’ experience developing new drugs in therapy areas including Infection, Respiratory and Inflammation and Oncology, whilst at AstraZeneca. Maria has been fortunate to provide Clinical Pharmacology leadership for 3 medicines which have reached the market doing her career. Recently, developing medicines for paediatric patients has provided exciting challenges, such as using PK extrapolation to bridge efficacy data from older to younger patients and predicting the dose for very young children using modelling and simulation approaches. Maria received her PhD. from The School of Pharmacy, University of Manchester and lives in the North-West of England.
