CNE Seminar, Technologiepark Basel, Switzerland, 6th of December 2017

Abstracts:

Dr. Maurice Cary:

Demystifying Histopathology for the Non-PathologistHints & Tips to Help Spot When Something is Not Ok in the Data

The seminar is organized for any individual working in any type of company ranging from a start up to a large company developing pharmaceuticals, biologics or nutrients; whose is responsible for receiving and reviewing histopathology data from  studies, albeit efficacy  or safety/toxicity. Such individuals, though having no to limited training in pathology, are nevertheless responsible for providing critical feedback or input to CRO or independent pathologists that might include, but not be limited to, spotting errors or at least providing proper perspective that in all likelihood will prove critical to the life of the compound or, as in the case of start-ups or small companies, the life of the company itself.

The presentation material will consist of basically what such individuals receive for review, i.e. report texts and tables. The presenter, Dr. Maurice Cary, DVM, PhD, DACVP with over 32 years of industry experience in drug development, will use this material to share with the attendees his tips and hints to identify possible problems that may require follow up. He will also share examples where text or speculation has been included that might not be obvious to the untrained eye, but would raise a red flag to the eye of a trained regulatory reviewer.

Dr. Barbara von Beust:

“Toxicologic Clinical Pathology – What is That and What is Toxic About It?” 

Toxicologic Clinical Pathology (Tox Clin Pathol) is a relatively new discipline within Veterinary Clinical Pathology, a veterinary specialty getting more and more established in many internationally successful Pharma Companies and CRO’s. Tox Clin Pathol includes data generation, analysis, interpretation and reporting in drug development and safety evaluation in  established laboratory animal models such as rodents, dogs, monkeys and mini pigs. Data interpretation is not focused on diagnosing a disease but rather treatment related changes in hematologic or clinical chemistry variables relative to a control group and /or pretreatment data. Especially method and instrument validation, particularly when measuring new biomarkers, the importance of quality control in the laboratory and careful planning and implementing of standard procedures in study protocols may necessitate the contribution of a veterinary clinical pathologist, ie a veterinarian especially trained and certified in clinical pathology and laboratory medicine.

Dr. Barbara von Beust is one of the very few European veterinary clinical pathologists with significant experience in the pharmaceutical industry and with excellent contacts with many North American peers, which have culminated in co-authorship of several Best Practices publications in Tox Clin Pathol and the delivery of many invited lectures and workshops.

This particular seminar will first present a definition of clinical pathology, followed by the different study phases including an optimized study plan and standard procedures (GLP) and recommended practices in data interpretation in different species. As time allows some examples  will also be presented in hematology, coagulation and clinical chemistry.

 

Please sign up per e-mail here.