Durham, NC (PRWEB) November 07, 2013
Cato Research clinical research physician and managing director for Cato Research’s Washington office, Jack Snyder, M.D., Ph.D., R.A.C., D.A.B.T., C.P.I., and Cato Research regulatory expert Elinore M. Mercer, Ph.D., R.A.C., will present in Rockville, Maryland, at the Korea-Maryland, United States of America Bio Expo, Drug Development Process and Regulatory Approaches.
Dr. Jack Snyder will present the following sessions:
Session 1: “IND Process – Nonclinical”
1. Pharmacology and Toxicity Study Design and Guidance
2. Case Studies in Pharmacology and Toxicology
Session 2: “CMC Process”
1. USP Identification Standards
2. Chemistry Section
3. Specifications for CMC / CMC
4. FDA Pertinent Guidance
Session 3: “Pharmacometrics and Clinical Trials Design”
1. Data Analysis, Pharmacometrics and Clinical Trial Design Statistical Methodology for Design
2. and Evaluation of Clinical Trials
3. Use of SAS, Population Modeling, PK/PD Modeling
4. Case Studies and Pertinent FDA Guidances
Dr. Elinore Mercer will copresent Friday, November 8th on the following:
Session 7: "Innovative Strategies for New Drug Development"
1. Current Initiatives for Repurposing Pharmaceuticals and New Development
2. Biosimilar Strategies and Current Guideline Discussion
3. Biosimilar/Follow-on Biologics; Pertinent FDA Guidance
Dr. Snyder serves as a Clinical Research Physician and managing director for Cato Research’s Washington office as well as a Medical Analyst for Cato BioVentures. Dr. Snyder is a pharmacologist-toxicologist-pathologist with more than 25 years’ experience in academia, government, and industry. Dr. Snyder has experience in diverse ar
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