This was a joint workshop of the Chinese National Center for Safety Evaluation of Drugs, NICPBP and the ILSI Health and Environmental Sciences Institute.
From September 26-29, 2010, HESI staff members Mike Holsapple (Executive Director) and Syril Pettit (Associate Director) accompanied by HESI President Marc Bonnefoi (sanofi-aventis) participated in jointly-organized scientific meetings with representatives from the Chinese State FDA’s National Institute for Control of Pharmaceutical and Biological Products (NIPCBP) and China-based pharmaceutical scientists. The visit included a full day seminar on novel approaches in preclinical safety and informal meetings with NICPBP staff. Other meeting participants included Dr. William Slikker (Director of the FDA’s NCTR), Dr. Masa Honma (Japan National Institute of Health Sciences), Dr. Rick Paules (US NIEHS) and senior pharmaceutical company scientists including Dr. Jiri Aubrecht (Pfizer), Dusty Sarazan (DSI), and Ernie Harpur (sanofi-aventis).
Photos from the event are available here.
| Chair: Dr. Li Bo, NCSED and NICPBP | |
| 8:30 am | Welcome and Introduction from NCSED, Dr. Li Yunlong, Director General NIPCBP |
| 8:45 am | Introduction to HESI and Thank You to NCSED for Invitation – Marc Bonnefoi, sanofi-aventis, HESI President |
| Chair – Xue Wang (NCSED), Masahiro Nishijima (NIHS) | |
| 9:00 am | HESI's Role in Innovation in Preclinical Safety – Syril Pettit, HESI Associate Director for Scientific Outreach |
| 9:15 am | Imaging Technologies for Nonclinical Safety Assessment - William Slikker, FDA, NCTR |
| 9:50 am | Nonclinical Cardiovascular Safety Assessments - Opportunities for Improve Predictivity and Translation - R.D. Sarazan, Data Sciences International |
| 10:25 am | Novel Biomarkers of Renal Toxicity - Dr. Ernie Harpur, sanofi-aventis |
| 11:00 am | Break |
| Chair – Guocai Lu (Second Military Medical University), William Slikker (FDA/NCTR) | |
| 11:15 am | Novel Biomarkers of Renal Toxicity study in NCSED – Li Liu, NCSED |
| 11:50 am | Advances in Preclinical Immunotoxicology Safety Assessment - Michael Holsapple, HESI Executive Director |
| 12:30 - | Lunch |
| Chairs – Zuyue Sun (Shanghai Institute for Planned Parenthood Research), Syril Pettit (HESI) | |
| 1:30 pm | Studies on Methods for Immunotoxicity Tests - Li Bo, NCSED |
| 2:05 pm | Biomarkers of Genomic Toxicity - Jiri Aubrecht, Pfizer |
| 2:40 pm | NIEHS program on Toxicogenomics - Richard S. Paules, US NIEHS |
| Chairs – Xiaobo Cen (National Chengdu Center for Safety Evaluation of Chinese Materia Medica), Michael Holsapple (HESI) | |
| 3:15 pm | Toxicogenomics at the FDA’s NCTR P Weida Tong, NCTR |
| 3:45 pm | Novel Approaches for In Vitro Genotoxicity Assessment - Masamitsu HONMA, Ph.D., Japan National Institute of Health Sciences |
| 4:15 pm | Concluding Remarks – Syril Pettit (HESI), Xiuwen Wang (NCSED) |
| 4:30 pm | Adjorn (5:00 – 5:45 p.m. Roundtable for sFDA and HESI) |
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