No. : #12/2021
Topic : Opportunities & Challenges for In vitro toxicology
resulting from USEPA announcement to be animal free by
2035
Date : Saturday 10th July
Time : 08:00 PM am India Time (Mumbai, GMT+05:30)
Speaker : Dr.Clive Roper, Director, Roper Toxicology Consulting,
Scotland, UK
Speaker Bio :
Dr. Clive Roper is presently working as Director, Roper Toxicology Consulting, UK, developing NAMs and supporting regulatory acceptance of NAMS. Earlier he was associated with Charles River for 25 years. Clive graduated with a PhD in in vitro dermal metabolism and toxicology from Newcastle University. Later he pursued post-doctoral research from the same university. He has presented at many meetings and organized small meetings (Skin Metabolism) and large conferences (WC9). Dr. Roper has authored and co-authored many posters and abstracts as well as peer review papers. He is a peer reviewer for journals including TIV, Regulatory Pharmacology & Toxicology, Annals of Work Exposures, and Health and Skin Pharmacology and Physiology. He has been actively involved in advising regulatory agencies including NIH, SCCS and EPA as well as industry bodies and has presented a webinar on in vitro toxicology with the FDA. He is a founding member of the North American 3Rs Collaborative and active in the MPS subgroup. He is most proud of having 4 peer review papers quoted in 2 OECD Test Guidelines (OECD 492 and 428) and working with US EPA, Health Canada, and other regulatory agencies towards ending the dermal triple pack.
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No. : #11/2021
Topic : Early safety screening and species selection for safety
studies of pharmaceuticals
Date : Saturday 12th June
Time : 08:00 PM am India Time (Mumbai, GMT+05:30)
Speaker : Dr. Claudia Stark, Vice President, Experimental
Toxicology, Bayer Pharma, Berlin
Speaker Bio :
Dr.Claudia Stark is presently working as Vice President, Toxicology at Bayer Pharma, Berlin, Germany. She has more than 25 years of experience in pharmaceutical industry. She did her PhD in Veterinary Pathology from Freie university, Berlin. Dr.Stark is experienced with designing of complete safety testing programs for drugs, diagnostics and radiopharmaceuticals. She is experienced with supervising reproduction toxicology, pathology and in vivo toxicology laboratories. She has many publications in the field of nonclinical safety testing,
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No. : #10/2021
Topic : Clinical pathology: Principles of data interpretation
Date : Saturday 8 th May
Time : 08:00 PM am India Time (Mumbai, GMT+05:30)
Speaker : Dr. Niraj Tripathi, Veterinary Clinical Pathologist, Covance
USA
Speaker Bio :
Dr.Niraj Tripathi is presently working as a Veterinary Clinical Pathologist with Covance. He completed his PhD and residency in clinical pathology from University of Georgia. He did his BVSc and MVSc education from G.B.Pant University. He has been working in the field of Toxicologic Clinical pathology for more than 18 years. Primary responsibilities include data interpretation, report writing, providing scientific consultation to the sponsors and internal scientific staff, and scientific oversight to Clinical Pathology lab staff. He has been actively involved in profession scientific societies and several book chapters and journal article in peer review journals. He has developed deep understanding of novel methods and biomarkers used in preclinical/toxicity studies for the advancement of drug development.
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No. : #09/2021
Topic : Humanized Mouse Models for Preclinical Research:
Opportunity and Limitations
Date : Saturday, April 24, 2021
Time : 08:00 PM am India Time (Mumbai, GMT+05:30)
Speaker : Dr. Kuldeep Singh, Director of Pathology, Wuxi AppTec ,
USA
Speaker Bio :
Dr.Kuldeep Singh (Diplomate ACVP) currently serve as a Director of Pathology at WuXi AppTec Inc He has over 10 years of experience in anatomic pathology Prior to joining WuXi AppTec Inc he worked at Sanofi as a Senior and Principal Scientist He has also held position at University of Illinois as a Clinical Assistant and Associate Professor, and Head of Anatomic Pathology. He completed his PhD and residency in anatomic pathology at Oklahoma State University, MS at University of Utrecht, and BVSc at G B Pant University of Agriculture and Technology, Pantnagar His PhD was focused on molecular pathology and MS on experimental pathology. He has experience in investigative, toxicologic, and diagnostic pathology His experience in investigative pathology include working on studies aimed at target identification, target validation, lead candidate optimization, efficacy assessment, model characterization, and biomarker identification. His experience in toxicologic pathology include conducting preclinical safety assessment of both small and large molecules intended for several therapeutic areas including oncology, immunology, rare diseases, and neuroscience. His areas of interests are investigative pathology, toxicologic pathology, digital pathology, biomarker identification, investigative toxicology, neuropathology, and immune system pathology.
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No. : #08/2021
Topic : Determining adversity in non-clinical toxicity studies
Date : Saturday, March 13, 2021
Time : 9:30 am India Time (Mumbai, GMT+05:30)
Speaker : Dr. Bhanu Singh
Speaker Bio :
Dr. Bhanu Singh is currently working as Senior Director, Pathology, at Gilead Sciences. Bhanu is a board certified veterinary anatomic pathologist (DACVP) and toxicologist (DABT) and is also a Fellow of International Academy of Toxicologic Pathology (IATP). He has over ten years of industry experience, most recently as Scientific Director, Pathology at Janssen Pharmaceuticals supporting discovery and nonclinical safety of Oncology and Cardiovascular & Metabolic Diseases programs. Dr. Singh has a strong scientific interest in drug discovery (oncology and cardiovascular metabolism), molecular pathology, liver toxicity, development of animal models of human diseases, and chemical carcinogenesis. He has authored over 20 peer-reviewed publications, five book chapters, and 80+ regulatory and research pathology reports and delivered more than 70 presentations in various scientific meetings. Dr. Singh is actively involved in professional activities for various societies of toxicology and pathology, such as Chair for the STP education course committee, and in the past has served as Associate Editor for Drug and Chemical Toxicology, Chair for the IFSTP-IATP webinar committee, and Chair for Dog INHAND committee. Dr. Singh completed his pathology residency training at the Royal Veterinary College, London (United Kingdom). During his residency training, he did internships and externships at Bern University (Switzerland); the University of California, Davis (United States); the Armed Force Institute of Pathology (Washington, DC); and the National Institute of Environmental Health Sciences (NIEHS). After finishing his residency, he worked at NIEHS/NTP (Research Triangle Park, North Carolina) as a Visiting Fellow in Dr. Dave Malarkey’s laboratory. He received his veterinary training at G. B. Pant University (Pantnagar, India) and a masters at Utrecht University (Netherlands).
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No. : #07/2021
Topic : Health Based Exposure Limits (HBELs) in Risk Assessment
Date : Saturday, February 13, 2021
Time : 8:00 pm India Time (Mumbai, GMT+05:30)
Speaker : Dr.Ester Lovsin Barle (DVM, MScTox, PhD)
Speaker Bio :
Dr.Ester Lovsin Barle (DVM, MScTox, PhD) is the Head of Product Stewardship & Health at Takeda, Switzerland. Her responsibilities include scientific development and cross-organizational implementation of health based exposure limits (HBEL), compiling global policy on occupational toxicology and patient safety related process in support of manufacturing globally, as well as global implementation of safe handling of chemicals.
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No. : #06/2021
Topic : Development of Anticancer Therapeutics: Challenges for
Assessing Human Safety
Date : Saturday, January 9, 2021
Time : 8:00 pm India Time (Mumbai, GMT+05:30)
Speaker : Dr. Vijayapal Reddy (DVM, PhD, DABT)
Speaker Bio :
Dr. Vijayapal Reddy (DVM, PhD, DABT) is Director at Vipra LLC, USA. He has over 30 years of experience in global pharmaceutical drug discovery. He worked as an ICH S9 Expert Working Group (EWG) member for developing anticancer pharmaceuticals.
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No. : #05/2020
Topic : Impurity Profiling and Qualification
Date : Saturday, December 12, 2020,
Time : 8.00pm.Indian Standard Time
Speaker : Dr. Sol Bobst (MBA, PhD, DABT)
Speaker Bio :
Dr. Sol Bobst (MBA, PhD, DABT) has over 15 years of professional experience. He is the founder, President, and Principal Advisors of ToxSci Advisors LLC. Ms. Gowri Sukumar (MS, RAC) is the Director, CMC and Regulatory Affairs for Iterion Therapeutics. She has broad responsibilities that include process development, Drug Substance and Drug Product manufacturing from the CMC side. From the Regulatory affairs perspective, she provides regulatory leadership and expertise for regulatory strategy, liaises with the regulatory agencies including FDA, Health Canada and other Health authorities.
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No. : #04/2020
Topic : Alternative Methods and 3D tissue models
Date : Saturday 7th November 2020
Time : 8.00pm.Indian Standard Time
Speaker : Dr.Helena Kandarova, Senior Scientist, Centre of
Experimental Medicine, Slovak Academy of Sciences,
Slovakia
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No. : #03/2020
Topic : Fundamentals of Pharmacokinetics
Date : Saturday 8th August 2020
Time : 8.00 p.m. IST; 4.30 p.m. German Time; 10.30 a.m. Eastern Time (US)
Speaker : Dr. Gerhard Gross, Germany
Speaker Bio: Dr. Gerhard Gross has worked at several senior positions in the pharmaceutical industry, including Department Head of ADME at Novartis, Head DMPK AP at AstraZeneca as well as Section Director ADME at AstraZeneca UK, Global Discipline Leader in ADME and Head of Drug Metabolism department at Lundbeck A/S in Copenhagen. He was also a member of the scientific advisory board of Entomopharm and a guest lecturer at the university of Copenhagen.
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No. : #02/2020
Topic : Fundamentals of Toxicology, Part 2
Date : Saturday, July 11, 2020 9:00 pm India Time (Mumbai, GMT+05:30)
Speaker : Dr. Wallace Hayes
Speaker Bio: Dr. Hayes (MS, PhD, DABT, ERT) is a toxicologist with more than 35 years of experience in industry and academics. He has authored > 250 peer-reviewed publications. He is a Senior Science Advisor at ChromaDex Spherix Consulting. Dr. Hayes also holds appointments at the Harvard School of Public Health as a Visiting Scientist and with the School of Public Health, University of Massachusetts, Amherst as a Research Professor. Dr. Hayes has interacted with regulatory bodies worldwide including Canada, Japan, South Korea, EU and Latin America as well as the US FDA. the US EPA and the US DOD. Dr Hayes is currently a member of the Food Advisor Committee, US FDA.
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No. : #01/2020
Topic : Fundamentals of Toxicology, Part 1
Date : Saturday, June 13, 2020 9:00 pm India Time (Mumbai, GMT+05:30)
Speaker : Dr. Wallace Hayes
Speaker : Dr. Wallace Hayes
Speaker Bio: Dr. Hayes (MS, PhD, DABT, ERT) is a toxicologist with more than 35 years of experience in industry and academics. He has authored > 250 peer-reviewed publications. He is a Senior Science Advisor at ChromaDex Spherix Consulting. Dr. Hayes also holds appointments at the Harvard School of Public Health as a Visiting Scientist and with the School of Public Health, University of Massachusetts, Amherst as a Research Professor. Dr. Hayes has interacted with regulatory bodies worldwide including Canada, Japan, South Korea, EU and Latin America as well as the US FDA. the US EPA and the US DOD. Dr Hayes is currently a member of the Food Advisor Committee, US FDA.