Well-designed and meticulously implemented preclinical toxicology studies are crucial for the success of any drug development program. Preclinical toxicology studies should reliably assess the safety of new drug entities, thus building a multi-faceted understanding of compounds to lay the groundwork for clinical trials and regulatory approval. At times, preclinical studies may lead to the attrition of compounds during preclinical development or the Good Laboratory Practices (GLP) toxicology phase; this helps save millions of dollars during the drug development program.
In this webinar, our featured speaker will present a roadmap that seamlessly integrates the various preclinical studies, thus accelerating the initiation of clinical trials. The roadmap covers various aspects of the preclinical journey, developing a tox-suitable formulation, running the dose range finding (DRF) to set the doses for GLP toxicology and the full scale of GLP tox studies.
Register for this webinar to learn about the best way to plan for investigational new drug (IND)-enabling preclinical toxicology studies.
Speaker
Dr. Mohan Krishnappa, DVM, Ph.D., DABT., Head – Safety Assessment, Syngene International Ltd.
Mohan is the Head of Safety Assessment at Syngene and has over 12 years of GLP toxicology experience in the safety evaluation of compounds to support drug discovery and development and toxicology risk assessment of health care products and industry chemicals. Mohan is proficient in execution of GLP preclinical toxicology/safety studies in accordance with global regulations/compliance for submissions to regulatory agencies, including the EMEA, USFDA and MHRA. He served as study director/toxicologist/scientific director/study monitor for several toxicology projects (involving new chemical entities, generics, pivotal GLP toxicology studies, PK/TK, juvenile and DART toxicity studies, impurity qualification studies, biocompatibility testing including IND enabling toxicology and safety pharmacology programs). He has an undergraduate degree in veterinary medicine and did his post-graduation and doctorate in veterinary pharmacology and toxicology at Veterinary College, Bangalore, India.
Message PresenterWho Should Attend?
Senior professionals, with relevant job titles including:
- Head of Drug Discovery
- Head of Preclinical Safety
- Head of Safety Assessment
- Head of Toxicology
- Head of Bioinformatics
- Director of Drug Discovery
- Research Director
- Global Category Manager Drug Discovery
- Vice President – Drug Discovery
- Head of Translational Research
- Head of Research informatics
- Chief Scientific Officer
- Head of Chemistry
- Head of Biology
What You Will Learn
Join this webinar to learn about:
- The ideal pre-IND, IND and NDA tox roadmap
- Dose formulation strategies
- Species selection criteria
- IND GLP tox and safety pharmacology approach and timelines
Xtalks Partner
Syngene
Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022) is an integrated contract research, development and manufacturing services company serving the global pharma, biotech, nutrition, animal health, consumer goods and specialty chemical sectors.
Our 4200 scientists have both the skills and the capability to deliver great science, ensure robust data management, IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation.
With 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene offers dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife. We also work with biotech companies pursuing leading edge science, and MNCs including GSK and Merck KGaA.
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