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Volume 3, Issue 1 (Suppl) Toxicol Open Access
ISSN: 2476-2067 TYOA, an open access journal Toxicology Congress 2017
April 13-15, 2017
Page 41
Notes:
conferenceseries.com
April 13-15, 2017 Dubai, UAE
8th World Congress on
Toxicology and Pharmacology
Preclinical development of biopharmaceuticals (r-DNA Products)
Biopharmaceuticals are an important component of pharma industry & have grown exponentially in the last decade. The
growth is driven by factors such as growing pressure for affordable product development, advances in biochemical and
molecular biology instrumentation, growing demand for biosimilar drugs to address ever growing chronic diseases, increasing
number of off-patented therapeutics and monoclonals. Great successes were achieved and multiple life-altering therapies were
developed for indications like cancer, rare genetic diseases, and immune disorders. Significant guidance has been released by
regulatory agencies to help the rational and scientifically based development of these complex products. The goal of preclinical
development of biosimilar is to demonstrate that, the drug is ‘highly similar’ to the reference biologic product in terms of ‘Safety,
Efficacy and Quality’. Monitoring biopharmaceutical drug safety deserves special attention. In this presentation, challenges in
the preclinical development of biologicals (particularly ‘Biosimilars’) will discussed in short. Key features of biotechnology-
derived molecules (Biosimilars including Vaccines), how they compare to traditional chemical drugs, and the impact these
features on preclinical safety testing during their development will also be discussed.
Biography
Mukul P Pore is one of the founders and is the Lifetime Director of INTOX Pvt. Ltd. which is a well-known GLP certified contract research organization. He is a
Diplomate of the American Board of Toxicology (DABT), European Registered Toxicologist (ERT) and Fellow of Indian Society of Toxicology (FST). He has designed
and conducted number of toxicology studies for diverse kind of products - pharmaceuticals, agrochemicals, biotechnology products, specialty chemicals, vaccines,
medical devices, industrial chemicals etc., during his experience of over 28 years in regulatory/descriptive toxicology. Since 1996, he has played an important role
in establishing and bringing INTOX to international standard and repute. He is an Ad Hoc specialist for AAALAC International, USA (2010-2013; 2013-2016; 2016-
2019). He is member of many professional bodies/societies including Indian Society of Toxicology (STOX), Chinese Society of Toxicology, Japanese Society of
Toxicology (JST), UK Registry of Toxicology and Laboratory Animal Scientists Association of India. He was nominated on ‘REACH Expert Committee” as “Expert
in the field of Environment, Health and Safety” by Ministry of Chemicals & Fertilizers, Govt. of India (2015). He was nominated as Advisor of Editorial Board of
“Toxicology International” journal in 2009.
Mukul P Pore
Intox Pvt. Ltd., India
Mukul P Pore, Toxicol Open Access 2017, 3:1 (Suppl)