Mukul Pore
Intox Pvt. Ltd., India
Title: Preclinical Development of Biopharmaceuticals (r-DNA Products)
Biography
Biography: Mukul Pore
Abstract
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.