Opportunities for Biotechnology Research and Entrepreneurship

Promising Roadmap in the Development and Commercialization of Pharmaceutical Products for Early Career Researchers

Author(s): Saranga Rajesh, Selva Sudha N., Raksha Goswami, Kunal Kishore and Hannah R. Vasanthi *

Pp: 309-337 (29)

DOI: 10.2174/9789815196115124010018

* (Excluding Mailing and Handling)


Translational research by budding scientists in the pharmaceutical and biotechnological field demands the application of their knowledge to a bedside medical problem. Career opportunities in the pharmaceutical sector range from bench-side research which includes screening, discovery and development, and operational activities to manufacture, quality control, and marketing, including pharmacovigilance. The success of trials leading to commercialization is determined by the quality of research conducted in academia with the ultimate goal of moving the product ahead. Early career researchers should have a deep understanding of pharmaceutical products, particularly advanced drug delivery systems (DDS). Advanced DDS such as niosomes, liposomes, dendrimers, nanoparticles, and others are developed to increase drug distribution and bioavailability. DDS can accomplish localized or systemic drug distribution by careful selection of excipients. DDS could be used to deliver all types of therapeutic molecules, including biological macromolecules, to the site of action with more stability. However, one must be aware of several factors, including the physicochemical properties of the drug, formulation parameters, physiological considerations, intersubject variability, and the choice of an appropriate animal model for in vivo studies. In addition, the in vitro and in-vivo correlation (IVIVC) should be considered, as it confidently converts the bench trial to a market level for bedside applications. Accordingly, this review focuses on factors that influence drug delivery, approaches to drug delivery systems, excipient selection strategies, ways to translate the pilot scale to industrial scale, and the basic requirements of the pharmaceutical sector for product commercialization. Furthermore, this chapter will also discuss some of the possible funding avenues to nurture drug discovery and development to motivate early-career entrepreneurs.

Keywords: Active Pharmaceutical Ingredient (API), ADMET, Biosimilar, Bioavailability, BA/BE Studies, Clinical research, Drug delivery system, Excipients, Early career researchers (ECR), Innovation, Inter-subject Variability, In vitro- In vivo Correlation (IVIVC), Pharmaceuticals, Pharmacokinetics, Pharmacodynamics, Pre-clinical Research, Toxicity.

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