Overview

Strategic decision-making focusing on economics is the fundamental requirement to generate efficiency and improve productivity in any manufacturing environment.  In the 21st century, the science of drug development is an established field that requires a dedicated and synergistic partnership between various subject matter experts.  Unfortunately, pharmaceutical research is complicated, time-consuming, attritive, and costly, with development costs ranging from $4 billion to $11 billion per commercialized drug.  There are more than 750 biotech and big pharma companies in the US that are developing new drug products for a vast number of therapeutic indications.  Due to the high attrition rate in clinical trials, a small percentage of these drugs get commercialized.  Still, a very high amount of resources are being spent on drug development from a societal perspective.   Despite being an economically intense activity, the current state of drug product development makes a limited effort to integrate economics into product design and development.  For example, pharmaceutical scientists are excellent at a data-driven decision-making process that requires technical elements and a few strategic elements.  However, there is minimal integration of financial valuation elements (commonly employed in other high-tech industries such as fine chemicals, automotive, aerospace, etc.) into pharmaceutical drug development.  Unfortunately, this hurts the sustainability of the health system of which these products will be a part in the future.    A desirable future state integrates fundamentals of economics in product design and development so that the decision-making is parameterized, the cost of goods can be lowered, wastage can be reduced, patient-centricity is built into the design, and manufacturing/distribution efficiencies can be gained.  The financial benefits of such an approach could allow for these savings to be passed on to the stakeholders and improve the value proposition of pharmaceuticals, which is critical to maintaining the innovation potential.  This book hopes to introduce the reader to this desired future state of pharmaceutical drug development.  

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9783031504143

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Bhavishya Mittal is the Senior Director of Formulation and Process Development at Kronos Bio (San Mateo, CA) where he is leading the strategy for drug product development for all small molecule oncology assets within the portfolio.  Before Kronos, Bhavi worked at AbbVie (Irvine, CA), leading a global CMC team for a BLA-bound molecule.  Bhavi has also worked at the US FDA (Silver Spring, MD), Takeda Pharmaceuticals (Cambridge, MA), and Astellas Pharmaceuticals (Norman, OK).  Bhavi is also a former adjunct faculty at the Keck Graduate Institute’s Henry E. Riggs School of Applied Life Sciences (Claremont, CA).  He has a Ph.D. in Materials Engineering from the Pennsylvania State University and a BS in Chemical and Bio Engineering from the National Institute of Technology, Jalandhar (India). Bhavi has 19+ years of industrial experience in the formulation design, process development, and project management of numerous drug products of small therapeutic molecules (oncology, inflammation, GI, and CNS indications) aimed for NDA, BLA, and ANDA filings.  He is the past Vice-Chair for the Manufacturing Sciences and Engineering (MSE) section of AAPS and is currently the chair of AAPS’ Southern California Pharmaceutical Discussion Group (SCPDG).  He is the author of 2 published books (with 17 combined chapters), 3 granted US patents, 11 peer-reviewed manuscripts, and numerous conference papers and posters published/presented in various international journals and conferences. He is also very active in organizing conferences and moderating technical sessions on cutting-edge topics related to compaction simulation and manufacturing sciences. His expertise includes product development strategy, project management, outsourcing management, phase-appropriate formulation design (immediate and modified release), process engineering, statistical process control, QbD implementation, FMEA/risk mapping, and process modeling/simulation of unit operations for solid oral dosages.

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