Sustainable Global Health Systems and Pharmaceutical Development
Mittal, Bhavishya
- 出版商: Springer
- 出版日期: 2024-09-03
- 售價: $6,270
- 貴賓價: 9.5 折 $5,957
- 語言: 英文
- 頁數: 247
- 裝訂: Hardcover - also called cloth, retail trade, or trade
- ISBN: 3031504143
- ISBN-13: 9783031504143
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商品描述
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.
商品描述(中文翻譯)
戰略決策專注於經濟學是在任何製造環境中產生效率和提高生產力的基本要求。在21世紀，藥物開發科學是一個已建立的領域，需要各種專業主題的專家之間的專注和協同合作。不幸的是，製藥研究是複雜、耗時、耗能且昂貴的，開發成本範圍從40億美元到110億美元不等。在美國有超過750家生物技術和大型製藥公司正在為大量治療指標開發新的藥物產品。由於臨床試驗的高淘汰率，這些藥物中只有一小部分得到商業化。然而，從社會角度來看，仍然有大量資源被用於藥物開發。
儘管是一項經濟密集型活動，目前的藥物產品開發狀況在產品設計和開發中對經濟學的整合努力有限。例如，製藥科學家在需要技術元素和少數戰略元素的數據驅動決策過程中表現出色。然而，在製藥藥物開發中，對財務評估元素（在其他高科技行業如精細化學品、汽車、航空航天等中常用）的整合非常有限。不幸的是，這損害了這些產品將來將成為健康系統可持續性的健康。
理想的未來狀態將經濟學基礎融入產品設計和開發中，以使決策參數化，降低商品成本，減少浪費，將以患者為中心的設計融入其中，並提高製造/分銷效率。這種方法的財務效益可以使這些節省成本傳遞給利益相關者，並改善藥物的價值主張，這對於保持創新潛力至關重要。本書希望向讀者介紹這種期望的藥物開發未來狀態。
作者簡介
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.
作者簡介(中文翻譯)
Bhavishya Mittal是Kronos Bio（位於加州聖馬特奧）的制劑和工藝開發高級總監，他負責領導該公司組合中所有小分子腫瘤學資產的藥物產品開發策略。在加入Kronos之前，Bhavi在AbbVie（位於加州爾灣）工作，領導全球CMC團隊負責BLA產品的開發。Bhavi還曾在美國FDA（位於馬里蘭州銀泉市）、Takeda Pharmaceuticals（位於麻省劍橋市）和Astellas Pharmaceuticals（位於俄克拉荷馬州諾曼市）工作。Bhavi還曾是Keck Graduate Institute的Henry E. Riggs應用生命科學學院（位於加州克萊蒙特）的兼職教師。他擁有賓夕法尼亞州立大學的材料工程博士學位和印度國家技術學院資訊化學和生物工程學士學位。
Bhavi在制劑設計、工藝開發和多個藥物產品的項目管理方面擁有19年以上的工業經驗，這些藥物產品是針對NDA、BLA和ANDA申請的小分子治療藥物（包括腫瘤學、炎症、胃腸和中樞神經系統疾病）。他曾擔任AAPS製造科學和工程（MSE）部門的副主席，目前是AAPS南加州藥學討論小組（SCPDG）的主席。他是兩本出版書籍的作者（共17章），擁有3項美國授權專利，發表了11篇同行評審的論文，並在各種國際期刊和會議上發表/展示了眾多會議論文和海報。他還積極參與組織會議，並主持與壓片模擬和製造科學相關的前沿技術專題。
他的專業知識包括產品開發策略、項目管理、外包管理、適應性制劑設計（即時和改性釋放）、工藝工程、統計過程控制、QbD實施、FMEA/風險映射以及固體口服劑型單元操作的工藝建模/模擬。
