Sustainable Global Health Systems and Pharmaceutical Development
暫譯: 可持續全球健康系統與藥品開發
Mittal, Bhavishya
- 出版商: Springer
- 出版日期: 2024-09-03
- 售價: $5,660
- 貴賓價: 9.5 折 $5,377
- 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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相關主題
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)
策略性決策專注於經濟學是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，藥物開發的科學已成為一個成熟的領域，這需要各種專業領域專家的專注和協同合作。不幸的是，製藥研究是複雜、耗時、流失率高且成本昂貴的，開發成本從每種商業化藥物的40億美元到110億美元不等。在美國，有超過750家生技和大型製藥公司正在為大量治療適應症開發新藥產品。由於臨床試驗的高流失率，這些藥物中只有少數能夠商業化。然而，從社會的角度來看，藥物開發仍然消耗了大量資源。
儘管藥物產品開發是一項經濟密集型活動，但目前的藥物產品開發狀況對於將經濟學整合進產品設計和開發的努力有限。例如，製藥科學家在數據驅動的決策過程中表現出色，這需要技術元素和一些策略元素。然而，將財務評估元素（在其他高科技行業如精細化學品、汽車、航空航天等中常用）整合進製藥藥物開發的程度非常有限。不幸的是，這對未來這些產品所屬的健康系統的可持續性造成了傷害。
理想的未來狀態是在產品設計和開發中整合經濟學的基本原則，使決策參數化，降低商品成本，減少浪費，將以病人為中心的設計融入其中，並提高製造/分配效率。這種方法的財務效益可以使這些節省的成本轉嫁給利益相關者，並改善製藥的價值主張，這對於維持創新潛力至關重要。本書希望向讀者介紹這一理想的製藥藥物開發未來狀態。
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（位於加州聖馬刁）的配方與工藝開發高級總監，他負責制定所有小分子腫瘤學資產的藥品開發策略。在加入 Kronos 之前，Bhavi 曾在 AbbVie（位於加州爾灣）工作，領導一個全球 CMC 團隊，專注於一個即將提交生物藥品許可申請（BLA）的分子。Bhavi 也曾在美國食品藥品監督管理局（FDA，位於馬里蘭州銀泉）、武田藥品（位於馬薩諸塞州劍橋）和阿斯特拉製藥（位於俄克拉荷馬州諾曼）工作。Bhavi 也是 Keck 研究生院亨利·E·里格斯應用生命科學學校（位於加州克萊蒙特）的前任兼任教員。他擁有賓夕法尼亞州立大學的材料工程博士學位，以及印度賈蘭達爾國立技術學院的化學與生物工程學士學位。
Bhavi 擁有超過 19 年的工業經驗，專注於小型治療分子（腫瘤學、炎症、腸胃道和中樞神經系統適應症）的配方設計、工藝開發和專案管理，並針對 NDA、BLA 和 ANDA 提交進行開發。他曾擔任美國藥物科學學會（AAPS）製造科學與工程（MSE）部門的副主席，目前是 AAPS 南加州製藥討論小組（SCPDG）的主席。他是兩本已出版書籍的作者（共 17 章），擁有 3 項美國專利，發表了 11 篇經過同行評審的手稿，以及在各種國際期刊和會議上發表/展示的多篇會議論文和海報。他在組織會議和主持與壓實模擬及製造科學相關的前沿主題的技術會議方面也非常活躍。
他的專業領域包括產品開發策略、專案管理、外包管理、階段適當的配方設計（即時釋放和改良釋放）、工藝工程、統計過程控制、QbD 實施、FMEA/風險映射，以及固體口服劑型的單元操作過程建模/模擬。
