Nội dung được dịch bởi AI, chỉ mang tính chất tham khảo
Phát Triển Thuốc Trong Thế Kỷ 21: Sự Hợp Tác Giữa Công, Tư Nhân và Quốc Tế
Tóm tắt
Mô hình kinh tế truyền thống cho phát triển thuốc của các công ty dược phẩm hàng đầu ở các nước phát triển đã cho thấy những phần thưởng ngày càng giảm trong những năm gần đây, khi các công ty dược phẩm lớn dựa ít hơn vào nghiên cứu và phát triển và nhiều hơn vào việc cắt giảm chi phí cũng như tìm kiếm những ứng viên thuốc đầy hứa hẹn thông qua việc sáp nhập và mua lại. Đồng thời, các công ty dược phẩm ở các thị trường mới nổi đã phát triển mạnh mẽ dưới một mô hình kinh tế khác, đặc trưng bởi các quan hệ đối tác công-tư, trợ cấp của chính phủ và việc tiếp thị sinh lợi của các loại thuốc generic. Những công ty này hiện đang tập trung vào nghiên cứu và phát triển các ứng viên thuốc đổi mới, bao gồm các loại thuốc điều trị các bệnh bị bỏ quên như lao và viêm gan. Tuy nhiên, các công ty dược phẩm ở các nước đang phát triển có thể thiếu chuyên môn của các công ty dược phẩm hàng đầu để điều hướng hệ thống quy định phức tạp. Bài báo này nêu bật cơ hội cho các công ty có chuyên môn phát triển thuốc hợp tác với các công ty ở các nước đang phát triển có các loại thuốc trong ống nghiệm đổi mới.
Từ khóa
#phát triển thuốc #hợp tác công-tư #các bệnh bị bỏ quên #nghiên cứu và phát triển #dược phẩm #thị trường mới nổiTài liệu tham khảo
Baum S. Big Pharma shrink continues with more AstraZeneca job cuts. MedCity News. Available at: https://medcitynews.com/2012/02/big-pharma-shrink-continues-with-more-astrazeneca-job-cuts/. Accessed May 16, 2012.
Alazraki M. Pfizer shrinks its drug pipeline amid R&D cuts. DailyFinance. Available at: https://www.dailyfinance.com/2011/03/01/pfizer-shrinks-its-drug-pipeline-amid-randd-cuts/. Accessed May 16, 2012.
Fuchs D. FDA suddenly bans drugs that have been on the market for decades. Tech Dirt. Available at: https://www.techdirt.com/articles/20110324/02181913605/fda-suddenly-bans-drugs-that-have-been-market-decades.shtm. Accessed May 16, 2012.
US Food and Drug Admnistration. Orange Book: approved drug products with therapeutic equivalence evaluations. Available at: https://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=020702&TABLE1=OB_Rx. Accessed March 30, 2012.
Pfizer Inc. Pfizer consolidated statements of income for 2009. Available at: https://www.pfizer.com/files/investors/presentations/q4performance_020310.pdf. Accessed March 30, 2012.
Pfizer Inc. Pfizer joins forces with Warner-Lambert. Available at: https://www.pfizer.com/about/history/pfizer_warner_lambert.jsp. Accessed March 30, 2012.
Castellani JJ. New drug approvals in 2010: biopharmaceutical research companies receive approval for 26 new treatments in 2010. PhRMA. Available at: https://www.phrma.org/sites/default/files/422/newdrugapprovalsin2010.pdf. Accessed March 28, 2012.
Mullard A. 2011 FDA drug approvals. Nat Rev Drug Discov. 2012;11:91–94.
LaMattina J. When it comes to NDA approvals, is 30 the new 50? Drug Truths. Available at: https://johnlamattina.wordpress.com/tag/pharma-rd-productivity/. Accessed May 16, 2012.
Qureshi ZP, Seoane-Vazquez E, Rodriguez-Monguio R, Stevenson KB, Szeinbach SL. Market withdrawal of new molecular entities approved in the United States from 1980 to 2009. Pharmacoepidemiol Drug Saf. 2011;20:772–777.
Lee BL, Higgins MJ, Goss PE. Denosumab and the current status of bone-modifying drugs in breast cancer. Acta Oncol. 2012;51:157–167.
Adamo V, Iorfida M, Montalto E, et al. Overview and new strategies in metastatic breast cancer (MBC) for treatment of tamoxifen-resistant patients. Ann Oncol. 2007;18:vi, 53–57.
Novo Nordisk. Levemir, NovoLog M, NovoLog: Full Prescribing Information. Princeton, New Jersey: Novo Nordisk; 2008.
Chapman CR, Nakamura Y. A passion of the soul: an introduction to pain for consciousness researchers. Conscious Cogn. 1999;8:391–422.
Tanaka M, Katayama F, Kato H, et al. Hepatitis B and C virus infection and hepatocellular carcinoma in China: a review of epidemiology and control measures. J Epidemiol. 2011;21:401–416.
Mitra AK, Rodriguez-Fernandez G. Latin America and the Caribbean: assessment of the advances in public health for the achievement of the Millennium Development Goals. Int J Environ Res Public Health. 2010;7:2238–2255.
Boutayeb A. The impact of HIV/AIDS on human development in African countries. BMC Public Health. 2009;9:S3.
US Department of Energy Genome Programs. Human Genome Project information. Available at: https://www.ornl.gov/sci/techresources/Human_Genome/home.shtml. Accessed March 30, 2012.
Romero R, Corrigan B, Neville J, Kopko S, Cantillon M. Striving for an integrated drug-development proces for neurodegeneration: the coalition against major diseases. Neurodegener Dis Manag. 2011;1:379–385.
Wizemann T, Robinson S, Giffin R. Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies: Workshop Summary. Washington, DC: The National Academies Press; 2009.
Gergel IP. Research & development re-imagined: how Endo is leveraging intellectual arbitrage to build global partners for value creation in R&D. Presented at: US-India BioPharma & Healthcare Summit; June 23, 2011; Cambridge, Massachusetts.
Share C. Endo a lot more than just Percocet. PharmaLive. Available at: https://blog.rddirections.com/index.php/2010/07/20/endo-a-lot-more-than-just-percocet/. Accessed March 20, 2012.
Ablett J, Baijal A, Beinhocker E, et al. The “Bird of Gold”: the rise of India’s consumer market. McKinsey Global Institute. Available at: https://www.mckinsey.com/Insights/MGI/Research/Asia/The_bird_of_gold. Accessed August 30, 2012.
PharmPro. Report: China offfers strategic advantages for drug discovery outsourcing. Available at: https://www.pharmpro.com/news/2011/03/outsourcing-news-China-Offers-Strategic-Advantages-for-Drug-Discovery-Outsourcing/. Accessed August 30, 2012.
Luhby T. China’s growing middle class. CNNMoney. Available at: https://money.cnn.com/2012/04/25/news/economy/china-middle-class/index.htm. Accessed August 30, 2012.
People’s Daily Online. China’s middle class to reach 48% in 10 years. Available at: https://english.people.com.cn/90001/90778/90862/7071235.html. Accessed August 30, 2012.
Klein PG, McGahan AM, Rezaie R. Entrepreneurship and desperate poverty: biopharmaceutical innovation in China, India, and Brazil. Available at: https://extranet.isnie.org/uploads/isnie2012/klein_mcgahan_rezaie-.pdf. Accessed August 30, 2012.
Rischitelli DG, Karbowicz SH. Safety and efficacy of controlled-release oxycodone: a systematic literature review. Pharmacotherapy. 2002;22:898–904.
Bijlsma JW. Analgesia and the patient with osteoarthritis. Am J Ther. 2002;9:189–197.
Mathew J. Pfizer fastest-growing drug MNC in India. Business Standard. Available at: https://business-standard.com/india/news/pfizer-fastest-growing-drug-mnc-in-india-/460815/. Accessed August 30, 2012.
BioSpectrum Asia. Foreign ownership of domestic companies not equivalent to high price of medicines, says GSK CEO. Available at: https://www.biospectrumasia.com/content/290911IND17185.asp. Accessed April 2, 2012.
Soby S. Work outsourced to Indian biotech and pharma companies is not yet significantly innovative. Curr Sci. 2012;102:401–404.
Koshy JK. Prospects poor for original drug discovery in India, finds study. LiveMint. Available at: https://www.livemint.com/2012/02/10010649/Prospects-poor-for-original-dr.html. Accessed March 20, 2012.
The Hindu Business Line. Patents from domestic drug companies low despite high R&D spend. Available at: https://www.thehindubusinessline.com/industry-and-economy/economy/article2998368.ece. Accessed March 20, 2012.
Kamath G. Now, Indian pharma companies like Jubilant Group, TCG Life Sciences and Piramal Life Sciences venture to share new drug R&D risks. The Economic Times. Available at: https://articles.economictimes.indiatimes.com/2012-03-13/news/31159880_1_cro-new-drug-big-pharma. Accessed March 20, 2012.
The Global Fund. The Global Fund to fight AIDS, tuberculosis and malaria. Available at: https://www.theglobalfund.org/en/about/whoweare/. Accessed August 30, 2012.
Buse K, Walt G. Global public-private partnerships, part I: a new development in health? Bull World Health Organ. 2000;78:549–561.
Allison M. Reinventing clinical trials. Nat Biotechnol. 2012;30:41–49.
Pharmaceutical Research and Manufacturers of America (PhRMA). New drug approvals in 2010: biopharmaceutical research companies receive approval for 26 new treatments in 2010. https://www.phrma.org/sites/default/files/422/newdrugapprovalsin2010.pdf. Accessed March 28, 2012.
Kessel M. The problems with today’s pharmaceutical business—an outsider’s view. Nat Biotechnol. 2011;29(1):27–33.
Goldman M. Reflections on the Innovative Medicines Initiative. Nat Rev Drug Discov. 2011;10(5):321–322.
National Institute for Health Research. Public/private partnership improves UK’s clinical research competitiveness. https://www.europeanpharmaceuticalreview.com/5088/news/industry-news/publicprivate-partnership-improves-uk’s-clinical-research-competitiveness Accessed March 25, 2013.
