Investments in Pharmaceuticals Before and after Trips: How Public Policy, Technology and Globalization Shaped Drug Development

2007 ◽  
Author(s):  
Margaret K. Kyle ◽  
Anita McGahan
Keyword(s):  
Public Policy ◽  
Drug Development ◽  
Before And After

scholarly journals The Practical Effect of New Ethics Rules: Responding to Subpoenas and Document Requests About Client Information

2018 ◽  
Vol 36 (2) ◽  
pp. 157-168
Author(s):  
Steven L. Lovett
Keyword(s):  
Public Policy ◽  
Practical Application ◽  
The Public ◽  
Fair Disclosure ◽  
Judicial Efficiency ◽  
Discovery Phase ◽  
Model Rule ◽  
Before And After ◽  
Malpractice Liability ◽  
Practical Effect

            This article is a comparative overview of the American Bar Association’s Model Rule 1.6(b) before and after the issuance of the ABA’s Formal Opinion 473, issued on February 17, 2016, which was an attempt to restate and revise the rule’s ethical expectations and to help settle several questions that had plagued the rule’s practical application. A lawyer’s duty of confidentiality to his or her client, and the public policy favoring judicial efficiency and fair disclosure during the discovery phase of litigation, often places lawyers in precarious ethical positions. This article attempts to provide guidance on this issue through an analysis of the rule and the context in which a lawyer’s overarching duty to keep his or her client’s information confidential can be precluded by the lawful compulsion to disclose such information without incurring malpractice liability.  

scholarly journals Testing the Stability of Drug Resistance on Cryopreserved, Gene-Engineered Human Induced Pluripotent Stem Cells

2021 ◽  
Vol 14 (9) ◽  
pp. 919
Author(s):  
Dilaware Khan ◽  
Ann-Christin Nickel ◽  
Sebastian Jeising ◽  
Constanze Uhlmann ◽  
Sajjad Muhammad ◽  
...  
Keyword(s):  
Stem Cells ◽  
Drug Development ◽  
Induced Pluripotent Stem Cells ◽  
Pluripotent Stem Cells ◽  
Medium Size ◽  
Long Term Storage ◽  
Before And After ◽  
In Vitro Pharmacology ◽  
Induced Pluripotent

Human induced pluripotent stem cells (hiPSCs) have emerged as a powerful tool for in vitro modelling of diseases with broad application in drug development or toxicology testing. These assays usually require large quantities of hiPSC, which can entail long-term storage via cryopreservation of the same cell charges. However, it is essential that cryopreservation does not oppose durable changes on the cells. In this project, we characterize one parameter of functionality of one that is well established in the field, in a different research context, an applied hiPSC line (iPS11), namely their resistance to a medium size library of chemo interventions (>160 drugs). We demonstrate that cells, before and after cryopreservation, do not change their relative overall drug response phenotypes, as defined by identification of the top 20 interventions causing dose-dependent reduction of cell growth. Importantly, also frozen cells that are exogenously enforced for stable overexpression of oncogenes myelocytomatosis (cMYC) or tumor protein 53 mutation (TP53R175H), respectively, are not changed in their relative top 20 drugs response compared to their non-frozen counterparts. Taken together, our results support iPSCs as a reliable in vitro platform for in vitro pharmacology, further raising hopes that this technology supports biomarker-associated drug development. Given the general debate on ethical and economic problems associated with the reproducibly crisis in biomedicine, our results may be of interest to a wider audience beyond stem cell research.

scholarly journals ANALISIS KEBIJAKAN PUBLIK DALAM PEMERIKSAAN KINERJA

2015 ◽  
Vol 1 (1) ◽  
pp. 67
Author(s):  
Denny Wahyu Sendjaja ◽  
Gregorius Yorrie Rismanto ◽  
Nico Andrianto
Keyword(s):  
Public Policy ◽  
Policy Analysis ◽  
Policy Cycle ◽  
Literature Study ◽  
Governance System ◽  
Ex Post ◽  
Public Policy Analysis ◽  
Ex Ante ◽  
Before And After ◽  
Performance Audit

One of issues in performance audit is what method to be used if auditor wants to gain understanding of policies underlying entity’s activities. This study aims to provide an understanding regarding policy cycle and its development; to describe the relationship between governance system, understanding of public policy and performance audit; and to develop framework and scope of public policy analysis in the performance audit. The study prepared by Tim Litbang BPK using literature study, enriched by discussions with speakers from Vrije Universiteit, as well as field trips to ARK and other government entities inNetherlands. Furthermore, the team developed initial information and analysed i t using ISSAI 3000 perspective. Based on policydevelopment cycle, team has developed a framework for public policy analysis on performance audit. The study concluded that ideal entity’s performance evaluation would be to assess the policy before and after the policy implementation (ex-ante and ex-post). Ideally, performance audit over policy is held by entity other than the policy’s subject itself. BPK meets the criteria.KEYWORDSpolicy, performance audit, ex-ante, ex-postABSTRAKSalah satu isu dalam pemeriksaan kinerja yang memiliki urgensi tinggi yaitu metode apakah yang dapat digunakan pemeriksa untuk mendapatkan pemahaman atas kebijakan yang melatarbelakangi kegiatan utama entitas. Analisis kebijakan publik dalam pemeriksaan kinerja ini bertujuan untuk memberikan pemahaman khususnya mengenai siklus kebijakan dan pengembangannya; menjelaskan hubungan sistem tata kelola pemerintahan, pemahaman kebijakan publik dan pemeriksaan kinerja; serta mengembangkan kerangka kerja dan menjelaskan cakupan analisis kebijakan publik dalam pemeriksaan kinerja. Kajian ini disusun oleh Tim Litbang BPK dengan menggunakan studi literatur mengenai teori-teori kebijakan publik, diskusi dengan nara sumber dari Vrije Universiteit, serta kunjungan lapangan ke Algemene Rekenkamer (ARK) dan beberapa entitas pemerintah lainnya di Belanda. Selanjutnya, Tim mengembangkan informasi awal tersebut serta menganalisisnya dengan mempertimbangkan perspektif ISSAI 3000 Performance Audit Guidelines. Dengan menggunakan siklus pengembangan kebijakan, Tim telah menyusun kerangka kerja analisis kebijakan publik dalam pemeriksaan kinerja. Hasil kajian menyimpulkan bahwa penilaian kinerja entitas yang ideal adalah dengan mengukur suatu kebijakan pada tahap sebelum dan sesudah pelaksanaan kebijakan (ex-ante dan ex-post). Pemeriksaan atas kinerja suatu kebijakan pada tahap ex-ante dan ex-post (kecuali produk kebijakan itu sendiri) secara ideal dilakukan oleh entitas pengendali yang bukan merupakan subjek kebijakan itu sendiri. BPK sebagai badan pemeriksa eksternal pemerintah memenuhi syarat tersebut.KATA KUNCIkebijakan, pemeriksaan kinerja, ex-ante, ex-post

scholarly journals Impact of a public policy restricting staff mobility between long-term care homes in Ontario, Canada during the COVID-19 pandemic

2020 ◽  
Author(s):  
Aaron Jones ◽  
Alexander G. Watts ◽  
Salah Uddin Khan ◽  
Jack Forsyth ◽  
Kevin A. Brown ◽  
...  
Keyword(s):  
Public Policy ◽  
Long Term Care ◽  
Care Home ◽  
Relative Difference ◽  
Care Staff ◽  
Care Homes ◽  
Term Care ◽  
Undirected Network ◽  
Before And After

AbstractObjectivesTo assess changes in the mobility of staff between long-term care homes in Ontario, Canada before and after enactment of public policy restricting staff from working at multiple homes.DesignPre-post observational study.Setting and Participants623 long-term cares homes in Ontario, Canada between March 2020 and June 2020.MethodsWe used anonymized mobile device location data to approximate connectivity between all 623 long-term care homes in Ontario during the 7 weeks before (March 1 – April 21) and after (April 22 – June 13) the policy restricting staff movement was implemented. We visualized connectivity between long-term care homes in Ontario using an undirected network and calculated the number of homes that had a connection with another long-term care home and the average number of connections per home in each period. We calculated the relative difference in these mobility metrics between the two time periods and compared within-home changes using McNemar’s test and the Wilcoxon rank-sum test.ResultsIn the period preceding restrictions, 266 (42.7%) long-term care homes had a connection with at least one other home, compared to 79 (12.7%) homes during the period after restrictions, a drop of 70.3% (p <0.001). The average number of connections in the before period was 3.90 compared to 0.77 in after period, a drop of 80.3% (p < 0.001). In both periods, mobility between long-term care homes was higher in homes located in larger communities, those with higher bed counts, and those part of a large chain.Conclusions and ImplicationsMobility between long-term care homes in Ontario fell sharply after an emergency order by the Ontario government limiting long-term care staff to a single home, though some mobility persisted. Reducing this residual mobility should be a focus of efforts to reduce risk within the long-term care sector during the COVID-19 pandemic.

Paternalism and Public Health

2017 ◽  
Author(s):  
Jessica Flanigan
Keyword(s):  
Public Health ◽  
Public Policy ◽  
Drug Development ◽  
New Drugs ◽  
Health Policies ◽  
Clinical Context ◽  
Public Health Policies ◽  
Patients Rights ◽  
Medical Paternalism ◽  
New Drug Development

Since medical paternalism is wrong in the clinical context, it should be rejected in public policy as well. But even if paternalistic public health policies were permissible, it is not clear that prohibitive pharmaceutical regulations are necessary to promote public health. Prohibitions could undermine health in some cases, for example, if prescription requirements make patients more deferential to physicians and tolerant of medical risks. Premarket testing requirements cause people to suffer and die waiting for new drugs to get approved, and they discourage new drug development. This is not to say that regulation serves no purpose. Pharmaceutical regulators provide a valuable pubic good by overseeing testing for new drugs and by certifying drugs that they deem generally safe and effective. But the benefits of regulation do not require that the regulations be prohibitive, and prohibitive regulations not only violate patients’ rights, they may also cost lives.

scholarly journals Cigarette Smoking and Secondhand Smoke Exposure Before and After a Tobacco-Free Olympic Policy Period: Qingdao, China

2018 ◽  
Vol 21 (11) ◽  
pp. 1531-1538 ◽  
Author(s):  
Jing Zhao ◽  
Xiaojing Li ◽  
Susan LeRoy Stewart ◽  
Weiguo Gao ◽  
Fei Qi ◽  
...  
Keyword(s):  
Public Policy ◽  
Secondhand Smoke ◽  
Large Scale ◽  
Smoking Prevalence ◽  
Olympic Games ◽  
Smoke Exposure ◽  
Secondhand Smoke Exposure ◽  
Before And After ◽  
The Impact ◽  
Exposure To Secondhand Smoke

Abstract Introduction We explored the impact of a temporary tobacco-free public policy for the 2008 Summer Olympics on the smoking prevalence and secondhand smoke exposure among the population of a co-hosting city, Qingdao, China. Methods The Qingdao Diabetes Survey was analyzed for 2006 (n = 4599) and 2009 (n = 4680), which are survey years before and after the tobacco-free Olympics public policy period (July 2007 to January 2009). We analyzed the differences in self-reported smoking prevalence and exposure to secondhand smoke at home and/or workplace, and compared odds of smoking by survey year and of exposure to secondhand smoke among nonsmokers. Results From 2006 to 2009, the male smoking prevalence declined from 51.4% (95% confidence interval [CI] = 49.0% to 53.9%) to 42.6% (95% CI = 40.2% to 45.1%), and the proportion of lighter smokers decreased more. Among nonsmokers, the secondhand smoke exposure rate declined from 62.2% (95% CI = 60.5% to 63.9%) to 56.8% (95% CI = 55.1% to 58.6%). Regression analyses show 34% lower odds of men smoking after Olympics (OR = 0.66, 95% CI = 0.57% to 0.77%). Rural residents and individuals who are not retired were more likely to smoke. Female nonsmokers report 17% less exposure to secondhand smoke after Olympics (OR = 0.83, 95% CI = 0.70% to 0.98%). Urban nonsmokers were more likely to be exposed than their rural counterparts. Conclusions Smoking prevalence among men and secondhand smoke exposure among women significantly decreased in Qingdao, China, after the tobacco-free Olympics public policy period. As only the proportion of lighter smokers decreased, this may help explain why urban nonsmokers reported increased exposure. Unintended increased secondhand smoke exposure and cessation support need to be addressed in large-scale policy campaigns. Implications Hosting the Olympic Games can help to initiate large-scale tobacco-free public policies for hosting cities. Although previous studies have demonstrated reduction in nonsmoker exposure to secondhand smoke, the impact on the hosting city’s smoking prevalence or exposure rates is unclear. After the Olympic Games in Qingdao, China, smoking prevalence among men significantly decreased, mostly due to light smokers. Secondhand smoke exposure at home and/or workplace significantly decreased among female nonsmokers. Urban nonsmokers had an unintended consequence of increased secondhand smoke exposure after the tobacco-free Olympic policy period. Concurrent promotion of cessation support for heavier smokers may be needed.

Neoadjuvant Therapy for Melanoma: A Promising Therapeutic Approach and an Ideal Platform in Drug Development

2015 ◽  
pp. e535-e542 ◽  
Author(s):  
Ahmad A. Tarhini
Keyword(s):  
Drug Development ◽  
Tumor Tissue ◽  
Predictive Biomarkers ◽  
Clinical Activity ◽  
Standard Management ◽  
Neoadjuvant Immunotherapy ◽  
Significant Toxicity ◽  
Promising Therapeutic Approach ◽  
Before And After ◽  
Management Approaches

Patients with locoregionally advanced but surgically operable melanoma continue to carry a high risk of relapse and death despite the best available standard management approaches. Neoadjuvant studies targeting this patient population tested chemotherapy with temozolomide and biochemotherapy (BCT), in which BCT demonstrated high tumor response rates but was eventually abandoned with the failure of BCT to deliver survival benefits in randomized trials of metastatic disease. Smaller neoadjuvant immunotherapy studies with interferon (IFN) alfa and ipilimumab have yielded promising clinical activity and important mechanistic insights and biomarker findings. Newer targeted and immunotherapeutic agents and combinations currently are being translated into the neoadjuvant setting at an accelerated pace and carry significant clinical promise. In drug development, the neoadjuvant approach allows access to blood and tumor tissue before and after initiation of systemic therapy, which allows for the conduct of novel mechanistic and biomarker studies in the circulation and the tumor microenvironment. Such studies may guide drug development and allow for the discovery of predictive biomarkers selected on the basis of their capacity to classify patients according to the degree of benefit from treatment or the risk for significant toxicity.

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