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1.
J Ocul Pharmacol Ther ; 37(7): 383-385, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1821676
3.
ACS Infect Dis ; 8(3): 557-573, 2022 03 11.
Article in English | MEDLINE | ID: covidwho-1758137

ABSTRACT

Rising antimicrobial resistance challenges our ability to combat bacterial infections. The problem is acute for tuberculosis (TB), the leading cause of death from infection before COVID-19. Here, we developed a framework for multiple pharmaceutical companies to share proprietary information and compounds with multiple laboratories in the academic and government sectors for a broad examination of the ability of ß-lactams to kill Mycobacterium tuberculosis (Mtb). In the TB Drug Accelerator (TBDA), a consortium organized by the Bill & Melinda Gates Foundation, individual pharmaceutical companies collaborate with academic screening laboratories. We developed a higher order consortium within the TBDA in which four pharmaceutical companies (GlaxoSmithKline, Sanofi, MSD, and Lilly) collectively collaborated with screeners at Weill Cornell Medicine, the Infectious Disease Research Institute (IDRI), and the National Institute of Allergy and Infectious Diseases (NIAID), pharmacologists at Rutgers University, and medicinal chemists at the University of North Carolina to screen ∼8900 ß-lactams, predominantly cephalosporins, and characterize active compounds. In a striking contrast to historical expectation, 18% of ß-lactams screened were active against Mtb, many without a ß-lactamase inhibitor. One potent cephaloporin was active in Mtb-infected mice. The steps outlined here can serve as a blueprint for multiparty, intra- and intersector collaboration in the development of anti-infective agents.


Subject(s)
COVID-19 , Mycobacterium tuberculosis , Animals , Drug Industry , Mice , SARS-CoV-2 , Universities , beta-Lactams/pharmacology
4.
Recenti Prog Med ; 113(3): 157-160, 2022 03.
Article in Italian | MEDLINE | ID: covidwho-1753251

ABSTRACT

The covid-19 pandemic and the anti-SARS-CoV-2 vaccines have once again brought to the fore the issue of patents in the health sector. The current European panorama on the patenting of pharmaceuticals is rather confused and difficult to understand, characterized by a precarious (dis)balance between the commercial incentives guaranteed to the industry by supply-side patents and the regulatory framework in support of public interests on the demand side. Here, we first focus on a regulatory analysis of pharmaceutical patenting and more in general on market exclusivity within the European Union, and then set out some proposals for a radical reform of European legislation. In particular, we believe that there are three major critical issues on the subject that must be addressed and reformed as soon as possible: 1. the management of pharmaceutical patents through the European Patent Office and the parallel network of national offices, 2. the excess of discretion of pharmaceutical companies in the filing of patents and 3. the short duration of market exclusivity on drugs. In fact, the right moment has come to definitively reform the European legislation on pharmaceutical patents in line with the tradition of continental welfare.


Subject(s)
COVID-19 , Pandemics , Drug Industry , Europe , Humans , Pharmaceutical Preparations
5.
Int J Environ Res Public Health ; 19(5)2022 03 02.
Article in English | MEDLINE | ID: covidwho-1736916

ABSTRACT

The innovation and development practices of the pharmaceutical industry are of great importance for the continual enhancement of public health. Industrial clusters are one of the important means by which the pharmaceutical industry can be transformed and developed, but there is a lack of research on the evolutionary path and development innovation of pharmaceutical industrial clusters. As a country with a major pharmaceutical industry, the transformation and development path of traditional pharmaceutical industrial clusters in China has important reference value for the sustainable development of the global pharmaceutical industry. Through an analysis of the evolution of traditional pharmaceutical industrial clusters in Shijiazhuang, this study explores the law of the dynamic evolution of pharmaceutical industrial clusters and the associated mechanisms. Specifically, we conclude that the evolutionary path of traditional pharmaceutical industrial clusters can be divided into the government-led pharmaceutical industrial cluster start-up stage, the government-guided pharmaceutical industrial cluster development stage, and the government-served pharmaceutical industrial cluster transformation stage. The operating mechanisms include a self-organization mechanism, an innovation-driven mechanism, and an outward associated mechanism, each of which plays different roles in the different stages of the dynamic evolution of the cluster, and the synergistic operation of the three mechanisms forms an important basis for the evolution of pharmaceutical industrial clusters. We found that the innovation development of traditional pharmaceutical industrial clusters is influenced by the synergy of the self-organization, innovation-driven, and outward associated mechanisms. The self-organization mechanism is a necessary condition for pharmaceutical industrial clusters to realize the transition from disorder to order. The innovation-driven mechanism is the core driving force for the innovative development of pharmaceutical industrial clusters. Finally, the outward associated mechanism is the main means by which pharmaceutical industrial clusters integrate into the global value chain.


Subject(s)
Drug Industry , Inventions , China , Government , Pharmaceutical Preparations
7.
Molecules ; 27(3)2022 Feb 05.
Article in English | MEDLINE | ID: covidwho-1674738

ABSTRACT

Similar to last year, 2021 will be remembered for the COVID-19 pandemic. Although five vaccines have been approved by the two most important drug regulatory agencies, namely the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), the pandemic has still not been brought under control. However, despite the context of a global pandemic, 2021 has been an excellent year with respect to drug approvals by the FDA. In 2021, 50 drugs have been authorized, making it the fourth-best year after 2018 (59 drugs) and 1996 and 2020 (53 each). Regarding biologics, 2021 has been the third-best year to date, with 14 approvals, and it has also witnessed the authorization of 36 small molecules. Of note, nine peptides, eight monoclonal antibodies, two antibody-drug conjugates, and two oligonucleotides have been approved this year. From them, five of the molecules are pegylated and three of them highly pegylated. The presence of nitrogen aromatic heterocycles and/or fluorine atoms are once again predominant among the so-called small molecules. This report analyzes the 50 new drugs approved in 2021 from a chemical perspective, as it did for those authorized in the previous five years. On the basis of chemical structure alone, the drugs that received approval in 2021 are classified as the following: biologics (antibodies, antibody-drug conjugates, enzymes, and pegylated proteins); TIDES (peptide and oligonucleotides); combined drugs; natural products; nitrogen aromatic heterocycles; fluorine-containing molecules; and other small molecules.


Subject(s)
Drug Approval , Drug Industry , United States Food and Drug Administration , Biological Products , Drug Approval/history , Drug Approval/statistics & numerical data , Drug Industry/history , History, 21st Century , Humans , United States
8.
Ther Innov Regul Sci ; 56(2): 366-377, 2022 03.
Article in English | MEDLINE | ID: covidwho-1670084

ABSTRACT

The COVID-19 pandemic required urgency in the development and delivery of effective vaccines and therapeutics; meanwhile, ongoing clinical research, regulation and supply for other much-needed therapeutics and vaccines needed to be sustained. In Europe, the European Commission, the European Medicines Agency (EMA) and the national regulatory agencies (NRAs) responded by issuing guidance outlining regulatory flexibilities mainly directed at COVID-19 vaccines and, belatedly, therapeutics. Using a survey methodology, this study gathered the views of the R&D based pharmaceutical industry in May-June 2021 on the value of these flexibilities for continued use in the post-pandemic era as well as for future use in health emergency situations. Findings indicate that many flexibilities were foreseen to have value beyond the pandemic, particularly where EU and Member States aligned closely to provide a singular, streamlined regulatory environment. Digitalization was a notable driver of these flexibilities, but innovations in regulatory process (e.g. rolling reviews, flexible Scientific Advice) improved the process and outcomes measurably. Finally, the rapid reaction of the EU regulatory system and extensive efforts by all involved in providing innovative therapeutics and vaccines to patients in need provides learnings for the upcoming overhaul of the pharmaceutical acquis.


Subject(s)
COVID-19 , COVID-19 Vaccines , Drug Industry , Humans , Pandemics , SARS-CoV-2
10.
J Health Econ ; 82: 102591, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1654746

ABSTRACT

This paper studies the global R&D effort to fight the deadliest diseases. We find: (1) the elasticity of R&D effort with respect to market size is about 1/2 in the cross-section of diseases; (2) given this elasticity, the R&D response to COVID-19 has been 4 to 26 times greater than that implied by its market size; (3) the aggregate short-term elasticity of science and innovation can be very large, as demonstrated by the aggregate flow of clinical trials increasing by 38% in 2020, with limited crowding out of trials for non-COVID diseases; and (4) public institutions and government-led incentives were a key driver of the COVID-19 R&D effort-with public research institutions accounting for 70 percent of all COVID-19 clinical trials globally. Overall, our work suggests that leveraging early-stage incentives, non-monetary incentives, and public institutions may be important for scaling up global innovation.


Subject(s)
COVID-19 , COVID-19/epidemiology , Drug Industry , Humans , Motivation
16.
Salud Colect ; 16: e2897, 2020 10 17.
Article in Spanish | MEDLINE | ID: covidwho-1608979

ABSTRACT

Taking into account the latent threat of future pandemics, the objective of this study is to analyze - particularly with respect to medications - the sustainability of the health system, healthcare coverage, budgetary efficiency, and connections with the pharmaceutical patent system. In this context, the pharmaceutical patent system acts as a determining factor, given that promoting its existence stimulates the production of research, but in turn its existence stands in the way of rapid advancements, primarily due to the development of protective legislation concerning patents, which has largely accommodated the industry. Given that the pharmaceutical industry has managed to extend the duration of patents and avoid the incorporation of generics, our analysis focuses on the influence of pharmaceutical patents; this influence has led to reflection on the possibility of combining efforts by forging alliances between numerous companies and the public sector in order to face the challenges posed by new diseases caused by viruses that give rise to epidemics and pandemics.


Ante la amenaza latente de futuras pandemias, este estudio tiene como objetivo analizar ­desde el eje de los medicamentos­ la sostenibilidad del sistema sanitario, la cobertura, la eficiencia del gasto y su vinculación al sistema de patentes farmacéuticas. En este marco, el sistema de patentes farmacéuticas adquiere un papel determinante, dado que fomentar su existencia estimula la producción de investigación pero, a su vez, su existencia no suscita un rápido avance, debido al desarrollo legislativo protector que han tenido las patentes y que ha dado lugar a un acomodamiento de la industria. Como la industria farmacéutica ha conseguido extender la duración de patentes y evitar la incorporación de genéricos, se analiza la influencia de las patentes farmacéuticas que ha dado lugar a reflexionar acerca de la posibilidad de consorciar esfuerzos realizando alianzas entre varias empresas y el sector público para afrontar los retos que plantean nuevas enfermedades producidas por virus que dan lugar a epidemias y pandemias.


Subject(s)
Antiviral Agents , Drug Costs , Drug Industry/organization & administration , Health Policy , Health Services Accessibility/organization & administration , Patents as Topic , Virus Diseases/drug therapy , Antiviral Agents/economics , Antiviral Agents/therapeutic use , Drugs, Generic , Global Health , Humans , Pandemics , Program Evaluation , Virus Diseases/economics , Virus Diseases/epidemiology , Virus Diseases/prevention & control
17.
Yakugaku Zasshi ; 142(1): 75-84, 2022 Jan 01.
Article in Japanese | MEDLINE | ID: covidwho-1599886

ABSTRACT

The spread of COVID-19 has re-affirmed the crucial importance of the pharmaceuticals industry in improving the level of citizens' health and medical care, as well as the industry's importance in terms of contribution to economic growth and tax revenues. Although some time has passed since the importance of industry-academia collaboration was first raised in relation to the creation of innovative new drugs and the continuation of global competitiveness, conflicts between academia and companies have also been highlighted as barriers that hinder efforts to promote the practical realization of academia-initiated seeds. The authors have hypothesized that conflicts between academia and companies can be attributed to the vulnerability of innovation creation environments, including drug discovery, on the academia side, insufficient awareness concerning human resources that will undertake industry-academia operations, and inadequate development of structures. Consequently, we implemented fact-finding investigations in relation to universities and public research institutions in Japan, with the objective of ascertaining the actual status of innovation creation environments, including drug discovery, on the academia side. From the results of these investigations, we will clarify the issues that may present barriers to innovation creation, and consider policies, etc. for the enhancement of innovation creation environments.


Subject(s)
Academies and Institutes , COVID-19 , Drug Discovery , Drug Industry , Intellectual Property , Intersectoral Collaboration , Humans , Universities , Workforce
18.
Pharmaceut Med ; 36(1): 1-10, 2022 02.
Article in English | MEDLINE | ID: covidwho-1593438

ABSTRACT

A number of developments, including increasing regulatory and compliance scrutiny, increased transparency expectations, an increasingly vocal patient, patient centricity and greater requirements for real-world evidence, have driven the growth and importance of medical affairs as a trusted, science-driven partner over the past decade. The healthcare environment is shifting towards a digital, data-driven and payor-focused model. Likewise, medical affairs as a function within the pharmaceutical industry has become more "patient-centric" with strategic engagements embracing payers and patients apart from clinicians. The pandemic has impacted the healthcare industry as well as the function of medical affairs in numerous ways and has brought new challenges and demands to tackle. There is indeed a silver lining due to intense digital transformation within this crisis. The emerging digital innovation and new technologies in healthcare, medical education and virtual communications are likely to stay and advance further. In this review, we discuss how the digital transformation sparked by the pandemic has impacted the medical affairs function in pharmaceuticals and provide further insights and learnings from the COVID-19 era and beyond. Based on the learning and insights, digital innovation in three key strategic imperatives of medical affairs-HCP engagement, external partnerships and data generation will enable medical affairs to become future-fit as a strategic leadership function.


Subject(s)
COVID-19 , Pandemics , Drug Industry , Humans , Leadership , SARS-CoV-2
19.
Lett Appl Microbiol ; 74(4): 536-542, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1583477

ABSTRACT

This study aimed to evaluate the performance of hydrogen peroxide vapour (HPV) to inactivate the chimpanzee adenovirus AZD1222 vaccine strain used in the production of recombinant COVID-19 vaccine for application in cleaning validation in pharmaceutical industries production areas. Two matrixes were tested: formulated recombinant COVID-19 vaccine (FCV) and active pharmaceutical ingredient (API). The samples were dried on stainless steel and exposed to HPV in an isolator. One biological indicator with population >106 Geobacillus stearothermophilus spores was used to validate the HPV decontamination cycle as standard. HPV exposure resulted in complete virus inactivation in FVC (≥5·03 log10 ) and API (≥6·40 log10 ), showing HPV efficacy for reducing chimpanzee adenovirus AZD1222 vaccine strain. However, the optimum concentration and contact time will vary depending on the type of application. Future decontamination studies scaling up the process to the recombinant COVID-19 vaccine manufacturing areas are necessary to evaluate if the HPV will have the same or better virucidal effectivity in each specific production area. In conclusion, HPV showed efficacy for reducing AZD1222 chimpanzee adenovirus strain and can be a good choice for pharmaceutical industries facilities disinfection during recombinant COVID-19 vaccine production.


Subject(s)
COVID-19 , Disinfectants , Adenoviridae , Animals , COVID-19 Vaccines , Drug Industry , Humans , Hydrogen Peroxide/pharmacology , Manufacturing Industry , Pan troglodytes , Pharmaceutical Preparations
20.
Drug Discov Today ; 27(3): 697-704, 2022 03.
Article in English | MEDLINE | ID: covidwho-1568633

ABSTRACT

Over the past decade, Pfizer has focused efforts to improve its research and development (R&D) productivity. By the end of 2020, Pfizer had achieved an industry-leading clinical success rate of 21%, a tenfold increase from 2% in 2010 and well above the industry benchmark of ∼11%. The company had also maintained the quality of innovation, because 75% of its approvals between 2016 and 2020 had at least one expedited regulatory designation (e.g., Breakthrough Therapy). Pfizer's Signs of Clinical Activity (SOCA) paradigm enabled better decision-making and, along with other drivers (biology and modality), contributed to this productivity improvement. These laid a strong foundation for the rapid and effective development of the Coronavirus 2019 (COVID-19) vaccine with BioNTech, as well as the antiviral candidate Paxlovid™, under the company's 'lightspeed' paradigm.


Subject(s)
Drug Industry/economics , Research/economics , Antiviral Agents/economics , COVID-19/economics , COVID-19 Vaccines/economics , Humans
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