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  Subjects -> PHARMACY AND PHARMACOLOGY (Total: 575 journals)
Showing 401 - 253 of 253 Journals sorted alphabetically
Microbial Drug Resistance     Hybrid Journal   (Followers: 3)
Molecular Informatics     Hybrid Journal   (Followers: 5)
Molecular Pharmacology     Hybrid Journal   (Followers: 2)
Molekul     Open Access   (Followers: 1)
Natural Product Communications     Open Access  
Nature Reviews Drug Discovery     Full-text available via subscription   (Followers: 316)
Naunyn-Schmiedeberg's Archives of Pharmacology     Hybrid Journal  
NeuroMolecular Medicine     Hybrid Journal  
Neuropharmacology     Hybrid Journal   (Followers: 6)
Neuropsychopharmacology     Hybrid Journal   (Followers: 18)
Neuropsychopharmacology Reports     Open Access  
Nigerian Journal of Natural Products and Medicine     Full-text available via subscription  
OA Drug Design & Delivery     Open Access  
OA Medical Hypothesis     Open Access  
Obesity Facts     Open Access   (Followers: 8)
Open Pharmacoeconomics & Health Economics Journal     Open Access  
Open Pharmacology Journal     Open Access  
OpenNano     Open Access   (Followers: 1)
Orbital - The Electronic Journal of Chemistry     Open Access   (Followers: 1)
Oriental Pharmacy and Experimental Medicine     Partially Free   (Followers: 2)
Pain and Therapy     Open Access   (Followers: 3)
Particulate Science and Technology: An International Journal     Hybrid Journal   (Followers: 1)
PDA Journal of Pharmaceutical Science and Technology     Full-text available via subscription   (Followers: 36)
Pediatric Drugs     Full-text available via subscription   (Followers: 4)
Pediatric Pharmacology     Open Access   (Followers: 1)
Pharmaceutica Analytica Acta     Open Access  
Pharmaceutical Biology     Open Access  
Pharmaceutical Care-La Farmacoterapia     Open Access  
Pharmaceutical Chemistry Journal     Hybrid Journal  
Pharmaceutical Development and Technology     Hybrid Journal   (Followers: 21)
Pharmaceutical Executive     Full-text available via subscription   (Followers: 6)
Pharmaceutical Fronts     Open Access   (Followers: 5)
Pharmaceutical Historian     Open Access  
Pharmaceutical Journal     Free   (Followers: 8)
Pharmaceutical Journal of Sri Lanka     Open Access  
Pharmaceutical Medicine     Full-text available via subscription   (Followers: 4)
Pharmaceutical Nanotechnology     Hybrid Journal  
Pharmaceutical Patent Analyst     Full-text available via subscription   (Followers: 3)
Pharmaceutical Research     Hybrid Journal   (Followers: 97)
Pharmaceutical Statistics     Hybrid Journal   (Followers: 16)
Pharmaceutical Technology     Full-text available via subscription   (Followers: 6)
Pharmaceuticals     Open Access   (Followers: 4)
Pharmacia     Open Access  
PharmacoEconomics     Full-text available via subscription   (Followers: 26)
PharmacoEconomics & Outcomes News     Full-text available via subscription   (Followers: 4)
PharmacoEconomics German Research Articles     Full-text available via subscription  
PharmacoEconomics Spanish Research Articles     Hybrid Journal   (Followers: 1)
Pharmacoepidemiology and Drug Safety     Hybrid Journal   (Followers: 34)
Pharmacogenetics and Genomics     Hybrid Journal   (Followers: 1)
Pharmacogenomics     Hybrid Journal   (Followers: 7)
Pharmacogenomics and Personalized Medicine     Open Access   (Followers: 2)
Pharmacogenomics Journal     Hybrid Journal   (Followers: 5)
Pharmacognosy Communications     Partially Free  
Pharmacognosy Magazine     Open Access   (Followers: 2)
Pharmacognosy Research     Open Access   (Followers: 2)
Pharmacological Reports     Hybrid Journal  
Pharmacological Research     Hybrid Journal   (Followers: 1)
Pharmacological Research - Modern Chinese Medicine     Open Access  
Pharmacological Reviews     Hybrid Journal   (Followers: 2)
Pharmacology     Full-text available via subscription  
Pharmacology & Therapeutics     Hybrid Journal   (Followers: 3)
Pharmacology & Pharmacy     Open Access   (Followers: 1)
Pharmacology Biochemistry and Behavior     Hybrid Journal   (Followers: 2)
Pharmacology Research & Perspectives     Open Access  
Pharmacon : Jurnal Farmasi Indonesia     Open Access  
Pharmacopsychiatry     Hybrid Journal   (Followers: 3)
Pharmacotherapy The Journal of Human Pharmacology and Drug Therapy     Hybrid Journal   (Followers: 38)
Pharmactuel     Open Access   (Followers: 1)
Pharmacy     Open Access   (Followers: 4)
Pharmacy & Pharmacology     Open Access  
Pharmacy Education     Full-text available via subscription   (Followers: 11)
Pharmacy Practice (Internet)     Open Access   (Followers: 8)
Pharmakon : Arzneimittel in Wissenschaft und Praxis     Full-text available via subscription   (Followers: 1)
PharmaNutrition     Hybrid Journal   (Followers: 3)
PharmaTutor     Open Access  
Pharmazeutische Industrie     Full-text available via subscription   (Followers: 11)
Pharmazeutische Zeitung     Full-text available via subscription   (Followers: 15)
Pharmazie in Unserer Zeit (Pharmuz)     Hybrid Journal   (Followers: 18)
Physiology International     Full-text available via subscription   (Followers: 3)
Plant Products Research Journal     Full-text available via subscription  
Planta Medica     Hybrid Journal   (Followers: 4)
Planta Medica International Open     Open Access  
Prescriber     Hybrid Journal   (Followers: 9)
Progress in Neuro-Psychopharmacology and Biological Psychiatry     Hybrid Journal   (Followers: 8)
Psychiatry and Clinical Psychopharmacology     Open Access   (Followers: 1)
Psychopharmacology     Hybrid Journal   (Followers: 16)
Pulmonary Pharmacology & Therapeutics     Hybrid Journal   (Followers: 2)
PZ Prisma : Materialien zur Fort- und Weiterbildung     Full-text available via subscription  
Redox Report     Open Access  
Regulatory Mechanisms in Biosystems     Open Access   (Followers: 1)
Regulatory Toxicology and Pharmacology     Hybrid Journal   (Followers: 41)
Research & Reviews : A Journal of Drug Design & Discovery     Full-text available via subscription  
Research & Reviews : A Journal of Pharmaceutical Science     Full-text available via subscription  
Research & Reviews : A Journal of Pharmacognosy     Full-text available via subscription  
Research & Reviews : A Journal of Pharmacology     Full-text available via subscription   (Followers: 1)
Research in Pharmaceutical Sciences     Open Access   (Followers: 3)
Research in Social and Administrative Pharmacy     Hybrid Journal   (Followers: 3)
Research Journal of Pharmacognosy     Open Access  
Research Results in Pharmacology     Open Access  
Reviews of Physiology, Biochemistry and Pharmacology     Hybrid Journal   (Followers: 4)
Reviews on Clinical Pharmacology and Drug Therapy     Full-text available via subscription  
Revista Colombiana de Ciencias Químico-Farmacéuticas     Open Access  
Revista Cubana de Plantas Medicinales     Open Access   (Followers: 1)
Revista de Ciências Farmacêuticas Básica e Aplicada     Open Access  
Revista Mexicana de Ciencias Farmaceuticas     Open Access  
Revue de Médecine et de Pharmacie     Full-text available via subscription  
Safety and Risk of Pharmacotherapy     Open Access   (Followers: 1)
Saudi Pharmaceutical Journal     Open Access  
Scandinavian Journal of Clinical and Laboratory Investigation     Hybrid Journal   (Followers: 8)
Scientia Pharmaceutica     Open Access  
Seminars in Hematology     Hybrid Journal   (Followers: 12)
Seminars in Oncology Nursing     Full-text available via subscription   (Followers: 10)
Separation Science plus (SSC plus)     Hybrid Journal  
Side Effects of Drugs Annual     Full-text available via subscription   (Followers: 2)
Skin Pharmacology and Physiology     Full-text available via subscription   (Followers: 6)
Substance Abuse : Research and Treatment     Open Access   (Followers: 5)
Suchttherapie     Hybrid Journal   (Followers: 1)
Sustainable Chemistry and Pharmacy     Full-text available via subscription   (Followers: 1)
Synfacts     Hybrid Journal   (Followers: 5)
SynOpen     Open Access  
The Botulinum J.     Hybrid Journal  
The Brown University Psychopharmacology Update     Hybrid Journal   (Followers: 2)
The Medical Letter     Full-text available via subscription   (Followers: 18)
The Pink Sheet     Full-text available via subscription   (Followers: 12)
The Pink Sheet Daily     Full-text available via subscription   (Followers: 5)
Therapeutic Advances in Drug Safety     Open Access   (Followers: 3)
Therapeutic Advances in Psychopharmacology     Open Access   (Followers: 4)
Therapeutic Advances in Vaccines     Hybrid Journal   (Followers: 1)
Therapeutic Drug Monitoring     Hybrid Journal   (Followers: 5)
Therapeutic Innovation & Regulatory Science     Hybrid Journal   (Followers: 7)
Thérapie     Full-text available via subscription   (Followers: 1)
TheScientist     Free   (Followers: 6)
Toxicological & Environmental Chemistry     Hybrid Journal   (Followers: 2)
Toxicological Research     Hybrid Journal  
Toxicological Sciences     Hybrid Journal   (Followers: 11)
Toxicology     Hybrid Journal   (Followers: 19)
Toxicology and Applied Pharmacology     Hybrid Journal   (Followers: 25)
Toxicology and Industrial Health     Hybrid Journal   (Followers: 6)
Toxicology in Vitro     Hybrid Journal   (Followers: 12)
Toxicology International     Full-text available via subscription   (Followers: 5)
Toxicology Letters     Hybrid Journal   (Followers: 16)
Toxicology Mechanisms and Methods     Hybrid Journal   (Followers: 9)
Toxicology Research     Partially Free   (Followers: 8)
Toxicon     Hybrid Journal   (Followers: 5)
Toxicon : X     Open Access  
Toxin Reviews     Hybrid Journal  
Translational Psychiatry     Open Access   (Followers: 14)
Trends in Peptide and Protein Sciences     Open Access  
Trends in Pharmacological Sciences     Full-text available via subscription   (Followers: 21)
Tropical Journal of Pharmaceutical Research     Open Access  
Ukrainian Biopharmaceutical Journal     Open Access  
Vascular Pharmacology     Hybrid Journal   (Followers: 2)
World Mycotoxin Journal     Hybrid Journal   (Followers: 3)
Yakugaku Zasshi     Open Access   (Followers: 1)
Zeitschrift für Phytotherapie     Hybrid Journal   (Followers: 1)
Актуальні питання фармацевтичної та медичної науки та практики     Open Access  
Фармацевтичний часопис     Open Access  

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Pharmaceutical Medicine
Journal Prestige (SJR): 0.187
Number of Followers: 4  
 
  Full-text available via subscription Subscription journal
ISSN (Print) 1178-2595 - ISSN (Online) 1179-1993
Published by Adis Homepage  [21 journals]
  • The Impact of the Priority Review Voucher on Research and Development for
           Tropical Diseases

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      Abstract: Background In 2007, the priority review voucher (PRV) was implemented in the US to incentivize research and development (R&D) for tropical diseases. The PRV is issued by the US FDA and grants a quicker review to manufacturers upon successful development of a product for a disease eligible for the program. Objective The objective of this analysis was to assess whether the PRV has incentivized R&D (measured as clinical trial activity) for the intended tropical diseases. Method We used a difference-in-difference-in-differences (DDD) strategy by exploiting variation in its implementation across diseases and registries around the world. Clinical trials were retrieved from the World Health Organization International Clinical Trials Registry Platform for the years 2005–2019. Results We found a positive, but not statistically significant, effect of the PRV on stimulating R&D activity. Delayed effects of the policy could not be found. Conclusion Our findings, which were robust across a series of robustness tests, suggest that the PRV program is not associated with a trigger in innovation for neglected diseases and therefore should not be considered as a stand-alone solution. It should be supplemented with other government measures to incentivize R&D activity. To increase the value of the program, we recommend that the PRV only be awarded to novel products and not to products that have already been licensed outside the US. Doing so would restrict the number of vouchers awarded and slow down their ongoing market depreciation. Finally, we propose that product sponsors be required to submit an access plan for PRV-awarded products.
      PubDate: 2022-05-19
       
  • Major Pharmaceutical Conferences and Courses: August to September 2022

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      PubDate: 2022-05-03
       
  • Dispositions and Causality Assessment in Pharmacovigilance: Proposing the
           Dx3 Approach for Assessing Causality with Small Data Sets

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      Abstract: Abstract A new approach is proposed for assessing causality in pharmacovigilance. The Dx3 approach is designed to qualitatively evaluate three types of dispositions when assessing whether a particular medicine has or could have caused a certain adverse event. These are: the drug disposition; the pre-disposition of the patient taking the drug (vulnerability) and; the disposition of the patient–drug interaction (mutuality). Each of these three types of dispositions will represent valuable causally relevant evidence for assessing a potential signal of harm. A checklist is provided to guide the assessment of causality for both single individual case safety reports (ICSRs) and case series. Different types of causal information are ranked according to how well suited they are for establishing a disposition. Two case examples are used to demonstrate how the approach can be used in practice for assessment purposes. One aim of the approach is to offer a qualitative way to assess causality and to make the reasoning of different assessors more transparent. A second aim is to encourage the collection of more qualitatively rich patient narratives in the ICSRs. Crucially, we believe this approach can support the inclusion of the single ICSR as a valid and valuable form of evidence.
      PubDate: 2022-04-29
       
  • Chaos to Clarity: Pragmatic Approaches to Overcome Challenges for
           Successful Implementation of Additional Risk Minimisation Measures in the
           European Union and the UK by a Marketing Authorisation Holder

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      Abstract: Background Most national competent authorities issue guidance on the dissemination and implementation of additional risk minimisation measures (aRMMs), like the European Medicines Agency. However, national competent authorities guidance includes additional regulatory requirements, the reasons for which are unclear. Objectives The purpose of this study was to identify significant barriers to risk management implementation and methodological challenges encountered by local safety managers in the European Union and the UK owing to differences in country-specific regulations and regional national competent authorities guidance. Methods The European Medicines Agency and national competent authorities guidance for each of the aRMM programme’s formative components were compared. A survey was conducted to ascertain the challenges encountered by local safety managers throughout the implementation phases and the responses analysed. Results Twenty-seven national guidance documents were compared with the European Medicines Agency’s guidance, and it was observed that national competent authorities provide additional aRMM dissemination and implementation parameters for the format and layout of aRMM, translation requirements, guidance on aRMM content, submission requirements, monitoring parameters and aRMM update requirements, among others. The survey was completed by 11 out of 21 local safety managers (52.38%). Eight local safety managers rated submission of an implementation plan as the most challenging aspect. Multiple national competent authorities requests, frequent updates, and delayed approval impacted planning and implementation, resulting in modifications and delays. Moreover, the study discovered that managing frequent version updates of digital aRMMs was challenging, and most national competent authorities neglected the post-implementation phase activities. Further, most local safety managers followed both the local and global processes to maintain documentation of aRMM implementation. Conclusions It was evident that the European Medicines Agency and national competent authorities empower marketing authorisation holders to implement and disseminate aRMM materials tailored to their local healthcare settings. However, this poses a challenge for marketing authorisation holders because of a lack of clarity in guidance in executing an aRMM programme and an added burden of complying with both European Medicines Agency and national competent authority requirements.
      PubDate: 2022-04-13
       
  • Medicines Regulatory Science Expertise in Africa: Workforce Capacity
           Development and Harmonisation Activities Towards the Establishment of the
           African Medicines Agency

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      Abstract: Abstract The medicines regulatory landscape in Africa is undergoing transformation with at least two countries having National Medicines Regulatory Authorities (NRAs) that operate at World Health Organization (WHO) maturity level 3. However, this represents the exception as over 90% of African NRAs have limited capacity to perform core medicine regulatory functions, have a shortage of competent regulatory professionals, have high staff turnover, lack diversity of scientific expertise, and have staffing shortages relative to the high workload. A systematic approach to developing the regulatory workforce is therefore crucial to addressing the existing shortfalls in regulatory capacity, particularly at this time when efforts are underway to operationalise the African Medicines Agency (AMA). In this article, initiatives that are building African NRAs’ regulatory capacity and developing their workforce are reviewed in preparation for work to be conducted by the AMA. We found that the African Medicines Regulatory Harmonisation (AMRH) initiative has been at the forefront of capacity building and workforce development mainly through the designation of specialised Regional Centres of Regulatory Excellence and the implementation of medicines regulatory harmonisation initiatives in regional economic communities. In addition, some NRAs within high-income countries and trusted institutions have been supporting regulators in low-income countries with registration assessments and facilitating access to quality-assured medical products through their stringent review procedures (SRPs). Capacity building has subsequently been facilitated through this active involvement of African regulators in SRPs. This article also provides recommendations for further capacity building and workforce development.
      PubDate: 2022-04-05
       
  • Medical Affairs and Innovative Medicinal Product Strategy Development

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      Abstract: Abstract Innovative medicinal products are required for progress in many therapeutic areas, and in particular, oncology. For these products to succeed, pharmaceutical companies must generate the relevant and robust clinical data required to meet the needs of regulators and healthcare providers. In addition, real-world and health economic evidence is increasingly required to support pricing and reimbursement for innovative medicinal products. To incorporate all of these requirements into the innovative medicinal product strategy early in development, the core principles of how product strategies are developed and applied must be revisited and end-to-end strategic planning implemented. This paper reviews the hurdles faced during development of the integrated strategy for innovative medicinal products, particularly in the oncology field, and examines which functions of a pharmaceutical company should play the greatest role in addressing patient and different stakeholders’ needs. It will then illustrate how Medical Affairs activities are evolving to take on this strategic leadership role.
      PubDate: 2022-03-13
       
  • Medical Affairs Transformation in Specialty Pharma: Next-Level
           Collaboration at the Core

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      Abstract: Abstract Pharmaceutical companies with a medical mindset and an empowered Medical Affairs function are well equipped to meet the needs and expectations of patients and society. Yet, as capacity to understand and serve those needs accelerates, so too do expectations. Evidence-based practice, without delay, is expected throughout the development and delivery of medicine, healthcare, and information, and potential sources of evidence are legion. To keep pace and go beyond, to innovate, requires efficiencies. Not the disguised cutbacks of political language, but the collaborative constructive efficiencies of shared learning, forming new evidence bases for further progress. Here, we describe the first year of a medical transformation process at a global mid-sized pharmaceutical company. Beginning with a broad review designed to leverage collective intelligence and focus on meaningful outcomes for patients, this process examined and reshaped the structure, culture, and tools of the medical organization and its interactions within and outside the company. We report the findings of the diagnostic phase, outline the solutions implemented to date, and anticipate the next steps in this dynamic evolving journey.
      PubDate: 2022-03-06
       
  • Major Pharmaceutical Conferences and Courses: June to July 2022

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      PubDate: 2022-03-05
       
  • Cannabidiol and Other Phytocannabinoids as Cancer Therapeutics

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      Abstract: Abstract Preclinical models provided ample evidence that cannabinoids are cytotoxic against cancer cells. Among the best studied phytocannabinoids, cannabidiol (CBD) is most promising for the treatment of cancer as it lacks the psychotomimetic properties of delta-9-tetrahydrocannabinol (THC). In vitro studies and animal experiments point to a concentration- (dose-)dependent anticancer effect. The effectiveness of pure compounds versus extracts is the subject of an ongoing debate. Actual results demonstrate that CBD-rich hemp extracts must be distinguished from THC-rich cannabis preparations. Whereas pure CBD was superior to CBD-rich extracts in most in vitro experiments, the opposite was observed for pure THC and THC-rich extracts, although exceptions were noted. The cytotoxic effects of CBD, THC and extracts seem to depend not only on the nature of cannabinoids and the presence of other phytochemicals but also largely on the nature of cell lines and test conditions. Neither CBD nor THC are universally efficacious in reducing cancer cell viability. The combination of pure cannabinoids may have advantages over single agents, although the optimal ratio seems to depend on the nature of cancer cells; the existence of a ‘one size fits all’ ratio is very unlikely. As cannabinoids interfere with the endocannabinoid system (ECS), a better understanding of the circadian rhythmicity of the ECS, particularly endocannabinoids and receptors, as well as of the rhythmicity of biological processes related to the growth of cancer cells, could enhance the efficacy of a therapy with cannabinoids by optimization of the timing of the administration, as has already been reported for some of the canonical chemotherapeutics. Theoretically, a CBD dose administered at noon could increase the peak of anandamide and therefore the effects triggered by this agent. Despite the abundance of preclinical articles published over the last 2 decades, well-designed controlled clinical trials on CBD in cancer are still missing. The number of observations in cancer patients, paired with the anticancer activity repeatedly reported in preclinical in vitro and in vivo studies warrants serious scientific exploration moving forward.
      PubDate: 2022-03-04
       
  • The Carbon Costs of In-Person Versus Virtual Medical Conferences for the
           Pharmaceutical Industry: Lessons from the Coronavirus Pandemic

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      Abstract: Background Many in-person congresses have shifted to a virtual format owing to coronavirus disease 2019 (COVID-19). We assessed carbon emissions savings associated with virtual attendance at international medical congresses for a mid-sized pharmaceutical company, to identify which aspects are driving the carbon cost. Methods We assessed carbon emissions that were the responsibility of company attendees (including their guests) for the most attended congresses by employees (American Society of Clinical Oncology [ASCO], European Neuroendocrine Tumor Society [ENETS], European Society for Medical Oncology [ESMO], World Congress for NeuroRehabilitation [WCNR]). For in-person estimates, we considered travel, accommodation and congress attendance; for online estimates, we considered office and internet-related energy use. Emissions were defined using recognised data sources. Results For 1723 anticipated in-person attendees, calculated total carbon emissions were 3,262,574 kgCO2e (mean per in-person company attendee, 1894 kgCO2e: ASCO, 4172; ESMO, 1479; WCNR, 1153; ENETS, 1009). For context, the average UK resident’s annual carbon footprint is 5600 kgCO2e. Travel accounted for 91–96% of total emissions, mainly through long distance and business-class air travel. Calculated total carbon emissions associated with 1839 virtual attendees were 19,095 kgCO2e (mean per virtual company attendee, 10.4 kgCO2e; equivalent to approximately 0.3–1.1% of in-person attendance emissions across all four congresses assessed). Conclusion Carbon emissions associated with virtual attendance were two orders of magnitude lower than for in-person attendance, and therefore the benefits of in-person attendance at medical congresses must be balanced against the carbon cost. Due diligence around who should attend and how they should travel to face-to-face meetings, and consideration of hybrid and domestic satellite options could be part of a balanced solution to reducing carbon emissions.
      PubDate: 2022-02-26
       
  • Impact of Changing Regulations and the Dynamic Nature of European Risk
           Management Plans for Human Medicines on the Lifecycle of Safety Concerns

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      Abstract: Introduction The European Risk Management Plan (EU-RMP) is a proactive planning tool for identification, characterisation and management of important risks and missing information throughout the lifecycle of a medicinal product. Over the past 15 years the EU-RMP has been a part of the pharmacovigilance practice in Europe, but there are no published studies assessing impact of the growing experience and evolving regulatory framework on the content and focus of the EU-RMP. Objectives The objectives were to study the real-world impact of evolving pharmacovigilance guidelines on the proactive lifecycle management of important risks and missing information through EU-RMPs, and to further explore the impact of different resources on the management of the benefit-risk profile. Methods A retrospective study based on the review of 64 EU-RMPs dated between 01 January 2006 and 01 October 2020 for seven human medicinal products for which Boehringer Ingelheim holds the Marketing Authorisation in the European Union. Data on the timing and rational behind changes (i.e., inclusion, reclassification, removal) to the safety concerns (Important Identified Risks, Important Potential Risks, Missing Information) and associated additional Pharmacovigilance activities and/or Risk Minimisation measures were collected and assessed. Results The analysed EU-RMPs included a total of 197 safety concerns, 129 of which were removed and 19 were reclassified during the observation period. The implementation of the Guidelines on Good Pharmacovigilance Practices Module V in 2012 and Revision 2 in 2017 resulted in a noticeable decrease in the number of safety concerns. Clinical trial, non-clinical and routine post-marketing data were common sources that influenced the safety concern dynamics, and results from dedicated post-authorisation studies lead to the removal of 21 important risks and missing information. Many safety concerns were related to pharmacological class effect (n = 55) and target population characteristics (n = 37). Conclusions This study demonstrated that the growing knowledge regarding benefit-risk of approved products and the introduction of new or revised regulatory guidelines influenced the EU-RMP lifecycle of safety concerns, and moreover, the results emphasise that exchange of knowledge about the pharmacological class and target population between stakeholders are important for keeping an up-to-date understanding of a medicinal product’s safety profile. The aim of improving the efficiency of risk management has leveraged the accumulation of knowledge leading to revision of regulatory guidelines and increasingly, proactive Risk Management Plans focused on safety concerns that are important for patients and public health.
      PubDate: 2022-01-31
       
  • Delivery Strategies for mRNA Vaccines

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      Abstract: Abstract The therapeutic potential for messenger RNA (mRNA) in infectious diseases and cancer was first realized almost three decades ago, but only in 2018 did the first lipid nanoparticle-based small interfering RNA (siRNA) therapy reach the market with the United States Food and Drug Administration (FDA) approval of patisiran (Onpattro™) for hereditary ATTR amyloidosis. This was largely made possible by major advances in the formulation technology for stabilized lipid-based nanoparticles (LNPs). Design of the cationic ionizable lipids, which are a key component of the LNP formulations, with an acid dissociation constant (pKa) close to the early endosomal pH, would not only ensure effective encapsulation of mRNA into the stabilized lipoplexes within the LNPs, but also its subsequent endosomal release into the cytoplasm after endocytosis. Unlike other gene therapy modalities, which require nuclear delivery, the site of action for exogenous mRNA vaccines is the cytosol where they get translated into antigenic proteins and thereby elicit an immune response. LNPs also protect the mRNA against enzymatic degradation by the omnipresent ribonucleases (RNases). Cationic nano emulsion (CNE) is also explored as an alternative and relatively thermostable mRNA vaccine delivery vehicle. In this review, we have summarized the various delivery strategies explored for mRNA vaccines, including naked mRNA injection; ex vivo loading of dendritic cells; CNE; cationic peptides; cationic polymers and finally the clinically successful COVID-19 LNP vaccines (Pfizer/BioNTech and Moderna vaccines)—their components, design principles, formulation parameter optimization and stabilization challenges. Despite the clinical success of LNP-mRNA vaccine formulations, there is a specific need to enhance their storage stability above 0 °C for these lifesaving vaccines to reach the developing world.
      PubDate: 2022-01-30
       
  • Digital Additional Risk Minimization Measures: An Exploratory Study Using
           Qualitative Feedback from Healthcare Professionals and Patients Across Six
           Countries

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      Abstract: Background Additional risk minimization measures (aRMMs) are required for some pharmaceutical products when routine risk minimization measures (i.e., product labeling) are deemed insufficient. Measures often include educational materials, such as paper brochures, leaflets, and/or alert cards that provide information to healthcare professionals and patients on the key risks associated with a product and risk minimization actions to take should particular signs or symptoms arise. Paper-based educational aRMMs have several limitations. They do not present information in an interactive manner, and their update and distribution can be costly and often complex. Measuring how effective they are in achieving their aims can also be difficult. Digital methods offer design and delivery flexibility, easier updating processes, opportunities to increase engagement with important information, as well possibilities for tracking distribution, receipt, and potentially understanding of the materials. Pharmaceutical companies have started to look to digital methods as an option for educational aRMMs, alongside paper materials. Objectives Research into healthcare professionals and patient needs and preferences, as well as the general acceptability of digital educational options is needed to establish a baseline. This was an exploratory study intended to provide initial insights on the acceptability of digital aRMMs and to inform future research directions. Methods Digital concepts for educational aRMMs, one for healthcare professionals and one for patients, were evaluated with 30 healthcare professionals and 20 patients in six countries through 1:1 Zoom calls, with responses recorded in a structured Qualtrics-based survey. Criteria for selecting the six countries included local familiarity with aRMMs as well as interest in and capability to deliver a potential digital aRMM program by the sponsoring company’s affiliate teams. Of the healthcare professionals, 19 were rheumatologists and 11 were dermatologists. 16 patients had rheumatologic (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis) conditions and four had atopic dermatitis. These conditions were chosen as they aligned to potential therapeutic areas where the sponsoring company may have the opportunity to use a digital aRMM. Participants were given an overview of the concept as well as the opportunity to interact with it directly via the “control screen” function in Zoom before questions were posed. Results The results demonstrated that the majority of healthcare professionals (87%) and all patients interviewed would prefer website-based or app-based delivery, respectively, of aRMM information instead of, or alongside traditional paper-based approaches, with only 13% of healthcare professionals and no patients expressing a preference for paper-only communication. Conclusions Given new options offered by digital technology, its widespread use in many fields, and the importance of patient safety as a topic, there is an imperative for pharmaceutical companies and regulators to work together to establish a way forward for the use of digital options for aRMMs. This study is limited in its generalizability but offers some ideas for future research directions.
      PubDate: 2022-01-08
       
  • Development and Validation of the Medical Affairs Pharmaceutical Physician
           Value (MAPPval) Instrument

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      Abstract: Background A pilot study conducted in 2020 suggested that Medical Affairs Pharmaceutical Physicians (MAPPs) may be inherently undervalued within the pharmaceutical industry and vulnerable to replacement by less qualified roles. There are currently no standardized metrics to measure MAPP performance, thus it is necessary to measure the value of MAPPs to employers and clarify the need for their specific skills. Objectives The first aim of this study was to identify a list of indicators to produce an MAPP value measurement tool, and the second aim was to determine its discriminant validity by showing that the ‘MAPPval instrument’ differentiated the MAPP role from other internal stakeholders (regulatory affairs, market access, commercial, and patient advocacy) in terms of accountability for pharmaceutical company activities and level of engagement with external stakeholders. Methods MAPPs were recruited using convenience sampling via professional networks and completed a qualitative online survey to identify a list of key role indicators using a consensus method known as the Jandhyala method. Responses were coded and scored, and aggregated responses were presented to participants in a Consensus Round. Participants rated their agreement with each item on a 5-point Likert scale, from strongly agree to strongly disagree. Indicators that reached a consensus index of > 50% (CI ≥ 0.51) were retained in the final MAPP performance instrument. Participants’ retrospectively self-reported professional activities over a period of 12 months were used to validate the measure. A two-proportion z-test and Mann–Whitney tests were used to determine discriminant validity by showing whether the value of the MAPP role as defined by the instrument was significantly different from that of other internal stakeholders in terms of their accountability for and external stakeholder benefit from each MAPP activity. Results In total, 11 MAPPs participated in the Jandhyala method, which generated 22 unique MAPP value indicators. Payor-targeted activities and journal publications had the two highest awareness indexes (1.00 and 0.98, respectively). The retrospective study confirmed the MAPPval instrument’s validity. MAPPs were the only internal stakeholder classified as accountable for at least one activity that benefited all four stakeholders. They were classified as accountable for activities that influenced significantly more external stakeholders than other internal stakeholders, even when activities influenced fewer than four external stakeholders. MAPPs were also accountable for significantly more activities recorded over the 12-month period than regulatory affairs, market access, commercial, and patient advocacy. Conclusions This study generated and validated the first measure of MAPP value to pharmaceutical companies. MAPPs have unique value to pharmaceutical companies compared with other roles in terms of their accountability for activities that influence regulators, payors, prescribers, and patients. Through their accountability for pharmaceutical company activities and influence of external stakeholders, MAPPs play a key role in medicine adoption.
      PubDate: 2022-01-07
       
  • Digital Transformation in Medical Affairs Sparked by the Pandemic:
           Insights and Learnings from COVID-19 Era and Beyond

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      Abstract: 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.
      PubDate: 2021-12-31
       
  • Major Pharmaceutical Conferences and Courses: April to May 2022

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      PubDate: 2021-12-29
       
  • 37th Congress of the European Committee for Treatment and Research in
           Multiple Sclerosis (ECTRIMS 2021): 13–15 October, 2021

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      PubDate: 2021-12-02
       
  • Acknowledgement to Referees

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      PubDate: 2021-11-30
       
  • Major Pharmaceutical Conferences and Courses: February to March 2022

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      PubDate: 2021-11-30
       
  • The Pharmaceutical Year that was, 2021

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      PubDate: 2021-11-17
       
 
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