Author: Malik Osmane Publisher: Anchor Academic Publishing (aap_verlag) ISBN: 3954891875 Category : Technology & Engineering Languages : en Pages : 285
Book Description
Biopharmaceutical medicinal products (biologics) represent a huge financial market. Thus upon patent protection expiry of the innovator (reference) biologic there is interest from industry to gain a portion of this market by launching a 'similar' biologic at a reduced development cost, thus boosting potential gains. The EMA responded to this desire and lead the guidance process with industry on the topic of biosimilars. Based on the experience gained with biosimilars in the past, the EMA started to introduce a second generation series of guidance documents, which take into account the past, current and possibly future challenges of biosimilars. Those proposals were evaluated by EMA and partially incorporated into new guidance documents. This work highlights the challenges and risks associated with biosimilar submissions for large and complex bio-molecules such antibodies. Results: There are unaddressed questions for the regulator with regard to the unsolved dynamic of heterogeneity and variations of the quality profile, which have potential implications on safety and efficacy. This is neglected and not taken into account seriously enough by the stakeholders. Solution: Further, the only (in my view) progressive way to deal with such foreseeable situations from the biosimilar developer’s point of view is to incorporate a design space.
Author: Malik Osmane Publisher: Anchor Academic Publishing (aap_verlag) ISBN: 3954896877 Category : Medical Languages : en Pages : 282
Book Description
Biopharmaceutical medicinal products (biologics) represent a huge financial market. Thus upon patent protection expiry of the innovator (reference) biologic there is interest from industry to gain a portion of this market by launching a 'similar' biologic at a reduced development cost, thus boosting potential gains. The EMA responded to this desire and lead the guidance process with industry on the topic of biosimilars. Based on the experience gained with biosimilars in the past, the EMA started to introduce a second generation series of guidance documents, which take into account the past, current and possibly future challenges of biosimilars. Those proposals were evaluated by EMA and partially incorporated into new guidance documents. This work highlights the challenges and risks associated with biosimilar submissions for large and complex bio-molecules such antibodies. Results: There are unaddressed questions for the regulator with regard to the unsolved dynamic of heterogeneity and variations of the quality profile, which have potential implications on safety and efficacy. This is neglected and not taken into account seriously enough by the stakeholders. Solution: Further, the only (in my view) progressive way to deal with such foreseeable situations from the biosimilar developer’s point of view is to incorporate a design space.
Author: Jean-Louis Prugnaud Publisher: Springer Science & Business Media ISBN: 2817803361 Category : Medical Languages : en Pages : 101
Book Description
Biologics have revolutionised the treatment of many severe conditions, delivering exceptional clinical results but also producing exceptionally high prices. As patents expire, copies and price competition are expected throughout the world. However, due to the intrinsic heterogeneity and molecular complexity of biologic medicinal products, their copies cannot simply be authorized under the “generic rule” valid for small chemical entities. In response, a dedicated regulation was issued in the European Union. It is based on the concept of “biological medicinal products similar to a biological reference product”, or “biosimilars”. This book analyses the context of biotechnological production and addresses the European legal framework for biosimilar market approval. It highlights post-market authorisation issues, such as Risk Management Plans and substitution of products, and outlines some other issues, such as cost management and international nomenclature. This book is primarily intended for hospital-based physicians and pharmacists. It will also be a valuable resource for all actors from all countries who want to better understand the emergence of these new medicinal products within the European context.
Author: Publisher: World Health Organization ISBN: 9240024379 Category : Medical Languages : en Pages : 291
Book Description
The seventy-second meeting of the WHO Expert Committee on Biological Standardization was held from 19 to 23 October 2020 by WebEx video conferencing due to the restrictions imposed during the coronavirus disease 2019 (COVID-19) pandemic. The meeting was opened on behalf of the Director-General of WHO by Dr Mariângela Batista Galvão Simão, Assistant Director-General, Access to Medicines and Health Products. Dr Simão welcomed Committee members, meeting participants and observers. Dr Simão began by noting that the Committee had met as recently as August 2020, primarily to address standardization activities related to COVID-19, and that much remains to be learnt about the pandemic. The WHO Solidarity Trial was continuing to facilitate the rapid and robust comparison of potential treatments. Recently published interim results indicated that the four small molecule treatments remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon had little or no benefit in terms of overall mortality or speed of recovery of hospitalized patients – to date only dexamethasone had proved to be effective against severe COVID-19.
Author: World Health Organization Publisher: WHO Technical Report ISBN: 9789241210133 Category : Medical Languages : en Pages : 0
Book Description
This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biological substances, and the establishment of international biological reference materials. Following a brief introduction, the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report, of particular relevance to manufacturers and national regulatory authorities, outlines the discussions held on the development and revision of WHO Guidelines for a number of vaccines, blood products and related substances. Specific discussion areas included WHO guidance on the production and evaluation of the quality, safety and efficacy of monoclonal antibodies as similar biotherapeutic products (SBPs); blood and blood components as essential medicines; estimation of residual risk of HIV, HBV or HCV infections via cellular blood components and plasma; snake antivenom immunoglobulins; human pandemic influenza vaccines in non-vaccine-producing countries; and clinical evaluation of vaccines: regulatory expectations. In addition, the following WHO guidance documents were also adopted: WHO manual for the preparation of secondary reference materials for in vitro diagnostic assays designed for infectious disease nucleic acid or antigen detection: calibration to WHO International Standards; and Human challenge trials for vaccine development: regulatory considerations. One WHO addendum document "Labeling information of inactivated influenza vaccines for use in pregnant women" was also adopted. Subsequent sections of the report provide information on the current status, proposed development and establishment of international reference materials in the areas of: biotherapeutics other than blood products; blood products and related substances; cellular and gene therapies; in vitro diagnostics; and vaccines and related substances. A series of annexes are then presented which include an updated list of all WHO Recommendations, Guidelines and other documents on biological substances used in medicine (Annex 1). The above nine WHO documents adopted on the advice of the Committee are then published as part of this report (Annexes 2-10). Finally, all additions and discontinuations made during the 2016 meeting to the list of International Standards, Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 11. The updated full catalog of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/.
Author: United Nations Publisher: UN ISBN: 9789211220537 Category : Languages : en Pages : 232
Book Description
This publication argues that Latin America and the Caribbean are in a position to move towards a "big push for sustainability" through a combination of economic, industrial, social and environmental policies capable of driving an equal and sustainable recovery and relaunching development in the region. Comprised of five chapters, the publication studies the three crises (slow growth, growing inequality and the environmental emergency) affecting economies and societies around the world, placing particular focus on those of Latin America and the Caribbean. It goes on to present a framework for analysing these crises in an integrated manner and measuring their magnitude in the specified regions. It then examines the quantitative impacts on growth, emissions, income distribution and the external sector under different policy scenarios, highlighting the potential of various policy combinations to forge a more dynamic growth path, with lower emissions and greater equality. Further identifying seven sectors that can drive sustainable development and proposing policies to foster these sectors, the publication concludes with an analysis that links up macroeconomic, industrial, social and environmental policies and the role of the State in building consensus for their implementation.
Author: UNESCO Publisher: UNESCO Publishing ISBN: 9231001299 Category : Education Languages : en Pages : 818
Book Description
There are fewer grounds today than in the past to deplore a North‑South divide in research and innovation. This is one of the key findings of the UNESCO Science Report: towards 2030. A large number of countries are now incorporating science, technology and innovation in their national development agenda, in order to make their economies less reliant on raw materials and more rooted in knowledge. Most research and development (R&D) is taking place in high-income countries, but innovation of some kind is now occurring across the full spectrum of income levels according to the first survey of manufacturing companies in 65 countries conducted by the UNESCO Institute for Statistics and summarized in this report. For many lower-income countries, sustainable development has become an integral part of their national development plans for the next 10–20 years. Among higher-income countries, a firm commitment to sustainable development is often coupled with the desire to maintain competitiveness in global markets that are increasingly leaning towards ‘green’ technologies. The quest for clean energy and greater energy efficiency now figures among the research priorities of numerous countries. Written by more than 50 experts who are each covering the country or region from which they hail, the UNESCO Science Report: towards 2030 provides more country-level information than ever before. The trends and developments in science, technology and innovation policy and governance between 2009 and mid-2015 described here provide essential baseline information on the concerns and priorities of countries that could orient the implementation and drive the assessment of the 2030 Agenda for Sustainable Development in the years to come.
Author: Zaheer-Ud-Din Babar Publisher: Springer ISBN: 3319121693 Category : Business & Economics Languages : en Pages : 410
Book Description
This book provides an overview of the global pharmaceutical pricing policies. Medicines use is increasing globally with the increase in resistant microbes, emergence of new treatments, and because of awareness among consumers. This has resulted in increased drug expenditures globally. As the pharmaceutical market is expanding, a variety of pharmaceutical pricing strategies and policies have been employed by drug companies, state organizations and pharmaceutical pricing authorities.
Author: Lisa D. Butler Publisher: Springer ISBN: 3030163954 Category : Psychology Languages : en Pages : 354
Book Description
Human rights violations and traumatic events often comingle in victims’ experiences; however, the human rights framework and trauma theory are rarely deployed together to illuminate such experiences. This edited volume explores the intersection of trauma and human rights by presenting the development and current status of each of these frameworks, examining traumatic experiences and human rights violations across a range of populations and describing efforts to remediate them. Individual chapters address these topics among Native Americans, African Americans, children, women, lesbian/gay/bisexual/transgender individuals, those with mental disabilities, refugees and asylees, and older adults, and also in the context of social policy and truth and reconciliation commissions. The authors demonstrate that the trauma and human rights frameworks each contribute invaluable and complementary insights, and that their integration can help us fully appreciate and address human suffering at both individual and collective levels.
Author: M O'Neill Publisher: Elsevier ISBN: 1908818158 Category : Business & Economics Languages : en Pages : 414
Book Description
A biotech manager's handbook lays out - in a simple, straightforward manner - for the manager or would-be entrepreneur the basic principles of running a biotech company. Most managers in biotechnology companies are working in their first company or in their first managerial role. Their expertise and experience in the scientific part of the work can be taken as a given but there is a whole range of other skills to be learned and areas of expertise to come to terms with. Small companies do not have big budgets to hire people or time to become an expert in so many areas. The book starts by outlining the state of the biopharmaceutical industry and goes on to explain the importance of planning (no matter what the size of the company). Succeeding chapters deal with the basics of intellectual property, perspectives from a university technology transfer office and how to raise some initial funding from an investor and entrepreneur. No other 'how to' manual exists for this sector Written by a range of expert professionals in each area, all in one book Is the only 'bench to bedside' book covering the whole spectrum of development
Author: Malik Osmane
Author: Malik Osmane
Author: Jean-Louis Prugnaud
Author: 
Author: World Health Organization
Author: United Nations
Author: UNESCO
Author: Zaheer-Ud-Din Babar
Author: Lisa D. Butler
Author: M O'Neill