Practical Aspects of Vaccine Development

Practical Aspects of Vaccine Development
Author: Parag Kolhe,Satoshi Ohtake
Publsiher: Elsevier
Total Pages: 386
Release: 2021-09-24
ISBN 10: 0128143576
ISBN 13: 9780128143575
Language: EN, FR, DE, ES & NL

Practical Aspects of Vaccine Development Book Review:

Formulation, Development and Manufacturing of Vaccines: The Practical Aspects provides an industry perspective on vaccine product development and manufacture that covers their formulation development, manufacture and delivery/in-use considerations of vaccine production. With the increasing complexity of vaccine products in development, there is a need for a comprehensive review of the current state of the industry and its challenges. While formulation scientists working in biotherapeutic development may be familiar with proteins, vaccines present unique challenges, including the wide range of vaccine components that may comprise proteins, polysaccharides, protein-polysaccharide conjugates, adjuvants, etc. and the varying stability and behavior of solution- and suspension-based systems. This book is an essential resource for formulation scientists, researchers in vaccine development throughout medical and life sciences, and advanced students. Includes formulation considerations for various vaccine types, including proteins, polysaccharides, conjugates and live vaccines Considers process development for solution, suspension and lyophilized products Explores the future potential of vaccines, including multi-component vaccines and novel delivery mechanisms/devices

Vaccine Development and Manufacturing

Vaccine Development and Manufacturing
Author: Emily P. Wen,Ronald Ellis,Narahari S. Pujar
Publsiher: John Wiley & Sons
Total Pages: 456
Release: 2014-10-06
ISBN 10: 1118870905
ISBN 13: 9781118870907
Language: EN, FR, DE, ES & NL

Vaccine Development and Manufacturing Book Review:

Vaccine Manufacturing and Production is an invaluable reference on how to produce a vaccine - from beginning to end - addressing all classes of vaccines from a processing, production, and regulatory viewpoint. It will provide comprehensive information on the various fields involved in the production of vaccines, from fermentation, purification, formulation, to regulatory filing and facility designs. In recent years, there have been tremendous advances in all aspects of vaccine manufacturing. Improved technology and growth media have been developed for the production of cell culture with high cell density or fermentation. Vaccine Manufacturing and Production will serve as a reference on all aspects of vaccine production by providing an in-depth description of the available technologies for making different types of vaccines and the current thinking in facility designs and supply issues. This book will provide insight to the issues scientists face when producing a vaccine, the steps that are involved, and will serve as a reference tool regarding state-of-the-art vaccine manufacturing technologies and facility set-up. Highlights include: Comprehensive coverage of vaccine production : from a process point of view- fermentation to purification to formulation developments; from a production point of view - from facility design to manufacturing; and from a regulatory point of view - requirements from government agencies Authors from different major pharmaceutical and biotechnology companies Describes the challenges and issues involved in vaccine production and manufacturing of the different classes of vaccines, an area not covered by other books currently on the market

Practical Aspects of Vaccine Development

Practical Aspects of Vaccine Development
Author: Parag Kolhe,Satoshi Ohtake
Publsiher: Academic Press
Total Pages: 386
Release: 2021-09-17
ISBN 10: 0128143584
ISBN 13: 9780128143582
Language: EN, FR, DE, ES & NL

Practical Aspects of Vaccine Development Book Review:

Practical Aspects of Vaccine Development provides an academic and industry perspective on vaccine development and manufacturing. With the increasing complexity of vaccine products in development, there is a need for a comprehensive review of the current state of the industry and challenges being encountered. While formulation scientists working in biotherapeutic development may be familiar with proteins, vaccines present unique challenges. Vaccines include a wide range of components including proteins, polysaccharides, protein-polysaccharide conjugates, adjuvants, and more. The container closure system may also be unique, and the product may require freezing storage or lyophilization based on the stability of the vaccine components. Based on the route of delivery, novel technologies and devices may be required. Covering formulation development, manufacture, and delivery considerations of vaccine production, this book is essential to formulation scientists, researchers in vaccine development throughout medical and life sciences, and advanced students. Includes formulation considerations for various vaccine types, including proteins, polysaccharides, conjugates, and live vaccines Covers process development for solution, suspension, and lyophilized products Explores the future of vaccines, including multi-component vaccines and novel delivery mechanisms/devices

Financing Vaccines in the 21st Century

Financing Vaccines in the 21st Century
Author: Institute of Medicine,Board on Health Care Services,Committee on the Evaluation of Vaccine Purchase Financing in the United States
Publsiher: National Academies Press
Total Pages: 264
Release: 2004-01-10
ISBN 10: 0309089794
ISBN 13: 9780309089791
Language: EN, FR, DE, ES & NL

Financing Vaccines in the 21st Century Book Review:

The national immunization system has achieved high levels of immunization, particularly for children. However, this system faces difficult challenges for the future. Significant disparities remain in assuring access to recommended vaccines across geographic and demographic populations. These disparities result, in part, from fragmented publicâ€"private financing in which a large number of children and adults face limited access to immunization services. Access for adults lags well behind that of children, and rates of immunizations for those who are especially vulnerable because of chronic health conditions such as diabetes or heart and lung disease, remain low. Financing Vaccines in the 21st Century: Assuring Access and Availability addresses these challenges by proposing new strategies for assuring access to vaccines and sustaining the supply of current and future vaccines. The book recommends changes to the Advisory Committee on Immunization Practices (ACIP)-the entity that currently recommends vaccines-and calls for a series of public meetings, a post-implementation evaluation study, and development of a research agenda to facilitate implementation of the plan.

Lyophilized Biologics and Vaccines

Lyophilized Biologics and Vaccines
Author: Dushyant Varshney,Manmohan Singh
Publsiher: Springer
Total Pages: 401
Release: 2015-05-19
ISBN 10: 1493923838
ISBN 13: 9781493923830
Language: EN, FR, DE, ES & NL

Lyophilized Biologics and Vaccines Book Review:

This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch a lyophilized biologics or vaccine product, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fused), complex biologics (e.g., antibody drug conjugate, PEGylated proteins), and vaccines (e.g., recombinant-protein based). The authors adeptly guide the reader through all crucial aspects, from biophysical and chemical stability considerations of proteins, analytical methods, advances in controlled ice nucleation and quality-by-design approaches, alternate drying technology, to latest regulatory, packaging and technology transfer considerations to develop a stable, safe and effective therapeutic protein, vaccine and biotechnology products. Lyophilized Biologics and Vaccines: Modality-Based Approaches is composed of four sections with a total of 17 chapters. It serves as a reference to all critical assessments and steps from early pre-formulation stages to product launch: Provides recent understanding of heterogeneity of protein environment and selection of appropriate buffer for stabilization of lyophilized formulations Details the latest developments in instrumental analysis and controlled ice nucleation technology Explains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics Details an exhaustive update on quality-by-design and process analytical technology approaches, illustrated superbly by case studies and FDA perspective Provides the latest detailed account of alternate drying technologies including spray drying, bulk freeze-drying and crystallization, supported exceptionally by case studies Provides a step-by-step guide through critical considerations during process scale-up, technology transfer, packaging and drug delivery device selection, for a successful lyophilization process validation, regulatory submission and product launch Chapters are written by one or more world-renowned leading authorities from academia, industry or regulatory agencies, whose expertise cover lyophilization of the diverse modalities of biopharmaceuticals. Their contributions are based on the exhaustive review of literature coupled with excellent hands-on experiences in laboratory or GMP setup, making this an exceptional guide to all stages of lyophilized or dehydrated product development.

Antiviral Discovery for Highly Pathogenic Emerging Viruses

Antiviral Discovery for Highly Pathogenic Emerging Viruses
Author: Rafael Delgado,Cesar Munoz-Fontela
Publsiher: Royal Society of Chemistry
Total Pages: 290
Release: 2021-12-08
ISBN 10: 1788015649
ISBN 13: 9781788015646
Language: EN, FR, DE, ES & NL

Antiviral Discovery for Highly Pathogenic Emerging Viruses Book Review:

Ideal for drug discovery scientists and medicinal chemists with an interest in antiviral drug discovery and development, this book provides a complete overview of the latest progress in the field, recent advances and the challenges that remain in developing these highly pathogenic agents.

IAP Textbook of Vaccines

IAP Textbook of Vaccines
Author: Vipin M Vashishtha,Ajay Kalra
Publsiher: Jaypee Brothers Medical Publishers
Total Pages: 894
Release: 2020-03-31
ISBN 10: 9352709896
ISBN 13: 9789352709892
Language: EN, FR, DE, ES & NL

IAP Textbook of Vaccines Book Review:

Vaccine Adjuvants and Delivery Systems

Vaccine Adjuvants and Delivery Systems
Author: Manmohan Singh
Publsiher: John Wiley & Sons
Total Pages: 416
Release: 2007-08-03
ISBN 10: 9780470134924
ISBN 13: 0470134925
Language: EN, FR, DE, ES & NL

Vaccine Adjuvants and Delivery Systems Book Review:

The authoritative reference on recent developments in vaccinology New technologies, including recombinant protein and DNA, have sparked phenomenal progress in vaccine development and delivery systems. This unique resource brings scientists up to date on recent advances and provides the information they need to select candidate adjuvants. With chapters written by leading experts in their fields, Vaccine Adjuvants and Delivery Systems: * Provides a comprehensive overview of the rapidly evolving field and developing formulation methods * Covers cutting-edge technologies and gives the current status of adjuvants in clinical trials and those still in the pre-clinical stage * Includes detailed information on specific vaccine adjuvants, including MF59, TLR4 agonists, new iscoms, cytokines, polyphosphazenes, and more * Provides a historical perspective on the development of vaccine adjuvants and discusses the mechanisms of adjuvant actions * Covers some novel adjuvants and delivery systems and the safety evaluation of adjuvants A great reference for researchers, scientists, and students in vaccinology, biotechnology, immunology, and molecular biology, this resource is also valuable for researchers and scientists in veterinary medicine who work to prevent diseases in animals.

The Vaccine Book

The Vaccine Book
Author: Barry R. Bloom,Paul-Henri Lambert
Publsiher: Academic Press
Total Pages: 664
Release: 2016-06-23
ISBN 10: 012805400X
ISBN 13: 9780128054000
Language: EN, FR, DE, ES & NL

The Vaccine Book Book Review:

The Vaccine Book, Second Edition provides comprehensive information on the current and future state of vaccines. It reveals the scientific opportunities and potential impact of vaccines, including economic and ethical challenges, problems encountered when producing vaccines, how clinical vaccine trials are designed, and how to introduce vaccines into widespread use. Although vaccines are now available for many diseases, there are still challenges ahead for major diseases, such as AIDS, tuberculosis, and malaria. This book is designed for students, researchers, public health officials, and all others interested in increasing their understanding of vaccines. It answers common questions regarding the use of vaccines in the context of a rapidly expanding anti-vaccine environment. This new edition is completely updated and revised with new and unique topics, including new vaccines, problems of declining immunization rates, trust in vaccines, the vaccine hesitancy, and the social value of vaccines for the community vs. the individual child’s risk. Provides insights into diseases that could be prevented, along with the challenges facing research scientists in the world of vaccines Gives new ideas about future vaccines and concepts Introduces new vaccines and concepts Gives ideas about challenges facing public and private industrial investors in the vaccine area Discusses the problem of declining immunization rates and vaccine hesitancy

Parenteral Medications Fourth Edition

Parenteral Medications  Fourth Edition
Author: Sandeep Nema,John D. Ludwig
Publsiher: CRC Press
Total Pages: 1125
Release: 2019-07-19
ISBN 10: 0429576838
ISBN 13: 9780429576836
Language: EN, FR, DE, ES & NL

Parenteral Medications Fourth Edition Book Review:

Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements

Epidemiology and Prevention of Vaccine Preventable Diseases 13th Edition E Book

Epidemiology and Prevention of Vaccine Preventable Diseases  13th Edition E Book
Author: Jennifer Hamborsky, MPH, MCHES,Andrew Kroger, MD, MPH,Charles (Skip) Wolfe
Publsiher: Public Health Foundation
Total Pages: 512
Release: 2015-10-19
ISBN 10: 0990449122
ISBN 13: 9780990449126
Language: EN, FR, DE, ES & NL

Epidemiology and Prevention of Vaccine Preventable Diseases 13th Edition E Book Book Review:

The Public Health Foundation (PHF) in partnership with the Centers for Disease Control and Prevention (CDC) is pleased to announce the availability of Epidemiology and Prevention of Vaccine-Preventable Diseases, 13th Edition or “The Pink Book” E-Book. This resource provides the most current, comprehensive, and credible information on vaccine-preventable diseases, and contains updated content on immunization and vaccine information for public health practitioners, healthcare providers, health educators, pharmacists, nurses, and others involved in administering vaccines. “The Pink Book E-Book” allows you, your staff, and others to have quick access to features such as keyword search and chapter links. Online schedules and sources can also be accessed directly through e-readers with internet access. Current, credible, and comprehensive, “The Pink Book E-Book” contains information on each vaccine-preventable disease and delivers immunization providers with the latest information on: Principles of vaccination General recommendations on immunization Vaccine safety Child/adult immunization schedules International vaccines/Foreign language terms Vaccination data and statistics The E-Book format contains all of the information and updates that are in the print version, including: · New vaccine administration chapter · New recommendations regarding selection of storage units and temperature monitoring tools · New recommendations for vaccine transport · Updated information on available influenza vaccine products · Use of Tdap in pregnancy · Use of Tdap in persons 65 years of age or older · Use of PCV13 and PPSV23 in adults with immunocompromising conditions · New licensure information for varicella-zoster immune globulin Contact [email protected] for more information. For more news and specials on immunization and vaccines visit the Pink Book's Facebook fan page

Hope for the Future Developing an Hiv aids Vaccine

Hope for the Future   Developing an Hiv aids Vaccine
Author: Anonim
Publsiher: DIANE Publishing
Total Pages: 135
Release: 2022
ISBN 10: 1422333000
ISBN 13: 9781422333006
Language: EN, FR, DE, ES & NL

Hope for the Future Developing an Hiv aids Vaccine Book Review:

Protecting the Frontline in Biodefense Research

Protecting the Frontline in Biodefense Research
Author: National Research Council,Division on Earth and Life Studies,Board on Life Sciences,Committee on Special Immunizations Program for Laboratory Personnel Engaged in Research on Countermeasures for Select Agents
Publsiher: National Academies Press
Total Pages: 184
Release: 2011-06-23
ISBN 10: 0309209277
ISBN 13: 9780309209274
Language: EN, FR, DE, ES & NL

Protecting the Frontline in Biodefense Research Book Review:

The U.S. Army's Special Immunizations Program is an important component of an overall biosafety program for laboratory workers at risk of exposure to hazardous pathogens. The program provides immunizations to scientists, laboratory technicians and other support staff who work with certain hazardous pathogens and toxins. Although first established to serve military personnel, the program was expanded through a cost-sharing agreement in 2004 to include other government and civilian workers, reflecting the expansion in biodefense research in recent years. Protecting the Frontline in Biodefense Research examines issues related to the expansion of the Special Immunizations Program, considering the regulatory frameworks under which the vaccines are administered, how additional vaccines might be considered for inclusion in the Program, and factors that might influence the development and manufacturing of vaccines for the Special Immunizations Program.

Viral Vectors in Veterinary Vaccine Development

Viral Vectors in Veterinary Vaccine Development
Author: Thiru Vanniasinkam,Suresh K. Tikoo,Siba K. Samal
Publsiher: Springer Nature
Total Pages: 232
Release: 2020-11-30
ISBN 10: 3030519279
ISBN 13: 9783030519278
Language: EN, FR, DE, ES & NL

Viral Vectors in Veterinary Vaccine Development Book Review:

This highly accessible textbook introduces readers to the development of viral vectors and discusses their application in veterinary vaccinology. It offers comprehensive information on the latest advances in this emerging research field, together with a broad overview of the history of veterinary vaccines and viral vectors. The book also addresses issues concerning funding, translational research and ethics that will impact the future development, manufacture and global use of viral vector-based veterinary vaccines. The book addresses the needs of graduate students and researchers in the fields of Veterinary Medicine, Virology and Immunology. ​

Quality by Design for Biopharmaceutical Drug Product Development

Quality by Design for Biopharmaceutical Drug Product Development
Author: Feroz Jameel,Susan Hershenson,Mansoor A. Khan,Sheryl Martin-Moe
Publsiher: Springer
Total Pages: 710
Release: 2015-04-01
ISBN 10: 1493923161
ISBN 13: 9781493923168
Language: EN, FR, DE, ES & NL

Quality by Design for Biopharmaceutical Drug Product Development Book Review:

This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.

Delivery Systems for Tuberculosis Prevention and Treatment

Delivery Systems for Tuberculosis Prevention and Treatment
Author: Anthony J. Hickey
Publsiher: John Wiley & Sons
Total Pages: 456
Release: 2016-08-25
ISBN 10: 1118943198
ISBN 13: 9781118943199
Language: EN, FR, DE, ES & NL

Delivery Systems for Tuberculosis Prevention and Treatment Book Review:

Provides a review of novel pharmaceutical approaches for Tuberculosis drugs Presents a novel perspective on tuberculosis prevention and treatment Considers the nature of disease, immunological responses, vaccine and drug delivery, disposition and response Multidisciplinary appeal, with contributions from microbiology, immunology, molecular biology, pharmaceutics, pharmacokinetics, chemical and mechanical engineering

Pharmaceutical Inhalation Aerosol Technology Third Edition

Pharmaceutical Inhalation Aerosol Technology  Third Edition
Author: Anthony J. Hickey,Sandro R. da Rocha
Publsiher: CRC Press
Total Pages: 730
Release: 2019-03-26
ISBN 10: 0429619561
ISBN 13: 9780429619564
Language: EN, FR, DE, ES & NL

Pharmaceutical Inhalation Aerosol Technology Third Edition Book Review:

This fully revised and updated third edition of Pharmaceutical Inhalation Aerosol Technology encompasses the scientific and technical foundation for the rationale, design, componentry, assembly and quality performance metrics of therapeutic inhalers in their delivery of pharmaceutical aerosols to treat symptoms or the underlying causes of disease. It focuses on the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery. The expanded scope considers previously unaddressed aspects of pharmaceutical inhalation aerosol technology and the patient interface by including aerosol delivery, lung deposition and clearance that are used as measures of effective dose delivery.

Sterile Product Development

Sterile Product Development
Author: Parag Kolhe,Mrinal Shah,Nitin Rathore
Publsiher: Springer Science & Business Media
Total Pages: 585
Release: 2013-10-12
ISBN 10: 1461479789
ISBN 13: 9781461479789
Language: EN, FR, DE, ES & NL

Sterile Product Development Book Review:

This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.

National Strategy for the COVID 19 Response and Pandemic Preparedness

National Strategy for the COVID 19 Response and Pandemic Preparedness
Author: Joseph R. Biden, Jr.
Publsiher: Simon and Schuster
Total Pages: 208
Release: 2021-05-18
ISBN 10: 1510767614
ISBN 13: 9781510767614
Language: EN, FR, DE, ES & NL

National Strategy for the COVID 19 Response and Pandemic Preparedness Book Review:

The ultimate guide for anyone wondering how President Joe Biden will respond to the COVID-19 pandemic—all his plans, goals, and executive orders in response to the coronavirus crisis. Shortly after being inaugurated as the 46th President of the United States, Joe Biden and his administration released this 200 page guide detailing his plans to respond to the coronavirus pandemic. The National Strategy for the COVID-19 Response and Pandemic Preparedness breaks down seven crucial goals of President Joe Biden's administration with regards to the coronavirus pandemic: 1. Restore trust with the American people. 2. Mount a safe, effective, and comprehensive vaccination campaign. 3. Mitigate spread through expanding masking, testing, data, treatments, health care workforce, and clear public health standards. 4. Immediately expand emergency relief and exercise the Defense Production Act. 5. Safely reopen schools, businesses, and travel while protecting workers. 6. Protect those most at risk and advance equity, including across racial, ethnic and rural/urban lines. 7. Restore U.S. leadership globally and build better preparedness for future threats. Each of these goals are explained and detailed in the book, with evidence about the current circumstances and how we got here, as well as plans and concrete steps to achieve each goal. Also included is the full text of the many Executive Orders that will be issued by President Biden to achieve each of these goals. The National Strategy for the COVID-19 Response and Pandemic Preparedness is required reading for anyone interested in or concerned about the COVID-19 pandemic and its effects on American society.

The Children s Vaccine Initiative

The Children s Vaccine Initiative
Author: Institute of Medicine,Committee on the Children's Vaccine Initiative: Planning Alternative Strategies
Publsiher: National Academies Press
Total Pages: 240
Release: 1993-02-01
ISBN 10: 0309049407
ISBN 13: 9780309049405
Language: EN, FR, DE, ES & NL

The Children s Vaccine Initiative Book Review:

The Children's Vaccine Initiative is an international endeavor to ensure that children throughout the world are immunized. This book notes that one of the best opportunities to address the growing problem of immunization in the United States and to improve the health of children in developing countries lies in marshaling the vaccine development and production efforts in the United States and abroad. The book contains information on the nature and status of vaccine development and production efforts in the United States and abroad, and it recommends ways to enhance participation in the International Children's Vaccine Initiative.