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IFPMA Health Partnerships Book 2008.

1. flosz 4 juni 2008 08:50

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   IFPMA Health Partnerships Book 2008.
   Partnerships to Build Healthier Societies in the Developing World.
   
   Crucell´s Malaria Vaccine R&D
   
   • Disease area(s): Malaria
   • Company(ies): Crucell, GlaxoSmithKline
   • Partner(s): (NIAID & other partners)
   • Since 2003
   • Program type(s): R&D
   • Developing country(ies): (Phase I in USA)
   
   Many of the vaccines Crucell develops combat diseases severely affecting developing countries, including vaccines against tuberculosis and malaria. Crucell is currently developing a malaria vaccine in collaboration with the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).
   The vaccine is specifically targeted at the Plasmodium falciparum malaria parasite, the most deadly of the malaria parasites. Under a cooperative research and development agreement with the Walter Reed Army Institute of Research (WRAIR) and GlaxoSmithKline Biologicals (GSK). Crucell's malaria vaccine candidate was tested in preclinical studies as a stand-alone vaccine and in combination with GSK´s RTS,S malaria vaccine candidate. These studies demonstrated that a combination of GSK´s candidate vaccine with Crucell´s candidate vaccine can lead to improved immunogenicity of the former.
   A Phase I study of a stand-alone vaccine is currently underway in the USA. Initial findings of the Phase I trial are expected to be available in 2008.
   
   Partners: US National Institute of Allergy and Infectious Diseases NIAID, US Walter Reed Army Institute of Research WRAIR
   
   
2. flosz 4 juni 2008 08:51

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   Aeras Global TB Vaccine Foundation
   Tuberculosis
   Crucell, GlaxoSmithKline
   Aeras Global TB Vaccine Foundation
   Since 2004
   R&D
   Philippines, South Africa
   www.aeras.org, www.crucell.com, www.gsk.com
   
   The Aeras Global TB Vaccine Foundation was founded in 1997 to
   develop new concepts and tools to control the global TB epidemic.
   It is the goal of Aeras to develop, test, characterize, license, manufacture
   and distribute at least one new TB vaccine within 10 years.
   In partnership with the Aeras Global TB Vaccine Foundation, Crucell
   is developing a recombinant vaccine against tuberculosis. The
   Crucell-Aeras TB vaccine program focuses on improvement of the
   only currently available TB vaccine, the Bacillus Calmette-Guérin
   (BCG) vaccine. Aeras and Crucell began jointly developing this vaccine
   candidate, called AERAS-402, in 2004.
   A Phase I clinical trial completed in the USA in BCG naïve healthy
   adults indicates that the vaccine candidate is well tolerated and stimulates
   an immune response. A second South African Phase I study
   in progress in healthy adults vaccinated at birth with BCG appears to
   show safety, tolerability and immunogenicity of the AERAS-402 vaccine.
   A new Phase I trial was initiated in the USA in 2007. After
   demonstration of safety, studies will also be conducted in infants and
   children.
   In 2005, GSK Biologicals and Aeras formed a partnership to collaborate
   in preclinical and clinical work to establish proof-of-concept, in
   infants in developing countries, of a potential tuberculosis vaccine
   candidate originating from GSK Biologicals (formerly Corixa). The
   candidate vaccine, Mtb72F/AS, had already started clinical trials in
   the USA and Europe in 2004, to investigate safety, tolerability and
   immunogenicity in health adult volunteers.
   Aeras’ aim is to conduct the next stage of clinical trials of the candidate
   vaccine in regions where TB remains a major public health
   issue, despite BCG vaccination and improved treatment strategies.
   To this end, two clinical studies were initiated in early 2008 in adult
   healthy volunteers in South Africa and in the Philippines. These studies
   will evaluate different formulations and doses of the vaccine, as
   well as an improved form of the vaccine antigen, M72.
   
3. flosz 4 juni 2008 08:52

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   GAVI Alliance
   Childhood diseases
   Crucell, GlaxoSmithKline, Merck & Co. Inc., Novartis, sanofi-aventis,
   Wyeth
   WHO & other partners
   Since 2000
   Access – Donation & Pricing, Capacity Building – Training & Support
   Low-income countries
   www.gavialliance.org
   
   The GAVI Alliance was created to reduce childhood morbidity and
   mortality from vaccine preventable diseases by increasing immunization
   rates and improving vaccine access for children in developing
   countries, in response to stagnating global immunization rates and a
   widening gap in vaccine access in developing countries. The GAVI
   Fund provides financial support to low-income countries, based
   upon applications to and recommendations by the GAVI Alliance
   Board.
   The Alliance’s partners include industrialized countries vaccine manufacturers
   (Crucell, GlaxoSmithKline, Merck & Co., Inc., Novartis,
   Sanofi Pasteur and Wyeth – all IFPMA members), developing countries
   vaccine industry, industrialized and developing country governments,
   UNICEF, the WHO, the World Bank, charitable foundations
   and NGOs. Industry partners invest in the development of new vaccines
   and in enhanced global vaccine manufacturing capacity,
   including facilities in developing countries. They also help to educate
   healthcare providers and develop technologies to facilitate vaccine
   distribution.
   Crucell support for GAVI includes supplying the world’s first monodose
   fully liquid pentavalent (5-in-1) vaccine Quinvaxem™, which
   protects children against 5 diseases (DTP-HepB-Hib) in one single
   shot. Country applications for Hib antigen have doubled in 2007 and
   over 110 million doses of pentavalent vaccine have been requested
   for 2008-2012.
   As part of its support for the GAVI Alliance, the Merck Company
   Foundation funds the Merck Vaccine Network – Africa. Merck also
   provided 1 million doses of MMR II vaccine for mumps, measles and
   rubella to Honduras over a three-year period and also committed to
   donate 5 million doses of hepatitis B vaccine in support of GAVI.
   Merck is also providing rotavirus vaccination for all infants in
   Nicaragua for a three-year period.
   sanofi pasteur supports GAVI’s polio eradication efforts and has
   donated 120 million doses of oral polio vaccine (OPV) since 1997. It
   also supports the GAVI Yellow fever vaccine initiative for Africa. In
   December 2007, sanofi pasteur sponsored the 1st EPIVAC technical
   conference on yellow fever, which drew 150 participants from Benin,
   Burkina Faso, Cameroon, Cote d'Ivoire, Guinea, Mali, Senegal and
   Togo.
   In November 2006, the GAVI Board approved investment in pneumococcal
   and rotavirus vaccines, including Wyeth’s Prevenar® vaccine
   from 2008-2010. In February 2007, donor countries approved
   an Advance Market Commitment (AMC) pilot program to encourage
   development of new pneumococcal vaccines.
   
4. flosz 4 juni 2008 08:53

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   IFPMA Influenza Vaccine Supply
   International Task Force
   Influenza
   IFPMA IVS
   World Health Organization (WHO) & other partners
   Since 2002
   R&D
   Worldwide
   www.ifpma.org/Influenza/index.aspx?45
   
   The IFPMA Influenza Vaccine Supply International Task Force (IFPMA
   IVS), established in 2002 under the IFPMA Biologicals and Vaccines
   committee, brings together research-based influenza vaccine manufacturers
   from around the world, representing more that 95% of the
   world seasonal influenza vaccine production. IFPMA IVS members*
   conduct the R&D needed to develop safe, effective, high-quality
   human vaccines against seasonal, avian and pandemic influenza
   threats.
   The IFPMA IVS works within anti-trust law to address the advocacy,
   communication, policymaking, regulatory, scientific and technical
   issues related to influenza vaccines. IVS members are committed to
   make their unique expertise in R&D, logistics, manufacturing, safety
   and regulatory issues available to help regional/national governmental
   and intergovernmental bodies as well as non-governmental stakeholders
   in pandemic planning and decision-making.
   The IFPMA IVS Scientific, Production and Regulatory working group
   looks at technical issues related to developing, licensing and producing
   influenza vaccines. It works closely with national and international
   agencies, including the World Health Organization (WHO), the
   WHO Collaborating Centers and Reference Laboratories in Australia,
   Japan, the UK and the USA.
   The IFPMA IVS Policy, Practices and Communication working group
   articulates key Industry messages, promotes the societal value of
   influenza vaccination and organizes technical briefings on avian/pandemic
   influenza issues. It helped collect data on influenza vaccine
   distribution worldwide and conducted a large health economics
   study on the expansion of influenza vaccination for adults 50 years
   and older instead of the recommended 65 years of age, which confirmed
   the cost effectiveness and economic value of influenza vaccination
   for public health.
   The IFPMA IVS also develops position papers providing the Industry
   perspective on pandemic preparedness and helps fund the development
   of high-growth reassortants and influenza virus egg isolates, as
   well as a computerized analytical system to monitor change in
   influenza viruses. This work is currently conducted by the WHO
   Collaborating Centers and Reference Laboratories, New York
   Medical College and the University of Cambridge in the UK.
   * IFPMA IVS members: Baxter, Biken, CSL Limited, Crucell, Denka
   Seiken, GlaxoSmithKline Biologicals, Kaketsuken, Kitasato Institute,
   MedImmune (AstraZeneca), Nobilon International (Schering-Plough),
   Novartis, PowderMed (Pfizer), sanofi pasteur, Sanofi Pasteur MSD,
   Sinovac and Solvay Pharmaceuticals.
   
5. flosz 4 juni 2008 08:54

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   This publication provides an overview of long-term health development programs
   implemented by the research-based pharmaceutical industry and partners to help achieve
   the health-related Millennium Development Goals (MDGs) and improve global health.
   Eight Millennium Development Goals (MDGs) were adopted by 189 United Nations’ member states in 2000. Some target
   poverty and illiteracy, but three specifically target health: 4 – Reduce child mortality, 5 – Improve maternal health and
   6 – Combat HIV/AIDS, malaria and other diseases.
   Improving health in resource-poor countries presents society with a complex challenge that requires a far larger
   mobilization of resources, capacities and skills than either the public sector or any single industry can achieve on its own.
   Public-Private Partnerships have now become a distinctive feature of the healthcare landscape in low- and middleincome
   countries. Carrying the burden of some of the world’s worst diseases whilst also facing severe shortages of all
   kinds, these countries need very broad health interventions, which experience has shown can only be delivered through
   multi-sector partnerships.
   In this publication, partnership programs are grouped by disease area. The programs listed in the sections on HIV/AIDS,
   Tuberculosis, Malaria, Tropical Diseases and Preventable Diseases are focused on MDG 6. A further section is devoted to
   Child and Maternal Health programs, aimed at MDGs 4 and 5. There is also a section for programs addressing Chronic
   Diseases, which are not strictly speaking the focus of the MDGs, but which pose a growing health challenge for middleand
   even low-income countries, while “Other Health Initiatives” documents programs which are not focused on a specific
   disease area.
   Some partnership programs focus on improving access to medicines, through donations or preferential pricing.
   Others aim to build health care capacity in recipient countries, primarily by training local health workers, or by providing
   material support, such as equipment and buildings. Many programs also aim to educate patients or the general
   population about specific health threats. Finally, there are many partnership programs which are focused on research
   and development for diseases of the developing world. The program information in this book is also available in
   searchable form in the IFPMA website, at www.ifpma.org/healthpartnerships/, and on the Global Health Progress website
   www.globalhealthprogress.org.
   The long-term contributions by the pharmaceutical industry to help improve developing world health are substantial.
   The IFPMA Health Partnerships Survey showed that, in the period 2000-2006, the industry provided enough health
   interventions – medicines, vaccines, training and education – to help nearly 1.4 billion people in developing countries.
   This assistance was valued conservatively at USD 6.7 billion (the survey methodology and data have been validated by
   the London School of Economics and Political Science). This contribution is consistent with the pharmaceutical sector’s
   established position as a leader in corporate philanthropy. The Committee Encouraging Corporate Philanthropy, the
   corporate philanthropy forum of global company CEOs, surveyed 136 major corporations’ giving in 2006. Overall, it found
   companies gave an average of 0.88% of pre-tax profit, but within the Health Sector (in which 10 out of 16 companies are
   pharmaceuticals) the average was far higher, at 3.70%.1
   While this publication it is not necessarily exhaustive, it does cover the great majority of initiatives currently underway in
   resource-poor countries. The short description of each program provides a general overview of objectives and achievements
   but cannot do justice to the economic, organizational and even political challenges that have to be overcome.
   The essence of any partnership is that it can only succeed through a collaborative effort on the part of all those willing
   and able to contribute. The pharmaceutical industry will continue to play its part in working to secure achievement of the
   Millennium Development Goals by making a sustained contribution to building healthier societies.
   Dr. Harvey E. Bale
   Director General
   IFPMA
   
   Crucell is committed to research and development of innovative vaccines and biologicals to support
   the developing countries in improving their population health status and reaching the UN Millenium
   Development Goals. The company is actively involved in private-public partnership R&D initiatives
   aimed at making available vaccines against malaria, tuberculosis, ebola and HIV to the most needy
   populations in the world. Crucell also believes in the benefit of collaboration with other vaccine manufacturers,
   and has recently engaged in co-developing with sanofi-aventis of anti-rabies monoclonal
   antibodies, thus making an important contribution to address this unmet public health need in
   endemic countries.
   www.ifpma.org/pdf/IFPMA_Partnerships_...
   
6. [verwijderd] 4 juni 2008 09:52

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   Hij is weer geweldig Flosz.
   AB
   
   Als grootste onafhankelijke vaccinmaker ter wereld, met een goed gevulde pijplijn,speelt Crucell een prominente rol tussen de allergrootste bio/pharmabedrijven.
   8 jaar na ipo
   
   Spannùùùnd
   
   Go Crucell grow.
7. [verwijderd] 27 april 2009 20:13

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   "The IFPMA IVS members are all involved in research, development and production of influenza vaccines, representing more than 95% of world production.
   
   As of April 2008, member companies are: Baxter, Biken, CSL Limited, Crucell (including Berna Biotech), Denka Seiken, GlaxoSmithKline Biologicals (including former ID Biomedical), Kaketsuken, Kitasato Institute, MedImmune, Nobilon International BV, Novartis Vaccines and Diagnostics (former Chiron Vaccines), PowderMed, sanofi pasteur, Sanofi Pasteur MSD, Sinovac, and Solvay Pharmaceuticals."
8. [verwijderd] 27 april 2009 20:15

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   Press Contacts
   Authoritative New Study Reveals Global Pandemic Influenza Vaccine Capacity
   
   IFPMA
   
   
   Geneva & Chicago, 2/24/2009 - Vaccine manufacturers have substantially increased their capacity to produce pandemic influenza vaccines during the past two years, according to a new study by Oliver Wyman, an international strategy consulting firm. Importantly, this study arrived at capacity estimate numbers that the global health community agrees upon, after considerable prior debate.
   
   Conducted in collaboration with the World Health Organization (WHO) and The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)1, the new study finds that while capacity is increasing, it would not be sufficient to meet the global need for emergency production of pandemic influenza vaccines at the time of a pandemic. However, the study notes that current and future surplus capacity could support the production of billions of doses of H5N1 influenza vaccine prior to a pandemic for stockpiling efforts and other utilization.
   
   “We found that considerable progress has been made to enhance the production capacity of pandemic influenza vaccine,” said Adam Sabow, partner at Oliver Wyman who led the study. “While capacity still falls short of global need during a pandemic, the surplus capacity during the inter-pandemic period creates opportunities for preparedness efforts. For example, we are working with the WHO to design a global H5N1 vaccine stockpile. If demand does not exist to utilize this excess capacity, however, manufacturers are likely to rationalize some of it, creating further shortages at the time of a pandemic.”
   
   IFPMA Director General Alicia D. Greenidge said, “This study advances our understanding of the world’s ability to address pandemic influenza, and demonstrates the progress made by our member companies in developing new vaccine technologies and expanding production facilities. Our member companies are committed to working with the WHO and countries to ensure that we make the best use of the surplus capacity to prepare for a pandemic. The findings suggest that the early use of stockpiled H5N1-based vaccines, followed by pandemic vaccines as soon as these become available, offers a realistic strategy to address this significant threat.”
   
   The new Oliver Wyman study provides a number of further insights:
   
   - Pandemic influenza vaccine production capacity has increased by 300 percent over the last two years, largely driven by improvements in production yields and dosage-sparing technologies.
   
   - With current technology, doses of vaccine tailored to the actual pandemic influenza strain will not be available until four months after identification of that strain by the WHO due to the technical lead time required to adapt the strain for vaccine production, manufacture vaccine, and distribute product.
   
   - In the base (most likely) case2, manufacturers could produce 2.5 billion doses of pandemic vaccine in the 12 months following receipt of the production strain, requiring 4 years to satisfy global demand. In the best case, 7.7 billion doses could be produced in the first 12 months, requiring 1 ½ years to satisfy global demand.
   
   - This capacity is expected to rise to 5 - 14.5 billion doses over the next five years. The resulting time to meet global demand would be reduced to between 2½ years (in the base case) and 1 year (in the best case).
   
   - Surplus capacity (above current seasonal influenza and stockpile demand) currently exists to produce 2.5 billion annual doses of H5N1 vaccine prior to a pandemic. This surplus capacity is expected to rise to between 2.6 and 5.4 billion doses per year over the next 5 years.
   
   Oliver Wyman initiated this study in 2008 in cooperation with the WHO and the IFPMA, with funding from the Bill & Melinda Gates Foundation.
   
   (ends)
   
   1 Oliver Wyman also consulted with 11 other current or potential influenza vaccine manufacturers in developing countries which are not members of the IFPMA.
   
   2 The “base” and “best” cases are based on different assumptions relating to a number of factors, including the level of demand for seasonal influenza and H5N1 vaccine in the inter-pandemic period, the yields that can be attained, the level of antigen-sparing achievable and the degree of rationalization of traditional egg-based vaccine production capacity as new cell-based capacity comes on line. In both cases, effective coverage is calculated based on 2 doses per person, for a global population of 6.7 billion.
   
   
9. [verwijderd] 15 mei 2009 21:52

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   Partnerships to Build Healthier Societies in the Developing World
   
   May 2009
   
   www.ifpma.org/pdf/IFPMA_Partnerships_...
   
   
10. flosz 17 mei 2009 10:33

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    quote:

    Rockefeller schreef:

    www.ifpma.org/pdf/IFPMA_Partnerships_...
    

    Thank you Rockefeller!
    
    International AIDS Vaccine Initiative (IAVI)
    HIV/AIDS
    Bristol-Myers Squibb, Crucell, GlaxoSmithKline, Merck & Co. Inc.,
    Pfizer
    IAVI, BD, Gates, Rockefeller, USAID, World Bank
    Since 1996
    R&D
    Worldwide
    www.iavi.org
    The International AIDS Vaccine Initiative (IAVI) was created in 1996
    out of the recognition that the best long-term solution to the growing
    AIDS epidemic is a vaccine. As a global organization operating
    across borders to meet the challenges posed by the epidemic, IAVI
    is working to ensure the development of safe, effective, accessible
    and preventive HIV vaccines for use throughout the world. IAVI’s
    work focuses on four areas:
    • Support through advocacy and education (by identifying and filling
    other scientific gaps);
    • Scientific progress (by supporting promising vaccine development
    partnerships);
    • Industrial participation in AIDS vaccine development (by expanding
    public-private collaboration and creating incentives for private sector
    investment and participation in HIV vaccine development); and
    • Global access (by creating the policies necessary for getting the
    vaccines to all those who need it).
    IAVI collaborates with developing countries, governments and international
    agencies that are dedicated to accelerating the development
    of a vaccine to halt the AIDS epidemic. IAVI is working on HIV/AIDS
    vaccine projects with Crucell and GlaxoSmithKline, while Bristol-
    Myers Squibb, Merck & Co., Inc. and Pfizer are IAVI funding partners,
    as are the Rockefeller Foundation, World Bank, USAID, the Bill and
    Melinda Gates Foundation and other donors.
    In 2005, GlaxoSmithKline launched the first formal public-private
    partnership with IAVI to research vaccines against HIV strains that circulate
    predominantly in Africa. IAVI contributes technical expertise
    and funding, and GSK and IAVI researchers form a joint research
    team. The partnership is doing preclinical research for a vaccine
    using a vector derived from an adenovirus common in non-human
    primates carrying pieces of the HIV genome. Disabled adenoviruses
    are innocuous and produce a very strong immune response.
    Previous exposure to naturally occurring adenoviruses may limit the
    potency of such vaccines, which is why GSK and IAVI are concentrating
    on adenoviruses that do not occur in humans.
    IAVI entered into an agreement with Crucell to develop an HIV
    vaccine based on Crucell’s AdVac adenovirus vector technology and
    obtained the rights from Crucell to use a cell line for these vectors.
    IAVI intends to bring a candidate vaccine based on this technology
    into human clinical trials in 2009.
    P.38
    
    Aeras Global TB Vaccine Foundation
    Tuberculosis
    Crucell, GlaxoSmithKline
    Aeras & other partners
    Since 2004
    R&D
    Kenya, Philippines, South Africa
    www.aeras.org, www.crucell.com, www.gsk.com
    The Aeras Global TB Vaccine Foundation was founded in 1997 to
    develop new concepts and tools to control the global TB epidemic.
    It is the goal of Aeras to develop, test, characterize, license, manufacture
    and distribute at least one new TB vaccine within 10 years.
    In partnership with the Aeras Global TB Vaccine Foundation, Crucell
    is developing a recombinant vaccine against tuberculosis. The
    Crucell-Aeras TB vaccine program focuses on improvement of the
    only currently available TB vaccine, the Bacillus Calmette-Guérin
    (BCG) vaccine. Aeras and Crucell began jointly developing this vaccine
    candidate, called AERAS-402, in 2004. Data from completed
    AERAS-402/Crucell Ad35 trials support the immunogenicity and
    acceptable safety profile of this candidate.
    Completed Phase I trials:
    • USA: safety;
    • South Africa: high CD8-cell immune response;
    • St. Louis, USA: immunogenicity and safety of 2 booster doses
    three month after BCG priming.
    Ongoing Phase I trials:
    • St. Louis, USA: evaluating longer prime-boost interval.
    Immunological data expected in 2009;
    • Kenya (KEMRI/Walter Reed Project Kisumu): evaluating safety.
    Ongoing Phase II trials:
    • South Africa (University of Cape Town Lung Institute & South
    African Tuberculosis Vaccine Initiative): safety in adults who have
    had active TB.
    In 2005, GSK Biologicals and Aeras formed a partnership to collaborate
    in preclinical and clinical work to establish proof-of-concept, in
    infants in developing countries, of a potential tuberculosis vaccine
    candidate originating from GSK Biologicals (formerly Corixa). The
    candidate vaccine, Mtb72F/AS, had already started clinical trials in
    the USA and Europe in 2004, to investigate safety, tolerability and
    immunogenicity in health adult volunteers.
    Aeras’ aim is to conduct the next stage of clinical trials of the candidate
    vaccine in regions where TB remains a major public health
    issue, despite BCG vaccination and improved treatment strategies.
    To this end, two clinical studies were initiated in early 2008 in adult
    healthy volunteers in South Africa and in the Philippines. These studies
    will evaluate different formulations and doses of the vaccine, as
    well as an improved form of the vaccine antigen, M72.
    P.45
    
    Crucell’s Malaria Vaccine R&D
    Malaria
    Crucell, GlaxoSmithKline
    NIAID & other partners
    Since 2003
    R&D
    Phase I in USA
    www.crucell.com
    Many of the vaccines Crucell develops combat diseases severely
    affecting developing countries, including vaccines against tuberculosis
    and malaria. Crucell is currently developing a malaria vaccine in
    collaboration with the US National Institute of Allergy and Infectious
    Diseases (NIAID), part of the US National Institutes of Health (NIH).
    The vaccine candidate is based on Crucell’s AdVac adenovirus
    technology.
    The vaccine specifically targets Plasmodium falciparum, the most
    deadly of the malaria parasites and is being developed under a cooperative
    research and development agreement with the Walter Reed
    Army Institute of Research (WRAIR) and GlaxoSmithKline Biologicals
    (GSK). Crucell’s malaria vaccine candidate was tested in preclinical
    studies as a stand-alone vaccine and in combination with GSK’s
    RTS,S malaria vaccine candidate. These studies demonstrated that
    a combination of GSK’s candidate vaccine with Crucell’s candidate
    vaccine can lead to improved immunogenicity of the GSK RTS,S
    vaccine.
    A Phase I study of a Crucell’s AdVac stand-alone vaccine candidate
    is currently underway in the USA. Initial findings of the Phase I trial
    are expected to be available in 2009.
    P.56
    
11. flosz 17 mei 2009 10:35

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    GAVI Alliance
    Childhood diseases
    Crucell, GlaxoSmithKline, Merck & Co. Inc., sanofi-aventis, Wyeth
    GAVI Alliance, WHO & other partners
    Since 2000
    Access – Donation & Pricing, Capacity Building – Support & Training
    Low-income countries
    www.gavialliance.org
    The GAVI Alliance was created to reduce childhood morbidity and
    mortality from vaccine preventable diseases by increasing immunization
    rates and improving vaccine access for children in developing
    countries, in response to stagnating global immunization rates and a
    widening gap in vaccine access in developing countries. The GAVI
    Fund provides financial support to low-income countries, based
    upon applications to and recommendations by the GAVI Alliance
    Board.
    The Alliance’s partners include industrialized countries vaccine manufacturers
    (Crucell, GlaxoSmithKline, Merck & Co., Inc., Novartis,
    Sanofi Pasteur, the vaccines division of sanofi-aventis, and Wyeth),
    developing countries vaccine industry, industrialized and developing
    country governments, UNICEF, the WHO, the World Bank, charitable
    foundations and NGOs. Industry partners invest in the development
    of new vaccines and in enhanced global vaccine manufacturing
    capacity, including facilities in developing countries. They also help to
    educate healthcare providers and develop technologies to facilitate
    vaccine distribution.
    Crucell support for GAVI includes supplying large quantities of the
    first internationally available thiomersal-free fully liquid pentavalent (5-
    in-1) vaccine Quinvaxem™ which protects children against 5 diseases
    (DTP-HepB-Hib) in one single shot. Country applications for
    Hib-containing combinations grew to their historical high in 2008 and
    over half a billion doses of liquid pentavalent vaccine have been
    requested for 2009-2012.
    Of the 1.1 billion vaccine doses GSK supplied in 2008, almost 80%
    went to developing countries. GSK has actively supported GAVI
    since its inception and was its main pentavalent and tetravalent vaccine
    supplier during GAVI Phase I. GSK has also developed new
    pneumococcal, rotavirus and cervical cancer vaccines, which will be
    made available in developing countries with help from GAVI. GSK is
    developing new vaccines for diseases which are future GAVI targets,
    including dengue and malaria.
    As part of its support for the GAVI Alliance, the Merck Company
    Foundation funds the Merck Vaccine Network – Africa. Merck also
    provided 1 million doses of MMR II vaccine for mumps, measles and
    rubella to Honduras over a three-year period and donated hepatitis
    B vaccine in support of GAVI. Merck is also providing rotavirus vaccination
    for all infants in Nicaragua for a three-year period. In 2008,
    Merck contributed USD 2 million to the GAVI-supported Measles
    Initiative of the UN Foundation, for disease surveillance activities in
    Africa. Since 2001, the Measles Initiative has supported the vaccination
    of more than 600 million children in more than 60 countries.
    Sanofi Pasteur supports GAVI’s polio eradication efforts and has
    donated 120 million doses of oral polio vaccine (OPV) since 1997. It
    also supports the GAVI Yellow fever vaccine initiative for Africa. In
    2007, Sanofi Pasteur sponsored the first EPIVAC technical conference
    on yellow fever, which drew 150 participants from Benin,
    Burkina Faso, Cameroon, Côte d’Ivoire, Guinea, Mali, Senegal and
    Togo.
    In November 2006, the GAVI Board approved investment in pneumococcal
    and rotavirus vaccines. In February 2007, donor countries
    approved an Advance Market Commitment (AMC) pilot program to
    encourage development of new pneumococcal vaccines. In 2007,
    WHO recommended inclusion of PCV7 pneumococcal vaccine
    in immunization programs with priority for high-risk populations,
    mostly in the developing world. In November 2008, GAVI accepted
    Wyeth’s proposal to donate more than 3 million doses of its
    Prevnar® pneumococcal vaccine to protect children in Rwanda and
    the Gambia, countries with very high mortality from pneumococcal
    disease. Immunization should start in 2009 – the first time a pneumococcal
    conjugate vaccine will have been used into the developing
    world.
    P.79
    
    Crucell Vaccine Research
    Ebola, HIV/AIDS, malaria, rabies, tuberculosis
    Crucell, sanofi-aventis
    Various partners
    Since 2002
    R&D
    Developing countries
    www.crucell.com
    Crucell is committed to research and develop innovative vaccines
    and biologicals, to help developing countries improve their public
    health and reach the UN Millennium Development Goals. The company
    is actively involved in private-public partnership R&D initiatives
    aimed at making available vaccines against malaria, tuberculosis,
    Ebola and HIV/AIDS to the most needy populations in the world.
    Crucell also believes in the benefit of collaboration with other vaccine
    manufacturers, and has recently engaged in co-development of antirabies
    monoclonal antibodies with sanofi-aventis, thus making an
    important contribution to address this unmet public health need in
    developing countries.
    
    P.84
    www.ifpma.org/pdf/IFPMA_Partnerships_...
12. flosz 17 mei 2009 10:36

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    IFPMA Influenza Vaccine Supply
    International Task Force
    Influenza
    IFPMA IVS
    WHO & other partners
    Since 2002
    R&D
    Worldwide
    www.ifpma.org/influenza/index.aspx
    The IFPMA Influenza Vaccine Supply International Task Force (IFPMA
    IVS), established in 2002 under the IFPMA Biologicals and Vaccines
    committee, brings together research-based influenza vaccine manufacturers
    from around the world, representing more that 95% of the
    world seasonal influenza vaccine production. IFPMA IVS members*
    conduct the R&D needed to develop safe, effective, high-quality
    human vaccines against seasonal, avian and pandemic influenza
    threats.
    The IFPMA IVS works within anti-trust law to address the advocacy,
    communication, policymaking, regulatory, scientific and technical
    issues related to influenza vaccines. IVS members are committed to
    make their unique expertise in R&D, logistics, manufacturing, safety
    and regulatory issues available to help regional/national governmental
    and intergovernmental bodies as well as non-governmental stakeholders
    in pandemic planning and decision-making.
    The IFPMA IVS Scientific, Production and Regulatory working group
    looks at technical issues related to developing, licensing and producing
    influenza vaccines. It works closely with national and international
    agencies, including the World Health Organization (WHO), the
    WHO Collaborating Centers and Reference Laboratories in Australia,
    Japan, the UK and the USA.
    The IFPMA IVS Policy, Practices and Communication working group
    articulates key Industry messages, promotes the societal value of
    influenza vaccination and organizes technical briefings on avian/pandemic
    influenza issues. It helped collect data on influenza vaccine
    distribution worldwide and conducted a large health economics
    study on the expansion of influenza vaccination for adults 50 years
    and older instead of the recommended 65 years of age, which confirmed
    the cost effectiveness and economic value of influenza vaccination
    for public health.
    The IFPMA IVS also develops position papers providing the Industry
    perspective on pandemic preparedness and helps fund the development
    of high-growth reassortants and influenza virus egg isolates, as
    well as a computerized analytical system to monitor change in
    influenza viruses. This work is currently conducted by the WHO
    Collaborating Centers and Reference Laboratories, New York
    Medical College and the University of Cambridge in the UK.
    *IVS members: Baxter, Biken, CSL Limited, Crucell, Denka Seiken,
    GlaxoSmithKline Biologicals, Kaketsuken, Kitasato Institute,
    MedImmune (AstraZeneca), Nobilon International (Schering-Plough),
    Novartis, PowderMed (Pfizer), Sanofi Pasteur (sanofi-aventis), Sanofi
    Pasteur MSD, Sinovac and Solvay Pharmaceuticals.
    P.84
    www.ifpma.org/pdf/IFPMA_Partnerships_...
13. flosz 11 juli 2009 21:40

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    IFPMA R&D Status Report 2009: Industry Research
    increasing in less well-known Tropical Diseases
    Geneva, 7 July 2009 – The IFPMA has just published the 2009 edition of its Status Report on
    Pharmaceutical Industry R&D for Diseases of the Developing World(1). This documents research
    and development projects by IFPMA member companies(2), alone or with partners, to develop
    medicines and vaccines for the 10 diseases of the developing world (DDW)(3) prioritized by the
    United Nations’ TDR tropical disease research and training organization(4). Member company
    DDW medicine and vaccine projects have increased from 67 last year to a total of 84 this year.
    While the number of tuberculosis and malaria projects has grown slightly, projects for the
    remaining eight tropical diseases have increased markedly from 11 in 2008 to 25 in 2009.
    Michael D. Boyd, Acting Director General of the IFPMA, said: “It is obvious that the world does not
    have all the medicines it needs to address developing world diseases. Research is vital if we are
    to improve global public health, which is the focus of a high-level ECOSOC(5) meeting in Geneva
    this week. The IFPMA’s report underlines the commitment of the research-based pharmaceutical
    industry and its many partners to fill these gaps. The public-private partnership model is delivering
    increased research and development efforts on diseases primarily affecting the developing world.
    
    Status Report
    IFPMA / FIIM I Chemin Louis-Dunant 15 I P.O. Box 195 I 1211 Geneva 20 I Switzerland
    Tel: +41-22-338 32 00 I Fax: +41-22-338 32 99 I E-mail: info@ifpma.org I Web: www.ifpma.org
    Pharmaceutical Industry R&D for Diseases of the Developing World – 2009
    This document lists research-based pharmaceutical company(1) projects(2) to develop new medicines and
    vaccines for the ten diseases of the developing world (DDW) prioritized by the Programme for Research and
    Training in Tropical Diseases (TDR), co-sponsored by the UNICEF, the UNDP, the World Bank and the
    WHO.
    
    Crucell/ MVI/ AdVac®-based malaria vaccine/ Preclinical
    Crucell/NIAID/ AdVac®-based malaria vaccine/ Clinical
    
    Crucell/ Aeras/ Aeras-402 vaccine (AdVac®)/ Phase I / II
    www.ifpma.org/documents/NR12400/Statu...
    __________
    
    Alicia Greenidge, outgoing IFPMA Director General, to launch New Platform
    IFPMA
    Geneva, 6/25/2009 - Alicia Greenidge, formerly the IFPMA’s Director General, will launch a new platform in Geneva to build relationships between developing countries, governments, organizations and industries and will shortly issue a communiqué.
    www.ifpma.org/documents/NR12353/Relea...
    _________________
    
    Research-based Pharmaceutical Industry's Health Contribution presented to Special United Nations Session on Health in Africa and Other Least Developed Countries
    IFPMA
    Geneva, 7/8/2009 - Geneva, 8 July 2009 – The IFPMA was invited to attend a special session of the United Nations (UN) today in Geneva on health in Africa and other least developed countries, organized by the UN Economic and Social Commission (ECOSOC). Michael D. Boyd, Acting Director General of the IFPMA, gave a briefing on the research-based pharmaceutical industry’s contribution to improving health in the developing world, speaking to an audience which included foreign ministers of UN Member States and senior UN officials.
    Mr. Boyd commented: “A quiet transformation has been going on over the last decade or so, strengthening links between the developed world and least developed countries, especially in the area of health. As a single industry sector, the IFPMA’s member companies have made an unprecedented contribution to improving health in the countries which have the greatest needs.”
    Since the inception of the UN Millennium Development Goals, through to the end of 2007, IFPMA member companies made available enough medical assistance to reach nearly 2 billion people in low and middle income countries - assistance conservatively valued at USD 9.2 billion(1). The growing range of industry-backed partnership programs to help improve health in developing countries is documented in an annual IFPMA partnerships book(2) and in a searchable online database, at www.ifpma.org/healthpartnerships.
    The research-based pharmaceutical industry has also been steadily increasing its R&D into diseases of the developing world. In 2005, IFPMA Member Companies were working on 32 new medicine projects for the top 10 diseases of the developing world; this year, they are working on 75 such projects(3) . The research-based pharmaceutical industry’s commitment to help develop new medicines for the developing world is underlined by the existence of five company R&D centers which are dedicated purely to research into diseases which disproportionately affect developing countries(4).
    www.ifpma.org/documents/NR12402/Relea...
    
14. flosz 14 december 2009 13:29

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    (Óók via de Ph.-Novartis site).
    October 26, 2009
    
    The Philippine Star (Health & Medicine)
    Editor: Antonio F. Katigbak
    Global immunizations hit record high in 2008
    WASHINGTON (Reuters) - Global efforts to immunize children against life-threatening diseases set a record high last year but failed to protect millions of youngsters in the world's poorest countries, health officials said on Wednesday.
    A joint report by the World Health Organization, United Nations and World Bank said 106 million babies under the age of one were vaccinated in 2008, while a record 120 vaccines became available against a host of diseases from measles and flu to meningitis and a virus linked to cancer.
    The data provide a snapshot of an immunization boom that has tripled the global vaccine market to $17 billion in eight years and set off a renaissance of vaccine development aimed at AIDS, malaria, tuberculosis and dengue fever.
    The report coincides with new efforts to provide the world with a vaccine against the H1N1 flu that WHO declared a pandemic in June.
    Immunization, in a downward spiral before 2000, has gained momentum in recent years partly through a financing partnership among WHO, the U.N. childrens' fund UNICEF, the World Bank and the Bill & Melinda Gates Foundation.
    The partnership, known as the GAVI Alliance, also includes drug makers such as GlaxoSmithKline Plc, Novartis AG, Crucell NV, Merck & Co. Inc., Sanofi Pasteur and Wyeth.
    As a result of recent efforts, vaccines now reach more than 200 million children in developing countries.
    But the report also acknowledged significant shortcomings in the immunization campaign, saying that 24 million infants -- almost 20 percent of the children born each year -- did not receive first-year-of-life vaccinations that are common in the wealthiest countries.
    The children who missed out typically live in poorly served remote rural areas, deprived urban settings, fragile states and strife-torn regions, mostly in Africa and Asia.
    Major push
    The report said a major push was under way to protect children in difficult-to-reach areas.
    It estimated that an additional investment of $1 billion would be needed to ensure that new and existing vaccines are available to all children in the world's 72 poorest countries where preventable diseases take their deadliest toll.
    Rising demand for immunization has been a boon to manufacturers in the developing world, which now meet 86 percent of global demand for traditional vaccines against disease such as measles, whooping cough, tetanus and diphtheria.
    But so-called middle-income countries are not eligible for financial assistance from the GAVI Alliance, even though many of their people live on less than $2 a day. That makes it hard for them to afford new vaccines against pneumococcal disease, rotavirus diarrhea and the human papillomavirus that can cause cervical, penile and head and neck cancers.
    "Even at greatly reduced prices, the cost of new vaccines ... are individually greater than the cost of all other traditional vaccines combined," the report said.
    Still the report said immunization was partly responsible for the first documented decline in annual deaths among children to below 10 million. Clean water, sanitation and better care were the other contributing factors.
    The report also credited immunization with helping to bring about a 74 percent drop in worldwide deaths from measles between 2000 and 2007.
    www.novartis.com.ph/newsroom/2009/new...
    
15. flosz 20 januari 2010 19:57

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    IFPMA: R&D Pharmaceutical Industry Emergency Aid for Haiti
    The FINANCIAL -- The research-based pharmaceutical industry represented by the IFPMA is providing significant emergency aid following the major earthquake that struck Haiti on 12 January.
    The total value of assistance provided so far by IFPMA member companies*, including both cash and donation of medicines and other medical supplies, already amounts to more than USD 16.9 million. Total industry assistance can be expected to increase further, as many companies have also committed to match employee contributions which are still being collected.
    
    Mr. Haruo Naito, President of the IFPMA and President and CEO of Eisai Co., Ltd. said: “The world has been touched by the suffering of the people of Haiti, and I would like to extend the sincere sympathies of the IFPMA and its members to all the people affected. In helping them, we must be guided by both heart and head, to ensure that they receive the assistance they most need. Our member companies are therefore working with expert NGO partners which specialize in disaster relief and can help to ensure that our aid is coordinated as part of the overall international assistance effort.”
    
    "Companies and their related philanthropic foundations which have reported making donations so far include: Abbott, Amgen, Astellas, AstraZeneca, Bayer, Boehringer ING elheim, Bristol-Myers Squibb, CRUCELL, Daiichi Sankyo, Eisai, GlaxoSmithKline, Johnson & Johnson, Lilly, Merck & Co., Inc., Merck KGaA, Novartis, Novo Nordisk, Pfizer, Roche, sanofi-aventis and Takeda," IFPMA reported.
    
    To ensure that the assistance provided is appropriate and coordinated, companies are using long-established partnerships with a range of expert medical and disaster relief organizations. These include the WHO, UNICEF, PAHO and the Red Cross (via various national Red Cross associations), as well as Aide Action Internationale Pompiers, Aide Médicale Internationale, Americares, Catholic Mission Board, Clinique Degand Dutour, Comité de Secours Internationaux, Corps Mondial de Secours, Direct Relief International, Esperanza International, Hospital Albert Schweitzer, International Medical Assistance, Japan Platform, Jewish Renaissance Foundation, MAP International, Medical Teams International, Operation USA, Partners in Health, Project HOPE, Save the Children, Surgical Implant Generation Network and World Vision.
    
    In an emergency situation such as that in Haiti, the groups which specialize in coordination of company medicine donations are particularly important partners for IFPMA member companies. These are Health Partners International Canada, International Health Partners (UK), Partnership for Quality Medical Donations (USA) and TULIPE (France). Their close working relationship with companies allows them to channel coordinated supplies of urgently needed medicines and medical supplies to Haiti as quickly as possible.
    finchannel.com/news_flash/Pharmacy/56...
    _Pharmaceutical_Industry_Emergency_Aid_for_Haiti/
    
    www.ifpma.org/fileadmin/webnews/2010/...
16. flosz 17 november 2010 17:30

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    IFPMA Status Report
    Pharmaceutical Industry R&D for Diseases of the Developing World – 2010
    This document lists research-based pharmaceutical company(1) projects(2) to develop new medicines and
    vaccines for the ten diseases of the developing world (DDW) prioritized by the Programme for Research and
    Training in Tropical Diseases (TDR), co-sponsored by the UNICEF, the UNDP, the World Bank and the
    WHO. The diseases are, in order of decreasing mortality: tuberculosis, malaria, human African
    trypanosomiasis (sleeping sickness), leishmaniasis, dengue, onchocerciasis (River blindness), American
    trypanosomiasis (Chagas disease), schistosomiasis, leprosy and lymphatic filariasis. Data on projects
    published in 2005 by the Pharmaceutical R&D Policy Project(3) under Dr. Mary Moran, George Institute, and
    subsequently by the IFPMA show the evolution and status of industry R&D for DDW.
    www.ifpma.org/fileadmin/webnews/2010/...