Delegates will have a chance to become a part of real-life case studies delivered by industry professionals of the best contract manufacturers and by the WHO’s Director of Vaccine Project Optimization who will reveal best practices of manufacturing and distribution.

Top vaccine experts such as Gerd Zettlmeissl, the CEO of Intercell and the winner of the Vaccine Industry Excellence Award of 2010, Danilo Casimiro, the Director of Viral Vaccine Research of Merck, Dr Farshad Guarikhoo, the Senior Director of External Research and Development of Sanofi Pasteur and Ed Geuns, the Head of Global Regulatory Affairs Liaison Vaccines of Abbott Biologicals will provide delegates with overall walkthrough of the whole Vaccine Value Chain.

The special feature of this event is an interactive Workshop day, held on 20th October. Workshop will include three unique sessions with a strong focus on accelerated process development, excellence in the proof-of concept clinical trials and vaccine manufacturing challenges.

How to obtain funding & financing for vaccines?
What are the main issues in establishing industry partnership?
And how to provide vaccination against influenza on a large scale?

All these and many other questions will be answered by Dr Jerald C. Sadoff, the experienced CMO of Crucell, Dr Hansi Dean and Dr Philip Dormitzer, the Head of the Viral Advanced Programs of Novartis.
For further information and to book your place at the event, please contact:

Peter Novak
T: +421 257 272 110
E: peter.novak@jacobfleming.com
W: www.jacobfleming.com

Provenge is an autologous cellular immunotherapy, designed to stimulate a patient’s own immune system to respond against the cancer. Each dose of Provenge is manufactured by obtaining a patient’s immune cells from the blood, using a machine in a process known as leukapheresis. To enhance their response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After this process, the patient’s own cells are returned to the patient to treat the prostate cancer. Provenge is administered intravenously in a three-dose schedule given at about two-week intervals.

The effectiveness of Provenge was studied in 512 patients with metastatic hormone treatment refractory prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial, which showed an increase in overall survival of 4.1 months. The median survival for patients receiving Provenge treatments was 25.8 months, as compared to 21.7 months for those who did not receive the treatment.

Almost all of the patients who received Provenge had some type of adverse reaction. Common adverse reactions reported included chills, fatigue, fever, back pain, nausea, joint ache and headache. The majority of adverse reactions were mild or moderate in severity. Serious adverse reactions, reported in approximately one quarter of the patients receiving Provenge, included some acute infusion reactions and stroke. Cerebrovascular events, including hemorrhagic and ischemic strokes, were observed in 3.5 percent of patients in the Provenge group compared with 2.6 percent of patients in the control group.

Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men. In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed and about 27,000 men died from the disease, according to the National Cancer Institute.

The topics include:

• Enhancing DNA Vaccine Immunity in Vivo
• The Future of Vaccines from an Industry Perspective
• Human Immune Responses to Vaccination
• Preclinical and Clinical Studies of DNA Vaccines for Biodefense
• Live Attenuated Influenza Vaccine for Seasonal and Pandemic Applications
• and many others.

The Phase III clinical study found a 78 percent overall protection rate against culture-confirmed influenza from influenza strains that matched those in the vaccine and a 71 percent rate of prevention of influenza from all circulating strains.

The study was conducted during the 2008/2009 influenza season in the United States in more than 7,000 healthy clinical trial participants ages 18 to 49. This is a landmark study assessing the efficacy of a cell culture-based, non-adjuvanted and preservative-free vaccine in the prevention of seasonal influenza.

In 2010, approximately 5,050 new cases will be diagnosed with CML and approximately 470 people will die. The average person’s lifetime risk of getting CML is about 1 in 645. The average age at diagnosis of CML is around 66 years. Over half of cases are diagnosed in people 65 and older. This type of leukemia mainly affects adults, and is rarely seen in children.

Investigators used a vaccine made from CML cells irradiated to halt their cancerous potential and genetically altered to produce an immune system stimulator called GM-CSF. The treated cells also carry molecules, called antigens, specific to CML cells, which prime the immune system to recognize and kill circulating CML cells. All patients enrolled in the trial used Gleevec for at least one year and still had cancer cells present.

The GVAX Leukemia vaccine was given to 19 CML patients with measurable cancer cells, despite taking Gleevec for at least one year (range 13-53 months). Each patient was given a series of four vaccines administered in three-week intervals while remaining on a stable dose of Gleevec. After a median of 72 months of follow-up, the number of remaining cancer cells declined in 13 patients, eight of whom had increasing disease burden before vaccination. Twelve patients reached their lowest levels of residual cancer cells to date following vaccination. In seven patients, CML became completely undetectable.

Patients receiving the GVAX Leukemia vaccine experienced relatively few side effects that included injection site pain and swelling, occasional muscle aches and mild fevers.

Most patients with CML will need to remain on Gleevec therapy for the rest of their lives. More than 90 percent of them will achieve remission, but about 10 to 15 percent of patients cannot tolerate the drug long term. Gleevec, one of the first targeted cancer therapies with wide success in CML patients, destroys most leukemic cells in the body, but in most patients, some cancerous cells remain and are measurable with sensitive molecular tests. These remaining cells are a source of relapse, according to the investigators, especially if Gleevec therapy is stopped.

According to a recent market study “Global Pandemic Influenza Preparedness Market Forecast 2010-2015“, cell-based development will be the core of the intermediate and long-term pandemic influenza preparedness strategy for larger, more flexible, and less vulnerable manufacturing surge capacity for production of seasonal and pandemic influenza vaccines. Cell-based production capability provides unprecedented manufacturing flexibility. The transition from egg-based to cell-based production sets the stage for the development of next generation vaccines. Recombinant and universal influenza vaccines will almost inevitably be produced in cell culture facilities, not in living, embryonated eggs fresh from the farm.

The new document Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications will help manufacturers developing safe and effective cell-based viral vaccines to address emerging and pandemic threats, such as for influenza vaccines.

Currently, all licensed influenza vaccines are produced in chicken eggs. Cell cultures are now used to produce licensed vaccines that help protect against diseases such as rubella and polio.

The contract modification, which is effective February 22, 2010 and extends until December 31, 2012, provides for up to $61 million during a “base period” of performance with options for an additional $17 million on a cost reimbursement plus fixed fee basis in additional advanced development funding for SparVax™. Provided that certain milestones are achieved, and that all contract options and extensions are exercised by the government, the contract has a total potential value of $78.4 million. The modification will include non-clinical safety and efficacy studies, assay development and qualification, and process scale up and validation.

SparVax™ is a highly purified recombinant protective antigen vaccine being developed for pre and post exposure protection against anthrax infection. Phase I and Phase II clinical trials involving 770 healthy human subjects have been completed and demonstrated that SparVax™ appears to be well tolerated and immunogenic in humans. These studies suggest that three doses of SparVax™, administered over a 56 day period, are sufficient to induce protective immunity. The vaccination regimen for the currently licensed anthrax vaccine, BioThrax®, requires five doses over a period of eighteen months.

Prevnar 13 is approved for the prevention of invasive disease caused by 13 different serotypes of the bacterium Streptococcus pneumoniae and for the prevention of otitis media caused by the seven serotypes shared with Prevnar. The bacterium can cause infections of the blood, middle ear, and the covering of the brain and spinal cord, as well as pneumonia.

The seven Streptococcus pneumoniae serotypes against which Prevnar is directed accounted for about 80 percent of IPD in young children in North America at the time that the vaccine was licensed. With the use of Prevnar, by 2007 the overall rate of IPD caused by these seven serotypes in children less than 5 years old was reduced by 99 percent. However, at that time, it was also shown that of the remaining invasive pneumococcal disease in this age group, 62 percent are caused by the six additional serotypes that will be included in Prevnar 13.

Safety was evaluated in clinical trials for 5,084 infants and young children who received Prevnar 13, compared with 2,760 who received Prevnar, the control vaccine. Common adverse reactions reported after administration of Prevnar 13 were pain, redness and swelling at the injection site, irritability, decreased appetite and fever. These reactions were similar to what has been observed with Prevnar, which has a good safety record in the United States. Vaccine effectiveness was assessed in a randomized U.S. multi-center immunogenicity study. Prevnar 13 post-vaccination antibody response comparisons to Prevnar were evaluated by several immunological measures. An evaluation of all these measures showed that Prevnar 13 induced antibodies that were comparable to those shown to be protective in Prevnar. Post marketing studies will include continued monitoring for reduction in IPD and otitis media, as well as continued evaluation of safety.

The vaccine is administered in a four-dose schedule given at 2, 4, 6 and 12-15 months of age. The vaccine is available in single-dose, pre-filled syringes.

Prevnar 13 is manufactured by Wyeth Pharmaceuticals Inc. of Collegeville, Pa., a wholly owned subsidiary of Pfizer Inc.

If additional vaccines are developed and introduced in this decade—such as for tuberculosis—even more lives could be saved. The new funding announced today is in addition to the $4.5 billion that the Gates Foundation has already committed to vaccine research, development and delivery to date across its entire disease portfolio since its inception.

Recent years have seen the remarkable success stories of vaccine development:

• Record-breaking vaccine access: New WHO data show that global vaccination rates have reached all-time highs, rebounding from years of decline in the 1990s. Between 2000 and 2009, the percentage of children receiving the basic DTP3 vaccine in the poorest countries of the world jumped from 66 percent to 79 percent, the highest on record. The number of people who died of measles worldwide fell by 77 percent between 2000 and 2008, and in Africa, measles deaths fell by 92 percent.
• Improved routine immunization: Partnerships focused on reducing diseases like polio and measles are also helping build a stronger foundation for the delivery of both new and existing vaccines. Trained health workers, proper cold chain function, and surveillance are all necessary to ensure vaccines reach every child who needs them.
• New vaccine introduction: Important new vaccines for the two leading causes of global child deaths—severe diarrhea and pneumonia—are becoming available. Research published this week in The New England Journal of Medicine shows that introducing a rotavirus vaccine in South Africa and Malawi reduced severe diarrhea caused by the virus by more than 60 percent.
• R&D momentum: The vaccine research and development pipeline is more robust than ever. Late-stage trials have begun on a promising vaccine to protect children from malaria, and a new vaccine to prevent meningitis outbreaks in Africa is likely to be introduced this year.

Many of the recent advances in vaccine development and delivery have been driven by public-private partnerships such as the GAVI Alliance and the Rotavirus Vaccine Program at PATH, which coordinate the resources and expertise of vaccine companies, donors, UNICEF, WHO, the World Bank, and developing countries.

The GAVI Alliance—launched at the World Economic Forum 10 years ago this week—has reached 257 million additional children with new and underused vaccines, and prevented 5 million future deaths. In the coming years, GAVI will focus on rapidly introducing vaccines to tackle diarrhea and pneumonia.

Today’s commitment will support a broad spectrum of vaccine-related activities, from basic research to innovations in delivery. However, billions more are needed from other donors to achieve the goal of 90 percent coverage of childhood immunization. Critical funding gaps exist at GAVI and in the global polio and measles programs, and more support is needed for the research and development necessary to produce new vaccines.

Still new funding from donors, governments and the private sector is badly needed to:

• Rapidly scale immunization programs in order to reach all those in need
• Conduct the laboratory research and clinical trials needed to create new vaccines
• Introduce life-saving new vaccines for pneumonia and severe diarrhea, as well as other promising vaccines currently in the development pipeline
• Ensure a steady market for vaccines in developing countries, and an adequate supply from manufacturers

“Whether the threat is from naturally occurring disease or bioterrorism, the United States needs to be able to produce vaccines and other medicines faster and less expensively. We had six months of advance warning for the H1N1 pandemic. A bioterrorism attack will have no advance warning. Creating the infrastructure for rapid development of large quantities of safe vaccines and medicine is a win-win for public health and national security,” said Senator Bob Graham, chairman of the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism.

The Commission released the two-minute video to engage the U.S. public on the need to improve the nation’s capability to produce vaccines and medicines faster and less expensively—and just as safely. The video and resources are available at www.FasterVaccines.org.

The United States—unlike the European Union and China—continues to use a 60-year old production method, using chicken eggs, to make H1N1 and other important vaccines. Modern methods will shave months off the typical six-to-nine months that current processes require. These newer methods can produce more vaccine and be quickly scaled-up, on demand.

The consequences of ignoring the bioterrorist threat could be dire. For example, one recent study from the intelligence community projected that a two-to-four pound release of anthrax spores from a crop duster plane could kill more Americans than died in World War II. Clean-up and other economic costs could exceed $1.8 trillion. A large public investment today will greatly mitigate the risk posed by pandemic disease and terrorist attack alike.