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Early bird offer closing soon!
Don’t miss your chance to receive a free room at the Four Seasons Hotel complements of the World Vaccine Congress Washington.
Attending an event should be enjoyable, informative and relaxing experience. We have taken the hassle out of finding a place to stay by offering one free room night at the Four Seasons Hotel Washington worth $412. In order to take advantage of this offer you must book your attendance at the event by December 23rd 2005.
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Congress at a glance
| Pre-congress briefing Monday 20th March 2006 |
| Vaccine design and development issues |
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This full day agenda will look at the most recent developments within vaccine design and development. Is there a clear choice between therapeutic and prophylactic vaccines? What is the future for recombinant and polypeptide vaccine design? Optimising vaccine manufacture, scale-up and delivery will also be covered along with the regulatory considerations for developing genetically-defined live attenuated biodefense vaccines.
- Therapeutic and prophylactic vaccines
- Scale-up, manufacture and development
- Regulatory considerations for vaccine development
Key speakers include:
Dr Doris M. Snow, Director Regulatory Affairs, DVC LLC, a CSC Company
Dr Una Ryan, President & Chief Executive Officer, AVANT Immunotherapeutics
Dr Richard Nolan, Senior Advisor to the Director, Strategic National Stockpile, CDC |
| Day one Tuesday 21st March 2006 |
| Plenary Morning |
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Vaccine funding and development
This morning session looks at the recent vaccine funding pledges. Where has this money come from, what are the long term plans and is this money sustainable? The challenges vaccine manufacturers in developing countries face and the need for technological support will be discussed. The role of partnerships in accelerating vaccine product development will be covered.
- Vaccine funding
- Global vaccine development
- Understanding vaccine partnerships and alliances
Key speakers include:
Dr Julian Lob-Levyt, Chief Executive Officer, The Vaccine Fund, Executive Director, GAVI
Senator Dale Bumpers, U.S. Senate |
| Chose from one of the following sessions |
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Session one or |
session two |
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Regulation
Regulation is an issue faced by all vaccine developers at different stages of the development process. This afternoon session dedicated to the regulatory issues within vaccine development will look at areas such as: risk management strategies, managing vaccine development costs, effective development and validation of biological potency assays and assembling a therapeutic vaccine BLA. The session will also cover the lessons to be learnt from pitfalls experienced in recent registration processes.
Key speakers include:
Dr Luc Hessel, Executive Director, Medical & Public Affairs Europe, sanofi aventis MSD
Mark Leuchtenberger, President & Chief Executive Officer, Therion Biologics Corporation |
Influenza vaccines
With the recent concerns regarding influenza and avian flu and the concerns of the shortages of vaccine supply for the 2005 season, this afternoon session is dedicated to developments in influenza vaccines. Topics to be covered include: novel inactivated intranasal flu vaccines and recombinant influenza vaccines. Issues of validation, development, regulation and the future of influenza vaccines will be discussed.
Key speakers include:
Michel Greco, Independent Vaccine Expert, former President, Aventis Pasteur
Dr Litjen Tan, Director Infectious Disease, Immunology & Molecular Medicine, American Medical Association |
| Day two Wednesday 22nd March 2006 |
| Vaccine delivery and development |
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This morning session will present six case studies of vaccines in development. Including: anthrax, TB, HIV and HPV giving an update on current data and results. The afternoon begins with two roundtable discussions focusing on therapeutic vaccines and biodefense, giving you an opportunity to openly discuss the issues affecting these areas. This is then followed by the final session looking at vaccine delivery and adjuvants.
- Six case studies of vaccines in development
- Interactive roundtable discussions on therapeutic and biodefense vaccines
- Vaccine manufacturing and delivery
Key speakers include:
Dr Lance Gordon, President, Vaxgen
Dr Stephen Bell, Vice President Research & Preclinical Development, Biosante Pharmaceuticals
Dr Ronald Ellis, Senior Vice President, Development and General Manager, ID Biomedical Corporation |
| Post-congress workshop Thursday 23rd March 2006 |
| Clinical plans, practices and procedures for vaccine trials |
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This full day workshop will provide delegates with insight into prophylactic and therapeutic vaccine trial design, conduct and oversight. It will also provide perspectives on regulatory requirements and expectations for Phase I through Phase III trials, including discussion regarding safety monitoring, data collection and report preparation. Trial design for different stages of development, prophylactic indications and therapeutic indications will be presented. The main aim of this workshop is:
- To provide information that aids in design and conduct of clinical trials that will support marketing approval
- To provide insight into conduct of cost-effective and time-effective clinical trials
- To provide templates and examples of trial related documents to facilitate successful outcomes
Key speakers include:
Dr Jeanne M Novak, Chief Executive Officer & Principal Consultant, CBR International Corp |
TOP OF NEWSLETTER
Making markets for vaccines
Dr Ruth Levine, Director of Programs & Senior Fellow, Center for Global Development
Existing strategies and technologies will not be enough to combat some of the developing world’s major killers. AIDS, malaria and TB all require new and better technologies for both prevention and treatment. In particular, focused efforts to stimulate the development of effective vaccines against these diseases are absolutely essential.
But that innovation will be slow in coming without greater commercial investment in R&D and manufacturing. Advance market commitments – in which donors make a legally binding pledge to pay for a new vaccine if and when one is developed – have been proposed to create a larger and more certain market imitating the conditions that stimulate research for diseases of developed countries and thereby counteract the present bias against R&D in products for the developing world. By creating incentives for firms to identify and pursue promising avenues of research and to compete in bringing these to market as quickly as possible, this innovative mechanism would attract more firms to develop new products.
Such a commitment, which is currently being considered for action by the G-8, would be a very strong signal to the pharmaceutical industry and the world that the wealthy nations recognise important global health connections – and are committed to success today and in the future.
Features of an advance market commitment
- An agreed technical specification—in terms of outputs—required of a new vaccine.
- A minimum price guarantee, available up to a fixed number of treatments.
- Guaranteed co-payments on products meeting the specification, paid by sponsors, permitting eligible countries to buy vaccines at affordable prices.
- An overall market size of about $3 billion—enough to make it worthwhile for firms to accelerate investment in research and development, but well below the social value of the vaccine.
- An independent adjudication committee to oversee the arrangements and commitments enforceable under the law.
- A price guarantee that would apply to a maximum number of treatments.
- In return for taking up the guaranteed price on the first treatments sold, the producer would be obliged to commit to produce and sell further treatments in eligible countries at a fixed sustainable price.
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Total sales of each qualifying product would depend on demand from developing countries. This in turn would depend on the effectiveness of the vaccine and the alternatives available. |
[1] Material in this section is adapted from Barder et al, Making Markets for Vaccines: Ideas to Action (Center for Global Development, 2005), representing the final report of the Center for Global Development Advance Market Commitment Working Group. For more information and a detailed explanation of the contract design, please see the full analysis at www.cgdev.org/vaccine.
 How can vaccine companies get from start-up phase to being a significant player?
Dr Timothy Cooke, Chief Operating Officer, Avant Immunotherapeutics
Taking any biotechnology or pharmaceutical company from the start-up stage to being a significant industry player is a daunting task. The inherently long development timelines and high product attrition rates require sustainable financing, sometimes over decades. Biotechnology companies that are developing complex proteins or other biological products have the additional burden of capital-intensive process development and manufacturing in the context of ever-escalating regulatory standards.
Vaccine companies share the same challenges as other companies producing biologics but face additional challenges. For preventative vaccines, products are usually either subunit vaccines with multiple components (antigens, adjuvants, delivery systems, administration devices) or complex live or killed organisms (viruses or bacteria). The former requires access to several different proprietary technologies, while the latter requires highly complex production and characterization methods. The safety standards are very high since these vaccines are given to healthy people, which can lead to large clinical trials. Vaccines to be used for mass immunisation also require expensive manufacturing plants that need to be built on risk prior to regulatory approval. Lingering investor perception of the preventative vaccine market as a low-margin, government-controlled monopsony is an additional barrier to success. Therapeutic vaccines lower several of the barriers that face preventative vaccines but carry a higher degree of clinical risk that can deter investment. Autologous therapeutic vaccines and those delivered using ex-vivo dendritic cells carry additional regulatory and commercial risks.
Vaccine companies that are significant players have traveled far down the value chain, having built or acquired manufacturing capabilities to produce their own products. Start-up vaccine companies therefore first need to assemble the components required to produce stand-alone products. Many companies begin with intellectual property and know how concerning one component of a vaccine (e.g., “antigen discovery” or “adjuvant” companies) so they need to access other required components to be able to develop products. As the clinical feasibility of a candidate vaccine is established, companies need to build, acquire or “rent” manufacturing facilities and expertise to reach the next level of development. The need to combine various technologies and develop competencies down the value chain has led to a significant consolidation of vaccine companies. The significant new vaccine players have grown more through mergers and acquisitions than organic growth.
The classic ways to fund start-up vaccine companies are the same as for other biotechnology companies - venture capital and small grants in the early stage and eventually accessing the public equity markets. New sources of funding that are available for vaccines include significant biodefense grants from various government agencies, large grants for targeted infectious diseases (most notably HIV) from the NIH and other national research institutes and non-government grants for developing country vaccines, funded by the Bill and Melinda Gates Foundation. Blending the classic and new sources of funding to move your company’s goals forward without diffusing your resources is a difficult but necessary balancing act.
 Regulatory strategies in the development of biodefense vaccines for the US Government
Dr Doris M. Snow, Director, Regulatory Affairs, DVC LLC, A CSC Company
DVC LLC - A CSC Company, is a biodefense company dedicated to the development and licensure of safe and efficacious biological products. We accomplish this through an integrated program design, advanced technical development, and leading management strategies. Our government clients include the DoD Chemical Biological Medical Systems (CBMS) Joint Vaccine Acquisition Program (JVAP) and Medical Identification and Treatment Systems (MITS) Program, and the National Institute of Allergy & Infectious Diseases (NIAID).
DVC complies with government client specific requirements in addition to the US FDA regulations governing product development. We use subcontractors for all aspects of vaccine testing and production, allowing us to leverage the best practices of the biopharmaceutical industry to achieve success. Our regulatory strategy is to expedite approval and availability of biodefense products by utilizing existing programs, including the Animal Rule, Fast Track, Orphan Drug and Priority Review (refer to Table below). Strategic regulatory planning is essential to ensure that funding and subcontractors are available at times necessary to accelerate these important products to licensure; therefore, we integrate regulatory, quality assurance, and scientific staff into our subcontractor facilities to advantageously position products through development.
| DVC product |
Product type |
Regulatory highlights |
| Anthrax vaccine |
Recombinant vaccine |
IND Active
Phase 1 vaccinations complete Third generation product development ongoing |
| Botulinum A/B Vaccine |
Recombinant bivalent vaccine |
IND Active
Fast Track designation received
Phase 1 Trial vaccinations complete
Phase 2 manufacturing ongoing Multivalent product development ongoing |
| Plague vaccine |
Recombinant vaccine |
IND Active
Fast Track designation received
Phase 1 Trial initiated Product available for Phase 2 |
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Smallpox Vaccine (Cell-Cultured) |
Live, attenuated |
Phase 1 complete IND Inactivated |
| Tularemia Vaccine |
Live, attenuated bacterial |
Biologics Master File Entry into clinical development under NIAID IND |
| Vaccinia Immune Globulin (Human) IV |
Plasma-derived immunoglobulin |
Licensed, February 2005
Fast Track designation received
Orphan Drug designation received
Priority Review Accelerated Approval strategy |
| Venezuelan Equine Encephalitis Vaccine |
Live, attenuated viral |
IND Active
Fast Track designation received
Phase 1 Trial initiated Phase 2 manufacturing ongoing |
TOP OF NEWSLETTER
 HyClone Single-Use Bioreactor (S.U.B.)
Justin Hutchinson, BPC Market Development Manager, HyClone
HyClone and Baxter Biosciences have co-developed the Single-Use Bioreactor (S.U.B.) based on conventional stirred tank principles and single-use technologies. This significant disposables application advances the use of single-use products in animal cell culture processes. The S.U.B is designed to get bioprocesses up and running quickly and economically.
The S.U.B is based on HyClone Bioprocess Container™ Systems (BPC®) constructed of HyQ®CX5-14 film and includes several unique patent-pending technologies, including:
- Drop-in re-useable impeller shaft. This design feature allows for all shaft and impeller product contact surfaces to be single-use. The shaft passes through the motor and bearing assembly down inside tubing and locks into the impeller via a novel keyed design. This simple, flexible design also aids in the sterilisation process, providing flexible product construction that can be easily gamma irradiated.
- Single-use pitched blade impeller. This design mimics traditional stainless steel designs but in molded high-density polyethylene.
- Hydrophobic sparge disc. This is a gas permeable membrane integrated into the chamber film. It allows industry-standard oxygen flow rates.
- Probe ports. These allow interface with available industry-standard monitoring probes. Aseptic insertion is facilitated using single-use aseptic connectors.
As a true single-use product, all contact surfaces are discarded after use, meaning no sterilisation and cleaning are required. The first working volume units that will be introduced are 50 and 250 liter systems.
More information
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“Excellent event!! I enjoyed each session”
Brian Roberts, Business Development, DVC LLC a CSC Company
“Good networking, meeting colleagues”
Husslein, Director Marketing, Chiron Vaccines
“The meeting is well organised and provides plenty of opportunities for discussion and
networking outside the lectures. Speed networking was both challenging and fun”
Dr Howard Tranter, Business Development Manager, HPA
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