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Vaccine manufacture and timely immunisations are fundamental to individual and national health. Vaccine medicine has become synonymous with mainstream medical therapy and disease prevention, however it still remains one of the most controversial topics in modern medicine due to recent doubts about safety.

SMi’s conference ‘Vaccines’ aims to bring together key international leaders from major pharmaceutical companies, private-sector immunisation partners, healthcare executives and government agencies. Through plenary sessions, case studies and workshops, this event will report new scientific technologies, policies, and the development and implementation of successful immunisation programmes. Participants will gain the know how to investigate new strategies for designing and developing novel vaccines, complete all the necessary safety and legislative requirements to launch it onto the market and gain an insight into biodefence.

Hear international case studies and expert perspectives from leaders in the field, including:

  • Dr Clement Lewin, Vice President, US Government Affairs & Strategy, Acambis
  • Dr Stephen Lockhart, Assistant Vice President & Head, Bacterial Vaccine Clinical Research, Wyeth Vaccine Research
  • Dr Jeffrey Ulmer, Executive Director & Head, Immunology & Cell Biology, Chiron Vaccines
  • Dr Ed Nuzum, Chief, Biodefence Vaccines & Other Biological Products Development Section, Office of Biodefence Research Affairs, DMID/NIAID/NIH
  • Daniel Adams, President & Chief Executive Officer, Protein Sciences Corporation
  • Dr Martin Bachmann, Executive Vice President & Chief Scientific Officer, Cytos Biotechnology
  • Dr Daniel Zimmerman, Senior Vice President, Research & Development, CEL-SCI Corporation
  • Rajan George, Vice President, Division of Infectious Diseases, ViRexx

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Frank  Rapoport

Frank Rapoport, Managing Partner, McKenna Long & Aldridge LLP

9:10 KEYNOTE ADDRESS – VACCINE PROCESS DEVELOPMENT

Robert  Sitrin

Robert Sitrin, Executive Director, Bioprocess & Bioanalytical Research, Merck Research Labs

  • Rotateq (r), for the prevention of rotavirus disease
  • Process scale up issues
  • Development of the potency assay
  • Support for the large safety study
  • GARDASIL (r), for the prevention of HPV and cervical cancer
  • Developing the manufacturing process
  • Characterisation of the product
  • Development of the potency assay
  • 9:50 THERAPEUTIC VACCINATION

    Martin Bachmann

    Martin Bachmann, Executive Vice President & Chief Executive Officer, Cytos Biotechnology A G

  • The major causes of preventable death world-wide – smoking and obesity as chronic diseases
  • Current therapies and the requirement for a novel strategy of treatment
  • An overview of the therapeutic vaccines against both smoking and obesity
  • Preclinical and clinical evidence to support the induction of antibodies to nicotine and the regulatory hormones involved
  • Regulatory compliance
  • 10:30 Morning Coffee

    11:00 DNA VACCINES

    Jeffrey Ulmer

    Jeffrey Ulmer, Executive Director & Head, Immunology & Cell Biology, Chiron Vaccines

  • Mechanism of action
  • Limitations
  • Rational approaches to enhanced potency
  • Prospects for widespread utility
  • 11:40 DEVELOPMENT OF NOVEL VACCINES IN THE TRIANGLE OF NOVEL TECHNOLOGIES, PHARMA PARTNERS AND NGOS

    Alexander von Gabain

    Alexander von Gabain, Chief Scientific Officer, Intercell AG

  • New vaccine technologies
  • Costs and benefits to partner with established commercial vaccine players
  • Strengths and weaknesses of partnerships with NGOs
  • Is there a win-win situation for a triangle between biotech, NGOs and big pharma in the development of novel vaccines?
  • 12:10 THE DEVELOPMENT AND PRODUCTION OF A MULTIVALENT VACCINE

    John Dong

    John Dong, President & Chief Scientific Officer, GenPhar Inc

  • The need for a vaccine against multiple strains of Marburg, Ebola and Dengue viruses
  • Creating multiple serotype vaccines
  • Creating a safe and effective multivalent vaccine against some of the most dangerous infectious diseases
  • Demonstrating the induction of potent humoral and cell-mediated immune responses
  • Looking to the future using lessons learned from cAdVax
  • 12:50 Networking Lunch

    14:20 PANEL DISCUSSION

  • US government purchase of vaccines against bioterrorism and infectious diseases
  • Hear how federal regulators have implemented Project Bioshield
  • Understanding how to get US funds for your vaccine research
  • Availability of money for influenza countermeasures from HHS, NIH, CDC, Department of Homeland Security, Department of Defence
  • Key issues regarding the availability of vaccines
  • The history and purpose of developing such a vaccine
  • Strategies to achieve legislative conformity
  • Frank  Rapoport

    Frank Rapoport, Managing Partner, McKenna Long & Aldridge LLP

    John Clerici

    John Clerici, Managing Partner, McKenna Long & Aldridge LLP

    Thomas Fuerst

    Thomas Fuerst, Director, Vaccines & Biologics, US Dept of Health & Human Services

    Ed Nuzum

    Ed Nuzum, Chief Biodefense Vaccines & Other Biological Products Development Section, OBRA

    Rajan George

    Rajan George, Vice President, Research & Development, ViRexx Medical Corp

    15:20 Afternoon Tea

    15:40 A BIODEFENCE CASE STUDY

  • The necessity for a smallpox vaccine stockpile and the US Governments strategy for filling the need
  • Process for delivery of 180 million doses of conventional smallpox vaccine to the strategic national stockpile and next steps
  • Development of an MVA vaccine for the US Government
  • Differences between the two programmes and lessons learned in developing vaccines for the US government
  • Clement Lewin

    Clement Lewin, Vice President, US Government Affairs & Strategy, Acambis

    16:20 CHIMIGEN™ VACCINE PLATFORM: A NOVEL, VERSATILE AND ADAPTABLE PLATFORM FOR VACCINE DEVELOPMENT

    Rajan George

    Rajan George, Vice President, Research & Development, ViRexx Medical Corp

  • Dendritic cell receptor-targeted vaccines
  • Advantages of both antigen and antibody
  • Unique chimeric design facilitates formation of antibody like structure and appropriate antigen presentation
  • Soluble antigen, no added adjuvant necessary
  • Produced in insect cells, with higher immunogenicity
  • Generates broad immune responses, both Cellular & humoural
  • Can be used for the development of therapeutic and prophylactic vaccines
  • HepaVaxx B, ViRexx’s first ChimigenTM vaccine candidate, a therapeutic vaccine for the treatment of chronic hepatitis B virus infection, approved for Phase I clinical trial
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Stephen Lockhart

    Stephen Lockhart, Assistant Vice President & Head, Bacterial Clinical Research, Wyeth Vaccines Research

    9:10 NEW MARKETS FOR VACCINES

    Andrew Pasternak

    Andrew Pasternak, Director, Mercer Management Consulting Ltd

  • Vaccines - small commercial opportunity?
  • The contribution vaccines have made to human health and longevity by reaching more individuals than any other modern health intervention
  • How purchaser, legal and regulatory pressures have limited market attractiveness
  • The importance of scientific advances, public sector investment and increased social awareness of vulnerability to infectious disease in changing the future of vaccines
  • Vaccines - the fastest growing category in the pharmaceutical industry?
  • New challenges for all participants in the value-chain
  • Realising the full potential of the industry
  • 9:50 RESEARCHING MARKET REQUIREMENTS - EXISTING AND POTENTIAL VACCINES AND ANTI-VIRALS

  • Finding and developing the low hanging product fruit that has a market in healthcare - current and historical perspectives
  • Comparative analysis of epidemiology, current disease management and unmet needs
  • An overview of influenza vaccines and anti-virals - strengths and weaknesses and how they play out in addressing influenza pandemics
  • Accelerated approval of the recombinant FluBlok influenza vaccine - how can this happen?
  • Reducing the financial commitment to maximise the potential gain
  • Daniel Adams

    Daniel Adams, President & Chief Executive Officer, Protein Sciences Corporation

    10:30 Morning Coffee

    11:00 SOME UNSPOKEN PITFALLS OF DEVELOPING A THERAPEUTIC VACCINE FOR AUTOIMMUNE CONDITIONS

    Daniel Zimmerman

    Daniel Zimmerman, Senior Vice President, Research & Development, CEL-SCI Corporation

  • The product objective from model to man
  • Product specifications including the active antigenic component and adjuvant
  • Defining the market
  • Potential for the generation of autoimmune conditions
  • Changes and common misunderstandings in the regulatory environment
  • Beyond efficacy studies - financing preclinical safety / toxicology and early phase I studies
  • 11:40 PRICING VACCINES ON VALUE

    Denis Fung

    Denis Fung, Principal Consultant, PA Consulting Group

  • Changes in the importance of vaccines to payers
  • Consequences for revenue potential
  • Move toward pricing on value
  • Generic drivers of vaccine value
  • Understanding the epidemiology
  • Developing a standard tool set for vaccine valuation
  • 12:20 Networking Lunch

    13:50 ISSUES IN SCALING UP FROM EARLY TO LATE PHASE CLINICAL TRIALS

    Stephen Lockhart

    Stephen Lockhart, Assistant Vice President & Head, Bacterial Clinical Research, Wyeth Vaccines Research

  • Planning the size of late phase trials
  • Projecting and managing the cost of late phase trials
  • Interactions between clinical research and manufacturing in planning late phase trials
  • Bridging studies: love them or hate them?
  • Remember compliance
  • Post-licensure trial commitments
  • 14:30 2.30 STUDIES OF SKIN BASED AND RESPIRATORY DELIVERY OF VACCINES

    Vince Sullivan

    Vince Sullivan, Chemist & ormulations Group Leader, B D

  • Pros and Cons of different vaccine delivery routes
  • Delivery devices for intradermal and respiratory delivery of vaccines
  • Dry powder formulations for nasal and reconstitution-injection delivery
  • Results of in vivo studies
  • 15:10 Afternoon Tea

    15:40 ROUTES OF VACCINE ADMINISTRATION

  • A review of currently marketed formulations and products
  • Factors that affect the choice of route of vaccine administration
  • Alternatives to injectables: nasal and pulmonary opportunities
  • Challenges of developing needle-free injection systems
  • Complying to the regulatory issues
  • Noymer Peter

    Noymer Peter, Director, Systems Engineering, Aradigm Corporation

    16:20 FORMULATION STRATEGIES FOR ENHANCING PULMONARY DELIVERY OF VACCINES

    Satyanarayana Somavarapu

    Satyanarayana Somavarapu, Research Fellow, University of London School Of Pharmacy

  • Application of novel excipients to established platform polymeric delivery technologies
  • Effect of process parameters on final dosage form
  • An exploration of in vivo / in vitro correlation data
  • Long term stability and efficacy studies
  • 17:00 Chairman’s Closing Remarks and Close of Day One

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    Mayfair Conference Centre

    17 Connaught Mews
    London W2 2EL
    United Kingdom

    Mayfair Conference Centre

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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