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Can Canadian Vaccine Research Survive the Challenges of Globalization?
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Can Canadian Vaccine Research Survive the Challenges of Globalization?

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    Can Canadian Vaccine Research Survive the Challenges of Globalization? Can Canadian Vaccine Research Survive the Challenges of Globalization? Presentation Transcript

    • Can Canadian Vaccine Research Survive the Challenges of Globalization?
      David W. Scheifele
      Vaccine Evaluation Center, UBC
      BC Children’s Hospital
      Vancouver
    • OBJECTIVES
      To explore the full length of the “vaccinepipeline” noting the players, trends and influences on research
      To reflect on the consequences for Canada of globalization of the vaccine industry and marketplace
      To recommend means to stabilize the domestic research enterprise
    • VACCINE PIPELINE DEFINED: 3D’s
      Discovery – of a candidate antigen
      Development – of a licensed product
      Deployment – in a public program
    • PART ONE: VACCINE DISCOVERY
      Begins with identifying microbial components that can elicit protective immunity
      Modern technology has greatly accelerated the process – feasible as PhD projects
      CIHR (2008) survey noted >25 infectious agents under study re prevention (focus on influenza, HPV, HIV)
    • BUT a Molecule is not a Vaccine
    • DISCOVERY CHALLENGES
      “Easy” vaccines have already been developed
      New targets are more challenging:
      microbial diversity e.g. pneumococci, MenB, HPV
      generating adequate, appropriate immunity (for intracellular or mucosal pathogens)
      when natural immune response is non-protective (HIV)
    • VACCINE DEVELOPMENT FRONTIER
      New “enabling technologies” in development to cope with challenges:
      adjuvants, in great variety, to ↑ responses
      packaging molecules to resemble microbes
      finding common denominators among germs
      Typically undertaken by small biotechnology companies, spawned by academic and other researchers
    • CANADIAN VACCINE BIOTECHNOLOGY COMPANIES (2010)
      Amorfix Life Sciences Immunovaccine
      Theracarb Inc. Bioniche Life Sciences
      Medicago Variation Biotechnologies
      Generex Biotechnology Plantform Corp.
      VIDO (Coley Pharmaceuticals)
    • FOCUS OF SELECTED VACCINE BIOTECH COMPANIES
      Amorfix – vaccines for CNS disorders e.g. ALS, Alzheimer’s
      Medicago – plant-based vaccine production
      e.g. influenza VLPs
      Bioniche – E coli 0157 vaccine for cows
      Generex – oral spray delivery vehicle for
      vaccines, drugs
      Theracarb (U of A) – developing Candida
      vaccine
    • CHALLENGE FOR BIOTECHNOLOGY COMPANIES
      Exist to develop their innovation sufficiently to interest big pharma (eg Coley Pharma bought by Pfizer)
      Survive on venture capital, with limited time to succeed
      Recession was tough on such companies
      Canadian companies compete globally for attention
    • “PREVENT” AS HELPING HAND
      Pan-Provincial Vaccine Enterprise (PREVENT) is a federally funded NCE for commercialization of promising vaccines
      Partners with biotech companies to fund further product development (proof of concept) and favor buy out
      Current partnerships: chronic wasting disease vaccine (deer, elk), ALS vaccine, RSV vaccine, others
    • PART 2 – Vaccine Development
    • VACCINE DEVELOPMENT
      Only major vaccine companies are able to fund development of a “finished product”
      Typically acquire promising vaccines from biotech companies based on ongoing global searches
      Complete development to licensure
      Bringing a vaccine to market takes 15-20 years and costs $750M-$1Billion dollars
    • VACCINE DEVELOPMENT PROCESSES
      Formulation of consistent, stable, pure, defined product
      Pre-clinical studies: chemistry, animal toxicology, animal protection studies, production engineering
      Clinical trials: from earliest dose-finding to definitive protection studies in target population
    • PRODUCT DEVELOPMENT COSTS
      Major expenses:
      • Building specific production plant
      • Clinical trials – dozens, involving >10,000 subjects, high standards, trialists in many countries, many regulatory agencies
      • Vaccine trials ≥10x larger than drug trials, pivotal Phase 3 efficacy trials can take yrs
    • VACCINE MARKETPLACE
      • Global vaccine sales in 2007 were $16.3 billion US
      • Growing rapidly at ~14% per year ($30 B in 2013?), faster than drug sales
      • Vaccine sales = 2% of pharmaceutical business
      • Vaccines generally lack “blockbuster” potential of drugs
      • Market receptivity to new product unpredictable
    • GLOBALIZATION OF MAJOR COMPANIES
      Projected market growth has big pharma interested in vaccines
      Acquiring reasonable product portfolios has prompted many mergers, buy-outs of smaller companies, biotechs
      Only 5 majors remain (from 25): GSK, sanofi, Novartis, Pfizer, Merck, (Solvay)
    • GLOBALIZATION AND DOMESTIC STUDIES
      Canada no longer has domestic companies needing to conduct numerous vaccine trials here
      Decisions about placing pre-licensure trials in Canada are made elsewhere, at corporate HQ
      Future sales figure into trial placement plans: Canada accounts for ~2% of global sales, allows narrow profit margins on sales
    • OTHER GLOBAL CHANGES
      International harmonization of regulatoryrequirements is reducing req’d number of trials per vaccine
      Trial capabilities in E. Europe and Asia have grown greatly (and cost less than here)
      Health Canada does not require domestic trials if documentation elsewhere is satisfactory
    • CONSEQUENCES OF GLOBALIZATION
      Many fewer sponsored trials now in Canada
      Led to demise of some smaller CRO’s nationally
      Tenuous stability of academic vaccine centers without regular projects to employee staff
      Trend toward multinational trials with many centers diminishes academic kudos
    • CONSEQUENCES OF GLOBALIZATION (2)
      The 10 vaccine trial centers that currently exist in Canada will soon shrink in numbers
      The CAIRE/PCIRN network of trial centers that responded to the H1N1 pandemic won’t exist for the next crisis response – expertise will be lost
      UNLESS new means of funding centers is developed, similar to NIH Vaccine Units
    • Standing Taller Than 2%
    • STANDING TALLER THAN 2%
      A network of experienced, reliable trials centers will help to attract industry-sponsored studies to Canada (top quality studies please regulators everywhere)
      Potential to add value with world class immunology
      Multi-ethnic population a bonus, as is our potential for excellent post-marketing studies, long-term follow-up
    • PART 3: Deployment of Vaccines
    • PART 3: DEPLOYMENT OF VACCINES
      PARADOX:
      Canada is often among first countries globally to license a new vaccine but years can pass before public programs are implemented to use it to prevent infections.
      Why is that acceptable?
    • Case in Point : PCV7 Vaccine
    • WHY ARE NEW VACCINES NOT USED SOONER?
      • NACI statements are key but increasingly delayed after licensure granted
      • Canadian Immunization Committee even slower to advise eg HPV
      • Cost-effectiveness data not always available when needed
      • National Immunization Strategy faltering post-term (ended 2009)
      • Provincial funding processes, “sticker shock”
    • ABOUT VACCINE PRICES
      Costs to immunize a child to adolescence have risen from $35 in 1986 to about$450-$800 (M:F) today
      Vaccine costs reflect huge development costs (e.g. ever-larger clinical trials) which must be recouped (with profit) while market exists
      Trend will continue for challenging vaccines with new “enhancers,” to document safety
    • VACCINE BUDGETS IN PERSPECTIVE
      Canada spends ~$450 million/year for vaccines. This represents:
      ~2% of provincial drug budgets
      ~4% of public health budgets
      $14 of $5100 per citizen annual health costs
      <3 per1000 total health care dollars go to vaccines
      An ounce of prevention remains the case!
      Value to health of Canadians is grossly under-appreciated. Rationalizing cost-effective prevention should not be so difficult.
    • PROGRAM EVALUATION AND RESEARCH
      Immunization programs are now a large fiscal investment, rapidly growing health investment, dependent on public trust
      Increasingly important to systematically evaluate programs for safety, effectiveness, value
      All provinces and territories should have means for basic program evaluations (uptake, safety, disease impact)
    • PROGRAM EVALUATION AND RESEARCH (2)
      Means also needed for special studies (potential for fewer doses, timing of boosters, product comparison, crises etc)
      Greater similarity of P/T programs would aid collaborative evaluation processes, sharing of costs and insights
      Sensible funding model in Quebec (% of vaccine purchase cost set aside for evaluation studies) should be universal
    • Program Evaluations in the Sun
    • PROGRAM EVALUATION AND RESEARCH
      Likely the biggest growth area for domestic vaccinology
      Rewarding career potential, provided that training and sharing of expertise are facilitated, funding is provided
      Another area where Canada could distinguish itself internationally, favoring demonstration projects with new vaccines, schedule comparisons etc
    • The Other New Frontier
    • ADULT IMMUNIZATION: NEXT FRONTIER
      Adult immunization remains under-developed (no control success curves), minimally funded
      Boomer generation will demand more to keep healthy
      Flu and Pnc23 vaccine cost ~$25
      Unfunded for most adults: HAV, HB, HPV, MCC/MC4, Zoster, Tdap booster
      Self-pay = kiss of death
    • Adult Immunization Research
      Many advances needed to optimize adult protection
      How best to extend protection from adolescence?
      How to protect seniors better despite their diminished response capacity?
      Deploying better vaccines against influenza and other respiratory agents
    • WRAPPING UP
    • NEW RECIPE FOR SUCCESSFUL RESEARCH CENTERS
      Viable vaccine centers will be collaborations between public health and academic researchers
      With broad scope, including epidemiology, trials, safety studies, program evaluations
      Working together, with good lab support, responsive to strategic evidence requirements
    • SUCCESSFUL CENTERS (2)
      Will need some infrastructure funding for stability, preparedness, training
      Support should be tied to obligations to collaborate, respond to national priorities
      Network of such centers would attract good share of international trials, enable excellent domestic studies
      Suitable Canadian model, fit to size, avoiding duplication
    • RESEARCH IS NOT OPTIONAL
      Research is the means by which we
      demonstrate the VALUE of vaccines to
      politicians and the QUALITY and SAFETY
      of domestic programs to a skeptical public.
    • LAST WORD
      Let’s try harder in 2011 to make the vaccine pipeline
      flow smoothly, from beginnning to end,
      to the betterment
      of health of all Canadians. We have the tools…..