Can Canadian Vaccine Research Survive the Challenges of Globalization?<br />  David W. Scheifele<br />  Vaccine Evaluation...
OBJECTIVES<br />To explore the full length of the “vaccinepipeline” noting the players, trends and influences on research<...
VACCINE PIPELINE DEFINED: 3D’s<br />Discovery – of a candidate antigen<br />Development – of a licensed product<br />Deplo...
PART ONE:  VACCINE DISCOVERY<br />Begins with identifying microbial components that can elicit protective immunity<br />Mo...
BUT a Molecule is not a Vaccine<br />
 DISCOVERY CHALLENGES<br />“Easy” vaccines have already been developed<br />New targets are more challenging:<br />microbi...
VACCINE DEVELOPMENT FRONTIER<br />New “enabling technologies” in development to cope with challenges:<br />adjuvants, in g...
CANADIAN  VACCINE BIOTECHNOLOGY COMPANIES (2010)<br />Amorfix Life Sciences     Immunovaccine<br />Theracarb Inc.	        ...
FOCUS OF SELECTED VACCINE BIOTECH COMPANIES<br />Amorfix – vaccines for CNS disorders e.g. ALS,  Alzheimer’s <br />Medicag...
CHALLENGE FOR BIOTECHNOLOGY COMPANIES<br />Exist to develop their innovation sufficiently to interest big pharma (eg Coley...
“PREVENT” AS HELPING HAND<br />Pan-Provincial Vaccine Enterprise (PREVENT) is a federally funded NCE for commercialization...
PART 2 – Vaccine Development<br />
    VACCINE DEVELOPMENT<br />Only major vaccine companies are able to fund development of a “finished product”<br />Typica...
VACCINE DEVELOPMENT PROCESSES<br />Formulation of consistent, stable, pure, defined product<br />Pre-clinical studies: che...
PRODUCT DEVELOPMENT COSTS<br />Major expenses:<br /><ul><li>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</li></li></ul><li>VACCINE MARKET...
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</li></li></ul><li>GLOBALIZATION OF MAJOR COMPANIES<br />Projected market g...
GLOBALIZATION AND DOMESTIC STUDIES<br />Canada no longer has domestic companies needing to conduct numerous vaccine trials...
OTHER GLOBAL CHANGES<br />International harmonization of regulatoryrequirements is reducing req’d number of trials per vac...
CONSEQUENCES OF GLOBALIZATION<br />Many fewer sponsored trials now in Canada<br />Led to demise of some smaller CRO’s nati...
CONSEQUENCES OF GLOBALIZATION (2)<br />The 10 vaccine trial centers that currently exist in Canada will soon shrink in num...
      Standing Taller Than 2% <br />
STANDING TALLER THAN 2%<br />A network of experienced, reliable trials centers will help to attract industry-sponsored stu...
PART 3: Deployment of Vaccines<br />
PART 3: DEPLOYMENT OF VACCINES<br />PARADOX:<br />Canada is often among first countries globally to license a new vaccine ...
Case in Point : PCV7 Vaccine<br />
WHY ARE NEW VACCINES NOT USED SOONER?<br /><ul><li>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”</li></li></ul><li>ABOUT VACCINE PRICES<br />Costs to immunize a child to ado...
VACCINE BUDGETS IN PERSPECTIVE<br />Canada spends ~$450 million/year for vaccines. This represents:<br /> ~2% of provincia...
PROGRAM EVALUATION AND RESEARCH<br />Immunization programs are now a large fiscal investment, rapidly growing health inves...
PROGRAM EVALUATION AND RESEARCH (2)<br />Means also needed for special studies (potential for fewer doses, timing of boost...
Program Evaluations in the Sun<br />
PROGRAM  EVALUATION  AND RESEARCH <br />Likely the biggest growth area for domestic vaccinology<br />Rewarding career pote...
      The Other New Frontier<br />
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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?

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

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