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Emerging And Re Emerging Infectious Disease Vaccines 09 Dec08 Final
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Emerging And Re Emerging Infectious Disease Vaccines 09 Dec08 Final

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Brief review of current list of emerging and re-emerging infectious disease and related vaccine market analysis and development opportunities

Brief review of current list of emerging and re-emerging infectious disease and related vaccine market analysis and development opportunities

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Emerging And Re Emerging Infectious Disease Vaccines 09 Dec08 Final Presentation Transcript

  • 1. Emerging and Re-emerging Infectious Diseases: New Vaccine Product Opportunities
  • 2. Emerging and Re-Emerging Infectious Diseases: New Vaccine Product Opportunities • Who defines an emerging or re-emerging infectious disease? • What pathogens are we talking about? • Where are diseases emerging or re-emerging? • Why are diseases emerging or re-emerging? • How can we identify and analyze new vaccine markets associated with these diseases? • Where can we get capital to develop vaccines for these pathogens? • Are there overlooked vaccine product opportunities? • Can we overcome the development clinical and regulatory challenges?
  • 3. Emerging and Re-Emerging Infectious Diseases Who defines an emerging or re-emerging infectious disease? • National Institutes of Allergy and Infectious Disease, NIH – Emerging Infectious Diseases: • previously unknown diseases or known diseases whose incidence in humans has significantly increased in the past two decades – Re-Emerging Infectious Diseases: • known diseases that have reappeared after a significant decline in incidence
  • 4. Emerging and Re-Emerging Infectious Diseases What pathogens are we talking about? • Group I—Pathogens Newly Recognized in the Past Two Decades • Group II—Re-emerging Pathogens • Group III—Agents with Bioterrorism Potential – NIAID—Category A – NIAID—Category B – NIAID—Category C
  • 5. Emerging and Re-Emerging Infectious Diseases What pathogens are we talking about? • Group I—Pathogens Newly Recognized in the Past Two Decades • • Acanthamebiasis Helicobacter pylori • • Australian bat lyssavirus Hendra or equine morbilli virus • • Babesia, atypical Hepatitis C • • Bartonella henselae Hepatitis E • • Ehrlichiosis Human herpesvirus 8 • • Encephalitozoon cuniculi Human herpesvirus 6 • • Encephalitozoon hellem Lyme borreliosis • • Enterocytozoon bieneusi Parvovirus B19
  • 6. Emerging and Re-Emerging Infectious Diseases What pathogens are we talking about? • Group II—Re-emerging Pathogens – Enterovirus 71 – Clostridium difficile – Mumps virus – Streptococcus, Group A – Staphylococcus aureus
  • 7. Emerging and Re-Emerging Infectious Diseases What pathogens are we talking about? • Group III—Agents with Bioterrorism Potential • NIAID Category A • Bacillus anthracis (anthrax) • Viral hemorrhagic fevers – Arenaviruses (LCM, Junin • Clostridium botulinum toxin virus, Machupo virus, (botulism) Guanarito virus, Lassa Fever) • Yersinia pestis (plague) – Bunyaviruses (Hantaviruses, • Variola major (smallpox) and Rift Valley Fever) other related pox viruses – Flaviruses (Dengue) • Francisella tularensis – Filoviruses (Ebola, Marburg) (tularemia)
  • 8. Emerging and Re-Emerging Infectious Diseases What pathogens are we talking about? • Group III—Agents with Bioterrorism Potential • Food- and waterborne • NIAID Category B pathogens • Burkholderia pseudomallei – Bacteria • Coxiella burnetii (Q fever) • Diarrheagenic E.coli, Pathogenic Vibrios, Shigella species, Salmonella, • Brucella species (brucellosis) Listeria monocytogenes, Campylobacter jejuni, Yersinia enterocolitica • Burkholderia mallei (glanders) – Viruses • Chlamydia psittaci • Caliciviruses, Hepatitis A – Protozoa (Psittacosis) • Cryptosporidium parvum, Cyclospora • Ricin toxin (from Ricinus cayatanensis, Giardia lamblia, Entamoeba histolytica, Toxoplasma communis) – Fungi • Epsilon toxin of Clostridium • Microsporidia perfringens • Additional viral encephalitides • – Staphylococcus enterotoxin B West Nile virus, LaCrosse, California encephalitis, VEE, EEE. WEE. • Typhus fever (Rickettsia Japanese Encephalitis virus, Kyasanur Forest virus prowazekii)
  • 9. Emerging and Re-Emerging Infectious Diseases What pathogens are we talking about? • Group III—Agents with Bioterrorism Potential • NIAID Category C, Emerging infectious diseases • Tick-borne hemorrhagic fever • Rabies viruses (Crimean-Congo • Prions Hemorrhagic Fever virus) • Chikungunya virus • Tick-borne encephalitis viruses • Severe acute respiratory • Yellow fever syndrome-associated • Multidrug-resistant TB coronavirus (SARS-CoV) • • Coccidioides immitis Influenza • • Coccidioides posadasii Other Rickettsias
  • 10. Emerging and Re-Emerging Infectious Diseases Where are diseases emerging or re-emerging?
  • 11. Emerging and Re-Emerging Infectious Diseases Where are diseases emerging or re-emerging? • Latin America – Dengue, Yellow fever, Meningococcal meningitis outbreaks increasingly common – See http://www.paho.org/English/ad/dpc/cd/eid-eer-ew.htm for PAHO reports of emerging and re-emerging infectious disease reports • SE Asia – (WHO analysis) Avian influenza, measles, infectious hepatitus, Nipah virus, Meningococcal disease, Malaria, Tetanus, Scrub typhus, Dengue, Cholera, Mumps, Japanese Encephalitis, Poliomyelitis, Leptospirosis, Typhoid Fever – http://www.searo.who.int/LinkFiles/Publication_139-combating-emerging.pdf • China – Very challenging to obtain accurate epidemiologic information • Africa – Surveillance is in its infancy – HIV, Tuberculosis (incl MDR), Streptococcus pneumoniae, Haemophilus influenzae, Neisseria meningitidis, Staphylococcus aureus (incl MRSA), Enterococcus, Shigella dysenteriae, Viral Hemorrhagic Fevers, Schistosoma
  • 12. Emerging and Re-Emerging Infectious Diseases Why are diseases emerging or re-emerging? • Human social and behavioral changes – Travel with expanded distance, speed, ecological diversity – Demographic changes – Land use, habitat encroachment (rainforest, wetlands) – Use of antibiotics and pesticides – Host switching, exposure to pathogen reservoirs (animal, arthropod) • Consumption of Civet cat meat (SARS-CoV), Gambian rats as pets (monkeypox), Spreading of Aedes aegypti mosquito (Dengue/Yellow fever ) • Environmental changes – Global warming, changes in weather and precipitation patterns – Increased population density facilitates transmission, pathogen evolution • Technological changes – Research advances reveal new infectious disease basis for pathobiology • Helicobacter (ulcers) – New diagnostic technology and/or public health surveillance detecting new pathogens • Norovirus (diarrheal disease), Coronavirus (SARS-CoV)
  • 13. Emerging and Re-Emerging Infectious Diseases How can we identify and analyze new vaccine markets associated with these diseases? • Challenges in market analysis – How to define incidence and prevalence? – How to assess acceptable price per dose, and for which markets? – Can separate markets be defined or stratified at present or future • travelers vaccines, military purchasers, WHO/UNESCO • developed, emerging, third world economies and governments – What are the impacts and opportunities associated with government and NGO/non-profit actors on markets? • Opportunities with Emerging and Re-Emerging ID markets – Markets are often ―under the radar‖ • Large and well capitalized biopharma invests in well defined markets • Window of opportunity for flexible product development teams – Significant non-dilutive capital available to support product development – Stockpile or special markets (DoD) may be available • DoD/Stockpile purchases may be associated with easier target populations (healthy adults)
  • 14. Emerging and Re-Emerging Infectious Diseases How can we identify and analyze new markets? – Monitor formal surveillance networks • DoD Global Emerging Infections Surveillance and Response System (DoD- GEIS) – http://www.geis.fhp.osd.mil/ • Training in Epidemiology and Public Health Intervention Network (TEPHINET- 32 countries) – http://www.tephinet.org/ • WHO Collaborative Centers Network for Global Surveillance of Communicable Diseases currently in development – http://www.who.int/immunization_monitoring/en/ • US Centers for Disease Control and Prevention, UK Public Health Laboratory Service, the French Pasteur Institutes all maintain global and regional surveillance data – Consultations with in-country infectious disease and epidemiology thought leaders – Survey country-specific pricing structures for existing vaccines – Monitor acquisition and project strategies of forward-looking global and regional stakeholders • US DoD, NIAID, CDC, WHO, Bill and Melinda Gates Foundation, GAVI
  • 15. Emerging and Re-Emerging Infectious Diseases How can we identify and analyze new markets? GAVI (Global Alliance for Vaccines and Immunization) annual process – Step 1: Diagnostic • Gather relevant information to profile each disease/vaccine under consideration • Consider the types of associated activities that could be funded to ensure successful vaccine • introduction (February-March) – Step 2: Consultations • Carry out 7 in-country consultations along with online, video and phone consultations to solicit input from key stakeholders. • Most recent full consultation report of country input is available on the website (http://www.gavialliance.org/resources/Stakeholder_consultation_report_Jun08.pdf) – Step 3: Synthesis and Vaccine Evaluation • Identify a range of scenarios (vaccine portfolio themes) associated with packages of multiple vaccines over different timeframes. – Step 4: Strategy Development and Investment Requirements • Present recommended vaccine investment theme to the GAVI Alliance Board • Define investment envelope along with long-term income projections • Prepare implementation plan considering the specific financial implications (and corresponding fundraising strategy) as well as the associated activities and timeframe for investments. http://www.gavialliance.org/resources/3____Vaccine_Investment_Strategy.pdf
  • 16. Emerging and Re-Emerging Infectious Diseases How can we identify and analyze new markets? • WHO priority list defines global consensus for proven vaccine preventable diseases – Based on 10 criteria ranked by relative importance • mortality; epidemic/pandemic potential; economic impact; case fatality rate; disease incidence in the highest burden regions; long term sequelae; morbidity; inequity; lack of other alternative treatment or prevention measures; and severity of symptoms. – 18 diseases clustered into three groups • quot;Very High Priority― (Malaria and Pneumococcal Disease) • quot; High Priorityquot; (Cervical Cancer (HPV), Cholera, Dengue, Japanese Encephalitis, Meningococcal ACWY, Rabies, Rotavirus, Seasonal influenza, Typhoid Fever, and Yellow Fever) • quot; Medium Priorityquot; (Hepatitis A, Hepatitis E, Meningococcal B, Mumps, Rubella, and Varicella). – Additional emphasis on injectable polio vaccine (IPV) for GAVI countries (currently insufficient global supply capacity to meet projected need)
  • 17. Emerging and Re-Emerging Infectious Diseases How can we identify and analyze new markets? • WHO priority list defines global consensus for proven vaccine preventable diseases (continued) – Organizations managing global vaccine acquisition • UNICEF (http://www.unicef.org/supply/index_immunization.html ) • PAHO (http://www.paho.org/english/hvp/hvi/revol_fund.htm ) – List of United Nations Prequalified Vaccines and vaccine priorities is updated annually • http://www.who.int/immunization_standards/vaccine_quality/pq_suppliers/en/ – Standardized process for petitioning for WHO prequalification status • Requires submission of product summary file (PSF) • http://www.who.int/vaccines-documents/DocsPDF07/870.pdf
  • 18. Emerging and Re-Emerging Infectious Diseases Where can we get (non-dilutive) capital to develop vaccines for these pathogens? • NIH- NIAID – http://www3.niaid.nih.gov/topics/emerging/default.htm • US Department of Defense (US Army Medical Research & Materiel Command) – http://www.usamraa.army.mil/pages/Baa_Paa/baa_choice.cfm • DARPA – http://www.darpa.mil/dso/thrusts/bwd/act/rva/index.htm • Bill and Melinda Gates Foundation – http://www.gatesfoundation.org/grantseeker/Pages/overview.aspx • Wellcome Trust – http://www.wellcome.ac.uk/funding/ • PATH – http://www.path.org/ – http://www.path.org/vaccineresources/index.php
  • 19. Emerging and Re-Emerging Infectious Diseases Are there overlooked vaccine product opportunities? • Case study #1 Burkholderia pseudomallei (Melioidosis) ―The great mimicker‖- with no clear vaccine candidate – Gram negative bacterium (soil), infects when soil is disrupted – Endemic in Thailand, Singapore, Malaysia, Burma, Northern Australia – Reported in Southern China and Hong Kong, Brunei, Taiwan, India, and Laos, and sporadic cases in Central and South America, the Middle East, the Pacific, several African countries, and at least five cases in UK (likely underreported) – Often misdiagnosed as Tuberculosis (―Vietnamese Tuberculosis‖) – In northeast Thailand, 80% of children are seropositive by the age of 4 – Relatively refractory to medical management – Associated with increased rainfall (distribution likely impacted by global climate change) – Appears to require both humoral and cellular responses for control – High priority for US Military vaccine development programs – Genome comprised of two chromosomes is completely sequenced • http://www.sanger.ac.uk/Info/Press/2004/040914.shtml
  • 20. Emerging and Re-Emerging Infectious Diseases Are there overlooked vaccine product opportunities? • Case study #2 Norovirus (one leading vaccine candidate- Ligocyte) – RNA virus (Calciviridae, positive ssRNA genome) – Causitive agent of 90% of worldwide epidemic (non-bacterial) gastroenteritis – Common cause of epidemic outbreaks in closed environments (ships, geriatric care, pediatric daycare centers) – 12% of severe gastroenteritis cases among children <5 years of age and 12% of mild and moderate diarrhea cases among persons of all ages. – CDC estimates Norovirus infections cause 64,000 episodes of diarrhea requiring hospitalization and 900,000 clinic visits among children in industrialized countries, and up to 200,000 deaths of children <5 years of age in developing countries. – Cannot be cultured on any known cellular substrate – Incidence currently being defined (PCR stool analysis, diarrheal disease incidence monitoring due to rotavirus vaccine) – No reagents available to evaluate seroprevalence – Genetic analysis indicates genetic drift to escape mutant development approximately every two years – No current surveillance outside of North America, EU – High priority for US Military vaccine development programs
  • 21. Emerging and Re-Emerging Infectious Diseases Development, Clinical and Regulatory challenges? • Developmental challenges – Basic Scientific background and context may not be readily available • Protective antigens may need to be identified • Role of innate and adaptive immune responses may need to be characterized • Identification of mechanisms of host immune response, pathobiology and other mechanisms (or correlates) of protection may be necessary – Practical pre-clinical testing infrastructure is required • Conditions for propagation and standardization of research and challenge strains may need to be developed • Animal models of disease may need to be developed and validated • Standardized animal challenge protocols must be developed • Immunoassays and genetic analysis tools (PCR etc.) are required both to define human epidemiology and to assess animal testing outcomes • Novel vaccine (and adjuvant) technologies may require development of novel toxicology assays
  • 22. Emerging and Re-Emerging Infectious Diseases Development, Clinical and Regulatory challenges? • Clinical challenges – Defining the labeled indication • Protection against infection or disease- if disease, how defined? • What cohort(s) and target markets? – Travelers or military personnel? – All ages and risk groups or healthy adults at risk? – Multi-step licensure? – Defining efficacy endpoints (Phase 2) • Requires understanding of immunology, pathobiology and other mechanisms (or correlates) of protection – Demonstrating field efficacy (Phase 3) • Is the incidence high enough to warrant the investment? • May require studies in regions which may lack necessary clinical trial experience • Efficacy power calculations (study cohort size) require accurate estimates of incidence and prevalence
  • 23. Emerging and Re-Emerging Infectious Diseases Development, clinical and regulatory challenges? • Regulatory challenges – What countries competent regulatory authorities will support licensure? – International bioethical concerns may create barriers and complications to licensure – Will EMEA/CBER pathways for licensure of vaccines for non-EU/US markets be employed? – Correlates of protection are undefined (and may be undefinable) – Risk/benefit ratio may be difficult to define or may change over time – What strategic pathway will be employed to enable WHO selection and UNICEF/PAHO purchase (if this is intended) – Complexities and timelines for competent authorities in emerging economies may create significant barriers to time and cost-effective licensure – Application of animal rule (CBER) may be problematic
  • 24. Emerging and Re-emerging Infectious Diseases: New Vaccine Product Opportunities Robert W Malone, MD, MS http://www.rwmalonemd.com • Question and answer session • Thanks for participating! • If you wish a copy of this presentation with the associated web links, please send an email requesting a copy to the following address: marketing@biopractice.com