project management influenza annual update weesp, february 22 2011 dorine leyssius
DESCRIPTION
Annual Update Scope; re-registration of the vaccine Change; adaptations because of strain changes Planning; high level information in detailed plans Management; manage the team and objectives Success; timely registration Monitoring; lessons learnedTRANSCRIPT
PROJECT MANAGEMENTInfluenza Annual Update
Weesp, February 22 2011Dorine Leyssius
Agenda
• Annual Update• Influenza, the virus, the disease, the
vaccine• Manufacturing and Distribution• Project Integration Management
Annual Update
• Scope; re-registration of the vaccine• Change; adaptations because of strain
changes• Planning; high level information in detailed
plans• Management; manage the team and
objectives• Success; timely registration• Monitoring; lessons learned
Annual Update Timeline
• Recommendation by WHO on virus strains Feb• CHMP decision for EU production strains Mar• Seed provided by NIBSC Apr• Reagents produced by NIBSC May• Clinical Study Jun• Submission registration dossier Jul• Approval registration dossier Aug• Vaccination population Oct/Nov
Timelines are very strict!
Agenda
• Annual Update• Influenza, the virus, the disease, the
vaccine• Manufacturing and Distribution• Project Integration Management
Influenza, the virus and the disease The Influenza A and B Virus
Negative strand RNA virus of the orthomyxoviridae family
Influenza virus surface proteins:
Haemagglutinin (HA)
Neuraminidase (NA)
Influenza, the virus and the disease Influenza A and B Virus, Antigenic Drift (Seasonal)
Influenza, the virus and the disease The Influenza A Virus, Antigenic shift (Pandemic)
Can result in a Pandemic
Influenza, the virus and the disease
Symptoms and Transmission
Generally, the major difference between influenza and the common cold and other influenza-like illnesses is the sudden onset and the occurrence of high fever, frequent
chills and muscular aching.
Influenza is easily transmitted through contact with droplets from the nose and
throat of an infected person who is coughing and sneezing.
Influenza viruses can generally survive on surfaces for 2-8 hr.
Influenza, the virus and the disease Influenza Complications and Risk Groups
CommonCommon UncommonUncommonPneumonia Encephalopathy
Exacerbation of underlying diseases
Myositis
Sinusitis Myocarditis
Acute otitis media (children) Febrile seizures
Dehydration (infants) Reye syndrome (children)People at risk for influenza complications:All children <5 yrAll elderly people ≥60 yrAll pregnant womenPeople of any age with certain (chronic) medical conditions (e.g.,
asthma, diabetes, immune-deficiencies, renal dysfunction)
Source: WHO April 2009
Influenza, the virus and the disease Influenza Epidemics
Each year in the industrialized world, 3–5 million cases of severe influenza illness result in 250,000–500,000 deaths.
Influenza, the virus and the disease Influenza Epidemics, the Influenza Season in US
Timing and duration of influenza seasons varyInfluenza activity peaks most frequent in February
• Centers for Disease Control and Prevention (CDC)
Influenza, the virus and the disease Influenza Epidemics, Burden of Disease (in the US)
Deaths 23,607
Hospitalizations 142,000
Illnesses 40,000,000
Direct costs ($) 4,000,000,000
Indirect costs($) 8,000,000,000
CDC data
Influenza, the virus and the disease Influenza Pandemics
• Asiatic (Russian) Flu H3N8?(1889)
• Spanish Flu H1N1 (1918)
• Asian Flu H2N2 (1957)
• Hong Kong Flu H3N2 (1968)
• Russian Flu H1N1 (1977)
• Hong Kong Flu H5N1 (1997)
• Mexican Flu H1N1 (2009)
Agenda
• Annual Update• Influenza, the virus, the disease, the
vaccine• Manufacturing and Distribution• Project Integration Management
National Influenza Vaccine Summit 2007
National Influenza Vaccine Summit 2007
National Influenza Vaccine Summit 2007
National Influenza Vaccine Summit 2007
National Influenza Vaccine Summit 2007
National Influenza Vaccine Summit 2007
Agenda
• Annual Update• Influenza, the virus, the disease, the
vaccine• Manufacturing and Distribution• Project Integration Management
Annual Update Regulatory Agencies Activities
– Europe (Northern Hemisphere): data requirements according to EU GuidelineApr 1997,Harmonisation of Requirements of Influenza Vaccines
– Relates to annual virus strain changes due to WHO recommendation
• Submission via fast-track Type II variation procedure in 2 parts
• Administrative data & CMC
• Clinical (study results) & PSUR– CHMP: annual decision on strains to be used for manufacturing– Ph.Eur.: batch release by national control laboratories & mutual
recognition of test results
Annual Update Timeline
• Recommendation by WHO on virus strains Feb• CHMP decision for EU production strains Mar• Seed provided by NIBSC Apr• Reagents produced by NIBSC May• Clinical Study Jun• Submission registration dossier Jul• Approval registration dossier Aug• Vaccination population Oct/Nov
Timelines are very strict!
Project Integration Management
→ Lessons learned • Develop Project Charter• Develop Project Management Plan
Time managementDefine ActivitiesSequence ActivitiesEstimate Activity ResourcesEstimate Activity DurationsDevelop ScheduleControl Schedule
Project Communication Management
Stakeholder Management
• Direct and Manage Project Execution• Monitor and Control Project Work• Perform integrated Change Control• Close Project
Organizational Process Assets Updates
→ Lessons learned
Project Integration Management
• Develop Project Charter• Develop Project Management Plan
Time managementDefine ActivitiesSequence ActivitiesEstimate Activity ResourcesEstimate Activity DurationsDevelop ScheduleControl ScheduleProject Communication
ManagementStakeholder Management
• Direct and Manage Project Execution• Monitor and Control Project Work• Perform integrated Change Control• Close Project
Organizational Process Assets Updates
Lessons learned
Project Integration Management
• Develop Project Charter• Develop Project Management Plan
Time managementDefine ActivitiesSequence ActivitiesEstimate Activity ResourcesEstimate Activity DurationsDevelop ScheduleControl ScheduleProject Communication
ManagementStakeholder Management
• Direct and Manage Project Execution• Monitor and Control Project Work• Perform integrated Change Control• Close Project
Organizational Process Assets Updates
Lessons learned
Questions