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