Overcoming H1N1 / Swine Flu

Background

In mid to late March 2009, a new influenza A virus (subtype H1N1) of swine origin emerged in Mexico and the United States, quickly spreading to more than 30 countries by mid-May. In mid-June, the WHO declared the first flu pandemic in four decades, and the race was on to produce sufficient vaccine against the H1N1 virus by October 2009, the start of the Northern hemisphere flu season.

Problem

There were two main problems:-

 1.      How to manufacture enough vaccines for normal Northern hemisphere flu season, whilst developing and manufacturing H1N1 Swine flu vaccines.

2.     How to utilise new technology in vaccines manufacturing – cell culture to reduce the time to develop and manufacture.

QCS Staffing (a global staffing provider to the Life Science industry) had an established global partnership with Novartis Vaccines providing them with highly qualified freelance contractors and permanent employees in the UK, US, Germany and Italy.

Novartis responded with energy and confidence as the H1N1 swine flu outbreak became a global pandemic, with more than 182,000 cases and 1,000 deaths in 177 countries, by June 2009. As a result, Matt Stober Global Head of Technical Operations reported that Novartis was the first company to report it could successfully manufacture the H1N1 antigen. It was also the first “top flu vaccine player” to publish results from a H1N1 clinical trial, and the first company with both U.S. and European approvals for its vaccine. (reported in Xconomy)

In order for Novartis to maximise their market share, they engaged with QCS Staffing to deliver large volumes of highly skilled contractors with vaccine or biotech manufacturing experience from both cell culture and egg based backgrounds to support their operations in the UK, US, Germany and Italy. There were a broad range of skills to recruit against in multiple geographic locations.

These are listed below:-

• Pharmacovigilance Specialists                                 • M,S & T Specialists (Manufacturing, Science

• Drug Safety Specialists                                             • Technical Transfer Specialists

• Medical Writers                                                         • Production Managers (shift leaders)

• Regulatory Specialists                                              • Engineering Managers (shift leaders)

• Programme / Project Managers                               • QA Specialists / Managers

• PMO Managers                                                          • QC Managers

• Production Schedulers                                              • Supply Chain Specialists

• Process Development Specialists

• Validation Specialists (Process validation,Cleaning Validation, Analytical Validation,Validation Manager)

Subsequently, QCS Staffing received over 60 requirements (for “white collar” professional contractors) within the categories noted above, over the ensuing 6-month period to ramp up Novartis’s manufacturing capacity to deliver the H1N1 vaccines.

Challenges Identified

QCS Staffing identified a number of challenges relating to the staffing of this international programme. These included:

 1.      In-country competition:– in the UK similar projects and capital investment projects being Completed by the Novartis’s competitors - including two start up projects within one mile of their egg based manufacturing facility.

2.     Client locations:-

a)    In Germany (Marburg) and Italy (Sienna), site locations were not easily accessible for contractors who had to travel internationally to the sites.

b)   Managing multiple client points of contacts across multiple locations.

3.     Global competition:– around the world the race to secure the best expertise in order to bring the vaccine(s) and adjuvant to market to increase market share.

4.    Resource shortage:– globally it was very much a candidate focussed market and due to local and global projects, we anticipated a lack of skilled resource, especially subject matter experts.

5.     Compliance:– ensuring that all contractors were working legally in the country they were deployed to.

Process

QCS Staffing put in place a fast response team made up of an experienced client director, an account manager and a team of delivery executives experienced in staffing candidates to biopharma & vaccines projects.  The objectives of the team included:

1.      Qualify client requirements:–

a)    Weekly site meetings in the UK (Liverpool) were completed to ensure a full understanding of client needs.

b)   Weekly phone meetings and monthly site meetings were completed for the US, Germany and Italy to ensure a full understanding of client needs.

2.     Forward load analysis:– working with the client, QCS Staffing set in motion the identification and hire of consultants up to four months in advance of the actual start date.

3.     Location & project guides:– QCS Staffing created candidate guides and identified accommodation partners for all non-local consultants – this was for all locations.

4.    Candidate tracking:-

a)    QCS Staffing created technically specific ‘pools’ of relevant candidates who;

i) resided within commuting range of the production facility and

ii) for those that would travel nationally or internationally to the site

b) These candidates were then tracked and presented to client when they became available for their next assignment. In addition, QCS Staffing ensured these candidates were provided with the local tax/payroll solutions and managed the chosen solution.

5.     Created and implemented professional working day rate for each consultant, to ensure fixed costs for each technical hire for the duration of the project.

The Result

In summary, QCS Staffing delivered:

• 195 individual profiles to Novartis globally

• 107 interviews took place

• 51 individual staffing assignments

By delivering 51 specialist consultants to Novartis Vaccines we were able to support them globally in developing and manufacturing x3 (A)H1N1 vaccines that were distributed globally. This enabled Novartis to:

•     Within 6 months of identifying the strain, have their H1N1 vaccines approved by the US Food and Drug Administration (FDA)

•     In Europe, H1N1 vaccines from Novartis were approved by the European Medicines Agency on September 29th

•     The UK Novartis Vaccines plant was able to ship their conventional flu vaccine to the US  market early in order to ramp up for the swine flu vaccination drive. Delivering 27 million doses earlier than normal

•     On September 27 Novartis Vaccines in Liverpool also shipped the first doses of H1N1 vaccine to America as part of a $979m order from the US government

 Andrin Oswald, CEO of Novartis Vaccines and Diagnostics stated “Our modern cell culture technology can enable a faster start-up of vaccine manufacturing, offering the ability to respond more quickly to future pandemic threats. We quickly ramped up capacity at our licensed cell culture facility in Marburg, Germany, to respond to the need for pandemic vaccine.”

Novartis Vaccines Professional Reference

‘‘ Novartis Vaccines and Diagnostics have partnered QCS Staffing Consultancy Services in the hiring of specialist consultants over the past 5 years. Through our long term strategic alliance, QCS Staffing has acquired in depth knowledge of the culture and ways of working at our Speke site. This has enabled QCS Staffing to deliver high calibre individuals, ‘‘right first time’’. Novartis Vaccines enjoy working with the professional recruitment team at QCS Staffing and look forward to continuing this successful business partnership.’’

 Lydia Kneen, 2009

Recruitment Manager

Novartis Vaccines & Diagnostics, Speke