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The European Outsourcing Awards 2008: an innovation showcase for outsourcing.

Now fully established as the contract service industry's must-attend gala dinner event, the European Outsourcing Awards, held this year in Frankfurt, Germany, continues to celebrate and recognize excellence in R&D, marketing, business and technology across the pharmaceutical industry. A packed house of top-tier industry professionals gathered together to network, dine and eagerly await the results of this year's hard-fought competition. Dr Kevin Robinson congratulates the winners, commiserates with the runners up and reports on the evening's revelations.

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According to a new Visiongain report, "Contract Pharma 2008-2023," the revenue for world contract manufacturing business in 2007 was approximately $30 billion, with a growth rate of 6% from 2006. The technical expertise and cost savings offered by contract manufacturing organizations (CMOs) make them increasingly essential to you and your organization, it states, emphasizing the fact that significant pressure has been put on European CMOs to leverage low-cost contract manufacturing markets--such as those existing in India and China--to enhance cost-efficiency. Many CMOs in Europe have turned to biotech services as a means of avoiding competition with lower-cost API companies based in developing countries. In common with European service providers, North American CMOs are adopting a dynamic approach. Also, they are providing other services, such as packaging, logistics and marketing support. In addition, CMOs are increasingly undertaking analytical testing and other value-added services alongside the traditional contract manufacturing of APIs. In some major CMOs, these value-added services have taken up a significant proportion of their revenue generation. This rate will increase further during the coming decade, predicts the report; the establishment of large, global companies offering a full range of contract services has led to a change in the image of CROs and CMOs. There has been a shift in the business model of CMOs to integrate themselves more fully into the supply chain of pharmaceutical and biopharmaceutical companies by offering a wider range of services.

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The author clearly had a sneak preview of the results of this year's European Outsourcing Awards! Recently dubbed the "Outsourcing Oscars" by judge and presenter Dr Makarand Jawadekar of Pfizer Global R&D, the best and most innovative partnerships and relationships in the pharmaceutical contract services sector were honoured again at the EOA 2008 gala dinner. This year, more than 180 people attended the prestigious ceremony at Frankurt's Steigenberger Frankfurter Hof Hotel on the 1st of October, and were treated to a lavish meal before the lights were dimmed and the golden envelopes were opened. Masters of Ceremony Mr Rodney Steel, Chief Executive of the British Contract Packers and Manufacturers Association and Mrs Catherine Gonon, Executive Director of the SFSTP, did a sterling job on the night, co-ordinating the presentations and--aided and abetted by a host of outsourcing celebrities--presenting the now established awards.

Most Improved Process/Plant/Facility

First on stage this year was Pierre Fabre Medicament Productions for the nomination, "New Aquitaine Pharm International 2 Site." Following a global search, two partners found themselves unable to find a company to manufacture their highly explosive, potent freeze-dried products. Pricing and time restraints made it impossible for the organization to do it internally, as well as a lack of experience of working with such processes at an industrial scale. So, this project focused on building two brand new workshops to manufacture highly potent parenterals in a potentially explosive environment. The project focused on constructing the first explosion-proof facility for highly potent freeze-dried or liquid parenteral filling lines using 100% isolator technology. The technologies included in the project were so pioneering that, sometimes, the efficiencies had to be decreased to make them compliant with current regulations! Pierre Fabre took a gamble on the future of isolator technology and constructed a facility for next-generation pharmaceuticals. "They've grabbed the drug manufacturing industry by the scruff of the neck and given it a shake, saying there is still room for innovation--particularly for outsourcing activities in developing countries.

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They have pushed the boundaries of isolator technology and ATEX regulations and have created one of the most advanced plants on the planet," said a member of the judging panel. Presenting the award, Jim Miller, founder and president of PharmSource Information Services, Inc., commented that strong nominations were also received from JF Granulator and Bilcare, which were greatly appreciated, and added: "Congratulations to Pierre Pharma for upping their game and going from runner up in 2007 to genuine winner in 2008."

Most Effective Scale-Up/Tech Transfer

The next project to podium, as post-Olympic vernacular has it, was "IRIS," submitted by Procter & Gamble International Operations SARL and Patheon France SAS. A Patheon spokesperson noted: "Patheon has won in the category of Most Effective Scale-Up and Technical Transfer. This honour is in recognition of the impeccable work that Patheon has provided with Procter and Gamble Pharmaceuticals. Their strategic partnership has been very successful and has demonstrated their effectiveness and reliability during a very demanding technical transfer." The project target was to complete the transfer, qualification and validation of drug production at a new manufacturing site--without interrupting supply--while also overcoming cultural/social differences and diverse working practices, the decommissioning of the original plant and strict budgetary and time constraints. The result: an evolution from simple transfer activity to ongoing and long-term relationship. Phil Slater, Director of External Supply Organization for Procter and Gamble stated: "Patheon was selected as our partner in this project based on their experience, capabilities in technology and quality management. With Patheon, we could ensure we met the needs of our customers now and in the future." Terry Novak, President of North America and Chief Marketing Officer, stated: "Patheon is proud to have won the Most Effective Scale-Up and Technical Transfer award at this year's European Outsourcing Awards. Our performance in the industry is being recognized for a reason: we have dedicated ourselves to understanding our customer's needs and developing both the capability and capacity to deliver on those needs. It's rewarding to even be considered with Procter and Gamble for this award by other industry leaders." A highly commended nomination was also received from Marlborough Pharmaceuticals.

Most Innovative Relationship

Returning to the stage after their 2007 success, but having submitted a nomination in a new category, Burgopak Limited and Brecon Pharmaceuticals were delighted to receive the Most Innovative Relationship award for their submission, "Burgopak/ Brecon Pharmaceutical Packaging Automation Project," from award sponsor Timothy C. Tyson, Executive Chairman and CEO, Aptuit Inc. Both parties in this nomination had the same end goals in mind when they started the project. The main focus was to be able to provide innovative, patient-compliant packaging with the added benefits of anticounterfeiting/portable/child resistant formats on a fast, automated line. This project has brought a completely new pharmaceutical pack to the market, that combines patient safety, portability, branding opportunities and anticounterfeit potential. The companies believe that their design is an improvement on the standard carton packaging, which has remained basically unchanged for decades. The major outstanding characteristic was the ability of the parties to work together on the "evergreen design," as any changes had an impact elsewhere down the chain that required analysis and a solution. Brecon Pharmaceuticals had the foresight and risk appetite to take on a completely new and unproven packaging project. After 2 years of hard work and close co-operation, they can now proudly show a robust, fast (150 packs per minute) automated line with some major pharmaceutical companies utilizing the novel Burgopack packaging style. Assessing the nomination, a member of the judging panel observed: "It was much more of a technical challenge to automate something that was considered bespoke. Project managing that must have been really stressful and there must have been a lot of upfront investment. Sounds braver and more impressive than the other entries in this category."

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Outstanding Application in Nutraceuticals

A new addition to the programme for 2008, this award focused on understanding the requirements of working in the food-pharma crossover market. Introducing the award, Dr Kevin Robinson, editor of Via Media's Nutraceutical Business & Technology magazine said that this was a welcome and timely addition to the proceedings and firmly shines the spotlight on the rapidly developing and important business sector where food meets pharma. This award was fiercely contested but the main objective of the winning project was to develop a complete range of food supplement products that were innovative, high quality, easy to dispense and available to a wide range of patients. The main innovation from a galenic point of view was the choice of an orosoluble form as a practical and less expensive alternative to tablets, capsules or powders in sachets. Of note, said Dr Robinson, was that the sponsor company involved in the project was not previously active in the field of food supplements. Particular issues that were overcome involved formulation, time frames and introducing a well-established pharmaceutical company into a completely new market. The collaboration between the sponsor, one of the leading companies in the pharmaceutical business of generic drugs, and the winner, a leader in the contract manufacturing of pharmaceuticals and food supplements, has enabled a Big Pharma to utilize marketing and price strategies for food supplements as they are doing with pharmaceuticals. The result of this project means that the finished product will become the first registered brand name that will identify the sponsor company all over Europe, and beyond, in the field of food supplements. The award was presented to FINE FOODS NTM SpA and Ranbaxy Italia SpA for the submission, "Linea Oro: Orosoluble Line of Food Supplements Developed for Ranbaxy." Special mentions go to Custom Pharmaceuticals and Colorcon, who were pipped at the post for this year's award.

Best Contract Analytical Project

The R&D department from a major pharmaceutical player was going through a reorganization that led to its Infectious Disease Medical Development Centre (MDC) moving to a virtual operation. This left a very small team to manage both ad hoc requests and the statistical reporting and analysis of two large and complex HIV studies. The projects were themselves quite unusual in that part of the way through the studies, a conditional power analysis was to be performed to determine whether the study continued to completion or was stopped early. This decision was critical; it had both large cost and ethical implications. To facilitate the analysis and complete the trials, the winning company put together a team of programmers and statisticians with substantial experience of reporting and analysing HIV studies. It also altered its costing method to a hybrid between a fixed price model and its usual time and expenses one. This provided a very cost-effective solution that met fixed monthly budget targets. As such, they delivered high quality outputs to the Big Pharma, met all timelines and have provided additional ad hoc advice and support, often at short notice. They have done this through developing a relationship based on trust and experience and also delivered considerable cost savings to the customer. The sponsor company described the organization as having provided a "lifeline" to the Infectious Diseases MDC whilst it went through its move to a virtual world. The award was presented by Haf Cennydd, Event Director ICSE, to Satellite, for the nomination, "Conditional Power--Out of This World Solution Provided by Satellite." She cited the judging comment that "this nomination establishes a model that can be duplicated across multiple clients, and the quality of the presentation was excellent."

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Best Contract Manufacturing Project

When one member of the judging panel describes a nomination as having a crystal clear description of objective, challenge and delivery, and shows evidence of a can-do, will-do, got it done attitude, you know you're on to something. When another judges comments that "project management sounded sweaty and fun," you know you have a winner. In April 2007, Company X approached this company and advised them that one of their products was approaching patent expiry. The goal was to launch a reformulated version of the product using Geomatrix Delivery. During development, the sample tablets submitted for stability had no unique identification. US regulations require a unique identifier on the primary product for all commercial production--either by embossing or by tablet printing. Tablet embossing interfered with the delivery system and would mean beginning development again. This would have resulted in not meeting the required launch date and was, therefore, not an option. The only other solution was to print on the tablets. As the current facility was already packaging the old form and would also be doing the new version, a joint venture project was proposed. Tablet printing was a completely new technology to the facility but the companies' relationship was so strong that our winner agreed to take on the project. Presenting the award to Catalent Pharma Solutions for their "Sular Tablet Printing" nomination, Rodney Steel said: "The machine that is now being used is one of a kind. There is no other tablet printing system paired with this quality of vision and inspection system anywhere else in Europe: it is a state-of-the-art process. The timescale required was very aggressive and failure on implementation would have been a loss of revenue for both parties. This meant that everyone involved became focused on the end target and all the relevant deadlines needed to achieve the goal. Taking into consideration the complexity and uniqueness of the project, along with the fact that there were companies involved from the UK, US, Ireland, Belgium and Germany, one can appreciate the challenge that was faced."

Best New Partnership

As a result of growing demand from existing global clients and after extensive research and due diligence, in April 2006, this company launched a European Alliance of likeminded companies offering clients, for the first time ever, the ability to work with one organization in outsourcing health and beauty brands across Europe. The winner of the Best New Partnership award was Ceuta Healthcare Group for its nomination, "International Health & Beauty Outsource Alliance." Peter Burrows, Ceuta's Director of International Development, received the award and commented: "First, many congratulations on the success of the 2008 European Outsourcing Awards evening in Frankfurt, which we have thoroughly enjoyed. The awards evening is a fantastic event to recognize and celebrate excellence in outsourcing within the healthcare industry, which also offers a great opportunity to network with industry partners." He went on to explain that the most challenging part of the relationship between the company and its Alliance Partners has mainly been cultural, as all markets are different. Differences in the perception of 'fast response' or what constitutes a good opportunity can create frustration. One of the key factors of success in the Health & Beauty Alliance has been the visionary and entrepreneurial spirit of the company's Chief Executive in investing time and resources in setting up the Alliance. Almost all companies approached agreed to become members, as it was such a great idea that needed to be championed by one central management function. Presenting the award, Catherine Gonon quoted some judge feedback that praised the submission as a good presentation of a novel business model and a new service. Also worthy of mention, she said, are B Braun who submitted a strong nomination in this category as well.

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Best e-Business or IT Strategy

For this award, the judging panel took into account a number of factors when deliberating, including the effective deployment of the technology and its benefits to users. Exco InTouch received the award for its ATLAS short messaging service (SMS) technology for clinical trial applications and its submission based on the innovative integration of the ATLAS system with electronic data capture (EDC) technology, which enables pharmaceutical sponsors to quickly identify and contact potential clinical trial subjects, speeding up the recruitment process. ATLAS from Exco InTouch is also used within a number of clinical trials to improve patient retention and compliance. Using ATLAS, sponsors can send personalized text messages to subjects enrolled in a study, including clinic and medication reminders and motivational tips. This technology has been proven to increase retention and compliance by more than 20% and is currently being used by a number of pharmaceutical sponsors, patient recruitment agencies and CROs to drive better results from patients involved in clinical trials. "The judging panel was extremely impressed with the standard of entries for the 2008 awards," commented Kevin Robinson, Editorial Director, Via Media Ltd. "Exco InTouch's submission stood out as an innovative technology that provides real benefits to the pharmaceutical industry. Any solution that helps the patient, each and every day, as well as improves efficiency and data accuracy for the sponsor represents an extremely valuable combination. This kind of practical yet powerful technology is really unique and Exco InTouch is clearly very successful in capturing the imagination of the industry." Tim Davis, Co-Founder, Exco InTouch, added: "We are delighted that Exco InTouch has been presented with this industry honour. Patient communication through solutions such as SMS is an area of increasing technological growth with wide-ranging applications in the pharmaceutical industry. It offers unique benefits to sponsors in terms of facilitating clinical trials processes and it is extremely rewarding to see the industry recognizing the effectiveness and innovation of new technologies such as text messaging. Sponsors we are currently working with have vastly improved recruitment, retention and compliance within their clinical studies across a wide range of therapy areas and we are only just scratching the surface in terms of the potential applications and benefits to our clients."

Supply Chain Management

Sponsored by Pfizer, Inc., and introduced by Dr Makarand Jawadekar of Pfizer Global R&D, this award was presented to AstraZeneca and NYK Logistics for the nomination, "Benefits of Outsourced, Centralized pan-European Logistics Management or Creating a Blueprint for the Perfect Pharmaceutical Delivery." Described by one judge as "one of the most detailed and comprehensive nominations in the--albeit short--history of the EOA," Dr Kevin Robinson, Head of the Judging Panel added: "Amongst strong competition, the Supply Chain Management award nomination from NYK Logistics and AstraZeneca was a worthy winner on the night. Not only was the attention to detail and depth of the submission quite outstanding, what particularly impressed the judging panel was how this collaboration addressed the three principle cornerstones of cost, environmental responsibility and the maintenance of quality and security. This is a blueprint for pharmaceutical delivery that the drug manufacturing industry would do well to examine with care!" At an operational and cultural level, this is a genuinely collaborative buyer/supplier relationship based on the sponsor and supplier's shared commitment to achieving the original project objectives and continuous improvements and cost savings. NYK's ability to identify and exploit synergies between its pharmaceutical manufacturing customers' collection and delivery profiles and the willingness of AZ (and others) to embrace radical change, most significantly in the sharing of a pan-European transportation network with competing organizations, has the potential to deliver even greater cost and environmental benefits in the future and to create a blueprint for the 'perfect' pharmaceutical delivery based on maximum quality and security, optimum availability and minimum cost and environmental impact. Honorary mentions must go to both Kuhne + Nagel and Brecon who also submitted excellent applications in this category.

Best New Product

The successful entry in this category was part of the winning company's continuous efforts towards developing an innovative and effective tool to overcome the current challenges of the pharmaceutical industry regarding drug protection, delivery, promotion, and its distribution and delivery systems, known to them as the 5Cs (Counterfeiting, Compliance, Communication, Convenience and Cost). The project was to develop an innovative packaging system that could provide a single customized solution to all these 5C challenges. This was conceived in two stages: first, to develop a unique material and second, to couple this material innovation with creative designs to produce a smart packaging solution--with its own identity that cannot be duplicated. The award was presented to Bilcare Research for the nomination, "Innovative Blister Packaging Solution to Brand Challenges." The resulting material is a high barrier film with a unique metallic appearance, created in numerous shades and customized to individual brand and therapeutic sections. A specially designed blister pack, made using this material, is self-communicating and acts as an anticounterfeiting, promotional and protecting tool, which facilitates the safe and effective circulation of genuine brands, even by an uneducated end-user. Remaining on stage to present the final award, Dr Jawadekar commented that "Bilcare appear to be trying to change the mindset of companies with respect to packaging. This shows a long-term vision for the product and for their customers."

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Of Champagne Corks and Disappointment

When the stage had finally cleared, after an eternity of photography, Head of the Judging Panel and Via Media's Editorial Director, Dr Kevin Robinson, said of the competition: "The judging panel had a tough job this year. We received a record number of nominations and, overall, the quality was excellent. The EOA is establishing itself as a showcase for innovation and talent in the contract services sector. I'd like to sincerely thank all the companies who submitted an entry ... and all the judges for rigorously assessing them. We wouldn't have an event without them." Simon Jones, Managing Director of Via Media Ltd, added: "The EOA has become a prestigious occasion and a must-attend event for the outsourcing sector. We're very grateful for the support of our sponsors and partners, and we're very much looking forward to the next event in Madrid in 2009." The irrepressible Dr Mak summed up the evening and the event: "The European Outsourcing Awards, organized by Via Media Ltd, is now 3 years old and has become quite a 'household' name, almost synonymous with the Oscars of the contract services industry. The level of outsourcing being undertaken by life science companies--be they Big Pharma, SMEs or virtual organizations--has experienced a significant rise in recent years and, as such, the outsourcing sector is growing at a double digit rate. I sincerely believe that the peer recognition of companies at this forum brings the limelight on quality focused players who are ready to take on the pharmaceutical industry's outsourcing challenges of tomorrow! This exercise, in turn, benefits both sponsor companies as well as the service providers who take on these challenges." ICSE's Haf Cennydd, added: "In 2008, ICSE was yet again a partner in what was a great evening recognizing fantastic achievements in the outsourcing industry. Congratulations to all who entered and especially to those who won!" And, in closing, Event Director and Publisher of Pharma Magazine, Miranda Docherty, stated: "Since its launch in 2005, I'm delighted to have played an integral role in the growth and development of the European Outsourcing Awards. It gives me great pleasure to report that this year's event has been the best so far and the coming together of so many senior industry figures really highlights the networking value that the evening presents in addition to the Awards." See you in Madrid.

For more information

Miranda Docherty

Event Director

European Outsourcing Awards

Tel. +44 1372 471 542

miranda@via-medialtd.com

www.europeanoutsourcingawards.com
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Title Annotation:EOA review
Author:Robinson, Kevin
Publication:Pharma
Geographic Code:4EUGE
Date:Nov 1, 2008
Words:3829
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