Shire plc

Shire's winning formula

Highly-skilled and dedicated people, working together across functions and on a global basis, to develop and market specialty pharmaceuticals that fill unmet medical needs.

These, in a nutshell, are the qualities that make Shire one of the fastest growing specialty companies in today's pharmaceutical industry.

'Shire is a very dynamic organization,' says Barbara Deptula, Shire's Executive Vice President, Business Development. 'It's like a small start-up entrepreneurial company but has all the infrastructure, support and people of a large company. In this kind of environment, everyone can contribute to the success of the organization, which is very appealing to me.'

'Shire's adoption of a global operating structure, with cross-functional teams dedicated to developing and marketing products in core therapeutic areas, gives it a competitive edge in today's complex pharmaceutical market,' adds Dr Eliseo Salinas, Chief Scientific Officer and Executive Vice President, Global R&D. 'While drug development is a global task, customers in regional markets can be very different,' he notes. 'Our structure ensures we stay close to our customers and understand regional specificities, with their commercial and economic realities, allowing for a good integration of basic science and medical needs.'

Ms Deptula, a pharmacist and MBA in finance, has 20 years of pharmaceutical experience in commercial and business development. Since joining Shire in September 2004, she has been developing a Company-wide, streamlined business development process. 'We are now able more effectively to identify, evaluate and act on product ideas and opportunities, including partnerships, which will contribute to our growth. We can react expeditiously and with an entrepreneurial spirit.'

Ms Deptula heads a team which is based both in the UK and US and is composed of highly experienced and dedicated professionals with both scientific and business backgrounds. Business development efforts are coordinated throughout the Company, with ideas and contacts gained from individuals across the organization. 'Shire's interdisciplinary structure allows integrating the specific technical and scientific input brought by each function into a coherent plan that helps meet long-term corporate objectives,' she notes.

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Replenishing Shire's pipeline

Shire's Business Development team is firmly committed to expanding and constantly replenishing Shire's product pipeline. Accordingly, it is on the lookout for in-licensing opportunities for new products essentially in Phase 2 or 3 with robust intellectual property that offer a strategic fit with Shire's current business and allow for use of the Company's expanding specialty sales force. 'We seek product-oriented deals that would add value to a targeted audience of specialist physicians and their patients. There are literally thousands of opportunities in the market and it's important that we maintain a focus and prioritize them,' says Ms Deptula. Her team's biggest transaction to date is the acquisition of US biopharmaceutical company TKT. 'It was a very exciting process and a great opportunity for Shire. It allows us to move into a new direction while still ticking all our strategic boxes.'

Dr Salinas, a Psychiatrist with a Master's Degree in Pharmacology and 15 years of industry experience, says Shire's model of searching and developing lower-risk products is what attracted him to join the Company in 2004. 'We are focusing on searching and developing molecules intended for the specialist, where the added medical value of the compound is more important than marketing muscle. This approach is good for our business and for society as a whole.'

Over the past 24 months, Dr Salinas says, Shire has delivered on its promises while drastically transforming the way it operates its business. 'Management has done exactly what it said it would do: divest non-core businesses to reinvest freed-up resources in the core ones. In R&D, this has translated into applying additional resources, defining new processes to increase efficiency and reliability, and increasing the ownership and control of our data while still relying on outside vendors.'

Dr Salinas notes that Shire has decided to concentrate on the core areas of CNS, GI and General Products (GP) such as renal therapies, each led by dedicated Strategic Therapeutic Area Teams (STATs). In addition, with the acquisition of TKT, Shire has a new biologics business bringing exciting new products to its portfolio. The Shire HGT business is managed by Dr David Pendergast. Shire has very interesting compounds under development in these areas and managing the lifecycle of its current portfolio will be important. 'At the same time, we are actively supporting the search for new molecules, including some outside these areas on an opportunistic basis as long as they meet our risk criteria.'

Both Ms Deptula and Dr Salinas say Shire's biggest trump card is the quality and talent of its people, who share a strong entrepreneurial spirit and are highly motivated. 'Shire has a 'can do' culture based on an exceptional level of competence, experience, creativity and above all, energy. This is what makes us unique and destined for success.'

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Supporting a global vision

In today's pharmaceutical industry, bringing the right products to market in a timely manner is a critical challenge, requiring expert knowledge of complex regulatory requirements and a highly focused commercialization strategy. For a global Company such as Shire, this challenge is heightened by the need to gain new product approvals from dozens of regulatory bodies worldwide while managing hundreds of existing product licences and ensuring all products efficiently reach their target customers.

At Shire, these vital tasks are overseen by STATs responsible for the Company's core businesses: CNS, GI and GP and a Global Regulatory Affairs Group.

Mike Cola, Executive Vice President, Global Therapeutic Area, says his job is to build on this work by leveraging the Company's global resources and developing strategies to ensure approved products get to the patients who need them. 'The essence of a great company is a culture of commitment, excellence and discipline. The aim is to focus on your customers and provide them with the best products and services in the industry. Physicians tell us what they need and our role is to come up with the answers, ' he says. 'To provide this level of service the key is to build an effective link between product development and marketing to ensure successful delivery. In order to do that you need to further strengthen the connection between the Company's STATs and functional units, building a matrix that enables Shire people to work together toward well-defined and measurable goals.'

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Aligning the global effort

Mr Cola who joined Shire in mid-2005 with a wealth of pharmaceutical industry and business experience gained at companies such as AstraMerck, AstraZeneca and Safeguard Scientifics, says he's also very excited about the caliber of Shire's people.

'Shire has already taken many of the steps necessary to establish itself as a truly multi-product, multi-therapeutic, global organization,' he notes. 'It now is moving to the next tier, perfecting its business model, introducing truly global products such as FOSRENOL, ELAPRASE and MESAVANCE, and becoming the best specialty pharmaceutical Company in the world with the most dedicated employees to achieve this goal. Companies always like to talk about the future being bright. Here, we can use that phrase with absolute conviction.'

'Our regulatory experts on both sides of the Atlantic work closely with all the STATs, our R&D and manufacturing colleagues and worldwide regulatory agencies to ensure the successful registration and commercialization of Shire's new and existing products,' explains Doug Hay, Shire's Senior Vice President, Global Regulatory Affairs. 'Their role is proactively to identify and address regulatory challenges to minimize potential delays in product approvals and optimize approved labelling.'

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Building relationships and trust

Regulatory approvals have been complicated in recent years by increasing agency scrutiny on drug safety and effectiveness relative to standards of care. With regard to safety, regulatory agencies worldwide are seeking greater assurance that a drug is not associated with adverse events that may not be detected in clinical trials. In addition, many agencies are requiring more definitive data concerning a drug's effectiveness in comparison to approved therapies. 'We work closely with our R&D colleagues, strategic and commercial teams, as well as manufacturing, to optimize development programs and their documentation for each registration dossier,' says Dr Hay. 'Externally, this requires more frequent communication and meetings with regulatory agencies and the building of stronger professional relationships, broader respect and trust.'

Shire boasts a dedicated, experienced and talented team of regulatory professionals who are highly knowledgeable about regional regulatory requirements and accountable for achieving results. 'We have a regulatory group with the competence, expertise and capabilities that are far beyond those normally expected of a company our size,' says Dr Hay.

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