Eyes on the Prize

Karen Gotting-Smith tells NGP how AstraZeneca stays fighting fit in difficult times.

“We aim o produce two new medicines a year”
-Karen Gotting-Smith, AstraZeneca

No one can deny that these are challenging times for the pharmaceutical industry. With patents running out and new blockbusters thin on the ground – and now the well-publicized financial downturn on top of that – there is a certain amount of pessimism among industry leaders.

The key, according to Karen Gotting-Smith, is not to rest on your laurels. As Vice President of Business Performance and Continuous Improvement at AstraZeneca, Gotting-Smith should know whereof she speaks. The company has set some ambitious goals for its pharmaceutical R&D, despite – or perhaps because of – the current climate.

These goals include achieving a median eight-year product development cycle for small molecule medicines and biologics by 2010, and delivering two new molecular entity (NME) launches per year from 2010. In order to achieve these target NME launches per year, AstraZeneca will need to ensure that it has 10 or more NMEs in phase III development by that time.

This shouldn’t be too much of a problem for a company that has been awarded R&D Directions’ ‘Best Early Stage Pipeline’ in the industry for the second year in a row. What strategy does the company use to achieve this? “Our pipeline has continued to be based on our disease area strategies,” says Gotting-Smith.

“We aim to deliver a volume of products across all phases of development that will enable us to produce those two new medicines a year. Key milestones have included the increase in projects entering early development – 24 new candidate drugs in 2007 compared with 12 in 2006; as well as the increase in late stage development –12 phase III projects currently compared with five in 2006.”

Gotting-Smith’s new role as Vice President of Business Performance and Continuous Improvement, which she assumed in April 2008, has a pan-development focus, with aim of aligning all of the development function’s improvement initiatives with the company’s business goals. She is also in charge of reducing development cycle times, reducing overall costs and increasing quality.

A tall order, perhaps, but then Gotting-Smith has the experience to back it up: she has worked in global drug development for more than 20 years, on drug development projects across different disease areas in a range of roles with increasing responsibilities. “I’ve worked across all stages of development, from early development to regulatory submissions and life cycle management, plus line management experience in an organization of more than a thousand employees, and the breadth and depth of knowledge from ground level activities through to business level investment decisions have prepared me well for my current role. The ability to identify and communicate the business goals and to challenge the status quo is fundamental to the role.”

She also finds it relatively easy to take a global outlook, having studied in Wales, and worked on registration programs in the US, Europe and Asia. “The benefit of global working and living in different cultures has been the ability to re-energize regularly through having to adapt to the new culture and importantly through never taking anything for granted. This has given me an appreciation for diverse ways of thinking that I may not have otherwise gained. Though after a decade of living in the US and with two very American children, it is certainly home to us as a family now,” she says, laughing.

The need for speed

AstraZeneca remains focused on improving R&D speed while maintaining high levels of quality. But why is it important to speed up the R&D process and – more importantly – how will it go about achieving this lofty goal?

“Companies like AstraZeneca must improve R&D speed and quality both for the patients who depend on our next successful medicine and for our business, which needs an ongoing flow of new products delivered cost-effectively,” maintains Gotting-Smith. “The promise of science and technology is greater today than ever before, and if we both maximize and marry the two, we can be one of the fastest and most productive companies in the industry.

“Meeting the goal of two NMEs a year from 2010 has required an industry-leading approach to our portfolio management, a series of disease area strategies that are medically and commercially attractive, a strong internal and external science base and an innovative and efficient delivery organization. Our focus in each of these areas will continue so that we can continue to deliver innovative new medicines.

“Over recent years we have introduced a process improvement system based around the principles of Lean Sigma, which has significantly reduced project timelines and increased the quality and efficiency of our drug discovery and early development programs.”

Another trend driving change in AstraZeneca’s R&D is the current industry focus on translational medicine, as Gotting-Smith explains: “The collaboration between clinical medicine and basic science is critical to gain a deep understanding of human diseases, therapeutic targets and the suitability of future medicines. We’ve recruited and developed new skills in the field of translational medicine, focused on the development of biomarkers for our compounds, so that all compounds entering development now have a biomarker strategy. We’ve also developed new techniques and technologies around informatics and modelling and simulation. The adoption of these new approaches in drug discovery and development tie in with the increased quality of our candidate drugs.”

Top job

Fast, efficient pipelines along are not enough to keep a company afloat in difficult times – it’s equally important to look after your staff. AstraZeneca was identified as one of the ‘100 Best Companies to Work For’ 2008 by Fortune magazine. What is it about the company that makes it stand out?

“Multiple factors play a role in making a company a ‘best place to work,’” Gotting-Smith says. “From an R&D perspective, my belief is that we joined the industry to work in important disease areas and to have an impact on bringing medicines to patients, and we have been able to fulfill that goal.

“We foster a working environment that shapes leadership at all levels, encourages the exchange of diverse ideas and an appreciation of delivery and value. The company demonstrates respect for its employees both in and outside of work by providing flexible options like a nearby childcare facility, employee wellness programs and flexible working arrangements such as job-shares.”

As Gotting-Smith points out, the company’s continued success requires access to leading science both within AstraZeneca and through external alliances around the globe. “Our ability to develop our products efficiently, in terms of cost and speed, will continue to improve as well as our flexibility in adapting to an evolving external environment.” No matter how challenging that external environment gets.

Karen Gotting-Smith is Vice President of Business Performance and Continuous Improvement at AstraZeneca . In her previous position as Vice President of Clinical Development, Gotting-Smith was responsible for the US clinical development region, one of three regions within AstraZeneca responsible for the design and delivery of clinical development programs. She has more than 20 years of experience in global drug development both in clinical development and global leadership of cross-functional product teams.

AstraZeneca’s Global R&D focus areas

• Cancer

Need: Cancer now accounts for 7.6 million (or 13 percent) of all deaths worldwide each year, and these numbers are expected rise.

Global Focus: Continued growth of Arimidex, further launches and line extensions of newer products such as Faslodex, and the successful introduction of novel therapeutic approaches currently in development, including both small molecule and biological drugs.

• Cardiovascular

Need: CV disease claims more lives each year than the next four leading causes of death combined, accounting for 17 million deaths worldwide annually.

Global Focus: Growth areas of dyslipidaemia, thrombosis, type 2 diabetes/obesity, atherosclerosis and atrial fibrillation.

• Gastrointestinal

Need: In the Western World, between 10 and 20% of adults suffer from gastresophageal reflux disease (GERD). The prevalence rate of GERD in Asia is lower but increasing.

Global Focus: Life cycle initiatives for Nexium to gain further market penetration by broadening its use, coupled with innovative research and development of new therapies for GERD beyond acid expression.

• Infection

Need: World demand for antibacterial antibiotics remains high, due to escalating resistance and the increased risk of serious infections in both immuno-suppressed patients and ageing populations.

Global Focus: Increasing the sales of the marketed brands Synagis, Merrem and Flumist and bringing new products to market by exploiting its structural and genomic-based discovery technologies and antibody platforms.

• Neuroscience

Need: Depression and anxiety disorders remain under-diagnosed and under-treated; schizophrenia affects around 1% of the population; 17 million people suffer from bipolar disorder; Alzheimer’s disease affects approximately 24 million people worldwide today; and chronic pain affects over 20%.

Global Focus: Further growth of the Seroquel franchise and the successful introduction of a range of life-changing medicines aiming to meet significant medical need in pain control, neurology and psychiatry.

• Respiratory and inflammation

Need: Approximately 100 million people worldwide suffer from asthma and more than twice that from chronic obstructive pulmonary disease (COPD), which is currently the fifth leading cause of death in the world.

Global Focus: Growth of key products, particularly Symbicort, new indications and market launches and the successful introduction of novel approaches to other areas of inflammatory disease such as COPD and rheumatology.

Recent partnerships

Albireo – February 2008
AstraZeneca and Nomura Phase4 Ventures announced the signing of a deal to form Albireo, a company focused on developing new treatments for gastrointestinal (GI) disorders.

Albireo, based in Gothenburg, Sweden, has secured one clinical and a number of pre-clinical GI programmes from AstraZeneca as well as several researchers with extensive experience in AstraZeneca’s GI Research Area. The spinout is a result of AstraZeneca’s previously announced strategic decision to concentrate on Nexium and internal GI research focussed on gastroesophageal reflux disease (GERD).

Cancer Research UK – May 2008
AstraZeneca entered into an innovative new arrangement with Cancer Research UK and Cancer Research Technology (CRT) – the charity’s development and commercialisation arm – to progress into clinical development a potential anti-cancer compound from AstraZeneca.

AstraZeneca’s AZD0424 – a tyrosine kinase inhibitor – is the first drug to enter the charity’s clinical development partnerships (CDP) programme, which enables companies to retain rights to the compound throughout the development programme. The compound is expected to enter phase I trials within the next 18 months.