The game changers: WPF awards 2013

MOST INFLUENTIAL REGULATORS

Dr Janet Woodcock – Director of the FDA's Center for Drug Evaluation and Research

Having spent 27 years with the FDA, Woodcock continues to build a fruitful career. The past year has been as busy as ever: with 35 new drugs approved in 2012, she has demonstrated that a commitment to safety need not be an impediment to innovation.

Of course, finding a balance between the two is at the very crux of her profession and Woodcock has always taken a staunchly scientific approach to the issues in hand.

"Regardless of which development or review programme we use, the FDA never compromises its safety or efficacy standards in exchange for rapid approval," she commented on the organisation's blog.

That said, with ever more biomedical data available, there is a newfound scope to detect drug efficacy early and, therefore, accelerate time frames. Last year, the FDA launched its Breakthrough Therapy drug programme, which gives priority to critical therapies for life-threatening diseases. By June 2013, 20 potential new treatments had been granted this 'Breakthrough Therapy' designation.

The FDA is always likely to face controversies. But, having spent so many years at the helm of the Centre for Drug Evaluation and Research, Woodcock has proven herself more than capable of riding out the storm. She was granted the top spot in World Pharmaceutical Frontiers' Pharma 40 power list 2012 and, as we move into 2014, her focus seems clear: ensuring that the regulatory framework is up to date and meticulously well designed.

Professor Guido Rasi – Executive director of the European Medicines Agency

Guido Rasi joined the European Medicines Agency (EMA) at a very challenging time - having been appointed in November 2011 at the height of the eurozone crisis.

Despite contending with budget restrictions, the agency was gearing up for a raft of legislative changes that would
cover everything from pharmacovigilance right through to veterinary medicine.

Two years on, Rasi has made his presence felt. He has set out ambitious plans for the industry, drawing on his background as a scientist to rethink the role of medicines in public health. What's more, he has firmly endorsed the idea that clinical data should be made publicly available, thus staking his position in a key industry debate.

"We are not here to decide if we publish clinical trial data, but how," he said at an EMA seminar towards the end of 2012.

At present, he is overseeing a shake-up in the agency's operating structure. By the close of 2014, the EMA will be divided into four key areas: R&D, medicines evaluation, business support and inspections/pharmacovigilance.

This new divisional structure is intended to be 'future proof'. In Rasi's words, it "will enable us to use our resources more efficiently and effectively", ensuring the agency "is better prepared for future legislative and policy changes" as they arise.

TOP PHILANTHROPISTS

Bill and Melinda Gates

Six years after taking the top spot in our 2007 Pharma 40, the Bill and Melinda Gates Foundation remains unsurpassed in its commitment to egalitarian healthcare. Driven by the passions of its founders, the foundation aims to enhance public health across the globe and places a particular emphasis on developing countries. It is the largest transparently operated private foundation in the world.

Over the years, Bill Gates has worked with various significant pharmaceutical players to develop an array of vaccines and drugs. He has collaborated with the likes of Merck and Pfizer, and most notably supported GlaxoSmithKline in the creation of a malaria vaccine. Pending an EMA licence, the vaccine is set to be introduced as soon as 2015.

One of the foundation's highest-profile undertakings is a project targeting ten neglected tropical diseases. Aiming to control conditions such as schistosomiasis and river blindness, this project is structured around the World Health Organization's 2020 goals. It is unusual in its spirit of collaboration: Gates has brought together 13 pharma CEOs, alongside WHO's director-general Margaret Chan, and has pledged $363 million to the cause.

The Gates brand of 'philanthrocapitalism' has proven to be an abiding business model. Currently spending more on global health than the WHO, the foundation applies Microsoft-style business strategies to charitable activities. And while this model has come under scrutiny, it is a reality of our times that many ventures cannot function without private support.

Bill, Hillary and Chelsea Clinton

Formerly the Clinton Foundation, the Bill, Hillary and Chelsea Clinton Foundation was renamed this year to reflect the contributions of all three family members. Founded in 2001, it endeavours to help people "meet the challenges of global interdependence". In real terms, this has meant the creation of programmes such as the Clinton Health Access Initiative (CHAI), which improves access to care for those with HIV/AIDS, tuberculosis and malaria throughout the developing world.

A major focus has been reducing cost: since its launch in 2002, CHAI has negotiated price reductions for drugs and diagnostics, as well as customising products towards resource-limited settings. The initiative has brokered deals with various generic pharma companies, supporting their efforts to provide cheap AIDS drugs to countries in need. It works on the premise that the cost of treating HIV patients is far lower than commonly believed.

The foundation has also partnered with the IKEA Foundation to reduce diarrhoea deaths in Kenya and India - having committed $24 million, it aims to save 40,000 children's lives by 2015.

This is part of a coordinated global effort to combat child mortality by scaling up the use of zinc and oral rehydration salts. While inexpensive and effective, the treatment is not currently widely used. Perhaps the defining feature of these efforts is that they are not stand-alone programmes - rather, the foundation works in partnership with governments and pharmaceutical companies to improve healthcare provisions. With its eclectic range of donors and far-reaching focus, it has consistently demonstrated what can happen when resources are savvily deployed.

BEST BUSINESS LEADERS

Ian Read – CEO and chairman of Pfizer

As the CEO and chairman of the world's largest pharma company, it might be said that Ian Read has his work cut out for him. In truth, he has proven himself equal to the task. Joining Pfizer in 1978, the Scottish-born executive reached the top rung in December 2010 and has since guided the company through a clear change in direction.

Read's time at the top has been marked by organisational restructuring. First, the company sold its nutrition unit and animal health business, and then, in July this year, Read announced he would shake up its internal operations.

From January 2014, Pfizer will be divided into three units: two for 'innovative' drugs, of which the patents are yet to expire and another for 'value products' that have already gone generic (or will do so before 2015). This move provides the opportunity for a tighter focus within each unit, as well as being notably investor-friendly. It is expected to pave the way for a wholesale split in 2017.

The company has faced challenges in recent years - the patent loss of Lipitor hit it hard, and two new drugs (the blood thinner Eliquis and rheumatoid arthritis pill Xeljanz) have only compensated in part. In spite of this, Read has shown himself to be a strong and decisive leader during a turbulent time. No surprises that in September 2013, he was appointed as a member of the President's Export Council.

Robert Bradway – CEO and chairman of Amgen

This has been quite a year for Amgen's new boss. Replacing Kevin Sharer, former COO Robert Bradway became CEO in May 2012 and chairman in January 2013. Since then, he has made impressive inroads at the world's largest biotech firm.

As well as beating sales expectations and increasing the share dividend, Bradway has overseen the purchase of two companies - Icelandic genomics pioneer deCODE Genetics and US-based Onyx Pharmaceuticals. The latter deal, at $125 a share or $10.4 billion total, was widely billed 'the buyout of the summer'.

Both acquisitions are key to Bradway's strategy, helpinghim fill up Amgen's sorely depleted pipeline. He has expressed confidence that the company will accelerate growth for shareholders - particularly crucial given dwindling sales forthe company's key anaemia drugs.

Like many other pharma leaders, Bradway has also turned his focus to the Asian market. The company recently announced that it is setting up a new research centre at ShanghaiTech University, which looks set to become fully operational in 2014. This strategic partnership will aid the advancement of translational research in China, and cap off a year of Asian expansion for Amgen. Other initiatives have included an agreement with Zheijang Beta Pharma to commercialise a cancer drug.

Having wasted no time in making changes, Bradway is surely one to watch in the years ahead.

INNOVATORS TO WATCH

Francis Collins – Director of the US National Institutes of Health

A sure-fire contender for any lifetime achievement award, the director of the National Institutes of Health (NIH) is best known for sequencing the human genome (he headed the Human Genome Project from 1993).

Since resigning from the Human Genome Research Initiative in 2008, Collins was announced as NIH director in 2009. As well as endeavouring to improve the nation's healthcare infrastructure, he has supported research into Alzheimer's disease and advocated for the privacy of genetic information. Currently, he is working on the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative to develop brain-mapping technologies.

Collins' core achievement may be the National Centre for Advancing Translational Sciences, which was established at his behest in December 2011. This is intended to plug the gap between science in the lab and science in action, accelerating the pace that medical discoveries are translated into new drugs. "Patients suffering from debilitating and life-threatening diseases do not have the luxury to wait the 13 years it currently takes to translate new scientific discoveries into treatments that could save or improve the quality of their lives," Collins declared at the time.

Two years down the line, we are already seeing faster pipelines based on personalised medicine, thus bringing his genomics research full circle.

Eric Lander – Director of MIT's Broad Institute

In February 2013, Eric Lander became one of the first winners of the Breakthrough Prize in Life Sciences, seeing his achievements honoured to the tune of $3 million. If this sounds like a lot of money, it is worth remembering that Lander is one of the key driving forces behind the emerging field of personalised medicine.

Along with Frances Collins, Lander led the Human Genome Project and has gone on to apply genomic understanding to physiology and disease. Since 2003, he has headed up the Broad Institute at the Massachusetts Institute of Technology. A biomedical and genomic research centre, its stated goal is to "create tools for genomic medicine and make them broadly available to the scientific community; to apply these tools to propel the understanding and treatment of disease".

Most recently, the Broad Institute has entered into a strategic partnership with Bayer Healthcare. Together, the two parties are hoping to discover and develop therapeutic agents that selectively target cancer genome alterations. Beginning in September 2013, the project will run over the course of five years.

Alongside his work at MIT, Lander co-chairs US President Obama's Council of Advisors on Science and Technology and has amassed eight honorary doctorates. As oncogenomics advances further - with targeted drugs to match - his latest award may come to seem thoroughly well deserved.