2012 Pharma 40

Now in its sixth year, the Pharma 40 continues to map the most influential people in the diverse and innovative pharmaceuticals and biotechnology industry. The last 12 months have proved to be some of the most difficult in recent history; in fact, the last five years have been extremely challenging.

Expiring patents, increased regulation, falling revenues, job losses and reductions in spending have all had an impact on the pharmaceutical sector. Cuts to funding have defined the last 12 months, whether they are the result of pharma itself or governments looking to slash their deficits. But how would they play out in the list this year and what do today's concerns mean for the next 12 months?

Our judges share their thoughts and identify the finalists they feel are the 'ones to watch' over the next year, those potentially making a significant contribution. You may be surprised by our judges' final ranking but, rest assured, there is a lot to absorb and even more to talk about. In this year's final rundown, we give you an insight into the way the judges viewed the contenders and their potential contributions over the coming months. So enjoy, and remember if you have a view, email the editor at andrew.tunnicliffe@progressivedigitalmedia.com.

Our judges

• Michael Santoro, Rutgers Business School
• Agnes Klein, Health Canada
• Ed Silverman, pharmaceutical journalist
• John Rhodes, Deloitte
• Andrew Tunnicliffe, World Pharmaceutical Frontiers

1. Dr Janet Woodcock

Woodcock was judged by our panel to be worthy of the top spot in 2012 having worked within pharma and regulation for the past 25 years, enjoying a distinguished career in the field. The regulator has come in for criticism in recent months for taking too long to approve new medications; however, she threw the concerns back, arguing that manufacturers needed to put the initial groundwork in and provide all the required information at the first time of asking. Our judges said Woodcock was a strong leader who balanced the pace of drug approvals with patient safety. "She remains a strong voice for the FDA and regulatory world due to her vast experience of both the science and the regulation behind the FDA," said Agnes Klein.

2. President Barack Obama

Having claimed the number one spot back in 2009, the coming 12 months could be defining for his presidency and the global healthcare sector. He is facing a considerable political battle as he continues to push his healthcare reform plans on Capitol Hill, and in the face of growing disquiet among his peers and wider society; however, our judges felt that whatever the outcome, his influence will be crucial.

3. Sir Andrew Witty

Recently knighted for his service to the UK economy and specifically pharmaceuticals, Witty remains in the post he took up in 2008. The economic downturn was one of the biggest challenges to face the sector, which led him to raise concerns about the eurozone crisis, price cuts and discounts. In his capacity as EFPIA president, Witty said that the pressure on innovation was now "immense", and called for a review of pricing and reimbursement practices in Europe. The judges also applauded his leadership of GSK.

4. Margaret Hamburg

Hamburg has been US FDA commissioner for three years, offering a "consistent and steady" focus to improve safety, according to the judges. The agency was recently criticised because of delays in the approvals process. In answer, it announced recommendations to introduce additional user fees. Hamburg said their introduction would allow the agency to speed up what had become an increasingly complex process, partly because of the nature and rising number of generics and biosimilar biological products.

5. David Cameron

The challenges facing the UK's prime minister are unlike any other. He has set out his stall for the UK to become an innovation hub in science. At the FT Global Pharmaceutical & Biotechnology Conference 2011, Cameron hinted that the government would look to make the UK's £50 billion pharmaceutical sector more competitive in the hope of attracting further inward investment. He said that funding would be allocated to develop innovation centres and that there would be tax breaks. But our judges were worried about whether he could bring it to fruition.

6. Lamberto Andreotti

Andreotti was applauded by the panel for his leadership since becoming Bristol-Myers Squibb CEO two years ago. He is taking an aggressive, hands-on approach, turning the company's direction to pharma. "Focusing 100% on pharma is a brave move, with lots of potential risk and reward," said Michael Santoro. John Rhodes said he felt that Andreotti had a strong vision of transforming and executing the biopharma transition.

7. Bill and Melinda Gates

Supporting the Gateses' high ranking yet again, Klein said the work of the 2007 winners continues to be a "powerful influence" in the world of research and in building capacity in developing countries. "The funds administered by the foundation are generous with rigorous and strict accountability," she added. Santoro said that the Gateses had "shown a deep commitment over time to egalitarian healthcare".

8. Kathleen Sebelius

Sebelius has held the position of US secretary for health and human services during a particularly challenging time for the department, which included one of its biggest moves, taking the unprecedented step of overruling an FDA decision on Teva's Plan B. Santoro said: "Secretary Sebelius certainly does not shy away from strong and sometimes controversial decisions."

9. Francis Collins

Having led the Human Genome Project, overseeing the federal government's race to map people's DNA, Collins has set himself the goal of guiding the agency to use science to improve the nation's health and its healthcare infrastructure. Klein said that the high hopes for Collins were starting to be realised, adding: "With the creation of the Transitional Institute, he could be in the top five on this list next year."

10. Dr Margaret Chan

Coming in at number four in the last Pharma 40, Chan has slipped down the order in 2012. But her influence is still highly regarded by our judges. Santoro said that she "continued to grow as a global health leader", while Rhodes welcomed her coordinated leadership, bringing focus to global healthcare needs and trends.

11. Professor Guido Rasi

Relatively new to the role of EMA executive director, Rasi has already outlined his plans for the agency. While Klein believes there is reason to be hopeful, Santoro warns that the economic woes of the EU will place Rasi at the "centre of this unfolding drama". Klein said: "As each new executive director arrives, it is useful to ensure they are given visibility to help them in their task. The promise is high, but fulfilment remains to be seen."

12. Sir Michael Rawlins

Rawlins' role with NICE is highly regarded and crucial in the UK, but the organisation's ability to influence international standards is unclear. Having been a leading light in the global approvals framework, recent big decisions taken by other regulators have grabbed more of the headlines. Klein questioned whether the ranking of Rawlins, and ultimately NICE, could improve, stating that although technology assessment was important, is the influence of NICE important enough to rank higher? Santoro, however, offered some support saying: "Getting domestic drug policy right is necessary to keep the UK innovative. If the UK system won't support innovation, who will?"

13. Harold Varmus

Having already instigated initiatives towards reorganizing the US National Cancer Institute, Varmus has identified goals or 'shared ambitions' that he hopes it can achieve in the coming months.

14. Ian Read

Pfizer has seen huge growth in recent years, aided by a number of 'megadeals', but Read has said he is looking for smaller deals and research partnerships as he restructures the company and continues its push to be a leader in vaccines and biologic drugs.

15. Thomas Abrams

The past year has been noteworthy for the number of record fines for off-label marketing. Abrams' office, along with the Justice Department, was critical in the effort to curb the illegal promotion of medicine. "A job well done," said Klein. Santoro added: "The rules of the road for marketing drugs to doctors and the public in the US are changing dramatically, and Abrams is behind many of those changes."

16. Chris Viehbacher

The positioning of Viehbacher on this year's list raised a difference of opinion among the judges. One said that Sanofi Aventis's recent round of acquisitions attests to Viehbacher's vision of looking for a "string of pearls"; another said it seemed that the M&A strategy at the French drugmaker was "unfocused". But both agreed that his next moves would be interesting.

17. Miles D White

Abbott is in a transitional period having ended some of its partnerships to prioritise other areas of its portfolio, as well as a major restructuring programme that will see the company divide its research unit from its nutrition, diagnostic and generic drug business, which, according to Klein, will raise the profile of Abbott's R&D activities.

18. Shao Mingli

"The world has a big stake in effective Chinese regulation of the manufacturing pipeline," said Santoro. Counterfeit products remain a major challenge for China, both domestically and on the international market, but Mingli's efforts were "praiseworthy", according to Klein. Mingli has been in the post since 2007, working towards greater regulations and a more transparent pharma industry. Pharmaceuticals is one of China 's leading sectors and continues to grow at pace.

19. Dietmar Hopp

A notable absentee last year, Hopp is back on the list. While one judge said that it was amazing to think that private equity was today big enough to replace traditional government funding, another warned that the "vagaries of global finance" could erode his influence. Was this what influenced his absence from last year's list?

20. Elliott Sigal

According to Rhodes, Sigal's work was "reshaping the company's biopharma strategy" and helping to bring new medicines to market in some of the most underdeveloped regions. Klein said that his efforts were "paying off". In the coming months, Sigal will also be sharing the role of senior vice-president of strategy, alliances and transactions following the recent departure of Jeremy Levin.

21. Angela Merkel

Merkel is "in many ways the most dynamic global politician dealing with economic issues", said Santoro. Last year, the German pharmaceutical industry faced a $2.7 billion bill by way of price cuts as a result of AMNOG. AstraZeneca's Brilinta became the first to gain approval under the reforms; however, the country's robust regulatory structure has already slowed down the introduction of novel drugs has caused some pharma manufacturers considerable difficulty in getting products approved.

22. Eric Green

The National Human Genome Research Institute has recently announced that it is shifting funds from large-scale sequencing projects to studies of potential clinical applications of sequencing and translational projects, something that Klein said meant that the organisation was "headed in the right direction". It is now widely accepted that human genomics will be a big part of the future of pharmaceuticals as research continues to have medication that will be targeted for individuals with specific genetic make-up.

23. John Castellani

Said to be "the most influential chief executive lobbying group in the US" by the Financial Times, Castellani and PhRMA face a big year. Among the issues is the doc-payment disclosure rules currently open for public comment, the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act. Klein urged him to continue to maintain the influence of PhRMA: "If he does, it will strengthen the industry, again."

24. Jeremy Levin

This veteran of the pharmaceutical industry will take the helm of Teva Pharmaceuticals in May 2012, becoming the first non-Israeli to hold the post. A falling share price and the loss of patent on Copaxone are all challenges that Levin faces from the outset, but, says Klein, he is up to the task of steadying the ship.

25. Eric Lander

Described as one of the driving forces behind today's revolution in genomics, Lander has helped advance the realisation of personalised medicine through the Human Genome Research Project. Santoro said he remains a "key driver of research and innovation". Klein added: "Personalised medicine is coming into its own, hence the influence and knowledge of someone like Lander is continuously felt."

26. Dr John Lechleiter

Lechleiter has taken a different approach in the face of a tough market, simply warning investors not to expect growth until at least 2014 rather than seek large-scale M&As. He said the Eli Lilly has been planning for this difficult period and has restructured and invested in R&D, which has already led to new molecules. Lechleiter will also take up the post of PhRMA chairman, giving him an even louder voice in Washington, with healthcare reform still a major issue.

27. Dr David Brennan

AstraZeneca is believed to be on the hunt for new drugs as it prepares to lose patents on a number of products in its portfolio; however, the company has established a new research team, the Science and Technology Integration Office, to seek out partnerships with governments, academia, business and charities, but Santoro wonders if this model will lead to new discovery pathways. "Much will depend on the implementation," he said.

28. Margaret E O'Kane

Although she slipped from 20th in 2011, O'Kane is still a "visionary in managing the focus on quality through challenging times", according to Rhodes. Klein said that her influence will continue to be important, "especially in this time of escalating costs for drugs".

29. Andrew Lansley

Lansley has committed to ending the drugs 'postcode lottery' in the UK, saying that NHS trusts must accept decisions made by NICE and make drugs available without exception. This, as well as a push to promote pharma within the UK and attract investment, means that 2012 will be hugely interesting. Lansley also faces a battle over NHS reform that has led many to question if it will pass, or even if he will be in his post to see it through.

30. Joe Jimenez

Jimenez's appointment as Novartis CEO was seen by some industry watchers as a move towards helping contain costs. The company has announced thousands of job losses globally as it battles patent expirations on some of its leading drugs, and the overhaul of its General Medicines business, which is set to take hold later this year; however, said Klein, his true influence is yet to be seen.

31. Robert Bradway

Bradway will move into the post of CEO and later as chairman of Amgen, the world's largest biotech company, when Kevin Sharer retires towards the end of 2012. He has already indicated that the company will continue to look for sales growth. Sharer had his critics, but the company has seen exceptional growth - what will Bradway do to make his mark?

32. Jane Chin

The MSL Institute was founded by Chin in 2004 to highlight ethical and legal/compliance issues around the pharmaceutical industry, and its use of medical science liaisons. It aims to look at how companies can efficiently use the MSL role to appropriately respond to unsolicited drug information requests, and reduce the risks of off-label promotion. Regarded as an innovative approach, our judges feel that Chin and the institute are "ones to watch".

33. Fiona Godlee

The introduction of Godlee to the list in 2012 is perhaps one of the most interesting entrants. After 15 years in medical publishing, she was appointed British Medical Journal editor in chief in 2005. Klein said that Godlee is a woman of influence in a world where "there are too few".

34. Dr Marijn Dekkers

In just one year, Dekkers has instigated initiatives that, he argues, will change Bayer's strategic direction, including a cost-cutting regime that reduced its employees globally. At the end of 2011, the company said it had four drugs with the potential to be blockbusters; however, Dekkers' approach split opinion among judges, with one warning that if his approach failed, it could do so in "spectacular fashion".

35. Brian Druker

As oncologist at the Howard Hughes Medical Institute, Druker has revolutionised the treatment of cancer through research to develop Gleevec, the first drug to target the genetic defects of a particular cancer while leaving healthy cells unharmed. Rhodes described him as a "talented scientist", while Santoro said Gleevec was one of the few "miracle drugs" the industry has been able to deliver in recent years.

36. Severin Schwan

The first challenge that Schwan will face this year is an accusation that his company withheld clinical data on Tamiflu. Roche has denied the claims, but it remains to be seen how this case will evolve and what the wider implications will be for the company. However, Rhodes applauded Schwan's "strong leadership around a vast portfolio of healthcare business".

37. Dr Chen Zhu

The Chinese pharmaceutical sector has been described by some as 'exploding', but healthcare provision in the country falls far behind that of developed economies. Santoro said that "Zhu is leading dramatic structural reforms that make Obama's look like a modest incremental adjustment".

38. Professor Shinya Yamanaka

Yamanaka is known for his work on induced pluripotent stem cells, and having received the Robert Koch Prize and the Shaw Prize.

39. Professor Bruce Beutler

Beutler is regarded as an industry pioneer, having contributed to the discovery of Tolle genes that regulate immune responses against bacteria and fungi, for which he received the Nobel Prize in Physiology or Medicine 2011.

40. Sir Paul Nurse

Described by the judges as "effective", this Nobel Prize-winning biologist is one to watch. "A vigorous UK research capability is an essential pillar of an innovative global pharmaceutical industry," said Santoro. The Francis Crick Institute, until recently known as UKCMRI, aims to bring together world-class scientists and the latest technology.