Q&As in 2012

A year ago, Guido Rasi stepped into the role of executive director of the European Medicines Agency (EMA), becoming only the third person to fill that role since the inception of the continental drug advisory body, in 1995. He spoke with Roxanne Khamsi about how the EMA is working toward better safety guidance and improved transparency.

In late September, the Association of University Research Parks announced that David Baker would serve as president of the organization’s board of directors for the next year and help guide its strategic goals for the next five years. Baker spoke with Roxanne Khamsi about how the organization hopes to branch out and transform these workplaces.

As the US presidential campaign heads into the final stretch before the Election Day, the nonpartisan alliance known as Research!America is working to put health research high on the political agenda. Mary Woolley, president and chief executive officer of the Washington, DC–based organization, spoke with Roxanne Khamsi about what it will take to catalyze support among lawmakers for biomedical research.

By 2014, the UK will be changing the way it regulates the price it pays for medicines. The government has embraced an idea known as value-based pricing (VBP), with negotiations on how the system will work due to begin this month. One of the most influential thinkers on the UK’s proposed system is health economist Mark Sculpher, director of the Programme on Economic Evaluation and Health Technology Assessment at the University of York. Kate Ravilious met with Sculpher to discuss the value of VBP.

With a budget of $3.3 billion over the next seven years and an independent status, the Patient-Centered Outcomes Research Institute (PCORI) is tasked with creating the evidence base to help patients and doctors make more informed decisions about their medical choices. Elie Dolgin spoke with PCORI executive director Joe Selby, a family physician and clinical epidemiologist who joined the institute after 13 years as head of research at Kaiser Permanente, the California-based health provider.

Since its inception ten years ago, the Surviving Sepsis Campaign has successfully developed a series of best-practice criteria—the International Guidelines on the

Management of Severe Sepsis and Septic Shock, which are currently being revised under Phillip Dellinger’s leadership—as well as engaged physicians and the general public around the world in a broad educational program to warn about the threat posed by the disease. Dellinger spoke with Roxanne Khamsi about the struggle to catalyze change in the sepsis field.

Since last November, six biopharma buyouts have exceeded $1 billion each, with Gilead Sciences' purchase last year of the hepatitis C specialist Pharmasset topping the charts at a whopping $11.2 billion, the highest ever paid for a clinical-stage biotech and an 89% premium to its share price at the time. Mark Ratner sought out biopharma analyst Joseph Schwartz, a managing director at Leerink Swann in Boston, for his views on what’s behind the recent buyout spending.

In April, China's Minister of Health Chen Zhu and his mentor, Wang Zhen-yi of the Shanghai Jiao Tong University School of Medicine, received the Albert Szent-Györgi Prize from the Washington, DC–based National Foundation for Cancer Research, in recognition for their work on acute promyelocytic leukemia. On that occasion, Victoria Aranda and Roxanne Khamsi asked Chen about his plans for cancer research and for improving stem cell regulation in China.

Since inception of the Malaria Vaccine Initiative (MVI) in 1999, the Washington, DC–based initiative has played an instrumental part in advancing a number of leading vaccine candidates, including RTS,S, the first to show clinical efficacy in a major phase 3 trial. Steering the ship in the next phase of the journey is David Kaslow, who spoke with Roxanne Khamsi about how his experience in the public and private sectors will help inform his decisions in the nonprofit world.

When Robert J. Beall joined the Cystic Fibrosis Foundation in 1980, he launched a program aimed at absorbing the early financial risk involved in drug development as a way to entice for-profit companies to get involved in cystic fibrosis research. That strategy was vindicated with the approval in January of the first small-molecule drug that directly interacts with the mutated protein responsible for cystic fibrosis. Elie Dolgin spoke with Beall to learn more about his organization’s pioneering approach to venture philanthropy.

Patrick Soon-Shiong has only one mode of thinking: big. The South Africa-born surgeon-scientist has founded two multi-billion-dollar pharmaceutical firms and is now setting his sights on transforming the entire US biomedical system with a modern, high-speed data network. Amber Dance sat down with Soon-Shiong to talk about how uniting physicians and scientists will surmount the most pressing challenges in biomedicine and cancer research.

In September, Ronald DePinho became the new president of the MD Anderson Cancer Center at the University of Texas in Houston. He arrived there after 14 years at the Dana-Farber Cancer Institute in Boston. Rebecca Hersher spoke with him about his decision to go to the Lone Star State and the current status of the cancer field.