Vaccine Briefs

Global HIV Vaccine Enterprise Appoints Executive Director

The Global HIV Vaccine Enterprise announced the appointment of Alan Bernstein, founding president of the Canadian Institutes of Health Research (CIHR), as its executive director on October 11 at the Keystone Symposium on Challenges of Global Vaccine Development in Cape Town, South Africa (see Giving it their best shot). Bernstein will establish the permanent secretariat of the Enterprise in New York City. The Bill & Melinda Gates Foundation will provide US$20 million over the next four years for activities of the secretariat, and the US National Institute of Allergy and Infectious Diseases (NIAID) has committed $7 million over the next seven years.

The Global HIV Vaccine Enterprise is an alliance of independent organizations united by a scientific plan that focuses on accelerating six areas of AIDS vaccine research: vaccine discovery, laboratory standardization, product development and manufacturing, clinical trials capacity, regulatory issues, and intellectual property. But the "core of the enterprise is science," said José Esparza of the Bill & Melinda Gates Foundation.

To date, the constituent organizations of the Enterprise have mobilized $750 million to achieve the objectives of the scientific plan. The new executive director of this effort needs to see that this funding, and the science it supports, is deployed in innovative ways, said Esparza.

The idea of the Enterprise was first proposed in 2003 by a cadre of leading HIV researchers as a way to promote collaboration in the field. Since the inception of this virtual consortium, the interim secretariat was held by the Gates Foundation. In 2006, Adel Mahmoud was announced as Chief Executive of the Enterprise but his appointment never came to fruition.

"We are convinced Alan is the ideal choice [for executive director]," said Esparza. "He is an internationally renowned scientist. As the head of the Enterprise, Alan Bernstein will bring his passion and expertise to the challenge of developing an HIV vaccine."

Bernstein most recently presided over the $1 billion budget of CIHR, the Canadian equivalent of the US National Institutes of Health, and was a member of the scientific board of the Grand Challenges in Global Health Initiative, sponsored by the Gates Foundation. Bernstein views the fact that his scientific experience is outside the AIDS vaccine field as a strength. "I'm not an HIV researcher. I'm also not a vaccinologist," said Bernstein, who sees being an "outsider" in the field as an advantage because he can bring fresh perspective.

Bernstein said the job of the Enterprise is to coordinate efforts within the field and get funding agencies, industry, and regulators working together. Bernstein said he recognized that getting the scientific community to work together on an issue of global importance is a hefty task; he compared the efforts to develop an AIDS vaccine to the campaign to tackle global warming. He suggested that involving more young researchers and generating new ideas is more important than seeking harmony in the field, which is seen by many as the primary focus of the Enterprise. "As a group we've received hundreds of millions of dollars," said Bernstein. "The world is watching us."

He also referred to the recently reported results from the STEP trial as a "wake-up call" for the field and spoke about prospects for developing an AIDS vaccine in the wake of this trial. "It's going to be a long journey. We need to learn from the STEP trial and all other trials before and after that. The Enterprise will accelerate the development of a vaccine, [and] make the dream of a vaccine a reality," Bernstein said. "I think it's doable and I'm looking forward to it." —Kristen Jill Kresge

New Funding Focuses on Innovation in Global Health

Recently two new funding initiatives geared towards fostering innovation within the AIDS vaccine field, and beyond, have been announced by IAVI and the Bill & Melinda Gates Foundation.

In September, IAVI launched a US$10 million initiative to actively identify and fund small and medium-sized biotechnology companies that are developing innovative technologies in an effort to bring these novel applications to bear on the research and development of an effective AIDS vaccine. This new funding mechanism, called the Innovation Fund, was announced at the annual meeting of the Clinton Global Initiative in New York City. The Innovation Fund is being co-funded by IAVI and a grant from the Bill & Melinda Gates Foundation.

In October, at the Challenges of Global Vaccine Development Symposium, the Gates Foundation announced its new innovation program, called the Grand Challenges Exploration Initiative, which will fund academic or independent research and discovery efforts in several areas of public health. The Foundation has committed $100 million to the program over the next five years and will supply grants of $100,000 to selected applicants with the aim of encouraging the best minds to explore novel approaches to the world's greatest health challenges. "This is not about making money; this is not about publishing," said Tachi Yamada of the Gates Foundation. "It's about delivering to patients."

Both of these new initiatives will attempt to break down the interdisciplinary boundaries of research. "Innovation is a word that is misused by most," said Yamada. "They mean what I'm doing, not what you're doing." IAVI's Innovation Fund will target unconventional and unproven concepts from areas beyond those currently being investigated within the AIDS vaccine field. A panel of expert advisers will comb through promising technologies in diverse fields, such as cancer immunology and therapeutics and monoclonal antibody engineering, to search for the most promising and creative ideas. "We created the Innovation Fund to bring the best and the brightest minds from outside the field to AIDS vaccine development," says Seth Berkley of IAVI.

Another guiding principle of both efforts is speed. IAVI's Innovation Fund will seek to identify and fund roughly 15 to 20 companies over the next three years with seed money that will help grantees quickly determine whether these technologies are feasible for AIDS vaccine research. The Fund will also conduct rapid evaluations of the potential technologies, awarding grants within just eight weeks.

The Grand Challenges Exploration program will review and deliver grants within three months of receiving applications, which will require no advanced data and be limited to two pages. The initial target areas for the grants will be announced early next year and proposals for this initiative, which will be reviewed by experts in the areas of science and technology, will be accepted starting early to mid-2008. Grantees will be expected to take on big questions and big risks, and share information as soon as it's available, according to Yamada.

The grants issued by IAVI's Innovation Fund will focus primarily on areas that IAVI has identified as the major obstacles to AIDS vaccine development. They include technologies that address how to induce broadly neutralizing antibodies against HIV; how to identify and deliver HIV immunogens capable of inducing immune responses that can control HIV infection; and how to stimulate immune responses in mucosal tissues, which are a primary entry point for the virus during sexual transmission.

The need for pioneering approaches to AIDS vaccine design became even more apparent after Merck's leading AIDS vaccine candidate, MRKAd5, failed to provide any degree of protection against HIV infection or to modulate viral load in HIV-infected individuals in a large Phase IIb test-of-concept trial called the STEP study (see A STEP back?). "Let's face it, 25 years after the advent of HIV/AIDS and there's still no vaccine," said Yamada. "As a funder of this work we have to be willing to fail. But when we have success, we should be ready to invest very, very heavily in that success." —Kristen Jill Kresge