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Vol. LXVII, No. 14
July 3, 2015
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‘Intense Phase’
Comings, Goings, Upgrades Mark ACD Meeting

On the front page...

NLM working group cochairs Dr. Eric Green (l) and Dr. Harlan Krumholz of Yale

NLM working group cochairs Dr. Eric Green (l) and Dr. Harlan Krumholz of Yale

Enhanced visions for both the National Library of Medicine and the intramural research program (IRP) marked the 110th meeting of the advisory committee to the NIH director (ACD) June 11-12, along with a welcome to new NINDS director Dr. Walter Koroshetz and a fond farewell to NIH deputy director for extramural research Dr. Sally Rockey, who is leaving in September.

A congressionally mandated strategic plan for NIH, due by December, elicited lively discussion by the ACD and will continue to evolve as a working group decides on the proper taxonomy. And a game plan for the Precision Medicine Initiative announced by President Obama in January continues at a sprint to meet its September deadline; the last two of four national meetings on PMI are being held this month.

“If the history of the ACD is ever written, this will be remembered as a particularly intense phase,” said NIH director Dr. Francis Collins. The committee, which meets twice a year, has in recent years faced “a wide variety of really critical topics,” he said.

Continued...

Dr. Helen Haskell Hobbs
Dr. Helen Haskell Hobbs
NLM was hailed as the potential epicenter of open science and a Mecca for the era of Big Data, said Dr. Harlan Krumholz of Yale University, who cochaired the NLM working group. “NLM is the world’s resource, not just the nation’s,” he noted. “We were amazed” at the amount of goodwill generated globally toward NLM—“It’s a form of soft diplomacy.”

Former U.S. global AIDS coordinator Dr. Eric Goosby, now at the University of California, San Francisco, said a revitalized NLM “would be an international equalizer…that pushes everyone to the mean more rapidly.” It is a “wonderful motor” for translating science to underserved parts of the globe and “a wonderful example of soft power.” He suggested formal ties with the State Department “to look for opportunities, country by country.”

Dr. Helen Haskell Hobbs of the University of Texas Southwestern Medical Center called NLM an exemplar of the “democratization of science. It’s an incredible advertisement for NIH and what it does.”

Dr. Eric Goosby

Dr. Eric Goosby (above) of UCSF.

New NINDS director Dr. Walter Koroshetz (below)

ACD Photos: Ernie Branson

New NINDS director Dr. Walter Koroshetz

Although built “piecemeal over time,” the library, which dates back to 1836 but joined NIH in 1968, “has the opportunity to modernize the conceptualization of a library,” Krumholz said. “It’s time to seize the future.” His working group’s 6 recommendations for implementing a new vision for NLM were unanimously embraced by the ACD and can be found at http://acd.od.nih.gov/meetings.htm.

“I don’t want to be coy about my enthusiasm for this report,” said Collins, who accepted the recommendations on the spot. “There’s no need for delay.”

“We are very excited by the expanded vision for NLM,” said Betsy Humphreys, acting NLM director. “We’re all delighted about this.”

Also winning endorsement was NIH’s response to a series of recommendations made by an ACD working group on long-term planning for the IRP. Dr. Michael Gottesman, NIH deputy director for intramural research, reviewed measures that will strengthen the CC and clinical research, promote diversity, help NIH recruit scientific talent and optimize use of shared resources.

Among its initiatives, the IRP plans to start a new high school enrichment program, since “many more [students] apply each summer than NIH can take,” said Gottesman. And to augment the PMI, the CC plans to genotype all CC patients and “conduct comprehensive phenotyping of this valuable cohort of subjects who are seen repeatedly at the CC.”

Collins’ review of the issues engaging NIH included a summary of problems in the Clinical Center’s pharmaceutical development section (PDS), whose sterile manufacturing component was suspended by the FDA in mid-May after contamination was found in vials used for patient injections. Six patients were found to have received a tainted product, but with no ill effects to their health so far. Collins pledged to oversee corrective actions personally and will name an external group to review procedures at the PDS.

Also, NIAID director Dr. Anthony Fauci visited the meeting briefly to review progress on two candidate Ebola vaccines and a therapeutic known as ZMapp, which is a cocktail of three monoclonal antibodies. Fauci said safety data look good so far for the vaccines after completion of the 1,500-subject phase 2 trial, being tested in West Africa. Immunogenicity data that have been collected should prove extremely helpful if the vaccine receives accelerated approval in the future, he said. The randomized, controlled ZMapp clinical trial in Sierra Leone has already enrolled over 30 patients and extension of the trial to Guinea, where there is a surge of cases, hopefully will provide enough data to achieve an interpretable result, he added.

Fauci also summarized the outbreak of MERS in South Korea, which he called “a fascinating epidemiological story.” The 122 cases, including 9 deaths [as of June 11], are traceable to a 68-year-old man who was infected in the Arabian Peninsula, returned to South Korea and went from doctor to doctor, and hospital to hospital, May 11-20, inadvertently infecting hospital workers and family members via direct contact. There is no evidence, Fauci said, of community spread of the infection beyond contact within a health care setting.

He also commented briefly on the condition of a patient admitted to the CC with extensively drug-resistant tuberculosis: “The patient is stable and doing fine.”

Koroshetz Named NINDS Director

Dr. Walter Koroshetz was named director of the National Institute of Neurological Disorders and Stroke on June 11 by NIH director Dr. Francis Collins at the ACD meeting. Koroshetz came to NIH in 2007 as NINDS deputy director and has served as acting director since Dr. Story Landis retired in October 2014.

“I am very pleased that Dr. Koroshetz has accepted the enormous responsibility of being the NINDS director,” said Collins. “His deep grounding in clinical neurology and basic neuroscience research makes him the ideal candidate to lead NINDS into the future and to fulfill the institute’s mission to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease.”

Collins recognized Koroshetz’ role in the creation of StrokeNet, a national clinical trial network for research in stroke treatment, prevention and recovery, as well as his role as point person for traumatic brain injury research at NIH and co-founder of the NIH-Uniformed Services Center for Neuroscience and Regenerative Medicine (TBI research center).

Koroshetz serves as co-chair of the NIH BRAIN Initiative. He was instrumental in establishing the NIH Office of Emergency Care Research. He is the NINDS representative to the federal interagency autism coordinating committee, chair of the interagency pain research coordinating committee and the NIH Pain Consortium and co-chair of the Common Fund Undiagnosed Diseases program.

Before coming to NIH, Koroshetz was a Harvard professor of neurology, vice chair of neurology at Massachusetts General Hospital, director of stroke and neurointensive care and a member of the Huntington’s disease unit. He also led neurology resident training at MGH from 1990 until 2007.

A native of Brooklyn, he graduated from Georgetown University and received his M.D. from the University of Chicago. He trained in internal medicine at the University of Chicago, and in both internal medicine and neurology at MGH, after which he pursued postdoctoral studies in cellular neurophysiology at MGH and Harvard’s neurobiology department.


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