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SOT Breaking News
FDA Appoints Dr. Frank M. Torti as Principal Deputy Commissioner and New Chief Scientist
Submitted on Apr 09, 2008
Dear Constituent,
Today, Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. announced the appointment of Frank M. Torti, M.D., M.P.H., as the FDA’s Principal Deputy Commissioner and first Chief Scientist. The newly-created Chief Scientist position stems from the Food and Drug Administration Amendments Act of 2007 (see http://www.fda.gov/oc/initiatives/advance/fdaaa.html).
A prominent clinician, scientist and researcher in molecular oncology, Dr. Torti is currently serving as Charles L. Spurr Professor of Medicine, Chair of the Department of Cancer Biology, and Director of the Comprehensive Cancer Center at Wake Forest University School of Medicine in Winston-Salem, N.C. Throughout his career, Dr. Torti has served on and chaired a number of national health and medical committees. He currently serves on the National Institutes of Health’s National Advisory Council for Complementary and Alternative Medicine. He also founded and serves as President of the Cancer Biology Training Consortium, a national society of cancer biology department chairs and program directors. He is the recipient of a National Institutes of Health MERIT Award. More detailed information about Dr. Torti’s accomplishments is available on the FDA Web site.
Dr. Torti will join FDA in May.
Sincerely yours,
Ken Nolan
Senior Program Specialist
Office of External Relations
U.S. Food and Drug Administration
NIH-CSR and NIEHS Announce the Creation of a New Special Emphasis Panel Dedicated to the Review of Toxicology Grant Applications
Submitted on Mar 27, 2008
A February 20, 2008 letter to SOT from NIH Center for Scientific Review (CSR) Director Dr. Antonio Scarpa and National Institute of Environmental Health Sciences Acting Director Dr. Samuel Wilson announced the creation of a new Systemic Injury by Environmental Exposure (SIEE) Special Emphasis Panel (SEP). SIEE has been created as a temporary standing SEP and is a pilot program. SIEE reviews will begin with applications submitted in June 2008 and will continue for three review cycles into 2009, after which the performance of the SEP will be critically reviewed.
In 2002, the CSR completed an NIH-wide restructuring of Integrated Review Groups and Study Sections, based on the scientific boundaries report, to make the review system more organ- and disease-centered. This produced many enhancements, but also resulted in the elimination of 2 of 3 study sections that focused on toxicology research questions. What followed was the dispersal of toxicology-focused applications over a large number of diverse panels, and often poorer review outcomes. For the past five plus years, SOT has engaged in discussions with NIH leadership to resolve this issue. While SOT representatives continued working with CSR leadership, SOT members attended all six NIH-CSR Open House Workshops between March and December 2007. Input from both SOT lea dership and members was relayed to CSR and played an important role in the response of CSR to this issue with the creation of the new SIEE SEP.
The CSR has emphasized that the SIEE SEP is a pilot, and that there is no guarantee or expectation that SIEE will transition into a permanent Study Section. As noted in the Special Issue of the Communique, "For SIEE to be viable for conversion to a standing Study Section, it is imperative for toxicologists to request that their qualifying grants be assigned to this SEP" and for toxicologists to volunteer to serve on the panel. Small numbers of reviewed grant applications and poor review performance would pose significant barriers to success. Even with a successful SIEE SEP, much more remains to be done to strengthen the review process by increasing the clustering of toxicology grant applications.
The SIEE SEP will review applications related to the pharmacological and toxicological mechanisms whereby xenobiotics (including toxicants, alcohol, drugs, biopharmaceuticals, phytochemicals and other non-drug chemicals) affect distinct organ systems, other than the digestive and nervous systems, including cardiovascular, musculoskeletal, hematopoietic, renal, respiratory/pulmonary, immune, endocrine and reproductive systems. Other covered areas are skin, oral, dental and craniofacial tissues, pregnancy and development. Applications addressing the effects of xenobiotics at the multi-organ level may also be considered.
Click Here to visit the CSR web site and learn more, including the role of the SIEE SEP within the Digestive Sciences Integrative Review Group.
SOT Announces a Late-Breaking CSR Session on "Challenges and Opportunities in the NIH Peer Review. A Vision for Ensuring its National Strategic Value" at the 2008 Annual Meeting in Seattle
Dr. Antonio Scarpa will be a featured speaker at our Seattle meeting (Wednesday, March 19, 1:30–2:30 PM in Room 3A). This late-breaking session will be of considerable relevance to SOT Members seeking NIH funding. Dr. Scarpa will describe broad Challenges and Opportunities in the NIH Peer Review. A Vision for Ensuring its National Strategic Value. He will describe the new Systemic Injury by Environmental Exposure (SIEE) Special Emphasis Panel (SEP) under the existing Digestive Sciences Integrative Review Group (IRG). The SIEE SEP will provide for the review of a broad range of grant proposals related to systemic injury due to environmental factors. The session will also offer an opportunity for questions and answers.
Sincerely,
SOT Presidential Chain
George B. Corcoran, President
Kenneth S. Ramos, Vice President
Cheryl L. Walker, Vice President-Elect
James A. Popp, Past President
Creating a Safer and Healthier World by Advancing the Science of Toxicology
Draft Peer Review Report
Submitted on Mar 03, 2008
On February 28, 2008, the Final Draft of the NIH 2007–2008 Peer Review Self-Study was submitted to Dr. Elias Zerhouni, Director of NIH, marking
the end of the diagnostic phase of the peer review enhancement effort.
To obtain the PDF file of Final Draft Report: Final Draft Report (PDF,
1.69MB)—please go to the Peer Review Website
This Final Draft Report identifies the most significant challenges facing the NIH peer review system and proposes recommended actions. If you wish to comment on the Final Draft, please send your comments no later than Monday, March 17, 2008, via:
Electronically: PeerReviewRFI@mail.nih.gov
EPA/NIH Press Release
Submitted on Mar 03, 2008
NIH Collaborates with EPA to Improve the Safety Testing of Chemicals
New Strategy Aims to Reduce Reliance on Animal Testing
Testing the safety of chemicals ranging from pesticides to household cleaners will benefit from new technologies and a plan for collaboration, according to federal scientists from the National Institutes of Health (NIH) and the U.S. Environmental Protection Agency (EPA), who today announced a new toxicity testing agreement. The concept behind this agreement is highlighted in the Feb. 15, 2008 issue of the journal Science. Read More...
NIH CSR Creates Toxicology SEP
Submitted on Feb 26, 2008
Dear George:
As part of an effort to enhance peer review, the Center for Scientific Review (CSR) in cooperation with the National Institute of Environmental Health Sciences (NIEHS) will start a pilot in which a Special Emphasis
Panel (SEP) will review applications on systemic injury As this is a year when NIH Director Dr. Elias Zerhouni is focusing on enhancing peer review, other aspects of peer review are likely to be piloted that will eventually affect review of all applications, including those in which you and others in the Society of Toxicology have interest. We may have a better sense of those possibilities in a few weeks. Also, on a lesser scale, CSR is conducting a systematic study
of so-called orphan applications, those which number less than five per study section per cycle. This will require a significant amount of time; however, the outcome of this systematic study is likely to be precedent setting.
If you would seek clarification about any of these developments please let us know.
Sincerely,
Toni Scarpa, Director CSR
Samuel Wilson, Acting Director NIEHS
David Schwartz Steps Aside as Director of NIEHS/NTP
Submitted on Aug 20, 2007
Mary Gant, NIEHS/NTP Dear Colleagues: As you know, there have been recent inquiries
by members of Congress and others regarding certain activities and management decisions at the
National Institute on Environmental Health Sciences (NIEHS) and the National Toxicology Program (NTP).
Dr. Zerhouni has responded to these inquiries and is taking appropriate action to ensure that the
issues being raised are reviewed and, if necessary, properly addressed. Today, Dr. Zerhouni
announced an initiative that commissions senior management experts to conduct a comprehensive review
at NIEHS and NTP, focusing on the operations in the intramural, extramural and administrative arenas.
This review, which will be concluded within several months, will address areas such as governance,
internal controls and employee morale. In addition, this independent review will focus on personnel
issues, contracts, grants, and financial management issues, as well as the administration of the
ethics program. To ensure the independent nature of the review, while it is being conducted,
I will temporarily step aside as Director of the NIEHS and NTP. During this period, I will serve as
a senior advisor on environmental health sciences to Dr. Zerhouni and will continue to serve as Chief,
Laboratory of Environmental Lung Disease, NHLBI. Dr. Zerhouni has requested that Dr. Samuel H. Wilson,
serve as the Acting Director of NIEHS and the Acting Director of NTP during the review period. Dr. Wilson,
who is internationally recognized for his work genetic toxicology, has served ably as the Deputy at NIEHS and NTP.
He will consult regularly with Dr. Raynard Kington, Deputy Director of NIH, regarding management and operation
decisions. I urge you to cooperate fully with Dr. Wilson and provide him with the same professional support
and courtesy extended to me. Although this development is personally painful, I am committed to a full
and comprehensive review of the management of NIEHS/NTP. I urge all of you to fully cooperate with the experts
conducting the management review. I firmly believe this independent review will enable NIEHS/NTP to respond to
the recent inquiries and ultimately provide strong direction for the future leadership and management of NIEHS
and NTP. I am grateful to the staff of NIEHS and NTP who remain dedicated to the Institute's mission of improving
public health and look forward to continuing our work together. David David Schwartz, MD
Director,
National Institute of Environmental Health Sciences and National Toxicology Program
P.O. Box 12233, MD:B2-01
Research Triangle Park, NC 27709-2233
Phone: 919-541-3201
Fax: 919-541-2260
E-mail: david.schwartz@niehs.nih.gov
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