Kidney News February 2011 3#2 : Page 4
4 | ASN Kidney y News | February y 2011 Acute Kidney Injury Continued d from page e 1 Editorial Staff Editor-in-Chief: Pascale H. Lane, MD, FASN Managing g Editor: Dawn McCoy Design: Lisa a Cain Editorial Board: Matthew w D. Breyer, MD, FASN, Eli Lilly y and Company Wendy y Weinstock k Brown, MD, Jesse e Brown n VA A Medical l Center, Northwestern n University y Feinberg School l of f Medicine, University y of f Illinois at t Chicago Teri Browne, PhD, MSW, University y of f South Carolina Stephen Darrow, MD (fellow), University y of f Minnesota a Medical Center Ira a Davis, MD, Baxter Healthcare Corp. Caroline Jennette, MSW, University y of f North Carolina a Kidney y Center Richard Lafayette, MD, Stanford University y Medical Center Edgar V. Lerma, MD, FASN, University y of f Illinois – Chicago /Associates in Nephrology, SC Teri J. Mauch, MD, FASN, University y of f Utah Victoria a F. Norwood, MD, FASN, University y of f Virginia Sheila a M. O’Day, MSN, University y of f Nebraska a Medical Center Matthew w A. Sparks, MD (fellow), Duke University y Hospital Titte R. Srinivas, MD, Cleveland Clinic Advertising Sales : Scherago International, Inc. 525 Washington Blvd., Suite 3310 Jersey y City, NJ 07310 201-653-4777 phone 201-653-5705 fax mminakowski@scherago.com ASN Council: President: Joseph V. Bonventre, MD, PhD, FASN President-elect: Ronald J. Falk, MD, FASN Past-President: Sharon Anderson, MD, FASN Secretary-Treasurer: Donald E. Wesson, MD Publications Committee Chair: Sharon M. Moe, MD, FASN Councilors: Bruce A. Molitoris, MD, FASN, Sharon M. Moe, MD, FASN, Jonathan Himmelfarb, MD, FASN, Raymond C. Harris MD, FASN Executive Director: Tod Ibrahim Publications Manager: Robert Henkel ASN N Kidney y News s is published by y the American Society y of f Nephrology 1725 I Street NW, Suite 510, Washington, DC 20006. Phone: 202-659-0599 www.asn-online.org ASN N Kidney y News s is the authoritative source for r analysis of f trends in medicine, industry, and d policy aff ff ecting g all practitioners in nephrology. Th The statements and d opinions expressed d in ASN N Kidney y News are solely y those of f the authors and d not t of f the American Society y of f Nephrology y (ASN) or r the editorial policy y of f the editors. The Th appearance of f advertisements in ASN N Kidney y News is not t a warranty, endorsement, or r approval of f the products or r services advertised d or r of f their r eff ff ectiveness, quality, or safety. Th The American Society y of f Nephrology y disclaims responsibility y for r any y injury y to persons or property y resulting g from any y ideas or r products referred d to in the articles or r advertisements. The American Society Th y of f Nephrology is organized d and d operated d exclusively y for r scientifi fi c and educational purposes, including g enhancing g the fi eld d of f nephrology y by y advancing g the scientific fi knowledge and d clinical practice of f that t discipline through stimulation of f basic c and d clinical investigation, providing g access to new w knowledge through the publication of f journals and d the holding g of f scientifi fi c meetings, advocating g for r the development t of f national health policies to improve the quality y of f care for r renal patients, cooperating g with other r national and d international societies and organizations involved d in the field fi d of f nephrology, and d using g other r means as directed by y the Council of f the Society. strategies to reduce the morbidity y and mortality y of f patients with AKI are in-conclusive or generally y not eff ff ective. Th e workshop provided a unique forum for stakeholders across the AKI treatment spectrum—from basic researchers to in-dustry y and regulators—to brainstorm po-tential new w therapeutic compounds, drug targets, and optimal clinical trial designs for AKI. “Not t only y did d this workshop help us in the nephrology y research community y bet-ter r understand d what t the FDA A and d indus-try y need d and d want t from us, it t sets the stage for r more communication in the future— which will hopefully y translate to more treatments reaching g AKI patients faster,” said d Paul Palevsky, MD, who assisted d in organizing g the workshop. A well-designed d clinical trial with ap-propriate endpoints is necessary y for r suc-cessful translation of f a therapy y from the bench to the bedside. Trials must t meet not t only y researchers’ scientific fi c and d meth-odological standards, but t also those of industry y (which would d make the product available to patients) and d the FDA A (which must t approve the drug). Workshop par-ticipants debated d where to set t clinical end-points—or r a composite endpoint—that could d be shared d and d recognized d as accept-able by y researchers, the FDA, and d indus-try, in a manner r widely y agreed d as open and transparent. Industry y representatives also discussed d the limitations, needs, and d bar-riers they y face. “Everyone understood d that t we can-not t continue to work k in silos but t rather progress depends upon cooperation among g the stakeholders,” said d Mark k Oku-sa, MD, chief f of f the division of f nephrol-ogy y and d director, Center r for r Immunity, Infl fl ammation and d Regenerative Medicine at t the University y of f Virginia a in Charlottes-ville. “Th Th is highlighted d the necessity y of collaboration—and d an important t role for the NIH Public c Private Partnership p Pro-gram in facilitating g these interactions.” National Institutes of f Health (NIH) Public c Private Partnership Program (PPP) staff ff also participated d in the workshop. Th PPP facilitates collaborations between The the NIH and d other r organizations includ-ing g professional societies, industry y mem-bers, and d academic c institutions to improve public c health though research. The Th PPP also provides mechanisms by y which AKI researchers and d industry y members at t the workshop could d identify y shared d areas of f interest t and d conduct t studies that t NIH might t not t otherwise be able to support (see sidebar). Among the most important issues facing clinical trial design is identify-ing g approaches to mitigate the financial fi challenges NIH and d industry y face in con-ducting g the trials. One potential solution workshop participants identified fi d is to pool similar r placebo-treated d patients from dif-ferent Phase II studies into a large protect-ed d database available for r determination of f event t rates and d other r parameters. Such information is essential to the design and implementation of f appropriately y powered Phase III studies. Th workshop was in part The t the result t of f conversations between the NIDDK K and the ASN AKI Advisory y Group. “ASN was an important t force in con-vincing g NIH that t we have important t tools and d therapies to examine,” said d NIDDK K Acute Kidney y Injury y Program Director Paul Kimmel, MD, FASN, in his opening g remarks. “This Th [workshop] was a direct t re-sult t of f ASN dialogue with NIDDK.” “The Th AKI Advisory y Group was chal-lenged d by y NIH staff ff to delineate up-and-coming g therapies for r AKI that t would provide the stimulus for—and benefit fi from—a a workshop to facilitate interac-tions between an array y of f AKI stakehold-ers,” said d Bruce Molitoris, MD, FASN, chair r of f the nephrology y division at t Indi-ana a University y School of f Medicine and ASN’s AKI Advisory y Group Council Li-aison. “The Th NIH then worked d diligently y to deliver r an outstanding g meeting g based on an environment of understanding, cooperation and d respect. Participants left exhausted d and d exhilarated.” Public-Private Partnerships In an effort t to foster r better r working g relationships between government and industry, the National Institutes of f Health (NIH) initiated a pro-gram on public-private partnerships (PPP) in 2005. Housed under r the Office fi of f Science Policy, the PPP works to “facilitate collaborations that improve the public health through biomedical research.” Although the research benefits fi of the collaboration of f NIH with private industry y are well established, at t times structuring g these partnerships has proven cumbersome. The PPP acts as a central coordinator r helping to aid communication, establishing g a set t objective for r the partnership, and organizing g the parameters of f the collaboration. An example of f a recent t collaboration facilitated by y the PPP is the Biomarkers Consortium, consisting g of f the NIH, the Food and Drug Administration, the Centers for r Medicare & Medicaid Services, as well as private industry y and nonprofit fi t advocacy y groups. The project t works to speed the identification, fi testing, and regulatory y acceptance of f biomark-ers. The existence of f the PPP allowed the diverse stakeholders involved in the biomarkers consortium to work k collectively y toward a shared goal of f advancing g patient t health through new w diagnostic tools, technologies, and treatments. Postmaster: Please e send d address changes to ASN N Kidney y News , c/o Customer r Service, American n Society y of f Nephrology y 1725 I Street t NW, Suite e 510, Washington n DC C 20006. Publications mail l agreement t No. 40624074. Return n undeliverable e Canadian n addresses to PO Box x 503, RPO West t Beaver r Creek, Richmond d Hill l ON N L4B 4R6 ASN N Kidney y News (ISSN print t 1943-8044 and d online e 1943-8052) is an offi ffi cial l publication of the e American Society y of f Nephrology, 1725 I Street t NW, Suite e 510, Washington DC 20006, and is published d monthly. Application to mail l as Periodicals Postage e Pending g at t Washington, DC, and d at t additional l mailing g offi ffi ces. Subscription rates: $12 per r year. To order, please e email bhenkel@asn-online.org. Subscription prices subject t to change. Annual l ASN membership dues include e $12 for ASN N Kidney y News s subscription. Copyright© 2011 All l rights reserved
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