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HUNT Heartland Unit for Neuroscience Trials NeuroNext Network Richard Barohn, MD- PI Grand Rounds University of Kansas M

HUNT Heartland Unit for Neuroscience Trials NeuroNext Network Richard Barohn, MD- PI Grand Rounds University of Kansas Medical Center 2/1/2013. HUNT. NeuroNEXT Goals. Test promising therapeutics in Phase II clinical trials Using biomarkers when available

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HUNT Heartland Unit for Neuroscience Trials NeuroNext Network Richard Barohn, MD- PI Grand Rounds University of Kansas M

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  1. HUNT Heartland Unit for Neuroscience Trials NeuroNext Network Richard Barohn, MD- PI Grand Rounds University of Kansas Medical Center 2/1/2013 HUNT

  2. NeuroNEXT Goals • Test promising therapeutics in Phase II clinical trials • Using biomarkers when available • Providing results that allow for Go/No-Go decisions for Phase III trials • Accelerate drug development through established clinical trials infrastructure • Responding flexibly to opportunities • Sharing expertise between disease areas • Decrease time/cost between trial design and trial completion • Using a central IRB and standing master trial agreements • Coordinate public/private sector efforts • Testing best therapeutics, from academic or industry investigators • Leveraging NINDS’ existing relationships with academic investigators and patient advocacy groups • Engaging industry participation HUNT

  3. NeuroNEXT: Network Designed to Efficiently Conduct Phase II Clinical Trials • Central IRB • Reliance agreements between sites and CIRB • Academic IRB (CCC at MGH) IRB of record • One full committee protocol review • Central adverse event management and reporting • Standardized Master Trial Agreement • Clinical trial costs calculated on a per-patient basis go from CCC to sites • Recurring issues such as publications, data, and indemnification pre-negotiated • Use of appropriate technology transfer agreements to maximize industry participation and support in development of novel therapeutics HUNT

  4. NeuroNEXT: Network Designed to Efficiently Conduct Phase II Clinical Trials • 25 experienced, well-trained sites throughout the United States • All studies expected to use the NeuroNEXT Clinical Study Sites • Experienced Clinical and Data Coordinating Centers to help investigators bring new therapies forward • Investigators must use the Clinical and Data Coordinating Centers for all NeuroNEXT studies HUNT

  5. NeuroNEXT Coordinating Centers and Clinical Sites HUNT

  6. Clinical Study Sites • Albert Einstein College of Medicine-Yeshiva • Children’s of Boston • Children's National • Columbia-Cornell • Emory • Massachusetts General Hospital • Northwestern University • Ohio State University • Oregon Health and Science University • Swedish Health Services (Seattle) • SUNY (Buffalo, Downstate, Upstate, and Stony Brook) • University of Alabama, Birmingham • University of California, Davis • UCLA • University of Cincinnati • University of Colorado, Denver • University of Kansas • University of Miami • University of Pittsburgh • University of Rochester • University of Utah • University of Virginia • University of Texas, Dallas • Vanderbilt • Washington University in St. Louis

  7. NeuroNEXT Network Infrastructure • NIH/ NINDS • NeuroNEXT Scientific Program Director: Elizabeth McNeil, MD, MSc • NeuroNEXT Administrative Program Director: Claudia Moy, PhD • Director of the Office of Clinical Research: Petra Kaufmann, MD, MSc • Clinical Research Project Manager: Janice Cordell • Data and Safety Monitoring: A. Louise Ritz, MBA • Clinical Trials Recruitment Specialist: Jamie Roberts, MA, CCRP • Health Program Specialist: CrinaFrincu, PhD HUNT

  8. NeuroNEXT Network Infrastructure • Clinical Coordinating Center (CCC) • Massachusetts General Hospital • PI Merit Cudkowicz, MD, MSc • Data Coordinating Center (DCC) • University of Iowa • PI Christopher Coffey, PhD HUNT

  9. Why Apply to Use NeuroNEXT • Allows access to NeuroNEXT infrastructure • NeuroNEXT CCC and DCC • NeuroNEXT Central Pharmacy and Laboratory • 25 NeuroNEXT Clinical Study Sites • Efficient start up • Pre-existing master trial agreements for all 25 sites • Central IRB review administered through NeuroNEXT CCC • Assistance with protocol and grant development • NINDS provides infrastructure/partner provides funding HUNT

  10. Applying to NeuroNEXT • Three possible mechanisms: • Academic investigators: • NeuroNEXT Clinical Trials (U01) (PAR-11-343). • Upcoming Due Dates- December 3, 2012 • Industry: • NeuroNEXT Clinical Trials (U01) (PAR-11-343); OR • Expedited access to NeuroNEXT expertise and infrastructure through the NeuroNEXT Infrastructure Resource Access (X01) (PAR-11-344) • Small businesses: • NeuroNEXT Clinical Trials (U01) (PAR-11-343); OR • Small Business Program: NeuroNEXT Small Business Innovation in Clinical Trials (U44) (PAR-11-345 HUNT

  11. Who is Eligible to Apply? • ANYONE may apply. • You do not have to be based at a NeuroNexT site to apply. • If your proposal is approved for grant funding, your site becomes an ad hoc NeuroNext site for the duration of the study/trial. HUNT

  12. Resources on the public website • Clinical Study Concept Form • Overview of solicitation/review of proposals • Guidelines for rigorous study design • Links to primary clinical sites, CCC, DCC, and NINDS information • Information for academic and industry researchers HUNT

  13. What To Do First… Initial determination of project suitability for NeuroNext will be made by NINDS. • Let Dr. Barohn/ Pat Laubinger know about idea and strongly advise a meeting before submitting the NeuroNext Clinical Study Concept Synopsis Form. The form is at www.neuronext.org • Contact Elizabeth McNeil, MD at NINDS- informal discussion of proposal • mcneilde@ninds.nih.gov or 301-496-9135 • Submit the completed NeuroNext Clinical Study Concept Synopsis Form to Dr. McNeil at NINDS • NINDS program staff discusses the proposed study to determine if proposal is aligned with the overall mission and priority of NINDS. HUNT

  14. The Process Proposals with good NINDS program support are referred to the NeuroNext Executive Committee (NEC). Permanent Members: • CCC PI: Merit Cudkowicz, MD, MS • DCC PI: Christopher Coffey, PhD • NINDSScientific Program Director: Elizabeth McNeil,MD, MS Rotating Members: • Clinical site PI’s: Tracey Glauser, MD; E. Clarke Haley, MD; Karen Mardor, MD, MPH • PIs of all approved NeuroNextstudies

  15. NeuroNext Executive Committee (NEC) The NEC performs feasibility assessments on proposals including • availability of a sufficient number of NeuroNEXT sites with interest in conducting a study in specific disease population; • availability of patient population and feasibility of conducting trial at NeuroNEXT sites; • assessment of regulatory requirements; • availability of drug/placebo for the proposed trial; • biostatisticalfeasibility of study/trial Based on a majority vote of NEC members, a recommendation will be communicated to NINDSin the form of a brief written summary.

  16. Extramural Science Committee (ESC) The protocol synopsis and the projected study budget is sent to the NINDS Extramural Science Committee (ESC). • The focus of the NINDS ESC is to review the strength of the scientific rational and estimated budget of the proposal. • If approved by the ESC, then full protocol development begins.

  17. NeuroNext Decisions • Protocol PI works with CCC-DCC PWG (Protocol Working Group) to develop protocol design • Full protocol and grant development • Includes: assistance with biostatistics, central pharmacy and laboratory, budget, monitoring and other vendors as needed • Regulatory submission at least 31 days prior to grant submission (as needed) • Grant submission HUNT

  18. Grant Applications Must Include… • Compelling scientific evidence for evaluating the proposed investigational agent in the disease under study • Proposed methodology for testing whether the investigational agent has the expected biological effect in study patients • Documentation of an active IND/IDE for the investigational agent of IND exemption, if applicable HUNT

  19. NeuroNEXT Concept Proposal HUNT

  20. Additional Facts… • PI institution becomes site for their trial if not NeuroNEXT network site • Budget for PI and their site • PI becomes part of NEC and Publication/Data Sharing Committee for duration of their study • External Statistician possible as consultant HUNT

  21. NeuroNEXT Applications Year 1 (10/11-12/12) HUNT

  22. First Grant Funded • Principal Investigator: Steven Kolb, MD, PhD and John Kissel, MD, Ohio State University • Disease: Spinal Muscular Atrophy • Preliminary Aims: SMA Biomarkers in the Immediate Postnatal Period of Development • Approval Date: 2/29/2012 • Investigators Meeting- 9/2012 • As of 1/17/2013, 11 of the 15 sites has been activated with 6 participants enrolled.

  23. Grants Submitted Glyburide Advantage in Malignant Edema and Stroke (GAMES) study • PPI: Barney Stern, MD, University of Maryland • U01grant submitted on April 2nd, 2012 • SEP review August 13th, 2012 • Discussing resubmission Ibudilast(MN-166) in Subjects with Progressive MS • PPI: Robert Fox, MD, Mellen Center for MS, Cleveland Clinic • U01grant submitted June 8th, 2012 • SEP review August 13th, 2012 • Received score in potentially fundable range. Will go to February Council meeting. HUNT

  24. Grants Submitted EPONeuroprotection for Infants with Acute Brain Injury • PPI: Shenandoah Robinson, MD, Boston Children’s Hospital • SEP reviewed 1/7/13-pending summary statements Ofatumumab, a Human anti-CD20 Antibody for Treatment of Anti-MAG Neuropathy • PPI: Norman Latov, MD, PhD, Weill Cornell Medical College New York Presbyterian Hospital • SEP reviewed 1/7/13-pending summary statements Normothermia after Aneurysmal Subarachnoid Hemorrhage • PPI: NeerajBadjatia, MD University of Maryland • SEP reviewed 1/7/13-pending summary statements HUNT

  25. Grants Submitted An investigator-initiated clinical trial of dalfampridine in Primary Lateral Sclerosis: • PPI: James Wymer, MD Albany Medical College • SEP reviewed 1/7/13-pending summary statements Rituximab in the management of refractory autoimmune myasthenia gravis: • PPI: Jonathan Goldstein, MD Yale School of Medicine • Dr. Barohn and Dr. Dimachkie are co-investigators on this study • U01 grant submitted on Nov 30th, 2012 • SEP reviewed 1/7/13-pending summary statements HUNT

  26. Grants Submitted INT131 as an Adjunctive Therapy in Patients Currently Treated with the ABCR Therapies (Avonex, BetaSeron, Copaxone, Rebif) for Relapsing Remitting Multiple Scelorsis • PPI: David Weinstein, MD, PhD, InteKrin Therapeutics, Inc and Patricia Coyle, MD SUNY Stony Brook • Anticipate submission of X01 and U01 grants on Dec 10th, 2012 • SEP reviewed 1/7/13-pending summary statements HUNT

  27. Local Site’s Role in NeuroNext • Engage • Clinicians • Community • Patients • Advocacy groups • Leverage CTSA resources for NINDS funding • Dr. Barohn is Chairman of CTSA/ NeuroNextcommittee • Support new investigators HUNT

  28. HUNT Organization Chart Director Richard Barohn, MD Associate Director Jeffrey Burns, MD, MS Program Manager Pat Laubinger, MPA, BSN Asst. Coordinator Laura Herbelin, BSc Regulatory Core Outreach Core Molly Gunter, MS Director, Regulatory Core Project Management Peter Griffith, JD Budgets/Contracts Jo Denton, MSN Director, Outreach Core HUNT

  29. Website and Contact Information • National / Public Website:www.neuronext.org • KUMC website: http://www.kumc.edu/crc/heartland-unit-for-neuroscience-trials-(hunt).html • Local CTSA-Frontiers Website: www.frontiersresearch.org • Local Clinical Research Center Website: www.kumc.edu/crc.html HUNT

  30. Contact Information • Richard Barohn, MD at 913.588.6094 or rbarohn@kumc.edu • Jeffrey Burns, MD, MS at 913.588.0682 or jburns2@kumc.edu • Pat Laubinger, MPA, BSN at 913.588.0685 or plaubinger@kumc.edu HUNT

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