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PD Biomarkers Agenda

PD Biomarkers Strategic Planning Workshop

May 16-18, 2010
Ritz Carlton Hotel Georgetown
Washington, D.C.
Workshop    Participant List    Executive Summary


Sunday, May 16, 2010

7:00-9:30 p.m.

Lewy Body Working Group Summaries--Lewy Body Biomarker Workshop
James Leverenz, M.D.

Coalition Against Major Diseases (CAMD) Biomarker Presentations to the U.S. Food and Drug Administration and the European Medicines Agency
Louis Kirby, M.D.

Monday, May 17, 2010

8:30-8:45 a.m.
Welcome and Opening Remarks
Story Landis, Ph.D., Director, NINDS
Walter Koroshetz, M.D., Deputy Director, NINDS
8:45–9:30 a.m.
Parkinson’s disease drug development: The need for biomarkers (20 minutes each and 5-minute Q&A)
  • Clinical research perspective: Bernard Ravina, M.D.
  • Industry perspective: Ian Reynolds, Ph.D.
9:30–10:30 a.m.
Panel Discussion (Industry and Academia Perspectives)
How to establish a biologic biomarker for patients with Parkinson’s disease: Synuclein, mitochondrial dysfunction, others
John Trojanowski, M.D., Ph.D. (Clemens Scherzer, M.D.; Ted Dawson, M.D., Ph.D.; David Weiner, M.D.; Samuel Agus, M.D.; Rainer Kuhn, Ph.D.; Steve Hersch, M.D., Ph.D.; Jing Zhang, Ph.D.; Howard Schulman, Ph.D.)
10:30–10:45 a.m.
10:45–11:30 a.m.
Panel Discussion (Industry and Academia Perspectives)
Non-imaging biomarkers: How to discover and validate a marker of disease progression that would be useful in phase 2 clinical trials
Walter Koroshetz, M.D. (Steve Hersch, M.D., Ph.D.; Thierry Sornasse, Ph.D.; Mark Hallett, M.D.; Pieter Muntendam, M.D.; Robert Bowser, Ph.D.; Neil Buckholtz, Ph.D.; Ian Reynolds, Ph.D.; Franz Hefti, Ph.D.; Louis Kirby, M.D.)
11:30–12:00 p.m.
Imaging—Dopamine PET and SPECT for progression in Parkinson’s disease: Moving ahead after disparate results from clinical trials
David Brooks, M.D.
12:00–1:00 p.m.
Lunch (Innogenetics Presentation)
1:00–1:30 p.m.
Functional brain networks as biomakers for Parkinson’s disease
David Eidelberg, M.D.
1:30–2:15 p.m.
Panel Discussion (Industry and Academia Perspectives)
Neuroimaging as a biomarker: Opportunities and challenges for discovery and validation
Ken Marek, M.D. (David Brooks, M.D.; David Eidelberg, M.D.; David Burn, M.D.; David Vaillancourt, Ph.D.; Paul Sherwin, M.D., Ph.D.)
2:15–2:30 p.m.
2:30–3:45 p.m.
Pre-motor biomarkers of Parkinson’s disease: Where do we stand? What is needed to establish pre-motor disease cohorts for clinical trials? (10 minutes for each presentation)
  • Autonomic dysfunction—David Goldstein, M.D., Ph.D.
  • RLS—Xiang Gao, M.D., Ph.D.
  • RBD—Wolfgang Oertel, M.D.
  • Peripheral synuclein measurements—Clemens Scherzer, M.D.
  • Genetic risk factors—Andrew Singleton, Ph.D.
  • Dopamine and structural imaging in pre-symptomatics—David Vaillancourt, Ph.D.
3:45–5:00 p.m.
Panel Discussion (Industry and Academia Perspectives)
Pre-motor biomarkers: How to look earlier in the disease process
Tom Montine, M.D., Ph.D. (Andrew Singleton, Ph.D.; Clemens Scherzer, M.D.; Blair Leavitt, M.D.; David Vaillancourt, Ph.D.; Wolfgang Oertel, M.D.; Xiang Gao, M.D., Ph.D.; David Goldstein, M.D., Ph.D.)
5:00–5:30 p.m.
Summary and Recommendations From Today’s Panels
7:00–9:00 p.m.
Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, FDA, Biomarker Experience for Critical Path Activities
Carolyn Compton, M.D., Ph.D., Director, Office of Biorepositories and Biospecimen Research, National Cancer Institute, National Institutes of Health
Tuesday, May 18, 2010

8:30–10:00 a.m.
Pre- and Early Onset Parkinson’s Disease Cohorts―Updates (10 minutes each)
  • LRRK2 initiatives for genetic and environmental risk factor analysis and potential biomarker development—Susan Bressman, M.D.
  • Family-based Parkinson’s disease cohorts–Progeni—Tatiana Foroud, Ph.D.
  • A study of people with potential risk factors for Parkinson’s disease—David Goldstein, M.D., Ph.D.
  • Cross-sectional study of patterns in early Parkinson’s disease—Mya Schiess, M.D.
  • PARS—Ken Marek, M.D.
  • Core Parkinson’s Disease—Karen Marder, M.D.
  • Pacific Northwest Udall Center Cohort—Tom Montine, M.D., Ph.D.
  • U Penn Udall Center Cohort—John Trojanowski, M.D., Ph.D.
10:30–11:30 a.m.
Panel Discussion (Industry and Academia Perspectives)
Strategy(ies) for Choosing a Cohort for Validation and Discovery
Katrina Gwinn (Carlie Tanner, M.D., Ph.D.; Karen Marder, M.D.; Tom Montine, M.D., Ph.D.; Mya Schiess, M.D.; Susan Bressman, M.D.; Tatiana Foroud, Ph.D.; John Trojanowski, M.D., Ph.D.; Ken Marek, M.D.; Alberto Ascherio, M.D.)
11:30–11:45 p.m.
11:45–12:45 p.m.
Margaret Sutherland, Ph.D.; Debra Babcock, M.D., Ph.D.; Beth-Anne Sieber, Ph.D.
12:45 p.m.

Last Modified October 18, 2015