
Alzheimer's Disease Summit: The Path to 2025
Wednesday, November 6, 2013 - Thursday, November 7, 2013
The New York Academy of Sciences
Presented By
Presented by The New York Academy of Sciences, National Institute on Aging/NIH and the Global CEO Initiative on Alzheimer's Disease
The Live Stream for this event is no longer available.
Alzheimer's disease (AD) is a large and growing global health, fiscal and economic challenge, one whose current trajectory threatens to destabilize health care systems and economies in both developed and developing nations. Governments in Europe, Asia and North America have committed to making Alzheimer's a global priority, and they have created important engagements with key stakeholders in their efforts. Action must be taken now to avert this crisis by accelerating the development of new AD diagnostics and therapeutics through action-oriented programs.
A primary goal of this critical meeting is to convene leading industry, academic, and government stakeholders to actively participate in discussions regarding how to prevent and effectively treat Alzheimer's by 2025, by coordinating with governmental efforts to build research resources, reengineer our current drug development and evaluation systems, and identify innovative technologies and financing models. The outcome of this meeting will comprise a research agenda that will delineate the pathways needed to effectively treat and prevent Alzheimer's disease by 2025.
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Agenda
* Presentation titles and times are subject to change.
Day 1 — November 6, 2013 | |
8:00 AM | Breakfast and Registration |
8:45 AM | Opening Remarks |
9:00 AM | Keynote Lectures |
9:15 AM | Industry Perspective On Alzheimer's Disease |
9:30 AM | Global Perspective |
9:45 AM | Panel I: The Big Picture |
Industry will share lessons learned from previous clinical trials and articulate needs to design and run successful future trials. This discussion will focus on the infrastructure improvements needed in patient recruitment and enrollment, multisite collaboration, harmonization of methods and protocols, biomarkers, and the regulation needed to dramatically reduce the time, cost and risk of conducting clinical trials. | |
Moderator: Simon Lovestone, BM, PhD, King's College London Howard Feldman, MD, FRCP(C), University of British Columbia | |
11:00 AM | Networking Coffee Break |
11:15 AM | Panel II: Path Towards Diversifying Viable Therapeutic Approaches |
This panel will describe how to advance strong hypotheses that will lead to the development of therapies and treatments by 2025. How can the research milestones developed by NIA/NIH for the National Plan to Address Alzheimer’s, based on recommendations from the 2012 NIH AD Research Summit, be enhanced to ensure prevention and effective treatment of Alzheimer’s by 2025? | |
Moderator: Christopher P. Austin, MD, National Center for Advancing Translational Sciences Lefkos T. Middleton, MD, FRCP, Imperial College, London | |
12:30 PM | Lunch |
1:15 PM | Panel III: Innovative Platforms and Tools |
This panel will identify specific paradigm shifts, technology platforms or other disruptive approaches that would accelerate the breakthroughs needed in scientific research and drug development to achieve the 2025 goal, including open source methods and development of innovative therapeutics. | |
Moderator: Cristin Dorgelo, Office of Science and Technology Policy Allan Jones, PhD, Allen Institute for Brain Science | |
2:15 PM | Panel IV: Characteristics of a Better Biomarker |
What are the characteristics of a biomarker that industry needs/wants for AD that will assure our 2025 goals? We know that validation and qualification of a high performance surrogate biomarker which is rapid readout, predictive, prognostic, and pharmacodynamic would have a tremendous accelerative effect towards 2025. How do we identify, validate and qualify such a surrogate biomarker within the next five years? This panel will identify ways to overcome the barriers to creating specific biomarkers, based on the performance and outcomes measures researchers hope to receive. We hope to gain consensus on the process by which such biomarkers can be validated by the research community and qualified by the regulatory bodies for use in neurodegenerative clinical studies. | |
Moderator: Jeffrey S. Nye, MD, PhD, Janssen R&D Kaj Blennow, MD, PhD, University of Gothenburg | |
3:30 PM | Networking Coffee Break |
3:45 PM | Panel V: Outside the Box Approaches for Drug Development |
This panel will focus on other approaches to reduce the clinical trial timeline, including data sharing and standardization, drug repurposing, combination drug development, patient engagement, surrogate diseases and comorbidity therapies. | |
Moderator: Howard Feldman, MD, FRCP(C), University of British Columbia Samuel E. Gandy, MD, PhD, Mount Sinai School of Medicine | |
4:45 PM | Q&A: Achieving the 2025 goal |
5:15 PM | Closing Remarks Ellis Rubinstein, The New York Academy of Sciences George Vradenburg, The Global CEO Initiative on Alzheimer’s Disease |
5:30 PM | Networking Reception |
6:30 PM | Conclusion of Day 1 |
Day 2 — November 7, 2013 | |
8:00 AM | Breakfast and Registration |
8:45 AM | Keynote Lecture |
9:00 AM | Panel VI: Innovative Models of Funding |
To reach the 2025 goal, innovative funding models must be designed and implemented to advance critical research funding in the Alzheimer's space. Such models should address social, national, international, public, and private financing. | |
Moderator: George Vradenburg, The Global CEO Initiative on Alzheimer's Disease Labeeb M. Abboud, JD, International AIDS Vaccine Initiative/Global Health Investment Fund | |
10:30 AM | Networking Coffee Break |
10:45 AM | Panel VII: Public Private Partnerships |
The outcome of this panel will be a framework for creation of new forms of PPPs and list of policy changes that will facilitate public and private co-investments in precompetitive collaboration to rapidly advance research into improved AD diagnosis and treatment. | |
Moderator: Howard Fillit, MD, Alzheimer's Drug Discovery Foundation Randall Bateman, MD, Washington University | |
12:15 PM | Lunch |
Special Live Vote/Awards Session | |
1:00 PM | Vote online for the 2013 Geoffrey Beene Global NeuroDiscovery Challenge. Voting open November 1–5. |
This panel will highlight efforts into identifying gender-specific differences in early cognitive decline. | |
Introduction: George Vradenburg, The Global CEO Initiative on Alzheimer's Disease Maria Freire, PhD, Foundation for the National Institutes of Health | |
1:45 PM | Panel VIII: IT and Big Data |
This panel will describe a future healthcare system rooted in data standardization and liquidity, electronic health records, and remote monitoring of patients accessible to researchers. | |
Moderator: Andrew Holzapfel, MBA, The Global CEO Initiative on Alzheimer’s Disease Stephen H. Friend MD, PhD, Sage Bionetworks | |
3:00 PM | Panel IX: The Way Forward — Global Action on Alzheimer's Disease |
This panel discussion will outline the key steps we must take, globally, to reach the 2025 goal of preventing and treating Alzheimer’s disease. | |
Moderator: George Vradenburg, The Global CEO Initiative on Alzheimer's Disease David Ames, MD, FRCPsych, FRANZCP, The Australian Imaging, Biomarkers & Lifestyle | |
4:00 PM | Q&A: The Way Forward |
4:30 PM | Closing Remarks |
4:45 PM | Conference Conclusion |
Speakers
Organizers
Alan Cross, PhD
AstraZeneca
website
Howard Feldman, MD, FRCP(C)
University of British Columbia
Surya Kolluri
Bank of America
website
Michael Krams, MD
Janssen R&D
Ian Kremer, JD
Leaders Engaged on Alzheimer's Disease
website
Tetsuyuki Maruyama, PhD
Takeda
Richard C. Mohs, PhD
Eli Lilly and Company
website
Jeffrey S. Nye, MD, PhD
Janssen R&D
website
Ronald C. Petersen, MD, PhD
Mayo Clinic
website
Gregory A. Petsko, DPhil
Weill Cornell Medical College
website
Andrea Pfeifer, PhD
AC Immune
website
Thomas Rooney, PhD
Sanofi
Darryle D. Schoepp, PhD
Merck and Company, Inc.
website
Diane Stephenson, PhD
Critical Path Institute
website
Rudolph E. Tanzi, PhD
Harvard Medical School
John Q. Trojanowski, MD, PhD
University of Pennsylvania
Diana L. van de Hoef, PhD
The New York Academy of Sciences
George Vradenburg
The Global CEO Initiative on Alzheimer's Disease
website
Michael Weiner, MD
University of California, San Francisco
website
NIA Technical Advisor
Neil Buckholtz, PhD
National Institute on Aging/NIH
Keynote Speakers
Yuko Harayama, PhD
Council for Science and Technology Policy, Cabinet Office
website
Richard J. Hodes, MD
National Institute on Aging/NIH
website
Jan M. Lundberg, PhD
Eli Lilly and Company
website
Bengt Winblad, MD, PhD
Karolinska Institutet
Speakers
Labeeb M. Abboud, JD
International AIDS Vaccine Initiative
David Ames, MD
FRCPsych, FRANZCP, The Australian Imaging, Biomarkers & Lifestyle Flagship Study of Ageing
Robert J. Appel
Appel Associates
website
Christopher P. Austin, MD
National Center for Advancing Translational Sciences
Randall Bateman, MD
Washington University
Kaj Blennow, MD, PhD
University of Gothenburg
website
Chas Bountra, PhD
University of Oxford
website
Martha Brumfield, PhD
Critical Path Institute
website
Maria C. Carrillo, PhD
Alzheimer's Association
Meryl Comer
Geoffrey Beene Foundation Alzheimer's Initiative
website
Cristin Dorgelo
Office of Science and Technology Policy
Howard Feldman, MD, FRCP(C)
University of British Columbia
Howard Fillit, MD
Alzheimer's Drug Discovery Foundation
website
Paulo Fontoura MD, PhD
pRED Roche Pharmaceuticals
Maria Freire, PhD
Foundation for the National Institutes of Health
Stephen H. Friend MD, PhD
Sage Bionetworks
Michel Goldman, MD, PhD
Innovative Medicines Initiative
website
James C. Greenwood
Biotechnology Industry Organization
website
Jeffrey Hammerbacher
Mount Sinai Medical Center
website
Gigi Hirsch, MD
Massachusetts Institute of Technology
website
David M. Holtzman, MD
Washington University
Andrew Holzapfel, MBA
The Global CEO Initiative on Alzheimer's Disease
website
Maria Isaac, MASc, MD, PhD
European Medicines Agency
website
Clifford R. Jack, Jr, MD
Mayo Clinic
website
Allan Jones, PhD
Allen Institute for Brain Science
Kris Joshi, PhD
Oracle
Zaven S. Khachaturian, PhD
PAD2020 - The Campaign to Prevent Alzheimer's Disease by 2020
website
Surya Kolluri
Bank of America
website
Nicholas A. Kozauer, MD
US Food and Drug Administration
website
Michael Krams, MD
Janssen Pharmaceuticals
website
Peter L. Levin, PhD
Amida Technology Solutions
website
Freda C. Lewis-Hall, MD
Pfizer
website
Shari M. Ling, MD
Centers for Medicare & Medicaid Services
website
Raj Long
GE Healthcare
Simon Lovestone, BM, PhD
King's College London
website
Ijad Madisch, MD, PhD
ResearchGATE
website
Tetsuyuki Maruyama, PhD
Takeda
Henry McCance, MBA
Cure Alzheimer's Fund
website
Lefkos T. Middleton MD, FRCP
Imperial College, London
website
Donald B. Moulds, PhD
US Department of Health and Human Services
Bernard H. Munos, MBA
InnoThink Center for Research in Biomedical Innovation
website
Jeffrey S. Nye, MD, PhD
Janssen R&D
website
Liam O'Neil
Merrill Lynch
Ronald C. Petersen, MD, PhD
Mayo Clinic
website
Gregory A. Petsko, DPhil
Weill Cornell Medical College
website
Andrea Pfeifer, PhD
AC Immune
website
Gary Romano, MD, PhD
Johnson & Johnson
Elettra Ronchi, PhD
Organisation for Economic Co-operation and Development
website
Michael T. Ropacki, PhD
Janssen Alzheimer Immunotherapy R&D, LLC
website
Richard A. Rudick, MD
Cleveland Clinic Lerner College of Medicine
website
Dale Schenk, PhD
Prothena
Darryle D. Schoepp, PhD
Merck & Co.
website
David Schuette
Knowledgent
website
Eric R. Siemers, MD
Eli Lilly and Company
website
Gregory C. Simon, JD
Poliwogg Holdings, Inc
Holly D. Soares, PhD
Bristol-Myers Squibb
website
Claudio Soto, PhD
The University of Texas Medical School at Houston
Reisa A. Sperling, MD, MMSc
Harvard Medical School
website
Diane Stephenson, PhD
C-PATH/CAMD
website
Gustavo Stolovitsky, PhD
IBM
website
Rudolph E. Tanzi, PhD
Harvard Medical School
Ben Taylor
Goldman Sachs
John Q. Trojanowski, MD, PhD
University of Pennsylvania
Michael W. Weiner, MD
University of California San Francisco
website
Anne Whitaker, BBA
Sanofi US
David Wholley, MA
Foundation for the National Institutes of Health
Sponsors
Gold Sponsors
Silver Sponsors
Bronze Sponsors
Promotional Partners
American Journal of Alzheimer's Disease and Other Dementias
European Alzheimer's Disease Consortium
Journal of Alzheimer's Disease
Leaders Engaged on Alzheimer's Disease
Presented by
Abstracts
Alzheimer's Disease Research Priorities, Milestones, and Partnerships
Richard J. Hodes, MD, National Institute of Health
A goal of the United States National Alzheimer’s Plan is the development of a research strategy to accelerate progress toward identifying effective interventions to treat or prevent Alzheimer’s disease and related dementias. To achieve this end, the National Institutes of Health convened an international research summit in May of 2012. Experts from academic, government, and industrial sectors developed a set of research recommendations involving basic biological and behavioral research, translational, and clinical initiatives. Milestones were subsequently specified to enable tracking of progress over time in pursuit of these specific research directions. The National Institute on Aging and the Alzheimer’s Association collaboratively developed an ontology that allows detailed characterization of Alzheimer’s research, and this was used to construct an on-line public database aimed at providing information about all internationally funded research, thus facilitating planning, tracking, and coordination of research efforts. Over the past year, these priorities, milestones, and the data base have guided intensified NIH research efforts. Expanded partnerships have been created to leverage national and international public and private efforts. These efforts include NIH discussions with industrial and philanthropic partners to address collaborations in AD research; the current 2013 Alzheimer’s disease summit; and the December 11 G-8 Dementia Summit. These efforts and those to come will enable a dynamic and accountable process in pursuit of effective Alzheimer’s disease treatment and prevention.
Industry Perspective On Alzheimer's Disease
Jan M. Lundberg, PhD, Eli Lilly and Company
There is a large, growing and urgent unmet medical need in Alzheimer's Disease (AD). For 25 years, Lilly has been committed to discovering and developing potential new treatments for symptomatic treatment or delaying the progression of AD. There are breakthroughs in disease understanding and increasingly opportunities to tailor new therapeutic agents to the right patient and stage of disease. Furthermore, we need to evolve clinical measures of relevant cognition and functional changes. We now have a pipeline of potential medicines and diagnostics targeting the two known hallmarks of the disease – amyloid beta plaques and tau tangles. Currently, Lilly has a number of preclinical programs and one amyloid beta antibody, Solanezumab in phase III and a plaque specific antibody (N3PG) in phase I. Additionally, we have efforts in diagnostics for amyloid beta plaques and tau tangles, which include Amyvid, an approved PET imaging agent to estimate beta-amyloid plaque density in the brain.
The challenge of the current treatment paradigm is that it is late and based on what are observable symptoms. Diagnosis happens late and pending progress lies in early identification, diagnosis and treatment. There is a need to broaden the understanding of the AD pathology and its time course. Furthermore, we need diagnostic and therapeutic advances from symptomatic to prevention and stopping progression to retain quality of life. Our recent pooled data from Expedition 1 and 2 trials for Solanezumab in mild AD showed a 34% reduction in cognitive decline at 80 weeks with an acceptable safety profile. Our next started Expedition 3 phase III trial is focused on mild patients and only patients with amyloid pathology will be included to exclude patients whose dementia does not appear to progress. We are working closely with NIH, academic researchers, policy makers, patient advocates, and regulatory agencies to make further progress. Public/private partnerships will be critical, such as DIAN and A4 to continue to make progress and work together in meaningful ways to make AD preventable.
Keynote Lecture: Global Perspective
Bengt Winblad, Karolinska Institutet Alzheimer Disease Research Center
In 2012, the World Health Organization presented a report where Alzheimer Disease (AD) and other dementias should be regarded as a global public health priority. A similar policy declaration has been presented by the European Union and USA. The main reason for these policy declarations is the awareness of trends that sometimes are described as a “time-bomb”. In 2010, the number of people affected by dementia worldwide was estimated to 36 million, with an estimated cost of approx 600 bUSD. The prevalence of dementia is expected to reach 115 million in 2050, with an equivalent cost increase.
The progressive nature of dementia influences the whole life situation for families during several years-decades and so far, no cure or highly significant symptom relieving treatment is available. Increased understanding of the pathophysiology of AD has given us new therapeutic targets, and by using new biomarkers possibilities to diagnose patients earlier.
The last drug to enter the market place was in 2002. Since then, many products in different development phases have failed. Why? Wrong molecules, inappropriate animal models, inappropriate proof-of-concept studies, heterogeneous patient groups, too advanced disease, non-relevant outcome measures, inter-center variability in increasingly globalised multi-centre trials?
Our hope for the future is not only to give the patient an early symptomatic relief but that new therapies could potentially slow or even halt the progression of the disease. Increased global collaboration between academia, industry and regulatory authorities is a vital step for a successful drug development.
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