Alzheimer's Disease Summit: The Path to 2025

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.

Gold Sponsors

  • Janssen Pharmaceuticals
  • Eli Lilly and Company
  • Sanofi

 


Presented by

  • The New York Academy of Sciences
  • Global CEO Initiative on Alzheimer's Disease
  • NIH NIA

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
Diana van de Hoef, PhD, The New York Academy of Sciences
Ellis Rubinstein, The New York Academy of Sciences
George Vradenburg, The Global CEO Initiative on Alzheimer's Disease

9:00 AM

Keynote Lectures
Alzheimer's Disease Research Priorities, Milestones, and Partnerships
Richard J. Hodes, MD, National Institute on Aging/NIH

9:15 AM

Industry Perspective On Alzheimer's Disease
Jan M. Lundberg, PhD, Eli Lilly and Company

9:30 AM

Global Perspective
Bengt Winblad, MD, PhD, Karolinska Institutet Alzheimer Disease Research Center

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
Nicholas A. Kozauer, MD, US Food and Drug Administration
Michael Krams, MD, Janssen Pharmaceuticals
Ronald C. Petersen, MD, PhD, Mayo Clinic
Richard A. Rudick, MD, Cleveland Clinic Lerner College of Medicine
Eric R. Siemers, MD, Eli Lilly and Company
Reisa A. Sperling, MD, MMSc, Harvard Medical School

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
Darryle D. Schoepp, PhD, Merck & Company, Inc.
Dale Schenk, PhD, Prothena
Claudio Soto, PhD, The University of Texas Medical School at Houston
Rudolph E. Tanzi, PhD, Harvard Medical School

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
Ijad Madisch, MD, PhD, ResearchGATE
Tetsuyuki Maruyama, PhD, Takeda
Paulo Fontoura MD, PhD, pRED Roche Pharmaceuticals
Michael T. Ropacki, PhD, Janssen Alzheimer Immunotherapy R&D, LLC
Gustavo Stolovitsky, PhD, IBM

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
David M. Holtzman, MD, Washington University
Maria Isaac, MASc, MD, PhD, European Medicines Agency
Clifford R. Jack, Jr, MD, Mayo Clinic
Holly D. Soares, PhD, Bristol-Myers Squibb
Diane Stephenson, PhD, C-PATH/CAMD
John Q. Trojanowski, MD, PhD, University of Pennsylvania

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
Bernard H. Munos, MBA, InnoThink Center for Research in Biomedical Innovation
Gregory A. Petsko, DPhil, Weill Cornell Medical College
Andrea Pfeifer, PhD, AC Immune
Gary Romano, MD, PhD, Johnson & Johnson
Michael W. Weiner, MD, University of California San Francisco

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
'Getting to 2025' (Milestones and Momentum)
Yuko Harayama, PhD, Council for Science and Technology Policy, Cabinet Office

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
Robert J. Appel, Appel Associates
Chas Bountra, PhD, University of Oxford
Surya Kolluri, Bank of America
Henry McCance, MBA, Cure Alzheimer's Fund
Liam O'Neil, Merrill Lynch
Gregory C. Simon, JD, Poliwogg Holdings, Inc.
Ben Taylor, Goldman Sachs

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
Martha Brumfield, PhD, Critical Path Institute
Maria C. Carrillo, PhD, Alzheimer's Association
Michel Goldman, MD, PhD, Innovative Medicines Initiative
James C. Greenwood, Biotechnology Industry Organization
Gigi Hirsch, MD, Massachusetts Institute of Technology
David Wholley, MA, Foundation for the National Institutes of Health

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
Moderator: Meryl Comer, Geoffrey Beene Foundation Alzheimer’s Initiative

Maria Freire, PhD, Foundation for the National Institutes of Health
Freda C. Lewis-Hall, MD, Pfizer
Reisa A. Sperling, MD, MMSc, Harvard Medical School
Anne Whitaker, BBA, Sanofi US

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
Jeffrey Hammerbacher, Mount Sinai Medical Center
Kris Joshi, PhD, Oracle
Zaven S. Khachaturian, PhD, PAD2020 - The Campaign to Prevent Alzheimer's Disease by 2020
Peter L. Levin, PhD, Amida Technology Solutions
Shari M. Ling, MD, Centers for Medicare & Medicaid Services
David Schuette, Knowledgent

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
Flagship Study of Ageing (AIBL)
Yuko Harayama, PhD, Council for Science and Technology Policy, Cabinet Office
Raj Long, GE Healthcare
Simon Lovestone, BM, PhD, King’s College London
Donald B. Moulds, PhD, US Department of Health and Human Services
Elettra Ronchi, PhD, Organisation for Economic Co-operation and Development

4:00 PM

Q&A: The Way Forward

4:30 PM

Closing Remarks
Ellis Rubinstein, The New York Academy of Sciences
George Vradenburg, The Global CEO Initiative on Alzheimer’s Disease

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

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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