February 20-21, 2018
Boston, USA
Pre-Conference Workshop Day
Monday 20th February, 2016
09.00 - 15.40
A Trans-Continental Pre-Competitive Public-Private Entity Leveraging Open Science to Develop Effective Biomarkers For Use In Drug Development: Dream or Possible Reality?
Dementia due to neurodegenerative diseases has been the graveyard for many promising compounds.
A recent study reported that out of the 244 compounds (413 clinical trials) for the care of Alzheimer’s disease between 2002 and 2012, only one was approved. Alzheimer’s disease drug candidates have 99.6% of the failures rate, more than any disease area (81% for cancer).
Furthermore, Dementia is one of the main medical burdens for the global economy with £350 billion invested each year. Pharma companies need incentives to invest in research with the risk not to find a cure or disease-modifying therapy in the coming years.
The creation of a transcontinental Public-Private entity is a promising solution to speed up research. This will enable harmonized and cross-validated research that can improve the identification of novel biomarkers and effective drug development pathways.
However, this raises many questions such as:
- Is it feasible and realistic?
- How can we create a world class alliance that is able to orchestrate the sharing of pre-competitive pre-clinical and clinical data among industry, regulatory authorities, and academia?
- What would be a reasonable roadmap for this purpose?
The session will review the experience of four successful Public- Private entities created with such a mission at a European and USA level - namely the Innovative Medicine Initiative (IMI), The Coalition Against Major Diseases (CAMD) of C-Path, and the Accelerating Medicines Partnership - Alzheimer’s Disease (AMPAD) and the Global Alzheimer’s Platform Foundation (GAP-NET).
Engage with fellow peers to discuss topics and ways to align the distinct continental Public-Private entities. Share lessons learned, and brainstorm possible solutions towards the creation of a transcontinental Public-Private Entity in this field.
09.00 - 09.10
Chairman’s Opening Remarks
Workshop Leader:
Claudio Babiloni,
Associate Professor , University of Rome “La Sapienza”
Claudio Babiloni, Associate Professor , University of Rome “La Sapienza”
09.10 - 09.40
Alzheimer’s Disease – Not Only a Development Challenge!
Workshop Leader:
Sam Agus, Chief Specialist,
Medical Affiars, Neurology, H. Lundbeck A/S
- What happens when a disease modifying treatment (DMT) is approved?
- How many patients will get the treatment?
- The biggest gap is, understanding who is the patient
Sam Agus, Chief Specialist, Medical Affiars, Neurology, H. Lundbeck A/S
A board certified neurologist with training in neurology and neurosurgery from Israel and a senior medical affairs leader.
Joined the pharma industry in 2001, as a consultant to early-stage biotech companies. Then moved to mid to large size pharma companies, including: Teva Pharmaceuticals, Solvay Pharmaceuticals, Abbott Labs, Shire and Lundbeck.
Carried leadership positions in clinical development and medical affairs in various therapy areas: Neurology, Psychiatry, Gastroenterology, Women’s Health and a number of rare diseases.
Has worked on global and regional projects and brands in all development and life-cycle stages, with a special focus on: strategic planning and execution, clinical studies, patient-centric data generation, scientific communications, medical education and information, advocacy, business development and change management
10.40 - 11.00
Morning Refreshments & Networking
11.00 - 11.20
Public-Private Partnerships Through the Innovative Medicines Initiative (IMI)
Workshop Leader:
Andrew Satlin, M.D.,
Executive Vice-President, Head of Clinical Development, Neurology Business Group, Eisai
Andrew Satlin, M.D., Executive Vice-President, Head of Clinical Development, Neurology Business Group, Eisai
| Dr. Andrew Satlin serves as executive vice-president and head of Global Clinical Development in the Neurology Business Group at Eisai Inc., the U.S. subsidiary of Eisai Co., Ltd. In this role, which he has held since April 2013, Dr. Satlin is responsible for clinical development plans, biomarker strategies, and the operational excellence of all global drug development projects for Eisai’s Neurology Business Group. A graduate of Yale University and Harvard Medical School, Dr. Satlin trained in psychiatry and geriatric psychiatry at McLean Hospital in Belmont, Mass. As director of Geriatric Psychiatry at McLean, he conducted NIA-sponsored research on behavioral disorders associated with dementia and established an outpatient dementia clinic, where he conducted several industry-sponsored clinical trials. Dr. Satlin is board-certified in psychiatry by the American Board of Psychiatry and Neurology. He is a member of numerous scientific organizations, and has published widely in many medical and scientific fields. Dr. Satlin currently serves on the executive committee and as co-chair of the Scientific Challenges work package for the IMI-funded European Prevention of Alzheimer’s Dementia (EPAD) project consortium, and is Eisai’s representative on the Pharmaceutical Research and Manufacturers of America (PhRMA) Clinical and Preclinical Development Committee (CPCDC). |
11.20 - 11.40
The Accelerating Medicines Partnership-Alzheimer’s Disease (AMP-AD) as a Public-Private Space for Pre-clinical Validation in Drug Discovery in USA
Workshop Leader:
Michael Hutton, Ph.D,
CSO, Neurodegeneration, Eli Lilly & Company Ltd
Michael Hutton, Ph.D, CSO, Neurodegeneration, Eli Lilly & Company Ltd
Michael Hutton Ph.D. – Distinguished Research Fellow and CSO, Neurodegenerative Disease, Eli Lilly
Michael Hutton joined Eli Lilly as Chief Scientific Officer for Neurodegenerative Disease in 2009 and was appointed UK Site Scientific Leader in 2012. He is based at Lilly’s Research Centre in Surrey, England and leads drug discovery for Alzheimer’s Disease, Parkinson’s Disease and ALS. Lilly’s Alzheimer’s Disease Portfolio currently has seven experimental therapies in clinical development that target amyloid, tau and symptom relief. Prior to joining Lilly, Dr Hutton worked at Merck and at the Mayo Clinic Jacksonville as Professor of Neuroscience (11yrs). During his time at Mayo, Dr Hutton’s team played a major role in determining the causes of Fronto-temporal Dementia with the discovery mutations in tau and progranulin and the mechanism by which these lead to neurodegeneration. He has received the Potamkin and Metlife Prizes for his work on Alzheimer’s Disease and Fronto-temporal Dementia. Dr Hutton has published over 200 papers in peer reviewed journals and is a regular speaker at international conferences on Alzheimer’s Disease and related neurodegenerative conditions.
11.40 - 12.00
Foundational Regulatory Science Provides Actionable Solutions for Unmet Needs in Alzheimer Disease
Workshop Leader:
Stephen P Arnerić, PhD,
Executive Director, Coalition Against Major Diseases (CAMD)
• Examples highlighting the impact that could not have been achieved by one individual organization alone
• Exploring CAMD development of global consensus clinical data standards for Alzheimer’s disease (CDISC) including:
-Development of unified clinical trial database consisting of placebo data from multinational clinical trials
-Regulatory qualification and endorsment for neuroimaging biomarkers for enrichment in early AD clinical trials
Stephen P Arnerić, PhD, Executive Director, Coalition Against Major Diseases (CAMD)
Dr. Arneric joined the Critical Path Institute in June 2015 to lead CAMD, a consortium that advances the regulatory science for Drug Development Tools required to accelerate treatments for Alzheimer Disease, and related neurodegenerative disorders with impaired cognition and function.
Previously he was VP Research & Preclinical Development at Neuromed Pharmaceuticals, Chief Scientific Officer of the Pain & Migraine Drug Hunting Team at Lilly, and held senior management positions at Pfizer, Pharmacia, DuPont Pharmaceuticals, and Abbott. He has extensive leadership and scientific expertise in the areas of neurology, pain, psychiatry and urology, and over the last 25 years his teams have delivered more than 30+ drug candidates into clinical development. Dr. Arneric has also had late stage product experience with Mirapex™, Exalgo™, Lyrica™, Cymbalta™ and Detrol™. As a medical educator he has experience teaching medical students, graduate students, and neuroscience medical liaisons. Currently he is Adjunct Professor of Pharmacology, SIU School of Medicine, and Research Professor of Medicine, University of Arizona.
Dr. Arneric earned his Bachelor of Science degree in Physical Sciences (Lyman Briggs College, Michigan State University), his PhD in Pharmacology (University of Iowa) and Post-doctoral training at Cornell Medical College (New York Hospital). He is an accomplished author with 146 peer-reviewed articles, 201 abstracts, 17 chapters, 1 book, numerous IND submissions, as well as a co-inventor of 15 patents. He is also President of Horizons Pharma Consulting, LLC.
12.00 - 12.20
Global Alzheimer’s Platform Foundation (GAP-NET) as a Public- Private Space for Coordinating Stakeholders Initiatives Against Alzheimer’s Disease in USA
Workshop Leader:
Richard Mohs,
Chief Scientific Officer, GAP Foundation
Richard Mohs, Chief Scientific Officer, GAP Foundation
12.20 - 13.30
Lunch & Networking
13.30 - 15.00
Workshop Discussion with Audience
Workshop Leader:
Sam Agus, Chief Specialist,
Medical Affiars, Neurology, H. Lundbeck A/S
Workshop Leader:
Stephen P Arnerić, PhD,
Executive Director, Coalition Against Major Diseases (CAMD)
Workshop Leader:
Richard Mohs,
Chief Scientific Officer, GAP Foundation
Workshop Leader:
Andrew Satlin, M.D.,
Executive Vice-President, Head of Clinical Development, Neurology Business Group, Eisai
Workshop Leader:
Michael Hutton, Ph.D,
CSO, Neurodegeneration, Eli Lilly & Company Ltd
Sam Agus, Chief Specialist, Medical Affiars, Neurology, H. Lundbeck A/S
A board certified neurologist with training in neurology and neurosurgery from Israel and a senior medical affairs leader.
Joined the pharma industry in 2001, as a consultant to early-stage biotech companies. Then moved to mid to large size pharma companies, including: Teva Pharmaceuticals, Solvay Pharmaceuticals, Abbott Labs, Shire and Lundbeck.
Carried leadership positions in clinical development and medical affairs in various therapy areas: Neurology, Psychiatry, Gastroenterology, Women’s Health and a number of rare diseases.
Has worked on global and regional projects and brands in all development and life-cycle stages, with a special focus on: strategic planning and execution, clinical studies, patient-centric data generation, scientific communications, medical education and information, advocacy, business development and change management
Stephen P Arnerić, PhD, Executive Director, Coalition Against Major Diseases (CAMD)
Dr. Arneric joined the Critical Path Institute in June 2015 to lead CAMD, a consortium that advances the regulatory science for Drug Development Tools required to accelerate treatments for Alzheimer Disease, and related neurodegenerative disorders with impaired cognition and function.
Previously he was VP Research & Preclinical Development at Neuromed Pharmaceuticals, Chief Scientific Officer of the Pain & Migraine Drug Hunting Team at Lilly, and held senior management positions at Pfizer, Pharmacia, DuPont Pharmaceuticals, and Abbott. He has extensive leadership and scientific expertise in the areas of neurology, pain, psychiatry and urology, and over the last 25 years his teams have delivered more than 30+ drug candidates into clinical development. Dr. Arneric has also had late stage product experience with Mirapex™, Exalgo™, Lyrica™, Cymbalta™ and Detrol™. As a medical educator he has experience teaching medical students, graduate students, and neuroscience medical liaisons. Currently he is Adjunct Professor of Pharmacology, SIU School of Medicine, and Research Professor of Medicine, University of Arizona.
Dr. Arneric earned his Bachelor of Science degree in Physical Sciences (Lyman Briggs College, Michigan State University), his PhD in Pharmacology (University of Iowa) and Post-doctoral training at Cornell Medical College (New York Hospital). He is an accomplished author with 146 peer-reviewed articles, 201 abstracts, 17 chapters, 1 book, numerous IND submissions, as well as a co-inventor of 15 patents. He is also President of Horizons Pharma Consulting, LLC.
Richard Mohs, Chief Scientific Officer, GAP Foundation
Andrew Satlin, M.D., Executive Vice-President, Head of Clinical Development, Neurology Business Group, Eisai
| Dr. Andrew Satlin serves as executive vice-president and head of Global Clinical Development in the Neurology Business Group at Eisai Inc., the U.S. subsidiary of Eisai Co., Ltd. In this role, which he has held since April 2013, Dr. Satlin is responsible for clinical development plans, biomarker strategies, and the operational excellence of all global drug development projects for Eisai’s Neurology Business Group. A graduate of Yale University and Harvard Medical School, Dr. Satlin trained in psychiatry and geriatric psychiatry at McLean Hospital in Belmont, Mass. As director of Geriatric Psychiatry at McLean, he conducted NIA-sponsored research on behavioral disorders associated with dementia and established an outpatient dementia clinic, where he conducted several industry-sponsored clinical trials. Dr. Satlin is board-certified in psychiatry by the American Board of Psychiatry and Neurology. He is a member of numerous scientific organizations, and has published widely in many medical and scientific fields. Dr. Satlin currently serves on the executive committee and as co-chair of the Scientific Challenges work package for the IMI-funded European Prevention of Alzheimer’s Dementia (EPAD) project consortium, and is Eisai’s representative on the Pharmaceutical Research and Manufacturers of America (PhRMA) Clinical and Preclinical Development Committee (CPCDC). |
Michael Hutton, Ph.D, CSO, Neurodegeneration, Eli Lilly & Company Ltd
Michael Hutton Ph.D. – Distinguished Research Fellow and CSO, Neurodegenerative Disease, Eli Lilly
Michael Hutton joined Eli Lilly as Chief Scientific Officer for Neurodegenerative Disease in 2009 and was appointed UK Site Scientific Leader in 2012. He is based at Lilly’s Research Centre in Surrey, England and leads drug discovery for Alzheimer’s Disease, Parkinson’s Disease and ALS. Lilly’s Alzheimer’s Disease Portfolio currently has seven experimental therapies in clinical development that target amyloid, tau and symptom relief. Prior to joining Lilly, Dr Hutton worked at Merck and at the Mayo Clinic Jacksonville as Professor of Neuroscience (11yrs). During his time at Mayo, Dr Hutton’s team played a major role in determining the causes of Fronto-temporal Dementia with the discovery mutations in tau and progranulin and the mechanism by which these lead to neurodegeneration. He has received the Potamkin and Metlife Prizes for his work on Alzheimer’s Disease and Fronto-temporal Dementia. Dr Hutton has published over 200 papers in peer reviewed journals and is a regular speaker at international conferences on Alzheimer’s Disease and related neurodegenerative conditions.
15.05 - Close of Pre-Conference Workshop Day
