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Advancing Alzheimer's Innovation: Clinical Development Successes and Challenges
Program Code:
372
Date:
Wednesday, June 26, 2013
Time:
4:00 PM to 5:30 PM
EST
CHAIR
:
Andrew Satlin,
(SCHNON), Executive Vice President,
Eisai Inc., United States
Dr. Satlin is Senior Vice-President and Head of Clinical Development for Neuroscience at Eisai, Inc. He has over 15 years of experience in global drug development in the pharmaceutical industry. He received his MD from Harvard Medical School and trained in psychiatry at McLean Hospital.
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SPEAKER
(S):
Andrew Satlin, (SPKNON), Executive Vice President, Eisai Inc., United States
Reisa A. Sperling,
MD (SPKSUP), Director; Professor, Neurology, Harvard Medical School,
Brigham and Women's Hospital and Massachusetts General Hospital, United States
Prof in Neurology at Harvard and the Dir of the Center for Alzheimer Research and Treatment at Brigham and Women’s Hospital. She is the Principal Investigator on the NIA Program Project funded Harvard Aging Brain Study and the Dir of the Alzheimer’s Disease Neuroimaging Program at Mass General.
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Johan Luthman,
(SPKNON), Senior Program Leader, Early Development Neuroscience & Opthalmology R&D,
Merck & Co., Inc., United States
Sr Prog Lead Early Dev Neurosci & Ophthalm, Merck. Head Neurol, Immunol & Inflam, MerckSerono/Serono, CEO GeNeuro, Astra/AZ Dir Res & Transl Sci Neurol. Medic, dent & PhD Karolinska. Fellow Pharm & Psych Univ CO. Ass prof Neurobiol Karolinska, Prof Pharm Univ Chile. SIMI + Thunderbird, MIT/Sloan
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Description
Drug discovery is hard. In fact, approximately, only 11% of new drugs that enter clinical trials make it to the US market. For central nervous system (CNS) drugs, which includes Alzheimer's, this rate is even lower - only about 8%. The most troubling trend is the rate of failure for Alzheimer's drugs in Phase 3, the final step of the drug development process before regulatory submission.
This session will discuss innovative approaches to clinical trial design, and the use of companion diagnostic testing and biomarkers, to improve the success of clinical trials in Alzheimer's disease and mild cognitive impairment.