2010 Annual Meeting

ASENT's 12th Annual Meeting

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Thursday, March 4, 2010

Challenges in Conducting Drug Trials

Title Speaker(s) Duration Presentation Audio Video
Clinical Trial Methods: Reducing the Challenges in Conducting Clinical Trials Dave Zuckerman 19 min Presentation Audio  
IRB, Contract & Recruitment Issues Jacqueline A French MD for Joyce Cramer 22 min. 33 sec. Presentation Audio  
Trial Design Complexity and its Impact on Study Conduct Performance Ken Getz, Tufts CSDD 19 min. 0 sec. Presentation Audio  

Challenges in Conducting International Trials

Title Speaker(s) Duration Presentation Audio Video
Challenges in Conducting International Trials Trial Methods and Designs Differences from US based Trials Virinder Nohria, MD, PhD 17 min. 38 sec. Presentation Audio  
Challenges in Conducting International Trials - Trans-Regional Regulatory Issues Gene Wright, PharmD, PhD 20 min. 58 sec. Presentation Audio  

Post Marketing Trials

Title Speaker(s) Duration Presentation Audio Video
Changing Postmarket Landscape for Medical Devices Danica Marinac-Dabic, MD, PhD 25 min. 28 sec. Presentation Audio  
Industry Perspective and Response Nancy Santilli, BSN, MSN 21 min. 04 sec. Presentation Audio  

Challenges in Conducting Device Trials

Title Speaker(s) Duration Presentation Audio Video
Neurotherapeutic Devices: How Do Drugs and Devices Differ? Martha Morrell MD for Nina Graves PharmD 30 min. 09 sec. Presentation Audio  

Special Issues Conducting Drug Trials: Suicide Risk Associated with Neurological Therapies - Point/Counterpoint

Title Speaker(s) Duration Presentation Audio Video
Special Issues in Conducting Drug Trials: Suicide Risk Associated with Neurological Therapies There is a Significant Risk Russell Katz, M.D.   Presentation    
The Risk Is Overstated Dale C. Hesdorffer, Ph.D.   Presentation    

Conducting Trials in Vulnerable Populations

Title Speaker(s) Duration Presentation Audio Video
Ethical consideration in Conducting trials in Vulnerable Populations Barbara Illowsky Karp, MD   Presentation    
14 - Challenges in Conducting Device Trials - What Does the Future Hold for Device Trials? Panel Discussion   Presentation    
Pregnancy Registries John Messenheimer, MD   Presentation    

Dinner Session: Drug Development: Overcoming Challenges in the Road Ahead

Title Speaker(s) Duration Presentation Audio Video
What Does it Really Cost to Develop a New Treatment? Kenneth I Kaitin, Ph.D. 12 min. 01 sec. Presentation Audio  
Alleviating Burdens in Drug Development:The Clinical Trials Transformation Initiative (CTTI) Alberto Grignolo, Ph.D 14 min. 16 sec. Presentation Audio  
Innovative Strategies for Drug Development in Small Target Populations Frank L. Douglas Ph.D., M.D. 13 min. 59 sec. Presentation Audio  

Friday, March 5, 2010

A: Drug Development: Challenges, Consortia and CROs

Title Speaker(s) Duration Presentation Audio Video
Review of New Drug Development - Challenges for the Research-Based Industry Kenneth I Kaitin, Ph.D. 43 min. 49 sec. Presentation Audio  
Contract Research Organizations: How to Select, Problems and Experiences Christopher C. Gallen, M.D., Ph.D. 41 min. 45 sec. Presentation Audio  
The Duke Clinical Research Institute: An Academic Research Organization (ARO) John S. March, MD, MPH, 45 min. 55 sec. Presentation    
Academic Consortia: Clinical Trial Networks Karl Kieburtz, MD, MPH 27 min. 22 sec. Presentation Audio  
Consortia: An Industry Perspective R. Michael Poole MD FACP 24 min. 54 sec. Presentation Audio  

Pipeline Projects - NIH/NINDS Support for Drug Development

Title Speaker(s) Duration Presentation Audio Video
Therapeutic Development Resources at NINDS: Office of Translational Research William Matthew, PhD   Presentation    
A New Program to Support Drug Development: The Blueprint for Neuroscience Grand Challenge for Neurotherapeutics Rebecca Farkas, PhD   Presentation    

Pipeline Projects - Multiple Sclerosis/Motor Neuron Disease

Title Speaker(s) Duration Presentation Audio Video
Laquinimod, an Oral Product in Development for the Treatment of Relapsing Remitting Multiple Sclerosis Stephen Glenski, PharmD   Presentation    
Novel Compounds for the Treatment of Spinal Muscular Atrophy Jill Heemskerk, PhD   Presentation    

Pipeline Projects - Alzheimer's Disease, Neuroprotection and Cognition

Title Speaker(s) Duration Presentation Audio Video
CREB & The Development of Novel Memory Enhancers Tim Tully, PhD   Presentation    
Clinical development of davunetide in AD and cognitive impairment Alistair Stewart, PhD   Presentation    
AAV2-NRTN (CERE-120) In Parkinson's Disease: Phase 2 Trial Results And Path Forward Joao Siffert, MD   Presentation    

Pipeline Project - Partnerning with Large Pharma

Title Speaker(s) Duration Presentation Audio Video
Merck Research Laboratories Susan P. Rohrer, PhD   Presentation    

Pipeline Projects - Pain and Migraine

Title Speaker(s) Duration Presentation Audio Video
LEVADEX™, a Novel Orally Inhaled Treatment for Acute Migraine: Efficacy and Tolerability Results of a Phase 3 Study Shashidhar H Kori, MD   Presentation    
Sodium Oxybate in the Treatment of Fibromyalgia: Results from an International Phase 3 Clinical Trial Norman Rosenthal, MD   Presentation    
Overview of the Clinical Development EMBEDA™ (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules for oral use. Paul D. Meisner, PharmD   Presentation    

Pipeline Projects - Movement Disorders and Neuromuscular

Title Speaker(s) Duration Presentation Audio Video
Acetyl Hexapeptide-8 for Treatment of Blepharospasm Codrin Lungu, MD   Presentation    
Biomarker Development for HDAC Inhibitor Treatment of Friedreich’s Ataxia James Rusche, PhD   Presentation    
IMMUNOMODULATORY THERAPY FOR PARKINSON’S DISEASE - Induction of an anti-inflammatory immune response toward toxic species of alpha-synuclein Eric Zanelli, PhD   Presentation    
Human Pharmacokinetics of NBI-98854: A Selective Inhibitor of VMAT2 with an Attractive PK and Safety Profile for Hyperkinetic Movement Disorders Ajay Madan, PhD   Presentation    
Mitigating Effects of Oxidation in Aging and Diseases M. Shchepinov, R.J. Molinari *, V. Shmanai, C. Clarke, A. Manning-Bog   Presentation    

Pipeline Projects - Epilepsy

Title Speaker(s) Duration Presentation Audio Video
Intrapulmonary Propofol Analogs Michael A. Rogawski, M.D., Ph.D.   Presentation    
The NeuroPace RNS® System: Results of a Multicenter Double-Blinded Randomized Controlled Pivotal Investigation for Treatment of Intractable Partial Epilepsy Martha J Morrell MD   Presentation    
Novel Series of Antiseizures Compounds Roger Porter, MD for Stephen Collins, MD   Presentation    
An Overview of Eslicarbazepine Acetate (ESL) as Adjunctive Therapy for Partial-Onset Seizures Mark Versavel MD, PhD, MBA   Presentation    
Oxcarbazepine Extended Release - OXC XR Janet K. Johnson, Ph.D.   Presentation    
2DG - a glucose analogue and glycolytic inhibitor with anticonvulsant and antiepileptic actions Tom Sutula, MD, PhD   Presentation    

Saturday, March 6, 2010

Symposium: Comparative Effectiveness

Title Speaker(s) Duration Presentation Audio Video
Comparative effectiveness: What is it? Jacqueline A French MD 19 min. 09 sec. Presentation Audio  
ACTIVE CONTROL EQUIVALENCE TRIALS: GETTING IT RIGHT Susan S. Ellenberg, Ph.D. 35 min. 19 secs. Presentation Audio  
Regulatory Aspects of Comparative Trials Russell Katz, M.D. 45 min. 55 sec. Presentation Audio  
Guidelines and Comparative Effectiveness trials - A different Perspective Gary S Gronseth, MD, FAAN 42 min. 26 sec. Presentation Audio  
Health Economic Implications of Comparative Effectiveness: Will it Affect Who Will Pay for What and What Will be Available? Walter Koroshetz, MD 48 min. 49 sec. Presentation Audio