CSF biomarker variability in the Alzheimer’s Association quality control program

May 2013 -

Niklas Mattsson, Ulf Andreasson, Staffan Persson, Maria C. Carrillo, Steven Collins, Sonia Chalbot, Neal Cutler, Diane Dufour-Rainfray, Anne M. Fagan, Niels H. H. Heegaard, Ging-Yuek Robin Hsiung, Bradley Hyman, Khalid Iqbal, et al.

The Development of a Data Dictionary and Syntax for Optimizing the Utilization of the Coalition Against Major Diseases (CAMD) Alzheimer’s Disease Clinical Trial Database

Jul 2012 -

Lisle R. Kingery, Ph.D., Beth Friedmann, Psy.D., Erin Kornsey, M.A., Neal R, Cutler, M.D. & Henry J. Riordan, Ph.D. - Presented at the Alzheimer’s Association International Conference, 2012 (PDF)

Reliability and Reliable Change of the CAARS Self-Report Short Version and Observer Screening Version Scales in an Adult ADHD Clinical Trial

Jun 2012 -

Lisle Kingery, Ph.D., Beth Friedmann, Psy.D., Erin B. Kornsey, M.S., Cordelia Zakrajsek, M.Ph., Neal R. Cutler, M.D., Henry J. Riordan, Ph.D. – Presented at NCDEU 2012: An American Society of Clinical Psychopharmacology meeting (PDF)

CSF Sample Acquisition and Analyses for Translational Research Purposes

May 2012 -

Henry J. Riordan, Ph.D., Michael F. Murphy, M.D., Ph.D., William Nowatzke, Ph.D., Mark Leibowitz, M.D. & Neal R. Cutler, M.D. - Abstract presented at the 12th International Springfield / Stockholm Symposium on Advances in Alzheimer’s Therapy 2012 (PDF)

Quantitative Analysis of Cognitive and Imaging Biomarkers in Schizophrenia Medication Trials

Apr 2012 -

Henry J. Riordan, Ph.D., Paul J. Moberg, Ph.D., Kathy Dawson, Ph.D., Neal R. Cutler, M.D. - Presented at Cognition in Schizophrenia 2012: A Satellite Meeting of the Schizophrenia International Research Society (PDF)

A Randomized Crossover Study of the Sleep Effects of Naltrexone in Healthy Normal Subjects

Apr 2012 -

Mark Leibowitz M.D., James M. Andry M.D., Henry J. Riordan Ph.D., John Sramek Pharm.D. & Neal R. Cutler M.D - Presented at the Society of Biological Psychiatry, 2012 Annual Meeting (PDF)

Meta-Analysis of Structural Magnetic Resonance Imaging (sMRI) Biomarkers In Schizophrenia Medication Trials

Feb 2012 -

Henry J. Riordan, Ph.D., Kathy Dawson, Ph.D., Neal R. Cutler, M.D., Chwen-Cheng Nathan Chen, M.D., Ph.D., Steven Potkin, M.D. & Susan DeSanti, Ph.D. - Presented at the International Society for CNS Clinical Trials and Methodology meeting (PDF)

The Death of CNS Drug Development: Overstatement or Omen?

Dec 2011 -

Neal R. Cutler M.D., Henry J. Riordan Ph.D. - Journal for Clinical Studies Vol 3 (6) pp 12-15 (PDF)

Postapproval Development Options in COPD A Case Study in Value-Based Healthcare Systems

Oct 2011 -

Michael F. Murphy, MD, PhD; Paola Antonini, MD, PhD; Zhihong Vicki Lai, PhD

Stakeholder Perspective: Medical Claims Data Can Inform Coverage Decisions in Managed Care Health Plans

Oct 2011 -

Michael F. Murphy, MD, PhD (American Health & Drug Benefits; 4(6):361)

Updated Diagnostic Criteria for Alzheimer’s Disease: Implications for Clinical Trials

Sep 2011 -

Henry J. Riordan, Ph.D., Erin B. Kornsey, M.S. - Journal for Clinical Studies Vol 3 (5) pp 12-15 (PDF)

Atypical Antipsychotics and Metabolic Syndrome in Patients with Schizophrenia: Risk Factors, Monitoring, and Healthcare Implications

Sep 2011 -

Henry J. Riordan, PhD; Paola Antonini, MD, PhD; Michael F. Murphy, MD, PhD (American Health & Drug Benefits; 4(5):292-302)

Evaluation of Beta Amyloid Loss to CSF Sample Collection and Storage Containers

Jul 2011 -

Henry J. Riordan, Ph.D., Yoka Thomas, Neal R. Cutler,M.D., Mark Leibowitz, M.D., Kathryn Rogers, Kathryn Dawson, Ph.D., Michele Malone, Steve Unger, Ph.D., William Nowatzke, Ph.D. Presented at the Alzheimer’s Association International Conference (PDF)

FDA’s New Risk Evaluation and Mitigation Strategy for Opioids

Jul 2011 -

Henry J Riordan, Ph.D. - Journal for Clinical Studies, Vol 3 (4) pp 14-15 (PDF)

The Alzhiemer's Association external quality control program for cerebrospinal fluid biomarkers

Jul 2011 -

Neal R Cutler M.D., William Nowatzke Ph.D. - Alzheimer's & Dementia: The Journal of Alzheimer's Association (4):386-395

"Racial Disparities in a Community Based Sample of a Novel Memory Screening Protocol"

Jun 2011 -

Erin B. Kornsey, M.S., Barry W. Rovner, M.D., Robin J. Casten, Ph.D. (PDF)

Racial Differences in the Recognition of Cognitive Dysfunction in Older Persons Support

Jun 2011 -

Erin B. Kornsey, M.S., Barry W. Rovner, M.D., Robin J. Casten, Ph.D. (PDF)

Complying with FDA Guidance on the Prospective Assessment of Sucidiality in Clinical Trials

May 2011 -

Henry J Riordan, Ph.D. - Journal for Clinical Studies, Vol 3 (3) pp10-11 (PDF)

Optimizing the Assessment of CNS Side Effects of a Novel Neuropathic Pain Compound

Apr 2011 -

Henry J. Riordan, Ph.D., Andrew Kuhlman, M.S., Kathryn Dawson, Ph.D., Erin Kornsey, M.S., Alex Miller, Bethanne Friedmann, Psy.D., Neal R. Cutler, M.D. - Presented at the Society for Biological Psychiatry, Annual Meeting (PDF)

Vaptans: A Potential New Approach for Treating Chronic Hyponatremia in Psychotic Patients

Apr 2011 -

Richard C. Josiassen, Ph.D., Jessica L. Curtis, Rita A. Shaughnessy, M.D., Dawn M. Filmyer, B.S., Brett Audino, Nina Skuban, M.D. - Presented at the International Congress on Schizophrenia Research (PDF)

The Role of Amyloid Biomarkers in Accelerating Alzheimer’s Disease Drug Development.

Mar 2011 -

Henry J, Riordan, Ph.D. - Journal for Clinical Studies, Vol 3 (2) pp 10-11 (PDF)

Postapproval Development Options in COPD A Case Study in Value-Based Healthcare Systems

Feb 2011 -

Michael F. Murphy, MD, PhD; Paola Antonini, MD, PhD; Zhihong Vicki Lai, PhD (American Health & Drug Benefits; 4(1):19-23)

The Impact of Site Characteristics on Efficacy Measures

Feb 2011 -

Bethanne Friedmann, Psy.D. , Erin B. Kornsey, M.S., Kathryn Dawson, Ph.D., Henry J. Riordan, Ph.D., Michael F. Murphy, M.D., Ph.D., Neal R. Cutler, M.D. - Presented at the International Society for CNS Clinical Trials and Methodology meeting (PDF)

"The Emergency Environment’s Untapped Potential"

Jan 2011 -

Paola Antonini, M.D., Ph.D., Michael F Murphy, M.D., Ph.D.

FDA’s New Guidance on Biomarker and Patient Reported Outcome Qualification

Jan 2011 -

Henry J. Riordan, Ph.D. - Journal for Clinical Studies, Vol 3 (1), pp 12-13 (PDF)

Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis

Jan 2011 -

Lowes, Michele Malone

Unique challenges of providing bioanalytical support for biological theapeutic pharmacokinetic programs

Jan 2011 -

Nowatzke, Rogers, Wells, Bowsher, Ray, Unger

Improving academic leadership and oversight in large industry-sponsored clinical trials: the ARO-CRO model

Dec 2010 -

Neil A. Goldenberg, Alex C. Spyropoulos, Jonathan L. Halperin, Craig M. Kessler, Sam Schulman, Alexander G. G. Turpie, Allan M. Skene, Neal R. Cutler, William R. Hiatt a

Variations in Regional Healthcare Systems in Clinical Research and the Importance of Enabling Technologies

Dec 2010 -

Micheal F Murphy, M.D., Ph.D.

The Impact of DSM-5 on Psychiatric Clinical Trials: Challenges and Opportunities.

Nov 2010 -

Henry J. Riordan, Ph.D. - Journal for Clinical Studies, pp 14-15 (PDF)

Innovative Designs for Chronic Pain Trials

Sep 2010 -

Henry J Riordan, Ph.D., Michael F. Murphy, M.D., Ph.D. - Journal for Clinical Studies, pp 30-35 (PDF)

The Impact of Site Rater Monitoring and Refresher Training on Enrollment in a MCI Phenotype Trial

Aug 2010 -

Bethanne Friedmann, Psy.D., Erin B. Kornsey, M.S., Michael F. Murphy, M.D., Ph.D., Neal R. Cutler, M.D. - Presented at the European College of Neuropsychopharmacology (ECNP) Annual Meeting (PDF)

Validity of semantic memory test as predictor of change in ADAS-cog scores in MCI

Aug 2010 -

Erin B. Kornsey, M.S., Bethanne Friedmann, Psy.D., Michael F. Murphy, M.D., Ph.D., Neal R. Cutler, M.D. - Presented at the European College of Neuropsychopharmacology (ECNP) Annual Meeting (PDF)

Site vs remote inter-rater reliability of the PANSS and Information Demand

Jun 2010 -

Bethanne Friedmann, Psy.D., Henry Riordan, Ph.D., Erin Kornsey, M.S., Evan Braxton, Michael F. Murphy, M.D., Ph.D., Neal R. Cutler, M.D. - Presented at NCDEU 2010: An American Society of Clinical Psychopharmacology meeting (PDF)

Systematically Elicited Neuropsychiatric Adverse Events and Various Rating Scale Assessments of Withdrawal Symptoms in Smoking Cessation Trials

Jun 2010 -

Henry Riordan, Ph.D., Dahlia Garza, M.D., Anjan Chatterjee, M.D., M.Ph., Li-Jung Tseng, Ph.D., Michael F Murphy, M.D. Ph.D. - Presented at NCDEU 2010: An American Society of Clinical Psychopharmacology meeting (PDF)

Critical Pathways to Success in CNS Drug Development

Mar 2010 -

Neal R. Cutler, M.D., John J. Sramek, Pharm.D., Michael F. Murphy, M.D., Ph.D, Henry J Riordan, Ph.D., Peter Biek, M.D., Ph.D., Angelico Carta, M.D. (Publisher: Wiley Blackwell)

A post-hoc Examination of patient characteristics: Implications for enhanced medical surveillance

Jan 2010 -

Bethanne Friedmann, PsyD1, Henry J. Riordan, Ph.D.1, Erin B. Kornsey, MS1, Kenneth Williams, MD1, Kevin Cox, MD2, Neal R. Cutler, MD2,Michael F. Murphy, MD, PhD1

Quantitative Determination and Validation of Serotonin (5-HT) in Human CSF

Jan 2010 -

Espinosa

Systematic analytical validation of commercial kits for the determination of novel biomarkers for clinical drug development

Jan 2010 -

Nowatzke, Cole, Bowsher

A Meta-Analysis of Computerized Assessment Batteries in Alzheimer’s Disease Treatment Trials

Dec 2009 -

Henry J. Riordan, Neal R. Cutler, Farzin Irani, Paul J. Moberg. The International Society for CNS Clinical Trials and Methodology (ISCTM) 2010.

Quantitative Determination of Exemestane

Jan 2009 -

Tan

"Ticagrelor versus Clopidogrel in Patients with Acute Coronary Syndromes"

Dec 2008 -

Allan Skene, Ph.D,Lars Wallentin, M.D., Ph.D., Richard C. Becker, M.D., Andrzej Budaj, M.D., Ph.D., Christopher P. Cannon, M.D., Håkan Emanuelsson, M.D., Ph.D., Claes Held, M.D., Ph.D., Jay Horrow, M.D., Steen Husted, M.D., D.Sc., Stefan James, M.D., Ph.D

A Comparison of Rating Quality between Subtitle and Spoken Hamilton Depression Rating Scale Interviews

Dec 2008 -

Bethanne Friedmann, PsyD, Henry Riordan, Ph.D., Evan Braxton, Christopher J. Weber, Ph.D., Michael F. Murphy, M.D., Ph.D., Neal R. Cutler, M.D. European College of Neuropsychopharmacology (ECNP) 2009.

A Meta-Analysis of Computerized Assessment Batteries in Schizophrenia Medication Trials

Dec 2008 -

Henry Riordan, Luke Eastman, Lauren Hoffman, Neal Cutler, Paul J. Moberg. The International Society for CNS Clinical Trials and Methodology (ISCTM) 2009.

Determination of ?-Amyloid (1-42) Concentrations in Healthy Volunteers during Continuous CSF Sampling

Dec 2008 -

Nowatzke, W., Leibowitz, M., Breau, A., Delhaye, R., Bjornstal, O., Wells, E., Rogers, K., Zhang, W., Henry Riordan. 2009.

Does Naltrexone Block Appearance of Initial Morphine Side Effects in Healthy Volunteers?

Dec 2008 -

John J. Sramek, Pharm. D., Sherilyn A. Adcock, Ph.D. R.Ph., Neal R. Cutler, M.D. 2008.

Interactive Voice Response System for Patient Reported Changes in Mood State Using Outbound Call Prompting

Dec 2008 -

Christopher J. Weber, Ph.D., Henry Riordan, Ph.D, Evan Braxton, Bethanne Friedmann, Psy.D., Mark Leibowitz, M.D., Neal R Cutler, M.D. New Clinical Drug Evaluation Unit (NCDEU) 2009

Rapid Development of Tolerance to Adverse Events after Oral Morphine Administration to Opiate Naïve Subjects

Dec 2008 -

John J. Sramek, Pharm,D., Sherilyn Adcock, Ph.D., Henry Riordan, Ph.D., Neal R. Cutler, M.D. 2009

The Effect of Simultaneous Translations and Experience on Positive and Negative Syndrome Scale (PANSS) Scoring Performance for Eastern European Raters

Dec 2008 -

Bethanne Friedmann, Psy.D., Henry Riordan, Ph.D, Evan Braxton, Christopher J. Weber, Ph.D., Michael F. Murphy, M.D., Neal R Cutler, M.D. New Clinical Drug Evaluation Unit (NCDEU) 2009.

Use of Naltrexone to Block Opioid Side Effects in Healthy Volunteers: Effects of Dose and Food

Dec 2008 -

Henry Riordan, Ph.D., Barbara Newberry, John Sramek, Pharm. D., Sherilyn Adcock, Ph.D. R.Ph., Neal R. Cutler, M.D. American Pain Society (APS) 2009.

Alzheimer's Disease; Optimizing the Development of the Next Generation of Therapeutic Compounds

Jun 2008 -

Michael F. Murphy, M.D., Ph.D.; John J. Sramek, Pharm.D.; Neil M. Kurtz, M.D.; Angelico Carta, M.D.; Neal R. Cutler, M.D.

When Novelty Is Not Enough

Mar 2008 -

Michael F. Murphy, MD, PhD (American Health & Drug Benefits; 29-33)

A Sensitive Method for the Determination of Irinotecan and SN-38

Nov 2007 -

Keller

Determination of Risedronic Acid

Nov 2007 -

Ljungqvist

Evaluation of a novel anti-ischemic agent in acute coronary syndromes: Design and rationale for the Metabolic Efficiency with Ranolazine for Less Ischemia in Non–ST-elevation acute coronary syndromes (MERLIN)-TIMI 36 trial

Dec 2005 -

David A. Morrow, MD, MPH,a Benjamin M. Scirica, MD,a Ewa Karwatowska-Prokopczuk, MD, PhD,b Allan Skene, PhD,c Carolyn H. McCabe, BS,a and Eugene Braunwald, MDa for the MERLIN-TIMI 36 Investigators Boston, MA; Palo Alto, CA; and Nottingham, UK

"Early and Late Benefits of High-Dose Atorvastatin in Patients With Acute Coronary Syndromes Results From the PROVE IT-TIMI 22 Trial"

Oct 2005 -

Kausik K. Ray, MRCP, MD* Christopher P. Cannon, MD, FACC,* Carolyn H. McCabe, BS,* Richard Cairns, BSC,† Andrew M. Tonkin, MD,‡ Frank M. Sacks, MD,§ Graham Jackson, MD, FRCP,

"Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial"

Dec 2004 -

John A Dormandy, Bernard Charbonnel, David J A Eckland, Erland Erdmann, Massimo Massi-Benedetti, Ian K Moules, Allan M Skene, Meng H Tan, Pierre J Lefèbvre, Gordon D Murray, Eberhard Standl, Robert G Wilcox, Lars Wilhelmsen, John Betteridge, Kåre Birkelan

A Multicentre, randomised, double blind, placebo controlled phase II study of subcutaneous interfon beta-1a in the treatment of patients with active rheumatoid arthritis

Dec 2004 -

van Holten, K Pavelka, J Vencovsky, H Stahl, B Rozman, M Genovese, A J Kivitz, J Alvaro, G Nuki, D E Furst, G Herrero-Beaumont, I B McInnes, P Musikic, P P Tak

Antitumor Activity of HKI-272, an Orally Active, Irreversible Inhibitor of the HER-2 Tyrosine Kinase

Jun 2004 -

Sridhar K. Rabindran et al. - American Association for Cancer Research (PDF)

"Intensive versus Moderate Lipid Lowering with Statins after Acute Coronary Syndromes"

Apr 2004 -

Christopher P. Cannon, M.D., Eugene Braunwald, M.D., Carolyn H. McCabe, B.S., Daniel J. Rader, M.D., Jean L. Rouleau, M.D., Rene Belder, M.D., Steven V. Joyal, M.D., Karen A. Hill, B.A., Marc A. Pfeffer, M.D., Ph.D., and Allan M. Skene, Ph.D.,

Geographic variation in patient and hospital characteristics, management, and clinical outcomes in ST-elevation myocardial infarction treated with fibrinolysis. Results from InTIME-II

Jan 2001 -

R. P. Giugliano, J. Llevadot, R. G. Wilcox, E. P. Gurfinkel, C. H. McCabe, A. Charlesworth, S. L. Thompson4, E. M. Antman and E. Braunwald

Optimizing Therapeutic Development in Diabetes

Dec 1998 -

G. Alexander Fleming , Stanford S. Jhee , Robert F. Coniff , Henry J. Riordan , Michael F. Murphy , Neil M. Kurtz , Neal R. Cutler

Accelerating CNS Drug Development

Dec 1997 -

Neal R. Cutler , John J. Sramek , Neil M. Kurtz , Michael F. Murphy , Angelico Carta

Accelerating CNS Drug Development

Dec 1997 -

Neal R. Cutler , John J. Sramek , Neil M. Kurtz , Michael F. Murphy , Angelico Carta

Treatment of chronic polyarthritis with a human recombinant interleukin 1 receptor antagonist

Dec 1997 -

Rau R, Sander O, Musikic P.

Treatment of rheumatoid arthritis with recombinant human interleukin-1-receptor antagonist.

Dec 1997 -

Bresnihan B, Alvaro-Gracia J M, Cobby M, Docherty M, Domljan Z, Emery P, Nuki G, Pavelka K, Rau R, Rozman B, Watt I, Williams B, Atchinson R, McCabe D, Musikic P.

Optimizing the Development of Antipsychotic Drugs

Jun 1997 -

John J. Sramek, Pharm.D; Neal R. Cutler, M.D.; Neil M. Kurtz, M.D.; Michael F. Murphy, M.D., Ph.D.; Angelico Carta, M.D.

Contrast enhanced Gd-DTPA magnetic resonance imaging in evaluation of rheumatoid arthritis during a clinical trial with DMARD. A prospective two-year follow up study on hand joints in 31 patients.

Feb 1997 -

Jevtic V, Watt I, Rozman B, Kos M, Praprotnik S, Logar D, Presetnik M, Demsar F, Jahr O, Campion G, Musikic P.

Understanding Alzheimer’s Disease (Understanding health & sickness)

Feb 1997 -

Neal R. Cutler, M.D.; John J. Sramek, Pharm.D

Interleukin-1 receptor antagonist continues to demonstrate clinical improvement in rheumatoid arthritis.

Dec 1996 -

Nuki G, Rozman B, Pavelka K, Emery P, Musikic P.

Anxiolytic Compounds: Perspectives in Drug Development

Jan 1996 -

Neal R. Cutler, M.D.; John J. Sramek, Pharm.D; Neil M. Kurtz, M.D.

MRI Evaluation of the knee on rheumatoid arthritis

Dec 1995 -

L. POLEKSIC,* P. MUSEKICt D. ZDRAVKOVIC,* L WATTf and G.BACIC

Prognostic Value of contrast enhanced Gd-DTPA MRI for Development of Bone erosive Changes in Rheumatoid Arthritis

Dec 1995 -

V. JEVTIQ* I. WATT.f B. ROZMAN4 M. PRESETNIX4 D. LOGAR, % S. PRAPROTNIK^ M. TOMSIC4 A. SIPEK4 M. KOS-GOLJA4 A. SEPE,§ O. JARH,§ F. DEMSAR,§ P. MUSIKIC^ and G. CAMPION

Alzheimer's Disease: Clinical and Treatment Perspectives

Oct 1994 -

Neal R. Cutler, M.D.; C. G. Gottfries, M.D.; K. Siegfried M.D.

Alzheimer's Disease: Optimizing Drug Development Strategies

Jun 1994 -

Neal R. Cutler, M.D.; John J. Sramek, Pharm.D.; Amy E. Veroff, Ph.D. (20 July 1994)

Pharmacodynamics and Drug Development: Perspectives in Clinical Pharmacology

Jun 1994 -

Neal R. Cutler M.D., John J. Sramek Pharm.D., Prem K. Narang Ph.D.