Carman Research

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Transcript of Carman Research

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John S. Carman, M.D.Medical Director and Founder of Carman ResearchClinical research for over 38 yearsClinical trial investigator for over 300 clinical trialsBoard certified in psychiatryWell published with previous NIMH and academic experience (University of Alabama)

Nathan Andrew Shapira, M.D., Ph.D.Clinical research for over 12 yearsBoard certified in psychiatry; Ph.D. in neuropathologyWell published with previous industry (SolvayPharmaceuticals and Tikvah Therapeutics) and academic experience (University of Florida)

Experienced Physicians

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Edwinia Paden-JohnsonMedical Records CoordinatorWith Carman Research for 26 years

Casey ChaconaSenior Research CoordinatorWith Carman Research for 10 years

Becky Empric and Robin SwinksResearch CoordinatorsWith Carman Research for 7 and 3 years, respectively

Marc McLaughlin and Lori JohnsonOffice Administration and RecruitmentWith Carman Research for 3 years

Dedicated and Stable Team

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Broad ExperienceTherapeutic Area Number of Studies (by 2009)Major Depressive Disorder 139 (including 4 TRD)

Schizophrenia/Schizoaffective Disorder 44

Generalized Anxiety Disorder 37

Bipolar Disorder 27 (Mania); 15 (Dep); 4 (Proph)

Alzheimer’s Disorder 11

Panic Disorder 6

Insomnia 5

Social Anxiety Disorder 3

Obsessive-Compulsive Disorder 3

Adult Attention Deficit Disorder 3

Chronic Pain and Fibromyalgia 3

Obesity 1

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Clinical Trial Phase Experience

Phase of Development Number (by 2009)

Phase Ib/IIa 10

Phase II 112

Phase III 140

Phase IV 39

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Excellent EnrollmentIndication Screened Randomized

Major Depressive Disorder 35 30

Major Depressive Disorder 19 15

Major Depressive Disorder 22 16

Major Depressive Disorder 36 25

Major Depressive Disorder (ext) 15 10

Major Depressive Disorder 56 36

Generalized Anxiety Disorder 12 11

Generalized Anxiety Disorder 22 21

Generalized Anxiety Disorder 13 12

Generalized Anxiety Disorder 26 22

Bipolar Disorder, Depression 14 12

Overall for 2008-2009 (18 months) 270 210 (78%)

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Excellent RetentionIndication Randomized Completed

(> 8 weeks)Major Depressive Disorder 30 25Major Depressive Disorder 15 12Major Depressive Disorder 16 9Major Depressive Disorder 25 17Major Depressive Disorder (ext) 10 6Major Depressive Disorder 36 35Generalized Anxiety Disorder 11 9Generalized Anxiety Disorder 21 18Generalized Anxiety Disorder 8 7Generalized Anxiety Disorder 22 18Bipolar Disorder, Depression 12 9Overall for 2008-2009 (18 months) 210 165 (80%)

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Physicians integrally involved in every visit andadminister rating scales

Very low rate of rater switching during study

Electronic data capture entered efficiently

Low placebo response rates:24% for Major Depressive Disorder (5 studies)30% for Generalized Anxiety Disorder (3 studies)

High compliance:In a recent phase II GAD trial with pharmacokineticLevels, our subjects demonstrated the highest

Quality Data

For studies over the past 4 years, with greaterthan 10 per arm and code breaks available

Percent confirmed compliance with studymedication.

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In its 28 years of existence in Northwest Atlanta,Carman Research has conducted clinical studiesfor more than 60 sponsoring pharmaceutical companies. Carman Research has been involved inpivotal studies leading to approval and/or expansionof indications for 23 psychoactive compounds nowon the market, for over 30 different formulationsor indications:

Abilify Geodon SaphrisAricept Invega Seroquel (IR and XR)Celexa Lexapro Wellbutrin (IR,SR and XL)Depakote Namenda Xanax XRDesyrel (IR and Paxil (IR and CR) Zoloft

Contramid) Pristiq ZyprexaEffexor (IR and XR) ProzacEmsam RemeronExelon Risperdal

Proven Results

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