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Clinical Trial Centers Alliance offering specialized expertise to fit the unique needs of each client offering specialized expertise to fit the unique.

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Presentation on theme: "Clinical Trial Centers Alliance offering specialized expertise to fit the unique needs of each client offering specialized expertise to fit the unique."— Presentation transcript:

1 Clinical Trial Centers Alliance offering specialized expertise to fit the unique needs of each client offering specialized expertise to fit the unique needs of each client Bobbie Theodore Alliance Director

2 Executive Summary Our Alliance of experienced research sites and services can address portfolio clinical research needs. We propose flexible options to serve your clinical development needs as follows: A menu of services under one liaison and contract Expertise across a range of therapeutic areas, phase I through post- marketing Integrated services including clinical site conduct, with or without bundled CRO services such as protocol development, trial management, data management, statistical analysis, monitoring – any or all to meet your clinical program needs

3 Independent (Non-SMO) entities in California, Texas and Florida comprise the Alliance Combined 1,000+ clinical trials conducted, phases I-IV Central IRB Large patient databases, affiliated medical practices and proven recruitment methods

4 Alliance Facilities - C ALIFORNIA Principal Investigators: David Walling, PhD, (CEO) Psychologist Mark Leibowitz, MD, (Early Phase Medical Director) Internist Armen Goenjian, MD, (Medical Director) Psychiatrist Omid Omidvar, MD, Neurologist Nirav Patel, MD, Neurologist Steven Reynolds, DO, Family Practitioner 50+ bed CPU – targeted healthy subjects, CNS, stable psychiatry, neurology, pain, medical and bridging patient populations 20+ bed Licensed Psychiatric Hospital (JCAHO accredited) – acute psychiatry patient populations Outpatient offices – neurology, pain, and medical patient populations CNS, LLC Clinical Pharmacology Unit: Clinical Pharmacology Unit: 2600 Redondo Avenue, Suite 500, Long Beach, CA 90806

5 Alliance Facilities - C ALIFORNIA CNS, LLC Outpatient psychiatry offices: 12772 Valley View Street, Suite 3, Garden Grove, CA 92845 Principal Investigator: David Walling, PhD 19401 S. Vermont Avenue, Suite F-100, Torrance, CA 90502 Principal Investigator: Armen Goenjian, MD

6 Alliance Facilities - C ALIFORNIA Pacific Research Partners, LLC 1611 Telegraph Avenue, Suite 1550, Oakland, CA 94612 (San Francisco Bay area) Principal Investigators: Ira Glick, MD, Psychiatrist and Anand Mehta, MD, Double Boarded in Internal Medicine and Endocrinology Inpatient –psychiatric patient population trials conducted at nearby leased psychiatric facility Outpatient – psychiatry, cognition, MCI, fibromyalgia, pain, and general medical patient population trials

7 Alliance Facilities - T EXAS Inpatient and Outpatient – child - adult psychiatry including phase I special patient population trials Inpatient - 6 bed sleep lab for PSG and sleep trials6 bed sleep lab Outpatient – sleep, neurology, pain and general medical patient population trials 5445 La Sierra Drive, Suite 101, Dallas, TX 75231 Principal Investigator: Michael Downing, MD, Psychiatrist Inpatient – adult psychiatry population trials Outpatient – child – adult psychiatry, Alzheimer's, cognition, insomnia, pain and some general medical patient population trials FutureSearch Trials, LP 5508 Parkcrest Dr., Ste. 300, Austin, TX 78731 Principal Investigators: Donald J. Garcia, Jr., MD, (President) Psychiatrist and John D. Hudson, MD, Double Boarded in Neurology and Sleep Medicine

8 Alliance Facilities - F LORIDA Florida Clinical Research Center, LLC 8043 Cooper Creek Blvd., Suite 107, Bradenton, Florida 34201 Principal Investigators: Andrew J. Cutler, MD, (CEO) Double Boarded in Psychiatry and Internal Medicine, Jose T. Zaglul, MD, Psychiatry, and A. Jothivijayarani, MD, Obstetrics and Gynecology Inpatient – adult psychiatry, including targeted special phase I patient population trials Outpatient – child – adult psychiatry, cognition, insomnia, pain, and general medical patient population trials 2300 Maitland Center Pkwy, Ste. 230, Maitland, FL 32751 Principal Investigators: Martin S. Kane, MD, Board Certified Psychiatry and Neurology, Richard D. Knapp, DO, Board Certified Psychiatry and Addictions, and Joanne L. Northcutt, PhD, Child Health Psychologist Inpatient –psychiatry population trials, pediatric - adult Outpatient – child – adult psychiatry, cognition, insomnia, and pain patient population trials

9 Staff Highlights Each Research Site Has Fulltime Dedicated and Highly Experienced Staff Investigators Board Certified in Psychiatry, Neurology, Sleep Medicine, Internal Medicine, Family Practice, Endocrinology, Obstetrics and Gynecology, and Licensed Clinical Psychologists Protocol consultants to sponsors and CROs, and thought leaders in psychiatry, neurology, and sleep indications and phase I study designs Fulltime certified psychometric clinical raters – M.D., Ph.D. and M.A.-level with up to 20+ years rating experience Multiple fulltime study coordinators including CCRCs, RNs, and LVNs Dedicated recruitment and outreach specialists with established referral networks in their communities Regulatory, QA, training and IT personnel

10 Specialized Capabilities and Experience Dedicated Clinical Pharmacology Unit (CPU) in Long Beach, CA Healthy subjects, and special patient populations Cardiac, telemetry and holter monitoring QTc and TQTc EEG and qEEG evoked potentials Serial PK, serial ECG 1.5 and 3T MRI, fMRI bold and 64-Slice PET/CT system imaging Lumbar puncture and CSF collection PSG (polysomnography) Infusion, injection, oral, device, and transdermal patch delivery systems

11 Phase I-IV Trial Experience Psychiatry Addictions – smoking cessation, alcohol dependence, binge eating ADHD – adult and child, including classroom ADHD Anxiety – GAD, PTSD Bipolar – bipolar depression, mania, mixed Cognition – in schizophrenia, mild cognitive impairment Depression – MDD, refractory/treatment resistant, depression with sexual dysfunction Schizophrenia and schizoaffective disorders – acute, stable, cognitive dysfunction, negative symptoms Pediatric psychiatry Neurology Alzheimer’s – MCI, prodromal, mild, moderate, and severe Multiple Sclerosis – relapsing remitting Parkinson’s – early stage to advanced Post-stroke, Traumatic brain injury Sleep disorders – insomnia, narcolepsy, restless legs syndrome, shift worker, sleep apnea Pain Chronic pain, diabetic neuropathy, fibromyalgia, migraine, osteoarthritis, post herpetic neuralgia General Medical COPD, asthma, hypercholesterolemia, hypertension, obesity, OIC, type 2 diabetes, women’s health

12 Recruitment and Retention Recruitment Full time dedicated recruitment and outreach specialists on staff Large databases accumulated over 13+ years of research across all indications Affiliated PI physician private and group practice databases (psychiatry, neurology, family practice, specialty medical, OBGYN) Established relationships with network of physicians for additional patient referrals Outreach to and established relationships with residential facilities, board and cares, senior communities Participation in community events and support groups – provide free seminars, lunch and learns History of successful print, web, radio, and television advertising – recruitment departments have established relationships with media buyers for discounted advertising rates and preferred placement Ability to pre-qualify patients via IRB-approved pre-screen consent form Retention Inpatient facilities have private rooms, double occupancy for caregivers or loved ones as needed Site-provided patient transportation as needed Fulltime dedicated staff for regular communication with patient and family, reminder and follow- up phone calls, and thorough pre-screening Many of the study patients are treated in the Investigator’s practices allowing for ease in transition, follow up, and retention

13 Affiliated Practices Affiliated Medical Practices CNS, CA is aligned with Drs. Goenjian, Omidvar, Patel and Reynolds large psychiatry, neurology and family group practices respectively in the LA and Orange County regions. Pacific Research Partners, CA has exclusive relationship with the largest mental health clinics in the San Francisco Bay Area Counties, and Dr. Mehta’s Bay Area Medical group practice. FutureSearch Trials, Austin, TX is aligned with Dr. Hudson’s sleep medicine/neurology practice and sleep lab on premises of research facility. FutureSearch Trials, Dallas, TX is aligned with Dr. Downing‘s psychiatry practice. Both Austin and Dallas sites have established community referral relationships with several residential facilities and mental health agencies. Florida Clinical Research Center, FL is aligned with Dr. Zaglul’s large child and adult mental health agency and residential facilities., and Dr. Jothi’s women’s health group practice

14 Alliance Advantages and Expertise Menu of site and study management services based on sponsor need Responsiveness and ease of single point of contact with sponsor relations team Dedicated regulatory/budget/contract staff for quick turnaround times including use of Central IRB Best clinical and operational practices shared across sites Thought leaders in CNS and Phase I indications with multiple publications, and advisory board memberships Clinical, budget, and protocol feedback during development process, if needed Established vendor relationships for seamless execution

15 Testimonials CNS Sponsor Bobbie, we will likely initiate additional clinical trials early next year. Your team of investigators tops our list! (Their performance on our last protocol was outstanding on all levels.) Thank you! Depression Study Sponsor Dr. [Andrew] Cutler Dr. [Andrew] Cutler and Patricia, [Florida Clinical Research Center] YOU are NUMBER 1. My sincere appreciation and my congratulations to you for screening the first subject in the XXX depression study. The ice is broken and the ship has now sailed. Thank You. Depression Study Sponsor Dr. [Donald] Garcia’s Dr. [Donald] Garcia’s [FutureSearch Clinical Trials] site consistently came out excellent on rater performance as monitored by our vendor. They have also helped us get ahead of schedule on enrollment. Phase I Schizophrenia Study Sponsor We have been extremely pleased with Dr. [David] Walling’s [CNS] sites performance as a “rescue” site for our phase I schizophrenia study. We will use you again for any new early phase opportunities we have.Dr. [David] Walling’s Schizophrenia Study Sponsor Dr. [David] Walling’s Dr. [David] Walling’s [CNS] site has been selected for our new schizophrenia trial because they do excellent work, and they were specifically selected for a high-profile schizophrenia trial based on a detailed statistical analysis by the study team of past placebo response rates.

16 Testimonials Alzheimer’s Study Sponsor Good afternoon Dr. [Omid] Omidvar, [CNS], I am writing to invite you to participate in a Phase IIb Alzheimer’s trial. You and your team were one of the top enrolling sites for the XXX Elderly MRD trial and we think that you and your team could be perfect for the trial.Dr. [Omid] Omidvar ADHD Study Sponsor Dr. [Andrew] CutlerDr. [Andrew] Cutler, Patti, and Florida Clinical Research Center staff have been wonderful throughout their work on our studies. The team exceeded their enrollment goal and closed the study with a remarkably low screen failure and early discontinuation rate. In addition, and the quality of their work on both studies has been exceptional – their source and CRF data have been clean resulting in cost and time savings for our monitoring and data management activities. Dr. Cutler has also been incredibly helpful by collaborating with our team on patient recruitment strategies, the appropriate use of our study diagnostic tool, and sharing his thoughts about future development work with the compound. ADHD Study Sponsor I wanted to let you know what a nice job Dr. [Donald] Garcia’s [FutureSearch Clinical Trial] site has done in our adult ADHD trial. He is our highest recruiter by far! Very knowledgeable and good work. He will be on our upcoming studies as you are aware.Dr. [Donald] Garcia’s Multiple Sclerosis Study CRO Dr. [Omid] OmidvarDr. [Omid] Omidvar, [CNS], your pace of screening and randomizing patients over the last couple months is impressive. We need to clone your site J. Thank you.

17 Testimonials Multiple Sclerosis Study Sponsor Hi all, XXX (Senior Director of Clinical Operations with XXX) came by to meet with Dr. [Nirav] Patel, Anne Cabral, and the [CNS] team to acknowledge the outstanding job we all did on the XXX (MS) spasticity study! According to some of his internal metrics, we were performing at 300+% compared to other sites. That is amazing! Dr. [Nirav] Patel Migraine Study Sponsor Dr. [Eduard] GfellerDr. [Eduard] Gfeller [Florida Clinical Research Center] and Dr. [Omid] Omidvar [CNS] have received Elite enrollment site acknowledgement (Elite Enroller Badge) for their participation in the XXX adult migraine study.Dr. [Omid] Omidvar Migraine Study Sponsor [Dr. John Hudson[Dr. John Hudson and FutureSearch Trials of Neurology] the XXX study team appreciates your efforts to reduce screen failures for this study. Currently, you have the lowest SF rate out of 40 US sites and the most randomized patients. XXX appreciates your efforts and expertise in this clinical trial. Pain Study Sponsor Please pass my gratitude on to Dr. [John] Hudson and [FutureSearch Trials of Neurology] staff as they have really knocked a good many missing pages out (before deadline), I am very impressed. Other sites were not close to meeting this deadline. Please share my gratitude with Dr. Hudson next time you speak to him. I know Adam put a lot of time into this and it should not go unsung. Thank you.Dr. [John] Hudson Insomnia Sleep Sponsor Dear Dr. [John] Hudson, [FutureSearch Trials of Neurology], I hope you are doing well. I was reviewing the XXX-sponsored trial enrollment numbers in my region, and was impressed with your enrollment numbers in the PSG study. I just wanted to say thank you so much for all of the hard work by you and your staff!Dr. [John] Hudson

18 Cognitive Research Corporation Collaboration Based on sponsor’s requests for full service proposals, now offering a streamlined solution that evolved from our expanded early phase capabilities Cognitive Research Corporation (CRC) is a boutique, full-service CRO with decades of clinical trial experience specializing in conducting drug, device, and nutraceutical trials from early development to final analysis Collaborative (non-exclusive) relationship with Alliance sites allows flexibility for CRO proposals, site-only services or bundled options per sponsor preference Menu of services Trial Design (Phase I-IV)Phase I-IV Clinical Trial Management Established network Investigators Data Management Biostatistics Medical Writing Regulatory Affairs Quality Assurance Early Drug Development (Phase I, healthy subjects, and specialty populations)Phase I, healthy subjects, and specialty populations Expertise in neuro-cognitive testing including state of art, world class driving simulation

19 Psychiatry Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus A Phase II, 12 Week Randomized, Double-blind, Placebo- controlled, Parallel Group, Multiple Dose, Proof-of-Concept Study to Evaluate the Effects of XXX on Cognition in Stable Schizophrenia Patients 664110 month ( across 2 sites ) 2013Closed A Phase I, Open-label, Multiple Dose, Safety and Tolerability Study of XXX IM Depot Administered in the Deltoid Muscle in Adult Subjects with Schizophrenia 40281 month2013Closed A Double-Blind, Placebo-Controlled, Flexible-Dose Study of XXX in Patients with Generalized Anxiety Disorder 43226 months (across 2 sites) 2013Closed A Phase IV, Multi-national, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of XXX compared to Placebo for Smoking Cessation Through Reduction 58452 months2011Closed A Phase III, Long-Term Open-Label Study of the Safety and Tolerability of XXX in Patients with Bipolar I Disorder 23169 months2011TOP ENROLLING SITE A Phase III, Double-Blind, Randomized, Multi-Center, Placebo-Controlled, Relapse Prevention Study with XXX in Out-Patient Adults with Major Depressive Disorder 32243 months2010Closed

20 Phase I Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus A Phase I, Prospective, Randomized, Double-blind, Placebo- controlled, Sequential-cohort, Escalating, Single-dose Study designed to determine the maximum tolerated oral dose of XXX in Healthy, Male volunteers – 3 days/2 overnights Contracted for 5 cohorts of 12 (60) Screened 90 enrolled 60 (5 cohorts of 12) 5 months2013 2014 Active – 1 site A Phase I, 2-part, Open Label, Inpatient Study to Assess the Safety and Tolerability of Multiple Ascending Doses of XXX in Subjects with Schizophrenia (Extensive PKs & multiple ECGs) 62408 months2012Closed Phase I, Inpatient Open-Label, Randomized, Parallel Group, Crossover Study to Compare the Pharmacokinetcs of XXX in Migraine Subjects During an Acute Migraine Attack and During a Non-Migraine Period 5420 (SFs due to pts not having a migraine in req’d window) 8 months2012 TOP ENROLLING SITE A Phase I, Inpatient Multicenter, Open-Label Study to Determine the Effects of XXX on Sleep in Healthy Subjects 26135 months2012 TOP ENROLLING SITE A Phase I, Randomized, Double-Blind, Placebo-Controlled Study of Safety and Pharmacodynamic Effects of XXX in Major Depressive Disorder Subjects (Extensive PKs & multiple ECGs) 38226 weeks (across 2 sites) 2011TOP ENROLLING SITE A Phase I, Randomized, Double-Blind, Placebo-Controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, Immunogenicity, Pharmacodynamic Response, and Pharmacokinetics of Intravenous Infusions of XXX in Subjects With Mild to Moderate Alzheimer’s Disease Study design 5 cohorts; 1 pt/cohort from ea site 20 patients enrolled (2 cohorts of 10 each) 12 months2012 2013 TOP ENROLLING SITE

21 Neurology Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus A Multicenter, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of XXX in Pediatric Patients (Ages 6-12) with Attention Deficit Hyperactivity Disorder (ADHD) in a Laboratory Classroom 12112 weeks2014ADD ON SITE Closed A Phase III, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Effectiveness of XXX for the Treatment of Mild to Moderate Alzheimer’s Disease (includes IGIV, and infusion) 151014 months2013TOP ENROLLING SITE An Open-Label, Randomized, Multi-Center, Parallel-Arm Study to Assess the Safety and Tolerability of XXX 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily Subcutaneous Injections in Subjects with Relapsing-Remitting Multiple Sclerosis 762 weeks2013Closed A Phase II, Double-blind, Randomized, Placebo-controlled, Multicenter, Fixed-dose, Study to Assess Efficacy, Safety and Tolerability of XXX in Adults with Inattentive-Predominant Attention Deficit/ Hyperactivity Disorder (ADHD) 32275 months2012Closed A Phase IIa Randomized, Double-Blind, Cross over Study Comparing the Tolerability of Two Dose Regimens of XXX in Adult Patients with Parkinson's Disease who are receiving XXX 11101 month2010RESCUE SITE

22 Pain Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus A Phase III, Open-Label, Multicenter Study to Assess the Long -Term Safety of XXX Once-Daily in Subjects with Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain 22203 months2012Closed A Phase III, Double-blind, Randomized, Placebo-controlled, Safety and Efficacy Study of Once Daily Controlled Release XXX in the Treatment of Patients with Fibromyalgia (13-week single and double blind phases, outpatient study including Actigraphy, PK, Multiple Psychiatric, Sleep & Pain Assessments, and Diary) 49337 months2011TOP ENROLLING SITE A Phase III, Multicenter, 12-Month, Open-Label, Single-Arm, Safety Study of XXX and XXX Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain 28243 months2011TOP ENROLLING SITE A Phase III, Safety and Tolerability Study Comparing XXX Given as an Oral Solution to a Single-blinded Combination of Oral Tablets plus Oral Solution in Subjects with Fibromyalgia 14122 months2010Closed A Six Month Phase II/III, Randomized, Double-Blind, Placebo- Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of XXX for Prevention of Menstrually Related Migraine in Female Patients with Episodic Migraine 42413 months (across 2 sites) 2010Closed

23 Curriculum Vitae Click on PI names to view CVs: David P. Walling, Ph.D. David P. Walling, Ph.D. CEO and PI – CNS, LLC Armen K. Goenjian, M.D., D.F.A.P.A., F.A.C.G.S. Armen K. Goenjian, M.D., D.F.A.P.A., F.A.C.G.S. PI and Partner – CNS, LLC Omid Omidvar, M.D. Omid Omidvar, M.D. PI – CNS, LLC Nirav S. Patel, M.D. Nirav S. Patel, M.D. PI – CNS, LLC Steven Reynolds, D.O.Steven Reynolds, D.O. PI – CNS, LLC Mark Leibowitz, M.D.Mark Leibowitz, M.D. – PI – CNS, LLC Ira D. Glick, M.D. Ira D. Glick, M.D. PI – Pacific Research Partners, LLC Anand Mehta, M.D.Anand Mehta, M.D. PI – Pacific Research Partners, LLC Donald J. Garcia, M.D. Donald J. Garcia, M.D. President and PI – FutureSearch Clinical Trials, LP John Douglas Hudson, M.D. John Douglas Hudson, M.D. PI– FutureSearch Trials of Neurology, LP Michael Downing, M.D. Michael Downing, M.D. PI– FutureSearch Trials of Dallas, LP Andrew J. Cutler, M.D. Andrew J. Cutler, M.D. CEO and PI – Florida Clinical Research Center, LLC Jose T. Zaglul, M.DJose T. Zaglul, M.D. PI – Florida Clinical Research Center, LLC A. Jothi, M.D.A. Jothi, M.D. PI – Florida Clinical Research Center, LLC Richard D. Knapp, D.O. Richard D. Knapp, D.O. PI – Florida Clinical Research Center, LLC Joanne Northcutt, Ph.D.Joanne Northcutt, Ph.D. PI – Florida Clinical Research Center, LLC Martin Kane, M.D.Martin Kane, M.D. PI – Florida Clinical Research Center, LLC

24 Contact For further information on Alliance services contact: Bobbie Theodore (916) 939-6696

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