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2600 Redondo Avenue, Suite 500 Long Beach, CA 90806

Collaborative Neuroscience Network, Inc. CLINICAL PHARMACOLOGY UNIT. 2600 Redondo Avenue, Suite 500 Long Beach, CA 90806. Presented By Bobbie Theodore Alliance Director clinicaltrials@btheodore.com www.clinicaltrialcenters.com. CNS Network State-of-the-Art Clinical Pharmacology Unit.

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2600 Redondo Avenue, Suite 500 Long Beach, CA 90806

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  1. Collaborative Neuroscience Network, Inc. CLINICAL PHARMACOLOGY UNIT 2600 Redondo Avenue, Suite 500 Long Beach, CA 90806 Presented By Bobbie Theodore Alliance Director clinicaltrials@btheodore.com www.clinicaltrialcenters.com

  2. CNS Network State-of-the-Art Clinical Pharmacology Unit • Facility • 25,000 Square Feet, 2 units • Unit with 50 private and semi-private beds to conduct Phase I • clinical trials (35 beds for healthy, neurology, pain, medical, and ethno- • bridging populations; and 15 beds for psychiatry special patient populations) • Dedicated medication dispensary with a PharmD supervisor • PHF Unit (Psychiatric Hospital Facility) with 14 private patient • rooms licensed by the state of CA • Double occupancy to accommodate caregiver or significant other as needed • Building has video surveillance that can be monitored in all nurses stations • Secure offsite automatic data back up • Diesel generator provides 24-hour battery back up • Easy access to regional Long Beach airport • Full Time Experienced Staff • Board Certified Psychiatrists, Neurologists, Internists and Licensed • Psychologists PIs & Sub-Is • Operations Manager provides continuous staff training on GCP, SOPs and QA • RNs, Director of Nursing, Charge Nurse and Director of Social Services • Pharmacist, Caterer, Dietician and Recreational Therapist • PhD, MD and Masters Level Clinical Raters • Multiple Coordinators • Field based Recruitment Specialists

  3. CNS Network State-of-the-Art Clinical Pharmacology Unit (cont’d) Indications • Psych special patient populations – Schizophrenia, Bipolar Disorders, Cognition Disorders, Depression, Addictions (Smoking Cessation, Alcohol Dependence, Opioid Dependence) • Non-psych special patient populations - Alzheimer’s, Parkinson’s, MS, Pain Disorders (Migraine, Diabetic Neuropathy, Acute and Chronic pain, PHN, Fibromyalgia, Osteoarthritis), Epilepsy, Type 2 Diabetes, Hepatitis C, COPD, OIC/IBS, Bioequivalence and Biosimilar Studies • Japanese and Chinese Bridging • Healthy Normal

  4. CNS Network State-of-the-Art Clinical Pharmacology Unit (cont’d) Experience and Capabilities • Psychometric Ratings (scales page 12) • Extensive PKs • Imaging: • 3T MRI Scanner capable of FMRI Procedures • 64-Slice PET/CT System • SPECT Scanner • Site transports patients to and from the imaging facility • EEG/qEEG, Evoked Potentials • TQTc, Cardiac/Telemetry Monitoring/Continuous ECG • Delivery methods include transdermal patch delivery systems, IV infusion, oral and device • Lumbar Puncture/Continuous 24-hour CSF Collection • Neurologist PIs and Contracted Anesthesiologists from Surgical Center inside unit perform Lumbar Punctures • DDI • Food Effect • SAD/MAD • Bioavailibilty, Bioequivelance

  5. CNS Network State-of-the-Art Clinical Pharmacology Unit (cont’d) Emergency Capabilities and Training • Staff ACLS Certified • Staff trained and qualified in use of emergency crash cart, CPR, AED, oxygen tank • Stocked emergency cart checked every shift. • Automatic defibrillators on site tested and calibrated annually • 8AM-8PM Urgent Care on site (1st Floor) • In a medical HMO building with 7-days/week urgent care • ER ½ mile away • Arrangement with Pacific Hospital (2 miles) Clinical/Analytical Specimens and Laboratory • Relationship with local laboratory for services • 24/7 Pick-up • STAT capabilities analyze within 1-2 hours • Electronic transmission capabilities • Refrigerated and ambient centrifuges • Alarmed refrigerators/freezers (-20, -70 and -80 degrees) • CLIA waivered lab • Back-up Generator Data Collection • Collection and integration of laboratory data, images and scans • Bar-coded labeling to track samples from draw to dispatch • Call center with detailed metrics and recruitment plans tailored to each study • Central IRB

  6. CNS Network State-of-the-Art Clinical Pharmacology Unit (cont’d) Recreation • 32” LCD TVs in every room with cable • Community computers, wireless internet access for personal laptops • Recreation Therapist • Transportation Services • Lounge, break room, dining room with kitchen

  7. CNS Network Clinical Pharmacology Unit Floor Plan

  8. Phase I Trial Experience Psychiatry150+ studies, inpatient and outpatient • 100+ Schizophrenia and schizoaffective disorders - acute, negative symptoms, stable, cognition • 25+ Bipolar mania and mixed • 30+ Depression – MDD, refractory/treatment resistant, depression with sexual dysfunction • 10+ Other indications - anxiety, PTSD, chemical dependency, etc. Neurology50+ studies, broad range of indications • 20+ Alzheimer’s studies - mild-to-moderate, severe - CSF, MRI, PET, PK • 15+ Pain studies - migraine, diabetic neuropathy, OA, chronic back/knee pain, fibromyalgia • 5+ Parkinson’s trials - early stage and advanced • 5+ Epilepsy studies - adjunctive therapy and monotherapy • 10+ Sleep Disorders studies – insomnia, Restless Legs Syndrome General Medical • 5+ Type 2 Diabetes, Diabetic Neuropathy, OIC

  9. Phase I Trial Experience (cont’d) Phase I/Ib and IIa30+ studies in Special Patient Populations • Schizophrenia and schizoaffective disorders • Major depression • Parkinson’s • Alzheimer’s disease • Epilepsy Cognition20+ studies targeting cognitive primary endpoints • Cognition Dysfunction in Schizophrenia, and Depression; MCI • CANTAB Administered over 300+ times in 3 yrs

  10. Phase I Sample Metrics

  11. Phase IIa Sample Metrics

  12. Recruitment and Retention Recruitment: • Second largest market in the US with between 12-14 million population • Full time Recruitment Specialists • 3 full time Field Based Specialists (prior pharmaceutical reps) • Recruiters visit established relationships with a network of physicians (Neurologists, Psychiatrists and Internists) with access to patient databases and referrals • Community Outreach includes visiting residential facilities, senior communities and community events, providing free seminars, lunch and learns, and distributing flyers • Site Database of 12,000+ subjects across all indications accumulated over 10 years of research • 2,000+ schizophrenia patients, 1,500+ depression, 1,000+ AD, 1,000+ pain and 700+ Parkinson’s patients in practice and database • Ability to pre-qualify patients via IRB-approved pre-screen consent form for queries allowing non-evasive procedures High Retention / Low Drop Out: • Spacious 25,000 square feet of living space • Units designed for disease specific research with patient comfort and safety in mind • Private rooms for caregiver accommodations if requested • 32” flat screen TVs in each room and in community areas • Wireless Internet and community computers allows patients to keep in touch • Recreation Therapist provides ongoing activities for longer inpatient stays • Dietician provide palatable meals and protocol mandated special dietary requests • Site contracted with van service to provide patient transportation when needed • Dedicated staff for regular contact with patient and family to promote retention • PIs and Sub-Is treat these patients in practice for ease in transition and follow up

  13. Site Advantages • Swift start up – Central IRB • IRB-approved pre-screen consents to pre-qualify subjects • PIs provide clinical feedback and protocol consult during development process if needed • Ability to recruit quality patients • Low drop out / high retention • Placebo separation results • Repeat business • Participating in many pharmaceutical and CRO preferred site programs • Experienced, dedicated staff and PI expertise • Expedited feasibility and budget/contract negotiation handled by single point of contact with Site Relations Team: Bobbie Theodore, Annie Speno, Jeanette Caruso

  14. Rating Expertise Includes: Certified, experienced raters, including M.D., Ph.D. and M.A.-level

  15. Curriculum Vitae

  16. Contact Info Website: www.clinicaltrialcenters.com For more information or to arrange a site visit, please contact Alliance Team: Bobbie Theodore – Alliance Director clinicaltrials@btheodore.com email (866) 669-0234 or (916) 939-6696 Annie Speno – Operations Manager annie@btheodore.com email 916-934-0569 phone / 866-745-8708 fax Jeanette Caruso – Site Liaison & Budgets/Contracts Manager jeanette@btheodore.com email 916-933-3023 phone / 916-933-3097 fax

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