Cognitive Research Corporation

Transcription

1 Cognitive Research Corporation Contract Research Organization offering specialized expertise to fit the unique needs of each client Bobbie Theodore An Alliance of Quality Research Services

2 Therapeutic Experience Established in studies in last 5 years Phase I, II, and III (up to 500+ subject multi site programs) Cohorts and competitive enrollments 40+ sponsors from small biotechs to large pharmas Adolescent, adult and geriatric subjects Oral, nasal inhalation, implantable, injectable, transdermal patch, and CPAP drug delivery methods

3 Deliverables Seasoned Team of Professionals Ability To Meet and Beat Timelines Wide Menu of Adaptable Services Founders are core contributors on project deliverables You will always get the A Team from bid to final Managed over 450 clinical trials across multiple indications Recognized scientific and operational expertise in CNS clinical trials Worked on 25+ INDs Contributed to 17 programs that led to successful regulatory approvals in a number of indications Extensive experience with protocols and investigator sites allows us to manage data and enrollment to meet or exceed sponsor goals Relationships with high quality sites allows sponsors successful site selection Proactive management of vendors From program development to final analysis to seamlessly fit into your work processes Can provide CRO, or CRO + site service proposals

4 Indications Phase I - IV Psychiatry 20+ studies Addiction (cocaine, nicotine, opiates, hydrocodone) ADHD Anxiety Bipolar Disorders Depression Mania Panic Disorder Schizophrenia Healthy 50+ studies Adaptive and umbrella designs Driving Safety Crossover, pilot, pivotal designs SAD / MAD Bioequivalence and bioavailability Fed, fasted Healthy overweight and obese Smokers, non-smokers PK, PD EEG, qeeg QT, QTc Neurology 35+ studies Age Associated Memory Impairment Alzheimer s Disease ALS Epilepsy Head Injury Huntington s Disease Mild Cognitive Impairment Multiple Sclerosis Parkinson s Disease Spinal Cord Injury Stroke Tardive dyskinesia Tourette s Syndrome Pain 10+ studies Headache, migraine Neuropathic Pain Osteoarthritis Rheumatoid Arthritis General Medical 20+ studies Asthma and COPD Bone/Joint Reconstruction Cardiovascular Dermatology Diabetes Fibromyalgia Gastroenterology Hematology Immunology Infections Diseases (+HIV) Obesity Ophthalmology Osteoporosis Respiratory Sleep Disorders Urology Other 20+ studies Caffeine Driving Simulation Nutraceutical PET imaging Renal Impairment

5 Services Cognitive Research Corporation (CRC) is a boutique full-service CRO with decades of clinical trial experience. CRC specializes in conducting drug, device, and nutraceutical trials from early development to final analysis. Trial Design (Phase I-IV) Clinical Trial Management Established Network of Investigators Data Management Biostatistics Medical Writing Regulatory Affairs Quality Assurance Early Drug Development (Phase I, healthy subjects, and specialty populations) Neuro-cognitive testing (training, certification, implementation) State-of-the-art driving simulator and expertise

6 Principals and Founders Gary G. Kay, Ph.D., President Thomas J. Hochadel, Pharm.D., COO Stephen Horohonich, Chief Information Officer Albert J. Azzaro, Ph.D., Director of Pharmacologic Research Eva M. Kemper, Director of Clinical Projects

7 Driving Simulator (CRCDS) Exclusive partnership with the University of Iowa to equip and manage driving simulation studies (18+ driving simulator trials completed) The CRCDS-MiniSim Driving Simulator State-of-the-art, high performance unit based on the National Advanced Driving Simulator A fully standardized, portable, validated driving assessment platform Capitalizes on decades of research conducted by the University of Iowa for the National Highway Traffic Safety Administration Uniquely suited for multi-center clinical research and development Accurate driving performance data; comparable in sensitivity to over-the-road-testing Expeditious, cost-effective, safe solution for assessing drugimpaired driving

8 Relationships Collaborative relationship with thought leaders in CNS specialties including schizophrenia, depression, ADHD, sleep medicine, movement disorders, cognition, and pain CRC has a network of 100+ clinical research site affiliations including movement and memory disorder clinics, imaging centers, sleep labs, dedicated specialty clinical pharmacology unit and licensed, accredited psychiatric hospital Structure allows for standalone CRO proposals, or services bundled with leading research sites based on sponsor s preference Experience working with a range of lab, cardiac safety, centralized rating and other industry vendors

9 Recent Collaborative Studies with Clinical Trial Alliance Sites A Randomized, Double-Blind, Placebo-Controlled, Phase Ib, Safety, Tolerability, and Pharmacokinetic Study of Multiple Ascending Doses of XXX in Patients with Mild Alzheimer s Disease (multi-site) A Phase I, double blind, randomized, multiple ascending dose safety, tolerability and pharmacokinetics study in patients with schizophrenia on a stable anti-psychotic regimen (includes qeeg) 5 cohorts of 10 females (single site) A Phase II, randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety, and pharmacokinetic behavior of orally administered XXX in subjects with drug-induced Tardive Dyskinesia (multi-site) Phase I, randomized, double-blind, placebo-controlled, sequential dose escalation cohort study to evaluate the safety, tolerability, and pharmacokinetics of XXX in psychiatrically stable schizophrenia subjects 3 cohorts of 16 (single site) A Phase I uncontrolled, sequential cohort study in healthy subjects to assess the safety and tolerability of multiple-dose administration of XXX, assess the pharmacokinetics (PK) of XXX following multiple-dose administration, and assess the effect of dose titration schedules on the tolerability of XXX in healthy male subjects (single site) 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 5 cohorts of 9 (single site)

10 Contact Information For inquiries: Bobbie Theodore or Annie Speno (916) / (916) clinicaltrials@alliancesites.com / annie@alliancesites.com Cognitive Research Corporation 200 Central Ave, Suite 1230 St. Petersburg, Florida