Life Science Leader Magazine Supplements

CRO Supplement 2015

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QUALITY RELIABILITY PRODUCTIVITY REGULATORY INNOVATION K E Y W W W.C R O L E A D E R S H I PA W A R D S .C O M 2015 CRO LEADERSHIP AWARDS WINNERS Company Profiles LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2015 47 SCYNEXIS, Inc. Durham, NC +1 919 544 8600 Kerrie Powell Key locations: Durham, NC DRUG LIFE CYCLE STAGES: Research & Development: Clinical (Phase 1, Phase 2, Phase 3) Formulated Drug Production: Logistics DRUG LIFE CYCLE STAGES: Research & Development: Discovery, Preclinical Drug Substance Production: Primary Process Development, Drug Substance Production DRUG LIFE CYCLE STAGES: Research & Development: Discovery, Preclinical, Clinical MAIN SERVICE AREAS: Full Service Clinical MAIN SERVICE AREAS: Preclinical MAIN SERVICE AREAS: Lab, Preclinical "The award reflects the Sanaclis actual status. Our aim is to work according to the highest industry standards, and to be flexible and reliable so that our clients can benefit from our competitive advantages. Our reliability is based on our business model to provide all services including the logistics by our own staff in our own facilities and under one roof." "At SCYNEXIS we deliver integrated, efficient, and innovative drug discovery and development services that complement our customers' capabilities. Our expert team links great science with regulatory compliance expertise to consistently deliver high-quality GMP material. Our GMP facility has been FDA-inspected with no 483 issues. I'm proud our high standards for safety, quality, and compliance continue to be recognized as drivers of our clients' success as we rapidly solve the toughest drug development problems." "It is an honor to b e recognized with a CRO Leadership Award for Innovation. We put the needs of our clients first and share in their passion and sense of urgency to reach their goals. We understand time is money and we remain responsive and flexible, allowing the sponsor to customize each project to meet their needs. We are dedicated to being available to act as an extension of our clients' teams at all times." SERVICES & CAPABILITIES: Regulatory, import/ export licenses, clinical monitoring, project management, IMP/CTS local depots, logistics, customs clearance and brokerage, metrology/ certification, data management, biostatistics, medical writing, and comparator/rescue medication, and equipment sourcing THERAPEUTIC AREAS: Cardiology, gastroenterology, gynecology, hematology, metabolic, neurology, oncology, pain, psychiatry, respiratory, rheumatology, and urology SERVICES & CAPABILITIES: Process Development: novel chemistries, small and non-small molecules, bioactive lipids, glycolipids; cGMP Manufacture; analytical control of processes; impurity identification and characterization, method development, phase- appropriate validation, ICH stability, and final product release THERAPEUTIC AREAS: We have provided our expertise and support across multiple therapeutics areas. A few examples include but are not limited to: CNS, anti-infectives, etc. SERVICES & CAPABILITIES: Preclinical PK/ PD/TK studies and analysis, pharmacology and disease models, toxicology studies, in vitro ADME, histology, immunohistochemistry/ immunofluorescence, pathology, image analysis, stereology, clinical PK/PD analysis, and preclinical consulting ALEXANDER FETKOVSKY managing partner YVES RIBEILL CEO JOHN SAGARTZ president & CEO CATEGORIES WON CATEGORIES WON CATEGORIES WON Seventh Wave Laboratories Chesterfield, MO +1 636 519 4885 Joe Flynn Key locations: Chesterfield, MO; St. Louis, MO SanaClis s.r.o. Bratislava, Slovakia + 421917820310 Svitlana Udubkova Key locations: Czech Republic, Estonia, Hungary, Latvia, Lithuania, Russia, Slovakia, Ukraine

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