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 41 Eurofins Lancaster Laboratories, Inc. Lancaster, PA www.EurofinsLancasterLabs.com +1 717 656 2300 Michael McDowell MichaelMcDowell@eurofinsus.com Key locations: Lancaster, PA, Portage, MI, United States; Clogherane, Dungarvan Co. Waterford, Ireland; Munich, Germany DRUG LIFE CYCLE STAGES: Research & Development: Discovery, Preclinical, Clinical (Phase 1, Phase 2, Phase 3) DRUG LIFE CYCLE STAGES: Research & Development: Discovery, Preclinical, Clinical (Phase 1, Phase 2, Phase 3) Drug Substance Production: Primary Process Development, Drug Substance Production Formulated Drug Production: Dosage Form Development, Dosage Form Production, Packaging, Logistics DRUG LIFE CYCLE STAGES: Research & Development: Discovery, Preclinical, Clinical (Phase 1, Phase 2, Phase 3) Drug Substance Production: Primary Process Development, Drug Substance Production Formulated Drug Production: Dosage Form Development, Dosage Form Production MAIN SERVICE AREAS: Lab MAIN SERVICE AREAS: Lab MAIN SERVICE AREAS: Lab, Preclinical, F ull Service Clinical "The expertise and responsiveness of our staff is directly tied to our ability to meet and exceed the expectations of our pharmaceutical clients. We focus exclusively on bioanalytical services, building strong relationships with clients that allow us to develop programs that meet even the most difficult challenges. Bringing new drugs to market is more challenging than ever in today's environment, so we take great pride in doing everything we can to make your job easier." "We are delighted that Eurofins Lancaster Laboratories has been recognized with the CRO Leadership Award for the third year in a row. We know that quality, reliability, productivity, and innovation are among the most important criteria for our clients when choosing a contract lab, and so this recognition in these categories is very gratifying. We are extremely proud to serve our customers every day as a global leader in laboratory services for the bio/pharmaceutical industry." "In a highly collaborative setting, we are commit- ted to operate as an extension of clients' resourc- es. Our team consists of dedicated scientists and skilled professionals across multiple business units. This combination of technical expertise and focus on clients gives us the ability to maneuver the complex drug development process in a cost- effective manner. It is an honor to be recognized again for the prestigious CRO Leadership Awards for our innovation, productivity, and commitment to q uality." SERVICES & CAPABILITIES: LC-MS/MS & immunoanalytical services - small/large molecule, discovery, preclinical (GLP), clinical, non-proprietary assays; biomarkers - proprietary/ custom assays, CLIA/GLP-compliant, multiple platforms; specialized LC-MS/MS (proteins, oligonucleotides) and immunoanalytical ( immunogenicity, cell-based assays, vaccines) THERAPEUTIC AREAS: Inflammation, oncology, cardiovascular/metabolic, neuroscience, infectious disease, analgesic, anti-infectives, CNS, dermatology, GI, hematology, hormonal therapy, immunology, ocular, renal disease, and respiratory disease SERVICES & CAPABILITIES: Method development/op timization, validation/ qualification/transfer, product release testing, stability storage and testing, raw materials testing, impurities and residuals testing, characterization, cell banking, cell line characterization, viral clearance, bioassays, and professional scientific services SM THERAPEUTIC AREAS: As a testing laboratory, we support all therapeutic areas of large and small molecule products. Most importantly, we have expertise in various modalities, including synthetic small molecule pharmaceuticals, as well as cell and gene therapy, synthetic peptides, therapeutic proteins, conjugates, therapeutic enzymes, and vaccines. SERVICES & CAPABILITIES: Bioanalysis, preclinical DMPK, clinical and bioequivalence studies, API and product development with analytical support spanning discovery through late-stage clinical trials. Frontage supports clients with NDA, ANDA, and 505.b.2 submissions THERAPEUTIC AREAS: Frontage supports multiple therapeutic areas across different business areas with expanded expertise in pain management, oncology, endocrinology, and dermatology for small and large molecules. JAMES WILFAHRT vice president & general manager DR. TIMOTHY OOSTDYK president DR. SONG LI CEO CATEGORIES WON CATEGORIES WON CATEGORIES WON Frontage Laboratories Exton, PA www.frontagelab.com +1 610 232 0100 Azhar Kalim akalim@frontagelab.com Key locations: Changchun, Shanghai, Suzhou, Tianjin, Jirin, China; Exton, PA, Hackensack, NJ, Secausus, NJ, Somerset, NJ , United States Tandem Labs, now Covance Inc. Salt Lake City, UT www.covance.com +1 801 293 2400 Todd Grosshandler todd.grosshandler@covance.com Key locations: Durham, NC; Salt Lake City, UT; West Trenton, NJ

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