Panel Chews Over Dev. of PFE, J&J, REGN Pain Drugs - Mar. 12, 2012

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Monday, March 12, 2012  |   |   |   |  Reduce Risk and Maximize Potential in Ophthalmology Development Ophthalmic study design and execution can be quite different than other therapeutic areas. Pharm-Olam's team has a proven track record of excellence in achieving trial objectives and can provide strategic, operational and consulting to sponsors for phase I to phase IV development. The majority of our clinical staff in emerging markets are MDs or PhDs, including Ophthalmologists in strategic areas for clinical trials. The incidence of disorders and standards of treatment can vary widely, so let Pharm-Olam conduct a complimentary feasibility study specific to your protocol and study budgets to use in your resource planning. Contact us at www.pharm-olam.com, info@pharm-olam.com, USA 1-713-559-7900, UK +44-0-1344-891121. •   Panel Chews Over Dev. of Pfizer Inc. (PFE), Johnson & Johnson (JNJ), Regeneron Pharmaceuticals, Inc. (REGN) Pain Drugs More... More Drug Product News •  Organogenesis Inc. Announces FDA Approval of GINTUIT™ for Oral Soft Tissue Regeneration More... More Drug Approval News •  Cellceutix (CTIX) Files Pre-IND Documentation to FDA for New Psoriasis Drug More... •  Cannabis Science Inc. Confirms Target Indication for FDA and Prepares for Pre-IND Meeting with the FDA with its Team of FDA Specialists More... More BLA/NDA/ANDA News More IND News More MAA News •  Anthera Pharmaceuticals, Inc. (ANTH) Tanks as it Halts Phase III VISTA-16 Heart Drug Trial; Stock Falls -2.99(46.57%) @ 1:09PM EDT More... •  Tranzyme Pharma (TZYM) and Norgine Bowel Drug Fails Trial, Tranzyme Shares Crash -2.18(42.75%) @ 1:08PM EDT More... •  Pfizer Inc. (PFE) Ends Celebrex Post-approval Safety Study Because of Difficulty Finding Patients More... •  Pfizer Inc. (PFE)'s Prevnar Meets Safety Goals in Study of Children, Teens More... •  Aradigm Corporation (ARDM) Receives U.S. FDA Clearance for Phase 3 Clinical Trial of Pulmaquin™ in Patients with Non-Cystic Fibrosis Bronchiectasis More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News Building Novel Applications with Pipeline Pilot to Drive Next Generation Sequencing This case study shows how scientists are streamlining the process of analyses of DNA sequence information. Enabled by new DNA sequencing technologies, many more scientists and informaticians are interrogating larger and more complex data set. Request Now! •  Raising a Glass a Day to Lower Stroke Risk in Women, Brigham and Women's Hospital Study More... •  Kids Who Bully May Be More Likely to Smoke, Drink, Ohio State University Study More... •  Potential Role of Parents' Work Exposures in Autism Risk Examined: Possible Link Between Some Work Exposures and Risk for Offspring, National Institute for Occupational Safety and Health Study More... •  Reducing Academic Pressure May Help Children Succeed, University of Poitiers Study More... •  Studies Highlight Nuvilex Cell-In-A-Box® Technology Enhances Chemotherapy Effectiveness More... More General Clinical Research News Technical and Regulatory Challenges in Drug Development March 28, 2012 The Chauncey Hotel and Conference Center 1 Chauncey Road, Princeton, NJ Reaching drug development milestones quickly is a challenging process. During this half-day seminar, four scientific leaders will share their experiences and answer your questions on regulatory and technical strategies for progressing through the drug development cycle. They will focus on regulatory affairs, API supplies, and complex dosage forms and will provide case studies and lessons learned on developing a regulatory strategy, moving beyond Phase I and developing formulations to extend the life-cycle of a drug. Patheon is committed to providing effective science-based learning opportunities for local professionals. Lunch and an evening reception will be served and cost of event is free. E-mail events@patheon.com or view more information via the website: http://www.mtech.umd.edu/biotech/workshops/cell_culture_technology/index.html. Optimizing Clinical Trials Through IT • Examine the trends shaping clinical trials. • Learn how social media are being used in patient recruitment. • Analyse the potential of electronic health record data in clinical development. Click Here for More Information. • Biotech Bay (Sunnyvale, California) Pharmacyclics, Inc. Clinical Trial Manager/Senior Clinical Trial Manager Plans and manages clinical development trials to ensure studies are completed, on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. Oversees internal and external staff for timely and quality implementation of trials. • BioForest (Pacific NorthWest, Washington) Biotecher Senior Director Clinical Development Directs and oversees GCP and/or ICH global clinical team activities to ensure that clinical department deliverables are met. Lead clinical design, planning, execution, and development. • Pharm Country (Morris County, New Jersey) Omega Management Group Associate Director/Director Clinical Development Serve as disease area scientific and medical expert for internal (e.g., CTT, International Clinical Team, Scientific Review Committee, Franchise Boards, internal local medical organizations and other line functions) and external customers (e.g., Health Authorities, Key Opinion Leaders (KOLs)). Provide support for medical marketing activities (e.g., speaker training, advocacy, KOL management, advisory boards, launch support, promotional material). • Biotech Beach (Irvine, California) Allergan Inc. Senior Manager, Clinical Business Operations Oversees and ensures the successful execution many central business processes which enable the execution of clinical studies. The CS Manager may be responsible for contracting, vendor management, Beacon system support, Impact system support, metrics reporting, and/or budget & forecast development and support. • BioMidwest (Hinckley, Ohio) Clinical Research Management, Inc. Clinical Research Associate Manage the development, coordination, and implementation of clinical operations site management and clinical monitoring responsibilities for assigned projects with guidance, including trial-specific processes and systems. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! Pharm Country Career Fair Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, medical device and diagnostics companies in the tri-state area. Candidates with a 4-year degree in the life sciences and a minimum of 2-years of industry related experience are invited to attend. (Equivalent work experience may be considered in lieu of a four-year college degree. PhD and Postdoc candidates welcome.) Exhibiting companies are recruiting for positions in areas such as: QA/QC, clinical research, engineering, manufacturing, biostatistics, clinical data management, chemistry, regulatory affairs, and research. Job seekers may register here. • Pharm Country Career Fair, Bridgewater, NJ March 22, 2012 • Biotech Beach Career Fair, La Jolla, CA April 17, 2012 • BioCapital Career Fair, Bethesda, MD April 25, 2012 • Pharm Country Career Fair, King Of Prussia, PA May 1, 2012 • BioNC Career Fair, Durham, NC May 2, 2012 • Biotech Bay Career Fair, Burlingame, CA May 29, 2012 More information about BioSpace's Career Fairs BioSpace White Paper Biotech Career Fairs For Job Seekers 101: Control Your Experience By June Salvati, BioSpace Director of Events and Corporate Services Hot Company Coldstream Laboratories Inc. 1500 Bull Lea Road, Suite 250 11804 North Creek Parkway South Lexington, Kentucky 40511 U.S.A. Phone: 859-257-6600 Fax: 859-323-5985 At Coldstream Laboratories Inc., (CLI), we're seasoned at turning pharmaceutical development ideas into safe, pure, and effective clinical pharmaceutical dosage forms. Since 1986, we have completed more than 200 formulation development projects that led to clinical trials providing us extensive clinical manufacturing experience with both commercial product development and grant-funded projects from such sources as the National Institutes of Health. More Company Profiles Post Your: News | Jobs | Company Profile | Event | Advertising / Sponsorship ClinicaSpace 6465 South Greenwood Plaza, Suite 400 Centennial, Colorado 80111 U.S.A. Phone: 877-277-7585 Fax: 800-595-2929 ClinicaSpace 90 New Montgomery Street, Suite 414 San Francisco, California 94105 U.S.A. Phone: 877-277-7585 Fax: 415-576-9217 Send questions and comments to the ClinicaSpace News Beat Team. Editor & Publisher: Rosemary Do Editorial & Production Staff: Lana Ho, Maysa Darwish, Tammy Liu, Michelle Wong ClinicaSpace.com - Clinical Trials. Clinical Research. Community. • ClinicaSpace is a registered trademark of BioSpace, Inc. • Please distribute this e-cast freely. • Credit any excerpts as follows: Copyright 2012 ClinicaSpace http://www.clinicaspace.com • While BioSpace and its agents used their best efforts in collecting and preparing the information published herein, we do not assume, and hereby disclaim, any liability for any loss or damage caused by errors or omissions, whether such errors or omissions resulted from negligence, accident or other causes. If someone forwarded this news to you and you'd like to receive your own copy FREE of charge, simply Subscribe here. Safely unsubscribe from ClinicaSpace.com e-mail at any time by managing your account here.