Current Sustaining Member Companies

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CURRENT SUSTAINING MEMBER COMPANIES MEMBER FOR OVER: 10 Years 25 Years 50 Years Member Since (alphabetical order) 1976 3M Medical Markets Center 2010 Endo Pharmaceuticals 1963 Novartis Pharmaceuticals 2019 10-Square Solutions 2019 EMD Serono, Inc. 2019 Novo Nordisk, Inc. 1985 Abbott Laboratories, Inc. 2017 Exelixis 2019 Optinose 2013 AbbVie Inc. 2016 Express Scripts Federal Pharmacy 2018 Organogenesis 2017 ACADIA Pharmaceuticals, Inc. 2010 Federal Practitioner 2004 Otsuka America Pharmaceutical, Inc. 2019 Aimmune 2018 Foundation Medicine, Inc. 2018 Pacira BioSciences, Inc. 2003 Alcon Laboratories, Inc. 2006 Gilead Sciences 2018 Paratek Pharmaceuticals 2017 Alkermes, Inc. 1989 Genentech Inc. 1990 Pfizer Pharmaceuticals 2002 Allergan, Inc. 1983 GLAXOSMITHKLINE 2017 Pharmacyclics, LLC 2019 Almirall LLC 2013 Golden State Medical Supply, Inc. 2019 Portola Pharmaceuticals, Inc. 2019 Alnylam Pharmaceuticals 2019 Greenwich Biosciences 2019 Red One Medical 2019 Altarum Institute 2013 Gulf Coast Pharmaceuticals Plus, LLC 2009 Regenesis Biomedical, Inc. 2012 American Medical Depot 2008 Heritage Health Solutions, Inc. 2019 Relypsa, Inc. 2019 Aptive Resources LLC 2017 Hill-Rom Company 2011 Remund Group, LLC 2013 Arbor Pharmaceuticals, LLC 2018 Hu-Friedy Manufacturing Co 2018 Rigel Pharmaceuticals 2014 Argentum Medical, LLC 2019 Indivior 2016 Sage Products, LLC 2019 ARKRAY USA, Inc. 2019 ImmunoVation, LLC 2018 Sage Therapeutics 2019 ASM Research, LLC 2019 Incyte Corporation 2000 Sanofi 1986 Astellas Pharma US, Inc. 2015 Intercept Pharmaceuticals 2004 Siemens Medical Solutions 1995 AstraZeneca 2019 Ipsen Biopharmaceuticals, Inc. 2019 SK Life Science, Inc. 2018 Avanir Pharmaceuticals 2018 IT Cadre 2002 Smith & Nephew, Inc. 2017 Bausch Health Companies, Inc. 1989 J & J Health Care Systems, Inc. 2019 Sobi Inc. 1985 Baxter Healthcare Corporation 2014 Jazz Pharmaceuticals Inc. 2013 Stryker Orthopaedics 1996 Bayer Corporation 2007 Karl Storz Endoscopy America 2018 Sun Pharmaceutical 1954 BD 2010 LLC Federal Solutions 1999 Sunoovion Pharmaceuticals, Inc. 2002 Biogen 2014 Lovell Government Services LLC 2016 Taiho Oncology, Inc. 1995 Boehringer Ingelheim Pharm Inc. 2014 MALLINCKRODT PHARMACEUTICALS 2015 Takeda Oncology 1954 Bristol-Meyers Squibb 1999 Marketing Assessment, Inc. 2000 Takeda Pharmaceutical USA, Inc. 2018 Chartwell Governmental & Speciality Rx, LLC 2009 Masimo Corporation 2019 Tetraphase Pharmaceuticals 2019 Cerecor, Inc. 2019 Medical Strategies International, LLC 1990 Teva 2018 Coherus Biosciences 2016 MELLING MEDICAL 2019 The Coalition for Government Procurement 2017 Cook Medical, LLC 1954 MERCK & CO., INC. 2019 Tris Pharma, Inc. 2019 Collegium Pharmaceutical 2002 MerzNorth America 2001 UCB Inc. 2009 Deloitte 2018 Mitsubishi Tanabe Pharma America 2003 U.S. Medicine 2007 Daiichi Sankyo, Inc. 2001 Mylan Inc. 2016 US Worldmeds/Hema Biologics 2019 Diplomat 2019 Myriad Neuroscience 2017 Velocity BioGroup 2017 Eagle Pharmaceuticals, Inc. 2014 Nationwide Pharmaceutical LLC 2019 Veteran's Health Medical Supply 2005 Eisai, Inc. 2018 Neurocrine Biosciences 2017 Walgreens 2019 electroCore, Inc. 1998 Northrop Grumman Technology Services 2004 WSI PBG, LLC 2006 Zoll Medical Corporation .

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Recommendations for the Primary Analysis of Continuous Endpoints in Longitudinal Clinical Trials
02-DIJ42(4) 2348.qxd 6/9/08 1:46 PM Page 303 STATISTICS 303 Recommendations for the Primary Analysis of Continuous Endpoints in Longitudinal Clinical Trials Craig H. Mallinckrodt, PhD Research Advisor, Lilly This position paper summarizes relevant theo- simple methods in favor of joint analysis of Research Laboratories, Eli ry and current practice regarding the analysis data from all time points based on a multivari- Lilly and Company, of longitudinal clinical trials intended to sup- ate model (eg, of a mixed-effects type). One Indianapolis, Indiana port regulatory approval of medicinal prod- such newer method, a likelihood-based mixed- Peter W. Lane, MA, CStat ucts, and it reviews published research regard- effects model repeated measures (MMRM) ap- Director of Consultancy and Training, Research Statistics ing methods for handling missing data. It is proach, has received considerable attention in Unit, GlaxoSmithKline, one strand of the PhRMA initiative to improve the clinical trials literature. We discuss specif- Harlow, United Kingdom efficiency of late-stage clinical research and ic concerns raised by regulatory agencies with Dan Schnell, PhD gives recommendations from a cross-industry regard to MMRM and review published evi- Section Head, Pharmaceutical Statistics, team. We concentrate specifically on continu- dence comparing LOCF and MMRM in terms Procter & Gamble ous response measures analyzed using a linear of validity, bias, power, and type I error. Our Pharmaceuticals, model, when the goal is to estimate and test main conclusion is that the mixed model ap- Mason, Ohio treatment differences at a given time point. proach is more efficient and reliable as a Yahong Peng, PhD Traditionally, the primary analysis of such tri- method of primary analysis, and should be Senior Biometrician, Clinical Biostatistics, Merck als handled missing data by simple imputation preferred to the inherently biased and statisti- Research Lab, Upper using the last, or baseline, observation carried cally invalid simple imputation approaches.
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1 UNITED STATES DISTRICT COURT DISTRICT of MINNESOTA Shirley
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