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What follows is a guest post by Erik Ian Larsen, a former writer for the Chicago Tribune and an award-winning sports columnist. You can find the rest of his work atThe Sports Tzu or follow him on Twitter @erikianlarsen.
The scientific method relies on testing. If you don't test, you can never know if your theories, your hypotheses, are valid. It's the basis of all science, testing, and without it, we'd be left with an empirically-stagnant understanding of the world around us.
I don't know if Charlie Whitehurst is a good quarterback. He is an unknown variable, an untested theory. Pete Carroll and John Schneider, the Seahawks head coach and general manager, respectively, don't know that either. No amount of reps in practice or the classroom, hypotheticals at best, can accurately test whether or not Charlie Whitehurst is a good quarterback. We just don't know, nobody knows. What we do know is that the Seahawks gave up a lot to get him, both in picks and financially, signing Whitehurst to a two-year $10 million deal that expires at the end of next season. We paid a lot of money to not test a theory thus far, and, in science, you'd have your grant taken away.
What we also know is Matt Hasselbeck. We know exactly what we're going to get from Hasselbeck. 50-60% completions. 150-200 yards. 1-2 touchdowns. 1-2 turnovers. And a whole lot of panicky dives to the carpet under pressure. It was just announced today that, due to a "concussion" sustained last week against the Raiders, Hasselbeck is headed to the bench in favor of the non-concussed Whitehurst. My only question is: What took so long? Yes, we were winning (kinda), yes Hasselbeck had done what the coaches asked after a miserable start and managed his turnovers (kinda), but we were winning despite #8, we were winning because of defense and special teams. Why weren't the Seahawks testing their theory, the Whitehurst theory, to know if they had something special.
It's really easy to play it safe in the NFL. Most coaches do it to save their jobs. It's a lot easier to get fired for being crazy than it is for being conservative, and NFL coaches know that. It's why they don't go for it very often on 4th down, it's why they take a knee to end the half instead of launching a hail mary, and it's why they stick with the quarterback who can "manage the game." Just as NFL coaches have saved their jobs playing it safe, a lot of quarterbacks have done the same. But for this Seahawks team, the quarterback position is so much more important because of the critical timeline ahead. With Whitehurst's contract already running down before he's even thrown a pass in the league, with Hasselbeck's contract expiring at the end of this season, and with an upcoming NFL Draft stocked with high-profile quarterbacks, this is the time to put our experiment to the test.
Hasselbeck's concussion, real or not, should be the gateway to this profound scientific experiment. When Hasselbeck recovers, Whitehurst needs to remain the quarterback of the Seattle Seahawks for potentially the remainder of the year. One game isn't enough to come to a proper conclusion (in science or in sports, ever). Running one test in a lab is never going to be enough for science, and for a young quarterback getting his first real shot to show off his strong arm and needed athleticism, he needs more than just one fill-in game for an aging, struggling quarterback. He needs a real test, a real, sustained test against multiple opponents inside and outside the division, showing different defenses and working with adjustments on the offense. Charlie Whitehurst needs to be put through the NFL ringer. We need to know what he is, if he can be a great quarterback or if he's a lifetime back-up … either way, we need to know, because this has implications not only on this year, but on the long-term success of the franchise.
If he comes in and can't figure out the offense in a series of live games, if he can't complete passes or is too scared to stay upright, we already know what our other variable is going to bring (Hasselbeck) and can switch back without any impact to the team's chances to win games. If he can't cut it at this level, we should know. Not in practice (to quote Allen Iverson), not in the film room, but in real games. There's no excuse not to test him, especially when our current quarterback isn't contributing to the overall success of the team. This is a win-win situation for the franchise. We can find out, once and for all, what we have, what we gave up so much to get, in Charlie Whitehurst, and can also start planning for the future, either with Whitehurst at the helm or targeting one of the great QB prospects in the 2011 NFL Draft.
This Whitehurst start should be the beginning of something, not the Band-Aid for a wounded veteran. An untested hypothesis is a pointless hypothesis, and the Seattle Seahawks now have a wonderful opportunity to finally reach evidence-based conclusions on the future of the franchise. I like Matt Hasselbeck, I think he's been a great servant of the Seahawks, but this is a league built around strong-armed, athletic quarterbacks. Hasselbeck is neither. And if Whitehurst can be that guy, the Seahawks have no excuse not to find out.


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I've been ill again this week and completely losing the plot at work as we get closer to the fateful project go-live! This in combination with juggling family matters and photography work has left me little time to write much down here on the blog (excuses excuses). So to try and make up for it and in substitute of imparting my carefully thought out musings I shall leave you with another cool vimeo flick that caught my eye this week. I love searching the web for inspiration and this one really struck me for a number of reasons. It's not necessarily my kind of music (although it's a grower) but the video certainly rocks. I love the use of dark and light and then vibrant colour – especially alongside the animated vintage style drawings and the surreal action elements. Hopefully you get a kick out of it also…
"I Say Fever" – the first video from the Ramona Falls debut album Intuit. Directed by the ridiculously talented Stefan Nadelman, winner of a 2003 Sundance prize for his 22 minute film 'Terminal Bar', a prolific animator in the commericial field and the mastermind behind the Menomena Evil Bee video.
Ramona Falls is Brent Knopf's first solo venture, but he has an extensive musical resume as part of trio Menomena (an indie rock band from Portland, OR, that's snagged plaudits from such tastemakers as Pitchfork Media and the New York Times.)
Directed and Animated by Stefan Nadelman
Produced by Tourist Pictures

subset: commoncrawl


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NEW BRUNSWICK — Mason Gross School of the Arts graduate students are inviting members of the public to get an up-close look at their work and processes on Oct. 26 from 3 to 6 p.m.
MFA Open Studios will take place across two campuses, with young artists working in a variety of media. Locations for the self-guided tour will be:
• Civic Square Building, 33 Livingston Ave., New Brunswick;
• Studios at 123 Church St., third floor, New Brunswick;
• Livingston Arts Building, building 4169, Livingston campus, Piscataway.
For more information, call (848) 932-5399.
If you would like to submit news pertaining to your college, please send an e-mail to firstname.lastname@example.com.


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Cookie fun facts
Test your cookie trivia knowledge with these fun and interesting facts!
Cookie trivia
- Little Brownie bakes over 4.5 million Thin Mints per day during peak baking times.
- We make our own caramel for Samoas. It's cooked the old-fashioned way in copper kettles and heated to exactly 234 degrees.
- To bake Do-si-dos and Tagalongs, we use about 230,000 pounds of peanut butter a week during baking times.
- Peanut butter cream is deposited onto Do-si-dos at the rate of 2,800 per minute.
- After leaving the oven, Thin Mints travel 300 feet on a conveyer belt to cool before being coated in chocolate.
- A rotary die shapes Trefoils. There are 300 identical Trefoil shapes engraved in one rotary die. The die rotates 17 times a minute to produce 5,100 cookies a minute.
- Samoas go through a cooling tunnel with a temperature of 40-50 degrees before chocolate is applied.
- Do-si-dos are wrapped at 64 packages per minute.
Weekly ingredients during peak production:
- Flour: 21 truckloads or 1,050,000 pounds.
- Shortening: 7 truckloads or 300,000 pounds
- Cocoa: 50,000 pounds
- Chocolate coating: 500,000 pounds
- Sugar: 14.5 truckloads or 650,000 pounds
- Peanut butter: 230,000 pounds
- Toasted coconut: 75,000 pounds
Mixing trivia
- Mixers are machine-operated. Ingredients are weighed and released with the push of a button.
- Each batch is 1200-1500 pounds.
- It takes 10 minutes to mix the dough, which lasts 20-30 minutes and takes 5-7 minutes to bake.
Baking information
Each oven is approximately 100-280 feet long and has four baking zones with very specific jobs…
- The first zone prepares the cookies to be baked by softening them.
- The second zone bakes the cookies from the bottom up.
- The third zone brings the cookies to a flat shape.
- The fourth zone gives the cookies their color.


text: Houston, I have a problem. I am addicted to shimmery body oils. I can't help myself. I have to shine and sparkle all summer. I sometimes mix them with body lotion, but other times I use them alone. There are a few on the market, but my all time favorites are NARS Body Glow, Omorovicza Gold Shimmer Oil, and Nuxe Multi-Use Dry Oil Golden Shimmer. The oils have the best scent and remind me of the islands – any island to be exact. I also take a little of the NARS Body Glow and mix it with water in a spray bottle to add my own personal oil sheen to my hair so the aura of the island scent is everywhere. All summer long I pour some shimmer on me. If you haven't ever used a shimmer oil I advise you to start summer. It is a taste of summer goodness for your body.


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FLINT, MI -- Six people will be recognized for contributions to the health care community Monday, March 31.
The Genesee Health Plan will honor the six individuals during the third annual Health Care Hall of Fame ceremony, which will be at 5:30 p.m. Monday at the Flint Golf Club, 3100 Lakewood Drive.
The honorees include:
- Dr. F. Michael Jagg, Hurley Medical Center vice president, chief of emergency medicine and chief medical officer.
- Colleen Sproul, HealthPlus director of community and government relations.
- David Burr, The DM Burr Group CEO.
- Brenda Clack, Genesee County Commissioner, chair of the county's Human Services Committee.
- Dr. Brenda Fortunate, Genesys Family Practice clinic faculty adviser.
- Rick Wyles, McLaren-Flint vice president of finance and chief financial officer.
Genesee Health Plan is a community-initiated non-profit that aims to provide health care coverage to uninsured and low-income or indigent residents of Genesee County. For more information on Genesee Health Plan, visit their website at GeneseeHealthPlan.org.


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38 minutes ago, DeathByVisualStudio wrote
Like I said before I doesn't mean it's free to implement but it's a whole lot closer than you suggest.
Oh yay. Another free feature for Microsoft to implement, test, review, commit, merge, localize, security audit, and maintain for 10 years.
I hope you can see how easy it would be to make the "mistake" when you do so much of your defense here by taking things out of context or changing the scope. When you do that it makes you appear very desperate and at least in my book seem very disingenuine in your efforts. Even with great explanations like this:
Calling people who are trying to answer your questions "deperate" and "disingenuine" (sic), when they are trying to answer your question is against the ToS of C9.
I know I haven't necessarily been very diplomatic of late, but neither have you.
Let's move on.


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- All Unarmed Private Security Instructors will need to attend one of the Essentials Instructor Development courses in order to be successfully transitioned to the Essentials curriculum material.
- The Instructor Essentials Courses have been posted on the Private Security website and Instructors are welcome to register for the course date that suits them best.
- The Essentials Instructor Development class is held over two days. Course attendees are required to deliver a 15 minute Peer Instruction presentation on an assigned portion of the Essentials student manual, pass the open book DPSST policy and process exam with a score of 85% or above and pass an exam based on the Instructor and Student manual with a score of 85% or above.
- Classes will be conducted in the following regional areas; Medford, La Grande, Eugene, Bend Portland and at DPSST in Salem. Should you wish for a further regional area be added to the list, please let us know.
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High-stakes college football loyalty cuts both ways.
Coaches on Wednesday must avoid big signing day mistakes, or suffer the public indignity of having to return courtesy vehicles while accepting a seven-figure contract buyout.
Programs want to protect their recruiting investments, soon to get more costly with major conferences likely to embrace "full cost of attendance" scholarships.
But players only love you when they're playing - the earlier the better. More top prospects are looking at college as a brief stop on the way to big money; 103 players have declared for early entry into the 2014 NFL draft, up from the previous record of 73 set last year.
It all makes for pumped up signing day drama against an increasing backdrop of truth or dare. Many coaches dangle "committable" and "non-committable" offers to sophomores and juniors. Players "flip" from one school to another more frequently.
"Coaches, whether you like it or not, they're going to battle 'til the very end, until that pen hits paper," ESPN recruiting analyst Tom Luginbill said. "In their opinion, a verbal commitment is just an indication of who they have to beat on a prospect."
Cliffhangers aside, real recruiting battles last longer than signing day sound bites.
Longer and longer by the year, it seems.
The best prospects have all the leverage, but coaches are countering with early offers. Hedged offers, in some cases. Alabama head coach Nick Saban last spring acknowledged a poorly kept secret within the recruiting circles of various college sports - that many offers are "committable" only after the coaching staff has evaluated a player during an on-campus camp.
Particularly, Saban said, for those at "certain positions."
'How you intermingle'
Quarterback, for instance. Alabama gave class of 2014 Georgia high school star DeShaun Watson a non-committable offer after Watson gave a verbal commitment to Clemson (Watson is now enrolled at Clemson).
If you want these things to work out as well and fair as possible for players and programs, there's nothing wrong with a careful approach.
"Coaches are doing this not only to protect themselves but to be up front with the prospect," said Luginbill, Georgia Tech's starting quarterback in 1994. "They're saying, 'OK, we would like to offer you a scholarship but it is predicated upon you coming to campus, you coming to camp and participating so we can further evaluate you, see how you respond to us.
"See how you intermingle and interact with other prospects around you. Would you fit here?' So what they're trying to do is narrow the margin of error in making an error of evaluation because (recruiting) is happening so early."
This is the wave of the near future, complete with teenage negotiating tactics.
Promise breakers
"So what happens?" Luginbill said. "One of two things. The prospect goes, 'Well, why would I come to your camp when you haven't offered me yet?' That right there is a red flag to me if I'm a coach. Or, the prospect says, 'Absolutely, coach, I'll be there.' That tells you something about that guy."
Except that, too often, the promise makers break promises.
Coaches bolt for more cash, get fired, become TV experts.
"The reality of the situation is, kids are going to commit to coaches," Luginbill said. "They're going to commit to a relationship they've developed. They're going to commit to a comfort level with individuals who they've interacted with. The problem with that - and I'm not saying that's entirely bad - but in this day and age, the likelihood that a prospect will actually play for a position coach, coordinator or coach on the staff that recruited them for a span of three to five years is minimal."
Which is one of the reasons why some prospects consider flipping.
Which keeps fans flipping from smartphones to TV channels to websites on Signing Day.
Follow Gene Sapakoff on Twitter @sapakoff


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Azita Ahmadi, B.S., received her Bachelor of Science in Biology from the University of the Pacific along with a certificate in Clinical Trial Design and Management from the University of Santa Cruz. She eventually earned her position as a senior Drug Safety Associate at InterMune Inc. Her professional experience has provided exposure to drug safety, drug development process, clinical monitoring processes, collaborative opportunities, compliance, training, data collection, source documentation, and validation. She recently developed a comprehensive narrative writing training program to help others acquire and practice the skills necessary for generating well-written case narratives for reporting to regulatory authorities. Azita is currently working toward her M.S. in Public Health Economics at the Johns Hopkins Bloomberg School of Public Health.
Moe Alsumidaie, M.B.A., M.S.F., is a business strategist who specializes in predictive modeling and clinical trial technologies. Moe has extensive experience in Phase I-IV, IDE, and 510(k) clinical research and healthcare business operations. Moe has worked in-house for Stanford Medical Center, Abbott Vascular, Genentech, and Roche, and is currently affiliated with The Mount Sinai Hospital. Moe holds a Bachelor of Science in Physiology and Neuroscience from UC San Diego, an M.B.A. in Marketing, and an MS in Investment Finance and Technical Analysis from Northeastern University's D'Amore-McKim School of Business.
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Jerri Barden Perkins, M.D., spent eight years at FDA as a Medical Officer. She was an Acting Division Director for medical devices, involved in policy decisions in the Office of the Commissioner, and a Reviewing Medical Officer for drugs. She made recommendations to the FDA Commissioner on whether or not unsafe products should be recalled from the market. She also made recommendations on whether or not devices and drugs were safe and effective for the US market. Dr. Perkins has assisted both pharmaceutical and medical device industries with regulatory and clinical trials. She has given numerous presentations in the US and Europe, and was an invited speaker in China and India. She has published both research and articles regarding FDA issues such as, "How Does a Medical Officer Review an NDA Submission?" and "Tips on PMA Preparation/Presentation." Dr. Perkins did her post-doctoral training at the National Institutes of Health, and received her M.D. degree from the Medical College of Virginia.
Elizabeth Buchanan, Ph.D. is Endowed Chair in Ethics and Director of the Center for Applied Ethics at the University of Wisconsin-Stout. She is a scholar in the fields of research ethics, information/communication technology ethics, and research methods. Her work is particularly focused on the intersections of research regulation, Internet or online venues and tools, and the subsequent ethical challenges that arise for researchers and research board reviewers. She is professionally active in Public Responsibility in Medicine and Research, the International Society for Ethics and Information Technology (Co-Director), and the Association of Internet Researchers. Elizabeth serves as an Associate Editor for the Journal of Research on Human Research Ethics (JERHRE), on the Editorial Board of Philosophy and Technology, and reviews for many other scholarly journals and granting agencies. Elizabeth is Vice-Chair of the UW Stout's Institutional Review Board, and has served on both social science and medical school research ethics boards. She has presented her National Science Foundationfunded research on IRBs and Internet research to the Secretary's Advisory Committee to the Office for Human Research Protections in 2010, 2012, and 2013. She has also presented at the OHRP Community Research Forums, and has done professional development work with many IRBs. She has been on the Faculty of the Public Responsibility in Medicine and Research roster since 2008, and has participated in pre-conference workshops and many didactic sessions at PRIM&R. As of 2012, she is a member of the PRIM&R Conference Planning Committee and a member of the American Association for the Advancement of Science Committee on Scientific Freedom and Responsibility. Elizabeth holds BA degrees in Philosophy and English from Rutgers University and her M.S. and Ph.D. from University of Wisconsin-Milwaukee.
Nikki Christison, B.S., C.C.R.A. has worked extensively with both sponsors and CROs as a Study Coordinator, CRA, Project Manager, Auditor, and Director of Clinical Operations over the past 18 years, and has published articles in both The Monitor and The Journal of Clinical Research Best Practices on Risk Based Monitoring, Operational Advisory Boards, Study Feasibility, and CRO Relationship Management. Nikki has conducted hundreds of study visits and developed and facilitated training in multiple international venues. Nikki is an experienced speaker and has presented and conducted workshops at Association of Clinical Research Professionals (ACRP) Global Conferences, MAGI, Cambridge Healthtech Institute, iBIG, and Outsourcing Clinical Trials (OCT), and teaches seminars for Barnett International and ACRP.
Natalie Currie, B.Sc., is an instructional designer, facilitator, and learning and development consultant dedicated to academic research organizations, the pharmaceutical and biotechnology industries, and clinical research organizations. Harnessing her 18 years of broad-based clinical research experience, Natalie is sought after as a speaker and facilitator in the United States and Canada. Natalie's breadth of roles has spanned from Clinical Research Coordinator, Clinical Research Associate, Clinical Research Project Manager, and management roles in Government and Health Economics. She worked at the Addiction Research Foundation (now the Centre for Addiction and Mental Health [CAMH]) and Janssen-Ortho Inc. (a division of Johnson and Johnson), participated on international project teams for pivotal Phase III studies, and led Canadian Phase IIIb-IV studies. Natalie holds an honors life science degree from the University of Toronto and is a member of the Society of Clinical Research Associates (SoCRA), the American and Canadian Societies of Training and Development (ASTD & CSTD), Toastmasters International, and is on the organizing committee for the World Creativity and Innovation Week in Toronto. Natalie designs and facilitates engaging, customized corporate and public workshops in the areas of clinical research study management, good clinical practice, and communications, all with visual thinking in mind.
Anil D'Mello, Ph.D. is a Professor of Pharmaceutical Sciences at the Philadelphia College of Pharmacy at the University of the Sciences in Philadelphia. He has over 18 years experience in teaching Pharmacokinetics to Pharm.D. and Ph.D. students. Anil is the recipient of the Lindback Award for Distinguished Teaching and is listed in Who's Who Among America's Teachers. He has conducted Biopharmaceutics and Pharmacokinetics training courses at different pharmaceutical companies including Merck, Boehringer-Ingelheim, and Cephalon. His research examines the role of the maternal nutritional environment during pregnancy and lactation on the development of physiological systems in the offspring. He has numerous publications in peer reviewed journals in the area of pharmacokinetics, drug metabolism, and endocrinology. Anil is a member of the steering committee of the Delaware Valley Drug Metabolism Discussion Group.
Holly DeIaco-Smith, M.S., brings over seventeen years of management consulting experience to her clients, helping them change to be more successful. Holly's tenure in Big 4 consulting, including Accenture and IBM Global Services, grounded her with a foundation of best methodologies, leading practices, and outstanding client experience. It was these experiences that inspired and compelled her to found a management consulting organization serving the agriculture, education, financial services, pharmaceutical, and retail industries. Holly's experience includes strategic planning, process improvement, benchmarking for leading practices, organizational improvement, learning design and development, and change management. Given the critical need today for organizations to develop a talented workforce, Holly has helped her clients define and improve their learning strategies. Holly's unique collaborative approach of truly partnering with her clients and her strong focus on change management enable her to provide excellent service and results.
Sharon Donatucci is an experienced drug safety professional. In addition to the training she does with Barnett, she also serves as Vice President of Pharmacovigilance Sciences for the Drug Safety Alliance. Prior to her current role, Ms. Donatucci was responsible for overseeing DSA's case management function and ensuring that resources were properly allocated for optimal operating capacity and effective, efficient delivery of services. A member of DSA since its inception in 2000, Ms. Donatucci previously served as Senior Director of Training and Quality Control, overseeing the quality aspects of case processing to identify training needs and ensure client satisfaction. She also managed all aspects of DSA's employee development training program, facilitating classes for new hires and audit compliance courses for all employees and developed the company's Drug Safety Case Manager Certification Program. Prior to her training role, she served as a Drug Safety Associate and Project Manager for DSA.
Donna W. Dorozinsky, R.N., M.S.N., C.C.R.C., has over 25 years of experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management. She spent 15 years at SmithKline Beecham in early development and in 2005 founded DWD & Associates, Inc., which has most recently become Just in Time GCP. She has led the implementation of eSource and electronic Trial Master File solutions, and has expertise in clinical validation of these systems. She recently served as chair of the revisions to Zone 4 of the TMF Reference Model. Donna has presented numerous training programs in topics of GCP compliance, Quality Management Systems, and TMF Management and is a dynamic educator.
Christina Eberhart, B.S., has over 13 years of clinical research experience, contributing in such roles as director of clinical operations, director of quality assurance, manager of quality assurance, clinical research associate, and as the principle of an investigator trial network. Christina has conducted quality control monitoring and auditing for sponsors and CROs. She has contributed to the development of on-boarding and training systems for clinical research departments, academic medical centers, and the division of acquired immunodeficiency syndrome (DAIDS) within the National Institutes of Health (NIH). Christina is a national speaker on several clinical research topics for the Association of Clinical Research Professionals (ACRP), Drug Information Association (DIA), Society of Clinical Research Associates (SoCRA), and MAGI. She is a member of ACRP and ASQ. She is a member of the bioresearch central advisory board, and is past-president for the Greater Kansas City Chapter of ACRP.
Daniel J Filoramo, RN, B.S., is a successful pharmaceutical professional with over 18 years of diversified clinical research experience. Daniel's experience encompasses multiple roles in all phases of drug development and marketing. He has been employed with a large pharmaceutical company for the past 10 years as a Sr. Clinical Scientist in the department of Early Clinical Translational Research. In this capacity, he has had the opportunity to author protocols and clinical study reports, and monitor and manage operations for Phase I and Pharmacology studies. Daniel is also responsible for the overall operational management of early assets. With his strong clinical research background, he is instrumental with process improvement activities, authoring of Standard Operating Procedures, and providing training on various clinical research topics. In addition, Daniel's experience spans across multiple therapeutic areas such as Anti-Infectives, Cardiovascular, Immunology, Metabolic, and the Neurosciences.
Gary B. Freeman, M.S., C.C.R.A., provides quality clinical monitoring, auditing, training, project management, and consulting services internationally. He has personally worked in these areas with pharmaceutical, device, healthcare, and contract research organizations for over 30 years. Mr. Freeman has been a credentialed clinical research trainer through ACRP since its inception in 2003. Mr. Freeman holds a B.S. in Biology (pre-med program) from the University at Albany and an M.S. in Science Education from Russell Sage College. He has been actively involved in various clinical capacities for multiple therapeutic areas (Phase I-IV) for the following indications, as well as devices: allergy, anti-infective, cardiovascular, critical care, dental, dermatology, endocrinology, eye care, GI, imaging/diagnostics, immunology, infectious disease, oncology, organ transplant, OTC medications, psychiatric disorders, pulmonary, sleep disorders, and STDs. This experience includes pre-clinical laboratory work, data management, protocol writing and CRF design, clinical monitoring, clinical trial management, GCP auditing, developing and presenting clinical training programs, regulatory affairs management and overall responsibility for clinical operations in several settings, including presentations at FDA Advisory meetings. Mr. Freeman has also participated as a trainer for ACRP's CRA and CRC Certification Exam Review courses and other clinical offerings, and is an active instructor for several drug and device courses for Barnett International for public and on-site offerings. He lectures routinely worldwide and presents training workshops for drug and device companies, as well as investigator sites. He also conducts GCP audits at investigational sites and vendors for pharmaceutical and device studies. Mr. Freeman is currently an active member of ACRP (Association of Clinical Research Professionals), DIA (Drug Information Association) and SQA (Society of Quality Assurance).
Joy Frestedt, Ph.D., C.C.T.I., R.A.C., F.R.A.P.S., has over 30 years of experience, and provides clinical, regulatory, and quality affairs consulting services to the pharmaceutical, medical device, and food industries. She recently served as interim Regulatory Director at the University of Minnesota Academic Health Center and as a member of the Allina IRB. She previously held key positions at Ortho Biotech, Medtronic, Mayo Clinical Trial Services, AstraZeneca, and Orphan Medical. She holds a B.A. from Knox College and a Ph.D. in pathobiology from the University of Minnesota Medical School. Dr. Frestedt is a member of American Society of Clinical Oncology (ASCO), American Association of Pharmaceutical Scientists (AAPS), Association of Clinical Research Professionals (ACRP), and Society of Clinical Research Associates (SoCRA), and is a Fellow of Regulatory Affairs Professionals Society (RAPS). Dr. Frestedt was honored in 2011 as one of the "100 Most Inspiring People in the Life Sciences Industry" by PharmaVOICE and one of the top 25 "Industry Leaders," a "Women in Business Award" by the Minneapolis/St. Paul Business Journal.
Karen L. Gilbert, B.S., C.C.R.A. has worked in the clinical research industry since 1994 monitoring pharmaceutical and medical device trials, managing an investigational site, and serving as a global study manager. Her experience also includes two years serving as Clinical Trainer & Curriculum Manager with Barnett Educational Services. Karen's training courses and presentations have been delivered internationally to industry clients and at global professional conferences. She has co-authored two articles published in the clinical research industry journal, Clinical Researcher (formerly The Monitor). Ms. Gilbert received her certification as a Certified Clinical ResearchAssociate (CCRA) through the Association of Clinical Research Professionals (ACRP) in 2005 and remains active in this organization.
Susan Gordon, R.N., M.S.N. is an experienced drug safety professional with over 20 years of experience. In addition to her training work, she serves as CEO of the Drug Safety Alliance. Prior to her current role, Susan served as Senior Vice President of Global Case Processing, overseeing the company's case management function and ensuring the proper allocation of resources for optimal operating capacity and efficient delivery of services. Ms. Gordon has also served in senior leadership roles, including providing strategic direction and leadership for all project management, clinical operations and R&D sourcing and procurement activities within King Pharmaceutical's scientific operations. Before her tenure with King, Ms. Gordon spent 19 years in positions of increasing responsibility for GlaxoSmithKline and its parent companies, working within the full range of pharmaceutical clinical development including drug safety, clinical operations and project management. A licensed Registered Nurse, Ms. Gordon received both her Bachelor of Science degree and her Master's degree in Nursing from the University of North Carolina at Chapel Hill.
Glenda Guest, C.C.R.A., RQAP-GCP, specializes in medical device monitoring and project management, auditing and training on U.S.-regulated research, Quality Systems and Good Clinical Practices in clinical research settings. With her extensive background in a clinical CRO environment, she has developed a unique perspective, not only of the regulatory requirements for product development and market approval, but also the insights from collaboration with multiple sponsor companies' varying approaches in meeting those requirements. Ms. Guest has had the opportunity to work with large and small manufacturers in both the premarket approval and 510(k) realms. She is an active member of the MedTech Association, as well as the Association of Clinical Research Professionals (ACRP), Model Agreements & Guidelines International (MAGI), and the Society of Quality Assurance (SQA). She has been an ACRP Certified Clinical Research Associate status since April of 2002 and an SQA Registered Quality Assurance Professional – Good Clinical Practices since April 2007.
Elkan Halpern, Ph.D., is the chief statistician for the Department of Radiology and the Director of Statistics for the Decision Analysis and Technology Assessment Group, Massachusetts General Hospital. Formerly holding positions of Principal Statistician and Vice President, Dr. Halpern has had over 30 years of experience in all phases of clinical and statistical research for FDA submissions and post-marketing studies.
Beth D. Harper, B.S., M.B.A., has extensive clinical research consulting experience, focused on the delivery of timely and predictable clinical trials, and enrollment and site performance management. Previously, Beth was President of Clinical Performance Partners, Inc., a clinical research consulting firm specializing in enrollment and site performance management. In addition to her 25+ years of clinical research experience, she is an Adjunct Assistant Professor at the George Washington University, and has published and presented extensively in the areas of study feasibility, site selection, patient recruitment, and protocol optimization. Beth received her B. S. in Occupational Therapy from the University of Wisconsin, and an M.B.A. from the University of Texas.
Bart Harvey, M.D., Ph.D., M.Ed., is a Public Health Physician-Epidemiologist and Associate Professor in the University of Toronto's Dalla Lana School of Public Health where he teaches courses in public health, epidemiology, and statistics. He has been the principal or co-author of nearly 50 peer-reviewed publications, and has presented invited and peer-reviewed papers at national and international professional conferences. In addition, Bart has authored a self-study text, Statistics for Medical Writers and Editors (2009) and was the lead editor of The Research Guide: A Primer for Residents, Other Health Trainees and Practitioners (2011). He is a Fellow of the American College of Preventive Medicine (ACPM) and the American Medical Writers Association (AMWA). Bart was the recipient of the Eric Martin Award for Excellence in Medical Writing in 2011 and an AMWA Book Award for The Research Guide in 2012. Bart also serves as an investigating coroner in Toronto.
Jacqueline (Jackie) Hee, B.S.N., M.P.H., is an experienced drug safety professional with over 20 years of experience in both the pharmaceutical and contract research organization settings. In various leadership roles in pharmacovigilance (PV), she has collaborated with internal and external stakeholders in and outside of PV to support process improvement initiatives, decision making, and regulatory compliance, particularly in the setting of organizational transitions and implementation of new legislation and guidance in the GPvP environment. Most recently, she served as Director of Product Safety at Salix Pharmaceuticals, Inc., where she worked with senior management to develop the infrastructure for clinical trials safety management, signal detection and aggregate reporting, and the safety review team function, while making significant PV contributions to advisory committee meetings for new drug indications, international marketing authorization submissions, data driven responses to regulatory authority requests, and support of US and international PV directed regulatory inspections. Prior to her tenure at Salix, Jackie spent 9 years in positions of increasing responsibility for GlaxoSmithKline and its parent companies, working within the Global Clinical Safety and PV and Global PV Compliance Audit functions in the areas of pharmaceutical clinical development, postmarketing surveillance, business licensing collaborations, and activities to develop, implement, and assess pharmacovigilance and materiovigilance compliance strategies. Ms. Hee received a Bachelor of Arts degree in English Literature from Georgetown University, a Bachelor of Nursing degree from the Catholic University of America, and a Master's degree in Public Health from the University of North Carolina at Chapel Hill.
Marla Hoelle, B.S.N., R.N., C.C.R.A., P.M.P., is a Clinical Training Manager for Barnett International. She has over 20 years of experience in clinical research. Marla began her career in clinical research as a study coordinator for an academic medical center, followed by working in a private physician group conducting clinical research. She continued her career path in clinical research working as a CRA and Project Manager. She has served as a clinical project manager for pharmaceutical and medical device trials managing all operational aspects of clinical trial activities from study start-up to FDA submission. In the projects she has managed, she has led a team of research professionals including CRAs, biostatisticians, data managers, regulatory, medical writers, safety, and vendors. She has a passion for the development and mentoring of study coordinators, CRAs, clinical project managers. Marla brings her experience and lessons learned from the various clinical trial projects she has managed to the trainings she delivers. Areas of therapeutic experience include: Cardiovascular, Infectious Diseases, Oncology, Orthopaedics, and Women's Health.
Janet Ellen Holwell, C.C.R.C., C.C.R.A., is an independent consultant specializing in maximizing excellence in GCP quality, compliance, and training for both sites and industry. She works contractually with sponsors, CROs, academic medical centers, and site investigators and their personnel to provide training in the clinical research process, specializing in ICH GCP compliance and quality oversight. Janet began her career as a clinical research coordinator in academia over 30 years ago. Prior to transitioning to industry, she managed a clinical pharmacology unit at Columbia Presbyterian Medical Center in New York City, overseeing all operations. She was an instructor in GCP and helped develop the first GCP program in an academic institution. She was an invited lecturer for Columbia University School of Nursing's postgraduate Course for Clinical Research Coordinators. Prior to her position in quality management with Pfizer, she held positions as a clinical research associate, site selection specialist, study manager with oversight of vendor CRAs, and trainer for several pharmaceutical companies. Janet has been an active member of the Association of Clinical Research Professionals (ACRP) since 1992, having served on the board of trustees, North American Council, and various forums. She is a founding member, past president, and presently an active board member of the New York Metropolitan Chapter of ACRP. She is also an approved trainer for the ACRP Certification Examination Prep Course and Fundamentals in Clinical Research.
Treena Jackson, M.S., C.Q.A., R.A.C., C.S.S.G.B. is a consultant providing global quality auditing, regulatory, process improvement, and training services with a focus on GCP and GLP. She is also currently the GCP expert on staff at a major CRO, and teaches as an adjunct professor at Campbell University in the Clinical Research Program. At Campbell University, Treena has taught in the undergraduate and graduate degree programs for Clinical Research. She has been in the pharmaceutical industry for over 14 years working for a major pharmaceutical company, a small biotech, and a CRO prior to working as a consultant. She has also travelled to over 10 different countries for audits, including vendor audits, for causeaudits, process improvements, and routine site audits. Treena has her MS degree in Regulatory Affairs and Quality Assurance from Temple University and a BS degree in Laboratory Animal Science. She has been teaching and training on a College and University level since 2004 and has also spoken at several programs for American Society of Quality (ASQ) as well as other organizations. Treena is also very active on the board of directors for NC Society of Quality Assurance.
Véronique Lalevee, Pharm.D., P.M.P., is a proven leader with extensive experience assisting companies with their product development. Véronique has a wealth of experience in portfolio and project management for drugs, medical devices and cosmetics. During her career, Véronique has led international teams in pharmaceutical R&D coordination, planning and regulatory dossiers development, and project and portfolio management. She is recognized for successfully and consistently developing and implementing processes, procedures, and tools to enhance R&D performances and streamline the organization. One of Véronique's key strengths is building engaged teams that execute and deliver as promised. Using her experience as both a portfolio manager and a scientist, she applies project management best practices to the pharmaceutical, biotech, and life sciences industries.
Marina Malikova, Ph.D., M.S., M.A., C.C.R.A., has over 10 years of experience in the clinical research field. She has managed Phase I-IV studies involving investigational drugs, devices, and biologics. She has worked on industry-sponsored and investigator-initiated trials in the fields of vascular surgery, neurosurgery, cancer diagnostics, and interventional radiology. In her current role, she is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, strategic planning, and macro-management of research programs. She provides guidance and oversight to all clinical research personnel, and advises faculty/staff on protocol and informed consent writing; assists with applications and submissions; and ensures compliance. She also provides oversight for data user agreements; cost coverage analysis and budgets development; and contracts and licensing for clinical research. Dr. Malikova has a Ph.D. in Biochemistry, a Master's Degree in Clinical Investigation, and Project Management Certification from Boston University. She has seven years of teaching experience, and has developed several clinical research related courses. She is a member of Association for Clinical Research Professionals (ACRP), Drug Information Association (DIA), Regulatory Affairs Professionals Society (RAPS), and European Society of Radiology (ESR).
Anne McDonough, M.P.H., C.C.R.A., M.I.C.R., C.Sci., has over 16 years of experience in a variety of roles in clinical research. Ms. McDonough started her career working in investigational sites for HIV trials, spent over 10 years working in the American and European divisions of an international CRO, and is currently a freelance clinical research consultant based in London providing monitoring, project management, clinical science, medical writing, and training services. She has broad international experience in a full range of clinical trials (Phases I to IV, pharmaceuticals, biotechnology products, diagnostics, devices, and vaccines) and in a variety of therapeutic areas. She also currently serves on the exam committee for the CCRA exam (Association of Clinical Research Professionals) and is past chair of the European exam committee.
Kirsten Morasco brings over seventeen years of life sciences industry experience to her clients. She began her career in the pharmaceutical industry where she led teams that brought new products to market, managed global projects, and implemented training for new and existing employees. As a consultant, she has assisted her clients with change, process improvement, and meeting compliance standards and requirements. She is skilled in managing global process improvement/harmonization engagements dedicated to developing and implementing management solutions that enhance the speed and efficiency of clients' processes and enable the implementation of these processes among employees. In particular, Ms. Morasco has developed document management processes for companies implementing a document management system in a compliance environment; developed managed, and implemented controlled documents, including Standard Operating Procedures (SOPs) and Business Practices to ensure compliance with federal and state regulations; developed and delivered instructor-led training for pharmaceutical staff with regards to clinical trial procedures and monitoring; developed and conducted instructor-led Standard Operating Procedures training for pharmaceutical staff; developed educational materials and seminars for the marketing department and administrative staff of a pharmaceutical company; and worked with instructional designers to ensure development and delivery of instructor-led SOP training for a large pharmaceutical company.
Eric Morfin, M.B.A., P.M.P., has been a project manager since 1987. A sought after speaker on the subject of project management, portfolio management, and resource management at North American and European symposiums and conferences, Mr. Morfin has been published many times in project management magazines and pharmaceutical publications. Currently the co-author of several project management in pharmaceuticals books, Mr. Morfin is an active member of several professional societies and has developed several unique seminars on project management in drug development, such as "Project Management in Discovery and Preclinical" and "Project Management for Global Clinical Trials." He has consulted with clients in a variety of industry settings throughout North America, Europe, and Asia. He has worked with the World Bank, Merck Frost, Hewlett Packard, GlaxoSmithKline, Aventis, Novartis, Bristol Myers-Squibb, and AstraZeneca to name only a few. For 10 years, Mr. Morfin managed the project management practice of a worldwide training and consulting organization headquartered in the USA. Previously, he worked with a leading consulting group in the strategic field. In Europe, besides managing his own computer firm dealing in digital animation, he created and managed an entire new division for Apple Computer. Mr. Morfin is bilingual in French and English, has traveled extensively in Europe and Asia, and earned his M.B.A. in International Business in San Francisco. He currently lives in San Francisco with his wife and daughter.
Jeanne Morris B.S. MT (ASCP), is an ASQ Certified Manager of Quality/Organizational Excellence. Ms. Morris provides GMP, GCP, GPvP, and QMS expertise to the pharmaceutical and medical device industries. She has over 20 years of experience in regulated industry, including 15 years with the United States Food and Drug Administration. Her expertise includes risk assessment and mitigation, regulatory readiness support and mock inspections, process improvement project management, and procedure review and training. Prior to consulting, Ms. Morris held varied leadership positions at Takeda Global Research and Development, Inc., most recently as Director GxP Compliance, where she ensured drug development activities were conducted in compliance with regulations, guidance, and standards. While working for the FDA, Ms. Morris conducted over 300 inspections in the United States and internationally. She was a member of FDA's national training cadre, and recipient of the prestigious FDA Commissioner's Award of Merit.
Elizabeth Ronk Nelson, M.P.H., has over 20 years of experience in medical and clinical research. During her career, she has managed clinical trial site operations as a clinical research program coordinator and researcher, and has served as an IRB Quality Assurance Specialist and a Senior (GCP) Auditor, Trainer, and Compliance Director. Her professional areas of specialization include fraud detection and prevention; mock FDA audits; customized, audit finding-specific, risk-based training; independent GCP quality systems and compliance audits; SOP and training program development and gap analysis; corrective and preventive action (CAPA) and quality systems improvement plans for GCP; customized skill-based training for clinical research professionals; clinical investigator site and IRB development and quality improvement (QI) plans; vendor audits assessments; and site selection qualification assessments. Ms. Nelson has extensive experience in investigating and pursuing suspect clinical data cases and has worked professionally with industry and government representatives to pursue legal actions for severe noncompliance cases.
Randy Ramin-Wright, M.Sc., is a Program Manager and QRM Consultant with more than 20 years of experience in IT consulting, modeling, designing, and implementing information management systems. This expertise draws on project experience from a wide range of industries: pharmaceutical R&D, pharmaceutical finance, pharmaceutical informatics, systems biology research, material sciences, banking, and national security. His current focus is on the development and commercialization of Quality Risk Management products and services, and the development of industry standard risk metrics to help pharmaceutical companies optimize the use of their drug development resources. Randy has an M.Sc. in Physics and B.Sc. in Astro-Physics from Michigan State University.
Denise G. Redkar-Brown, MT, began her career as a Medical Technologist working in a hospital laboratory environment. She made the transition to the pharmaceutical industry, and after more than 20 years she has held positions in basic and clinical research. She is published in the European Journal of Pharmacology for her work in pharmacology while at AstraZeneca, and was published in the Good Clinical Practices Journal in 2008. Denise has contributed to the successful submissions for Accolate® (the first leukotriene antagonist for asthma therapy) and Seroquel® (Serotonin receptor compound for treatment of Schizophrenia and bi-polar disorder). Denise also worked at Dupont Pharma (Immunology), Knoll (Humira®), Sanofi (vaccines), and as Associate Director of Scientific Affairs, Data Management for Cetero Research, and is serving as a member of the Board of Trustees for the Society of Clinical Data Management (SCDM).
Lily Romero, P.A., C.C.R.C., has over 30 years of experience in clinical research. Her experience includes positions as Director of Global Development Training at Elan Pharmaceuticals, an Associate Director of Clinical Operations at Quintiles, Inc., a Clinical Research Coordinator and Research Administrator at the Allergy & Asthma Medical Group and Research Center, and a P.C. in San Diego, CA. She has worked on Phase I-IV clinical trials including pediatric studies. She was an instructor for and assisted in the development of an investigator GCP training workshop for the American Academy of Pharmaceutical Physicians. She is on the Advisory Board and an instructor for the Clinical Trials Design and Management certificate program at the University of California at San Diego (UCSD) Extension. Currently, she is a member of the Academy Board for the Associates of Clinical Research Professionals (ACRP).
John Serio, J.D., represents pharmaceutical, biotechnology, nutraceutical, and medical device companies, particularly as to patent prosecution, licensing, and litigation matters. Mr. Serio also has extensive expertise in food and drug law involving pharmaceuticals and medical devices. He advises companies on a wide variety of regulatory issues, including the national and international conduct of clinical studies, manufacturing, the preparation and filing of regulatory documents, compliance with FDA regulations, and FDA enforcement matters. Mr. Serio is a recognized expert on direct to consumer advertising of pharmaceuticals. As a licensed pharmacist and a registered patent attorney, Mr. Serio has a multilateral understanding of complex scientific principles and drug development within the pharmaceutical industry. He is an accredited speaker with the American College of Pharmaceutical Education and regularly speaks and writes on pharmaceutical issues. Mr. Serio received his undergraduate degree at the University of Rhode Island College of Pharmacy, and his law degree from Western New England School of Law. His recent publications include State-by-State Clinical Trial Requirements Reference Guide, Barnett Educational Services, 2012; "Pharma and Social Media: The Leaders and Followers," A FirstWord Market Intelligence Report (August 2009); and "Connecting with Patients, Overcoming Uncertainty," Regulatory Issues in Social Media for Pharmaceutical Marketers (2008).
Paul Strickland, B.Sc., FRQA, DipRQA, has over 23 years of experience in Clinical Quality Assurance. As a consultant he has audited across the world, in both GCP and PV areas. He has also given GCP training and refresher courses, inspection preparation guidance, and has spoken at numerous conferences. Paul previously worked for 12 years at Amgen Ltd, most recently as Director of Intelligence and Inspections, and Regional Head of Clinical Auditing. In former years, Paul worked in a GCP auditing capacity with the Wellcome Foundation and with Glaxo. From the beginning, he has led the facilitation of many regulatory inspections, both in-house and in the field in Europe, the U.S., and Africa. He also has several years' previous experience in QA of manufacturing with Serono Diagnostics. His first healthcare role was in 1979 with Amersham International. Paul has been course principal for the RQA GCP auditing course for 15 years, and was a tutor on the course for a number of years prior to that. He is chair of the Audit Working Party, a subgroup of the EFGCP, and has held this role since 2005. He is a member of the EFGCP Board and an invited member of the MHRA Stakeholder Engagement Meeting. He gained RQA's Diploma in Research Quality Assurance in 1998 and is a Fellow of the Association.
Vaska Tone is an internationally respected professional in clinical research and quality assurance (QA) with wide ranging experience in varying GxP auditing, training, standard operating procedures (SOPs), and corrective and preventive actions (CAPA) consultancy gained through increasing positions of responsibility in the pharmaceutical and CRO industries. She has 25 years of experience in clinical development for the pharmaceutical, biotechnology, and device industries, including extensive experience in GCP quality assurance including support for pharmacovigilance. She has directly managed staff and quality deliverables ensuring oversight and effective communications of audit findings to allow for appropriate CAPA and any necessary SOP development. She is a Society of Quality Assurance (SQA) committee member, and a pre-test writer for the RQAPGCP annual certification test. She is a participant on developing comprehensive auditing standards within QA Societies, namely joint projects with RQA, SQA, and JSQA. She is an American Society of Quality certified auditor with experience in lean-sigma standards, and a guest lecturer at the University of Southern California (USC) School of Pharmacy.
Susan Torchio, R.N., B.S.N., has over 20 years of clinical research experience. For the past 10, years she has been an instructor for Barnett International's CRA and CRC course. Sue started her career in clinical research as a study coordinator at a busy family practice site that participated in multiple studies in a wide range of therapeutic areas including cardiology, infectious disease, and gastrointestinal. After two years as a coordinator, Sue joined a large CRO as a Clinical Research Associate, conducting a variety of late phase clinical programs. She has been at two other CROs in her career as a Project Manager working in infectious disease, trauma, endocrinology, and cardiology. She joined a BioPharma company in 1998 as a consultant and later a Project Manager in Medical Affairs. Medical Affairs was combined with Clinical Operations and she was promoted to a Senior Manager working in the CNS group. In 2005, her role changed and she is now heading up leading the Resourcing Group as an Associate Director within Clinical Operations. In this role she is responsible for working with a Function Outsource Provider to manage a field force of Regional Managers and Regional CRAs. In addition to her other responsibilities, Sue is also heading up the Pain Program in Clinical Operations. In this role she is in charge of various pain compounds and the studies that are conducted with them.
Lee Truax-Bellows, FNP, C.C.R.A., RQAP-GCP, TIACR, has an extensive background in the pharmaceutical and medical device industries, having worked for both industry and a CRO as a Monitor, Medical Communications Associate, Project Manager, Senior Quality Auditor, Senior Trainer, and Regulatory and SOP Consultant. Lee has been involved in regulated research the past 25 years and currently specializes in product development, GCP auditing and SOP development and training on regulated research and Good Clinical Practice. She is an active member of the Association of Clinical Research Professionals (ACRP), New York State MedTech Association and Society of Quality Assurance (SQA). Lee is ACRP certified as a Certified Clinical Research Associate (CCRA) and registered through SQA as a Registered Quality Assurance Professional in Good Clinical Practices (RQAP-GCP).
Cheryl Vitow is a medical writer and clinical management consultant with over 25 years in the pharmaceutical, biotechnology, and device industries. She has a degree in Medical Technology, Biochemistry (Rutgers), and her Masters work is in Clinical Pharmacology (Jefferson). She began her career as a bench chemist. She has been involved in the design, conduct, and reporting of clinical studies from Phase 1 through Phase 4 and has worked for Johnson and Johnson, Aventis, Squibb (before BMS), Eisai, Lippincott, and many others. She has run a successful medical writing and clinical project management consulting firm for 15 years.
Tabitha Westbrook, M.A., LPCA, CCTP RQAP-GCP, has more than 20 years of experience in the pharmaceutical industry, 15 of which have been in Clinical Quality Assurance. Ms. Westbrook has both conducted and provided training on such topics as clinical quality auditing processes, process audits, vendor audits and vendor management, investigator site audits (both routine and for cause), hosting sponsor audits and regulatory inspections, standard operating procedure (SOP) creation and maintenance, identifying and managing protocol deviations, root cause analysis, and corrective and preventive actions. She also teaches courses on conflict management and resolution and leveraging emotional intelligence in the workplace. Her teaching style is interactive and interpersonal, using real-world scenarios to bring the information to life and help learners generalize information across their various roles and jobs. Ms. Westbrook also provides mentoring to newer members of industry.
Liz Wool, R.N., B.S.N., C.C.R.A., CID, CMT, is the Global Head of Training for Barnett International. She has 37 years' of experience in healthcare and 25 years in clinical research, and is a recognized industry thought leader, subject matter expert, trainer, and international speaker with a focus on solutions and added value results for Barnett clients. Her expertise is in the areas of clinical research, trial management, clinical quality management systems, vendor management and oversight, compliance, operations, personnel training and development, and, performance management methods. Liz's expertise produces results in both organizational effectiveness and efficiencies (design, re-design, modifications for growing companies, and post-mergers and acquisitions) in support of the organization's goals. Liz's strategic, operational, leadership, and facilitation expertise combined with her spirit of teamwork brings the ability to swiftly identify the organizational challenges. She draws on her experience working with the full range of national and international stakeholders in clinical research for the design, development, and deployment of enterprise solutions. Liz provides solutions focused services and recommendations that are a "right fit" for the organizational size, scope of business, business plan, business goals, and culture. Liz has provided consulting services to 6 of the 21 TransCelerate Biopharma, Inc. companies during her consulting tenure in the areas of department level strategic support, SOPs and performance management (post-merger/acquisitions), vendor program gap analyses, enterprise wide training strategy, and framework gap analyses, training courses, and metrics.
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Your sunrise summary of everything you need to know about weather in H-town.
Enjoy the 70s this morning because they'll be replaced by cold and blustery weather this afternoon.
A strong cold front is working its way through the greater Houston region this morning, and should push through downtown by around 10 a.m. or shortly thereafter.
Highs in the low 70s this morning across the metro area will fall this afternoon in the wake of the front, down to the 40s for inland areas and the 50s along the coast. Along with the cold air rain chances will increase in the wake of the front, with light rain, drizzle and showers possible.
With nighttime temperatures near freezing to the immediate north of downtown, and at or below freezing to the northwest of the metro area, it's possible some of this precipitation will turn into freezing drizzle on Friday and Saturday nights. The following map, from the National Weather Service, shows where a wintry mix of freezing precipitation is possible this weekend.
Daytime temperatures this weekend will be cold as well, with highs ranging from the upper 30s to mid-40s.
Then, early next week, a second shot of Arctic air will blast into the area, possibly pushing nighttime temperatures on Tuesday morning into the upper 20s for areas north of downtown Houston. It could be the coolest weather the city has experienced since February, 2011. On Tuesday morning many areas between downtown and the coast could also experience their first freeze of this season.
A freeze is possible on Wednesday morning as well.
Wondering when it might warm up again? We'll probably be back in the 70s, for daytime highs, by the weekend of Dec. 14.
Until then, be prepared to feel the chill.
We'll miss you, sunshine
The seventies were quite nice
Now they're put on ice
Wednesday's high temperature of 81 degrees was within 2 degrees of the all-time record for that date, set in 2012.


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In the following video, Motley Fool tech and telecom analyst Andrew Tonner takes a look at Google (NASDAQ: GOOGL ) and IBM (NYSE: IBM ) , now that both have released this quarter's earnings. While Andrew loves the management at IBM and likes its continued execution of its goals to move toward a business model focused more on software and services, which are higher-margin areas for the company, it's hard to argue with the idea that IBM is still positioned in a rapidly maturing industry, whereas Google has tremendous growth prospects ahead of it.
As one of the most dominant Internet companies ever, Google has made a habit of driving strong returns for its shareholders. However, like many other Web companies, it's also struggling to adapt to an increasingly mobile world. Despite gaining an enviable lead with its Android operating system, the market isn't sold. That's why it's more important than ever to understand each piece of Google's sprawling empire. In The Motley Fool's new premium research report on Google, we break down the risks and potential rewards for Google investors. Simply click here now to unlock your copy of this invaluable resource, and you'll receive a bonus year's worth of key updates and expert guidance as news continues to develop.


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LAS VEGAS — An Olympic gymnast, a fashion designer and a former beauty queen are among seven people set to judge the Miss America competition next month in Las Vegas.
The panel announced Wednesday on "Good Morning America" will be judging contestants during preliminary competitions and at the finals, set for Jan. 12 at Planet Hollywood Resort and Casino.
The judges include gold medal-winning gymnast McKayla Maroney, Miss America 2009 Katie Stam Irk, and fashion designer Bradley Bayou, who's a member of Oprah's "Glam Squad."
Others include professional dancer Cheryl Burke of "Dancing with the Stars" fame, weather anchor Sam Champion from "Good Morning America," longtime "Entertainment Tonight" host Mary Hart, and Daymond John of the show "Shark Tank."


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Decision Tree for State Government Fleets (Text Version)
Use this text version of the decision tree for state government fleets to determine whether your fleet is covered by the Energy Policy Act of 1992 (EPAct).
Question 1
Does your state government (or state agency) own, operate, or control at least 50 light-duty vehicles (LDVs) within the United States?
If yes, go to question 2. If no, go to conclusion 1.
Question 2
When you subtract excluded vehicles, does your fleet still total 50 or more LDVs?
If yes, go to question 3. If no, go to conclusion 1.
Question 3
Of those 50 LDVs, does your state government (of state agency) own, operate, or control 20 or more non-excluded LDVs that are used primarily within a Metropolitan Statistical Area/Consolidated Metropolitan Statistical Area (MSA/CMSA)?
If yes, go to question 4. If no, go to conclusion 1.
Question 4
Are at least 20 of those LDVs centrally fueled or capable of being centrally fueled?
If yes, go to conclusion 2. If no, go to conclusion 1.
Conclusion 1
Your fleet is not covered. If your fleet is not covered, your fleet must notify the U.S. Department of Energy (DOE) if circumstance change such that your fleet becomes covered.
Conclusion 2
Your fleet is covered by the EPAct alternative fuel vehicle–acquisition mandate.
More Information
If still uncertain about whether your fleet is covered, contact the Program's Regulatory Hotline at 202-586-9171, email email@example.com, or submit information concerning your situation to:
Regulatory Manager
Alternative Fuel Transportation Program
EE-2G/Forrestal Building
1000 Independence Avenue, S.W.
Washington, DC 20585
The number of non-excluded LDVs in your fleet and the number of your fleet's LDVs in MSAs/CMSAs is information your fleet should provide. DOE will provide a definitive answer.


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Last Sunday, the Buddhist Students Association had organized its annual trip to a Buddhist monastery. This year we went to Kagyu Thubten Chöling Monastery and Retreat Center in Albany, New York. The center, as I had expected, was a very peaceful place. Buddha's insistence on simplicity of life, love, and sympathy was visible in the interior design of the center as well as in the character and behavior of the people we met.
We did a meditation session followed by an insightful lecture on the teaching of Buddha's philosophy on the nature of things.
It was the first time I practiced Buddhist meditation. It was a wonderful experience. Sitting cross-legged on a small red round mat, with my knees slightly pointing down and touching the ground, I had to keep my spinal cord straight with my neck lightly bent forward; I learned how can one control the flow of energy and maintain it in his body to maximize focus and concentration.
It has been awhile, I practice to be more aware and in peace with myself, my feelings and my surrounding. Thanks to the Union's Buddhist Students Association for organizing this trip, it added to my knowledge and resources to achieve that goal.
Here is my favorite quote of Buddha"Do not dwell in the past, do not dream of the future, concentrate the mind on the present moment."
Jamal '17
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- Minerva Fellows - May 15, 2015
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- John Bolton to Speak at Unoin - May 1, 2015


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Sharing A Family Meal
Wednesday - May 10, 2006
This time last year I was writing this column for Mother's Day about to go into labor with our second son, Finn. The one thing that's true about having children is that the days may be long, but the years really do fly by. I've learned a lot these past few years, watching our children grow. I've learned that no matter how much you push organic yogurt, fresh fruit and green vegetables, little eyes will always light up at the sight of a bag of Doritos. I've learned that Cheerios can become a fashion accessory of sorts; certainly I've worn them in my hair and on my clothes on more than one occasion in public. I've learned that until the age of about 3, you can give your kids water in a colored plastic cup with a straw and they're happy to believe it's juice. And I've learned that there is possibly no better compliment in the world than a small voice telling you that your chicken noodle soup, made from scratch, is the best thing they ever had.
We'll be eating at home this Mother's Day, not least because it's the busiest dining day of the year, but also because for me, the place we connect best is around our dinner table. There's lots of information nowadays about the benefits of sitting down to a family meal. Funny, really, that something we never really gave much thought to as children has become such a focus for study groups and surveys. Children who sit down to a family meals four times a week or more do better in school, are less likely to smoke, do drugs or have alcohol problems than children who eat a family meal twice a week or less. It's tough, I know, to get together during the week. Sports practice, after-school activities, long work hours and the fact that many parents have more than one job mean that the days of mom and dad being home Ozzie and Harriet-style for dinner are long gone. I suspect, too, that childhood obesity is less in families where the family meal is the center of the evening. And children who are around adults cooking get a sense of the preparation involved in making good food - something that the drive-thru, with its instant gratification, can never bring.
But it's not just the fact that you probably eat healthier if you're making dinner yourselves that makes family mealtimes important. A 45-minute conversation as a family every day can mean the difference between knowing what's going on with everyone in your world - and what's not.
Still, I know it's hard. I know there are thousands of you out there juggling schedules along with mealtimes and just wondering how you'll make it to the weekend. So you can't do dinner. How about breakfast once or twice a week or even just on the weekends? Or if you have to get take-out, get it from a local restaurant that specializes in home cooking. At least you'll get the chance to sit down for a short time and connect with the reasons you became a family in the first place.
Trust me, I know it's not easy. Every night as we sit down to dinner, I look across the table at noodles dropping to the floor, squash between Finn's fingers and endless dollops of ketchup that end up everywhere but on the plate. I think about the time it will take to clean it all up and often wish I was sitting at the bar at Ruth's Chris Steakhouse. But then I take a deep breath, look at my husband, for whom family dinner is the most important time of the day, and wait for our 3-year-old, Max, to ask his favorite question. "So, guys, what do you want to talk about?"
I might have Cheerios in my hair and yogurt on my shirt for the next few years, but I'm sure one Mother's Day in the not-too-distant future I'm going to long to hear that little voice at the dinner table just one more time.
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The bed set is wonderful. Could not use the bed skirt on our sleep number bed but came with the package.
Nice "bed-in-a-bag" set! Colors shown are true. I'd have liked it better, had it not looked so fall/winterish. The fabric is almost suede looking but, maybe, I'll buy another set for spring/summer. Great price for all the pieces.
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Dance, Singing & Drumming Workshops
Dance Parties with Live Music, Fun & Entertainment
All sessions open to the general public
New Zealand's 9th camp for Recreational International Folk Dancers will be held at Sacred Heart Girls College, Hamilton, NZ. Follow the links for more info.
Click on the tabs above for more information. Contact: festival @ folkdance.nz
All information is correct at time of publication. The festival organising committee reserves the right to make any amendments to the programme as required. The festival organising committee and Folk Dance NZ will endeavour to take all reasonable precautions, however attendance at this event is at your own risk. No responsibility is accepted for injury or loss of personal items of value.
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Articles with keyword "Kentucky"
Berea College in Appalachia Charges Students Nothing but Expects Great Things in Return
A legacy of community and dedication continues at a college in Kentucky.
Living Traditions
The stories of Appalachian artists, singers, and coal miners are recorded in nearly four decades of filmmaking.
Wendell Berry, Landsman
NEH Chairman Jim Leach sits down with writer and farmer Wendell Berry, this year's Jefferson Lecturer.
Honorable Hotbloods
"A Killing Gentleman" by James M. Prichard delineates the carefully prescribed protocol of dueling in the April issue of Kentucky Humanities.


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Opposition to Keystone XL Pipeline Heating Up
Steve Horn | October 30, 2011
By Steve Horn • Sunday, October 30, 2011 - 22:12
The fight against the Keystone XL Pipeline is heating up, with many positive and important developments occuring this past week, excluding the disgraceful, though unsurprising decision by the Obama for President 2012 campaign team to bring a former TransCanada lobbyist, Broderick Johnson (husband of NPR's Michele Norris), onto its upper-level staff.
Six main big ticket items stand out, in particular:
- A call for a U.S. State Department Office of the Inspector General probe into the Keystone XL pipeline review process by 14 U.S. Congressional members.
- A call for a special session to occur on November 1 by Nebraska Republican Governor Dave Heineman regarding pipeline safety concerns.
- A meeting between leaders of the youth climate movement and Environmental Protection Agency (EPA) Administrator Lisa Jackson on the pipeline.
- A recent massive anti-pipeline action that took place in San Francisco, in which 1,000 protesters greeted Obama at one of his fundraising events for his 2012 presidential run.
- An announced push-back of the Keystone XL pipeline final decision date by the State Department.
- An acknowledgement, at last, by President Barack Obama that he is taking into consideration the concerns voiced by citizens nationwide about the potential risks to public health, water supplies and the global climate if he approves the Keystone XL pipeline.


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ADAM's Tensor Beta Mk.II
The German ADAM company has been developing the idea of the Air Motion Transformer HF unit, originally developed by Dr. Oskar Heil. The latest version of their tweeter, the X-ART tweeter, is featured in the Mk.II version of the Tensor Beta loudspeaker ($25,000/pair), which was being demmed with Cary electronics. The X-ART tweeter is married to a folded-ribbon upper-midrange unit, a new lower midrange unit and two woofers, all mounted on a solid aluminum baffle. The enclosure is made from 1" and 2" MDF panels, extensively crossbraced. Interestingly, waffle-shaped inner panels are loosely filled with steel shot, which absorbs vibrational energy. The speaker is also supported on fluid-filled feet to further absorb vibration.


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Jason Baker
PRIOR TO GW: Power pitcher who throws in the upper 80s, low 90s...named Atlantic 10 Pitcher of the Week on 3/20...led the Colonials in strikeouts (70), innings pitched (89.2) and complete games (5) last season...held opponents to a .238 batting average...pitched a complete game four-hitter at UNC-Wilmington in his GW debut on 2/17, followed it up with eight scoreless innings in GW's 1-0 victory over JMU on 3/8...played for the Orleans Cardinals of the Cape Cod League last summer...will be GW's number two starter this season...transferred from the University of Richmond prior to last season...pitched 54.2 innings for Richmond as a sophomore...struck out 42 batters...in 1999 he made 13 appearances with one start for the Spiders...did not have a decision, but earned two saves...struck out 17 and walked seven in 24.1 innings of work...registered a save in his first collegiate outing against South Carolina.
HIGH SCHOOL: Two-year starter at DeMatha and two-years at Gwyn Park High School...first team All-State, All-Met, All-Conference, All-District and All-County...struck out 87 hitters in 50 innings as a senior.
PERSONAL: Born September 18, 1980 in Washington, DC...son of Reuben Baker and Jacqueline Washington...enjoys cars...would like to become a coach after graduation...sociology major.
Year ERA W-L APP GS CG SV IP H R ER BB SO 2B 3B HR


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January 22, 2013
Name of Product: Perfect Resistance Bands
Units: About 75,600
Importer: Implus Footcare, LLC, of Durham, N.C.
Manufacturer: Dalps & Leisure Products Supply Corp, No. 5, of China
Hazard: The bands can detach from the mesh cloth loops posing an injury hazard to the user and those in the vicinity.
Description: The Perfect Bands are rubber tubes connected through a hole and secured by grommets to cloth sewn into loops. The bands can be used alone or in conjunction with optional handles, which are sold separately. The bands are approximately 40 inches long and are used for exercises described on the product packaging card and in a Workout Chart available on line on the product website. "Perfect Fitness" is printed on a tag on the cloth loop. UPC codes can be found on the package. The recalled bands are:
Perfect Bands Heavy 25 lb. capacity with UPC Code 096506310354, color purple
Perfect Bands Very Heavy 30 lb. capacity, UPC Code 096506310361, color gray
Perfect Bands Ultra Heavy 40 lb. capacity, UPC Code 096506310378, color black
Sold at: WalMart, and online at www.perfectonline.com for about $13 to $17.
Remedy: Consumers should immediately stop using the product and contact Implus Footcare for a refund or replacement product.
Consumer Contact: Implus Footcare at (800) 446-7587 select option 2, from 8 a.m. to 5 p.m. ET Monday through Friday, email at email@example.com, or online at www.perfectonline.com/recalls


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Date: September 19, 2013
Time: 5:00 - 8:30 pm
Southern California Institute of Architecture
350 Merrick Street, Los Angeles, CA 90013
While Los Angeles has begun gearing up for the sustainability race to become one of the leading "green" cities, there is still a lot of work to be done. With policy makers increasingly supporting energy efficient living, and the business community ceasing opportunities for a profitable market, there is "green" light in sight.
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text: In my quest to wear more red lipstick, I bring you the first red of my 30 Before 40 list. She's a beauty. Her name is Really Red and she's by Mary Kay. Don't go there. I know what you are thinking. Mary Kay? Yes. Mary Kay has done a great 360 and are putting out some amazing products. Let's start with this Really Red lipstick. This lipstick is creamy, goes on smooth, and has staying power. I have been wearing this every day for a week and I can't get enough, almost like J. Cole, which is this week's workout them song. You will see in the the photo.


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Rent Reconsidering Social Constructionism 1st edition today, or search our site for other textbooks by James A. Holstein. Every textbook comes with a 21-day "Any Reason" guarantee. Published by Aldine Transaction.
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A missing Iranian scientist has turned up alive in Washington, D.C.
Shahram Amiri was working for Iran's nuclear agency. He is just one of several Iranians who disappeared or were assassinated in connection with the Islamic regime's nuclear program.
Amiri went missing after he made a pilgrimage to Saudi Arabia in 2009.
At the time, Iran accused the Saudis of kidnapping and turning him over to the United States. However, the U.S. denies that.
Iran says Amiri has taken refuge at the Pakistani embassy in Washington and wants to return home.
"We contacted the Pakistani embassy and they confirmed that Shahram Amiri has taken refuge there," the Islamic Republic News Agency, the state news agency quoted the unnamed official as saying on Tuesday. "Further details will be revealed soon."
Intelligence analysts said Amiri's disappearance is part of a shadow war to prevent Iran from developing nuclear bombs.
CIA Says Iran Inching Toward Nuke Capability
Israel's Shadow War against a Nuclear Iran
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Bro i'm legit loving your stuff.
no, but i see that now. what's the significance?
also, almost done the outline to yours. tried something different, as usual.
yo bro that froze piece is lookn sicc, how long u been writen?
saw it, was blown away. dig the char, and the letters are immaculate. i haven't had enough spare time to start yours. i can't one up the 'm' in the last one i made for you, so i keep resketching that same M. writers block, i guess. i'm going to keep at it, whenever i have a chance. i still owe a few exchanges, and some fills on old ones, anyways. so it could be a bit.
same old shit bro... havent been painting/sketching much.... have a son now and a shit job lol fml
Yeah, I only set up this account a few days ago. But I write tasty.
Zookyook was tellin' me that my style reminds him of yours and that he thinks we should do an exchange. So whaddya say?
Senior Member
Junior Member


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WYOMING -- Just six weeks after General Motors Corp. ended production at its 36th Street SW stamping plant, the automaker won bankruptcy court approval to buy back another former GM parts plant in Wyoming -- the Burlingame Avenue SW valve-lifter plant now owned by Delphi Corp.
In federal bankruptcy court Monday in New York, Judge Robert Gerber approved a three-way deal to return the plant at 2100 Burlingame Ave. SW and four other Delphi sites to the "new" GM to ensure the automaker a steady supply of vital parts.
Gerber is overseeing the wind down of the Motors Liquidation Co., which is formerly General Motors Corp. and has been dubbed as "old" GM for the corporation's left-over assets and liabilities.
The deal still to be finalized would enable General Motors Co. and Parnassus Holdings II, a division of Platinum Equity, to buy most of Delphi's assets and enable the troubled supplier to finally emerge from its four-year climb through bankruptcy.
As part of the deal, Beverly Hills, Calif.-based Platinum will be allowed to operate Delphi's remaining businesses both in the U.S. and abroad. Detroit-based GM will contribute a total of about $3.9 billion, including a $2 billion equity investment in Platinum, to help finance the deal.
Platinum will contribute up to $500 million in financing.
In exchange, GM will get prime Delphi plants, including its Saginaw-based steering business, the Wyoming plant, a factory in Kokomo, Ind., and plants in Rochester, N.Y., and Lockport, N.Y.
Most of the fuel-injector production formerly done in the shuttered Coopersville plant is now made in Rochester.
Other noncore Delphi plants and assets will be sold off over time.
Delphi, which was GM's parts division before being spun off in 1999, filed for Chapter 11 protection in October 2005.
The company produces about 10 percent of parts used in GM's global production and its components go into nearly all of GM's North American production lines.
A hearing on the sale of Delphi's assets is scheduled July 23.
If a sale is approved, the company has said it could emerge from Chapter 11 later this summer.
-- The Associated Press contributed to this report.


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anyone tell me how to find those materials as I tried for long time but still not able to find that,I recall those materials located in eLearning area before in SDN.
Thanks in advance.
Here you go
Once you select your area, just click on Contents and then Documents.
Prateek Raj Srivastava
actually I have tried click on the items previously but it seems there has only clue types such as documents,blogs,discussions,polls, but no podcast(MP3) or videos.
could you pls tell me how to find the podcast and videos?
pls refer below link it contains Wiki, Code Samples and Videos Collections:


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Pikmin 3
Release Date???/
- Topic Archived
- Page 1 of 2
- Last
vaswuzhere 4 years ago#1
I have Spina Bifida. What's your excuse?
TNintendominate 4 years ago#2
It's somewhere around Q2 (April, May, June) 2013. It's exact date is unknown. Walmart and Amazon are just using placeholder dates.
Pikmin 3? It's been announced?
Must... own... NOW...
vaswuzhere (Topic Creator)4 years ago#3
I have Spina Bifida. What's your excuse?
Don't ever preorder a game.
All you're doing is giving people your money without getting anything in return.
There is never going to be a game that sells out so bad that you can't get it within the first two or three days of release. The only reason you should ever preorder a game is if a company has a deal with the company making the game that will get you something amazing like savings on DLC.
[[[|||||]]][[[[[]]]]This is confusion.[[[||||||]]][[[[[]]]||||
]]][[[||||]]][[[||Am I confusing you?]]]]][[[[|||[[[[]]]]]
bond007106 4 years ago#5
akanakin posted...
Don't ever preorder a game.
That's not strictly true. Some games can sell out on the day of release. But it's only ever niche games (for instance, when Tales of the Abyss on the 3DS was released in the UK last year, it sold out on pre-orders alone and was out of stock for almost 3 months).
Also, you're not giving the company your money. Most online pre-orders are no money down (they only take the money from your card when the order is shipped).
And also, speaking of shipping, in the UK at least (I don't know how things work in the US) a pre-ordered game ordered online will usually arrive a day or two before its official release date.
I agree that, with the exception of a small few very niche games and any possible pre-order bonuses, pre-ordering a game is not necessary, but there's no harm in it either, so if you want to then you may as well.
UltraMarcus 4 years ago#6
Games are unavailable on the first day all the time. When something first comes out, it's hard to get. Simple as that.
Anyway, I agree with not pre-ordering, unless theres free DLC, however I found a store that has a pre-order bonus program, where they'll give you a free game after 10 pre-orders.
"You're scared of being insulted on the internet by a guy who goes to work in his underwear?" - Sniper_Extreme
ArmorWolf01 4 years ago#7
April - May sounds about right.
"When a man talks dirty to a woman its sexual harassment but when a woman talks dirty to a man its $4.95 a minute."
Ghost-inZeShell 4 years ago#8
Official: Q2 2013
Reality: Q4 2014
I am a fish 4 years ago#9
From: Ghost-inZeShell | #008
Official: Q2 2013
Truth. It better make my sex life better after that kind of delay though.
Give a man a fish and you feed him for a day. Give a fish a man and you feed him for weeks! -ShinyMoogle
bond007106 4 years ago#10
UltraMarcus posted...
Games are unavailable on the first day all the time. When something first comes out, it's hard to get. Simple as that.
In bricks-and-mortar shops, sure. But never online, with the exception of very niche games, as I explained above.
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Advance discontinuation notice for openSUSE 11.1
Dear openSUSE users,
SUSE Security announces that the SUSE Security Team will stop releasing
As a consequence, the openSUSE 11.1 distribution directory on our
The discontinuation of openSUSE 11.1 enables us to focus on the openSUSE
This announcement holds true for openSUSE 11.1 only. As usual, the
openSUSE 11.2 (supported until approximately May 12th 2011)
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Raygo 107 Standard Keyboard - 107 Keys, PS/2, 6FT Cable, Black - R12-42523Item#: R12-42523 | Model#: R12-42523
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