Serious side effects reported in patients treated with liraglutide for chronic weight management include pancreatitis, gallbladder disease, renal impairment, and suicidal thoughts FDA, Both companies were founded more than a decade ago to address high failure rates of clinical trials of psychotropic drugs, the efficacy of which are measured with subjective ratings susceptible to biases, variability and error. Lord-Bessen oversees MedAvante-ProPhase Clinical Data Analytics services including data management, statistics, and psychometric activities, including consultation on the development and validation of new Clinician-Reported and Patient-Reported Outcomes as well as the conversion of existing assessments to electronic format. Advanced discussion of nutrient structure, function and interaction, metabolic pathways, and regulation and integration of metabolism. Results from a clinical trial that enrolled patients without diabetes showed that patients had an average weight loss of 4.
It's not what you'd think.
Litwin earned his M. Steve Herne, an experienced sales and business development executive in both technology and services, joined MedAvante-Prophase as Chief Commercial Officer in July with overall responsibility for sales and marketing. Prior to his appointment, he was Chief Commercial Officer, eHealth Solutions at Bioclinica, a provider of clinical trial management solutions.
Herne began his career as a Senior Research Scientist for Inveresk Research before moving to a business development position at Quintiles and then returned to Inveresk as Senior Business Development Manager.
In that position, he led the planning and implementation of a finance reorganization process. Downing also lent support to responsibility, strategy, capital investment, expansion and financial training. In addition, he led a team responsible for the overall financial health of projects, including profitability, revenue recognition, cash flow, invoicing, and financial training for project managers and their teams.
Before joining Covance, Mr. Greg Barrett leads worldwide software and platform development for MedAvante-ProPhase, supporting clinical science and signal detection capabilities. He joined the company in April , bringing 30 years of information technology experience. In his role as Global IT Leader for Covance, he oversaw team members supporting five business units with applications, architecture, business engagement and computer systems validation. As Vice President of Regulatory and Quality Assurance since she has been responsible for evaluating activities of regulatory significance and ensuring that quality standards and regulatory requirements are implemented and maintained throughout the organization while leading audit teams in successful completion of more than 60 customer audits without a single significant finding.
Widely recognized for her achievements in organizational leadership, Ms. Wilmer is often sought for advice and collaboration and asked to share her expertise with professionals worldwide through networking and consulting.
Wilmer worked for more than 20 years in health care where she developed expertise in regulation interpretation.
At Horizon Blue Cross Blue Shield of New Jersey, she successfully developed and managed health care policies and administrative procedures to ensure compliance with regulatory agencies and other standards for a network of over 10, providers.
She has developed recruitment, contracting, and retention strategies for employees, physicians, and ancillary providers. He also has a strong background and interest in psychometrics and neurocognitive assessment, having worked for over 20 years as a consultant on test development, including the revisions of the Wechsler intelligence and memory scales.
Randolph is Clinical Professor of Neurology and Director of the Neuropsychology service at Loyola University Medical Center and is board-certified in clinical neuropsychology. Before joining MedAvante-ProPhase in July , he held the position External Clinical Innovation Leader at Roche, where he was responsible for developing, integrating and operationalizing strategic innovations throughout drug development.
Prior to that post, he was Vice President, Project Management, Americas for the clinical research organization PRA HealthSciences, leading a team of clinical research professionals covering all therapeutic areas.
He also held senior project management and operations posts at Worldwide Clinical Trials, Inc. Cioffi holds the B. Detke is a psychiatrist with more than 20 years of research experience and extensive clinical and drug development expertise. This role included registration and regulatory commitment trials for Cymbalta, including major depressive disorder, diabetic peripheral neuropathic pain, generalized anxiety disorder, fibromyalgia and chronic pain, as well as pediatric trials.
Detke teaches and supervises medical students and residents as Clinical Professor of Psychiatry at Indiana University School of Medicine. He trained in medicine and psychiatry at Harvard Medical School and at the Mt.
Detke has published more than 60 manuscripts in peer-reviewed journals since Williams has more than 30 years of clinical research experience in both industry and academia.
She is now Professor Emerita at Columbia University. Williams is well known in the field for her development of psychiatric classifications and instruments to measure psychopathology.
She is the author of more than scholarly publications and serves on the editorial boards of several psychiatric and social work journals. She has received numerous awards for her achievements and contributions in social work and psychiatry. His research groups also led development programs for the analgesic drug tapentadol, the long-acting antipsychotic agent paliperidone palmitate, and other potential treatments for CNS disorders. Kobak is a psychologist with more than 30 years of clinical research experience in both industry and university medical settings.
Throughout his career, he has focused on clinical assessment, rater training, rating scale development and clinical trials methodology. Kobak founded the consultancy Research Training Associates, where he developed new methodologies for training and calibrating raters in clinical trials using digital technologies. Kobak managed a clinical trials unit and pioneered the use of computer-administered rating scales in clinical trials. He authored computer-administered versions of several clinician-administered rating scales, including depression and anxiety scales that are widely used today, and a computer-administered version of the PRIME-MD, a diagnostic interview that was published in JAMA.
Kobak received several NIMH grants to develop and study rater training methodology for depression, schizophrenia, and autism.
Negash serves as the scientific lead bridging research and operations to ensure MedAvante-ProPhase clinical trial services are implemented successfully from a scientific and service delivery perspective. Her work has focused on investigating factors associated with successful cognitive aging, including lifestyle factors such as cognitive activity, and on developing interventions that enhance cognitive fitness in older adults.
She also studies successful cognitive aging in minority populations, particularly African-Americans. Her other area of work focuses on examining implicit and explicit learning and memory systems in healthy aging and in mild cognitive impairment. Kane has been the principal investigator for research projects focusing on schizophrenia, psychobiolgy and treatment, recovery, and improving quality and cost of care. He is the author of over peer-reviewed papers and serves on the editorial boards of numerous journals.
Sue Vallow is a patient-reported outcomes PRO scientist with more than 20 years of experience developing and implementing patient-focused outcomes strategies and capabilities in numerous therapeutic areas with a specialty in CNS trials. She is a co-author of more than 20 peer-reviewed papers and more than 70 research posters and presentations. Sofija Jovic is focused on the strategic combination of MedAvante-ProPhase as the thought leader in using measurement science and data quality to transform clinical trials.
Jovic guided the transformation from a four-person start-up to a global industry leader in collaboration with ProPhase founder Dr. Jovic started her career as a clinical psychologist: Jovic has published in peer-reviewed journals and presented scientific papers at professional and industry conferences. His academic research focuses on the etiology, phenomenology, and treatment of serious and persistent mental disorders. He has co-authored over 40 peer-reviewed publications and has contributed to multiple book chapters and review articles on schizophrenia and mental health research.
Lord-Bessen oversees MedAvante-ProPhase Clinical Data Analytics services including data management, statistics, and psychometric activities, including consultation on the development and validation of new Clinician-Reported and Patient-Reported Outcomes as well as the conversion of existing assessments to electronic format.
Lord-Bessen has over twenty years of experience in statistics and measurement. Twelve board members from leading universities and research institutions provide counsel and guidance to MedAvante-ProPhase on initiatives relating to mood, anxiety, schizophrenia, and other psychiatric disorders. Co-chaired by John M. Richard Feinberg Chair in Schizophrenia Research. Eleven top leaders from major Japanese universities and research institutions provide their expertise to enhance the ability to collect high-quality research data with less error and greater signal detection.
At MedAvante-ProPhase, we look for colleagues who combine talent with a powerful desire to change healthcare for the better and ensure that effective therapies make it to the patients who need them. This is the mission uniting the clinicians, scientists, technologists, and operations experts whose mix of energy, inventiveness, and skill drives not only MedAvante-ProPhase but the entire WIRB-Copernicus Group family of companies in a relentless quest to improve clinical trials. What do you do at MedAvante-ProPhase?
We looked at two plans from eDiets - one that offers support alone, and another with meal delivery. You can choose from among more than 20 diet plans, including ones for diabetics and vegetarians. Online tools let you set goals, plan menus and generate shopping lists. There's no face-to-face support, but you get support through online message boards and a mentor program that connects newbies with an experienced member.
Also, you can reach a registered dietitian or personal trainer by phone at any time. The optional meal delivery service offers freshly prepared, calorie-controlled meals delivered by FedEx. But telephone support has some evidence in its favor: Yes, it's a bargain for round-the-clock support. For about the same money, other services offer better track records. For the first two weeks, you eat three extremely low-carb meals a day plus mandatory snacks. After that, you gradually add "good carbs," such as fruits and whole grains.
You can customize menus, search a database of more than 1, recipes and get a personalized shopping list. There's online support from staff dieticians and members plus daily motivational emails. Studies have shown that after one year, carb-restricted diets led to greater weight loss and increased heart health than low-fat diets.
However, the advantage disappeared over the long term. How much can you expect to lose? Figure on 8 to 13 pounds during the two- week kick-start phase, then 1 to 2 pounds a week thereafter. It doesn't cost much, but you don't get as much support as with Weight Watchers or eDiets.
The Zone diet is mostly meat, fruits, and vegetables. You eat three meals per day plus two Zone protein-powder snacks. A study of people in the Journal of American Medical Association found the Zone diet helped people achieve modest weight loss after one year, comparable with those on the Atkins , Weight Watchers and Ornish diets, and improved cardiac risk factors.
Premium-priced Jenny Craig lets you order its heart-healthy, nutritionally balanced packaged food by phone and pick it up at a Jenny Craig center or have it delivered through Jenny Direct. You eat three Jenny Craig meals plus a snack per day, and supplement with fruit, vegetables and dairy. Once a week, you get a weigh-in and pep talk with a consultant - who is not a dietician and who earns commissions from selling you products. There's also round-the-clock phone support. Jenny Craig has a good track record for short-term weight loss up to one year.
In a UC San Diego clinical trial of dieters funded by Jenny Craig , Jenny Craig clients lost 11 percent of their initial weight after 12 months, compared with 3 percent weight loss by those who were dieting on their own. The "doctor-designed" Bistro M. The price is a cut above the competition, too. The plan tries to help you avoid a weight-loss stall out by varying the daily calorie intake between 1, and 1, By eating a little more some days and a little less on others, you'll supposedly prevent your body from becoming used to the same number of calories every day.
While no university studies support the theory that varying caloric intake aids weight loss, the high quality of the food and the relatively large portion sizes have been praised by Health magazine, Dr. Phil and The New York Times. Some plan users have complained of a lack of choices and menu flexibility compared to other plans, but a company spokesman says they offer more than entrees and can make substitutions to accommodate allergies and food preferences.
It's a reasonable price for well-made food with slightly faster average weight loss than with Jenny Craig. This meal-delivery service, endorsed by Marie Osmond and Dan Marino, emphasizes foods with a low glycemic index.
The underlying premise is that controlling blood sugar levels leads to weight loss. The heat-and-eat prepared meals and snacks contain roughly 55 percent "good" carbs, 25 percent protein, and 20 percent fats; like Jenny Craig, you add fruits, vegetables and dairy.
Support is available through phone counseling and online chat rooms. There's plenty of research showing that following a diet of 1, to 1, calories a day, such as Nutrisystem, can cause weight loss.
For example, a study by the Obesity Research Center at St. Luke's Roosevelt Hospital in New York found that postmenopausal women who followed a 1,calorie plan for 16 weeks lost an average of 21 pounds. Just how much of an effect exercise has on cholesterol is also a matter of debate.
If you haven't been exercising regularly already, it's important to start slowly. Be sure to check in with your doctor, so that he or she can evaluate your current cardiovascular health. This could mean blood tests or a treadmill test to see how your heart reacts when you exercise. Of course, exercise alone won't guarantee a low cholesterol level. Genetics, weight, age, gender, and diet all contribute to an individual's cholesterol profile.
The most effective way to ensure a healthy cholesterol level is to modify your diet and, if need be, take cholesterol-lowering medications. But exercise has many advantages beyond lowering cholesterol. Exercise has been shown to keep bones strong, reduce the risk of cancer , diabetes , stroke , and obesity, and to improve mood.
The Exercise-Cholesterol Link Researchers aren't entirely sure how exercise lowers cholesterol , but they are beginning to have a clearer idea. Some exercise is better than none; more exercise is better than some. How Much Will It Help? Continued Once you're cleared to begin working out, follow these guidelines: Choose a form of exercise you can do for minutes at a time, with at least moderate intensity, such as walking, biking, swimming , jogging, or using an exercise machine at low speed.