Carol Rubin, PhD
Mental Health · Psychologist
58 Reservoir Ave, 02467 Chestnut HillPost office · Wedding services
For an international pharmaceutical company, IHS worked with a patient group to develop, implement and analyze a large-scale survey of patients with COPD, their caregivers, and physicians to assess the unmet needs of patients and caregivers. The survey instruments were developed using several focus groups and incorporated validated quality of life instruments. The data from these surveys were analyzed and incorporated into manuscripts and several poster presentations at prestigious scientific and medical outcomes meetings. For an international pharmaceutical company, IHS conducted a cost-effectiveness analysis for a new indication of a sedative for use in the intensive care unit. The project included review and recommendations on the Phase IV protocol, oversight of pharmacoeconomic data collection, selection of an appropriate quality of life instrument, preparation of a pharmacoeconomic statistical analysis plan, and cost-effectiveness analyses using the primary and secondary clinical endpoints. Using the perspective of the hospital, the pharmacoeconomic analysis was based on the resources used by each patient arm multiplied by US representative costs for these resources. Summary analyses characterized the total patient costs as well as costs associated with the following components: ICU time, mechanical ventilation time, and medications and procedures to treat study-related adverse events. Crude and multivariate-adjusted regressions were performed to relate total cost and treatment, controlling for patient (e.g. age, gender, race, Apache II score) and hospital (e.g. geographic location, affiliation, size, type) characteristics. The analysis results were incorporated into abstracts, posters, and manuscripts. For a small biotechnology company, IHS provided strategic recommendations for future pharmacoeconomic analyses of a new product based on the performance of similar products in the same therapeutic area. IHS performed an extensive literature review and synthesized available pharmacoeconomic and clinical information related to similar products in order to create scenarios providing credible estimates of potential cost-savings associated with the use of the new product. This information was synthesized with guidelines for product acceptance in the US and EU in a clear presentation for use in potential partnering discussions. For a biotechnology company, IHS developed an electronic model (eTool) to optimize red blood cell collection. The eTool synthesized and consolidated various manual models into a unique, user-friendly software program. The eTool allowed the company to automate current blood collection processes and enabled customers to position and evaluate their current resources in the most efficient manner. IHS also developed a clear and comprehensive User's Manual and provided training and technical assistance. IHS was asked by the federal government, the pharmaceutical manufacturer, and a law firm, to fairly and accurately compute the costs of various cardiovascular sequelae alleged to be related to the use of a particular blockbuster drug. IHS consulted with an expert cardiologist to determine the appropriate clinical events and resources to include in "decision tree" models of clinical events and medical resource utilization pertaining to the diagnosis and treatment of the cardiovascular events. IHS researched and reviewed all resource utilization and costs associated with each clinical event in order to create a weighted national average for expected utilization of each diagnostic and treatment resource. IHS then provided an estimate of costs to treat mild, moderate, and severe cases of each cardiovascular event. IHS was chosen by state governments, the pharmaceutical manufacture, and a law firm to fairly and accurately compute the costs of various clinical sequelae alleged to be related to of the use of a particular drug used to treat schizophrenia. IHS consulted with expert physicians and epidemiologists to determine the appropriate clinical events and resources to include in "decision trees" models of clinical events and medical resources used in the diagnosis and treatment of the clinical events. IHS researched and reviewed all resource utilization and costs associated with each clinical event in order to create a weighted national average for expected utilization of each diagnostic and treatment resource. IHS then provided an estimate of costs to treat the various clinical sequelae. For a major US pharmaceutical company, IHS undertook a pricing study for a novel rheumatoid arthritis (RA) treatment. The project included identification of relevant payer interviewees and product comparators, interviews with payers nationwide, analysis of results, and development of strategic price and product positioning recommendations. One year later, IHS conducted follow-on research to assess payers' experiences with - and perceptions regarding - the product's value and price in the evolving RA market, particularly in light of an added indication and the introduction of a new competitor. For a biotechnology firm, IHS conducted a market analysis and developed a pricing strategy for a line of blood component pathogen inactivation systems. The project included interviews with treating physicians, blood bankers, and hospital administrators; identification of relevant pricing references and frameworks; and development of potential price estimates and recommendations for a pricing strategy and tactical market measures. For a major US pharmaceutical company, IHS undertook a strategic economic and pricing analysis for a blood product for the treatment of a rare hereditary disorder. The project included development of a pharmacoeconomic-based model of treatment of the disease, interviews and focus groups with treating physicians, analysis of results, and development of strategic recommendations regarding price. For a biotechnology company, IHS conducted a strategic economic and pricing analysis of a new hemostatic device for use in surgical procedures. The project included development of a pharmacoeconomic-based model of the device in liver resection surgery and involved comparison to existing treatments on the market, analysis of market size, and development of recommendations for further research. For a biopharmaceutical company, IHS undertook market analyses and pricing studies for a novel product for the treatment of meningococcemia and trauma in the US and UK. The project included development of pharmacoeconomic-based models of treatment of meningococcemia and trauma, analysis of pricing based on launch timing and target population, interviews with specialists, and recommendations on stocking and delivering the product at hospitals. For a major pharmaceutical company, IHS conducted a market and pricing analyses for a new proton pump inhibitor, the third entrant in its class. The project included extensive interviews with payers and hospital administrators, case studies on other late-entry products in three therapeutic classes, and strategic recommendations on marketing, positioning, contracting, and discounting for the new product. For a major pharmaceutical company, IHS conducted a marketing and pricing analysis for a new oral erectile dysfunction medication. The project included interviews with payers, case studies on other "lifestyle" drugs, and strategic recommendations on marketing, positioning, contracting, and discounting for the new product. For a major international pharmaceutical company, IHS developed a pricing strategy designed to maintain a premium price and maximize revenue for the launch of a new product in Europe. The analysis included the implications of country-specific pricing regulations, launch sequence, parallel trade, patent expiry, competitive positioning, and market attributes. For a major pharmaceutical company, IHS conducted a pricing study and developed pricing recommendations for the company's line of hormone replacement therapies. The project consisted of an interview program to determine the price sensitivity of stakeholders in the managed care market. This market research was used to develop a model to evaluate the price-volume and price-revenue trade-offs in the managed care market. For an international pharmaceutical company, IHS developed a marketing, pricing, and reimbursement strategy for the company's replacement therapy for the acute treatment and long-term management of a rare, hereditary disease. The project focused on Germany, Spain, and the U.K., and involved the development of pharmacoeconomic-based models of current treatment; interviews with physicians, payers, and policy makers in each country; analysis of results; and development of strategic recommendations regarding price. For an international pharmaceutical company, IHS identified possible ways to gain Medicare reimbursement for the company's self-injectible product, despite Medicare's policy against reimbursement of outpatient drugs. The project involved interviews with representatives of HMOs and Medicare carriers and the preparation of case studies that focused on reimbursement for four other injectible drugs. For a major pharmaceutical company, IHS assessed the market potential and competitive environment for a product for palliative treatment of advanced prostate cancer. IHS formulated a reimbursement strategy for the product based on the results of interviews with urologists and payers, in which IHS determined guidelines and treatment procedures and probable payer and physician reaction. For an international healthcare supplier, IHS conducted an analysis of Medicaid's product reimbursement practices in order to identify inconsistencies and to ensure that the company's reimbursement strategy was efficient and effective. The project involved interviews with pharmacy program managers in Medicaid programs nationwide, quantitative analyses of interview results, identification of reimbursement challenges, and the development of recommendations for ensuring reimbursement in each state. For a mid-size pharmaceutical firm, IHS conducted two fully prospective pharmacoeconomic analyses of a novel analgesic delivery system in conjunction with the company's Phase III clinical trial. The project included developing research protocol and pharmacoeconomic case report forms, selecting appropriate quality of life instruments, surveying payers and stakeholders, conducting Delphi panels, and executing analyses and scenario modeling. For a major international pharmaceutical firm, IHS conducted a combination retrospective cost-effectiveness and modeling study to assist the health outcomes department in the competitive positioning of its novel hypertension treatment. The study was used to determine key drivers of the product's economic profile and relevant comparators for future studies. For an international pharmaceutical manufacturer, IHS developed a retrospective cost-effectiveness analysis based on clinical trial data and a meta-analysis to support the reimbursement of the firm's hypertension therapy in Canada. The study was used as the basis of the company's submission to the Ontario Ministry of Health for formulary acceptance. For a medical device manufacturer, IHS modeled and estimated the economic and clinical benefits of utilizing a new device for the assessment and management of hyperbilirubinemia (jaundice) in infants. The model was based on treatment algorithms described in the literature and outcomes data from clinical trials. For a development stage biotechnology company, IHS developed an economic model of periodontal disease to support pricing and market potential estimates. The model was based on literature reviews, interviews with clinical advisors, and focus groups with dentists and periodontists in four U.S. cities. The pricing and market potential estimates were used as the basis of future pharmacoeconomic analyses and were also used to support the company's efforts to develop a strategic partnership with a corporate partner. For a biotechnology company, IHS conducted a strategic economic and pricing analysis of a new hemostatic device for use in surgical procedures. The project included development of a pharmacoeconomic-based model of the device in liver resection surgery, including comparison to treatments currently on the market, analysis of market size, and recommendations for further research. The project was followed up with a strategic economic analysis of the company's second-generation product for use in vascular surgery. For an international medical device manufacturer, IHS conducted a prospective Therapy Economics analysis on the use of their biventricular pacing device in the treatment of Canadians with heart failure. The analysis was used to support pricing, justify reimbursement, and drive acceptance in the Canadian market. The project involved developing an analysis plan and data collection strategy, creating data collection instruments, training investigators, monitoring data, conducting economic analyses, and publishing results. For a medical device manufacturer, IHS conducted a combination retrospective cost-effectiveness analysis and prospective activity-based costing study of the company's infant hearing screening technology. The project involved development of research protocol and case report forms, surveys with payers and stakeholders, collection of activity-based cost data and retrospective clinical information at 5 sites nationwide, and execution of analyses. The project was followed up with a multi-site prospective study evaluating the costs and outcomes associated with starting up a universal newborn hearing screening program using various screening technologies. For a major pharmaceutical company, IHS developed an economic model of alternative treatment strategies for hemophilia in developing countries. The project included development of a pharmacoeconomic-based model for the treatment of hemophilia, interviews with specialists and key stakeholders in the government, collection of cost data, and execution of qualitative and quantitative analyses. The results of the analyses were used to develop a tool to demonstrate economic savings to physicians, payers, and policy makers and to shift the current treatment paradigm. For an international pharmaceutical company, IHS assisted in a study that provided the first comprehensive look at the cost of illness of overactive bladder (OAB) in the U.S. The project aimed to help to improve awareness of the disease and its burden to society. It included a literature review of OAB prevalence and cost data as well as analysis of both direct and indirect medical and non-medical costs. IHS also assisted in the development of a questionnaire for the National Overactive Bladder Evaluation (NOBLE) study. All data obtained from this study was analyzed and incorporated into a manuscript. For a major U.S. medical device manufacturer, IHS developed an economic model of heart failure in the United States that evaluated the potential benefits associated with pacing therapy. The project involved literature review, model development, evaluation of protocol and CRFs, development of a cost dictionary, data analysis, and a poster and manuscript presentation. For a major pharmaceutical company, IHS assisted in developing the protocol for a study assessing a new migraine treatment in over 10,000 migraine patients in the U.S. The project included developing health economics endpoints and outcomes measures and designing patient materials. IHS also provided advice in selecting both generic and migraine-specific quality of life instruments, and supported the development of all sections of the protocol. For a major pharmaceutical manufacturer, IHS conducted a quality of life and symptomatology survey of over 500 hypertension patients in the United States. The project included developing the analysis plan, designing and producing case report forms, monitoring response data, analyzing data, and developing conclusions. The results of the data analysis were used to develop a poster presentation for exhibition at an international conference on antihypertensive medications for the treatment of hypertension. For a major pharmaceutical company, IHS conducted the largest-ever study of overactive bladder (OAB) patients, enrolling approximately 1,400 patients and 500 urologists throughout the U.S. Outcomes measures included patient perceptions of OAB condition, treatment benefit, and quality of life. The project included designing and producing survey materials; training the sales force; monitoring physician and patient enrollment; monitoring phone, fax and email support lines; setting up the results database; and developing the analysis plan. For several international pharmaceutical companies, IHS analyzed study data, synthesized results, and prepared manuscripts for publication. Topics included:prevalence and incidence of GI disorders in post-menopausal women;international treatment patterns of arthritis based on focus group documentation;drug-switching behavior of patients on NSAIDs;adverse events associated with NSAID consumption in the elderly; anda new adherence model of asthma patients describing the relationship between prescribed and delivered doses. For a global pharmaceutical company, IHS prepared a manuscript based on extensive literature review on the economic and social burden of overactive bladder disease (OAB). The manuscript was targeted to the FDA and NIH to gain further support for research on OAB. For a medical device manufacturer, IHS created an electronic sales tool based on our cost-effectiveness analysis. The tool was designed to be easy to use and laptop-compatible. The tool provided sales reps with an understanding of the economic analyses and enabled them to create and discuss customized analyses for individual customers during sales presentations. For two international pharmaceutical manufacturers, IHS developed software programs designed to facilitate economic evaluations of existing products as well as products in development. The programs provided easy-to-use graphical and tabular outputs, flexibility for scenario analyses, international currency comparisons, and comparisons between specific drugs and multi-drug regimens. For a major international pharmaceutical company, IHS developed a Pricing Decision Support Tool (PDST) to assist in the design of a pricing strategy that maintains a premium price and maximizes revenue throughout various stages of a product's lifecycle. The PDST incorporated the implications of European pricing regulations, parallel trade, market forecasts, competitive positioning, launch sequence, floor prices, genericization, currency and exchange rates, and enabled "what-if" questions and analyses. For an international pharmaceutical company, IHS developed an electronic template model to estimate the economic impact of overactive bladder as well as potential cost savings due to therapy in several European countries and in the US. For a medical device manufacturer, IHS developed a customized Excel/Visual Basic-based tool to be used by the company's sales representatives. The tool is used to conduct customized Therapy Economics analyses to demonstrate the value of their line of haemostatic closure devices. The tool was based on economic research and allows sales representatives and/or customers to enter detailed cost and outcomes data to evaluate the value of these products for their specific institution. For a major pharmaceutical company, IHS assisted in the development of a three-year strategic plan for the company's transplantation franchise. The project included an analysis of the transplantation market, unmet medical needs, competitive intensity and development, the company's products and pipeline, in-licensing and out-licensing opportunities, and strategic recommendations for the franchise. For a major healthcare information company, IHS facilitated the strategic planning process by conducting on-site planning meetings to define the Unit's vision, evaluating key issues impacting the business, identifying critical success factors, and selecting strategic areas to focus planning efforts. The project included mapping the healthcare information industry, interviewing key customer and supplier constituents, and developing strategic recommendation and implementation steps. For a corporation that produces clinical information systems for office-based physicians, IHS assisted in the preparation of a market entry strategy for the company's new promotional, marketing, and strategic and competitive intelligence products and services. In completing this task, IHS conducted interviews with representatives of prominent pharmaceutical and biotechnology companies, analyzed interview results, and prepared a report that suggested ways to improve the products and services to meet industry needs, identified optimal ways to approach potential clients, and recommended pricing strategies. For a biotechnology firm, IHS assisted in the development of a business plan for the client's advanced cellular therapy services and products. The business plan detailed strategies for maximizing reimbursement, including evaluation of cost effectiveness, pricing, quality of life, and the design of economically based clinical studies. For a pharmaceutical company, IHS assessed the market potential, competitive environment, and reimbursement hurdles for a dental product in order to help the company make an informed decision as to whether in-licensing the product would be a worthwhile venture. The project involved reviewing market information and results of nationally conducted focus groups as well as interviewing dentists, health plans, and dental plans. For an emerging biotechnology company, IHS assisted in the development of a business plan related to market research on a pathogen that could lead to effective therapies and cures for several diseases, most predominantly, Multiple Sclerosis. The business plan detailed the market potential of the company's product(s), evaluated the potential sales of the product under a variety of revenue-generating scenarios, and assessed the corresponding costs of product development. For a pharmaceutical industry association, IHS undertook a study to assess the value of integrating pharmaceutical care on the diabetes population of a major integrated health system. The project included developing disease and site selection criteria, developing pharmaceutical integration criteria and metrics to assess the 'level' of integration, measuring integration 'level' and population outcomes, and analyzing the benefit of integration. For a national organization of pharmaceutical companies, IHS analyzed and compared formulary design and operation among private and public payers. The project focused on evaluation of new drugs, processes for obtaining off-formulary drugs, use of treatment guidelines, and coverage of drugs in select therapeutic classes. In completing the project, IHS conducted a literature review about the effects of restrictive formularies, and interviewed both public and private payers about their formulary operation and decision-making processes. For a national organization of pharmaceutical companies, IHS conducted research and analysis tailored to Italy and the Netherlands to support the argument for market-based pricing reform in each country. The project involved a review of publicly available data, IHS internal resources and contacts, and information provided by the organization and its member companies. For an international pharmaceutical company, IHS examined current pharmaceutical company practices in promoting cost-effectiveness and compared these practices with FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) policies regarding health care economic information. The project focused on advertisements in journals and magazines with clinical, pharmacist, and managed care audiences. For a major U.S. medical device manufacturer, IHS conducted an analysis of the disease state management industry, including disease evaluation, competitor mapping and evaluation, identification of key program attributes and determination of program characteristics. Strategic recommendations from the report were presented to key company executives and board members. For an international pharmaceutical company, IHS conducted an evaluation of the impact of health economics on the commercial performance of pharmaceuticals in both the U.S. and Germany. The project included development of case studies of twelve different products, interviews with stakeholders in both countries, a review of health economics literature, analysis of IMS data, and development of hypotheses and conclusions about the commercial value of health economic studies. For a global pharmaceutical company, IHS instituted a program to disseminate results of Health Economic studies throughout the company. The project involved contacting appropriate individuals globally; collecting, organizing and editing information; and developing a format to summarize results. For a pharmaceutical trade organization, IHS developed six case studies, which were used in an exercise at a special issues conference focusing on the impact that the UK's National Institute for Clinical Excellence (NICE) has had on the research-based pharmaceutical industry. IHS also helped to facilitate the case exercise at the conference, which was attended by leaders in the pharmaceutical industry. For a large international pharmaceutical company, IHS organized and analyzed IMS data in order to explore factors that may contribute to the disparity in launch dates of medical products across European countries. For a full-service, 500+ attorney law firm, IHS analyzed and revised the comprehensive medical care plan and medical care cost summary for a patient with chronic asthma and seizure disorder. IHS also analyzed the indirect costs of a disability through research and analysis of earnings and life expectancy data. For a full-service law firm, IHS evaluated the loss in earnings for a man who suffered serious neck, back, and foot injuries. IHS analyzed his without-injury earnings projections, including all growth and discount rates used in the analysis, in order to quantify his loss in productivity.
17 Lee Road, 02467 Brookline
Mental Health · Psychologist
58 Reservoir Ave, 02467 Chestnut Hill