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  • 1. Yaghi, Rose Strategizing A Vibrant and Competitive Market Integration of Biosimilars: A Health Care Provider Clinical Adoption Plan.

    Doctor of Healthcare Administration (D.H.A.), Franklin University, 2024, Health Programs

    As of the end of the twentieth century, biological drug therapies were at the forefront of health research for treating life-threatening diseases. Despite their therapeutical benefits stemming from providing great treatment hope against lethal diseases, biological drugs end up placing a financial burden on the American healthcare system. In the last decade, biological drug skyrocketing prices have significantly impacted net drug expenditures. The biological drug market needs more competitors. This impacted the passage of the Biological Price Competition and Innovation Act in 2010, introducing biosimilars, the highly safe and effective but less expensive biological copycat alternative drugs. However, a decade after biosimilars introduction, healthcare administration barriers limit American pharmacists and physicians from adopting biosimilars. Hence, the current low American health care provider biosimilar adoption rate must be improved to realize significant healthcare savings. Although many literature studies have examined biosimilar clinical adoption hurdles among American pharmacists and physicians in their siloed medical care settings, they have yet to focus on creating a comprehensive un-siloed biosimilar adoption plan based on their inputs. Therefore, to determine the essential elements to boost biosimilar adoption, this qualitative exploratory study thoroughly examined the literature. It then gathered the viewpoints of pharmacists and physicians who were acquainted with biosimilars by conducting semi-structured question interviews with 13 pharmacists and 8 physicians for a total of 21 participants. The findings of this study suggest that to create a dynamic and competitive biosimilar comprehensive clinical adoption plan, increasing HCPP education, having sufficient healthcare reimbursement, improving the roles of essential stakeholders, and increasing communication among key stakeholders are all necessary to increase biosimilars' trust and adoption, facilitati (open full item for complete abstract)

    Committee: David Meckstroth (Committee Chair); Karen Lankisch (Committee Member); Bora Pajo (Committee Member) Subjects: Health; Health Care; Health Care Management; Health Education; Health Sciences; Higher Education; Higher Education Administration
  • 2. Austin, Brittany A Biomechanical Investigation of Collagen, Platelet-rich Plasma, and Mesenchymal Stromal Cells on the Achilles Tendon in a Rat Model

    Master of Science in Engineering, Youngstown State University, 2019, Department of Mechanical, Industrial and Manufacturing Engineering

    It is estimated that about 18 out of 100,000 people rupture their Achilles tendon every year. A review of 4000 Achilles tendon ruptures found that 75% were related to sports activities. Currently, the methods for fixing Achilles tendon ruptures are in need of improvement. Due to the prevalence of Achilles tendon injuries in sports and the fact that tendons have poor wound healing, there has been an abundance of studies on treatments for Achilles tendon injuries. Many different techniques and therapies using biologics have been researched. One area, however, that has not been well researched is the addition of a combination of mesenchymal stromal cells and platelet-rich plasma as a treatment method for wound healing enhancement. There is also a lack of studies comparing different treatment methods as they progress through time. This study chose the following treatment methods: collagen (CoTa); collagen and platelet-rich plasma (PRP); collagen and mesenchymal stromal cells (MSC); and collagen, platelet-rich plasma, and mesenchymal stromal cells (CPM) to follow through two recovery times: 1 week and 2 weeks. Lewis rats were chosen and a full transection of the right Achilles tendon was performed 6 mm proximal to the calcaneal bone. At 1 or 2 weeks both Achilles tendons of the rats were extracted and tensile tests were performed. Maximum force, engineering stress, strain, modulus of elasticity, total strain energy, and elastic strain energy were determined. Differences in the treatment groups at 1 week recovery were notable, no differences were found between the treatment groups at 2 week recovery, however differences could be seen when compared to the left virgin tissue controls. Computational modeling led to preliminary finite element models for each treatment group. Validation for each model was achieved by comparison with experimental data. Further development of the finite element analysis would allow for a more accurate model and allow for better comparisons betwe (open full item for complete abstract)

    Committee: Hazel Marie PhD (Advisor); Diana Fagan PhD (Committee Member); Virgil Solomon PhD (Committee Member); Jason Walker PhD (Committee Member) Subjects: Biomechanics; Biomedical Engineering; Biomedical Research
  • 3. Atzinger, Christopher Impact of Ultrasonography on use of Biologics in Patients with Rheumatoid Arthritis

    PhD, University of Cincinnati, 2018, Pharmacy: Pharmaceutical Sciences/Biopharmaceutics

    Background: Advances in ultrasound technology and training have made it possible for physicians to conduct detailed imaging studies in an office setting. The use of ultrasound in the diagnosis of RA is not yet standard of care, and the clinical benefits of this procedure are not fully understood. Objectives: To describe the use, cost, and impact of ultrasound in patients with a confirmed diagnosis of RA, in the United States. Methods: This was a retrospective, longitudinal analysis of insurance claims data in 15,972 patients with a diagnosis of rheumatoid arthritis who were subscribers to private insurance plan between 2002 and 2013. Patients were divided in to case and control groups depending on their use of musculoskeletal ultrasound (MSUS) associated with rheumatoid arthritis. Patient level insurance claims data were analyzed for demographic characteristics using descriptive statistics. The time to initiation of a biologic was analyzed using Mann-Whitney-Wilcoxon test, Kaplan Meier Analysis, and Cox Proportional Hazard Ratios stratified by propensity score. An estimate of clinical effectiveness was calculated using a validated claims data algorithm. Patient costs were estimated using generalized linear models for total costs (two-part GLM with a log link and gamma distribution), adjusting for covariates. Results: The data show that there has been an increase in the use of MSUS over time, with only 61 patients receiving a procedure in 2002 compared to 1036 patients in 2013. In 2002, the majority of procedures (57.4%) were conducted by radiologist; however, by 2013, rheumatologists were conducting the majority (73.8%). Female patients were more likely to receive an ultrasound; however, female patients are more likely to be diagnosed with RA. Over time, the average comorbidity score, based on the Charlson Comorbidity Index, decreased from 3.5 in 2002 to 2.4 in 2013. The average disease severity score fluctuated over time. Patients who (open full item for complete abstract)

    Committee: Jianfei Guo Ph.D. (Committee Chair); Teresa Cavanaugh Pharm.D. (Committee Member); Marepalli Rao Ph.D. (Committee Member); Daniel Schauer M.D. (Committee Member); Patricia Wigle Pharm.D. (Committee Member) Subjects: Health Sciences
  • 4. Jackson, JeShaune Bench to Bone: Commercializing a Cellular Therapeutic for Regenerative Medicine

    Master of Sciences, Case Western Reserve University, 2018, Biology

    All bone regeneration requires bone forming cells (osteogenic connective tissue progenitors, CTP-Os). This thesis examines a clinically practiced method for selecting and rapidly concentrating CTP-Os for transplantation at point-of-care. Annually in the US alone, more than 1.5M bone regeneration procedures are performed. Autografting is the most common and often involves harvesting bone and bone marrow from the patient's hip and transferring to the site where new bone formation is desired. Autografting is preferred because it provides a graft material that contains viable ostoegenic cells (CTP-Os) that are immune compatible, has correct bone formation inducing proteins, and provides structural scaffold for bone ingrowth. However, due to pain, bleeding and scarring from the additional surgery, less invasive solutions have been demanded. Selective retention provides the properties needed for bone growth without the need for an additional procedure. This thesis describes the life cycle of a product from the lab to the market.

    Committee: George Muschler MD (Committee Chair); Christopher Cullis PhD (Committee Member); Elizabeth Sump MS (Committee Member); Stephen Haynesworth PhD (Committee Member) Subjects: Biology; Biomedical Engineering; Entrepreneurship