Ser1310 Phase 1 Reflection Journal

Phase 3 clinical studies - Intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.

The team is planning to start clinical trials with the help of the Department of Veterans Affairs. Also, they are looking forward to begin the tests sometime next year.

2. Denosumab has been FDA approved for 2 indications rather than 1 which is true for most of its competition. Both the conditions are prevalent in the population and their incidence is growing. This will allow the drug to tap unmet needs for the available market.

Tourette Syndrome, or TS, affects approximately one hundred thousand Americans of whom you will find in a variety of professions and social settings (7). It is a neurological disease which is characterized by repeated and involuntary body movements and vocal sounds. Before TS was known to be a health problem uncontrollable by the patient, it was seen as nervousness, possession by a spirit, epilepsy or simply as bad habits (5). Today it is known that imbalances in certain brain chemicals are what causes the symptoms of this disease. It is interesting to examine TS and use it as a tool for better understanding (in part) how, in what quantity, and at what level the brain (and the nervous system as a whole) contribute to

At any point in time in the research process, CDER can impose a clinical hold if a study is unsafe or if the detail is clearly insufficient in meeting its stated objectives. Great care is taken to ensure that this determination is not made in isolation, but reflects current scientific knowledge, agency experience with the design of clinical trials, and experience with the class of drugs under investigation.

It needs the approval of the FDA for release to the wide population of lupus patients. If this drug is approved, it will be the first new drug on the market to treat lupus in fifty years. Hopefully, since some research on lupus is being done, more medicines will be found, and more people

Discussed possibility of starting Extension when completed ARM 2 of Epi-743 trial. Reviewed the plan of care for the Extension phase.

The brand name Copaxone, technically called Glatiramer acetate, is “a synthetic protein that simulates myelin basic protein, a component of the myelin that insulates nerve fibers in the brain and spinal cord” (Copaxone). This drug seems to block myelin-damaging T-cells in a way that scientists do not completely understand. Nevertheless, results from “COPTIMIZE,” a two-year study that ended in 2013, clearly demonstrate that Copaxone is very effective in treating patients with Relapsing-Remitting MS when compared to other disease modifying therapies (Multiple Sclerosis Association of America). The COPTIZMIZE study followed 672 patients with RRMS who chose to switch to Copaxone due to a lack of effectiveness and/or

Another medication, SD-809 with a similar action to NBI-98854, also has ongoing Phase II and Phase III randomized controlled trials for evaluating the safety and efficacy of the drug in response to TD symptoms (Lockwood & Remington, 2015).

Treatment effectiveness has been defined as a clinically significant benefit to the patient, with the objective of the patient living for longer or better, or both, than if they did not receive the treatment (Wilson et.al., 2015). This measure of efficacy might be shown by symptomatic improvement, or improvement in established disease progression endpoints (Wilson et.al., 2015). Since clinical trial endpoints have profound effects on late phase clinical trial design, result interpretation, drug development, and regulatory approval of therapeutics, the characteristics of the disease and

The current market for clinical research trials is evolving towards increasing productivity in clinical trials. There is a demand for cost-effective, faster, and more efficient clinical trial processes. Clinician and regulatory agencies are requiring more data from clinical trials, increasing the complexity of clinical trials. Trends towards complex clinical trials have created a demand for increasing clinical trial staffing. In addition, companies aiming for more successful clinical trials have had an impact on staffing. Since 2008,

Table 1 - Phase III Clinical Trial Results (information taken from cited sources). The percentages shown indicate the overall increase (red) or decrease (green) of the indicated factor compared to the full four doses treatment (R3R).

During medical school I became very passionate about neurodegenerative diseases and as such, I have pursued a postdoctoral fellowship at Western. My experiences and knowledge have led me to not only find the pathophysiology of neurodegenerative diseases but to find new potential treatments; one of which is a potential patentable new medication. Both these experiences have taught me a lot in regards to the wide and complex field of medicine. I have learned the rigorous work it takes to do research as the business side of research. I believe innovations such as these, will open doors for healthcare providers to do their jobs effectively and efficiently, which improves the patient’s quality of life and

In 2002, data on gefitinib/Iressa, the first targeted therapy subsequently to win approval in NSCLC and the first drug developed simulataneously in the US, Europe and Japan were submitted.

It is an honor for me to lead Pfizer at this important time for both our company and the industry. I’ve spent my entire career at Pfizer and during this time I have seen the industry change and evolve in terms of customers’ needs, regulatory standards and where growth occurs. Among these changes, one of the most important has been the increasing pressure from payers, governments and society to deliver greater value. That’s why I believe there is a fundamental question facing the industry and Pfizer. Simply stated, it is: Do we have a research model that will consistently produce results that improve the lives of patients