Oncoshrink Pharma Simulation Paper

Improved Essays
I am Kerry Matthews, who just got a new job at Oncoshrink Pharmaceutical Inc. as a new manager of the new clinical operation department. Oncoshrink is a new established pharmaceutical company in the recent year, which eager to extend the scale and bring new products to the market. Even through there are few products processes on the pipeline, the product lines in the future still seems optimistic, especially the Shrivelstain, a novel anti-cancer agent, which had done with phase I clinical trials and also brought significant benefits to the participants. The phase I clinical trials of Shrivelstain was managed by a CRO-ORMC (Oncology Research Management Corporation) and completed by BBMC (Best and Brightest Medical Center). Oncology Research Management …show more content…
In addition, I know that OCRM employee seems pleasant, but not that knowledgeable about their responsibilities. I have been as a research nurse, and then research coordinator in the past; I learned some thing about regulatory, communication and clinical practice. However, I do not really have any management experience in the pharmaceutical industry. Therefore, I need to update my knowledge of this market, create sensitive intuition and improve executive skills; my first step is market researchOver view of the market, this is a high cost and time consuming industry, the average cost to research and develop a new drug is estimated to be $2.6 billion (incorporated the cost of failures) and took 10~15 years for the new drug from investigational process to reach the market. (Pharmaceutical Research and Manufacturers of America, 2015). In addition, pharmaceutical industry is getting more competitive due to more merge companies and harder to get product approval by FDA. In addition, the number of new IND application is increasing in every fiscal year and FDA does not ease the regulatory or expedite the NDA review

Related Documents

  • Improved Essays

    Bayh-Dole Act 1970

    • 796 Words
    • 4 Pages

    Under the Hatch-Waxman regime, a brand-name company seeking 26 FDA approval for a new drug must file a new drug application (NDA). In addition to detailed information about the properties of the drug, the application must include "the patent number and the expiration date of any patent which claims the drug . . . or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted," and this information must be amended as new patents are issued.27 After the drug is approved, the FDA must make this list public. 28 The FDA publication containing new drug information is known as the Orange Book, and it may be searched freely…

    • 796 Words
    • 4 Pages
    Improved Essays
  • Great Essays

    Unit 5 Assignment

    • 1637 Words
    • 7 Pages

    In response to my interpretation of the brief, my objectives for the Graded Unit 1 were clear: • Identify the clients’ aims and objectives towards their treatments. • Gather all information necessary to complete the treatments. • Follow a precise consultation to gather all the information required. • Use my knowledge and understanding from previous mandatory units which will assist in creating a well thought treatment plan. • Produce knowledge and understanding of products and resources required during each treatment.…

    • 1637 Words
    • 7 Pages
    Great Essays
  • Improved Essays

    Sickkids: A Case Study

    • 236 Words
    • 1 Pages

    I am interested to join in the administrative coordinator role at SickKids. This role is a great fit based on the pharmacology doctorate, cancer research experience, clinical trials knowledge, and advanced literature research and analytical skills. The pharmaceutical industry proficiency involved secondary research on oncology drug development, disease states, therapeutic area strategies and new treatment modalities. The proficiency in clinical trial methodologies, design and statistics enables to interpret and coordinate the scientific research and collaborative studies, documentation and support functions.…

    • 236 Words
    • 1 Pages
    Improved Essays
  • Decent Essays

    2 The quickest and most effective manner in which to achieve this vision is through a PBM acquisition. The internal development of pharmacy benefit competencies would be very difficult and time-consuming for Merck. When making its decision, Merck should not view moving into the pharmacy benefit management area as enhancing existing competencies, but rather expanding into a different business within the pharmaceutical industry in which new competencies will be needed. Based on the aforementioned quote by Grant that…

    • 6621 Words
    • 27 Pages
    Decent Essays
  • Improved Essays

    Amicus Therapeutic Summary

    • 1939 Words
    • 8 Pages

    Following last week’s theme, I will be discussing two smaller companies that just released positive Phase III results on their lead candidates. Amicus Therapeutics (FOLD), currently down to $7.98 a share from its 52 week high of $18.83, went up 12% premarket Tuesday after releasing encouraging data on migalastat in Fabry disease. Members of the Amicus team delivered an oral explanation on migalastat to the European Union’s (EU) Committee for Medicinal Products for Human Use (CHMP) in February, and they expect to receive an opinion on the drug at the next CHMP meeting (March 29 - April 1, 2016). They also expect to meet with the FDA in Q2 to present data and discuss a potential pathway to submit a New Drug Application (NDA) for migalastat in…

    • 1939 Words
    • 8 Pages
    Improved Essays
  • Great Essays

    Gilead Science, Inc.’s Total Rewards Program Introduction and Purpose This report describes Gilead Science, Inc.’s total rewards program. This includes the company’s capabilities, key goals, objectives, challenges, values, and core competencies that are required for the company to be successful. Knowledge of the company’s total rewards model is explained with its current total rewards philosophy, as well as its three categories of offerings.…

    • 1349 Words
    • 6 Pages
    Great Essays
  • Improved Essays

    These two methods in the articles described a way to change the regulation of how pharmaceuticals adjust their…

    • 1525 Words
    • 7 Pages
    Improved Essays
  • Decent Essays

    This is understandable because pharmaceutical companies, such as Allergan, thrive on having robust R&D activities for new inventions. Allergan has been able to control most of its operating costs resulting in higher profit margins,…

    • 175 Words
    • 1 Pages
    Decent Essays
  • Improved Essays

    NINR The National Institute of Nursing Research is one on the largest funding source for nursing research. They have been a vital part in the transitioning of nursing as a being defined as an art and a science. Art meaning we are caring, nurturing and science meaning we provide case base on the best evidence base practice available.…

    • 1205 Words
    • 5 Pages
    Improved Essays
  • Improved Essays

    Over Medicated Essay

    • 512 Words
    • 3 Pages

    Last year, pharmacist filled 4,468,929,929 prescriptions in the United States that is an 85 percent increase from just twenty years earlier (Carr, Rabkin, and Skinner 38). With these kinds of numbers, it must be obvious the process to develop drugs in America is working like a well-oiled machine, or is it? Prescription drug companies, the Food and Drug Administration (FDA) and independent research companies including universities all work together to develop improved medications. Each one has an unbiased, independent role to play in the process, however, over the years the unbiased independent part has become blurred. The Federal Government has made changes to regulations and health care policies, consequently, the prescription drug company’s…

    • 512 Words
    • 3 Pages
    Improved Essays
  • Superior Essays

    Pre-IND meeting also requires submitting a development plan with the meeting documents. The format of the strategy documents depends on the company, its culture, and the past experience of regulatory submission needs to be included in the final document. A strategy document is an organized combination of all the sides of the drug development from pre-IND to the NDA and up to product commercialization approved by several stakeholders. The document is an excel spreadsheet or a working “book,” it must capture and documented any changes to the…

    • 1496 Words
    • 6 Pages
    Superior Essays
  • Great Essays

    II. The company has grown greatly in Central and Eastern Europe. Their share price had rocketed and associated costs to maintain and grow their presence in these markets such as marketing of new products were growing quickly as well. It was important for them to expand globally as a first-rate competitor cannot conduct all its operations from only their US home market that represented 6 to 8 per cent of its existence. The US accounted for 45% of the global pharmaceutical market so growth was more feasible on a global…

    • 1125 Words
    • 5 Pages
    Great Essays
  • Great Essays

    Pfizer should also reduce their cost in administrative and advertising and pump in more resources into the research and development department so that they will be able to come up with new and improved drugs. Due to the decline in blockbuster sales and new inventions within the pipeline, it would be wise to move into more personalized treatment such as cancer. Pfizer should not only rely on the "Cash Cow "products because the industry is a now facing a shift and the one size fits all approach is not valid anymore. Pfizer should consider acquiring smaller drug companies to strengthen its portfolio since their labs are not churning out enough blockbuster products.…

    • 1041 Words
    • 5 Pages
    Great Essays
  • Improved Essays

    Healthcare Expensive Essay

    • 1122 Words
    • 5 Pages

    Why is Health Care Expensive? Today’s world revolves around money, whether it be for food, clothing, or bills. Hospital visits involve an extreme amount of money and appears to increase each day. People visit hospitals for illness, check-ups, broken bones, etc.…

    • 1122 Words
    • 5 Pages
    Improved Essays
  • Improved Essays

    The core of the pharmaceutical industry problems consists of the expiration of patents, rising R&D expenses, and uncertainties facing new researched products and their abnormal methods of circulation of returns from said product. As rooted in the topic of this case AstraZeneca upholds the gold of innovatively changing the way medicine reaches patients. When patents are first granted there are procedures that followed before a drug reaches the marketplace. Due to the extended timeframe that is required for clinical trials, studies and organizational processes to tested and developed the revenue phase of the drug decreases (Hitt, Ireland, & Hoskisson, 2015). More specifically after the developed drug is ready for sale the patent remaining on these products are near expiration.…

    • 703 Words
    • 3 Pages
    Improved Essays