Preview

Lifecycle Mgmt Pharmaceutical Bwp 070014

Powerful Essays
Open Document
Open Document
2598 Words
Grammar
Grammar
Plagiarism
Plagiarism
Writing
Writing
Score
Score
Lifecycle Mgmt Pharmaceutical Bwp 070014
Improving clinical development & manufacturing processes in pharmaceutical R&D organizations

Product Lifecycle Management for the Pharmaceutical Industry
An Oracle White Paper

Author: Todd Hein, Oracle Life Sciences

Key Contributors:
i.
ii. iii. Arvindh Balakrishnan, Oracle Life Sciences
Hardeep Gulati, Oracle Product Strategy
Michael Winkler, Oracle Life Sciences

Oracle Pharmaceutical Solution Set

Page 1

Improving clinical development & manufacturing processes in pharmaceutical R&D organizations

Introduction:
In recent years the pharmaceutical industry has faced declining R&D productivity, a rapidly changing healthcare landscape and fierce competition from generics resulting in lower growth and profit margins. Historically, drug development focused on clinical trials management and outcomes. Now however, the industry is looking at more holistic approaches to improve processes of bring new products to market that can accelerate product development while lowering operational costs. This is challenging because of the complex value chain and business processes required in this highly regulated environment. Additionally, it has proven difficult for the industry to effectively adapt as many pharmaceutical companies are simply not optimized for cross functional collaboration which is so desperately needed to support these changing market conditions. One meaningful and holistic approach to today’s current challenges within the pharmaceutical industry is to focus on Product Lifecycle Management (PLM), which is a business transformation approach to manage products and related information across the enterprise. In recent years PLM has provided many pharmaceutical organizations with the ability to increase their ability to get products to market quicker, ensure greater regulatory compliance and efficiencies while reducing development costs.
This article identifies some key business metrics that benchmark a company’s performance and key strategic business processes

You May Also Find These Documents Helpful

  • Satisfactory Essays

    A very dangerous thing that was exposed were the electricity cables, these cabled were all in the open and that is a really serious case a case of health and safety. But there is another problem, BCP is missing parts on the steam pipes, that means that the steam pipes are unprotected, and in some cases can be dangerous.…

    • 588 Words
    • 3 Pages
    Satisfactory Essays
  • Satisfactory Essays

    Patient requests medication renewal for propranolol. Patient has been taking propranolol 40mg once daily since 2000 for hypertension.It appears that the pt noncomplaint with hypertension tx. Under the medication list there are two prescription with refill for propranolol and the pt never picked up med. However, appears that pt inprocessed into this clinic in April. BP on 27Sep16 was 105/76. Labs overdue. Please…

    • 64 Words
    • 1 Page
    Satisfactory Essays
  • Powerful Essays

    Pharmasim Handbook

    • 3245 Words
    • 13 Pages

    . . . is one of the leading manufacturers of packaged goods in the world. Since its founding in 1924, the company has acquired or merged with a number of smaller packaged goods companies.…

    • 3245 Words
    • 13 Pages
    Powerful Essays
  • Powerful Essays

    Current legislation, guidelines policies and protocols relevant to the administration of medication we use is is mainly The Medicines Acts 1968. While we are not expected to have detailed knowledge of the legislation, we do need to be aware of the legal difference between types of drugs and the legal framework that allows them to handle medicines on behalf of the service user. The following is a list of legislation that has a direct impact upon the handling of medication within a social care setting are:…

    • 1814 Words
    • 8 Pages
    Powerful Essays
  • Good Essays

    616 Medication1

    • 863 Words
    • 4 Pages

    2.3 Describe the common adverse reactions to medication, how each can be recognised and the appropriation action(s) required…

    • 863 Words
    • 4 Pages
    Good Essays
  • Satisfactory Essays

    mgt 3830 ch 1-2-3-4-7-8

    • 8346 Words
    • 34 Pages

    1. Strategy today is essentially a detailed plan which every member of the organization must follow to ensure success.…

    • 8346 Words
    • 34 Pages
    Satisfactory Essays
  • Satisfactory Essays

    On a course of time, the role of a project manager is evolving very rapidly. Now, project managers are not evaluated solely on their expertise in their respective discipline but they are also judged on their leadership traits and attributes. This requires a great emphasis on the personal leadership development of project managers. In due course, the development goals that I have set is to further develop my passion for learning and commitment, being a proactive person and a leader rather than reactive, and the development of adaptability in diverse and complex situation and circumstances.…

    • 567 Words
    • 2 Pages
    Satisfactory Essays
  • Good Essays

    In 1999, the Institute of Medicine (IOM) released a report, "To Err is Human: Building a Safer Health System," in which, according to the report, between 44,000 and 98,000 deaths may result each year from medical errors in hospitals alone. And more than 7,000 deaths that occurred each year were related to medications. In response to the IOM's report, all parts of the U.S. health system put error reduction strategies into high gear by re-evaluating and strengthening checks and balances to prevent errors. In 2001, U.S. Department of Health and Human Services (HHS) announced a Patient Safety Task Force to coordinate a joint effort to improve data collection on patient safety. The lead agencies are the FDA, the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services, and the…

    • 1164 Words
    • 5 Pages
    Good Essays
  • Powerful Essays

    Pharm 100 Review

    • 6292 Words
    • 26 Pages

    Liver Cancer: higher incidence in China and other Asian countries due to Hep B infection and contamination of foods by aflatoxin B1 which is released from molds that grow on grains in warmer climates…

    • 6292 Words
    • 26 Pages
    Powerful Essays
  • Satisfactory Essays

    H&S Care, Unit 4, P3

    • 305 Words
    • 2 Pages

    P3 – Explain the influence of two predictable and two unpredictable major life events on the development of an individual.…

    • 305 Words
    • 2 Pages
    Satisfactory Essays
  • Better Essays

    Drug Study Assignment

    • 3259 Words
    • 15 Pages

    Past History: Smokes ½ a pack of cigarettes per day (since she was a teenager)…

    • 3259 Words
    • 15 Pages
    Better Essays
  • Best Essays

    The pharmaceutical company is made up of a number of different functions and departments. Each of these functions is given a responsibility in one area of the company’s activity. These departments are closely related and the success of the company is based on the ability of these functions to work together. The pharmaceutical companies rely on research and development to find new and innovation new drugs. In order for a drug to enter the market it must undergo a series of tests and clinical trials. There are phases the drug must go through and complete in order to meet the requirements of the FDA. The development of a drug is an ongoing journey, and it can take up to 12 years to develop a drug (Pharmaceutical Patents 2006). The pharmaceutical company uses…

    • 4398 Words
    • 18 Pages
    Best Essays
  • Good Essays

    Phase 5 Ip Procter & Gamble

    • 2299 Words
    • 10 Pages

    Procter & Gamble is a Fortune 500 company. Their views of combining their business ethics and what is best for their communities is what makes this company a success. The executives that run this company and the products they develop and manufacture make for a winning team. Their mission statement says “We will provide branded products and services of superior quality and value that improve the lives of the world’s consumers, now and for generations to come. As a result, consumers will reward us with leadership sales, profit and value creation, allowing our people, our shareholders and the communities in which we live and work to prosper.” Procter & Gamble is in over 180 countries and is hoping have one billion new customers by 2015; going into countries that have a higher poverty level is one way they are planning to achieve this goal They are already going into the back country of China to sell their products to the poorest of poor customers. Their CEO Robert McDonald has big plans and aims high since becoming the CEO of Procter & Gamble and is well on his way to making all this plans move along effectively. In this final essay I will be digging deeper into Procter & Gamble and giving an Executive summary about the current state of Procter & Gamble, discussing technological opportunities, marketing opportunities, the recruitment presentation and future opportunities.…

    • 2299 Words
    • 10 Pages
    Good Essays
  • Good Essays

    Yamada reorganization of drug discovery at GlaxoSmithKline (GSK) following a merger to combat bureaucracy in decision making, approval, and authorization. This reorganization was necessary for the continued success of the company. Often the process for drug discovery and market is a slow and tedious process which can cost a company a lot in resources and financially. The smaller biotech companies are able to move quicker and push new drugs to market faster. The shift, Yamada thinks, will help produce an entrepreneurial environment akin to a smaller, biotechnology outfit. This reorganization placed nearly 2,000 research scientists into six centers of excellence in drug discovery (CEDD). Each CEDD focused on a small set of therapeutic areas and possessed decision rights over the progression of pharmaceutical compounds through the early stages of development. These groups managed the pipeline from Lead Optimization through Proof of Concept. Each CEDD had full control over its own budget which could be spent internally or externally to deliver their best possible pipeline. The goals in each of these moves was to drive accountability deeper into the organization, reduce central oversight as much as necessary and foster a “biotech-like” atmosphere in a very large bio/pharmaceutical company.…

    • 756 Words
    • 4 Pages
    Good Essays
  • Good Essays

    Improving and updating product lines is crucial for the success for any organisation. Failure for an organisation to change could result in a decline in sales and with competitors racing ahead. The process of NPD is crucial within an organisation. Products go through the stages of their lifecycle and will eventually have to be replaced. New product development has eight stages.. These stages will be discussed briefly below:…

    • 563 Words
    • 3 Pages
    Good Essays