Pharmaceutical Industry Challenges
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Questions and Answers

What is the estimated annual loss of exclusivity for the pharmaceutical industry from 2008 to 2011?

  • $11 Bn (correct)
  • $5 Bn
  • $10 Bn
  • $15 Bn

    • What is the perception problem faced by Brand Pharma?

  • High research costs
  • The Big Evil Pharma (correct)
  • Increasing competition from generics
  • Inadequate safety measures

    • Which industry has the highest R&D percentage of sales?

  • Drugs & Medicine
  • Electrical & Electronics
  • Computer Software & Services
  • Research-based Pharmaceuticals (correct)

    • What is the pressure faced by the pharmaceutical industry due to healthcare reforms?

    <p>Further payor pressure</p> Signup and view all the answers

    What is the challenge faced by the pharmaceutical industry due to patent expiries?

    <p>Loss of exclusivity</p> Signup and view all the answers

    What percentage of sales do Research-based Pharmaceuticals spend on R&D?

    <p>17.5%</p> Signup and view all the answers

    What was the most significant discovery of the 20th century in the context of drug development?

    <p>The Randomised, Double Blind, Placebo Controlled Clinical Trial</p> Signup and view all the answers

    What is the cumulative success rate of the Pre-Clinical Phase in the 2000-2003 period?

    <p>68.23%</p> Signup and view all the answers

    What is the average development timeframe in years in the 2010s?

    <p>4.3</p> Signup and view all the answers

    What was the outcome of the drug amendments in the USA in the 1960s?

    <p>The establishment of the FDA</p> Signup and view all the answers

    What is the main challenge for Pharma innovation according to the Bain Consulting Drug Development Attrition Model?

    <p>All of the above</p> Signup and view all the answers

    What was the outcome of the enactment of the SAPHRA act in 2017?

    <p>The modernisation of clinical trials in South Africa</p> Signup and view all the answers

    How many total developments from first-time in man (FIM) to FDA registration has South Africa achieved?

    <p>3</p> Signup and view all the answers

    What is the primary reason for the decline in Pharma innovation?

    <p>Increasing payor pressures and shorter exclusivity periods</p> Signup and view all the answers

    What is the last anti-TB drug registered in South Africa?

    <p>Rifapentine</p> Signup and view all the answers

    What was the outcome of Pfizer's $900 million investment in testing its HDL increasing drug, torcetrapib?

    <p>The drug failed in Phase III</p> Signup and view all the answers

    What is the name of the device that is currently being developed in South Africa?

    <p>BURL- device</p> Signup and view all the answers

    What is one of the FDA's six priority public health challenges in 2004?

    <p>Developing antibiotics and countermeasures to combat emerging infections and bioterrorism</p> Signup and view all the answers

    What is one of the benefits of using innovative study designs in clinical trials?

    <p>Optimal designs of trial protocols</p> Signup and view all the answers

    What is a key aspect of the creative process delivery in clinical trials?

    <p>Electronic data capturing</p> Signup and view all the answers

    What is one of the areas where South Africa has a competitive edge?

    <p>Primate research</p> Signup and view all the answers

    What is required for research clinicians?

    <p>All of the above</p> Signup and view all the answers

    What is a key benefit of a drug development-friendly regulatory authority?

    <p>28-day CTA-exemption</p> Signup and view all the answers

    What can individuals do to support clinical research at the UP Medical school?

    <p>Create a research culture</p> Signup and view all the answers

    What was the outcome of the 15,000-patient study on torcetrapib in December 2006?

    <p>It revealed that the chemical increased death rates</p> Signup and view all the answers

    What is the main goal of personalised medicine?

    <p>To increase the efficacy of drugs while reducing adverse events</p> Signup and view all the answers

    According to the source, how much can the cost of drug development be reduced with the help of pharmacogenomics?

    <p>$1.3 billion to $200 million</p> Signup and view all the answers

    What is the potential benefit of using biomarkers in drug development?

    <p>Early elimination of unviable/unsafe candidates</p> Signup and view all the answers

    What is the main advantage of predictive bio-simulation in drug development?

    <p>It can replace distant clinical endpoints with more proximal surrogate endpoints</p> Signup and view all the answers

    What is the estimated time-to-market for a new drug with the help of pharmacogenomics?

    <p>2-4 years</p> Signup and view all the answers

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