Pharmaceutical Industry Challenges

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?

Further payor pressure (B) Signup and view all the answers

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

Loss of exclusivity (B) Signup and view all the answers

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

17.5% (C) Signup and view all the answers

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

The Randomised, Double Blind, Placebo Controlled Clinical Trial (C) Signup and view all the answers

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

68.23% (A) Signup and view all the answers

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

4.3 (B) Signup and view all the answers

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

The establishment of the FDA (C) Signup and view all the answers

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

All of the above (D) Signup and view all the answers

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

The modernisation of clinical trials in South Africa (C) Signup and view all the answers

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

3 (C) Signup and view all the answers

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

Increasing payor pressures and shorter exclusivity periods (A) Signup and view all the answers

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

Rifapentine (C) Signup and view all the answers

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

The drug failed in Phase III (D) Signup and view all the answers

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

BURL- device (D) Signup and view all the answers

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

Developing antibiotics and countermeasures to combat emerging infections and bioterrorism (A) Signup and view all the answers

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

Optimal designs of trial protocols (A) Signup and view all the answers

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

Electronic data capturing (D) Signup and view all the answers

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

Primate research (B) Signup and view all the answers

What is required for research clinicians?

All of the above (D) Signup and view all the answers

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

28-day CTA-exemption (C) Signup and view all the answers

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

Create a research culture (A) Signup and view all the answers

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

It revealed that the chemical increased death rates (D) Signup and view all the answers

What is the main goal of personalised medicine?

To increase the efficacy of drugs while reducing adverse events (C) 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?

$1.3 billion to $200 million (C) Signup and view all the answers

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

Early elimination of unviable/unsafe candidates (B) Signup and view all the answers

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

It can replace distant clinical endpoints with more proximal surrogate endpoints (B) Signup and view all the answers

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

2-4 years (D) Signup and view all the answers