Pharmaceutical Industry Challenges

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30 Questions

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

$11 Bn

What is the perception problem faced by Brand Pharma?

The Big Evil Pharma

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

Research-based Pharmaceuticals

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

Further payor pressure

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

Loss of exclusivity

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

17.5%

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

The Randomised, Double Blind, Placebo Controlled Clinical Trial

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

68.23%

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

4.3

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

The establishment of the FDA

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

All of the above

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

The modernisation of clinical trials in South Africa

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

3

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

Increasing payor pressures and shorter exclusivity periods

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

Rifapentine

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

The drug failed in Phase III

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

BURL- device

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

Developing antibiotics and countermeasures to combat emerging infections and bioterrorism

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

Optimal designs of trial protocols

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

Electronic data capturing

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

Primate research

What is required for research clinicians?

All of the above

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

28-day CTA-exemption

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

Create a research culture

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

It revealed that the chemical increased death rates

What is the main goal of personalised medicine?

To increase the efficacy of drugs while reducing adverse events

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

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

Early elimination of unviable/unsafe candidates

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

It can replace distant clinical endpoints with more proximal surrogate endpoints

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

2-4 years

Test your knowledge on the current challenges facing the pharmaceutical industry, including patent expiries, payor pressure, and growing safety concerns. Learn about the impact of exclusivity loss and generic competition from emerging markets.

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