Role of imaging in personalized medicine

Question 1

What is the current paradigm shift in medicine (research)?

Answer 1

A paradigm shift from a traditional ‘one size fits all’ approach into a much more powerful strategy that considers each individual as unique.

Question 2

What are the potential benefits of this paradigm shift?

Answer 2

• Improved patient safety
• Prevention of under-, over- and misdosing costs (100 billion dollars annually)
• Prevention of adverse reactions (including hospitalizations)
• Increased effectiveness and cost efficiency of treatment
• More cost effective development of drugs

Question 3

The current ineffectiveness of drugs means pharma needs new strategies. What could a new strategy be?

Answer 3

From blockbuster medicine for huge groups to more effective medicine for subgroups.

Question 4

What types of biomarkers are there (i.e. what can different biomarkers predict)?

Answer 4

• Risk
• Diagnostic
• Prognostic
• Therapeutic
• Predictive
• Surrogate

Question 5

Why is the paradigm shift discussed previously not really happening yet?

Answer 5

Because for personalized medicine, you need (genetic) data of patients to be able to personalize treatments. Currently, genetic testing is not being actively used and is only used when it is needed. Thus, instead of a paradigm shift, it is more a gradual process of incremental change, consistent with past trend in diagnostic innovation.

Question 6

What is the difference between ME and WE medicine?

Answer 6

• ME medicine → personalized treatment based on e.g. genetic profiling.
• WE medicine → one size fits all treatment (e.g. vaccination, screening and other public health measures)

Question 7

What are challenges to personalized medicine?

Answer 7

• Pharmaceutical companies are concerned about markets.
• Reimbursement remains stumbling block.
• Intellectual property for diagnostics is complex.
• Physicians lack the scientific background and confidence.
• Public concern surrounding genetic testing.

Question 8

What are challenges with drug development?

Answer 8

The drugs are expensive and there is late development failure.
- About 65% fail at phase II of clinical trials.
- The overall success rate of drug development is 10%.

Question 9

Small molecules were mostly used in the ‘early days’ of drug development. Now a diversity of biologicals are being used. Give examples.

Answer 9

• Peptides,
• Polysaccharides
• Proteins & peptibodies
• Recombinant proteins
• Monoclonal bodies

Question 10

What change is there in regard to imaging?

Answer 10

From imaging anatomy to imaging anatomy and function.

Question 11

Imaging is the navigator for all clinical handling. Why is that?

Answer 11

• To find out what/where/how the disease is.
• To find out if the disease is accurately targeted.
• To find out whether the treatment is effective.

Question 12

Don’t know how to form a question of this slide. So just read.

Question 13

What is companion diagnostics and complementary diagnostics?

Answer 13

• Companion diagnostics → an in vitro diagnostic device or an imaging tool that defines a subset of patients responding particularly well to a therapeutic drug, aid in risk/benefit assessment and is prerequisit for receiving the drug.
• Complementary diagnostics → a test that aids in the benefit–risk decision–making about the use of the therapeutic product, where the difference in benefit–risk is clinically meaningful

Question 14

What are theranostics?

Answer 14

The combination of using one radioactive drug to identify (i.e. diagnose) and a second radioactive drug to deliver therapy to treat e.g. the main tumor and any metastatic tumor.

Question 15

What could be the most informative in regard to diagnosis and treatment efficacy?

Answer 15

The use of labeled drugs might be more informative and needs just one single lead prdocut.

Question 16

Next slides of the lecture are just slides with evidence why imaging is so important in the validation and treatment efficacy of certain drugs.