How close are we to personalized medicine? Are we going to see the fruits of the Human Genome Project in the near future?

1. The Story of
Personalized
Medicine
(What it is, how far it has progressed, and how we can make it progress faster!)

2. Personalized Medicine
(also called Precision Medicine)
is a revolutionary change in the basic
practice of healthcare.

3. Without Personalized Medicine,
doctors have to rely on a limited set of
tools for diagnosing diseases.

4. This can lead to ambiguous diagnoses,
or worse, lengthy diagnostic odysseys
that can take years without a definitive
answer.
?

5. Drugs are prescribed with only a
limited understanding of how useful
they will be.

6. As a result, some people get the
benefit, some people get even sicker,
and many people have no response.

7. Personalized Medicine
changes all of this.

8. Personalized Medicine utilizes
biomarkers, which are simply genes
and proteins that can be measured to
precisely diagnose diseases.

9. Biomarkers take the guesswork
out of medicine.

10. Biomarkers are not new, but there has
been an enormous boom in the
discovery of new biomarkers since the
end of the Human Genome Project.
This biomarker boom is enabling the
Personalized Medicine revolution.

11. But Personalized Medicine is not yet
ubiquitous.
In fact, except for a few specialty areas
of medicine, it’s actually not used all
that often.

12. Why?

13. To understand,
let’s start at the beginning.

14. It all started in 1994 with the
Human Genome Project (HGP).
The HGP was a huge public & private
initiative focused on sequencing the
entire human genome.

15. In 2003, victory was declared by both
the public and private sectors.
Sequencing an entire human genome
was now possible.

16. During the HGP and since, billions have
been spent by the public and private
sectors to develop new technologies for
measuring biomarkers.
$ $

17. As a result, we can now do it faster,
more accurately, and cheaper than
ever before.

18. 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
This has led to a boom in
new biomarker
discoveries.

19. ?
But how have many of those
discoveries are actually being
used in Personalized Medicine?

20. 3 New Tests Per Year.

21. That would be depressing…
!
d

22. …except that it takes an average of
15 years for a biomarker to make the
journey from discovery to the clinic.

23. Biological
validation
There are many steps
along the way.

24. Biological
validation
Technical
validation

25. Biological
validation
Technical
validation
Clinical
validation

26. Biological
validation
Technical
validation
Clinical
validation
Regulatory
review

27. Biological
validation
Technical
validation
Clinical
validation
Regulatory
review
Endorsement

28. Biological
validation
Technical
validation
Clinical
validation
Regulatory
review
Reimbursement
Endorsement

29. With that kind of timeline,
last year’s crop of biomarkers...
2014

30. 2029
…will still require many years to mature.

31. Can anything be done to
accelerate things?

32. Yes!

33. We Can Improve
Basic Research
Limit the amount of investment in basic
research that doesn’t have identifiable
healthcare benefits. Utilize public sources
of research data.

34. We Can Improve
Regulatory Review
Review periods have doubled in the last
decade, and become significantly more
burdensome, and FDA is proposing more
regulation!
It’s time for a new approach.

35. We Can Improve
Reimbursement
It is currently inconsistent from payer to
payer, and not tied to test
development/manufacturing costs.
Medicare must take the lead in overhauling
reimbursement!

36. Let Your Voice Be Heard!
Send a message to Congress showing your
support for Personalized Medicine
Click to Send a Letter Now!
Our pre-formatted letter makes it easy!

37. One more thing…

38. Talk to Your Doctor!
Make sure you are asking about all
available personalized medicine options
relevant for you!

39. References