1. Charles Sharkey M.S., M.B.A. Pharm D. Pharmacy
Site Manager/PGY 1 Residency Coordinator
2. At the conclusion of the lecture dentists will
have an increased knowledge and
understanding of the following topics
Hepatitis C Drug Development
Oncology Drug Development
New trends in drug developments
Cost analysis of pharmaceuticals
3. Hepatitis C Treatment
Oncology Treatment
HIV Management
Drug Therapy Costs
Paradigm shift in treating diseases
4. 2014 represented an excellent year for the
pharmaceutical industry
Sky high merger and acquisition amongst
companies
High levels of drug financing
Peak in drug approvals
5. In 2014 there 41 New Molecular Entities
(NME) approved by the FDA.
Of the 41 NME’s approved 17 represented a
novel way of treating a disease
Most of the NME’s were large molecular
weight compounds such as proteins,
antibodies, and enzymes
There was also a glut of “me too, combination
drugs” approved
6.
7.
8. Used to treat life threatening parasitic
infections
Old drug out for many years.
Turing Pharmaceuticals buys old drugs used
for specific condition then raises prices
$13.50 per tablet to $750 per tablet
overnight
5,500% price increase overnight
9. Is this capitalism?
Free market at work?
Should government intervene?
Price controls?
What would be the effect of these actions?
10. FDA has a speedier approval process
Collaboration in the industry
Average cost of drug development $2.6
billion
Time to develop from bench to market is ten
years
Less than 12% chance of being developed as a
drug
11. Personalized Medicine
Immunobiology i.e. cancer cells presenting
themselves as foreign to the immune system
Maintenance of diseases i.e. Cancer, AIDS.
Curative therapy for Hepatitis C
How do we pay for all of this?
Drug costs vs. Society Costs.
12. Prevalence is about 1.3% of the USA
Population
Asymptomatic, chronic disease
Progression over time
Cirrhosis, hepatic cellular carcinoma
Liver transplants
13. Past regimens were not effective, requiring
long therapy with adverse effects.
2015 new developments in antiviral therapy
Ledipasvir 90mgs/Sofosbuvir 400mgs
(Harvoni)
Treatment is most cases is 12 weeks with one
tablet daily
Cost of treatment = $15,600+
23. Daratumumab (Darzalex) 400mgs $1800
Osimertinib (Tagrisso) 80mgs tablets $429
Nivolumab (Opdivo) 100mgs $1600
Cost of therapy can be as high as $100,000
per year depending on the drug
Survival benefits?
Quality of life?
What is the endpoint used?
24. Target therapy
Immune system attacking cancer cells
Programmed cell death inhibitors
Maintenance therapy
Ant angiogenesis drugs
Add all of these on to existing drugs
25.
26.
27. Entry Inhibitors
Fusion Inhibitors
Reverse Transcriptase Inhibitors
Integrase Inhibitors
Protease Inhibitors
****Combination therapy is the key
****Treat early in the disease
28.
29. Long term therapy
Atripla is combination therapy
$12,000 per patient per year
Disease treatment model changes from acute
management to long term management
Live with the disease
30. New drugs have complex pharmacology
Not sure how they effect the oral cavity
Drug interaction potential exists
Cost of therapy
Will patients have to choice what medication
they will take?
