Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Open Public Meeting December 14-15, 2006. Prabhavathi Fernandes, Ph.D. President and CEO Cempra Pharmaceuticals, Inc. [email protected]
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Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Drug Safety and Risk Management Advisory CommitteeOpen Public MeetingDecember 14-15, 2006
Prabhavathi Fernandes, Ph.D.
President and CEO
Cempra Pharmaceuticals, Inc.
We all want
affordable antibiotics -that are safe and
effective against resistant bacteria
Success REQUIRES that we are all on the same tablet !
Lack of clear guidelines to develop antibacterials makes the financial risk too high
Pharma & Biotech
The return on investment is too low
There are not enough safe and effective antibiotics
We need extraordinarily safe antibiotics that are more effective than placebo
Antibiotics developed & used for serious infections
Patients demand for antibiotics for simple “infections”
FDA, patients & Congress
question use and safety of antibiotics
Physician & Patient comfort
WHERE ARE THE MAGIC BULLETS?
Increased profits from antibiotic sales for simple infections
Increased patient exposure –increased reporting of adverse effects
Patient demand and
pharma greed for
drugs for simple infections
Pharma markets aggressively for simple infections