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Does anyone have an opinion to share on the following debate:
Targeted Therapy vs Individualized Therapy
1. Which way will the pharmaceutical industry go?
2. Can you predict the FDA perspective?
3. What major factors support Individualized Therpapy?
4. What criteria are involved?
5. Is there a lucrative incentive to lean either direction?
In particular, I am hoping to secure opinions from academia.
I am operating under a significant deadline of TODAY, NOVEMBER 22!
Please share your comments, suggestions and leads with me. If my
deadline passes, I am still very interested to hear your thoughts.
Thank you,
Leslie Keating
Vice President
Pharmaceutical Division
Institute for International Research
703/741-0673
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Dear Leslie Keating,
In my opinion i think as follows,
for
1. Pharmaceutical Industry will go for Targeted therapy
2. FDA will [might] allow both Targeted Therapy and Individualized
Therapy for time being, but later it will
definately go for Individualized Therapy,
3. PK parameters of the patient and pathological situation of the
patient
4. mainly for efficient therapy
5. Might be, but individualized therapy might lead to high cost of
treatment
I hope my opinion will be useful to you
sincerely,
K.B.Koteshwara B.Sc., M.Pharm, DCA
Principal,
Farooqia College of Pharmacy,
Mysore 570021, India
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Dear Leslie:
I am confused. Can you tell me what is the difference between
targeted therapy and individualized therapy? Then the discussion can
begin. Our view has been that individualized therapy is designed to
achieve a selected target serum concentration or level in a
peripheral nonserum compartment, for example, for an individual
patient, with the greatest possible precision. This appears to be
especially important for drugs having narrow margins of safety. So
they seem the same to me. The principle thrust of our lab is to do
such individualized, target - oriented, model - based therapy
optimally. That is why we use nonparametric population models,
multiple - model dosage design, and interacting multiple model
sequential Bayesian posterior updating of the patient's parameter
values, to detect changes in those parameter values even during the
period of data analysis. You can find references on our web site,
which is given below. I look forward to hearing more from you.
Very best regards,
Roger Jelliffe
Roger W. Jelliffe, M.D. Professor of Medicine, USC
USC Laboratory of Applied Pharmacokinetics
2250 Alcazar St, Los Angeles CA 90033, USA
Phone (323)442-1300, fax (323)442-1302, email= jelliffe.aaa.hsc.usc.edu
Our web site= http://www.usc.edu/hsc/lab_apk
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Dear Roger Jelliffe
Assuming targeted therapy is something like treating specific disease
which is is being practised now every where, for eg. if you are suffering
from let us say severe pain, there are set of drugs available already in
the market and dr. will prescribe in conventional manner, I wrote some of
my opinion. I hope Leslie do mean the same targeted therpay.
with regards,
koteshwara
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Dear koteshwara:
I still do not understand what you mean by "targeted"
therapy. Do you mean that a standard protocol is followed? What do
you mean by "in a conventional manner"? In what way is this
"targeted"? Can you be more specific?
Best regards,
Roger Jelliffe
Roger W. Jelliffe, M.D. Professor of Medicine, USC
USC Laboratory of Applied Pharmacokinetics
2250 Alcazar St, Los Angeles CA 90033, USA
Phone (323)442-1300, fax (323)442-1302, email= jelliffe.aaa.hsc.usc.edu
Our web site= http://www.usc.edu/hsc/lab_apk
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Leslie,
I'm not sure about how you differentiate targeted vs individualized
therapy. Are you using "Targeted" therapy to refer to specific
disease/clinical conditions and "Individualized" therapy referring to
patient specific approaches?
I work in a small (~200 bed) community hospital and both approaches
are considered essential. Disease targeted therapy is essential to
start treatment, but after that, the individual becomes more distinct
and required a more individualized approach. This is not unlike using a
population model to initiate therapy and incorporating individual
patient information to refine the model.
Bob Brennan
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