ICAAC satellite pharmacokinetic conference, September 13-14, 1996

Roger Jelliffe jelliffe at hsc.usc.edu
Thu Jun 6 17:26:56 EST 1996



                                                        June 10, 1996

Dear Colleague:

     The Laboratory of Applied Pharmacokinetics of the USC School of
Medicine is putting on another satellite pharmacokinetic conference
on September 13th and 14th, 1996, just before the annual ICAAC
meeting from September 15-18, in New Orleans, Louisiana. It is on
"Model-Based, Goal-Oriented Drug Therapy: New Advances in Population
PK/PD Modeling, Individualized Antibiotic Regimens, and 'Multiple
Model' Drug Dosage". The emphasis will be on general aspects of and
new advances in Population Modeling, modeling drug diffusion, and
efficacy in kill. CME credit is being sought.

WHERE?    WHEN?  The conference will be held on Friday and Saturday,
September 13 -14, 1996, in a room in the Marriott Hotel in New Orleans.
One must arrange travel, hotel, and meal accommodations independently.
Specific room information will be mailed to registrants as the room is
assigned to us.

     The conference is intended to increase the understanding of
recent new advances in Population Pharmacokinetic Modeling and its role
in optimization of clinical trials and optimal antibiotic therapy. The
concepts and software to implement them (the parametric USC*PACK clinical
and iterative Bayesian and the nonparametric NPEM2 programs) are intended
for general use, with special application to the optimal modeling of
drugs used in cardiovascular and infectious disease, AIDS, cancer,
transplant situations, psychiatric illnesses, and for Phase 1-2 and
2-3 trials and concentration-controlled clinical trials. Information
obtained in this conference can also be implemented on other software.

WHO IS IT FOR? The conference is for physicians and pharmacists with a
working knowledge of pharmacokinetics (Vd, Kel, etc) to apply modern
parametric and nonparametric modeling concepts to the study of population
models. Methods to describe diffusion of antibiotics into simulated
endocardial vegetations, the post-antibiotic effect, and its results on
bacterial killing curves will be discussed, and 'Multiple Model' (MM)
approaches to optimally precise dosage regimens will be introduced.
Applications to Trimethoprim, Aminoglycosides, Vancomycin, Digoxin, and
other drugs will also be discussed.

BRING YOUR NOTEBOOK!  For those who already have or  wish to obtain
relevant clinical software for the purposes of this workshop, and who
wish to bring it in your own laptop or notebook computer to the workshop,
you are cordially invited to bring it along to obtain further tutorial
and hands-on experience.

OBJECTIVES: After the conference, participants should be able to: 1) Define
the concepts behind parametric and nonparametric population modeling,
2) Understand the iterative Bayesian and nonparametric  NPEM2 population
modeling programs, 3) Implement population modeling and Bayesian adaptive
control methods to introduce a new drug to the marketplace with optimal
strategies for its precise and safe use, 4) Compute bacterial growth and
killing curves and drug diffusion into endocardial vegetations, and
5) Understand the application of Bayesian Adaptive Control concepts to
practical aspects of managing drug therapy optimally for patients.

THE FACULTY are: Roger Jelliffe, M.D., Prof. of Medicine, USC School of
Medicine, Los Angeles, CA, Course Coordinator; George Drusano, M.D., Chief
of Clinical Pharmacology, Albany Medical College, NY, Courtney Fletcher,
Pharm.D., University of Minnesota School of Pharmacy, Alan Forrest,
Pharm.D., Director of Pharmacometrics and Biostatistics, Millard Fillmore
Hospital, Buffalo, NY, George Jaresko, Pharm.D., USC School of Pharmacy,
Pascal Maire, Pharm.D., Hospital Antoine Charial, Hospices Civils de Lyon,
France, and John Rodman, Pharm.D., Vice Chairman, Pharmaceutical Department,
St. Jude Children's Research Hospital, Memphis, TN.

     Please call (213) 342-1300, or Fax us at (213) 342-1302 if you have
     any questions.

                                                Sincerely,

                                                Roger W. Jelliffe, M.D.
               Professor of Medicine

Preliminary Program: "Model-Based, Goal-Oriented Drug Therapy: New
Advances in Population PK/PD Modeling, Individualized Antibiotic Regimens,
and 'Multiple Model' Drug Dosage".
*************************************************************
Day 1 - Friday, September 13, 1996
*************************************************************
8:30 AM - Registration
9:00 AM - Welcome - Dr. Roger Jelliffe
9:05 AM - An Overview of Population Modeling - Dr. Jelliffe
9:15 AM - Parametric Population Models - Dr. Alan Forrest, SUNY, Buffalo
                Naive Pooling, Standard Two Stage, NONMEM
9:45 AM - The Parametric Iterative 2-Stage Bayesian (IT2B) Procedure
                    - Dr. Forrest
10:15 AM - Nonparametric Population Models - Dr. Jelliffe
                NP Maximum Likelihood
                NP Expectation - Maximization
          Their Relationship to the Separation Principle and to Optimal
                    Drug Regimens

10:45 AM - Break

11:00 AM - Clinical and Research Issues in Population Modeling
                    - Dr. Jelliffe
                Evaluating Renal Function
          Determining the Assay Error Pattern and the Weighting Scheme
                    for Measurements
                When to Get Serum Levels: Optimal Sampling Schedules
          Modeling Environmental Errors in Dosage Preparation and
                    Administration
11:45 AM - Modeling Pharmacologic Effects and Drug Binding to Effect Sites
                    - Dr. Jelliffe
12:00 Noon - Current Bayesian Modeling and Clinical Models of Drug
                    Diffusion - Dr. Jelliffe
12:15 PM - Modeling Bacterial Growth and Kill, and the Post-Antibiotic
                    effect - Dr. Jelliffe

12:30 PM - Lunch

1:30 PM - Modeling Antibiotic Combinations and Killing - Dr. Forrest
2:00 PM - "Multiple Model" Adaptive Control and Optimal Drug Dosing
                    - Dr. Jelliffe
2:30 PM - Applying "Multiple Model" Concepts to Therapy with Suramin
                    - Dr. Forrest

3:00 PM - Break

3:15 PM - How to make a Population Model of Amikacin with NPEM2 - Dr. Jelliffe
3:35 PM - The Front part - an Iterative Bayesian Population Modeler
                    - Drs. Jelliffe and Forrest
                Selecting patient data file types
                Evaluating Bioavailability
                Parameterizing the Model: Choosing Volume, 1/V, Clearance,
                    or  Kel
                Entering the Assay Error Pattern Polynomial
                Selecting the Convergence Criterion and iterations
                Defining the first Bayesian prior
                Setting the Initial estimates for the parameter ranges
                Defining the ranges to pass to the nonparametric back part
4:15 PM - The Back part - the Nonparametric Population Modeler itself
                    - Drs. Jelliffe and Forrest
          Using the program the standard way - picking up data and ranges
                    from the front part
          Selecting the number of grid (support) points for the initial
                    joint probability density
                function (PDF)
                Choosing plot and print options
                Evaluating the Nonparametric Output
                        The log-likelihood function
                        The difference between a cycle likelihood and the max
                        The means, modes, skewnesses, kurtoses, and
                                   the percentiles
                        New Descriptors of Dispersion - the DF-50 and DF-95
                        The 2-D plots of the Marginal PDF's
                        The 3-D plots of pairs of Joint Marginal PDF's
                            Comparing these with covariances and correlations
                        Summarizing the grid points and their probabilities
               Linking Nonparametric models to Multiple Model Adaptive
                    Control
               Evaluating the convergence - Absolute and normalized
                    convergence plots
               Evaluatine the entropy and the scaled information of
                    a distribution
               Getting individual patient parameters as a
                    "population of one"

5:30 PM - Adjourn

*************************************************************
Day 2 - Saturday, September 14, 1996
*************************************************************

9:00 AM - A Review of Yesterday's Population Modeling - Dr. Jelliffe
9:15 AM - A tougher Problem: Modeling Trimethoprim - Drs. Jelliffe,
                    Forrest, and Jaresko
10:15 AM - Running the modeler without the front part - Dr. Jelliffe
          Recovering and continuing after a power failure, or continuing
                    a previous run
                Plotting results of a previous run

10:30 AM - Break

10:45 AM - Clinical Applications: Digoxin - Dr. Jelliffe
          Planning the initial regimen. Controlling the Peripheral
                    Compartment
                An interesting patient with Atrial Fibrillation
                A patient with very high levels - why?
11:15 AM - Clinical Applications: Trimethoprim - Dr. Jelliffe
                Setting the goals for PCP pneumonia
11:45 AM - Clinical Applications: Antiviral Pharmacodynamics
                    - Dr George Drusano

12:30 PM - Lunch

1:30 PM - Clinical Applications: Individualizing Cancer Chemotherapy in
                    the Pediatric Patient -
                Dr. John Rodman, St. Jude Hospital
2:15 PM - Clinical Applications: Theophylline - Dr. Jelliffe
          Setting the goals and planning the regimen: regular and
                    sustained release forms
2:45 PM - Clinical Applications: Prolonged Vancomycin Therapy
                    - Dr. Marcus Haug, Cleveland Clinic
                A Deeper Tissue Compartment? Its Relation to Outcome?

3:15 PM - Break

3:30 PM - Clinical Applications: Analyzing Bacterial Growth and Kill
                    - Dr. Pascal Maire
4:00 PM - Clinical Applications: Zidovudine Chemotherapy
                    - Dr. Courtney Fletcher
4:00 PM - Clinical Applications: Gentamicin - Dr. Jelliffe
                Setting the goals: once daily or what?
                Modeling diffusion into vegetations or abscesses
                Effect models - occupation of toxic binding sites
                Modeling bacterial growth and kill, and post
                    - antibiotic effect.
4:50 PM - Once Daily Aminoglycoside Therapy - Pros and Cons
                    - Drs. Jelliffe, Forrest, and Rodman
                Evaluating 80 q 8 versus 240 q 24 - 2 cases, 3 values of CCr
                Serum AUC, and AUC in a peripheral effect compartment
                Evaluating the relative benefit of nonlinear uptake
                General Discussion

5:30 PM - Adjourn

PLEASE USE THE REGISTRATION FORM ON THE BACK OF THIS PAGE,
and also check our web address



Registration Form

     I wish to register to attend the USC Symposium on "Model-Based,
Goal-Oriented Drug Therapy: New Advances in Population PK/PD Modeling,
Individualized Antibiotic Regimens, and 'Multiple Model' Drug Dosage"
on September 13th and 14th, 1996.

                Registration________________________________________________
($275.00. For members of  ASM, only $245.00)

                Total:   $________________

          (Sorry - we cannot handle credit cards or purchase orders.
          We can handle checks and foreign travelers checks in US dollars.)

                Please make checks payable to the:

                        Laboratory of Applied Pharmacokinetics

                Name of Registrant ______________________________       _

                Institution________________________________________

                Address__________________________________________         _

                _______________________________________________ __

                City, State, Zip_______________________________      _____

                Country

                Phone (____)________________Fax (____)_________________

                Your Email address, please! ____________________________

                I am___________am not____________a member of ASM.

                Please return this form, with your check, directly to:

                Roger W. Jelliffe, M.D.
                Laboratory of Applied Pharmacokinetics
                USC School of Medicine
                CSC 134-B
                2250 Alcazar Street
                Los Angeles, CA 90033

     Phone : (213) 342-1300, Fax : (213) 342-1302,
     email: jelliffe at hsc.usc.edu

     Note:  Please register early! First come are first served. Registration
     is limited to the spaces available. Cancellations must be made at least
     10 days before the workshop in order to obtain a refund.

     I would _____ would not _____ also like to receive information about
     the USC software. I heard about this conference from______mailing
     _____word of mouth _____electronic bulletin board_____other (please
     specify)______________________

*************************************************************
We also have a page on the World Wide Web!! Its address is
          http://www.usc.edu/hsc/lab_apk/
You might check it from time to time to see about new workshops
and software developments.
*************************************************************




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