2007 AAPS Annual Meeting and Exposition
November 11 – 15, 2007
San Diego Convention Center
San Diego, California
Friday, November 9
8:00 am – 5:00 pm
CRS Workshop on Development and Regulatory Challenges for Controlled Release Formulations
Co-sponsored with AAPS
An additional fee is required to attend this satellite program
Saturday, November 10
Back to Top8:30 am – 5:00 pm
2007 AAPS Executive Council Meeting
8:30 am – 5:30 pm
CRS SATELLITE WORKSHOP
CRS Workshop on Development and Regulatory Challenges for Controlled Release Formulations
Co-sponsored with AAPS
An additional fee is required to attend this satellite program
AAPS Workshop on Stress Testing and Degradation Chemistry
An additional fee is required to attend this satellite program
AAPS Workshop on Quantitative Pharmacology: A Roadmap for Rational, Model-based Drug Development
An additional fee is required to attend this satellite program
AAPS Workshop on Enzyme- and Transporter-Based Drug Interactions: Progress and Future Challenges
Co-sponsored with ISSX
An additional fee is required to attend this satellite program
2:00 pm – 5:00 pm
AAPS Speaker Ready Room
4:00 pm – 7:00 pm
AAPS Registration
Sunday, November 11
Back to Top7:00 am – 7:00 pm
AAPS Registration
7:00 am – 5:00 pm
AAPS Speaker Ready Room
8:00 am – 5:00 pm
AAPS Press Room
8:30 am – 4:00 pm
AAPS SHORT COURSES
Challenges and Opportunities in Developing Drug Substance and Product CMC Dossiers: CTD Submission (RS)
Challenges in Developing Biologics: Industry and Regulatory Expectations (PDD)
Methods for Pre-Screening Protein Therapeutics for Potential Clinical Immunogenicity (BIOTEC)
Monitoring Impurities in Pharmaceuticals (APQ)
Recent Techniques in HPLC and Related Chromatographic Procedures: Small vs. Large Molecule Application; Cross-Fertilization Between Disciplines (APQ)
Science and Engineering Principles Applied to Pharmaceutical Technology for Solid Formulations (PT)
Introduction to Laboratory Automation
Co-sponsored with ALA
An additional fee is required to attend the Short Courses.
12:00 pm – 1:00 pm
Short Course Luncheon
12:00 pm – 3:00 pm
AAPS Career Center
(Recruitment Hall Only)
Funded by Grants from
2:00 pm – 3:00 pm
AAPS Career Center Opening Reception
4:30 pm – 6:30 pm
AAPS Opening Session
Funded by a Grant from
Keynote Address by Dr Roger J. Pomerantz, M.D., F.A.C.P.
Awards Ceremony
7:00 pm – 8:30 pm
AAPS Welcome Reception
Funded by Grants from
8:00 pm – 10:00 pm
American Society of Iranian Pharmaceutical Scientists (ASIPS) Meeting
Purdue University School of Pharmacy Alumni and Friends Reception
Monday, November 12
Back to Top7:00 am – 8:00 am
University of Minnesota College of Pharmacy Alumni Breakfast
7:00 am – 8:30 am
Philadelphia College of Pharmacy/University of the Sciences in Philadelphia Alumni Breakfast
7:00 am – 5:00 pm
AAPS Press Room
7:00 am – 5:00 pm
AAPS Speaker Ready Room
7:00 am – 6:00 pm
AAPS Registration
8:00 am – 10:00 am
ROUNDTABLES
Clinical Trial Simulations: Many Questions, Few Answers (CPTR/PPDM)
Functionality Testing of Excipients (APQ/PT)
Selection of Efficient Cleaning Validation Strategies (APQ/PT)
AAPS Graduate Student Symposium in Biotechnology
Sponsored by Pfizer Global Biologics
9:00 am – 5:00 pm
AAPS Career Center
Funded by Grants from
10:00 am – 12:00 pm
AAPS Plenary Session
12:00 pm – 1:30 pm
AAPS Luncheon for Graduate Students and Postdoctoral Fellows
Funded by a Grant from
University of Connecticut Alumni Luncheon
University of Texas Alumni Luncheon
12:00 pm – 5:30 pm
AAPS Exposition
12:00 pm – 1:15 pm
HOT TOPIC
Title to be Announced
Speaker(s) to be Announced
12:15 pm – 1:15 pm
FOCUS GROUP MEMBERSHIP MEETINGS
Animal Pharmaceutics and Techology
Bioequivalence and Generic Pharmaceuticals Joint Focus Groups Membership Meeting
Intellectual Property
Ligand Binding Assay Bioanalytical
Lipid-Based Drug Delivery Systems
Manufacturing, Engineering, and Quality
1:00 pm – 5:00 pm
Contributed Papers Poster Session
2:00 pm – 4:00 pm
ROUNDTABLES
Making a Decision on Drug Metabolism Data – Go or No Go (PPDM)
Pediatric Drug Development – Identifying the Needs, Meeting the Challenges (PT)
Preparedness for Question Based Review in Drug Approval – Role of Analytical Chemist (APQ)
2:00 pm – 4:00 pm
STUDENT/POSTDOC OUTREACH AND DEVELOPMENT (SPOD) COMMITTEE ROUNDTABLE
Scientific Research Integrity
2:00 pm – 4:30 pm
SYMPOSIA
In Vitro Release Testing of Dosage Forms Based on Novel Technologies: Developments and Challenges (APQ) (PT)
Monocarboxylate Transporters in Drug Disposition: Characterization, Regulation and Significance (PPDM)
Risk-based CMC Review and Quality Assessment: How Well Is It Working? (RS) (PDD)
Technology Challenges and Risk Analysis of Immunogenicity Assessment on Biologics (BIOTEC)
AAPS/ACCP Joint Symposium
Innovative Opportunities for Early Phase Drug Development
5:00 pm – 6:00 pm
AAPS MEMBERSHIP MEETINGS
Clinical Pharmacology and Translational Research (CPTR)
Biotechnology (BIOTEC)
Drug Design and Delivery (DDD)
Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM)
Regulatory Sciences (RS)
5:00 pm – 6:30 pm
AAPS JOINT MEMBERSHIP MEETINGS & RECEPTIONS
Pharmaceutics & Drug Delivery
Pharmaceutical Technologies
5:00 pm – 7:00 pm
China Pharmaceutical University Alumni and Friends Reception
University of Michigan College of Pharmacy Alumni and Friends Reception
5:00 pm – 7:30 pm
University of North Carolina School of Pharmacy Alumni Reception
5:00 pm – 8:00 pm
University of Washington Department of Pharmaceutics Alumni and Friends Reception
5:10 pm – 6:10 pm
AAPS Analysis & Pharmaceutical Quality (APQ) Section Membership Meeting
5:30 pm – 7:00 pm
University of Cincinnati Alumni Reception
University of Maryland School of Pharmacy Alumni and Friends Reception
6:00 pm – 7:00 pm
University of Tennessee Alumni and Friends Reception
6:00 pm – 7:30 pm
University of Rhode Island College of Pharmacy Alumni Reception
6:15 pm – 7:15 pm
AAPS SECTION RECEPTIONS
Biotechnology (BIOTEC)
Clinical Pharmacology and Translational Research (CPTR)
Drug Design and Discovery (DDD)
Pharmacokinetics, Pharmacodynamics & Drug Metabolism (PPDM)
Regulatory Sciences (RS)
6:30 pm – 7:30 pm
Analysis & Pharmaceutical Quality (APQ) Section Reception
6:30 pm – 9:30 pm
West Virginia University School of Pharmacy Alumni and Friends Dinner
7:00 pm – 9:30 pm
Jadavpur University Overseas Pharmacy Alumni Association Dinner
Tuesday, November 13
Back to Top7:00 am – 8:00 am
Temple University School of Pharmacy Alumni Breakfast
University of Florida College of Pharmacy Alumni Breakfast
7:00 am – 8:15 am
SUNRISE SESSIONS
Dissolution Method Validation and Method Transfer (APQ)
Imaging Technology and Clinical Target Site PK and PD Assessments: Emerging Opportunities and Potential Limitations (CPTR)
Introduction to PAT (PT)
Metabolic and Transporter Drug Interactions: Design and Conduct of Preclinical and Clinical Studies (PPDM)
7:00 am – 8:30 am
University of Kansas Alumni Breakfast
University of Utah Alumni and Friends Breakfast
7:00 am – 4:00 pm
AAPS Press Room
7:00 am – 5:00 pm
AAPS Speaker Ready Room
7:00 am – 5:30 pm
AAPS Registration
8:00 am – 12:00 pm
Contributed Papers Poster Session
8:30 am – 11:00 am
SYMPOSIA
AAPS Graduate Student Symposium in Analysis and Pharmaceutical Quality (APQ)
Sponsored by UCB, Inc.
AAPS Graduate Student Symposium in Drug Delivery and Pharmaceutical Technologies (PDD/PT)
Sponsored by Bristol-Myers Squibb Company
AAPS Graduate Student Symposium in Drug Design and Discovery (DDD)
Sponsored by Bristol-Myers Squibb Company
AAPS Graduate Student Symposium in Pharmacokinetics, Pharmacodynamics, Drug Metabolism and Clinical Sciences (PPDM/CS)
Sponsored by Eli Lilly and Company
Development and Regulatory Challenges for Drug-Device Combination Products (RS)
Pharmaceutical Nanoparticle Drug Delivery Systems (PDD)
Preclinical Safety Evaluation for High Risk Therapeutic Proteins (BIOTEC)
9:00 am – 11:00 am
ROUNDTABLES
Clinical and CMC Regulatory Considerations in Pediatric Drug Development (RS)
Formulation and Stability of Nutraceuticals (PT)
Translational Medicine: The Time is Now (CPTR)
Variability of Ligand Binding Assays Used for PK Protein Drug Bioanalysis – Database Collected as a Follow-up to the 2006 AAPS Crystal City III Workshop (BIOTEC)
9:00 am – 11:00 am
PERSONAL DEVELOPMENT COURSE
Building a Winning Scientific and Technical Team
9:00 am – 5:00 pm
AAPS Career Center
Funded by Grants from
9:30 am – 6:15 pm
AAPS Exposition
11:30 am – 1:30 pm
American Association of Bangladeshi Pharmaceutical Scientists Luncheon
12:00 pm – 1:00 pm
FOCUS GROUP MEMBERSHIP MEETINGS
Drug Metabolism
Drug Transport and Uptake
Excipients
Inhalation Technology
Microdialysis
Modified Release
12:00 pm – 1:15 pm
HOT TOPIC
Imaging Options to Survive in the Drug Development Environment
Co-sponsored with the Society of Non-invasive Imaging in Drug Development (SNIDD)
12:00 pm – 1:15 pm
STUDENT/POSTDOC OUTREACH AND DEVELOPMENT (SPOD) COMMITTEE ROUNDTABLE
Opportunities in Academia – Myths vs. Realities
12:00 pm – 1:30 pm
AAPS Past Presidents’ Luncheon
University of Nebraska Medical Center Department of Pharmaceutical Sciences Alumni Luncheon
University of the Pacific Alumni Luncheon
1:00 pm – 5:00 pm
Contributed Papers Poster Session
2:00 pm – 4:00 pm
ROUNDTABLES
Challenges and Opportunities for Implementation of QbD (RS)
Dispersed Phase Formulations: What It Takes to Take It From Bench Scale to Commercialization Scale (PDD)
Impact of Efflux Transporters in Drug Delivery (PDD)
The Value of Domestic and International Outsourcing (APQ)
2:00 pm – 4:30 pm
SYMPOSIA
Current Issues and Advances in the Determination of Bioequivalence (Statistical Challenges) (PT)
Determination of In Vivo In Vitro Correlations (IVIVC) for Sustained Release (SR) Parenterals (Depo Formulations) (APQ/PDD)
Development of a Clinically Meaningful Immunogenicity Assessment Program (BIOTEC)
Marine Natural Products As Candidates for Clinical Development (DDD)
Role of Enzymes in Toxicity: Reactive Metabolites (PPDM)
Supply Chain Optimization in the Pharmaceutical Industry – Drivers and Challenges (PT)
2:00 pm – 4:30 pm
AAPS Exposition Coctail Reception
Funded by Grants from all AAPS Exhibitors and
4:45 pm – 6:15 pm
POSTER PODIUM
Translational Research (CPTR)
5:00 pm – 6:00 pm
Stability Focus Group Membership Meeting
5:00 pm – 6:30 pm
Duquesne University Alumni and Friends Reception
5:30 pm – 7:30 pm
Rutgers University Alumni and Friends Reception
St. John’s University Alumni Reception
6:00 pm – 7:30 pm
University of Southern California Alumni and Friends Reception
6:00 pm – 8:00 pm
University of Kentucky College of Pharmacy Alumni Reception
Virginia Commonwealth University Department of Pharmaceutics Alumni and Friends Reception
6:00 pm – 11:00 pm
American Chinese Pharmaceutical Association (ACPA) Dinner
7:00 pm - 9:30 pm
Mercer University Alumni Reception
Wednesday, November 14
Back to Top7:00 am – 8:15 am
SUNRISE SESSION
Appropriate Selection of Animal Models and Their Use in Drug Development (PDD)
Assessment of Nasal Drug Delivery in Humans Using Radionuclide Imaging Techniques (DDD)
Evaluation of Selectivity and Specificity of a Ligand Binding Assay for Macromolecules: An Underestimated Challenge (BIOTEC)
Regulatory Relief from PAT and ObD: Does It Truly Exist? (RS)
7:00 am – 8:30 am
Student/Postdoc Outreach and Development (SPOD) Committee
AAPS Mentoring Breakfast
Funded by a Grant from
7:00 am – 4:00 pm
AAPS Press Room
7:00 am – 5:00 pm
AAPS Speaker Ready Room
7:00 am – 5:30 pm
AAPS Registration
8:00 am – 12:00 pm
Contributed Papers Poster Session
8:30 am – 11:00 am
Wednesday Morning Symposia Funded by a Grant from
SYMPOSIA
Adaptive Design for Clinical Trials (BIOTEC) (PDD) (PT)
Current Studies in Xenobiotic Biotransformation and Transport (PPDM)
Design and Conduct of First-in-Human Studies for High Risk Therapeutic Proteins (PPDM)
Evolution of Analytical Methods from Pre-clinical Phase Through Registration-Ensuring Method Performance and Regulatory Compliance (APQ)
New Paradigms in the Field of Chemical Penetration Enhancers (PDD)
Using PAT Effectively (PT)
9:00 am – 11:00 am
ROUNDTABLES
Cost-effective Stability Program to Support Global Supply Chain of Drug Products (APQ)
Impact of Quality by Design on Pharmaceutical and Analytical Development (RS)
Pathophysiology Meets Modeling: Development of Disease Progression Models (CPTR/PPDM)
Toxicity Testing and Qualification of Impurities: How Far is Too Far? (DDD)
9:00 am – 11:00 am
PERSONAL DEVELOPMENT COURSES
Redefining Leadership: What Highly Effective Leaders Do
Hiring and Retention of Key Employees, a Story of Great Management
9:00 am – 5:00 pm
AAPS Career Center
Funded by Grants from
9:30 am – 4:30 pm
AAPS Exposition
12:00 pm – 1:00 pm
FOCUS GROUP MEMBERSHIP MEETINGS
Contract Research Organization
Dermatopharmaceutics
In Vitro Release and Dissolution Testing
Manufacturing, Engineering and Quality
Nutraceutical
Process Analytical Technology
Prodrug
12:00 pm – 1:15 pm
HOT TOPIC
Title to be Announced
HOT TOPIC
Title to be Announced
12:00 pm – 1:30 pm
University of British Columbia Alumni and Friends Luncheon
2:00 pm – 3:00 pm
AAPS Presidential Debate
Topic to be Announced
2:00 pm – 4:00 pm
ROUNDTABLES
Devices Used for Nucleic Acid Delivery – Graduate Student Programming (BIOTEC)
Predicting Metabolism and Toxicity Between Species – Consequences for Human and Veterinary Medicine (PPDM)
Science and Regulation of QbD (PDD)
Tumor-activated Prodrug and Tumor-targeting Technologies ADEPT, GDEPT, and PDEPT to Increase Drug Efficacy and Reduce Drug Toxicity (DDD)
2:00 pm – 4:00 pm
PERSONAL DEVELOPMENT COURSE
Redefining Leadership: What Highly Effective Leaders Do
2:00 pm – 4:30 pm
SYMPOSIA
Advances in Analytical Techniques for Preformulation Support in Pharmaceutical R&D (PT)
Advances in Modeling and Simulation of Drug Absorption to Support Oral Formulation Development (PDD)
Clinical Supplies and their Stability Evaluation – Scientific Insights for Drug Development and Regulatory Expectations in the U.S. and EU (RS)
Osteoporosis and Bone Disorders: A Showcase for Model-based Drug Development (CPTR)
Regulatory Considerations on the Use of Lipid Excipients in Oral an Parenteral Drug Products (PDD)
Transporters in Pathophyiology and Toxicology (PPDM)
Enabling the Drug Development and Delivery Interface (D3I)
5:00 pm – 6:00 pm
Modeling and Simulation & Population PK Joint Focus Group Membership Meeting
Thursday, November 2
Back to Top7:00 am – 8:15 am
SUNRISE SESSIONS
Thursday Sunrise Sessions Funded by a Grant from
Practical LC-MS/MS Method Development Supporting the Drug Development Process (APQ)
The Critical Path to Establishing Equivalence of Advanced Dosage Forms (RS)
Understanding Multivariate Analysis (PDD) (PT)
What Does Food Have to Do With It? (PPDM)
7:00 am – 12:00 pm
AAPS Speaker Ready Room
7:00 am – 2:30 pm
AAPS Registration
8:00 am – 12:00 pm
AAPS Speaker Ready Room
8:00 am – 12:00 pm
Contributed Papers Poster Session
8:30 am – 11:00 am
SYMPOSIA
BCS Class IV Drugs: Develop or Discard? (PDD)
Biomarkers and Metabolic Profiles: Microdialysis Sampling and Analytical Frontiers in Tissue Targeted Metabonomics (APQ)
Evaluation of Pharmaceutical Powder Properties to Ensure Product Quality by Design (PT)
New Frontiers in Inhalation (PT)
Validation of Non-chromatographic Methods (NIRA, Bioanalysis and Particle Size Analysis) (APQ)
POSTER PODIUM
PK/PD Modeling and Simulations in Drug Discovery (PPDM)
9:00 am – 11:00 am
ROUNDTABLES
Biosimilar/Biogenerics: A Review of Regulatory Pathway (RS)
Emerging Pharmaceutical Markets: Are We Afraid of Outsourcing Yet? (APQ)
Keys to a Successful Thorough QTc Trial (CPTR)
Prodrug Approaches for Site-specific Cellular Targets (DDD/PDD)
1:00 pm
Adjournment
1:30 pm – 5:00 pm
APQ OPEN FORUM
Analytical Instrument Qualification: An Update and Current Industry Trends
An additional fee is required to attend this workshop
BIOTEC OPEN FORUM
Practical Biomarker Assay Development, Validation and Sample Results for Drug Exposure – Effect Assessment
An additional fee is required to attend this workshop
CPTR OPEN FORUM
Point/Counterpoint
An additional fee is required to attend this workshop
Topic #1: ‘Individualized’ (PK/PD-Guided) But Not ‘Personalized’ (Pharmacogenetic-Guided) is a Better Approach to Dosing of Medicines Than ‘One-Dose-Fits-All’
Topic #2: Concentrations are Better Than Dose for Predicting Drug Response
PDD OPEN FORUM
Understanding the Impact of FDA’s Quality by Design Initiative on Establishment of Drug Product Specification
An additional fee is required to attend this workshop
PPDM OPEN FORUM
QTc Assessment in Drug Development: Challenges and Novel Approaches
An additional fee is required to attend this workshop
PT OPEN FORUM
Title to be Announced
RS/APQ OPEN FORUM
Clinical Trial Materials – Clinical and CMC Challenges for Successful Conduct of MultiRegional Clinical Trials
An additional fee is required to attend this workshop
AAPS Section Key
APQ: Analysis and Pharmaceutical Quality
BIOTEC: Biotechnology
CPTR: Clinical Pharmacology and Translational Research
DDD: Drug Design and Discovery
PDD: Pharmaceutics and Drug Delivery
PPDM: Pharmacokinetics, Pharmacodynamics and Drug Metabolism
PT: Pharmaceutical Technologies
RS: Regulatory Sciences
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