9th Annual Biomarkers Congress
2008 AAPS Annual Meeting and Exposition
Georgia World Congress Center
285 Andrew Young International Blvd. NW
Atlanta,, GA, USA 30313
http://
2008 AAPS Annual Meeting and Exposition 
American Association of Pharmaceutical Scientists
Georgia World Congress Center
285 Andrew Young International Blvd. NW
Atlanta

Schedule of Presentations:

Saturday, November 15, 2008
07:30:00 Registration
08:00:00 Pre-conference Workshops
08:00:00 aa PS Workshop on Pharmacogenetics in Iindividualized Medicine: Methods, Regulatory and Clinical Aapplications
08:30:00 CRS Workshop on Critical Variables in In Vitro and In Vivo Parenteral Product Performance
08:30:00 aa PS Workshop on Biomarker Aassay Development and Validation: Challenges and Creative Solutions Aassociated with Emerging Biomarker Aassays
08:30:00 2008 AAPS Executive Council Meeting
14:00:00 AAPS Speaker Ready Room
Sunday, November 16, 2008
07:00:00 AAPS Speaker Ready Room
07:00:00 AAPS Registration
08:00:00 Pre-conference Workshops
08:00:00 AAPS Press Room
08:30:00 Short Courses
08:30:00 aa PS Workshop on Biomarker Aassay Development and Validation: Challenges and Creative Solutions Aassociate with Emerging Biomarker Aassays
08:30:00 Short Course #1
08:30:00 CRS Workshop on Critical Variables in In Vitro and In Vivo Parenteral Product Performance
08:35:00 Short Course #2
08:40:00 Short Course #3
08:45:00 Short Course #4
08:55:00 Short Course #5
09:00:00 Short Course #6
12:00:00 Short Course Luncheon
13:00:00 Open Forum
16:30:00 AAPS Opening Session William E Evans, Jessica Melore
19:00:00 AAPS Welcome Reception
Monday, November 17, 2008
07:00:00 AAPS Registration
07:00:00 AAPS Press Room
07:00:00 AAPS Speaker Ready Room
08:00:00 Monday Morning Roundtables
10:00:00 Presentation Title to be Determined Gregory L. Kearns
11:00:00 Searching for Genomic Biomarkers of Drug Risk in Children Bruce Carleton
12:00:00 AAPS Exposition and Career Center
12:00:00 Hot Topic-Pediatric Investigation Plans (PIPS)
13:00:00 AAPS Contributed Papers Poster Session
13:30:00 Monday Afternoon Professional Development
14:00:00 Approaches to First-in-Human Formulation Development (FDD & PPB)
14:00:00 Student/PostDoc Outreach and Development (SPOD) Committee Roundtable
14:00:00 Critical Versus Non-critical – Classification in the Absence of a Biorelevant Method (RS)
14:00:00 Monday Afternoon Roundtables
14:00:00 Publishing and Maintaining Scientific Rigor in an Industrial Research Position in the Pharmaceutical Industry
14:30:00 PATability of Excipients (FDD, MSE & PPB)
14:50:00 Leachables and Extractables in Solid Dosage Forms (APQ)
15:00:00 Why Absorption and Pharmacokinetic Models Are More Important in Future Drug Development (PPB & CPTR)
15:05:00 The Exubera Case – Is There a Chance for Biopharmaceuticals for Inhalation? (BIOTEC)
15:20:00 Application of Bio-relevant USP IV Dissolution Method in Pharmaceutical Development (APQ)
15:25:00 Green Pharmaceutical Sciences (DDD)
15:30:00 Particle Size Analysis and Specification of Pharmaceutical Powders (FDD, PPB & MSE)
15:30:00 siRNA’s as Pharmacological Tools and Therapeutic Agents: Challenges and Opportunities (PPDM)
17:00:00 Biotechnology (BIOTEC) Section
17:00:00 AAPS Joint Membership Meetings and Receptions
17:00:00 AAPS Membership Meetings
17:00:00 Clinical Pharmacology and Translational Research (CPTR) Section
17:00:00 Regulatory Sciences (RS) Section
17:10:00 Formulation Design & Development (FDD) Section
17:10:00 Analysis and Pharmaceutical Quality (APQ) Section
17:30:00 Drug Design and Discovery (DDD) Section
17:30:00 Manufacturing Science & Engineering (MSE) Section
18:00:00 Physical Pharmacy and Biopharmaceutics (PPB) Section
18:15:00 AAPS Section Receptions
18:15:00 Clinical Pharmacology and Translational Research (CPTR) Section
18:30:00 Analysis and Pharmaceutical Quality (APQ) Section
19:00:00 Drug Design and Discovery (DDD) Section
Tuesday, November 18, 2008
07:00:00 Clinical Applications of Pharmacogenetics (CPTR)
07:00:00 AAPS Speaker Ready Room
07:00:00 AAPS Registration
07:00:00 AAPS Press Room
07:15:00 The ABC’s of Drug Master Files (RS)
07:30:00 Rational Drug and Prodrug Design via Computational Modeling (DDD)
07:35:00 PK/PD of Biologics: From Discovery to Successful Development (PPDM)
07:40:00 Quality Agreements (MSE)
08:00:00 Contributed Papers Poster Session
08:00:00 Application of Design of Experiments to Analytical Method Development (APQ)
08:30:00 AAPS Graduate Student Symposium in Analysis and Pharmaceutical Quality (APQ)
08:30:00 Drug Discovery and Drug Developability for Lead Optimization (PPB)
09:00:00 Tuesday Morning Roundtables
09:00:00 Tuesday Morning Roundtables
09:00:00 Diabetes Disease Progression Modeling (CPTR)
09:00:00 AAPS Graduate Student Symposium in Drug Delivery and Pharmaceutical Technologies (PDD & PT)
09:00:00 Biosimilars/Follow-on-Proteins: The Latest Regulatory Position in the U.S. and E.U. (BIOTEC & RS)
09:30:00 AAPS Exposition and Career Center
09:30:00 AAPS Graduate Student Symposium in Drug Design and Discovery (DDD)
09:50:00 AAPS Graduate Student Symposium in Drug Delivery and Pharmaceutical Technologies (PDD & PT)
10:00:00 AAPS Graduate Student Symposium in Pharmacokinetics, Pharmacodynamics, and Clinical Pharmacology and Translational Research (PPDM & CPTR)
10:10:00 Need for New Product Development Model in Generic Pharmaceutical Industry: Science vs. First to File Opportunities (FDD & MSE)
10:30:00 Emerging Technologies: Liquid Fill Hard Capsule Technology in the Pharmaceutical Industry (FDD & MSE)
10:30:00 Regulatory Challenges and Perspectives of Handling Impurities Not Covered by ICH Q3A and Q3B (APQ & RS)
12:00:00 How Safe is Your Global Pharmaceutical Supply Source? Quality and Regulatory Perspectives Based on Recent Glycerin and Heparin Events
12:00:00 Student/PostDoc Outreach and Development (SPOD) Committee Roundtable
13:00:00 Contributed Papers Poster Session
13:30:00 The Seven C’s of Leadership
13:30:00 Tuesday Morning Professional Development
13:30:00 Tuesday Morning Professional Development
14:00:00 Searching for the New Technologies for Immunogenicity Testing: Life After Demise of an ECL-based Assay Platform (BIOTEC)
14:00:00 Technologies and Science Behind Enhancing Bio-availabilities of Poorly Soluble Compounds (APQ)
14:30:00 Quantitative Clinical Pharmacology Analyses: Communicating to Influence Decisions (CPTR)
14:30:00 Sigma Receptors: Viable Therapeutic Targets for Medication Development (DDD)
14:45:00 25th Anniversary of Pharmaceutical Research: Impact on Drug Development and Roadmap to Future Innovations (PPM & MSE)
15:00:00 Food Effect or No Food Effect: From Bench Findings to Reality (FDD & PPB)
15:00:00 Emerging Technologies for Development of Oral Delivery Systems (FDD)
15:15:00 In Silico/In Vitro Models for Compound Profiling (PPDM)
16:00:00 The Next Generation of Antibodies? Engineered Antibody Fragments (BIOTEC)
16:00:00 Challenges in Developing Inhalation and Nasal Products: Linking to Quality by Design (FDD & MSE)
16:45:00 Bars funded by the 2008 AAPS Annual Meeting Exhibitors
17:30:00 AAPS Joint Membership Meeting and Reception
17:30:00 Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) Section
19:00:00 Controversies in PK/PD Model Development (CPTR)
19:00:00 Open Forum
20:10:00 Dinner served
21:05:00 End of the day
21:30:00 Announcements
Wednesday, November 19, 2008
07:00:00 AAPS Speaker Ready Room
07:00:00 AAPS Registration
07:00:00 Root Cause Analysis During Out of Specification Investigation: A Step-by-Step Procedure (APQ)
07:00:00 AAPS Press Room
07:00:00 Student/Postdoc Outreach and Development (SPOD) Committee
07:15:00 Generic Biologics – What you Always Wanted to Know but Were Afraid to Ask (RS)
07:45:00 Tumor Imaging and Targeted Drug Delivery (FDD & PPB)
08:00:00 Green Pharmaceutical Sciences: An Overview (DDD)
08:00:00 Contributed Papers Poster Session
08:05:00 Accurate Prediction of Metabolic DDI – From Preclinical Discovery to Clinical Development (PPDM)
08:10:00 A Patent Primer for Pharmaceutical Scientists (RS)
08:30:00 Parenteral Controlled Release Invited Poster-Podium Session (FDD)
08:45:00 IVIVC/R for Solid Oral Dosage Forms: Objectives and Challenges (APQ)
09:00:00 Incurred Sample Analysis: Experiencing the Workshop in 2008 (APQ & BIOTEC)
09:05:00 Challenges and Opportunities in the Implementation of PAT and Real-time Release in the Pharmaceutical Industry (RS)
09:05:00 The World Within and Beyond P-gp: Do We Underestimate or Overestimate P-gp? (PPB)
09:10:00 Drug Substance and Drug Product Interface: A Critical Step Toward Quality by Design for Pharmaceutical Products (FDD, PPB & MSE)
09:30:00 AAPS Exposition and AAPS Career Center
09:45:00 Outsourcing Drug Product Development to India and China (MSE)
10:30:00 Changing Models of Drug Development (DDD)
10:40:00 Structure-activity Relationship (SAR) in ABC Transporters (PPDM)
12:00:00 The Impact of Pharmaceutical Residues in the Environment
13:00:00 Contributed Papers Poster Session
13:30:00 The Seven C’s of Leadership
14:00:00 Oral Absorption/Transporter/Metabolism Focus Groups (PPDM)
14:00:00 Pharmaceutical and Biotech Products in the Race to Cure Cancer (AAPS/PSJ Joint Symposium)
14:00:00 Human Pharmacokinetics and Efficacious Dose Prediction from Preclinical Species Data: Approaches, Successes, and Challenges (PPDM)
14:00:00 Outsourcing – Mechanisms and Case Studies for Development and Manufacturing at a Contract Facility (MSE)
14:30:00 CMC Aspects of First-in-Human Studies with Biopharmaceuticals (BIOTEC)
15:00:00 The Impact of Kidney Disease/Renal Impairment on Drug Metabolism and Transport (CPTR)
15:00:00 Combination Products – Scientific and Regulatory Challenges (FDD, MSE, PPM & RS)
15:00:00 In Vitro Bioequivalence Testing for Aerosol Products: From Today to Tomorrow (FDD)
15:05:00 Development and Maintaining a Biomarker Monitoring Program (APQ)
15:45:00 Transporters as Prodrug Carriers for Oral Drug Delivery (FDD & PPB)
16:15:00 High Energy Solids for Delivering Poorly Water-soluble Drugs: Opportunities and Challenges (FDD & PPB)
16:35:00 End of the day
16:35:00 Announcements
Thursday, November 20, 2008
07:00:00 Check-In
07:00:00 Dealing with Contamination and Carry Over in Analytical Research (APQ)
07:00:00 AAPS Press Room
07:00:00 AAPS Speaker Ready Room
07:00:00 AAPS Registration
07:15:00 Introduction to Quality Systems (RS)
07:30:00 Analytical Method Development Based on QbD Principles (APQ)
07:45:00 Organic Cation Transporter Family: From Discovery to Clinical Impact (PPDM)
08:00:00 Biomarkers of Local Drug Delivery from Pulmonary Drug Products (FDD & PPB)
08:00:00 Contributed Papers Poster Session
08:10:00 Pharmaceutical Co-crystals (PPB)
08:30:00 BDDCS – At the Beginning of a New Era (PPDM)
09:00:00 Particle Formation in Protein Therapeutics: Mechanisms & Characterization (BIOTEC)
09:00:00 Prodrug Approaches for Organ Specific Targeted Therapy (DDD)
09:10:00 Celebrating the Nanotechnology R&D Act: Then, Now and the Future (CPTR, FDD, MSE & PPB)
09:30:00 Simultaneous Global Regulatory Submissions (RS)
09:30:00 In Vitro Oral Drug Transport Data: Approaches to Data Analysis and Modeling (PPB)
10:00:00 Effective Interactions from preIND to IND and Beyond: “Getting your Ducks in the Row” with the FDA (PPDM & RS)
10:15:00 Quality by Design and its Role in Developing Analytical Methods (APQ & RS)
10:35:00 Advancing Technologies in Nutraceutical Research (FDD, MSE & PPB)
10:45:00 Quality by Design: Defining Clinically Relevant Design Goals (MSE)
11:00:00 2008 AAPS Annual Meeting Adjournment
13:30:00 An additional fee is required to attend open forums
14:05:00 Application of Principles of QbD to Analytical Methodologies, Specification and Control Strategies (APQ)
14:45:00 An additional fee is required to attend this open forum
15:05:00 Particle and Powder Technologies for Solid Dosage (FDD, MSE & PPB)
15:30:00 Real-time Adaptive Early Clinical Development – An Open Debate on Pharmaceutical, Clinical and Regulatory Challenges (PPDM)
16:05:00 An additional fee is required to attend this open forum
16:10:00 An additional fee is required to attend this open forum
16:15:00 Establishment and Maintenance of Design Space (RS)
17:00:00 End of the day
17:05:00 Announcements
4th Annual Pharma R&D Asia Congress
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