Preliminary Program Topics
Analysis and Pharmaceutical Quality
- A Close Look at Subdivisible Particle in Protein Therapeutics
- Affinity-based Media: Analytical Aspects and Applications
- Analytical Instrument Qualification: Towards Globalization
- Antibody Interference in Biological Methods
- Bioanalytical Procedures and Regulations: Towards Global Harmonization
- Bridging the Gap Between Traditional Medicine and the Western Approach to Natural Products
- Developments in Technologies for Process Related Impurities Detection and Identification for Biologics
- Dissolution Testing: Relevance in a Quality-by design Approach to Drug Release?
- Dried Blood Spot Analysis and Novel Sample Preparation
- Excipients for Protein Drugs Revisited
- Genotoxic and Carcinogenic Impurities: Control and Regulation
- GMP Training and ICHQ8-Q11
- High pH Mobile Phase (LC-MS/MS) to Optimize Analytical Sensitivity
- ICH Guidelines Q8, Q9, Q10, Q11: How Do They All Fit Together?
- In Vitro Release of Drugs from Non-oral Dosage Forms
- Neutralizing Antibodies: Alternatives to Cell-based Assays
- Non-clinical Dose Formulations: Time for Regulatory Guidance?
- Quality Assurance of Medicines: the Detection of Counterfeits and Adulterants
- Single Cell Analyses for Accelerating Drug Discovery and Diagnosis
- Stability Testing in Pharmaceutical Development
- Standards for Essential Drugs
Biotechnology
- A Close Look at Subdivisible Particle in Protein Therapeutics
- Antibody Interference in Biological Methods
- Biosimilars and Follow-on Biologics: A Global Perspective
- Customized Vaccines for the Future
- Cutting Edge in Vaccine Delivery
- Developments in Technologies for Process Related Impurities Detection and Identification for Biologics
- Excipients for Protein Drugs Revisited
- Immune Response to Biotechnology Products
- Neutralizing Antibodies: Alternatives to Cell-based Assays
- New Challenges in Biologics Development: Understanding and Mitigating Uncommon Protein Degradation Pathways
- New Molecular Targets-based Anti-cancer Drugs: from Small Molecules to Antibodies
- PEGylated Proteins: Analytical and Pharmacokinetic Issues
- Preservatives in Parenteral Products
- siRNA Delivery: Challenges and Opportunities
- The Revival of Synthetic Peptides and Small Proteins in Biopharmaceuticals
Clinical Pharmacology and Translational Research
- Genomics Issues and Solutions in Oncology, Drug Discovery and Development
- How Predictive of Clinical Efficacy are Animal Models?
- Mechanistic Pharmacokinetic/Pharmacodynamic Modeling
- Metabolomics in Pharmaceutical Development
- Molecular Imaging Technologies for ADME-Tox Studies
- Nanotechnology: Clinical Aspects
- Pediatric Drug Formulation and Development: A Learning Curve for Grown-up Scientists and Regulators
- Personalized Medicine – Integrated Technologies
- Pharmacogenetics – a Testing Issue
- Pharmacogenetics – Educating the Doctor, the Pharmacist and the Patient
- Pharmacogenetics – Found in Translation I?
- Pharmacogenetics – Found in Translation II?
- Pharmacogenomics: Current Status in Drug Development and Clinical Translation
- Phase 0 Pharmacodynamics Trials in Oncology – a Paradigm Shift in Drug Development?
- Placental ABC Transporters – Impact on Drug/ Xenobiotic Disposition and Toxicity
- Predicting Clinical Outcome from Biomarker Progression
- Progress in Modeling Disease Progression
- The Art and Science of Model Evaluation
- Traditional Medicines in a New Paradigm of Global Health
- Translation of Pharmaceutical Science to Practice
- Transport Proteins III: Clinical Relevance and Applications
- What do Industry and Regulators Need from Imaging?
Drug Design and Discovery/Medicinal Chemistry and Natural Products
- Bridging the Gap Between Traditional Medicine and the Western Approaches to Natural Products
- Current Status of Oligonucleotide Chemistry and Application
- Enzyme Directed Prodrug Activation
- Genomics Issues and Solutions in Oncology, Drug Discovery and Development
- Individualizing (Small Molecule) Drugs: From Subtype Specificity to Multi-target Design and Metabolic Network Strategies
- Natural Products: Interface Between Science and Practice
- Nature’s Chemical Diversity: Science and Practice
- New Molecular Targets-based Anti-cancer Drugs: from Small Molecules to Antibodies
- New Molecular Targets for Drug Discovery
- New Synthetic Technology in Drug Development?
- Nuclear Receptors: Important New Players in Pharmacology
- Pharmaceutical Challenges to Alzheimer’s Disease
- Rational Drug Design and Discovery via Computational Modeling
- Recent Advances in Natural Products
- The Revival of Synthetic Peptides and Small Proteins in Biopharmaceuticals
- Traditional Medicines in a New Paradigm of Global Health
- Single Cell Analyses for Accelerating Drug Discovery and Diagnosis
- siRNA Delivery: Challenges and Opportunities
Education
- Development and Evaluation of Academic Curriculum and Clinical Clerkship for Modern Pharmaceutical Education
- Pharmacogenetics – Educating the Doctor, the Pharmacist and the Patient
- Safety Sciences – Education and Training
- Sharing Global Best Practice in Educating Pharmaceutical Scientists
Environmental Sciences
- Pharmaceutical Waste and Environmental Pollution
Formulation Design and Development
- BCS/BDDCS Based Strategies for Oral Drug Development
- Can Nanoparticles be Simultaneously used for Multimodality Imaging and Targeted Drug Delivery?
- Computer-aided Drug Development: A Rational Approach to Improve the Speed and Reduce the Cost
- Delivery of Poorly Soluble Drugs: Evolving Science and Technology
- Dissolution Testing: Relevance in a Quality-by design Approach to Drug Release?
- Formulation Stability: Science and Regulation
- Helping the Medicine Go Down – Pediatric Medicines: Formulation, Manufacturing and Compliance Challenges
- Improving Oral Absorption of Compounds Using High Energy Forms: Evaluation of Physical Stability
- Improving Pulmonary Delivery of Drugs and Biologics
- In Vitro Release of Drugs from Non-oral Dosage Forms
- Intelligent Pharmaceutical Product Design and Processing Using Data Mining Methods Lipid-based Drug Delivery Systems
- Molecular Imaging Technologies for ADME-Tox Studies
- Nanoparticles from A to Z – Achievement in Drug Delivery & Tissue Engineering
- Nanoparticulate Drug Delivery Systems: Fundamentals
- Nanotechnology: Clinical Aspects
- Nutraceuticals – Quality by Design
- Nose to Brain – Reality or Blowing Smoke?
- Novel Drug Delivery Systems: Definition of New Excipients
- Pediatric Drug Formulation and Development: A Learning Curve for Grown-up Scientists and Regulators
- Preservatives in Parenteral Products
- Reactive Impurities in Excipients – Characterization and Stabilization Strategies
- The Science of Freezing: Control, Excipients, Storage and Freeze-drying
- Treating Blindness in the Developing World
- Solid State Forms of Drugs and Intellectual Property
- Stability Testing in Pharmaceutical Development
Global Health
- Bridging the Gap Between Traditional Medicine and the Western Approach to Natural Products
- Development of effective Fixed Dose Combination Therapies for Global Diseases: Recent Successes and Advances
- Impact of the Pharmaceutical Sciences
- Pharmaceuticals Without Borders I: Developing and Delivering Medicines to Underserved Populations
- Pharmaceuticals without Borders II: The Regulatory and Supply Chain Challenges of Providing Medicines to Emerging Markets
- Pharmaceuticals Without Borders III: Ensuring the Integrity and Quality of Medicines Reaching the Patient
- Treating Blindness in the Developing World
Manufacturing Science & Engineering
- Continuous Manufacturing: Benefits and Challenges
- Graduate Student Symposium in Formulation, Design & Development (FDD), Manufacturing Science & Engineering (MSE) and Physical Pharmacy & Biopharmaceutics (PPB)
- Helping the Medicine Go Down - Pediatric Medicines: Formulation, Manufacturing and Compliance Challenges
- Imaging Technology for Understanding Process in Pharmaceutical Manufacturing
- Intelligent Pharmaceutical Product Design and Processing Using Data Mining Methods
- Lipid-based Drug Delivery Systems
- Nanocrystals: Production, Stability and Applications
- Nutraceuticals: Quality by Design
- Particles in Biopharmaceutical Parenteral Products
- Real-time Release: Are We There Yet?
- Sharing Global Best Practices in Educating Pharmaceutical Scientists
- Stability Testing in Pharmaceutical Development
- Technology Transfer and Process Validation in the Context of QbD
- The Science of Freezing: Control, Excipients, Storage and Freeze-drying
Pharmacokinetics, Pharmacodynamics and Drug Metabolism
- BCS and BDDCS Based Strategies for Oral Drug Development
- Drug-drug Interactions: Are they Predictable?
- Ethnic Sensitivity in PK/PD: Leveraging Clinical Development in Emerging Countries - Using Knowledge of Ethnic Differences to Facilitate Drug Development
- Fractal Pharmacokinetics and Non-linear Dynamics
- Graduate Student Symposium in Pharmacokinetics, Pharmacodynamics & Drug Metabolism (PPDM) and Clinical Pharmacology & Translational Research (CPTR)
- How Predictive are Animal Models of Clinical Efficacy?
- Implementation of Dried Blood Spot (DBS) Sampling in Regulated Bioanalysis
- Inflammation and Stress Signaling
- Is the Cocktail Approach Useful in the Assessment of Drug-drug Interactions?
- Mechanistic PK/PD Modeling
- Metabolomics in Pharmaceutical Development
- Molecular Imaging Technologies for ADME: Tox Studies
- Nose to Brain Delivery: Reality or Just Blowing Smoke?
- Ocular Drug Delivery
- Pediatric Drug Development: A Learning Curve for Grownup Scientists and Regulators
- PEGylated Proteins: Analytical and Pharmacokinetic Issues
- Penetrating the Brain
- Personalized Medicine: Integrated Technologies
- Pharmacogenetics: A Testing Issue
- Pharmacogenetics: Educating the Doctor, the Pharmacist and the Patient
- Pharmacogenetics: Found in Translation?
- Pharmacogenetics: Translational Aspects
- Phase 0 Pharmacodynamics Trials in Oncology – a Paradigm Shift in Drug Development?
- PK: Bottom-up, Top-down, or Both?
- Placental ABC Transporters: Impact on Drug/Xenobiotic Disposition and Toxicity
- Prediction of Human Oral Pharmacokinetic Profiles from Preclinical and In Vitro Data
- Progress in Modeling Disease Progression
- Systems Approaches to Adverse Drug Reactions
- Transport Proteins I: Regulatory Mechanisms that Modulate Drug Disposition and Response
- The Art and Science of Model Evaluation
- The Gut Wall as a Metabolic Barrier to Drug Development
- Transporter Proteins II: How to Scale In Vitro Data on Human Transporters to Predict In Vivo Outcome?
- Transporter Proteins III: Clinical Relevance and Applications
Pharmacology and Biochemistry
- Immune Response to Biotechnology Products
- Individualizing (Small Molecule) Drugs: From Subtype Specificity to Multi Target Design and Metabolic Network Strategies
- Inflammation and Stress Signaling
- Mechanistic PK/PD Modeling
- New Molecular Targets for Drug Discovery
- Nuclear Receptors: Important New Players in Pharmacology
- Personalized Medicine: Integrated Technologies
- Transport Proteins I: Regulatory Mechanisms that Modulate Drug Disposition and Response
Physical Pharmacy & Biopharmaceutics
- Can Nanoparticles Be Simultaneously Used for Multimodality Imaging and Targeted Drug Delivery?
- Computer-aided Drug Development: A Rational Approach to Improve Speed and Reduce the Cost
- Delivery of Poorly Soluble Drugs: Evolving Science and Technology
- Development of Effective Fixed Dose Combination Therapies for Global Diseases: Recent Successes and Advances
- Graduate Research Symposium in Formulation, Design & Development (FDD), Manufacturing Science & Engineering (MSE) and Physical Pharmacy & Biopharmaceutics (PPB)
- Globalization of Pharmaceutical Regulations in U.S., EU and China
- Imaging Technology for Understanding Process in Pharmaceutical Manufacturing
- Improved Pulmonary Delivery of Drugs and Biologics
- Improving Oral Absorption of Compounds Using High Energy Forms: Evaluation of Physical Stability
- Integrating Dissolution Testing with Permeability to Predict Product Performance
- In Vitro Release of Drugs from Non-oral Dosage Forms
- Lipid-based Drug Delivery Systems
- Molecular Imaging Technologies for ADME: Tox Studies
- Nanocrystals: Production, Stability and Applications
- Nanoparticulate Drug Delivery Systems: Fundamentals
- Nanotechnology from A – Z: Achievement in Drug Delivery and Tissue Engineering
- New Frontiers in Biologics Development: Understanding and Mitigating Uncommon Protein Degradation Pathways
- Novel Drug Delivery Systems: Definition of New Excipients
- Ocular Drug Delivery
- Pharmaceutical Stability: Science and Regulation
- Reactive Impurities in Excipients: Characterization and Stabilization Strategies
- Solid State Forms of Drugs and Intellectual Property
- The BCS, BDDCS and Regulatory Guidances
- The Gut Wall as a Metabolic Barrier to Drug Development
- The Science of Freezing: Control, Excipients, Storage and Freeze-drying
Regulatory Sciences
- Bioanalytical Procedures and Regulation: Towards Global Harmonization
- Biosimilars and Follow-on Biologics: A Global Perspective
- Developments in Technologies for Process Related Impurities Detection and Identification for Biologics
- Establishing Clinically Relevant Dissolution Specifications In the Quality-by-Design World: Practical Implications and Regulatory Challenges
- Enhancing the Development Pipeline: Strategies for Repurposing, Fixed-Dose Combinations, 505(b)(2) Filings, and Patent Protection
- Evaluating Medicines in the European Union
- Genotoxic and Carcinogenic Impurities: Control and Regulation
- Helping the Medicine Go Down - Pediatric Medicines: Formulation, Manufacturing and Compliance Challenges
- ICH Guidelines Q8, Q9 Q10 and Q11: How Do They all Fit Together?
- Non-clinical Dose Formulation: Time for Regulatory Guidance?
- Pharmaceutical Stability: Science and Regulation
- Quality Assurance of Medicines: the Detection of Counterfeits and Adulterants
- Risk Management Planning: An Essential Component of Pharmacovigilance
- Similarities and Differences in Global Safety Regulation
- Solid State Forms of Drugs and Intellectual Property
- Technology Transfer and Process Validation in the Context of QbD
- The Globalization of Pharmaceutical Regulation?
- What Do Industry and Regulators Need from Imaging?
Safety Sciences
- Pharmaceutical Waste and Environmental Pollution
- Quality Assurance of Medicines: The Detection of Counterfeits and Adulterants
- Risk Management Planning: An Essential Component of Pharmacovigilance
- Safety Sciences: Education and Training
- Similarities and Differences in Global Safety Regulation
- Systems Approaches to Adverse Drug Reactions