Program Agenda
Monday, September 19
Please visit the Continuing Education Course page for descriptions.
AM Courses: 08:00–12:00
- AM1: Intermediate Cardiovascular
- AM2: Study Design—Considerations for Balancing the Scientific, Economic, and Regulatory Equation
- AM3: Supplemental Safety Pharmacology Studies
- AM4: Microsampling Techniques and Novel Applications in Exposure Assessment
Lunch Time Mini Course: 12:30–13:30
- PM9: Case Studies—The Journey from PreClinical to Clinical
PM Courses: 14:00–18:00
- PM5: Drug Abuse Liability Testing
- PM6: ECG Interpretation
- PM7: Principles of Best Practice: How Will You Know When You Get There?
- PM8: Safety Pharmacology Endpoints: Integration into Toxicology Studies
18:00–19:00
- Welcome Reception and Exhibition Opening, Congress Innsbruck
Tuesday, September 20
Keynote: Assessment of Nephrotoxicity—What We Know and What We Still Need to Know!
Professor W. Pfaller, Innsbruck Medical University, Innsbruck, Austria
*Annual Business Meeting*
Morning Sessions: 10:30–12:00
Track A: Bridging Safety Assessment between Academia, Regulators, and Industry
- IMI: Academia-Industry Interface
- Safety Assesment: The Regulators Perspective
- Safety Assessment in An Academic Setting
Track B: Applied Technology—In Silico: Science in the IT Age
- The Use of In Silico Technology to Predict Secondary Pharmacology Effects During High Throughput Screening of Compounds
- The Use of In Silico Technology in Cardiovascular Safety: Modeling of Action Potentials
- Company Data Warehouses—How Useful are they for Predicting Safety?
Track C: Translation—Impact of Early Screens in Safety Strategy: Biomarkers
- Decision-Making Process
- Predicting the Clinical Safety of the Sodium Channel Late Current Blocker Ranolazine from Preclinical Studies: No Loss in Translation
- Reverse Translation: Man to Preclinical Biomarkers (Renal and Hepatotoxicity)
*Lunch Break, Poster Viewing, and Networking*
*Poster Judging*
*Invited Oral Communications 1–3*
*Networking and Poster Viewing*
Afternoon Sessions: 16:00–18:00
Track A: Integrating Safety Pharmacology in Toxicology
- To Implant or Not To Implant: What Are the Long-term Implications of Implants
- Long-term Implication of Implanted Telemetry Devices in Dogs
- When and How to Integrate Telemetry in Toxicology Studies
- Integrating Safety Pharmacology End Points in Rodent Toxicology Studies—“The How”
Track B: Applied Technology-Biomimetic Microsystems and Cellular Technologies: Potential Utility in Predicting Safety
- Biomimetic Microsystems Technologies: Organs-on-Chips for Safety Evaluation
- Screening for Cardiac Liabilities of Drug Candidates in Human iPSC—cardiomyocytes using MEA and xCelligenece Cardio
- Advances in the Assessment of Acute/Long-term and Repeated Dose Inhalation Toxicity In Vitro
- Primary Hepatocytes in Hanging Droplets: Towards a Functional 3-D Microtissue Amendable to Toxicity Assays
Track C: Translation- Non-CV Adverse Effects
- Preclinical Assessment of Proconvulsive Drug Activity and its Relevance for Predicting Adverse Events in Humans
- Use of EEG in the Preclinical Assessment of Seizure Risk: A Regulatory Perspective
- Stress Endocrinology
- Respiratory Safety Concerns
Wednesday, September 21
Morning Sessions: 08:30–10:00
Track A: Bridging Safety Assessment between Academia, Regulators, and Industry
- Systems Pharmacology: As Important Dimension for Future Safety Assessment
- Human Tissue Approaches for Studying Drug Safety—Challenges and Opportunities
- miRNA and Cardiotoxicity
Track B: Other Perspectives of Arrhythmia Detection
- U.S. FDA Perspective: Case Study—Ranolazine
- Pharma Perspective: In Vitro/Vivo Proarrythmia Models Used by the Industry
- Other Parameters of Proarrhythmia Risk
Track C: Translation—Practical Implications of Chronopharmacology
- Cardiovascular Clinical Chronopharmacology: The Ticking of the Biological Clock
- Implications of Chronopharmacology in the Elderly Patients
- Safe Cancer Chronotherapy: A Critical Determinant of Antitumor Efficacy
Track A: Applied Technology—Additional Safety Information to Be Gained from Safety Pharmacology Studies
- The Benefits of Synchronized EEG and Video Recording
- Acute Drug-Induced Kidney Injury: Use of Biomarkers in a Safety Pharmacology Setting
- The Use of VP Loops as a Measure of Contractility
Track B: Applied Technology—The Early Detection of Impending Sudden Death
- Strategy for Assessing the Role of Acute Organ Failure in Drug-induced Sudden Death
- The Electro-Mechanical Window as a TdP Risk-Marker following Iks-blockade in Different Species
- Ex Vivo Pro-arrhythmic Investigations in Göttingen Minipig Hearts—Comparison to Other Models
Track C: Translation—Consortia Updates
- Conscious Dog Cardiovascular Telemetry Predictive Value to Man as Defined by the Animal Model Framework
- Translation of Drug-Induced QTc Interval Prolongation from Early Discovery to Clinical Development
- HESI Pro-Arrhythmia Project
*Lunch Break, Poster Viewing, and Networking*
*Invited Oral Communications 4–6*
*Networking and Poster Viewing*
Special Session: Environmental Pharmacology
- Safety Assessment of Residues of Veterinary Medicinal Products in Foodstuffs of Animal Origin
- Diclofenac Related Decline in Southasian Vulture Populations—Facts and Options
Afternoon Sessions: 16:00–18:00
Track A: Best Practice in Safety Pharmacology
- Best Practice Consortia Update
- Best Regulatory Practice in Safety Pharmacology
- Raising the Bar of Best Practices—Due Diligence and the Implications of Poor Safety Pharmacology Data
- Pharmacological Mechanism-Based Safety Prediction
Track B: Applied Technology—Sleep Disorders: From Technological Advances to Market
- Technical Advances Involved in the Evaluation of Sleep/Walk Cycle and Data Analysis
- The Importance of Using the Right Technology for the Right Species When Evaluating the Sleep/Wake Cycle
- Sleep Wake EEG—A Clinical /Transitional Point of View
- Developing a Compound for Sleep Disorders—A Case Study
Track C: Translation—In Vitro Safety Profiling Strategies
- Identification of Risk, and Mitigation of Risk: From In Vitro Results to In Vivo
- Case Study: Just How Much In Vitro Information Do We Consider?
- In Vitro, In Vivo Relationships for Drug Induced Phospholipidosis: Mechanistic Insights and Case Studies
- Translating In Vitro Mitochondrial Toxicity to Predict Cardiovascular Safety
Thursday, September 22
Morning Sessions: 08:15–10:15
Track A: Advanced Therapeutic Medicinal Products Safety of Cell Therapeutics
- Preclinical Considerations in the Development of Stem Cells as Medicinal Products
- Regulator’s View
- Industry Case Story: Stem Cell-based Therapies for the Treatment of Cardiovascular Diseases
- Stem Cell Imaging
Track C: Translation—Better Clinical Predictions Using Better Preclinical Models
- The Fantasies and Realities of Diabetes and Diabetologists
- Cardiovascular Safety Assessment for Diabetic Therapeutics
- Safety Pharmacology Support of Paediatric Clinical Development
*Awards Ceremony and Distinguished Service Award Presentation*
Plenary: Value of Safety Pharmacology/What the Future Holds
*Lunch Break*
Special Session—Safety Pharmacology in a Fiscally-Constrained Environment: How are safety pharmacologists and the Safety Pharmacology Society to respond?
There continues to be intense pressure on the pharmaceutical industry to do things in new, more effective and cost-efficient ways whilst safety hurdles continue to rise. New strategies, enabled by new technologies, are emerging such as incorporating safety pharmacology endpoints into longer term toxicology studies. Many of these new technologies and trends will be discussed in the main sessions of the annual meeting. Alongside this, the balance of where safety studies are conducted continues to shift and 2011 has already brought a closure for two large European safety pharmacology groups. There are also blossoming safety pharmacology groups across Asia.
Large pharma companies are not the major source of compounds entering first in human studies—many compounds emerge from smaller companies who either take them all the way through development or partner with other companies later in the process. Against all this backdrop, how should the safety pharmacology discipline, safety pharmacologists, and the Safety Pharmacology Society respond? In this afternoon summit opinion leaders will offer their thoughts, but come prepared to discuss what the safety pharmacologist of 2020 looks like and how SPS could respond.