World Drug Safety USA 2017 - Day Two

 
08:00

Registration & Breakfast

 
08:55

Opening Remarks from the chair

 
 
 

RISK MANAGEMENT AND SAFETY SIGNAL DETECTION

 
09:00

Keynote Presentation: Harmonising risk management strategies globally

  • Proactive planning for risk management, minimization, and through the lifecycle
  • Utility of a core strategy for risk management planning
  • Challenges in maintaining a core strategy globally
  • Balancing it all
 
09:20

Keynote Presentation: Overcoming the hurdles of Big Data and Social Media

  • Identifying and understanding the drivers for utilizing social media for pharmacovigilance
  • Exploring the value of social media for pharmacovigilance through research
  • Understanding limitations and challenges with social media
 
09:40

How to determine the effectiveness of risk management

  • Success Factors
  • ​When do you need to revise your program
  • Outcome detection
 
10:00

Big data and pharmacovigilance: potential for web-based data mining- Review of examples of ongoing initiatives across different data sources

  • Social media
  • Query search logs
  • Patients forums
  • Future directions of using big data for pharmacovigilance
 
 
10:30

Morning Refreshments

 
10:50

The impact of biomarkers on drug safety throughout the drug lifecycle

  • What is a drug safety biomarker
  • ​Why drug safety biomarkers are important and what makes a good one
  • ​How drug safety biomarkers can contribute to research efficiency, competitive success and patient safety
 
Raj More
11:10

Modern Technology Solutions to Address Aggregate Reporting, Signal Evaluation and Data Analysis Challenges

  • Review of Example Use Cases
Raj More, Chief Executive Officer, Rxlogix
 
11:30

INTERACTIVE ROUNDTABLES

 
  • Big Data - Overcoming challenges in drug safety data
Carol Shaheen

Carol Shaheen, Drug safety case manager, CSL Behring

  • Data Sharing: Improved information sharing to drive compliance and organizational efficiency
Stephen Charles Schmidt

Stephen Charles Schmidt, Project Manager, Aris Global

  • Deloitte Roundtable
 
  • Google Insights for Search – how useful is this tool and how could it be improved
 
  • Patient Centricity - How to enable patient adherence through patient support programs
Graydon Forrer

Graydon Forrer, Principle, G4 Communications

  • Pharmacovigilance - Challenges in immune-oncology drug development

Manu Sondhi, Senior Director, Novartis

  • REMS - their impact on the health care delivery and patient access

Margaret Nagle, PV Operations, Dr Reddy's Laboratories

  • Risk Management - Innovative approach to structural benefit risk assessment
Shefali Saini

Shefali Saini, Clinical Safety Physician, CSL Behring

 
12:10

LUNCH

 
13:30

Outsourcing: Finding the Right Provider, Model and Services

  • Why do Pharma and Biotech companies outsource
  • Outsourcing models (e.g. Preferred provider, single area outsourcing and Functional Providers)
  • Which PV services are outsourced
  • How to find the right partner
  • How to work with your chosen partner
 
 

PREDICTING DRUG TOXICITY

 

PATIENT-CENTRIC PHARMACOVIGILANCE

 
 
PREDICTING DRUG TOXICITY
13:50

Physiological, pharmacological and toxicological evaluation of current and novel test systems for understanding hepatotoxicity: A consolidated view from the IMI MIP-DILI project

  • Major outcome from the large EU funded IMI project MIP-DILI
  • Validation of 3D hepatic spheroid model
  • Clear road map for the implantation, validation of novel in vitro hepatic models in Industry, including Decision Tree’s and SWOT analysis of specific hepatotoxicity mechanistic endpoints
 
PATIENT-CENTRIC PHARMACOVIGILANCE
13:50

Achieving proactive drug safety through patient engagement

  • Embedding a patient centered culture within the drug safety organization
  • Developing a framework to engage with patients
  • Using eHealth tools to engage with patients
  • Developing patient orientated benefit risk aids
 
 
PREDICTING DRUG TOXICITY
14:10

From QSAR to big data: developing data-driven predictive models for drug induced liver injury

  • Challenges of cheminformatics modeling in drug delivery.
  • Chemical in-vitro in-vivo profiling target drug molecules.
  • Adverse outcome pathway models for hepatotoxicity.
 
PATIENT-CENTRIC PHARMACOVIGILANCE
14:10

Panel Discussion: Developing pragmatic measures for pharmacovigilance through patient-centeredness

  • Forming a patient centered ecosystem – internally and externally
  • Patient preference assessment methods
  • Incentivizing staff to engage in cross-functional collaboration and rewarding ‘patient centered’ activities
 
 
Martin Bluth, Chief Medical Officer, Consolidated Laboratory Management Systems
 
 
 
PREDICTING DRUG TOXICITY
14:30

Case study: The Promise of Tissue Chips in Drug Discovery and Development

  • Modelling the structure of multiple organ systems
  • How gene mutations can be studied using a tissue chip approach
  • Assessment of drug compounds and establishing the pre-clinical foundation to inform clinical trial design
 
PATIENT-CENTRIC PHARMACOVIGILANCE
14:30

Panel Discussion: Patient Centricity via Public Health Efforts: Public, Private, Academic

  • PV Systems in emerging nations
  • PV Awareness and engagement in education to build academic curricular
  • Human factors taking center stage in PV
 
 
James Duhig, Director Behavioral Sciences, AbbVie
 
 
PREDICTING DRUG TOXICITY
15:00

Case Study: Gut-on-a-Chip, changing the future of PV for the Microbiome

  • A microphysiological human intestine model
  • In vitro host-gut microbiome ecosystem and long-term maintenance
  • Modeling intestinal diseases to validate therapeutic interventions
 
PATIENT-CENTRIC PHARMACOVIGILANCE
15:00

Using technology to give patients a bigger voice in risk management

  • Risk management, risk minimization and risk communication
  • Including patients in the risk cycle
  • Tech tools for the future
 
 
15:20

Afternoon refreshments

 
 

GLOBAL OUTLOOKS ON PV

 
15:50

Data value versus data volume: Simplifying AER capture across intake routes while addressing product risk management commitments

  • As volumes of AER’s continue to increase 10-20% year on year, how do we address the challenges of content quality and case processing efficiency?
  • Can we adapt our methods to meet the needs of diverse product portfolios, allowing us to manage labelled AEs from established products and Events of Interest for products with Risk Management commitments appropriately?
  • Join us as we look at how intelligent technology that provides harmonized intake solutions and configurable workflow is available today to solve these challenges
 
16:10

Planning PV in emerging markets

  • The role of social media in PV
  • The impact of regulatory agencies
  • Understanding cultural impacts in PV
 
William W. Gregory
16:30

Global perspectives on QP’s and Regulation

 
William W. Gregory, Senior Director , Safety & Risk Management, Pfizer
 
Martin Bluth

Are those side effects due to my drug? The case for clinical laboratory toxicology and drug testing in clinical trials

  • The opioid epidemic has changed the landscape of clinical treatment approaches
  • Side effects of pharmaceuticals affect drug launch, recalls, and post market economics
  • Laboratory toxicology and drug testing can identify unreported narcotic / analgesics that may contribute to clinical trial results
Martin Bluth, Chief Medical Officer, Consolidated Laboratory Management Systems