Predictive Safety

 

Bringing together toxicology, translational data, trial design, and model selection to help your company increase the accuracy of safety predictions.

 

Key Speakers

 

PREDICTIVE SAFETY, Tuesday 16 April 2019

08:00

8:00 Registration and Breakfast

Jose Vega
09:00

Collaboration: utilizing cross-company teams for PV initiatives - how Transcelerate prepares for four massive projects

Alexandre Kiazand
09:20

Proactive strategy: bringing a lean biotech approach to big pharma using early value assessment - improving safety and lowering cost

Bruce Palsulich
09:40

AI and Machine Learning: Using advanced technologies to help make PV operations more efficient

10:00

Speed Networking

10:20

Networking coffee break

Jennifer Brown
PREDICTIVE SAFETY
11:00

Understanding Toxicology: How understanding drug product attributes, toxicology study design, and measures of toxicity can help assess safety for moving into clinical trials

Elizabeth Baker
PREDICTIVE SAFETY
11:20

The Nonclinical Innovation and Patient Safety Initiative (NIPSI): supporting human-based non-clinical approaches through global advances in regulation, policy, science, education and training

Tom Parry
PREDICTIVE SAFETY
11:40

How to utilize toxicity data in team decision making: how linking preclinical data to predictive safety can be applied to making executive decisions

12:20

Networking lunch

Elena Davison

10) 21st Century Reporting: How to properly, efficiently, and compliantly handle adverse event reports in today’s segmented digital age

Elena Davison, Director of Global Pharmacovigilance Informatics, Sunovion Pharmaceuticals

1:40 ROUNDTABLES (1-hour roundtable sessions split between 2 rounds of 30 minutes – attendees can select two roundtables to attend)

Vicki Edwards

3) Brexit and PV: How the United Kingdom’s retreat from the European Union continues to affect pharmacovigilance and patient safety

Gabrielle Sellick

4) Affiliate Pharmacovigilance Transformation

How to build a high-performing, sustainable and nimble Affiliate PV system that addresses the challenges of rising local volume of adverse event case processing, increasingly diverse local regulatory obligations and internal pressures to realize the value of safety in affiliate business strategies.
Fatima Yousef Ali Ghethan

5) Using automation to decrease errors: how computerized physician order entry, medication administration records, and discharge prescriptions and instructions can decrease errors and adverse events

Michael Von Forstner

9) Regulatory requests for large post authorization studies from multiple companies

How to organize class-related post-authorization studies (Art. 31), obtain/analyze data across regions, communicate with different national authorities, and manage stakeholder expectations.
Ignacio Rodriguez
PREDICTIVE SAFETY
14:50

Translational safety management: how to approach the transition from non-clinical to clinical safety and its impact on predictive safety

Martin Bluth
PREDICTIVE SAFETY
15:10

Predictive safety to prevent pain and suffering: how the clinical laboratory can utilize predictive safety to avoid adverse events in both trials and post market populations

Javier Waksman
PREDICTIVE SAFETY
15:30

Liver toxicity in clinical trials: how to apply liver safety data to avoid drug induced liver injury

16:10

Networking coffee break

Steven Beales
16:40

Think globally, report locally: how safety reporting technology and strategic utilization of local laws has enabled Roche to save $80M and overcome the complex processes of global harmonization

Sundeep Sethi
17:00

The digital revolution and implications for pharmacovigilance: using technology platforms to transform data analytics, risk management and the implementation of PV programs

5:20 Closing remarks followed by networking drinks reception

last published: 06/Mar/19 17:05

PREDICTIVE SAFETY, Wednesday 17 April 2019

PREDICTIVE SAFETY
08:00

8:00 Registration and Breakfast

Susan Welsh
08:55

Chairperson opening remarks:

Sherry Winter
09:00

A new approach to developing advanced drug safety solutions

Using access to a wide range of information, including medical journals, regulatory filings, and relevant scientific data to help inform analytics and create more efficient PV operations.
10:00

Networking coffee break

Andrew Olaharski
PREDICTIVE SAFETY
11:00

Predictive toxicity and using models to assess safety: case study examples on targeting safety, identifying an issue, and using different models to assess whether that issue is on/off target

Frederick Sannajust
PREDICTIVE SAFETY
11:20

Use of human iPSC-derived cardiomyocytes and iPSC-derived neurons in-vitro models: the human imperative for better science and safer medicines

Jim Buchanan
PREDICTIVE SAFETY
11:40

Enhanced evaluation of drug induced hepatotoxicity

How to use the interactive safety graphic tool to analyze drug induced liver injury data values across varying platforms to increase efficiency and reliability of your PV models.
12:20

Networking lunch

Nicole Baker

1) PV processes in Africa and Asia: how to implement new processes and adapt to change in these regions

Steven Beales

10) Deep Dive into the Technology & Processes Behind the Roche Clinical Trial Safety Portal

A case study in eliminating over-distribution and improving patient safety, while significantly reducing costs.
Leo Russo

12) The role of patient preference studies in supporting benefit-risk profiles: how to determine the impact on a specific product/disease area, identify key therapeutic decisions, and obtain alignment

1:40 ROUNDTABLES (1-hour roundtable sessions split between 2 rounds of 30 minutes – attendees can select two roundtables to attend)

Rudi Scheerlinck

2) Signal Detection: data sources, challenges, and innovative approaches

David Chonzi

4) Cell Therapies: Understanding the safety requirements and post marketing monitoring processes

Tanja Fahlbusch

8)Preventative safety and cross functional teams: How to communicate across teams and implement interdepartmental strategy

Hedva Voliovitch

9) Small bio startups: how to approach regulatory changes, implement PV programs, and provide training and support without wasting limited resources

Yolanda Yang
PREDICTIVE SAFETY
15:10

Dose-limiting toxicity: how to understand DLT in oncology clinical trials and approach challenges with modern agents and combination therapies

William Wang
PREDICTIVE SAFETY
15:30

Safety Evaluation in Early Phase Oncology

How to identify opportunities in Early Clinical Development for safety profile characterization and expedite development through FDA guidance on early oncology trials.
Susan Welsh
15:55

Chairperson Closing Remarks:

4:00 END OF CONFERENCE

last published: 06/Mar/19 17:05

 

 

 

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