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Agenda

Progressive Insights and Practical Strategies to Drive Clinical Trial and Supply Chain Efficiencies

October 29-30, 2019
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE | TUESDAY, OCTOBER 29, 2019

7:30

Conference Registration and Networking Breakfast

8:30

Advisory Board Welcome and Opening Remarks

Trends Impacting IRT and Clinical Supply

8:40

2019 ADVISORY BOARD KICK OFF Industry Initiatives to Drive Collaboration and Create Efficiencies in Trial Design

MODERATOR:

Paul Hughes
Senior Manager, IRT Global Oversight
Pfizer Inc

FACILITATORS:

Simi Nischal
Head, IRT Target to Patient Supply Chain
GSK

Jon Paras
Senior Manager, Clinical Systems and Analytical Reporting
Amgen

Craig Mooney
Director, IRT
Bristol-Myers Squibb

9:25

Evaluate How Standards Management and Protocol Machine Learning Will Create Efficiencies for RTSM

Jennifer Bush
Director, Life Sciences Product Strategy
Oracle

Nobendu Roy
Drug Safety and Clinical R&D Solution Architect
Cognizant

10:05

CASE STUDY Managing a Successful Direct-to-Patient Trial Using IRT

Chris Petruzela
Design Consultant Group Lead
Suvoda

Lisa Killi
Director, Clinical Supplies Management
Bellerophon Therapeutics

10:40

Networking and Refreshment Break

11:10

CASE STUDY Rapid Study Start-Up —
From Manual Processes to RTSM Standardization and Resupply Logic

Jonathan Chalifoux
Client Services Lead
4G Clinical

Luis Alves
Manager, Supply Chain
Apellis Pharmaceuticals

11:50

Considerations for Optimizing End-to-End IRT Operating Model to Enhance Quality and Collaboration

Prasann Mehta
Director, IRT and COA Services
Merck

Igor Druker
Associate Director, IRT Services
Merck

12:30

Networking Luncheon Sponsored by:

1:30

CASE STUDY Best Practices for IRT Audit Trail Reporting and Review

Andrew Rohrbaugh
Director, Client Delivery
Cenduit

Sarosh Anjum
Senior Manager
Astellas Pharma US Inc

2:15

Rate Cards That Reflect Recent Market Trends

Bryan Clayton
Vice President, Strategic Solutions
YPrime

3:00

Networking and Refreshment Break

3:30

CHOOSE BETWEEN TWO TRACKS OF CONTENT (I-II)

TRACK I Back to Basics — Fundamentals of IRT & Supply Management

For newcomers and seasoned IRT professionals looking for a refresher course, this track provides a comprehensive overview on key components of IRT and clinical supply.

3:30

Track Chair’s Welcome

Craig Mooney
Director, IRT
Bristol-Myers Squibb

3:40

Implement a Dynamic Predictive Algorithm to Optimize Lot Utilization

Natalie Nicholson
Director, Systems Analysis and Design
Signant Health

4:20

Effective Strategies to Manage Clinical Integrations and Data Feeds

Cheryl Kole
Director, Strategic Solutions
Almac Clinical Technologies

Katarina Wikstrom, Ph.D.
Head, U.S. Operations – Diagnostics
Almac Clinical Technologies

5:00

PANEL DISCUSSION Best Practices and Design Considerations for IRT System Components

MODERATOR:

Kevin Collier
SVice President, Product - RTSM
Medidata Solutions

PANELISTS:

Steven Palmatier
Assistant Director, IRT
Rho

Melissa Bernardo
IVRS/IWRS Manager
Janssen

 
TRACK II Advanced Thinking — Trial Design &
Clinical Supply

This track invites senior-level professionals looking to tailor discussions around complex topics related to trial design, clinical supply and complex protocol management.

3:30

Track Chair’s Welcome

Amy Rupp
Associate Director, IRT
CSL Behring

3:40

Technology Considerations to Accommodate Complexities of Platform, Basket and Umbrella Trials

Catherine Hall
Vice President, Product Strategy
endpoint

4:20

Strategies for Managing and Tracking Supplies for Open Label Study Designs

Katherine Mucci
Associate Director, Clinical Supply Chain
Alnylam Pharmaceuticals

5:00

Senior Think Tank —
Hot Topic Exchange and Industry Benchmarking

FACILITATOR:

Amy Sonderman, MS
IRT Expert, Clinical Trial Supplies Unit
Boehringer Ingelheim Pharmaceuticals, Inc.

5:45

Close of Day One

Please Join Us! Networking Cocktail Receptionfollowing the final session, hosted by:

DAY TWO | WEDNESDAY, OCTOBER 30, 2019

8:00

Networking Breakfast

8:30

Advisory Board’s Review of Day One

8:45

KEYNOTE ADDRESS Technologies That Drive Innovation in Healthcare and Patient Engagement Always Use Behavior Science (Whether They Know It or Not!)

Kyra Bobinet, MD, MPH
CEO and Founder
engagedIN

9:30

Update on Blockchain for Clinical Supply Management and IRT

Barry Moore
Head, Clinical Supply Chain Solutions
GSK

Imran Shakur
Senior Manager, Clinical Planning and Operations
Biogen

10:15

Networking and Refreshment Break

Operational Efficiencies to
Enhance Trial Management

10:45

PANEL DISCUSSION IRT Vendor Management and Oversight

MODERATOR:

Kevin Collier
SVice President, Product - RTSM
Medidata Solutions

PANELISTS:

Simi Nischal
Head, IRT Target to Patient Supply Chain
GSK

Imran Shakur
Senior Manager, Clinical Planning and Operations
Biogen

Craig Mooney
Director, IRT
Bristol-Myers Squibb

11:30

Smarter Integrations — Moving from Integration to Interoperability

Diane Greenlaw
Product Director
Oracle

Dhiren Savla
Consulting Practice Director
Oracle

12:15

Networking Luncheon

1:15

PANEL DISCUSSION Approaches to Streamline UAT and IRT System Validation

MODERATOR:

Laura Araujo
Vice President, Quality
4G Clinical

PANELISTS:

Dawn Sorenson
Associate Director, Clinical Systems and Devices
Theravance Biopharma US, Inc

Amy Rupp
Associate Director, IRT
CSL Behring

Julie Kremzier
Senior IXRS Analyst, Clinical Data Management
Vertex Pharmaceuticals

2:00

BENCHMARKING SURVEY RESULTS REVEALED Exclusive Intelligence around the State of IRT and Clinical Supply

Rodney Erickson
IRT Expert - CTSU
Boehringer Ingelheim Pharmaceuticals, Inc.

2:30

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE | TUESDAY, OCTOBER 29, 2019

7:30

Conference Registration and Networking Breakfast

8:30

Advisory Board Welcome and Opening Remarks

Trends Impacting IRT and Clinical Supply

8:40

2019 ADVISORY BOARD KICK OFF Industry Initiatives to Drive Collaboration and Create Efficiencies in Trial Design

MODERATOR:

Paul Hughes
Senior Manager, IRT Global Oversight
Pfizer Inc

FACILITATORS:

Simi Nischal
Head, IRT Target to Patient Supply Chain
GSK

Jon Paras
Senior Manager, Clinical Systems and Analytical Reporting
Amgen

Craig Mooney
Director, IRT
Bristol-Myers Squibb

9:25

Evaluate How Standards Management and Protocol Machine Learning Will Create Efficiencies for RTSM

Jennifer Bush
Director, Life Sciences Product Strategy
Oracle

Nobendu Roy
Drug Safety and Clinical R&D Solution Architect
Cognizant

10:05

CASE STUDY Managing a Successful Direct-to-Patient Trial Using IRT

Chris Petruzela
Design Consultant Group Lead
Suvoda

Lisa Killi
Director, Clinical Supplies Management
Bellerophon Therapeutics

10:40

Networking and Refreshment Break

11:10

CASE STUDY Rapid Study Start-Up —
From Manual Processes to RTSM Standardization and Resupply Logic

Jonathan Chalifoux
Client Services Lead
4G Clinical

Luis Alves
Manager, Supply Chain
Apellis Pharmaceuticals

11:50

Considerations for Optimizing End-to-End IRT Operating Model to Enhance Quality and Collaboration

Prasann Mehta
Director, IRT and COA Services
Merck

Igor Druker
Associate Director, IRT Services
Merck

12:30

Networking Luncheon Sponsored by:

1:30

CASE STUDY Best Practices for IRT Audit Trail Reporting and Review

Andrew Rohrbaugh
Director, Client Delivery
Cenduit

Sarosh Anjum
Senior Manager
Astellas Pharma US Inc

2:15

Rate Cards That Reflect Recent Market Trends

Bryan Clayton
Vice President, Strategic Solutions
YPrime

3:00

Networking and Refreshment Break

3:30

CHOOSE BETWEEN TWO TRACKS OF CONTENT (I-II)

TRACK I Back to Basics — Fundamentals of IRT & Supply Management

For newcomers and seasoned IRT professionals looking for a refresher course, this track provides a comprehensive overview on key components of IRT and clinical supply.

3:30

Track Chair’s Welcome

Craig Mooney
Director, IRT
Bristol-Myers Squibb

3:40

Implement a Dynamic Predictive Algorithm to Optimize Lot Utilization

Natalie Nicholson
Director, Systems Analysis and Design
Signant Health

4:20

Effective Strategies to Manage Clinical Integrations and Data Feeds

Cheryl Kole
Director, Strategic Solutions
Almac Clinical Technologies

Katarina Wikstrom, Ph.D.
Head, U.S. Operations – Diagnostics
Almac Clinical Technologies

5:00

PANEL DISCUSSION Best Practices and Design Considerations for IRT System Components

MODERATOR:

Kevin Collier
SVice President, Product - RTSM
Medidata Solutions

PANELISTS:

Steven Palmatier
Assistant Director, IRT
Rho

Melissa Bernardo
IVRS/IWRS Manager
Janssen

 
TRACK II Advanced Thinking — Trial Design &
Clinical Supply

This track invites senior-level professionals looking to tailor discussions around complex topics related to trial design, clinical supply and complex protocol management.

3:30

Track Chair’s Welcome

Amy Rupp
Associate Director, IRT
CSL Behring

3:40

Technology Considerations to Accommodate Complexities of Platform, Basket and Umbrella Trials

Catherine Hall
Vice President, Product Strategy
endpoint

4:20

Strategies for Managing and Tracking Supplies for Open Label Study Designs

Katherine Mucci
Associate Director, Clinical Supply Chain
Alnylam Pharmaceuticals

5:00

Senior Think Tank —
Hot Topic Exchange and Industry Benchmarking

FACILITATOR:

Amy Sonderman, MS
IRT Expert, Clinical Trial Supplies Unit
Boehringer Ingelheim Pharmaceuticals, Inc.

5:45

Close of Day One

Please Join Us! Networking Cocktail Receptionfollowing the final session, hosted by:

DAY TWO | WEDNESDAY, OCTOBER 30, 2019

8:00

Networking Breakfast

8:30

Advisory Board’s Review of Day One

8:45

KEYNOTE ADDRESS Technologies That Drive Innovation in Healthcare and Patient Engagement Always Use Behavior Science (Whether They Know It or Not!)

Kyra Bobinet, MD, MPH
CEO and Founder
engagedIN

9:30

Update on Blockchain for Clinical Supply Management and IRT

Barry Moore
Head, Clinical Supply Chain Solutions
GSK

Imran Shakur
Senior Manager, Clinical Planning and Operations
Biogen

10:15

Networking and Refreshment Break

Operational Efficiencies to
Enhance Trial Management

10:45

PANEL DISCUSSION IRT Vendor Management and Oversight

MODERATOR:

Kevin Collier
SVice President, Product - RTSM
Medidata Solutions

PANELISTS:

Simi Nischal
Head, IRT Target to Patient Supply Chain
GSK

Imran Shakur
Senior Manager, Clinical Planning and Operations
Biogen

Craig Mooney
Director, IRT
Bristol-Myers Squibb

11:30

Smarter Integrations — Moving from Integration to Interoperability

Diane Greenlaw
Product Director
Oracle

Dhiren Savla
Consulting Practice Director
Oracle

12:15

Networking Luncheon

1:15

PANEL DISCUSSION Approaches to Streamline UAT and IRT System Validation

MODERATOR:

Laura Araujo
Vice President, Quality
4G Clinical

PANELISTS:

Dawn Sorenson
Associate Director, Clinical Systems and Devices
Theravance Biopharma US, Inc

Amy Rupp
Associate Director, IRT
CSL Behring

Julie Kremzier
Senior IXRS Analyst, Clinical Data Management
Vertex Pharmaceuticals

2:00

BENCHMARKING SURVEY RESULTS REVEALED Exclusive Intelligence around the State of IRT and Clinical Supply

Rodney Erickson
IRT Expert - CTSU
Boehringer Ingelheim Pharmaceuticals, Inc.

2:30

Close of Conference