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Agenda

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

October 22-23, 2018
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE MONDAY, OCTOBER 22, 2018

7:30

Registration and Continental Breakfast

8:30

Chairperson’s Welcome and Opening Remarks

Craig Mooney
Director, IRT
Bristol-Myers Squibb

Trends Impacting IRT and Clinical Supply

8:35

STATE OF THE INDUSTRY AND CALL TO ACTION Emerging Trends, Trial Designs and Complex Protocol Support

Craig Mooney
Director, IRT
Bristol-Myers Squibb

9:05

Not Your Grandma’s IRT —
A New Approach to Randomization and Trial Supply Management

Andy Alasso
Global Vice President, Product Management
Oracle Health Sciences

9:45

Leverage Blockchain Technology to Enhance Supply Chain Management

Imran Shakur
Senior Manager, Clinical Supply Capabilities
Biogen

Chad Sklodosky
Director, Digital Clinical Supply Chain
Pfizer Inc

10:25

Networking and Refreshment Break

Clinical Supply and Inventory Management

10:55

Standardize Processes to Create Newfound Efficiencies in Supply Management

Craig Duffy
Senior Manager, Investigational Supply Chain Operations
Blueprint Medicines

Vincent Puglia
Account Director
endpoint

11:35

Navigate the Complexity of Supply Forecasting — Leveraging Both General and Clinical Trial Supply Chain Concepts to Design Your Supply Strategy

Cedric Druck
Vice President, Forecasting
4G Clinical

Jan Pieter Kappelle
Vice President, Strategy
4G Clinical

12:05

CASE STUDY Utilize Temperature Management to Enhance Supply Chain Visibility

Jon Paras
Senior Manager, Clinical Systems and Analytical Reporting
Amgen

Tim Gilbert
Senior Director, Product Management, Randomization and Trial Supply Management
PAREXEL

12:45

Networking Luncheon

1:45

CASE STUDY Streamline Forecasting to Drive Demand Planning and Supply Chain Optimization

Oliver Cunningham
Director, Client Enablement
Bracket

2:25

PANEL DISCUSSION Key Approaches to Select and Implement IRT Systems

MODERATOR:

Matt Lowrie
Quality Assurance Group Leader
Almac Clinical Technologies

PANELISTS:

Sarosh Anjum
Senior Systems Manager
Astellas Pharma US Inc

Kyle Rader
Senior IXRS Analyst
Vertex Pharmaceuticals

Megan Dunham
Clinical Systems Leader
Genentech

3:15

Networking and Refreshment Break hosted by

3:45

CASE STUDY Fueling your Supply Chain to Overcome Drug Availability and Expiry Issues

Nick Hargaden
Director, RTSM Delivery
Bioclinica

4:25

INTERACTIVE TABLE TALKS

During this collaborative and engaging session, benefit from the opportunity to break into focused groups to engage, share insights and benchmark with peers. At the conclusion of the session there will be a comprehensive wrap-up of salient points.

A Ensuring Audit and Inspection Readiness

Audrey Hill
Senior Director,Data Management
Advaxis, Inc.

Frances Gavigan
Associate Director, Clinical Quality Assurance
Advaxis, Inc.

B Vendor Management and Supply Agreement Negotiations

Sarosh Anjum
Senior Systems Manager
Astellas Pharma US Inc

C Streamline UAT and IRT System Validation

Evan Wohl, RPh
Director, Clinical Supplies
Intercept Pharmaceuticals

D Impacts of Brexit on Clinical Trial Supply

Anne Marie Bencivengo
Associate Director, Comparator Strategy
Bristol-Myers Squibb

John Burns
IRT Specialist
Bristol-Myers Squibb

5:30

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one Hosted By:

DAY TWO TUESDAY, OCTOBER 23, 2018

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Craig Mooney
Director, IRT
Bristol-Myers Squibb

8:35

Transitioning IRT Vendors and Systems Post-Acquisition

Janel Kelly
IRT Specialist, Clinical Supply Capabilities
Biogen

9:15

SURVEY RESULTS REVEALED Rethinking Randomization and Trial Supply Management with Modern Technology

Liam Wood
Vice President, Clinical One Product Management
Oracle

Clinical Trial Design and Supply Innovation

9:55

CASE STUDY Approaches to the Efficient Deployment of System Change Requests

Andrew Rohrbaugh
Director, Client Delivery
Cenduit

Chris Gent
Associate Director, Operational and Process Excellence
Cenduit

10:35

Networking and Refreshment Break

11:05

CASE STUDY Using IRT to Implement Bayesian Futility Analysis in Basket Trials

Erica Jonas
Associate Director, Services Delivery
Suvoda

Feng Zhou
Principal Biostatistician
Incyte

11:45

The Great Debate — Configuration vs. Customization

Bryan Clayton
Vice President, Strategic Solutions
YPrime

12:25

Networking Luncheon

1:25

Extend IRT Drug Supply Features for Advanced IRT Users

Vicky Martin
Senior Director, U.S. Business Development
IDDI

Ejup Latifi
Clinical System Designer
IDDI

2:05

CASE STUDY Overcome Unique Challenges of Clinical Trials for Rare Diseases

Maria Humagain
Lead IRT and ePRO Operations Specialist
Shire

2:45

SITE PERSPECTIVE Determine the Impact of Protocol Complexity on Research Site Productivity

David Morin, MD, FACP, CPI, FACRP
Director, Clinical Research
Holston Medical Group

3:30

Conference Chairman’s Closing Remarks

Craig Mooney
Director, IRT
Bristol-Myers Squibb

3:35

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE MONDAY, OCTOBER 22, 2018

7:30

Registration and Continental Breakfast

8:30

Chairperson’s Welcome and Opening Remarks

Craig Mooney
Director, IRT
Bristol-Myers Squibb

Trends Impacting IRT and Clinical Supply

8:35

STATE OF THE INDUSTRY AND CALL TO ACTION Emerging Trends, Trial Designs and Complex Protocol Support

Craig Mooney
Director, IRT
Bristol-Myers Squibb

9:05

Not Your Grandma’s IRT —
A New Approach to Randomization and Trial Supply Management

Andy Alasso
Global Vice President, Product Management
Oracle Health Sciences

9:45

Leverage Blockchain Technology to Enhance Supply Chain Management

Imran Shakur
Senior Manager, Clinical Supply Capabilities
Biogen

Chad Sklodosky
Director, Digital Clinical Supply Chain
Pfizer Inc

10:25

Networking and Refreshment Break

Clinical Supply and Inventory Management

10:55

Standardize Processes to Create Newfound Efficiencies in Supply Management

Craig Duffy
Senior Manager, Investigational Supply Chain Operations
Blueprint Medicines

Vincent Puglia
Account Director
endpoint

11:35

Navigate the Complexity of Supply Forecasting — Leveraging Both General and Clinical Trial Supply Chain Concepts to Design Your Supply Strategy

Cedric Druck
Vice President, Forecasting
4G Clinical

Jan Pieter Kappelle
Vice President, Strategy
4G Clinical

12:05

CASE STUDY Utilize Temperature Management to Enhance Supply Chain Visibility

Jon Paras
Senior Manager, Clinical Systems and Analytical Reporting
Amgen

Tim Gilbert
Senior Director, Product Management, Randomization and Trial Supply Management
PAREXEL

12:45

Networking Luncheon

1:45

CASE STUDY Streamline Forecasting to Drive Demand Planning and Supply Chain Optimization

Oliver Cunningham
Director, Client Enablement
Bracket

2:25

PANEL DISCUSSION Key Approaches to Select and Implement IRT Systems

MODERATOR:

Matt Lowrie
Quality Assurance Group Leader
Almac Clinical Technologies

PANELISTS:

Sarosh Anjum
Senior Systems Manager
Astellas Pharma US Inc

Kyle Rader
Senior IXRS Analyst
Vertex Pharmaceuticals

Megan Dunham
Clinical Systems Leader
Genentech

3:15

Networking and Refreshment Break hosted by

3:45

CASE STUDY Fueling your Supply Chain to Overcome Drug Availability and Expiry Issues

Nick Hargaden
Director, RTSM Delivery
Bioclinica

4:25

INTERACTIVE TABLE TALKS

During this collaborative and engaging session, benefit from the opportunity to break into focused groups to engage, share insights and benchmark with peers. At the conclusion of the session there will be a comprehensive wrap-up of salient points.

A Ensuring Audit and Inspection Readiness

Audrey Hill
Senior Director,Data Management
Advaxis, Inc.

Frances Gavigan
Associate Director, Clinical Quality Assurance
Advaxis, Inc.

B Vendor Management and Supply Agreement Negotiations

Sarosh Anjum
Senior Systems Manager
Astellas Pharma US Inc

C Streamline UAT and IRT System Validation

Evan Wohl, RPh
Director, Clinical Supplies
Intercept Pharmaceuticals

D Impacts of Brexit on Clinical Trial Supply

Anne Marie Bencivengo
Associate Director, Comparator Strategy
Bristol-Myers Squibb

John Burns
IRT Specialist
Bristol-Myers Squibb

5:30

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one Hosted By:

DAY TWO TUESDAY, OCTOBER 23, 2018

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Craig Mooney
Director, IRT
Bristol-Myers Squibb

8:35

Transitioning IRT Vendors and Systems Post-Acquisition

Janel Kelly
IRT Specialist, Clinical Supply Capabilities
Biogen

9:15

SURVEY RESULTS REVEALED Rethinking Randomization and Trial Supply Management with Modern Technology

Liam Wood
Vice President, Clinical One Product Management
Oracle

Clinical Trial Design and Supply Innovation

9:55

CASE STUDY Approaches to the Efficient Deployment of System Change Requests

Andrew Rohrbaugh
Director, Client Delivery
Cenduit

Chris Gent
Associate Director, Operational and Process Excellence
Cenduit

10:35

Networking and Refreshment Break

11:05

CASE STUDY Using IRT to Implement Bayesian Futility Analysis in Basket Trials

Erica Jonas
Associate Director, Services Delivery
Suvoda

Feng Zhou
Principal Biostatistician
Incyte

11:45

The Great Debate — Configuration vs. Customization

Bryan Clayton
Vice President, Strategic Solutions
YPrime

12:25

Networking Luncheon

1:25

Extend IRT Drug Supply Features for Advanced IRT Users

Vicky Martin
Senior Director, U.S. Business Development
IDDI

Ejup Latifi
Clinical System Designer
IDDI

2:05

CASE STUDY Overcome Unique Challenges of Clinical Trials for Rare Diseases

Maria Humagain
Lead IRT and ePRO Operations Specialist
Shire

2:45

SITE PERSPECTIVE Determine the Impact of Protocol Complexity on Research Site Productivity

David Morin, MD, FACP, CPI, FACRP
Director, Clinical Research
Holston Medical Group

3:30

Conference Chairman’s Closing Remarks

Craig Mooney
Director, IRT
Bristol-Myers Squibb

3:35

Close of Conference