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Agenda

Next-Generation Systems and Operational Best Practices to Drive Clinical Trial and Supply Chain Excellence

October 26-27, 2017
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE | THURSDAY, OCTOBER 26, 2017

7:00

Registration and Continental Breakfast

8:00

Co-Chairs’ Welcome and Opening Remarks

Kristin Sullivan
Director, IRT Global Oversight Team
Pfizer Inc

Bryan Clayton
Vice President, Strategic Solutions
YPrime

8:15

KEYNOTE ADDRESS Reimagining Clinical Trials and Unifying Your Clinical Development World

Jim Streeter
Global Vice President, Life Sciences Product Strategy
Oracle

Enable Supply Chain Innovations
through IRT Optimization

8:45

Evaluate the Benefits of Leveraging IRT Data Integration

Jackie Kent
Senior Director, Product Delivery Supply Planning and Systems
Eli Lilly and Company

9:30

Streamline IRT Operations and Ensure Supply Chain Agility

Dawn Sorenson
Associate Director, Clinical Data Management – Clinical Systems
Theravance Biopharma US, Inc

Jon Paras
Senior Manager, GSO Clinical Systems and Analytical Reporting
Amgen

10:15

Networking and Refreshment Break

10:45

PANEL DISCUSSION Leverage End-to-End IRT for Drug Accountability and Return

MODERATOR:

Theodora Sarver
Manager, Product Management
Almac Clinical Technologies

PANELISTS:

Sarosh Anjum, MPH
Senior Systems Manager
Astellas Pharma U.S.

Racquel Mangaser
Lead Analyst, IVRS Central Management
Celgene

Jon Paras
Senior Manager, GSO Clinical Systems and Analytical Reporting
Amgen

Next-Generation Agile,
Interoperable IRT Systems

11:30

Apply Design Thinking Principles to IRT Implementation

Imran Shakur
Senior Manager, Clinical Supply Capabilities
Biogen

12:15

Networking Luncheon Hosted by:

Next-Generation in IRT Platforms
and Functionality

1:15

A Transformative Approach to IRT Systems Built —
Rapid-Deployment IRT Using an Iterative UAT-Design Process

Natalie Nicholson
Associate Director, Client Services
Bracket

1:55

Seven Must-Have Technology Innovations When Evaluating IRT Solutions

Chris Huang
Director, Life Sciences
Oracle Health Sciences

2:35

Configurable vs. Custom Systems — Reducing Timelines to Implement IRT

Sarosh Anjum, MPH
Senior Systems Manager
Astellas Pharma U.S.

Andrew Rohrbaugh
Director, Client Delivery
Cenduit

3:15

Networking and Refreshment Break Hosted by:

3:45

CASE STUDY The Power of Site Feedback in Clinical Systems

Christine Hurley
Chief Operations Officer
4G Clinical

Amy Ripston
Head of Marketing
4G Clinical

4:25

Innovative Approaches to Integrate eSource and IRT to Simplify the Site Experience

Vincent Puglia
Lead Project Manager
Endpoint Clinical

5:05

Leverage the Right Approach to Drug Accountability to Avoid Regulatory Pain

Wade Wirta
Managing Director
Medidata Solutions

5:45

Close of Day One

PLEASE JOIN US... Networking Cocktail Reception immediately following the conclusion of day one

DAY TWO | FRIDAY OCTOBER 27, 2017

7:30

Continental Breakfast

8:00

Conference Co-Chairs’ Review of Day One

Kristin Sullivan
Director, IRT Global Oversight Team
Pfizer Inc

Bryan Clayton
Vice President, Strategic Solutions
YPrime

8:05

A Sponsor Takes Control — What Are the Benefits of Taking Control of IRT?

Simi Nischal
Head of IRT – Target to Patient Supply Chain R&D, PT&S
GlaxoSmithKline

Herag Frankian
Program Director, RTSM
Bioclinica

8:45

Meeting the Challenges of Complex Study Design with Progressive IRT Solutions

Andrew Rohrbaugh
Director, Client Delivery
Cenduit

9:25

You’re Hot, Then You’re Cold — Temperature Management and RTSM Integration

Colette Thorold
Associate Product Manager
PAREXEL

10:05

Networking and Refreshment Break

10:35

LIVE POLLING Mobile IRT to Increase Compliance, Review Data and More

Bryan Clayton
Vice President, Strategic Solutions
YPrime

11:15

CASE STUDY Facilitate Web-Based Tools to Expand IRT Systems and Avoid Duplicate Enrollment

Jonathan Rabinowitz, PhD
Professor, Bar Ilan University;
Director, DupCheck

Michaele Du Metz
Clinical Project Manager
Pfizer Inc

Best Practices to Drive
Operational Efficiencies

11:55

Creating Efficiencies in Day-to-Day IRT Activities

Amy Neubauer
Associate Director, Data Management/Technical Solutions
Alkermes, Inc.

Robert Hummel
Co-Founder and Chief Operating Officer
Suvoda LLC

12:35

Networking Luncheon

1:30

PARTNERSHIP PAVILION
Harmonize Relationships to Ensure a Successful and Streamlined Trial

During this collaborative and engaging session, partner with your clinical systems and operations counterparts to overcome challenges around site operations, clinical supply management and regulatory requirements. Discuss key challenges, roadblocks and hurdles faced by each stakeholder and then join forces to devise solutions and strategies for enhanced partnerships.

FACILITATORS:

Vivienne van de Walle, MD, PhD, CPI
Medical Director/Owner
PT&R

Gauri Nagrani, HBSc, Pharm R&D, CCPE, CCDM
Associate Director, eClinical Solutions
Chiltern

Craig Mooney
Director, IRT
Bristol-Myers Squibb

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

2:30

INTERACTIVE TABLE BREAK-OUTS
Hot Topic Exchange and Industry Benchmarking

FACILITATORS:

Rita Herman
Associate Director, CDM and Project Manager, IRT and eCOA Services
Merck

Romayne Brecht
IRT Coordinator
Merck Sharp & Dohme

3:15

Close of Conference

Agenda

Want more agenda details? Download the brochure.
Want more agenda details? Download the brochure.

DAY ONE | THURSDAY, OCTOBER 26, 2017

7:00

Registration and Continental Breakfast

8:00

Co-Chairs’ Welcome and Opening Remarks

Kristin Sullivan
Director, IRT Global Oversight Team
Pfizer Inc

Bryan Clayton
Vice President, Strategic Solutions
YPrime

8:15

KEYNOTE ADDRESS Reimagining Clinical Trials and Unifying Your Clinical Development World

Jim Streeter
Global Vice President, Life Sciences Product Strategy
Oracle

Enable Supply Chain Innovations
through IRT Optimization

8:45

Evaluate the Benefits of Leveraging IRT Data Integration

Jackie Kent
Senior Director, Product Delivery Supply Planning and Systems
Eli Lilly and Company

9:30

Streamline IRT Operations and Ensure Supply Chain Agility

Dawn Sorenson
Associate Director, Clinical Data Management – Clinical Systems
Theravance Biopharma US, Inc

Jon Paras
Senior Manager, GSO Clinical Systems and Analytical Reporting
Amgen

10:15

Networking and Refreshment Break

10:45

PANEL DISCUSSION Leverage End-to-End IRT for Drug Accountability and Return

MODERATOR:

Theodora Sarver
Manager, Product Management
Almac Clinical Technologies

PANELISTS:

Sarosh Anjum, MPH
Senior Systems Manager
Astellas Pharma U.S.

Racquel Mangaser
Lead Analyst, IVRS Central Management
Celgene

Jon Paras
Senior Manager, GSO Clinical Systems and Analytical Reporting
Amgen

Next-Generation Agile,
Interoperable IRT Systems

11:30

Apply Design Thinking Principles to IRT Implementation

Imran Shakur
Senior Manager, Clinical Supply Capabilities
Biogen

12:15

Networking Luncheon Hosted by:

Next-Generation in IRT Platforms
and Functionality

1:15

A Transformative Approach to IRT Systems Built —
Rapid-Deployment IRT Using an Iterative UAT-Design Process

Natalie Nicholson
Associate Director, Client Services
Bracket

1:55

Seven Must-Have Technology Innovations When Evaluating IRT Solutions

Chris Huang
Director, Life Sciences
Oracle Health Sciences

2:35

Configurable vs. Custom Systems — Reducing Timelines to Implement IRT

Sarosh Anjum, MPH
Senior Systems Manager
Astellas Pharma U.S.

Andrew Rohrbaugh
Director, Client Delivery
Cenduit

3:15

Networking and Refreshment Break Hosted by:

3:45

CASE STUDY The Power of Site Feedback in Clinical Systems

Christine Hurley
Chief Operations Officer
4G Clinical

Amy Ripston
Head of Marketing
4G Clinical

4:25

Innovative Approaches to Integrate eSource and IRT to Simplify the Site Experience

Vincent Puglia
Lead Project Manager
Endpoint Clinical

5:05

Leverage the Right Approach to Drug Accountability to Avoid Regulatory Pain

Wade Wirta
Managing Director
Medidata Solutions

5:45

Close of Day One

PLEASE JOIN US... Networking Cocktail Reception immediately following the conclusion of day one

DAY TWO | FRIDAY OCTOBER 27, 2017

7:30

Continental Breakfast

8:00

Conference Co-Chairs’ Review of Day One

Kristin Sullivan
Director, IRT Global Oversight Team
Pfizer Inc

Bryan Clayton
Vice President, Strategic Solutions
YPrime

8:05

A Sponsor Takes Control — What Are the Benefits of Taking Control of IRT?

Simi Nischal
Head of IRT – Target to Patient Supply Chain R&D, PT&S
GlaxoSmithKline

Herag Frankian
Program Director, RTSM
Bioclinica

8:45

Meeting the Challenges of Complex Study Design with Progressive IRT Solutions

Andrew Rohrbaugh
Director, Client Delivery
Cenduit

9:25

You’re Hot, Then You’re Cold — Temperature Management and RTSM Integration

Colette Thorold
Associate Product Manager
PAREXEL

10:05

Networking and Refreshment Break

10:35

LIVE POLLING Mobile IRT to Increase Compliance, Review Data and More

Bryan Clayton
Vice President, Strategic Solutions
YPrime

11:15

CASE STUDY Facilitate Web-Based Tools to Expand IRT Systems and Avoid Duplicate Enrollment

Jonathan Rabinowitz, PhD
Professor, Bar Ilan University;
Director, DupCheck

Michaele Du Metz
Clinical Project Manager
Pfizer Inc

Best Practices to Drive
Operational Efficiencies

11:55

Creating Efficiencies in Day-to-Day IRT Activities

Amy Neubauer
Associate Director, Data Management/Technical Solutions
Alkermes, Inc.

Robert Hummel
Co-Founder and Chief Operating Officer
Suvoda LLC

12:35

Networking Luncheon

1:30

PARTNERSHIP PAVILION
Harmonize Relationships to Ensure a Successful and Streamlined Trial

During this collaborative and engaging session, partner with your clinical systems and operations counterparts to overcome challenges around site operations, clinical supply management and regulatory requirements. Discuss key challenges, roadblocks and hurdles faced by each stakeholder and then join forces to devise solutions and strategies for enhanced partnerships.

FACILITATORS:

Vivienne van de Walle, MD, PhD, CPI
Medical Director/Owner
PT&R

Gauri Nagrani, HBSc, Pharm R&D, CCPE, CCDM
Associate Director, eClinical Solutions
Chiltern

Craig Mooney
Director, IRT
Bristol-Myers Squibb

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

2:30

INTERACTIVE TABLE BREAK-OUTS
Hot Topic Exchange and Industry Benchmarking

FACILITATORS:

Rita Herman
Associate Director, CDM and Project Manager, IRT and eCOA Services
Merck

Romayne Brecht
IRT Coordinator
Merck Sharp & Dohme

3:15

Close of Conference