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DAY ONE WEDNESDAY, FEBRUARY 6, 2019

7:30

Conference Registration and Continental Breakfast

8:30

Workshop Leaders’ Welcome and Opening Remarks

CHOOSE BETWEEN TWO IN-CONFERENCE WORKSHOPS (A-B)

WORKSHOP A
Process, Tools and Considerations in Building Your IISR

WORKSHOP LEADERS:

Jan Fourman, PhD
Regulatory Scientist, Biotechnology Innovation and Regulatory Science (BIRS) Center
Purdue University

Sloan Stribling
Associate Director, Primary Care Team Lead
Merck

WORKSHOP B
Navigate the Complexities of Budgeting and
Contracting to Improve Timelines

WORKSHOP LEADERS:

Terry Burton
Associate Director, Clinical Contracts & Finance
Gilead Sciences

Dianne Archer
Corporate Counsel
Gilead Sciences

Jon Behrens
Senior Manager, Clinical Contracts & Finance
Gilead Sciences

Annmarie Galli
Head, Global Medical Affairs Research
TESARO

There will be a 30-minute networking and refreshment break at 10:00 a.m.

12:00

Networking Luncheon

1:00

Chairperson's Welcome & Opening Remarks

Theresa Bucher
Associate Director, Global Medical Affairs Research
Takeda

1:15

OPENING ADDRESS FDA Registration Studies in the Cooperative Group Setting

Nathan Eriksen
Chief Administration, SWOG
Oregon Health & Science University

How to Build and Maintain Successful IISR Programs

2:00

Guidance for Developing a Global IISR Process

Joe Kerkering, MBA
Director, Global Medical Affairs Operations
Incyte Corporation

2:45

Doing More with Less — Scalable Solutions to Improve Program Development

Kelli Walker, PharmD, MS
Portfolio Manager
Envision Technology Solutions

3:30

Networking and Refreshment Break

4:00

CASE STUDY Build an Investigator-Sponsored Research Unit from Scratch

Michael C. Oldfield, JD, MBA, CCRP
Director, Regulatory Affairs & ISRU
Fox Chase Cancer Center

Approaches to Improve Your IISR Programs

4:45

CASE STUDY Process Improvement — The Ever-Changing World of IISRs

Carol Richardson
Senior Research Data Coordinator
Abbott Nutrition

Janice Fonarow, RD, LD
Senior Clinical Research Associate
Abbott Nutrition

5:45

Close of Day One

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

DAY TWO THURSDAY, FEBRUARY 7, 2019

7:30

Continental Breakfast

8:00

Chairperson's Review of Day One

Theresa Bucher
Associate Director, Global Medical Affairs Research
Takeda

8:15

Tips and Traps When Allocating Risk in Investigator Initiated Sponsored Research Agreements (IISRAs)

Marlon Rajakaruna
Partner and Global Co-Leader, Life Sciences and Healthcare Practice Groups
Dentons

9:00

Determining FMV for IISRs

John Moose
Principal
Polaris

9:45

FIRESIDE CHAT Manage Interaction with Investigators

MODERATOR:

Theresa Bucher
Associate Director, Global Medical Affairs Research
Takeda

CONVERSATION CONTRIBUTORS:

Alison Urton
Group Administrator
Canadian Cancer Trials Group (CCTG)

Alyssa Truong, MPH
Senior Manager, Medical Affairs
Jazz Pharmaceuticals

10:30

Networking and Refreshment Break

11:00

Site Perspectives on IISR Success — Getting the Most from Your KOLs and IISRs

Christy Gilchrist, PhD
Director, Clinical Programs
HHS St. Vincent Hospital

11:45

FIRESIDE CHAT Establish the Value of IISR Programs to Internal Stakeholders

CONVERSATION CONTRIBUTORS:

Alyssa Truong, MPH
Senior Manager, Medical Affairs
Jazz Pharmaceutical

Michael Martineau
Senior Manager, Global Medical Operations
Ipsen Biopharmaceuticals

12:30

Networking Luncheon

The Evolution of Collaborative Studies

1:30

PANEL DISCUSSION Defining Investigator Initiated Sponsored Versus Collaborative Research

MODERATOR:

Ashley Wills
Senior Director, Global Medical Affairs Strategic Initiatives & Research
TESARO

PANELISTS:

Dana Sparks
Director of Operations and Protocols
SWOG

Nathan Eriksen
Chief Administration
SWOG

Alison Urton
Group Administrator
Canadian Cancer Trials Group (CCTG)

Christy Gilchrist, PhD
Director, Clinical Programs
HHS St. Vincent Hospital

2:30

ROUNDTABLE DISCUSSION Harmonize IST Programs Across Industry

FACILITATOR:

Ashley Wills
Senior Director, Global Medical Affairs Strategic Initiatives & Research
TESARO

3:15

Close of Conference

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DAY ONE WEDNESDAY, FEBRUARY 6, 2019

7:30

Conference Registration and Continental Breakfast

8:30

Workshop Leaders’ Welcome and Opening Remarks

CHOOSE BETWEEN TWO IN-CONFERENCE WORKSHOPS (A-B)

WORKSHOP A
Process, Tools and Considerations in Building Your IISR

WORKSHOP LEADERS:

Jan Fourman, PhD
Regulatory Scientist, Biotechnology Innovation and Regulatory Science (BIRS) Center
Purdue University

Sloan Stribling
Associate Director, Primary Care Team Lead
Merck

WORKSHOP B
Navigate the Complexities of Budgeting and
Contracting to Improve Timelines

WORKSHOP LEADERS:

Terry Burton
Associate Director, Clinical Contracts & Finance
Gilead Sciences

Dianne Archer
Corporate Counsel
Gilead Sciences

Jon Behrens
Senior Manager, Clinical Contracts & Finance
Gilead Sciences

Annmarie Galli
Head, Global Medical Affairs Research
TESARO

There will be a 30-minute networking and refreshment break at 10:00 a.m.

12:00

Networking Luncheon

1:00

Chairperson's Welcome & Opening Remarks

Theresa Bucher
Associate Director, Global Medical Affairs Research
Takeda

1:15

OPENING ADDRESS FDA Registration Studies in the Cooperative Group Setting

Nathan Eriksen
Chief Administration, SWOG
Oregon Health & Science University

How to Build and Maintain Successful IISR Programs

2:00

Guidance for Developing a Global IISR Process

Joe Kerkering, MBA
Director, Global Medical Affairs Operations
Incyte Corporation

2:45

Doing More with Less — Scalable Solutions to Improve Program Development

Kelli Walker, PharmD, MS
Portfolio Manager
Envision Technology Solutions

3:30

Networking and Refreshment Break

4:00

CASE STUDY Build an Investigator-Sponsored Research Unit from Scratch

Michael C. Oldfield, JD, MBA, CCRP
Director, Regulatory Affairs & ISRU
Fox Chase Cancer Center

Approaches to Improve Your IISR Programs

4:45

CASE STUDY Process Improvement — The Ever-Changing World of IISRs

Carol Richardson
Senior Research Data Coordinator
Abbott Nutrition

Janice Fonarow, RD, LD
Senior Clinical Research Associate
Abbott Nutrition

5:45

Close of Day One

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

DAY TWO THURSDAY, FEBRUARY 7, 2019

7:30

Continental Breakfast

8:00

Chairperson's Review of Day One

Theresa Bucher
Associate Director, Global Medical Affairs Research
Takeda

8:15

Tips and Traps When Allocating Risk in Investigator Initiated Sponsored Research Agreements (IISRAs)

Marlon Rajakaruna
Partner and Global Co-Leader, Life Sciences and Healthcare Practice Groups
Dentons

9:00

Determining FMV for IISRs

John Moose
Principal
Polaris

9:45

FIRESIDE CHAT Manage Interaction with Investigators

MODERATOR:

Theresa Bucher
Associate Director, Global Medical Affairs Research
Takeda

CONVERSATION CONTRIBUTORS:

Alison Urton
Group Administrator
Canadian Cancer Trials Group (CCTG)

Alyssa Truong, MPH
Senior Manager, Medical Affairs
Jazz Pharmaceuticals

10:30

Networking and Refreshment Break

11:00

Site Perspectives on IISR Success — Getting the Most from Your KOLs and IISRs

Christy Gilchrist, PhD
Director, Clinical Programs
HHS St. Vincent Hospital

11:45

FIRESIDE CHAT Establish the Value of IISR Programs to Internal Stakeholders

CONVERSATION CONTRIBUTORS:

Alyssa Truong, MPH
Senior Manager, Medical Affairs
Jazz Pharmaceutical

Michael Martineau
Senior Manager, Global Medical Operations
Ipsen Biopharmaceuticals

12:30

Networking Luncheon

The Evolution of Collaborative Studies

1:30

PANEL DISCUSSION Defining Investigator Initiated Sponsored Versus Collaborative Research

MODERATOR:

Ashley Wills
Senior Director, Global Medical Affairs Strategic Initiatives & Research
TESARO

PANELISTS:

Dana Sparks
Director of Operations and Protocols
SWOG

Nathan Eriksen
Chief Administration
SWOG

Alison Urton
Group Administrator
Canadian Cancer Trials Group (CCTG)

Christy Gilchrist, PhD
Director, Clinical Programs
HHS St. Vincent Hospital

2:30

ROUNDTABLE DISCUSSION Harmonize IST Programs Across Industry

FACILITATOR:

Ashley Wills
Senior Director, Global Medical Affairs Strategic Initiatives & Research
TESARO

3:15

Close of Conference