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Agenda

Proactive, Scalable Solutions for IISR Program Development, Negotiations and Results Reporting

February 7-8, 2018
  • Boston, MA

Agenda

Want more agenda details? Download the brochure.

DAY ONE WEDNESDAY, FEBRUARY 7, 2018

CHOOSE FROM TWO IN - CONFERENCE WORKSHOPS

7:30

Conference Registration and Continental Breakfast

8:30

Workshop Leaders’ Welcome and Opening Remarks

WORKSHOP A
Oncology — Navigate Cooperative Group Clinical Trial Agreements from Concept to Conception

WORKSHOP LEADERS

Meg Mooney, M.D., MBA
Chief, Clinical Investigations Branch, CTEP, DCTD
NCI

Nathan Eriksen
Chief Admin SWOG
Oregon Health & Science University

Theresa Bucher
Associate Director, Global Medical Affairs Research
Takeda

WORKSHOP B
Devices and Diagnostics — Leveraging IISRs to
Inform Clinical Development

WORKSHOP LEADER

Anton Ehrhardt
Vice President, Global Medical Affairs
Mitra Biotech

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

12:00

Networking Luncheon

1:00

Co-Chairs’ Welcome & Opening Remarks

Ashley Wills
Associate Director, Medical Affairs Research
TESARO

Roxanne Cacioppo, Ph.D.
Head, GMA Research, Global Medical Affairs
Takeda

Strategic Frameworks for Developing
Successful IISR Programs

1:15

Negotiating Reasonable IISAs and Sub-Site Agreements — A Site’s Perspective

Marlon Rajakaruna
Partner and Global Co-LeaderLife Sciences and Health Care Practice Groups
Dentons

2:00

Determining IISR Criteria for Approval and Review Teams

Anton Ehrhardt
Vice President, Global Medical Affairs
Mitra Biotech

2:45

Ensuring Global Processes Account for the Local Culture

Kelli Walker, Pharm.D., M.S.
Director, Platform Strategy
Envision Pharma Group

3:00

Networking and Refreshment Break

4:00

CHOOSE BETWEEN TWO LEARNING LABS (1-2)

1BEST PRACTICES IN CREATING A FOCUSED IISR PROGRAM THAT IS TIGHTLY ALIGNED WITH COMPANY STRATEGY

Gurveen Saberwal
Investigator Initiated Research Program Manager, Oncology and Immunology
Shire

2KEY QUESTIONS AND DIALOGUE ON CONTRACT AND BUDGET CHALLENGES IN GLOBAL IISR PROGRAMS

Terry Burton
Senior Manager, Clinical Contracts & Finance
Gilead Sciences

Dianne Archer
Corporate Counsel
Gilead Sciences

5:00

Close of Day One

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

DAY TWO THURSDAY, FEBRUARY 8, 2018

7:30

Continental Breakfast

8:00

Co-Chairs’ Review of Day One

Ashley Wills
Associate Director, Medical Affairs Research
TESARO

Roxanne Cacioppo, Ph.D.
Head, GMA Research, Global Medical Affairs
Takeda

8:15

GUIDED Q&A Demonstrating IISR Value to Your Organization

Ashley Wills
Associate Director, Medical Affairs Research
TESARO

Roxanne Cacioppo, Ph.D.
Head, GMA Research, Global Medical Affairs
Takeda

Overcoming Operational Hurdles

9:00

STAKEHOLDER SHOWCASE How to Become the Partner of Choice for Principal Investigators

STAKEHOLDERS

PHARMACEUTICAL
Kyle Jensen
Director, Medical and Scientific Affairs
Karyopharm Therapeutics Inc.

MEDICAL CENTER
Christy Gilchrist
Director of Cancer Research Institute
St. Vincent Hospital

ACADEMIC HEALTH ORGANIZATION
Joseph Cosico
Director, Clinical Research Operations
Cedars-Sinai Heart Institute

10:00

Networking and Refreshment Break

10:30

Establish Compliance and Process Efficiencies Within IIS

Speaker TBD

11:15

PANEL DISCUSSION Best Practices for Providing Feedback on IISR Protocols

PANELISTS

Mike Marshall
Associate Director, Medical Research and Education
Horizon Pharma

Alyssa Truong
Research Grants Manager, Medical Affairs
Jazz Pharmaceuticals

Dana Sparks
Director of Operations and Protocols
SWOG

12:15

Networking Luncheon

1:15

CASE STUDYIMP Supply Chain — Ensure your IISR Doesn’t Have Any Missing Links

Sarah Henry
Associate Director, Investigator Sponsored Trials
Karyopharm Therapeutics Inc

2:00

Overall IISR Program Management — Day-to-Day Operations

Jennifer Gaskin
Director, Investigator Sponsored Trials
Karyopharm Therapeutics Inc.

2:45

Close of Conference

Agenda

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

DAY ONE WEDNESDAY, FEBRUARY 7, 2018

CHOOSE FROM TWO IN - CONFERENCE WORKSHOPS

7:30

Conference Registration and Continental Breakfast

8:30

Workshop Leaders’ Welcome and Opening Remarks

WORKSHOP A
Oncology — Navigate Cooperative Group Clinical Trial Agreements from Concept to Conception

WORKSHOP LEADERS

Meg Mooney, M.D., MBA
Chief, Clinical Investigations Branch, CTEP, DCTD
NCI

Nathan Eriksen
Chief Admin SWOG
Oregon Health & Science University

Theresa Bucher
Associate Director, Global Medical Affairs Research
Takeda

WORKSHOP B
Devices and Diagnostics — Leveraging IISRs to
Inform Clinical Development

WORKSHOP LEADER

Anton Ehrhardt
Vice President, Global Medical Affairs
Mitra Biotech

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

12:00

Networking Luncheon

1:00

Co-Chairs’ Welcome & Opening Remarks

Ashley Wills
Associate Director, Medical Affairs Research
TESARO

Roxanne Cacioppo, Ph.D.
Head, GMA Research, Global Medical Affairs
Takeda

Strategic Frameworks for Developing
Successful IISR Programs

1:15

Negotiating Reasonable IISAs and Sub-Site Agreements — A Site’s Perspective

Marlon Rajakaruna
Partner and Global Co-LeaderLife Sciences and Health Care Practice Groups
Dentons

2:00

Determining IISR Criteria for Approval and Review Teams

Anton Ehrhardt
Vice President, Global Medical Affairs
Mitra Biotech

2:45

Ensuring Global Processes Account for the Local Culture

Kelli Walker, Pharm.D., M.S.
Director, Platform Strategy
Envision Pharma Group

3:00

Networking and Refreshment Break

4:00

CHOOSE BETWEEN TWO LEARNING LABS (1-2)

1BEST PRACTICES IN CREATING A FOCUSED IISR PROGRAM THAT IS TIGHTLY ALIGNED WITH COMPANY STRATEGY

Gurveen Saberwal
Investigator Initiated Research Program Manager, Oncology and Immunology
Shire

2KEY QUESTIONS AND DIALOGUE ON CONTRACT AND BUDGET CHALLENGES IN GLOBAL IISR PROGRAMS

Terry Burton
Senior Manager, Clinical Contracts & Finance
Gilead Sciences

Dianne Archer
Corporate Counsel
Gilead Sciences

5:00

Close of Day One

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

DAY TWO THURSDAY, FEBRUARY 8, 2018

7:30

Continental Breakfast

8:00

Co-Chairs’ Review of Day One

Ashley Wills
Associate Director, Medical Affairs Research
TESARO

Roxanne Cacioppo, Ph.D.
Head, GMA Research, Global Medical Affairs
Takeda

8:15

GUIDED Q&A Demonstrating IISR Value to Your Organization

Ashley Wills
Associate Director, Medical Affairs Research
TESARO

Roxanne Cacioppo, Ph.D.
Head, GMA Research, Global Medical Affairs
Takeda

Overcoming Operational Hurdles

9:00

STAKEHOLDER SHOWCASE How to Become the Partner of Choice for Principal Investigators

STAKEHOLDERS

PHARMACEUTICAL
Kyle Jensen
Director, Medical and Scientific Affairs
Karyopharm Therapeutics Inc.

MEDICAL CENTER
Christy Gilchrist
Director of Cancer Research Institute
St. Vincent Hospital

ACADEMIC HEALTH ORGANIZATION
Joseph Cosico
Director, Clinical Research Operations
Cedars-Sinai Heart Institute

10:00

Networking and Refreshment Break

10:30

Establish Compliance and Process Efficiencies Within IIS

Speaker TBD

11:15

PANEL DISCUSSION Best Practices for Providing Feedback on IISR Protocols

PANELISTS

Mike Marshall
Associate Director, Medical Research and Education
Horizon Pharma

Alyssa Truong
Research Grants Manager, Medical Affairs
Jazz Pharmaceuticals

Dana Sparks
Director of Operations and Protocols
SWOG

12:15

Networking Luncheon

1:15

CASE STUDYIMP Supply Chain — Ensure your IISR Doesn’t Have Any Missing Links

Sarah Henry
Associate Director, Investigator Sponsored Trials
Karyopharm Therapeutics Inc

2:00

Overall IISR Program Management — Day-to-Day Operations

Jennifer Gaskin
Director, Investigator Sponsored Trials
Karyopharm Therapeutics Inc.

2:45

Close of Conference