Skip navigation
Agenda

Ensure Rapid, Efficient and Flexible Trial Operations

March 7-8, 2019
  • Boston, MA

Agenda

Want more agenda details? Download the brochure.

DAY ONE THURSDAY, MARCH 7, 2019

7:30

Registration and Continental Breakfast

8:30

Chairman’s Welcome and Opening Remarks

Frank Leu
CEO
Novapeutics

Start Your Partnership on the Right Foot —
Evaluate CROs and Create Comprehensive Contracts

8:45

Develop and Revise a Streamlined Strategy for CRO Governance and Incentives at Scale

Elspeth Carnan
VP Global Head, Service Provider Management
EMD Serono

Richard Butterworth
Senior Director Alliance Management, Service Provider Management
Merck KGaA

Jennifer Allen
Director, Sourcing Strategy and Operations
EMD Serono

9:30

Legal Considerations in First Time CRO Contracts —
Pitfalls, Risks and Protections

Masha Chestukhin
Associate Director, Compliance Officer R&D
Sanofi Genzyme

Kyle Faget
Special Counsel
Foley & Lardner LLP

10:15

Networking and Refreshment Break

10:45

Uncover Solutions and Strategies to Master Budgetary Challenges in
CRO Oversight and Monitoring

Michael McNamara
Director of Finance and Corporate Controller
Marinus Pharmaceuticals

Outsourced Service Optimization

11:30

Cross-Organizational TMF & CTMS Implementation for Streamlined Studies

Stephanie Viscomi
Associate Director, Clinical Trial Office
ImmunoGen

12:15

Networking Luncheon

1:30

Identify the Right CRO Partners for Your Organization and Key Projects

Frank Leu
CEO
Novapeutics

Optimize Clinical Partnerships to
Ensure Oversight and Productivity

2:15

ROUNDTABLE
Master Key Performance Indicators (KPIs) for Optimizing CRO and Sponsor Partnerships

Matthew Weinberg
Director, Procurement
Agios Pharmaceuticals

2:45

Early Phase Clinical Trials in the UK and Europe: A Cost-Effective Solution to Achieving Optimal Results

Peter MacLennan, PhD
Chief Operating Officer
Tailored Clinical Research Solutions Ltd

3:30

Networking and Refreshment Break

4:00

Scalable CRO Governance and Inspection Readiness

Geoff Garabedian
Founder and President
TriRadial Solutions

Leo Dodds
Partner
TriRadial Solutions

4:45

Master Regulatory Oversight for CRO Partnerships

Celeste Gonzalez
Principal Specialist, Clinical Quality Assurance
Boston Scientific

5:30

Chairman’s Day One Closing Remarks

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

DAY TWO FRIDAY, MARCH 8, 2019

7:30

Continental Breakfast

8:00

Chairman’s Review of Day One

Frank Leu
CEO
Novapeutics

CRO Management and Oversight

8:15

ROUNDTABLE
Establish Strong Project Management Principles for CRO Oversight

Frank Leu
CEO
Novapeutics

9:00

Determine the Proper Level of CRO Oversight Accountability Delegation vs. In-House Management

Ran Frenkel
Chief Development Operations Officer
Karyopharm Therapeutics

9:45

Networking and Refreshment Break

10:15

CASE STUDY
Lessons Learned — CRO Alignment in a Large Scale Rare Disease Study

Eliezer Katz
Senior Director, Clinical Development RIA
MedImmune/VielaBio

11:00

Streamline CRO Data Management and Reporting Oversight

Sharon Crugnale
Director, Clinical Operations
Kiniksa

11:45

Chairman’s Closing Remarks and Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE THURSDAY, MARCH 7, 2019

7:30

Registration and Continental Breakfast

8:30

Chairman’s Welcome and Opening Remarks

Frank Leu
CEO
Novapeutics

Start Your Partnership on the Right Foot —
Evaluate CROs and Create Comprehensive Contracts

8:45

Develop and Revise a Streamlined Strategy for CRO Governance and Incentives at Scale

Elspeth Carnan
VP Global Head, Service Provider Management
EMD Serono

Richard Butterworth
Senior Director Alliance Management, Service Provider Management
Merck KGaA

Jennifer Allen
Director, Sourcing Strategy and Operations
EMD Serono

9:30

Legal Considerations in First Time CRO Contracts —
Pitfalls, Risks and Protections

Masha Chestukhin
Associate Director, Compliance Officer R&D
Sanofi Genzyme

Kyle Faget
Special Counsel
Foley & Lardner LLP

10:15

Networking and Refreshment Break

10:45

Uncover Solutions and Strategies to Master Budgetary Challenges in
CRO Oversight and Monitoring

Michael McNamara
Director of Finance and Corporate Controller
Marinus Pharmaceuticals

Outsourced Service Optimization

11:30

Cross-Organizational TMF & CTMS Implementation for Streamlined Studies

Stephanie Viscomi
Associate Director, Clinical Trial Office
ImmunoGen

12:15

Networking Luncheon

1:30

Identify the Right CRO Partners for Your Organization and Key Projects

Frank Leu
CEO
Novapeutics

Optimize Clinical Partnerships to
Ensure Oversight and Productivity

2:15

ROUNDTABLE
Master Key Performance Indicators (KPIs) for Optimizing CRO and Sponsor Partnerships

Matthew Weinberg
Director, Procurement
Agios Pharmaceuticals

2:45

Early Phase Clinical Trials in the UK and Europe: A Cost-Effective Solution to Achieving Optimal Results

Peter MacLennan, PhD
Chief Operating Officer
Tailored Clinical Research Solutions Ltd

3:30

Networking and Refreshment Break

4:00

Scalable CRO Governance and Inspection Readiness

Geoff Garabedian
Founder and President
TriRadial Solutions

Leo Dodds
Partner
TriRadial Solutions

4:45

Master Regulatory Oversight for CRO Partnerships

Celeste Gonzalez
Principal Specialist, Clinical Quality Assurance
Boston Scientific

5:30

Chairman’s Day One Closing Remarks

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

DAY TWO FRIDAY, MARCH 8, 2019

7:30

Continental Breakfast

8:00

Chairman’s Review of Day One

Frank Leu
CEO
Novapeutics

CRO Management and Oversight

8:15

ROUNDTABLE
Establish Strong Project Management Principles for CRO Oversight

Frank Leu
CEO
Novapeutics

9:00

Determine the Proper Level of CRO Oversight Accountability Delegation vs. In-House Management

Ran Frenkel
Chief Development Operations Officer
Karyopharm Therapeutics

9:45

Networking and Refreshment Break

10:15

CASE STUDY
Lessons Learned — CRO Alignment in a Large Scale Rare Disease Study

Eliezer Katz
Senior Director, Clinical Development RIA
MedImmune/VielaBio

11:00

Streamline CRO Data Management and Reporting Oversight

Sharon Crugnale
Director, Clinical Operations
Kiniksa

11:45

Chairman’s Closing Remarks and Close of Conference