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DAY ONE TUESDAY, DECEMBER 5, 2017

7:00

Conference Registration and Continental Breakfast

8:00

Conference Chairman’s Welcome and Opening Remarks

Suzan Levin
Assistant General Counsel
Pfizer Inc

8:15

Animal, Vegetable or Mineral — What Exactly Is a Clinical Research Collaboration?

Suzan Levin
Assistant General Counsel
Pfizer Inc

Explore Regulations and Implications for Compliance in Clinical Agreements

9:00

Human Subject Research — How to Ensure Compliance

Bruce Frederick Howell, JD, MS
Schwabe Williamson & Wyatt

9:40

Informed Consent — Considerations for Alleviating Risk in Trial Agreements

Kyle Faget
Special Counsel
Foley & Lardner LLP

10:10

Networking and Refreshment Break

10:40

Investigator Sponsored Research — What You Need to Know

Kyle Faget
Special Counsel
Foley & Lardner LLP

Masha Chestukhin
Associate Director, Compliance Officer, R&D, IA, FMV
Sanofi

Guidance on Legal Contracting Issues to
Effectively Manage IP, Liability and Personal Data

11:20

Ensure a Reasonable Allocation of Risk and Liabilities in Contracts

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

12:30

Networking Luncheon

1:30

How to Effectively Contract with Vendors without Slowing Down the Trial

Sue Vestri
Chief Financial Officer
Greenphire

Rob Roshkoff
Corporate Counsel
Greenphire

2:15

Data Policy and the Protection of Research Participant Data —
Legal and Ethical Considerations

Linda Coleman
Director, Human Research Protection Program
Yale University

2:55

How to Mitigate the Risk of Fraud and Abuse in Clinical Trials

Jeffrey Antoon
Director, Internal Audit
Johnson & Johnson

Aditya Misra
Senior Manager, Corporate Internal Audit
Johnson & Johnson

3:35

Networking and Refreshment Break

4:05

Overcome Common Publication and Intellectual Property Challenges

Matthew Rogers
Associate Director, Project Management Clinical Operations
Merck & Co.

4:45

FACULTY THINK TANK Create the Framework for Your Trial Agreements

During this session, attendees and speakers identify concrete best practices and actionable take-aways for developing comprehensive trial agreements. Faculty members begin this session by sharing some of their tips and answering questions from attendees that were submitted prior to the conference. Live Q&A and real-time problem-solving follow up.

Suzan Levin
Assistant General Counsel
Pfizer Inc

5:15

Close of Day One

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

DAY TWO WEDNESDAY, DECEMBER 6, 2017

8:00

Continental Breakfast

8:30

Conference Chairman’s Review of Day One

Suzan Levin
Assistant General Counsel
Pfizer Inc

Streamline Contract Negotiations to
Expedite Clinical Trials

8:45

Remote Clinical Trials and Monitoring Contracting Best Practices

Penny S. Smith, Esq.
Founding Partner
Life Science Law Group, LLC

Peter Sullivan, CIC
Principal
Sullivan Group-Insurance & Risk Management

9:30

Streamline Your Contracting —
The CLEAR Initiative and Related Common Language Approaches

FACILITATOR:

Suzan Levin
Assistant General Counsel
Pfizer Inc

10:00

Networking and Refreshment Break

10:30

Strategies for Negotiating with Sponsors to Speed Up Site Activation

Karen Lodigani
Director, Site Contracts and ICR
Biogen

11:15

Subject Injury — Protecting Sponsors, Sites and Subjects Through Consistency, Clarity and Carrier Coverage Compliance

Stephen J. Smith
Assistant General Counsel
Sanofi

12:00

Close of Conference

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, DECEMBER 5, 2017

7:00

Conference Registration and Continental Breakfast

8:00

Conference Chairman’s Welcome and Opening Remarks

Suzan Levin
Assistant General Counsel
Pfizer Inc

8:15

Animal, Vegetable or Mineral — What Exactly Is a Clinical Research Collaboration?

Suzan Levin
Assistant General Counsel
Pfizer Inc

Explore Regulations and Implications for Compliance in Clinical Agreements

9:00

Human Subject Research — How to Ensure Compliance

Bruce Frederick Howell, JD, MS
Schwabe Williamson & Wyatt

9:40

Informed Consent — Considerations for Alleviating Risk in Trial Agreements

Kyle Faget
Special Counsel
Foley & Lardner LLP

10:10

Networking and Refreshment Break

10:40

Investigator Sponsored Research — What You Need to Know

Kyle Faget
Special Counsel
Foley & Lardner LLP

Masha Chestukhin
Associate Director, Compliance Officer, R&D, IA, FMV
Sanofi

Guidance on Legal Contracting Issues to
Effectively Manage IP, Liability and Personal Data

11:20

Ensure a Reasonable Allocation of Risk and Liabilities in Contracts

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

12:30

Networking Luncheon

1:30

How to Effectively Contract with Vendors without Slowing Down the Trial

Sue Vestri
Chief Financial Officer
Greenphire

Rob Roshkoff
Corporate Counsel
Greenphire

2:15

Data Policy and the Protection of Research Participant Data —
Legal and Ethical Considerations

Linda Coleman
Director, Human Research Protection Program
Yale University

2:55

How to Mitigate the Risk of Fraud and Abuse in Clinical Trials

Jeffrey Antoon
Director, Internal Audit
Johnson & Johnson

Aditya Misra
Senior Manager, Corporate Internal Audit
Johnson & Johnson

3:35

Networking and Refreshment Break

4:05

Overcome Common Publication and Intellectual Property Challenges

Matthew Rogers
Associate Director, Project Management Clinical Operations
Merck & Co.

4:45

FACULTY THINK TANK Create the Framework for Your Trial Agreements

During this session, attendees and speakers identify concrete best practices and actionable take-aways for developing comprehensive trial agreements. Faculty members begin this session by sharing some of their tips and answering questions from attendees that were submitted prior to the conference. Live Q&A and real-time problem-solving follow up.

Suzan Levin
Assistant General Counsel
Pfizer Inc

5:15

Close of Day One

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

DAY TWO WEDNESDAY, DECEMBER 6, 2017

8:00

Continental Breakfast

8:30

Conference Chairman’s Review of Day One

Suzan Levin
Assistant General Counsel
Pfizer Inc

Streamline Contract Negotiations to
Expedite Clinical Trials

8:45

Remote Clinical Trials and Monitoring Contracting Best Practices

Penny S. Smith, Esq.
Founding Partner
Life Science Law Group, LLC

Peter Sullivan, CIC
Principal
Sullivan Group-Insurance & Risk Management

9:30

Streamline Your Contracting —
The CLEAR Initiative and Related Common Language Approaches

FACILITATOR:

Suzan Levin
Assistant General Counsel
Pfizer Inc

10:00

Networking and Refreshment Break

10:30

Strategies for Negotiating with Sponsors to Speed Up Site Activation

Karen Lodigani
Director, Site Contracts and ICR
Biogen

11:15

Subject Injury — Protecting Sponsors, Sites and Subjects Through Consistency, Clarity and Carrier Coverage Compliance

Stephen J. Smith
Assistant General Counsel
Sanofi

12:00

Close of Conference