DGE’s First Annual Clinical Trial Agreements Forum

Negotiating Budgetary Restraints, Protecting IP and Clinical Data and Avoiding Indemnification while Preparing for New Methods of Testing

January 25-26, 2021

Online Livestream

What To Expect

A Clinical Trial Agreement determines the contractual relationship between sponsors and investigators and governs the administrative/ legal terms under which a clinical trial will be conducted. In certain cases, a sponsor may enter a contract with a contract research organization (CRO), and the CRO will have agreements with various investigators to conduct the clinical trials. The program offers an in-depth look at the common issues which arise during the negotiations of these agreements.

Hilton East Brunswick

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3 Tower Center Blvd.
East Brunswick, NJ 08816

(732) 828-2000

Hotel Website

About the Chairperson

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Dr. Matthew T. Roe has been a faculty member at Duke University School of Medine and the Duke Clinical Research Institute (DCRI) since 1999. As a senior investigator at the DCRI, he has been the principal investigator for numerous phase II-IV cardiovascular clinical trials and is currently a co-principal investigator for the ADAPTABLE trial—the first large-scale pragmatic trials being conducted in the PCORnet network. He has also served in leadership roles for several observational registries focusing upon the treatment and outcomes of patients with cardiovascular disease and has served as the Director of the DCRI Clinical Research Fellowship since 2010.

Featured Speakers

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Craig Lipset

Head of Clinical Innovation
Pfizer

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Jeff Kingsley

Chief Executive Officer
IACT Health 

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Dawn Anderson

Managing Director, Life Sciences Strategy and Operations, R&D Practice
Deloitte

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Ross Friedberg

General Counsel & Chief Privacy Officer
Doctor on Demand

Why Attend?

  • A look at the latest updates on Clinical Trial Agreements during the COVID-19 pandemic
  • Site perspective on the latest challenges they face when agreeing to clinical trial contracts
  • A look at risk involved surrounding indemnification and patient injury
  • The growing use of telemedicine as a part of these agreements
  • The use of third-party investigators in clinical trial agreements and the obligations they hold

Who Should Attend?

Professionals of Pharmaceutical, Biologics, and Medial Device companies working in the areas of:

  • Clinical Operations
  • Clinical Development and Analytics
  • Associate General Counsel
  • Contract Managers
  • Regulatory Officer
  • Clinical Research and Development
  • Compliance Officer
  • Global Site Agreements
  • Clinical Data
  • Site Development
  • Clinical Innovation
  • Business Development
  • Clinical Trial Manager
  • Project Leads
  • Program Manager
  • Supply Manager
  • Medical Affairs
  • Medical Operations/Documentation
  • Global Analytics
  • Internal Clinics
  • Clinical Project Manager
  • Medical Director
  • Quality and Compliance
  • Clinical Pharmacology
  • Ethics

This Event is also of Interest to:

  • Law Firms
  • Patient Recruitment Specialists
  • Data Security, Analytics and Reporting Companies

Monday

January 25th, 2020 | Day 1

8:00 AM - 9:00 AM

Login

9:00 AM - 9:15 AM

Chairperson’s Opening Remarks

9:15 AM - 10:00 AM

Utilize Clear and Concise Language and Limitations within a Contract

One of the most important things in developing a clinical trial agreement remains the language found within the contract. Even the smallest mistake can open the door to a huge amount of risk to a site or a sponsor. This session provides an in-depth look at the framework for these contracts.

  • Explore the language regularly seen within the contracts
  • Avoid limiting terms within the agreement
  • Differentiate the preferred terminology between sites and sponsors

10:00 AM - 10:45 AM

Negotiate a Budget to Meet the Needs of the Clinical Trials

Sonia Kissi - Senior Director, Clinical Contracts and Outsourcing 
INTERCEPT PHARMACEUTICALS

Budget may be one of the first things discussed during clinical trial negotiations. Agreements must specify budgetary guidelines within the total amount allotted to the trial, as well as how this money will be dispersed.  

  • Ensure the budget for the testing falls with Fair Market Value (FMV) 
  • Set the terms for the release of funding to the site
  • Amend the contract for an expanded budget and why this may be needed
  • Understand the relation of a trial’s budget to the review of case report forms

10:45 AM - 11:00 AM

Networking Break

11:00 AM - 11:45 AM

Prepare Agreements During the Pandemic

Christopher Mikson (Invited) - Partner
DLA PIPER LLP

COVID-19 still remains the focus on all clinical trial professionals. With many of the trials reaching stages 3 and 4, we are hopeful for vaccine sooner or later. But prior to these trials commencing, what considerations were given to the contracts?

  • Incorporate the guidance issued by the FDA in relation to COVID-19
  • Evaluate how the terms of an agreement changed to allow for expedited testing of the drug
  • Confront how has the COVID-19 pandemic has changed clinical trial agreements 

11:45 AM - 12:30 PM

Negotiate for the Use of Biospecimens Outside of the Trial

Christy Gilchrist (Invited) - Medical Science Liaison
IPSEN PHARMACEUTICALS

When one clinical trial concludes, another begins. There can be occasions in which biospecimens remain from a previous trial that are a fit for the next. Prior to their use, sponsors must include the proper language in multiple agreements with participants to avoid any type of fiscal penalties. This session explores what must be agreed upon prior to additional uses of these biospecimens. 

  • Review HIPAA privacy rules surrounding biospecimens
  • Fold biospecimen rights into informed consent documentation 
  • Center the confidentiality of identifiable protected health information

Christy Gilchrist - Medical Science Liaison
Ipsen Pharmaceuticals (INVITED)

12:30 PM - 1:00 PM

Luncheon

1:00 PM - 1:45 PM

Protect Intellectual Property Rights in Clinical Trial Agreements

Secrecy remains the top priority of pharmaceutical and biologics manufacturers when contracting with sites. Incorporating clauses within clinical trial agreements to protect a sponsor’s right remains crucial to control shared information.  

  • Assess the site’s participation in drafting the protocol in the clinical trial agreement
  • Scrutinize U.S. patent law to ensure the sponsor retains ownership of the IP
  • Prepare for the full gamut of associated time limits and costs

1:45 PM - 2:30 PM

Prioritize Data Confidentiality in Clinical Trial Agreements

With clinical trial agreements holding stringent confidentially terms between sites and sponsors, it is important to understand the rights of each.  You can improve confidence on trial results by making certain the contract features firm clauses protecting a sponsor’s IP.  

  • Incorporate confidential disclosure agreements into the overall agreements
  • Distinguish between Investigator Initiated Trial vs. Sponsor-Authored Trial
  • Define terms surrounding electronic medical records
  • Emphasize a site’s right to publish findings 
     

Tuesday

January 26th, 2020 | Day 2

8:00 AM - 9:00 AM

Login

9:00 AM - 9:15 AM

Chairperson’s Recap of Day One

9:15 AM - 10:00 AM

Reach Contractual Agreements when Working with CROs

Tal Bar-El - Legal Counsel
TEVA PHARMACEUTICALS

Negotiating directly with a sponsor is quite different from having a CRO negotiate on the sponsor’s behalf.  While they are third-party organizations, their representation of the sponsor can have a large effect on all other parties involved. 

  • Incorporate terminology to protect the trade secrets of the sponsor into the contract
  • Understand the sponsor’s definition of “poor performance” by the CRO, and the effect this holds on the contract
  • Determine protections are offered to the sponsor when they are represented by a CRO

Tal Bar-El - Legal Counsel
Teva Pharmaceuticals

10:00 AM - 10:45 AM

A Site’s Perspective on a Clinical Trial Agreement

Jason Cline - Research Contracting Officer II
UNIVERSITY OF FLORIDA, OFFICE OF CLINICAL RESEARCH

Jamie Valentine - Research Contracting Officer I
UNIVERSITY OF FLORIDA, OFFICE OF CLINICAL RESEARCH

10:45 AM - 11:00 AM

Networking Break

11:00 AM - 11:45 AM

Map Indemnification Risks for Sites and Sponsors

Indemnification remains a huge issue in the world of clinical trial agreements. With both the constant development of new pharmaceutical and biologics, as well as methods of testing ever expanding, ensuring that the proper protections are in place is critical.

  • Compare and contrast negligence between sites and sponsors
  • Analyzing the “carve-outs” built into indemnification clauses within CTAs
  • Track increased indemnification requests from vendors

11:45 AM - 12:30 PM

Highlight Clauses in CTAs Surrounding Subject Injury

Donald Louis Joseph CampodonicoClinical Trials Contracts Officer One
STANFORD UNIVERSITY SCHOOL OF MEDICINE 

Nothing is a bigger risk in the clinical trial space than subject injury. Should participant face any sort of harm, both the site and sponsor can be held responsible. Ensuring that the proper protections are placed in the contract are what protects you from potentially facing huge financial penalties. 

  • Prepare the necessary informed consent documentation
  • Outline the institution’s role to offer an acceptable standard of care
  • Incorporate clauses for compensation within the contract

Donald Louis Joseph Campodonico - Clinical Trials Contracts Officer One
Stanford University School of Medicine

12:30 PM - 1:00 PM

Luncheon

1:00 PM - 1:45 PM

Grasp Telemedicine as the Wave of the Future

Linda Reig (Invited) - Partner
BUCHANAN INGERSOLL & ROONEY PC

Currently, no type of testing is being used more than telemedicine. While COVID-19 has slowed a lot of research, technology allows these essential tests to continue. However, regulations have changed surround clinical trials in this form and it is crucial that your agreements meet the regulations which have been put into place.  

  • Analyze the state regulations surrounding virtual Clinical Trial Agreements 
  • Alter a CTA to transition to telemedicine
  • Evaluate the use of virtual clinical trials during the COVID-19 outbreak
  • Guide sites to conduct the proper testing virtually

Linda Reig - Partner
Buchanan Ingersoll & Rooney PC

1:45 PM - 2:30 PM

Dissect Negotiations Between Sites and Sponsors

Tammie Bain - Assistant Director, Industry Contracting
EMORY UNIVERSITY

FEATURED SPEAKERS

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Sonia Kissi

INTERCEPT PHARMACEUTICALS

Senior Director, Clinical Contracts and Outsourcing

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Christopher Mikson (Invited)

DLA PIPER LLP

Partner

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Tal Bar-El

MEDTRONIC

Manager, Human Factors Engineering, Surgical Robotics

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Christy Gilchrist (Invited)

IPSEN PHARMACEUTICALS

Medical Science Liaison

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Jason Cline

UNIVERSITY OF FLORIDA, OFFICE OF CLINICAL RESEARCH

Research Contracting Officer II

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Jamie Valentine

UNIVERSITY OF FLORIDA, OFFICE OF CLINICAL RESEARCH

Research Contracting Officer I

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Donald Louis Joseph Campodonico

STANFORD UNIVERSITY SCHOOL OF MEDICINE

Clinical Trials Contracts Officer One

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Linda Reig (Invited)

BUCHANAN INGERSOLL & ROONEY PC

Partner

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Tammie Bain

EMORY UNIVERSITY

Assistant Director, Industry Contracting

CONFERENCE REGISTRATION

LIVESTREAM PRICING

SUPER EARLY BIRD

$696


Before 11/6/20

EARLY BIRD

$796


Before 12/14/20

STANDARD

$896


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SPONSORED BY

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OFFICIAL LIVESTREAM PROVIDER

MEDIA PARTNERS

PM360 - Media Partner

PREMIER MEDIA PARTNER


SPONSOR THIS EVENT

Are you a vendor, consultancy or solutions provider? Our attendees want to hear what you have to offer their organization. We can customize sponsorship packages tailored to your marketing needs. Whether you’re interested in sponsoring our networking reception, meals or breaks, or simply would like to host an exhibit booth at this event, please contact Amy Chapman at (561) 571-7687achapman@dgeconfs.com