August 8-9, 2021
Online Livestream
Agreements
2nd Clinical TrialAgreements
Obtaining Successful Agreements Utilizing the Latest Strategies in the Negotiating Process
Days
Hours
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With clinical trial agreements setting the stage for the first step in the research process, identifying the risks and challenges within them prior to their signing remains crucial. These binding agreements are essential in protecting the data gathered throughout the trial while limiting potential risks. DGE’s 2nd Clinical Trials Agreements Conference offers a industry leading faculty ready to offer strategies best practices that will guide you throughout the negotiating process towards successful results.
Top Reasons to Attend
  • Hear the perspectives of sites, sponsors and CROs when negotiating these agreements
  • Implement methods for limiting company risk related to indeminification and subject injury
  • Compare and contrast domestic and international agreements
  • Network with industry leaders to discuss alternative methods in developing clinical trial agreements
Agenda at a Glance

Topics covered will include:

  • Data Privacy and Intellectual Property Challenges
  • The role of CROs in the contracting process
  • In-depth look at the negotiations between sites and sponsors
  • Telemedicine and its role in remote trial agreements
  • Patient recrutiement and non-disclosure agreements
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
Conference
New Topics
Featured Speakers
Alice Um Kope
ATARA BIOTHERAPEUTICS
Assistant General Counsel, Corporate Transactions
Donald Louis Joseph Campodonico
STANFORD UNIVERSITY SCHOOL OF MEDICINE
Clinical Trials Contracts Officer I
Jamie Valentine
UNIVERSITY OF FLORIDA, OFFICE OF CLINICAL RESEARCH
Research Contracting Officer I
Jason Cline
UNIVERSITY OF FLORIDA, OFFICE OF CLINICAL RESEARCH
Research Contracting Officer III
Kyle Faget
Foley & Lardner, LLP
Special Counsel
Linda Reig
BUCHANAN INGERSOLL & ROONEY PC
Partner
Nicholas Zepnick
Foley & Lardner LLP
Senior Counsel
Piotr Sławik
GILEAD SCIENCES
Senior Manager, Clinical Legal Advisor
Sarina Rivera
GENENTECH
Assistant General Counsel
Sonia Kissi
INTERCEPT PHARMACEUTICALS
Senior Director, Clinical Contracts and Outsourcing
Tal Bar-El
TEVA PHARMACEUTICALS
Legal Counsel
Tammie Bain
EMORY UNIVERSITY
Assistant Director, Industry Contracting
Event Schedule
     

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

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

COVID-19 still remains the focus on all clinical trial professionals. With the approval of a couple of vaccines (and more to come) and hospital staff being first to be vaccinated, hope of the impact of COVID-19 being reduced to happen soon is on the horizon. But prior to COVID-19 no longer being an issue on clinical studies, what considerations were given to the contracts?

  • Look at the impact of the guidance issued by the FDA in relation to COVID-19

  • Evaluate how the terms of an agreement and study procedures have changed to allow for impact of COVID-19 on clinical studies

  • Confront how has the COVID-19 pandemic has changed clinical trial agreements

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

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

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
     

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

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

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
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Event Sponsors
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15
Speakers
21
Days
251
Participants
125
Workshops
90
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